FORMULARI UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA

MINISTRY OF HEALTH MALAYSIA DRUG FORMULARY

BAHAGIAN PERKHIDMATAN FARMASI KEMENTERIAN KESIHATAN MALAYSIA BEG BERKUNCI NO. 924 PEJABAT POS JALAN SULTAN 46790 PETALING JAYA, SELANGOR.

EDISI KE EMPAT Disember 2004 (sehingga Pekeliling Senarai Ubat KKM Disember 2004) Semua Hak Terpelihara
Senarai ini adalah untuk kegunaan Kementerian Kesihatan Malaysia sahaja. Sebarang bahagian dalam buku ini tidak boleh diterbitkan semula atau dipetik untuk diterbitkan dalam mana-mana penerbitan, disimpan dalam cara yang boleh dipergunakan lagi atau pun dipindahkan dalam sebarang bentuk atau dengan sebarang cara, baik dengan elektronik, mekanikal, penggambaran semula, perakaman, diedarkan kepada badan-badan atau orang perseorangan atau lain-lain sebelum mendapat kebenaran bertulis dari Ketua Pengarah Kesihatan.

FOURTH EDITION December 2004

(until Drug list Circular December 2004)

All Rights Reserved

No part of this publication may be reproduced, stored or transmitted in any form or by any means whether electronic, mechanical, photocopying, tape recording or others without written permission from the Director General of Health.

TABLE OF CONTENTS
PENDAHULUAN SENARAI SINGKATAN YANG DIGUNAKAN INTRODUCTION ABBREVIATIONS USED iv vii viii xi

A A01 A02 A03 A04 A05 A06 A07 A09 A10 A11 A12 A14 B B01 B02 B03 B05 C C01 C02 C03 C04 C05 C07 C08 C09 C10 D D01 D02 D03 D04

ALIMENTARY TRACT AND METABOLISM STOMATOLOGICAL PREPARATIONS DRUGS FOR ACID RELATED DISORDERS DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS ANTIEMETICS AND ANTINAUSEANTS BILE AND LIVER THERAPY LAXATIVES ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS DIGESTIVES, INCL. ENZYMES DRUGS USED IN DIABETES VITAMINS MINERAL SUPPLEMENTS ANABOLIC AGENTS FOR SYSTEMIC USE BLOOD AND BLOOD FORMING ORGANS ANTITHROMBOTIC AGENTS ANTIHEMORRHAGICS ANTIANEMIC PREPARATIONS BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS CARDIOVASCULAR SYSTEM CARDIAC THERAPY ANTIHYPERTENSIVES DIURETICS PERIPHERAL VASODILATORS VASOPROTECTIVES BETA BLOCKING AGENTS CALCIUM CHANNEL BLOCKERS AGENTS ACTING ON THE RENIN -ANGIOTENSIN SYSTEM SERUM LIPID REDUCING AGENTS DERMATOLOGICALS ANTIFUNGALS FOR DERMATOLOGICAL USE EMOLLIENTS AND PROTECTIVES PREPARATIONS FOR TREATMENT OF WOUNDS AND ULCERS ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.

1 1 12 17 19 21 25 30 31 36 48 51 52 59 64 68 90 102 105 110 111 114 119 124 129 133 140 143 144

D05 D06 D07 D08 D09 D10 D11 G G01 G02 G03 G04 H H01 H02 H03 H04 H05 J J01 J02 J04 J05 J06 J07 L L01 L02 L03 L04 M M01 M02 M03 M04 M05 M09

ANTIPSORIATICS ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS ANTISEPTICS AND DISINFECTANTS MEDICATED DRESSINGS ANTI-ACNE PREPARATIONS OTHER DERMATOLOGICAL PREPARATIONS GENITO URINARY SYSTEM AND SEX HORMONES GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS OTHER GYNECOLOGICALS SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM UROLOGICALS SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES CORTICOSTEROIDS FOR SYSTEMIC USE THYROID THERAPY PANCREATIC HORMONES CALCIUM HOMEOSTASIS ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE ANTIMYCOBACTERIALS ANTIVIRALS FOR SYSTEMIC USE IMMUNE SERA AND IMMUNOGLOBULINS VACCINES ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS ENDOCRINE THERAPY IMMUNOSTIMULANTS IMMUNOSUPPRESSIVE AGENTS MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN MUSCLE RELAXANTS ANTIGOUT PREPARATIONS DRUGS FOR TREATMENT OF BONE DISEASES OTHER DRUGS FOR DISORDERS OF THE MUSCULOSKELETAL SYSTEM

145 152 155 161 167 168 170 171 174 183 199

202 207 213 215 215 216 260 265 269 283 287 294 321 326 331 340 348 350 355 355 357

ii

N N01 N02 N03 N04 N05 N06 N07 P P01 P02 P03 R R01 R02 R03 R05 R06 R07 S S01 S02 S03 V V03 V04 V07 V08 V09 V10

NERVOUS SYSTEM ANESTHETICS ANALGESICS ANTIEPILEPTICS ANTI-PARKINSON DRUGS PSYCHOLEPTICS PSYCHOANALEPTICS OTHER NERVOUS SYSTEM DRUGS ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS ANTIPROTOZOALS ANTHELMINTICS ECTOPARASITICIDES, INCL. SCABICIDES, INSECTICIDES AND REPELLENTS RESPIRATORY SYSTEM NASAL PREPARATIONS THROAT PREPARATIONS DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES COUGH AND COLD PREPARATIONS ANTIHISTAMINES FOR SYSTEMIC USE OTHER RESPIRATORY SYSTEM PRODUCTS SENSORY ORGANS OPHTHALMOLOGICALS OTOLOGICALS OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS VARIOUS ALL OTHER THERAPEUTIC PRODUCTS DIAGNOSTIC AGENTS ALL OTHER NON -THERAPEUTIC PRODUCTS CONTRAST MEDIA DIAGNOSTIC RADIOPHARMACEUTICALS THERAPEUTIC RADIOPHARMACEUTICALS

358 369 381 393 400 423 433

437 440 442

445 451 452 469 471 476 477 498 502

504 511 513 516 522 524 527 542 550 553 559 568

Index -Generic name Index -Trade name Proforma A Proforma B Proforma D KPK Approval Form (KPK02)

iii

PENDAHULUAN 1. Formulari Ubat-ubatan Kementerian Kesihatan Malaysia mengandungi senarai ubat-ubatan yang diluluskan untuk digunakan di hospital/institusi Kementerian Kesihatan, tertakluk kepada syarat-syarat tertentu, jika ada. Ia diwujudkan sebagai alat perancangan dan pengawalan penggunaan ubat-ubatan di Kementerian Kesihatan dengan objektif pengurangan pembaziran, penggunaan optima peruntukan kewangan serta penggalak penggunaan ubatubatan secara rasional. 2. Ubat -ubat dalam formulari ini telah dikelaskan mengikut sistem ATC (Anatonical Therapeutic Chemical) dari WHO. Ubat-ubat dibahagikan kepada kumpulan yang berlainan mengikut organ atau sistem di mana ubat berkenaan bertindak dan sifat kimia, farmakologi dan terapeutik. Ubat dikelaskan mengikut kegunaan terapeutik utama bahan aktifnya dan hanya satu kod ATC diberi untuk setiap formulasi farmaseutikal. 3. Malaysian Drug Code (MDC) diberi kepada setiap ubat yang terdapat dalam formulari untuk identifikasi. Ia terbentuk dari kod ATC (7 digit), kod base/garam (3 digit), kod bentuk dosej (3 digit), kekuatan ubat (2 digit) serta nama dagangan (2 digit) yang ketika ini ditandakan sebagai XX dalam formulari ini. 4. Ubat -ubat dalam formulari ini disenaraikan mengikut nama generik. Nama perdagangan diberi hanya sebagai contoh. Ubat-ubat yang terdapat dalam Senarai Ubat Penting Kebangsaan ditandakan sebagai NEDL. Ubat yang diperolehi dari Syarikat konsesi ditandakan sebagai APPL. 5. Formulari ini juga menunjukkan kategori kakitangan yang dibenarkan mempreskripsi/memulakan ubat tersebut serta sebarang had kegunaannya, jika ada. Pegawaipegawai yang berkuasa untuk mempreskrib adalah dinyatakan mengikut kategori dibawah. Konsultan atau pakar pergigian dan pegawai pergigian turut dimasukkan didalam golongan ini tetapi untuk ubat -ubat yang digunakan dalam rawatan pergigian sahaja.

iv

A* A A/KK B C C+

= Konsultan/Pakar untuk indikasi yang spesifik

sahaja.

= Konsultan/Pakar = Konsultan/Pakar /Pakar Kesihatan Keluarga = Pegawai Perubatan = Kakitangan Paramedik = Kakitangan Paramedik dalam perbidanan

6. Panel Kajisemula Senarai Ubat -ubatan Kementerian Kesihatan di anggotai oleh Pakar-pakar Perunding Kanan dan Pegawai-pegawai Farmasi Kementerian Kesihatan yang dilantik oleh Ketua Pengarah Kesihatan. Panel ini ditubuhkan untuk mengkaji semula dan mengemaskini senarai ubat-ubatan Kementerian Kesihatan Malaysia dari masa ke semasa dengan dibantu oleh 16 Jawatankuasa Kerja Ubat-ubatan dari berbagai disiplin kepakaran. Ini bertujuan untuk mewujudkan satu senarai ubat yang komprehensif, evidence-based dan dinamik untuk diagnosa, pencegahan dan rawatan pesakit-pesakit yang mendapatkan perkhidmatan di Kementerian Kesihatan Malaysia. 7. Panel Kajisemula Ubat-ubatan Kementerian Kesihatan bermesyuarat dua hingga tiga kali setiap tahun untuk menimbang cadangan-cadangan yang diterima dari Jawatankuasa-jawatankuasa Ubat-ubatan Negeri/Institusi. Cadangan-cadangan hendaklah dibuat mengikut proformaproforma berikut yang disediakan: Proforma A - Cadangan untuk memansuhkan ubat / bentuk dosej/kekuatan dalam senarai semasa. Cadangan untuk menambah atau meminda formulasi/bentuk dosej/kategori/dos/indikasi Cadangan untuk memasukkan ubat baru ke dalam Senarai.
v

Proforma B

Proforma D

8. Semua cadangan Jawatankuasa Ubat-ubatan Negeri/Institusi untuk pertimbangan Panel dikehendaki sampai tidak lewat daripada 1hb. Mac, 1hb. Julai dan 1hb. November setiap tahun kepada: Pengarah Perkhidmatan Farmasi Bahagian Perkhidmatan Farmasi Kementerian Kesihatan Malaysia Beg Berkunci No. 924 Pejabat Pos Jalan Sultan 46790 Petaling Jaya. 9. Kelulusan untuk memperolehi dan menggunakan ubat diluar dari senarai ubat yang terdapat dalam formulari ubat Kementerian Kesihatan Malaysia perlu diperolehi daripada Ketua Pengarah Kesihatan. Permohonan dihantar kepada urusetia diBahagian Perkhidmatan Farmasi yang akan memproses permohonan berdasarkan kriteria yang telah ditetapkan oleh Panel Kajisemula Ubat-ubatan Kementerian Kesihatan sebelum dimajukan kepada Ketua Pengarah Kesihatan Malaysia.

Ketua Pengarah Kesihatan Kementerian Kesihatan Malaysia.

vi

SENARAI SINGKATAN YANG DIGUNAKAN: bd tds/tid qid eod om on prn d/dly Twice a day Three times a day Four times a day Every other day In the morning At night When necessary Day/daily mcg mg G/g kg sec min max IU Microgram Milligram Gram Kilogram Second Minutes Maximum International Units Million International Units Subcutaneous injections Intramuscular injections Intravenous injection Intra-articular injection Eye drops gram negative National Essential Drug List

hr/hrly

Hour/hourly

MIU

wk/wkly yr mth/mthly ml occ gram+ve

Week/weekly years Month/monthly Milliliter Eye ointment gram positive Approved Purchase Price List

S.C. I.M. I.V. I.A. gutt

gram-ve -

APPL

NEDL

vii

INTRODUCTION 1. Ministry of Health Drug Formulary contains a list of drugs approved for use in all hospitals/Institutions in the Ministry of Health. The Formulary is to promote rational, cost-effective use of drugs whereby newer and effective drugs were introduced in a controlled manner so as to minimize wastages and funds set aside for the purchase of drugs are optimally used. 2. Drugs in this formulary are classified according to WHO ATC (Anatomical Therapeutic Chemical) classification system. Drugs are divided into different groups according to organ or system on which they act and their chemical, pharmacological and therapeutic properties. The drugs are classified according to the main therapeutic use of the main active ingredients, on the basic principle of only one ATC code for each pharmaceutical formulation. 3. Malaysian Drug Code (MDC) is assigned to each particular drug in the formulary for identification. It is made up of ATC code (7 digit), base/salt code (3 digit), dosage form code (3 digit), concentration code (2 digit) and brand code (2 digit) which is currently designated as XX in this formulary. 4. The drugs in the formulary are listed according to generic names. The brand name is only given as an example. Those drugs currently listed in the National Essential Drug List are marked as NEDL. Drugs which are procured from the concession company are marked as APPL. 5. This formulary also indicates the category of prescriber authorized to initiate the prescription for the drug. Dental Consultant, Dental specialist and Dental Officers are also included in this category but only for the drugs used in dental treatment.

viii

A* A A/KK B C C+

= Consultant/ Specialists for specific Indications

only.

= Consultant/ Specialists = Consultant/ Specialists/ Family Physician

Specialists

= Medical Officers = Paramedical staff = Paramedical Staff doing midwifery

6. The Ministry of Health Drug List Review Panel which is made up of Senior Consultants and pharmacists in the Ministry of Health, will review and update the drug listed in the formulary from time to time. The Panel is assisted by 16 Drug Working Committee from various specialized disciplines. This is to ensure a comprehensive, evidence based and dynamic list of drugs available for diagnosis, prevention and treatment of patients in the Ministry of Health. 7. The Ministry of Health Drug List Review Panel will meet two to three times per year to consider proposals received from State/Institution drug committees. Proposals should be made in the proforma as laid down together with this formulary. Proforma A - Proposal to delete any of the drug/ dosage form/ formulation in the Ministry of Health Drug Formulary. - Proposal to alter/ add formulation/ dosage form/ category of the prescriber/ indication in the Ministry of Health Drug Formulary. - Proposal to introduce new drugs into the Ministry of Health Drug Formulary.
ix

Proforma B

Proforma D

8. All recommendations from the states/Institutions drug committees for consideration by the Panel should be send and reach the Secretariat at the following address not st st st later than 1 March, 1 . July and 1 . November every year. DIRECTOR PHARMACEUTICAL SERVICES DIVISION MINISTRY OF HEALTH LOCKED BAG NO. 924 POST OFFICE JALAN SULTAN 46790 PETALING JAYA SELANGOR. 9. Approval for procurement and use of drugs outside the Ministry Of Health Drug Formulary must be from the Director General of Health. The secretariat at the Pharmaceutical Services Division will process the request based on the criteria set by the Ministry Of Health Drug List Review Panel.

DIRECTOR GENERAL OF HEALTH MINISTRY OF HEALTH MALAYSIA

ABBREVIATIONS USED bd tds/tid qid eod om on prn d/dly Twice a day Three times a day Four times a day Every other day In the morning At night When necessary Day/daily mcg mg G/g kg sec min max IU Microgram Milligram Gram Kilogram Second Minutes Maximum International Units Million International Units Subcutaneous injections Intramuscular injections Intravenous injection Intra-articular injection Eye drops gram negative National Essential Drug List

hr/hrly

Hour/hourly

MIU

wk/wkly yr mth/mthly ml occ gram+ve

Week/weekly years Month/monthly Milliliter Eye ointment gram positive Approved Purchase Price List

S.C. I.M. I.V. I.A. gutt

gram-ve -

APPL

NEDL

xi

MINISTRY OF HEALTH DRUG FORMULARY

Triamcinolone Acetonide 0.1 % In Dental Paste A01AC01351G3101XX (B) NEDL Kenalog - Trade Name System: Ear, Nose and Oropharynx Indications: Oral and perioral lesions. Dosage: Apply a thin layer to affected area bd - qid. Contraindications: Hypersensitivity to any of its components, fungal or bacterial infections of the mouth or throat, herpetic lesions of known viral origin or intraoral lesions. Precautions: Tuberculosis, peptic ulcer, diabetes mellitus, pregnancy. Interactions: No interaction found. Adverse Reactions: Weakness or dizziness. Benzydamine HCl 0.1 % Solution D i f f l a m - Trade Name
A01AD02110M2001XX (B) NEDL

System: Ear, Nose and Oropharynx Indications: For relief of painful condition of the oral cavity. Dosage: Used as a 30 seconds gargle or rinse, undiluted. Adult : 15 ml. Child > 12 yrs : 5 - 15 ml. Uninterrupted treatment should not be more than 7 days. Contraindications: Known hypersensitivity to the drug or to any of the components of the vehicle. Precautions: Hepatic or renal impairment, pregnancy, children < 6 yr, in bacterial infection, appropriate antibacterial therapy should be used in addition to product. Interactions: No interaction found. Adverse Reactions: Oral numbness, dryness or thirst, tingling, warm feeling in mouth, altered sense of taste. Thymol Compound Gargle
A01AD11985M2001XX (C) NEDL

System: Ear, Nose and Oropharynx Indications: For sore throat and minor mouth inflammation. Dosage: To be gargled tds - qid. Contraindications: Not known. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: Irritant to the gastric mucosa. Magnesium Trisilicate Mixture System: Gastro-Intestinal Indications: Heartburn, dyspepsia. Dosage: 1
A02AA10912L2101XX (C) NEDL

10-20 ml 3-4 times daily before meals. Contraindications: Acute surgical abdomen, hypersensitivity to antacids, hypophosphataemia. Precautions: Renal impairment. Interactions: Tetracyclines, ketoconazole, itraconazole, dipyridamole, quinolones, captopril, iron and aspirin. Adverse Reactions: Diarrhoea. Magnesium Trisilicate Tablet
A02AA10912T1001XX (C) NEDL APPL

System: Gastro-Intestinal Indications: Heartburn, dyspepsia. Dosage: Adult: 1-2 tab to be chewed up to 6 times a day before meals. Children over 6 yrs: 1 tab to be taken 3-4 times a day. Contraindications: Hypersensitivity to antacids, hypophosphataemia. Precautions: Renal impairment. Interactions: Tetracyclines, ketoconazole, itraconazole, dipyridamole, quinolones, captopril, iron and aspirin. Adverse Reactions: Diarrhoea. Aluminium Hydroxide 300 mg/5 ml Liquid
A02AB01250L8001XX (A) NEDL

System: Gastro-Intestinal Indications: Dyspepsia, hyperphosphataemia. Dosage: 300 - 600 mg as needed between meals and at bedtime or as directed by physician. Contraindications: Hypophosphataemia, porphyria. Precautions: Chronic renal failure, may cause phosphate depletion. Interactions: Affects absorption of tetracyclines, penicillins, sulfonamides, quinidine, iron, digoxin, indomethacin, naproxen, phenylbutazone. Adverse Reactions: Constipation. Aluminium Hydroxide Dried Gel 600 mg Tablet A02AB01250T1001XX (A) NEDL A l u t a b - Trade Name System: Gastro-Intestinal Indications: Dyspepsia, hyperphosphataemia. Dosage: 600 mg - 1.2 g qid. Contraindications: Hypophosphataemia, porphyria. Precautions: Chronic renal failure, may cause phosphate depletion. Interactions: Affects absorption of tetracyclines, penicillins, sulfonamides, quinidine, iron, digoxin, indomethacin, naproxen, phenylbutazone. Adverse Reactions: Constipation. 2

Sodium Bicarbonate Mixture (Paediatric) M i s t C a r m i n a t i v e P a e d - Trade Name

A02AH00131L2101XX (C) NEDL

System: Gastro-Intestinal Indications: Heartburn, for rapid relief of dyspepsia. Dosage: Up to 1 yr : 5 ml; 1 - 5 yrs : 10 ml. Contraindications: Alkalosis, hypocalcaemia, hypochloraemia. Precautions: History of congestive heart failure, history of renal impairment, cirrhosis, hypertension, concurrent corticosteroids, maintain high urine output, monitor acid-base balance and electrolytes. Interactions: Amphetamine, aspirin, chlorpropamide, itraconazole, ketoconazole, lithium, pseudoephedrine. Adverse Reactions: GI cramps, flatulence, alkalosis. Sodium Bicarbonate 1 g/15 ml Mixture
A02AH00131L2102XX (B)

System: Nutrition and Blood Disorder Indications: For acceleration of excretion in drug intoxication (where excretion of the drug into the urine is accelerated by elevated urine pH) and for acidosis. Dosage: According to the needs of the patient. Contraindications: Alkalosis, hypernatraemia, hypocalcaemia, hypochloraemia, severe pulmonary oedema, unknown abdominal pain. Precautions: Renal impairment, peptic ulcer, congestive heart failure, oedema, cirrhosis. Interactions: Amphetamine, aspirin, chlorpropamide, dextroamphetamine, ephedrine, flecainide, itraconazole, ketoconazole, lithium, pseudoephedrine. Adverse Reactions: GI cramps, flatulence, alkalosis. Sod Bicarb, Mag Carb, Co Card Tinct, etc Mixture C a r m i n a t i v e - Trade Name
A02AH00912L2101XX (C) NEDL APPL

System: Gastro-Intestinal Indications: Heartburn, for rapid relief of dyspepsia. Dosage: Adult : 10 - 20 ml tds. Contraindications: Hypersensitivity to antacids, hypophosphataemia. Precautions: Renal impairment. Interactions: Tetracyclines, ketoconazole, itraconazole, dipyridamole, quinolones, captopril, lithium and aspirin. Adverse Reactions: Diarrhoea; belching due to liberated carbon dioxide.

Cimetidine 400 mg Tablet Cimetidine 800 mg Tablet Tagamet - Trade Name

A02BA01000T1001XX (B) NEDL APPL A02BA01000T1002XX (B) NEDL

System: Gastro-Intestinal Indications: i) Peptic ulcer disease ii) Non-ulcer dyspepsia. Dosage: i) 800 mg at bedtime. Treatment should be continued for at least 4 - 8 wks. Maintenance : 400 mg at bedtime. ii) 800 mg in 2 - 4 divided doses. (Each course of treatment should normally not exceed 4 wks.) Contraindications: Hypersensitivity to cimetidine. Precautions: Elderly, pregnancy, lactation, impaired renal & liver function. Interactions: Increases plasma concentration of coumarin anticoagulants, phenytoin, propranolol, some benzodiazepines, lidocaine, theophylline, metronidazole, triamterene & tacrolimus. Adverse Reactions: Mild diarrhoea, muscle pain, dizziness, skin rash, confusion in elderly, gynaecomastia, erectile dysfunction derangement of liver function. Cimetidine HCl 200 mg/10 ml Suspension Tagamet - Trade Name
A02BA01110L8001XX (B) NEDL

System: Gastro-Intestinal Indications: Only for gastroesophageal reflux and peptic ulcer in children. Dosage: Infant (under 1 yr) : 20 mg/kg/day in divided doses; (over 1 yr) : 25 - 30 mg/kg/day in divided doses. Contraindications: Hypersensitivity to cimetidine. Precautions: Pregnancy, lactation, impaired renal & liver function. Interactions: Increases plasma concentration of coumarin anticoagulants, phenytoin, propranolol, some benzodiazepines, lidocaine, theophylline, metronidazole, triamterene & tacrolimus. Adverse Reactions: Mild diarrhoea, muscle pain, dizziness, skin rash, gynaecomastia, erectile dysfunction & derangement of liver function. Cimetidine HCl 200 mg/2 ml Injection Tagamet - Trade Name
A02BA01110P3001XX (B) NEDL APPL

System: Gastro-Intestinal Indications: Peptic Ulcer Disease. Dosage: IM or IV 200 mg 4 - 6 hrly. Slow IV 200 mg over at least 2 mins, may be repeated every 4 - 6 hrs. IV infusion : 400 mg in 100 ml sodium chloride 0.9 % over 1/2 - 1 hr may be repeated every 4 - 6 hrs or by continuous infusion at an average rate of 50 - 100 mg/hr over 24 hrs. Max : 2.4 g daily. 4

Infant under 1 yr : Slow IV/Infusion : 20 mg/kg/day in divided doses. Child > 1 yr : 25 - 30 mg/kg/day in divided doses. Contraindications: Hypersensitivity to cimetidine. Precautions: Pregnancy, lactation, impaired renal & liver function, rapid administration by intravenous bolus may cause cardiac arrhythmias and hypotension. Interactions: Increases plasma concentration of coumarin anticoagulants, phenytoin, propranolol, some benzodiazepines, lidocaine, theophylline, metronidazole & triamterene. Adverse Reactions: Mild diarrhoea, muscle pain, dizziness, skin rash, agranulocytosis, neutropenia. Ranitidine 150 mg/10 ml Syrup Zantac - Trade Name
A02BA02110L9001XX (A)

System: Gastro-Intestinal Indications: Peptic ulcer disease. Dosage: Child : 2 - 4 mg/kg bd. Maximum 300 mg daily. Contraindications: Hypersensitivity to ranitidine. Precautions: H2-receptor antagonists should be used with caution in hepatic impairment, in renal impairment, pregnancy, and in breast- feeding. H2-receptor antagonists might mask symptoms of gastric cancer. Avoid in porphyrias. Interactions: Absorption may be reduced by concomitant administration with high doses (2 gm) of sucralfate. Adverse Reactions: GI disturbances, diarrhoea, altered liver function tests (rarely liver damage), headache, dizziness, rash, and tiredness. Rare sideeffects inc lude acute pancreatitis, bradycardia, AV block, confusion, depression, and hallucinations particularly in the elderly or the very ill, hypersensitivity reactions (including fever, arthralgia, myalgia, anaphylaxis), blood disorders (including agranulocytosis, leucopenia, pancytopenia, thrombocytopenia), and skin reactions (including erythema multiforme and toxic epidermal necrolysis). There have been occasional reports of gynaecomastia and impotence. Ranitidine 50 mg/2 ml Injection Zantac - Trade Name System: Gastro-Intestinal
A02BA02110P3001XX (A)APPL

Indications: i) Benign gastric/duodenal ulceration, reflux oesophagitis, Zollinger Ellison Syndrome ii) Stress Ulcer Prophylaxis in post-operative & high risk patients. Dosage: i) Adult : Slow IV injection of 50 mg diluted to 20 ml and given over at least 2 min. May be repeated every 6 - 8 hrs or IV infusion at rate of 25 mg/hr for 2 hrs, may be repeated at 6 - 8 hrs intervals or IM. Child : 1 mg/kg/dose 6 - 8 hrly. ii) Initial slow IV injection of 50 mg, then continuous infusion of 125 - 250 mcg/kg/hr. Contraindications: Hypersensitivity to ranitidine. Precautions: H2-receptor antagonists should be used with caution in hepatic impairment, in renal impairment, pregnancy, and in breast- feeding. H2-receptor antagonists might mask symptoms of gastric cancer. Avoid in porphyrias. Interactions: Absorption may be reduced by concomitant administration with high doses (2 gm) of sucralfate. Adverse Reactions: GI disturbances, diarrhoea, altered liver function tes ts (rarely liver damage), headache, dizziness, rash, and tiredness. Rare sideeffects include acute pancreatitis, bradycardia, AV block, confusion, depression, and hallucinations particularly in the elderly or the very ill, hypersensitivity reactions (including fever, arthralgia, myalgia, anaphylaxis), blood disorders (including agranulocytosis, leucopenia, pancytopenia, thrombocytopenia), and skin reactions (including erythema multiforme and toxic epidermal necrolysis). There have been occasional reports of gynaecomastia and impotence. Ranitidine 150 mg Tablet Zantac - Trade Name
A02BA02110T1001XX (A/KK) APPL

System: Gastro-Intestinal Indications: i) Benign gastric & duodenal ulcer ii) Reflux oesophagitis iii) Non-ulcer dyspepsia iv) Zollinger-Ellison Syndrome Dosage: i) 150 mg bd (om & on) or 300 mg on for 4 - 8 wks. Maintenance : 150 - 300 mg on. ii) 150 mg bd or 300 mg on for 8 - 12 weeks. iii) 150 mg dly or bd. iv)150 mg and may be increased as necessary to 6 g/day. Contraindications: Hypersensitivity to ranitidine. Precautions: H2-receptor antagonists should be used with caution in hepatic impairment, in renal impairment , pregnancy, and in breast-feeding. H2receptor antagonists might mask symptoms of gastric cancer. Avoid in porphyrias. Interactions: Absorption may be reduced by concomitant administration with high doses (2 gm) of sucralfate. Adverse Reactions: GI disturbances, diarrhoea, altered liver function tests (rarely liver damage), headache, dizziness, rash, and tiredness. Rare side6

effects include acute pancreatitis, bradycardia, AV block, confusion, depression, and hallucinations particularly in the elderly or the very ill, hypersensitivity reactions (including fever, arthralgia, myalgia, anaphylaxis), blood disorders (including agranulocytosis, leucopenia, pancytopenia, thrombocytopenia), and skin reactions (including erythema multiforme and toxic epidermal necrolysis). There have been occasional reports of gynaecomastia and impotence. Ranitidine 300 mg Tablet Zantac - Trade Name
A02BA02110T1002XX (A) APPL

System: Gastro-Intestinal Indications: i) Benign gastric & duodenal ulcer ii) Reflux oesophagitis iii) Non-ulcer dyspepsia iv) Zollinger-Ellison Syndrome Dosage: i) 150 mg bd (om & on) or 300 mg on for 4 - 8 wks. Maintenance : 150 - 300 mg on. ii) 150 mg bd or 300 mg on for 8 - 12 weeks. iii) 150 mg dly or bd. iv)150 mg and may be increased as necessary to 6 g/day. Contraindications: Hypersensitivity to ranitidine. Precautions: H2-receptor antagonists should be used with caution in hepatic impairment, in renal impairment, pregnancy, and in breast- feeding. H2-receptor antagonists might mask symptoms of gastric cancer. Avoid in porphyrias. Interactions: Absorption may be reduced by concomitant administration with high doses (2 gm) of sucralfate. Adverse Reactions: GI disturbances, diarrhoea, altered liver function tests (rarely liver damage), headache, dizziness, rash, and tiredness. Rare sideeffects include acute pancreatitis, bradycardia, AV block, confusion, depression, and hallucinations particularly in the elderly or the very ill, hypersensitivity reactions (including fever, arthralgia, myalgia, anaphylaxis), blood disorders (including agranulocytosis, leucopenia, pancytopenia, thrombocytopenia), and skin reactions (including erythema multiforme and toxic epidermal necrolysis). There have been occasional reports of gynaecomastia and impotence. Omeprazole 10 mg Capsule Losec - Trade Name
A02BC01000C1001XX (A*)

System: Gastro-Intestinal Indications: Only for :i) Reflux oesophagitis, ii)For eradication of Helicobacter Pylori infection, iii)Benign peptic ulcer not responding to conventional therapy, iv) Zollinger-Ellison Syndrome. Dosage: 7

i) 20 - 80 mg once dly - bd up to 8 - 12 wks. ii) 20 mg bd in combination with any of the 2 antibiotics (clarithromycin 500 mg bd, amoxycillin 1 g bd or metronidazole 400 mg bd ) for 1 - 2 wks iii) 20 mg once dly for 4 - 6 wks. iv) 20 - 120mg once dly adjusted according to the patient's response. Child : 0.4 - 0.8 mg/kg/day. Contraindications: Hypersensitivity to omeprazole or to any of its components. Precautions: Proton pump inhibitors i) reduce gastric acidity & increase the risk of GI infections. ii) may mask symptoms of gastric cancer (exclude malignancy in suspected gastric ulcers). Interactions: May prolong elimination of diazepam, warfarin & phenytoin. Increases plasma concentration of clarithromycin, ketoconazole. Adverse Reactions: GI effects such as diarrhoea, nausea & constipation, headache, cough, upper respiratory tract infection, rash. Omeprazole 20 mg Capsule Losec - Trade Name
A02BC01000C1002XX (A*) APPL

System: Gastro-Intestinal Indications: Only for :i) Reflux oesophagitis, ii) For eradication of Helicobacter Pylori infection, iii) Benign peptic ulcer not responding to conventional therapy, iv) Zollinger-Ellison Syndrome. Dosage: i) 20 - 80 mg once dly - bd up to 8 - 12 wks. ii) 20 mg bd in combination with any of the 2 antibiotics (clarithromycin 500 mg bd, amoxycillin 1 g bd or metronidazole 400 mg bd ) for 1 - 2 wks. iii) 20 mg once dly for 4 - 6 wks. iv) 20 - 120 mg dly. Child : 0.4 - 0.8 mg/kg/day. Contraindications: Hypersensitivity to omeprazole or to any of its components. Precautions: Proton pump inhibitors i) reduce gastric acidity & increase the risk of GI infections. ii) may mask symptoms of gastric cancer (exclude malignancy in suspected gastric ulcers). Interactions: May prolong elimination of diazepam, warfarin & phenytoin. Increases plasma concentration of clarithromycin, ketoconazole. Adverse Reactions: GI effects such as diarrhoea, nausea & constipation, headache, cough, upper respiratory tract infection, rash. Omeprazole 40 mg Injection Losec - Trade Name System: Gastro-Intestinal Indications: 8
A02BC01000P4001XX (A*)

i) Reflux oesophagitis, eradication of H.Pylori infection, benign peptic ulcer not responding to conventional therapy, Zollinger-Ellison Syndrome. ii) Endoscopically confirmed peptic ulcer. Dosage: i) 40 mg IV once dly when oral therapy is inappropriate. ii) 40 - 160 mg IV in single or divided doses. Contraindications: Hypersensitivity to omeprazole or to any of its components. Precautions: Proton pump inhibitors i) reduce gastric acidity & increase the risk of GI infections. ii) may mask symptoms of gastric cancer (exclude malignancy in suspected gastric ulcers). Interactions: May prolong elimination of diazepam, warfarin & phenytoin. Increases plasma concentration of clarithromycin, ketoconazole. Adverse Reactions: GI effects such as diarrhoea, nausea & constipati on, headache, cough, upper respiratory tract infection, rash. Pantoprazole 40 mg Injection Controloc - Trade Name
A02BC02000P3001XX (A*)

System: Gastro-Intestinal Indications: Bleeding peptic ulcer and acute stress ulceration. Dosage: 40 mg bd until oral administration can be resumed. Not recommended for use in children. Contraindications: Pregnancy, lactation. Combination therapy for eradication of H. Pylori in patients with moderate to severe hepatic or renal impairment. Precautions: Not for mild GI complaints eg nervous dyspepsia. Proton pump inhibitors i) reduce gastric acidity & increase the risk of GI infections. ii) may mask symptoms of gastric cancer (exclude malignancy in suspected gastric ulcers). Interactions: May affect absorption of drugs which are pH-dependant. Adverse Reactions: GI disturbances (nausea & vomitting, diarrhoea, constipation, upper abdominal pain, flatulence) skin rash, pruritus, dizziness, oedema, fever, depression, vision disturbances, headache, liver enzyme changes, raised triglycerides. Pantoprazole 40 mg Tablet Controloc - Trade Name
A02BC02000T1001XX (A*)

System: Gastro-Intestinal Indications: i) Helicobacter Pylori eradication ii) Peptic ulcer disease iii) Erosive and non-erosive reflux oesophagitis (GERD & NERD) iv) Zollinger-Ellison Syndrome v) Prevention of NSAID induced gastropathy Dosage: 9

i) 40 mg bd in combination with any of the 2 antibiotics (clarithromycin 500 mg bd, amoxycillin 1 g bd or metronidazole 400 mg bd ) for 1 - 2 wks. ii) 40 mg dly for 2 - 4 wk. iii) 20 - 40 mg dly om for 4 wk. iv) 40 mg bd. Max: 240 mg dly. v) 20 mg daily. Not recommended for use in children. Contraindications: Pregnancy, lactation, moderate to severe hepatic or renal impairment. Precautions: Not for mild gastrointestinal complaints eg nervous dyspepsia. Proton pump inhibitors i) reduce gastric acidity & increase the risk of GI infections. ii) may mask symptoms of gastric cancer (exclude malignancy in suspected gastric ulcers). Interactions: May affect absorption of drugs which are pH-dependant. Adverse Reactions: GI disturbances (nausea & vomitting, diarrhoea, constipation, upper abdominal pain, flatulence) skin rash, pruritus, dizziness, oedema, fever, depression, vision disturbances, headache, liver enzyme changes, raised triglycerides. Lansoprazole 30 mg Tablet P r e v a c i d - Trade Name
A02BC03000T1001XX (A*)

System: Gastro-Intestinal Indications: i) Peptic ulcer disease ii) Reflux oesophagitis iii) Zollinger-Ellison Syndrome iv) For eradication of Helicobacter Pylori in combination with antibiotic Dosage: i) 30 mg dly for 8 wks. ii) 30 mg once dly - bd for 4 - 8 wks. iii) 60 -120mg once dly adjusted according to the patient's response. iv) 30 mg bd in combination with any of the 2 antibiotics (clarithromycin 500 mg bd, amoxycillin 1 g bd or metronidazole 400 mg bd ) for 1 - 2 wks. Contraindications: Hypersensitivity to lansoprazole. Precautions: Hepatic impairment, elderly, pregnancy, lactation. Interactions: May retard metabolism & excretion of diazepam & phenytoin. May decrease plasma concentration of theophylline. Adverse Reactions: Agitation, constipation, diarrhoea, dry mouth, abdominal distension, headache, sleepiness, insomnia, dizziness, rash, pruritus, fever. Sucralfate 1 g Tablet
A02BX02000T1001XX (A)

System: Gastro-Intestinal Indications: Benign gastric and duodenal ulceration, Stress ulcer prophylaxis. Dosage: Prophylaxis of stress ulceration : 1 g 6 times dly (max 8 g dly). Benign gastric & duodenal ulcers : 2 g bd or 1 g qid for 4-6 weeks or in 10

resistant cases up to 12 weeks (max 8 g daily). Not recommended for use in children. Contraindications: Hypersensitivity to sucralfate products. Precautions: Chronic renal failure (avoid if severe), pregnancy, breast feeding. Administration of sucralfate and enteral feeds should be separated by 1 hour. Interactions: Fluoroquinolones, tetracycline, warfarin, phenytoin, ketoconazole, lansoprazole, digoxin, ranitidine, cimetidine, theophylline and levothyroxine. Adverse Reactions: Constipati on, diarrhoea, nausea, gastric discomfort, indigestion, dry mouth, drowsiness, dizziness, skin rash, hypersensitive reaction including pruritus, back pain, vertigo. Colloidal Bismuth Subcitrate 120 mg Tablet De -N o l - Trade Name
A02BX05136T1001XX (A)

System: Gastro-Intestinal Indications: Eradication therapy for Helicobacter Pylori in combination with antibiotics & antisecretory drugs. Dosage: 240 mg bd for 1 - 2 wks. Contraindications: Hypersensitivity to bismuth salts. Precautions: Concomitant administration of antacids, milk, food, and H2receptor antagonists may impair efficacy, hepatic dysfunction, renal impairment (potential accumulation and bismuth neurotoxicity), toxicity may occur with prolonged therapy due to sequestration of bismuth. Interactions: Concomitant administration of colloidal bismuth subcitrate with antacids may result in preferential chelate formation. The effect of antacids on gastric pH may also affect precipitation of colloidal bismuth subcitrate. Adverse Reactions: Increases in haemoglobin levels, mild reductions in diastolic blood pressure, headache and dizziness, Bismuth encephalopathy; characterized by ataxia, confusion, memory impairment, mood disturbances, myoclonus, hallucinations, seizures, darkens tongue & blackens faeces, nausea, diarrhoea, dyspepsia, elevations in aspartate transaminase levels, acute renal failure, allergic skin rashes. Dimethyl Polysiloxane 20 mg/ml Liquid Babcon - Trade Name
A02DA00262L5001XX (A)

System: Gastro-Intestinal Indications: Antifoaming agent for use in upper GI Endoscopy. Dosage: 2 - 4 ml with 10 ml of water 15 - 40 min prior to endoscopic examination. Contraindications: Hypersensitivity to simethicone intestinal perforation and obstruction. Precautions: May possibly be associated with aspiration, especially in patients with tracheoesophageal fistula. Interactions: No significant interactions. Adverse Reactions: Headache, nausea, vomiting, diarrhoea, dyspepsia & 11

flatulence, pharyngitis, rhinitis, skin rashes. Mebeverine HCl 100 mg Tablet D u s p a t a l i n - Trade Name
A03AA04110T1001XX (A)

System: Gastro-Intestinal Indications: Irritable Bowel Syndrome Dosage: 100 mg 3-4 times daily. Contraindications: Hypersensitivity to mebeverine HCl, severe hepatic insufficency, porphyria. Precautions: Mild-to-moderate hepatic or renal dysfunction, cystic fibrosis, pregnancy & lactation, cardiac disorders (heart blocks). Interactions: No known drug interactions. Adverse Reactions: Dizziness, headache, nausea, peritonitis, skin reactions. Glycopyrrolate 200 mcg/ml Injection
A03AB02320P3001XX (A*)

System: Anaesthesia Indications: i) To reduce secretions (respiratory tract) for certain types of surgery. ii) Reversal of neuromuscular block in patients where atropine is contraindicated. Dosage: i) Adults and older patients : 0.2 - 0.4 mg IV before anaesthesic induction or intraoperatively. Children: 4 - 8 mcg/kg up to a max of 200 mcg (0.2 mg) IV. ii) Doses for reversal of neuromuscular block will be higher. Contraindications: Glaucoma, obstructive uropathy, GI obstruction, myasthenia gravis, hypersensitivity to glycopyrrolates newborns less than 1 month of age Precautions: Autonomic neuropathy, children and elderly patients, congestive heart failure, coronary heart disease, hypertension, hyperthyroidism, ileostomy or colostomy, mild hepatic or renal disease, prostatic hypertrophy, tachyarrythmia, tachycardia. May cause heat prostration, neuromuscular blockade. Interactions: Cisapride. Adverse Reactions: Dry mouth, blurred vision, tachycardia, urinary retention, constipation. Propantheline Bromide 15 mg Tablet P r o b a n t h i n e - Trade Name
A03AB05320T1001XX (B) NEDL

System: Gastro-Intestinal Indications: Symptomatic relief of GI disorders characterised by smooth muscle spasm. Dosage: 15 mg tds at least 1 hr before meals and 30 mg at night, max : 120 mg dly. Not recommended for use in children. Contraindications: Hypersensitivity to propantheline or other anticholinergic drugs, myasthenia gravis, narrow-angle glaucoma, obstructive gastrointestinal 12

disease, obstructive uropathy, paralytic ileus or intestinal atony, reflux oesophagitis, ulcerative colitis or toxic megacolon. Precautions: Use with caution in Down's Syndrome, in children and in elderly patients.; they should also be used with caution in autonomic neuropathy, congestive heart failure, acute myocardial infarction, hypertension, hyperthyroidism, reflux oesophagitis, diarrhoea, ulcerative colitis, prostatic hypertrophy, tachyarrhythmia. Interactions: Loss of cisapride efficacy, increased serum digoxin levels, procainamide coadministered with propantheline may result in additive antivagal effects on atrioventricular nodal conduction. Adverse Reactions: Xerostomia, paralytic ileus, constipation, heartburn, bloating and reduced salivation. Tegaserod 6 mg Tablet Zelmac - Trade Name
A03AE02253T1001XX (A*)

System: Gastro-Intestinal Indications: Irritable bowel syndrome where constipation is the predominant feature in female patients only. Dosage: 6 mg twice daily prior to a meal for 4-6 weeks and if responding extend for an additional of 4-6 weeks. Contraindications: History of bowel obstruction, hypersensitivity to tegaserod or any component of the formulation, severe renal and moderate-severe hepatic impairment. Precautions: Cardiovascular disease, discontinue if abdominal pain worsen, diarrhoea, pregnancy, breast feeding. Interactions: No interactions found. Adverse Reactions: Abdominal pain, diarrhoea which can be severe, including hypotension, hypovolemia, or syncope, dizziness, headache. Atropine Sulphate 1mg/ml Injection
A03BA01183P3001XX (B)NEDL

System: Anaesthesia Indications: i) Drying secretions ii) Reversal of excessive bradycardia iii) Reversal of muscarinic effects of agents used for neuromuscular blockade reversal iv) Toxicity from cholinesterase inhibitors, organophosphate poisoning Dosage: i) 300-600mcg immediately before induction of anaesthesia ii) Incremental doses of 100mcg(larger doses in emergencies) iii) 0.6-1.2mg iv) 2mg(20mcg/kg in a child) every 5-10 mins until muscarinic symptoms disappear Contraindications: Hypersensitivity to atropine or anticholinergics, narrowangle glaucoma, reflux oesophagitis, obstructive gastrointestinal disease/uropathy, ulcerative colitis or toxic megacolon, unstable cardiovascular 13

status in acute haemorrhage or thyrotoxicosis. Precautions: Paediatric and geriatric patients, debilitated patients with lung disease, autonomic neuropathy, hepatic or renal disease, may cause heat prostration, patients with ileostomy or colostomy, diarrhoea may indicate incomplete intestinal obstruction, avoid driving or hazardous activities, may cause neuromuscular blockade resulting in weakness or paralysis, hyperthyroidism, coronary heart disease, acute myocardial ischemia, CHF, tachyarrhythmia, tachycardia, HTN, or prostatic hypertrophy, pregnancy, neonates. Interactions: Loss of cisapride efficacy, procainamide coadministered with atropine may result in additive antivagal effects on atrioventricular nodal conduction. Adverse Reactions: Constipation, transient bradycardia (followed by tachycardia, palpitations & arrhythmias), reduced bronchial secretions, urinary urgency & retention, dilatation of the pupils with loss of accommodation, photophobia, dry mouth, flushing & dryness of the skin. Hyoscine N-Butylbromide 1 mg/ml Liquid Buscopan - Trade Name
A03BB01320L5001XX (B) NEDL

System: Gastro-Intestinal Indications: Gastrointestinal tract and genito-urinary tract spasm, dyskinesia of the biliary system. Dosage: Adult & child >6 yrs: 10 ml tds. Contraindications: Obstructive disease of the GI or urinary tract, narrow-angle glaucoma, cardiac tachyarrhythmias, myasthenia gravis, prostatic hypertrophy with urinary retention. Precautions: Geriatric and pediatric patients, pregnancy, breastfeeding, intestinal atony, paralytic ileus and ulcerative colitis, coronary artery diseases, arrhythmias , heart failure, hypertension, xerostomia, hiatal hernia with reflux esophagitis, prostatic hypertrophy. Interactions: Intensifies anticholinergic effects of tricyclic antidepressants, antihistamines, quinidine, amantadine & disopyramide. Enhances tachycardic effects of beta-adrenergic agents. Dopamine antagonist eg metoclopramide reduces effects of both drugs on GIT. Adverse Reactions: Xerostomia, dyshidrosis, tachycardia, urinary hesistancy and retention, allergic reactions, skin reactions, confusions, excitement, constipation, paralytic ileus. Hyoscine N-Butylbromide 20 mg/ml Injection A03BB01320P3001XX (B) NEDL APPL Buscopan - Trade Name System: Gastro-Intestinal

14

Indications: Gastrointestinal tract and genito-urinary tract spasm, dyskinesia of the biliary system. Dosage: Adult : 20 - 40 mg. Max : 40 mg 6 - 8 hrly. Child : 0.5 mg/kg/dose. Contraindications: Obstructive disease of the GI or urinary tract, narrow-angle glaucoma, cardiac tachyarrhythmias, myasthenia gravis, prostatic hypertrophy with urinary retention, paraben allergy (multi-dose vial for injection contains parabens). Precautions: Geriatric and pediatric patients, Pregnancy, breastfeeding, intestinal atony, paralytic ileus and ulcerative colitis, cardiac disease, coronary artery diseases, arrhythmias , heart failure, hypertension, xerostomia, hiatal hernia with reflux esophagitis, prostatic hypertrophy. Interactions: Intensifies anticholinergic effects of tricyclic antidepressants, antihistamines, quinidine, amantadine & disopyramide. Enhances tachycardic effects of beta-adrenergic agents. Dopamine antagonist eg metoclopramide reduces effects of both drugs on GIT. Adverse Reactions: Xerostomia, dyshidrosis, tachycardia, urinary hesistancy and retention, allergic reactions, skin reactions, confusions, excitement, constipation, paralytic ileus, rarely anaphylactoid reactions & anaphylactic shock. Hyoscine N-Butylbromide 10 mg Tablet Buscopan - Trade Name
A03BB01320T1001XX (B) NEDL APPL

System: Gastro-Intestinal Indications: Gastrointestinal tract and genito-urinary tract spasm, dyskinesia of the biliary system. Dosage: Adult: 10-20 mg tid or qid. Child 6 - 12 yrs: 10 mg tds. Contraindications: Obstructive disease of the GI or urinary tract, narrow-angle glaucoma, cardiac tachyarrhythmias, myasthenia gravis, prostatic hypertrophy with urinary retention. Precautions: Geriatric and pediatric patients, pregnancy, breastfeeding, intestinal atony, paralytic ileus and ulcerative colitis, coronary artery diseases, arrhythmias , heart failure, hypertension, xerostomia, hiatal hernia with reflux esophagitis, prostatic hypertrophy. Interactions: Intensifies anticholinergic effects of tricyclic antidepressants, antihistamines, quinidine, amantadine & disopyramide. Enhances tachycardic effects of beta-adrenergic agents. Dopamine antagonist eg metoclopramide reduces effects of both drugs on GIT. Adverse Reactions: Xerostomia, dyshidrosis, tachycardia, urinary hesistancy and retention, allergic reactions, skin reactions, confusions, excitement, constipation, paralytic ileus. Hyoscine HBr 600 mcg/ml Injection System: Anaesthesia Indications: 15
A03BB01330P3001XX (B)NEDL

To reduce oral secretions before surgery. Dosage: 200 - 600 mcg SC or IM 60 min before induction of anaesthesia. Contraindications: History of hypersensitivity to hyoscine. Porphyria, closedangle glaucoma, urinary retention. Precautions: Cardiovascular disease, avoid in the elderly. Interactions: Sedative effects enhanced by alcohol. Concurrent administration with MAOIs, tricyclic antidepressant, antihistamine, amantadine can potentiate antimuscarinic effect of hyoscine. Adverse Reactions: Tachycardia, bradycardia, mydriasis, dry mouth, CNS depression, urinary urgency. Metoclopramide HCl 5 mg/5 ml Syrup M a x o l o n - Trade Name
A03FA01110L9001XX (B) NEDL

System: Gastro-Intestinal Indications: i) Dyspepsia, flatulence, hiatus hernia, peptic ulceration, reflux oesophagitis, gastritis, duodenitis, cholelithiasis, nausea, vomiting and ii) Promote bowel transit during diagnostic procedures. Dosage: i) 0.12 mg/kg/dose 6 - 12 hrly. ii) single dose 5 - 10 min before examination, child <3 yrs: 1 mg; 3 - 9 yrs: 2 mg; 9-14 yrs: 5 mg. Contraindications: Concomitant therapy with drugs which are likely to cause extrapyramidal reactions, epileptics, gastrointestinal haemorrhage, obstruction (mechanical), or perforation, hypersensitivity to metoclopramide, pheochromocytoma. Precautions: Hepatic and renal impairment, elderly, young adults and children; may mask underlying disorders such as cerebral irritation; avoid for 3 - 4 days following gastro-intestinal surgery, may cause acute hypertensive response in phaeochromocytoma; pregnancy and breast feeding; porphyria. Use cautiously in patients with depression, Parkinsons disease or hypertension. Interactions: Increased absorption of aspirin and paracetamol; opioid analgesics and antimuscarinics antagonise effect on gastro-intestinal activity, antipsychotics (increased risk of extrapyramidal effects). Decrease absorption of Digoxin. Adverse Reactions: Extrapyramidal effects (especially in children and young adults), hyperprolactinaemia, tardive dyskinesia, drowsiness, restlessness, anxiety, drowsiness, fatigue, akathesia, insomnia, depression, neuroleptic malignant syndrome, diarrhoea, bronchospasm and cardiac conduction abnormalities. Metoclopramide HCl 10 mg/2 ml Injection Metoclopramide HCl 10 mg Tablet M a x o l o n - Trade Name
A03FA01110P3001XX (B) NEDL A03FA01110T1001XX (B) NEDL

System: Gastro-Intestinal Indications: i) Dyspepsia, flatulence, hiatus hernia, peptic ulceration, reflux oesophagitis, 16

gastritis, duodenitis, cholelithiasis, nausea, vomiting and ii) Promote bowel transit during diagnostic procedures. Dosage: i) >20 yrs : 10 mg tds; Young adults (12 - 20 yrs) : 5 mg tds; <12 yrs : 0.12 mg/kg/dose 6 - 12 hrly. ii) Single dose 5 - 10 min before examination; >15 yrs : 10 - 20 mg; <15 yrs: 0.12 mg/kg/dose 6 - 12 hrly. Contraindications: Concomitant therapy with drugs which are likely to cause extrapyramidal reactions, epileptics, gastrointestinal haemorrhage, obstruction (mechanical), or perforation, hypersensitivity to metoclopramide, pheochromocytoma. Precautions: Hepatic and renal impairment, elderly, young adults and children; may mask underlying disorders such as cerebral irritation; avoid for 3 - 4 days following gastro-intestinal surgery, may cause acute hypertensive response in phaeochromocytoma; pregnancy and breast feeding; porphyria. Use cautiously in patients with depression, Parkinson's disease or hypertension. Interactions: Increased absorption of aspirin and paracetamol; opioid analgesics and antimuscarinics antagonise effect on gastro-intestinal activity, antipsychotics (increased risk of extrapyramidal effects). Decrease absorption of Digoxin. Adverse Reactions: Extrapyramidal effects (especially in children and young adults), hyperprolactinaemia, tardive dyskinesia, drowsiness, restlessness, anxiety, drowsiness, fatigue, akathisia, insomnia, depression, neuroleptic malignant syndrome, diarrhoea, bronchospasm and cardiac conduction abnormalities. Domperidone 1mg/ml Suspension Motilium - Trade Name
A03FA03000L8001XX (B)

System: Gastro-Intestinal Indications: Prokinetic Agent. Dosage: Adult : 10 - 20 mg every 4 - 8 hrs. Child : 200 - 400 mcg/kg every 4 - 8 hrs. Contraindications: Hypersensitivity to domperidone. Precautions: Babies < 1 yr, hepatic impairment, renal insufficieny, pregnancy and lactation. Interactions: Anticholinergic drugs, antacids or antisecretory agents. Adverse Reactions: Mild abdominal cramps, raised serum prolactin level. Ondansetron 4 mg/2ml Injection Ondansetron 8 mg/4ml Injection Zofran - Trade Name
A04AA01110P3001XX (A)APPL A04AA01110P3002XX (A)APPL

System: Gastro-Intestinal Indications: i) Prevention of nausea & vomiting induced by cytotoxic chemotherapy & radiotherapy. ii) Postoperative nausea & vomiting. Dosage: 17

i) A single dose of 32 mg given by IV infusion over 15 min immediately before chemotherapy followed by 8 mg orally every 12 hrs for up to 5 days. Paed: 5 mg/m2 body surface IV over 15 min immediately before chemotherapy followed by 4 mg orally every 12 hrs for up to 5 days. ii) Prevention of postoperative nausea & vomitting : 16 mg orally 1 hr before anaesthesia or 4mg IV at induction of anaesthesia. For post- operative nausea & vomitting 4mg IV. Children 100micro-gms/kg (max 4mg) orally or IV. Contraindications: Hypersensitivity to any component of the preparation. Precautions: Pregnancy, lactation, hepatic impairment. Interactions: No known drug interactions. Adverse Reactions: Headache, malaise, fatique, sedation, diarrhea, constipation, anaphylaxis sensation of flushing or warmth in the head & epigastrium, occasionally transient visual disturbances & dizziness, involuntary movements, seizures & arrhythmias. Ondansetron 4 mg Tablet Ondansetron 8 mg Tablet Zofran - Trade Name
A04AA01110T1001XX (A) APPL A04AA01110T1002XX (A) APPL

System: Gastro-Intestinal Indications: i) Prevention of nausea & vomiting induced by cytotoxic chemotherapy & radiotherapy. ii) Postoperative nausea & vomiting. Dosage: i) A single dose of 32 mg given by IV infusion over 15 min immediately before chemotherapy followed by 8 mg orally every 12 hrs for up to 5 days. Paed: 5 mg/m2 body surface IV over 15 min immediately before chemotherapy followed by 4 mg orally every 12 hrs for up to 5 days ii) Prevention of postoperative nausea & vomitting : 16 mg orally 1 hr before anaesthesia or 4mg IV at induction of anaesthesia. For post- operative nausea & vomitting 4mg IV. Children 100micro-gms/kg (max 4mg) orally or IV. Contraindications: Hypersensitivity to any component of the preparation. Precautions: Pregnancy, lactation, hepatic impairment. Interactions: No known drug interactions. Adverse Reactions: Headache, malaise, fatique, sedation, diarrhea, constipation, anaphylaxis sensation of flushing or warmth in the head & epigastrium, occasionally transient visual disturbances & dizziness, involuntary movements, seizures & arrhythmias. Granisetron HCl 3 mg/3 ml Injection K y t r i l - Trade Name System: Gastro-Intestinal
A04AA02110P3001XX (A)

18

Indications: i) Prevention of nausea & vomiting induced by cytotoxic chemotherapy & radiotherapy. ii) Postoperative nausea & vomiting. Dosage: Adult: Prevention:- 3 mg diluted in 20 - 50 ml infusion fluid and administered over 5 min up to 2 additional doses within 24 hours. Treatment:- Three infusions of 3 mg given at least 10 mins apart in 24 hrs. Max: 9 mg/day. Child: Prevention:- 40 mcg/kg IV infusion. Treatment:- as for prevention plus one additional dose of 40 mcg/kg to be given not less than 10 minutes apart in 24 hours. Max: 3 mg/day. Contraindications: Hypersensitivity to granisetron or related substances. Precautions: Subacute intestinal obstruction, pregnancy and lactation. Interactions: No known interactions. Adverse Reactions: Headache, asthenia, fever, pain, bradycardia, constipation, nausea, leukopenia, thrombocytopenia, hypersensitivity reaction, transiet increases in liver enzymes, rash. Granisetron HCl 1 mg Tablet K y t r i l - Trade Name
A04AA02110T1001XX (A)

System: Gastro-Intestinal Indications: Prevention of nausea & vomiting induced by cytotoxic chemotherapy and radiotherapy. Dosage: 1- 2 mg 1 hr before chemotherapy and then 2 mg daily in 1-2 divided doses during treatment. Max: 9 mg in 24 hrs. Child: 20 mcg/kg (max: 1 mg) 1 hr before treatment then 20 mcg/kg (max: 1 mg) bd for up to 5 days. Contraindications: Hypersensitivity to granisetron or related substances. Precautions: Subacute intestinal obstruction, pregnancy and lactation. Interactions: No interactions found. Adverse Reactions: Headache, asthenia, fever, pain, bradycardia, constipation, nausea, leukopenia, thrombocytopenia, hypersensitivity reaction, transiet increases in liver enzymes, rash. Ursodeoxycholic Acid 250 mg Capsule U r s o f a l k - Trade Name
A05AA02000C1001XX (A)

System: Gastro-Intestinal Indications: Cholestatic liver diseases eg. Primary biliary cirrhosis, primary cholangitis etc. Dosage: 10-15 mg/kg daily in 2 to 4 divided doses. Contraindications: Radio-opaque stones, pregnancy, non-functioning gall bladder, chronic liver disease, peptic ulceration, inflammatory diseases and other conditions of the small intestine and colon which interfere with enterohepatic circulation of bile salts. Precautions: Hepatic enzymes (alanine and aspartate transaminase) should be monitored upon the initiation of therapy and thereafter as indicated by the 19

particular clinical circumstances. Interactions: Absorption decreased by cholestyramine, colestipol or aluminium hydroxide containing antacids. Should not be used with drugs such as oestrogenic hormones that increase bile cholesterol. Adverse Reactions: Nausea, vomiting, diarrhoea, gallstone calcification, pruritus. Essential Phospholipids Capsule E s s e n t i a l e - Trade Name
A05BA00924C1001XX (A/KK)

System: Gastro-Intestinal Indications: Nutritional supplement in liver disorders. Dosage: Adult: 1-2 capsules tds. Contraindications: Not known. Precautions: Not Known. Interactions: Cholestyramine, colestipol or antacids containing aluminium hydroxide. Adverse Reactions: No information available. Essential Phospholipids 250 mg/5 ml Injection A05BA00924P9901XX (A/KK) E s s e n t i a l e - Trade Name System: Gastro-Intestinal Indications: Nutritional supplement in liver disorders. Dosage: 5 ml dly. Contraindications: Not known. Precautions: Not Known. Interactions: Cholestyramine, colestipol or antacids containing aluminium hydroxide. Adverse Reactions: No information available. Glucometamine Capsule Jetepar - Trade Name
A05C000920C1001XX (A/KK) APPL

System: Gastro-Intestinal Indications: For disorders in which hepatic function is impaired. Dosage: 2 capsules tds. Contraindications: Not known. Precautions: Not known. Interactions: No known interactions. Adverse Reactions: No information available.

20

Glucometamine 150 mg Injection Jetepar - Trade Name

A05C000920P3001XX (A)

System: Gastro-Intestinal Indications: For disorders in which hepatic function is impaired. Dosage: Newborn, below 8 kg body wt : 2 ml dly IV or infusion diluted in saline or glucose. Adult : 2 - 10 ml dly single or bd by IV or infusion. Contraindications: Not known. Precautions: Not known. Interactions: No known interactions. Adverse Reactions: No information available. Liquid Paraffin
A06AA01000L5001XX (C) NEDL

System: Gastro-Intestinal Indications: Constipation. Dosage: Adult: 10-30 ml daily. Not recommended for use in children. Not for prolonged use. Contraindications: Nausea, vomiting, undiagnosed abdominal pain, pregnancy, difficulty swallowing, bedridden patients, children < 3 yrs. Precautions: In patients with with recent change of bowel habits or suspected bowel malignancy and rectal bleeding. Not to be taken with meals. Interactions: May impair the absorption of fat soluble nutrients and this would enhance effects of oral anticoagulants. Impair absorption of warfarin. Adverse Reactions: Anal seepage of paraffin and consequent anal irritation after prolonged use, granulomatous reactions caused by absorption of small quantities of liquid paraffin, lipoid pneumonia and interference with the absorption of fat soluble vitamins. Bisacodyl 5 mg Suppository Dulcolax - Trade Name
A06AB02000S2001XX (B)NEDL

System: Gastro-Intestinal Indications: Constipation. Dosage: The use of stimulant laxatives in children is to be discouraged except under the supervision of a paediatrician. The dose in children under 10 years of age shold not exceed 5mg. Contraindications: Ileus, intestinal obstruction, acute abdominal conditions, rectal bleeding, appendicitis. Precautions: Prolonged use, abdominal pain, inflammatory bowel disease, sudden, persistent change in bowel habits & ulcerated haemorrhoids of rectal fissures. Interactions: No known drug interactions. Adverse Reactions: Rarely, abdominal discomfort & diarrhoea. 21

Bisacodyl 10 mg Suppository Dulcolax - Trade Name

A06AB02000S2002XX (B) NEDL APPL

System: Gastro-Intestinal Indications: i) Constipation ii) Bowel preparation for radiological procedures and surgery. Dosage: i) 10mg suppository inserted rectally. ii) 10mg suppository inserted 1 hr before the examination/intervention. Contraindications: Acute abdominal conditions like ileus, intestinal obstruction, appendicitis & rectal bleeding. Precautions: Prolonged use, abdominal pain, inflammatory bowel disease, sudden, persistent change in bowel habits. Interactions: No known drug interections. Adverse Reactions: Rarely, abdominal discomfort & diarrhoea. Bisacodyl 5 mg Tablet Dulcolax - Trade Name
A06AB02000T1001XX (B) NEDL

System: Gastro-Intestinal Indications: i) Constipation ii) Bowel preparation for radiological procedures and surgery. Dosage: i) 5 - 10 mg at bedtime (not exceeding 15-20mg) ii) 10 mg at bedtime for 2 days before examination and if necessary supplemented by a 10mg suppository 1 hour before the examination/procedure. Child: under 10 years: 5mg. Contraindications: Ileus, intestinal obstruction, acute abdominal conditions, rectal bleeding, appendicitis. Precautions: Prolonged use, abdominal pain, inflammatory bowel disease, sudden, persistent change in bowel habits. Interactions: No known drug interactions. Adverse Reactions: Rarely, abdominal discomfort & diarrhoea. Sodium Sulphate Anhydrous, Sodium Chloride, Sodium Bicarbonate & Potassium Chloride Powder/Solution A06AD10921L9901XX (A) C o l o n i c L a v a g e - Trade Name System: Gastro-Intestinal Indications: Bowel cleansing before colonic surgery, colonoscopy, or radiological examination to ensure the bowel is free of solid contents. It is not to be used for treatment of constipation. Dosage: Adult : 3 - 4 litres. Child : 30 ml/kg/hr over 4 - 8 hrs (until rectal effluent is clear). Contraindications: Dehydration, severe heart failure, colonic disease, actual or suspected ileus or intestinal occlusion, children. 22

Precautions: Pregnancy, renal impairment, heart disease, ulcerative colitis, reflux oesophagitis, preexisting electrolyte disturbances. Interactions: Diarrhoea is likely to result in considerable perturbation of the absorption of simultaneously administered drugs. Adverse Reactions: Nausea, bloating, vomiting. Lactulose 3.35 g/5 ml Liquid Duphalac - Trade Name
A06AD11000L5001XX (A/KK) NEDL

System: Gastro-Intestinal Indications: i) Constipation ii) Hepatic encephalopathy Dosage: i) 15 ml bd adjusted to patient's need. Paed: 0.5 ml/kg/dose bd or once dly. ii) 30-50 ml tds or qid, dose adjusted to produce 2 - 3 soft stools dly. Child: 1 ml/kg/dose tds - qid. Contraindications: Galactosaemia, intestinal obstruction. Precautions: Diabetics, patients with lactose intolerance, pregnancy, lactation. Interactions: Response may be altered by anti-infective agents. Adverse Reactions: Flatulence, cramps and abdominal discomfort. Sodium Biphosphate 16% & Sodium Phosphate 6% Enema Fleet enema
A06AG01162G2001XX (A)
- Trade Name

System: Gastro-Intestinal Indications: Bowel cleansing before colonic surgery, colonoscopy, or radiological examination to ensure the bowel is free of solid contents. It is not to be used for treatment of constipation. Dosage: Adult : 133 ml (1 bottle) administered rectally. Child > 2yrs : half the adult dose. Contraindications: Gastro-intestinal obstruction, gastric retention, gastrointestinal ulceration, perforated bowel, congestive cardiac failure, toxic colitis, toxic megacolon or ileus. Precautions: Pregnancy, renal impairment, heart disease, ulcerative colitis, diabetes mellitus, reflux oesophagitis, impaired gag reflex, unconscious or semiconscious or possibility of regurgitation or aspiration, preexisting electrolyte disturbances. Interactions: No interaction found. Adverse Reactions: Local irritation & tenesmus. Monobasic Sodium Phosphate 48 %, Dibasic Sodium Phosphate 18% F l e e t P h o s p h o- s o d a
A06AG01162L5001XX (A)
- Trade Name

System: Gastro-Intestinal

23

Indications: Bowel cleansing prior to colonoscopy, radiological examination or bowel surgery. Dosage: 45ml diluted with half a glass (120ml) of water, followed by one full glass (240ml) of water to be taken depending on the time of the procedure. For morning procedure, 45ml dilute with half glass of water should be taken at 7 am and the second 45mls at 7 pm on the day before the procedure. For afternoon procedure, the first dose should be taken at 7pm on the day before and the second dose at 7 am on the day of the procedure. Solid food must not be taken during the preparation period ; clear fluids or water can be taken liberally. Not recommended for use in children. Contraindications: Gastro-intestinal obstruction, gastric retention, gastrointestinal ulceration, perforated bowel, congestive cardiac failure, toxic colitis, toxic megacolon or ileus. Precautions: Pregnancy, renal impairment, heart disease, ulcerative colitis, diabetes mellitus, reflux oesophagitis, impaired gag reflex, unconscious or semiconscious or possibility of regurgitation or aspiration. Interactions: No known drug interactions. Adverse Reactions: Nausea and bloating, abdominal cramps, vomiting. Sodium Biphosphate 16 %, Sodium Phosphate 6 % Solution Fleet solution
A06AG01162L9901XX (A)
- Trade Name

System: Gastro-Intestinal Indications: Bowel cleansing before colonic surgery, colonoscopy, or radiological examination to ensure the bowel is free of solid contents. It is not to be used for treatment of constipation. Dosage: 45 ml diluted with half a glass (120 mL) of water, followed by one full glass (240 mL) of water. Timing of doses is dependent on the time of the procedure For morning procedure, first dose should be taken at 7 a.m. and second at 7 p.m. on day before the procedure For afternoon procedure, first dose should be taken at 7 p.m. on day before and second dose at 7 a.m. on day of the procedure. Solid food should not be taken during the bowel preparation period; However clear fluids or water can be taken liberally. Not recommended for use in children under 12 years. Contraindications: Gastro-intestinal obstruction, gastric retention, gastrointestinal ulceration, perforated bowel, congestive cardiac failure, toxic colitis, toxic megacolon or ileus. Precautions: Pregnancy, renal impairment, heart disease, ulcerative colitis, diabetes mellitus, reflux oesophagitis, impaired gag reflex, unconscious or semiconscious or possibility of regurgitation or aspiration. Preexisting electrolyte disturbances. Interactions: No known interactions. Adverse Reactions: Nausea, bloating; less frequently abdominal cramps and 24

vomiting. Sodium Citrate, Sodium Lauryl Sulphoacetate, Glycerin, Sorbitol, Sorbic Acid Enema A06AG11921G2001XX (A/KK) Microlax - Trade Name System: Gastro-Intestinal Indications: Constipation, preparation for sigmoidoscopy, pre and postoperative use. Dosage: 5 ml rectally. Contraindications: Acute gastro-intestinal conditions. Precautions: Elderly and debilitated. Interactions: No known interactions. Adverse Reactions: Slight cramps, tenesmus. Glycerin 25 % & Sodium Chloride 15 % Disposable Enema Ravin
- Trade Name

A06AG20921G2001XX (C) NEDL APPL

System: Gastro-Intestinal Indications: Constipation. Dosage: 1 enema as required. Contraindications: Hypersensitivity to any component in the preparation. Precautions: Frequent or prolonged use of laxatives may result in dependence. Interactions: No interaction found. Adverse Reactions: Rectal discomfort, burning sensation. Glycerin System: Ear, Nose and Oropharynx Indications: As a lubricant. Dosage: Apply to area prn. Contraindications: Not known. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: Irritation. Nystatin 100,000 units/ml Suspension Mycostatin - Trade Name
A07AA02000L8001XX (B) NEDL A06AX01000L5001XX (C) NEDL

System: Antiinfectives Indications: Prevention and treatment of cutaneous or mucocutaneous infections caused by Candida albicans. Dosage: 25

Newborn : 50,000 - 100,000 units daily. Child : Up to 5 yrs: 100,000 units 6 hrly. 6 - 12 yrs and Adults : 500,000 units qid . Continue treatment for > 48 hrs after clinical care. Contraindications: Patients with a history of hypersensitivity to any of the compound. Precautions: Not intended to treat systemic mycoses. If hypersensitivity develops, discontinue use. Interactions: No interactions found. Adverse Reactions: GastrointestinaI disturbances, rash. Nystatin 500,000 units Tablet Mycostatin - Trade Name
A07AA02000T1001XX (B) NEDL APPL

System: Antiinfectives Indications: Prevention and treatment of infections caused by candida albicans in the oral cavity, intestinal candidiasis and protection against candidas overgrowth during antimicrobial /corticosteroid therapy. Dosage: Adult : 500,000 units 6 hrly, doubled in severe infections. Child : 100,000 500,000 units 6 hrly. Contraindications: Patients with a history of hypersensitivity to any of the compound. Precautions: Not intended to treat systemic mycoses. If hypersensitivity develops, discontinue use. Interactions: No interactions found. Adverse Reactions: GastrointestinaI disturbances, rash. Charcoal, Activated 250 mg Tablet
A07BA01000T1001XX (C)

System: Emergency Indications: i) Diarrhoea and food poisoning. ii) Reduction of absorption in poisoning by most drugs and chemicals. Dosage: i) Adult : 500 mg - 1 g tds - qid. Child : 1/2 adult dose. ii) 200 tabs (50 g) dissolved in liquid every 4 hrs or 25 g every 2 hrs. Contraindications: An unprotected airway, gastrointestinal tract not anatomically intact. Precautions: Aspiration of charcoal, hydrocarbons, corrosive, imaging of gastroesophageal. Interactions: Acarbose, carbamazepine, digoxin, frusemide, olanzapine, phenytoin : decreased effectiveness of these drugs. Adverse Reactions: Black stools, vomiting, gastrointestinal obstruction. Oral Rehydration Salt System: Nutrition and Blood Disorder
A07CA00905F2101XX (C)NEDL

26

Indications: For hypotonicity, dehydration resulting from diarrhoea, vomiting and physical exercise. Dosage: Adult: 200 - 400 ml ( 1 - 2 sachets ) for every loose motion. Child : 200 ml for every loose motion. Infant : 1 - 1.5 times their usual feed volume. Contraindications: Patients with renal failure or hyperkalaemia. Precautions: Cardiac failure, hypertension, impaired renal function, peripheral and pulmonary oedema, toxaemia in pregnancy. Interactions: Potassium sparing diuretics. Adverse Reactions: Hypernatraemia, retention of sodium and water, nausea and vomiting. Diphenoxylate with Atropine Sulphate Tablet A07DA01922T1001XX (B) NEDL APPL Lomotil - Trade Name System: Gastro-Intestinal Indications: Acute Diarrhoea. Dosage: Adult: Initially 4 tab followed by 2 tab qid until diarrhoea is controlled. Contraindications: Hypersensitivity to diphenoxylate HCl or atropine, jaundice, acute diarrhoeal conditions like antibiotic associated diarrhoea, pseudomembranous enterocolitis, acute ulcerative colitis & infective diarrhoeas. Paralytic Ileus & Aganglionosis. Not recommended for use in children. Precautions: Advanced hepatorenal disease, abnormal liver function. Down's syndrome. Interactions: Barbiturates, tranquilizers, alcohol, MAOIs. Adverse Reactions: Euphoria, paraesthesia, CNS effects, angioneurotic oedema & other allergic reactions, toxic megacolon, paralytic ileus, GI disturbance. Atropine effects : Hyperthermia, tachycardia, urinary retention, flushing, dry skin & mucous membranes. Loperamide 2 mg Capsule Imodium - Trade Name
A07DA03110C1001XX (B)

System: Gastro-Intestinal Indications: Adjunct to rehydration in acute diarrhoea in adult, also in chronic diarrhoea in adult. Dosage: Acute diarrhoea : Adult : 4 mg stat, followed by 2 mg after each unformed stool (up to 5 days). Usual 6 - 8 mg dly. Max : 16 mg dly. Chronic diarrhoea : Initially 4 - 8 mg dly in divided doses, adjust according to response. Max : 16 mg dly. Contraindications: Children younger than 2 years of age, hypersentivity to the drug. Infective or antibiotic induced colitis. Precautions: Hepatic dysfunction; acute dysentery, acute ulcerative colitis with abdominal distension (discontinue use), children < 6 yr, lactation & pregnancy. 27

Interactions: Increased risk of severe constipation when used with opioid analgesics. Adverse Reactions: Abdominal pain, constipation, nausea, vomiting, toxic megacolon, dry mouth, drowsiness, dizziness, fatigue. Hydrocortisone Enema 0.17 %
A07EA02000G2001XX (B)

System: Gastro-Intestinal Indications: Adjunctive treatment for ulcerative colitis and proctitis. Dosage: Adult : 100 mg 1 - 2 times/day for 2 - 3 wks. If used for longer than 3 weeks, taper treatment over 2 - 3 weeks. Contraindications: Hypersensitivity, bowel obstruction & perforation, extensive fistulas. Precautions: Prolonged use, untreated infection. Interactions: No interaction found. Adverse Reactions: Local irritation. Salicylazosulphapyridine (Sulphasalazine) 500 mg Tablet Salazopyrin
A07EC01000T1001XX (A/KK)
- Trade Name

System: Gastro-Intestinal Indications: i) Treatment of Inflammatory bowel disease (Ulcerative colitis and Crohn's disease) ii) Rheumatoid arthritis. Dosage: i) During an acute attack 12 g 4 times daily until remission occurs (if necessary corticosteroids may also be given), reducing to a maintenance dose of 500 mg 4 times daily; Children over 2 years, acute attack 4060 mg/kg daily, maintenance dose 20 30 mg/kg daily ii) Initially, 0.5-1 gram/day as once daily or twice daily divided doses; maintenance with 1 gram twice daily up to a maximum of 3 grams/day Juvenile rheumatoid arthritis: (6 yrs and older) 30-50 mg /kg/day in 2 evenly divided doses up to a maximum of 2 grams/day. Contraindications: Hypersensitivity to sulfonamides & salicylates, acute intermittent porphyria, and children < 2 yr. Precautions: Hepatic or renal impairment; G6PD deficiency; risk of haematological and hepatic toxicity (differential white cell, red cell and platelet counts initially and at monthly intervals for first 3 months, liver function tests at monthly intervals for first 3 months); kidney function tests at regular intervals; upper gastro-intestinal side-effects common over 4 g daily; porphyria. Interactions: Reduced absorption of folate & digoxin. Adverse Reactions: Nausea, anorexia; fever; blood disorders (megaloblastic anaemia); hypersensitivity reactions (including exfoliative dermatitis, epidermal necrolysis, pruritus, photosensitisation, anaphylaxis, serum sickness); ocular complications (including periorbital oedema); stomatitis, parotitis; ataxia, 28

aseptic meningitis, vertigo, tinnitus, insomnia, depression, hallucinations; kidney reactions (including proteinuria, crystalluria, haematuria); oligospermia; urine may be coloured orange. Mesalazine 6.67 % w/w Enema S a l o f a l k - Trade Name
A07EC02259G2001XX (A) NEDL

System: Gastro-Intes tinal Indications: i) Inflammatory bowel disease (patients who cannot tolerate or do not respond to Sulphasalazine) ii) Treatment of distal ulcerative colitis. Dosage: Dose : 60 ml (4 g) at bedtime, retained overnight, approx. 8 hrs. Contraindications: Severe hepatic & renal function disorders, active peptic ulcer, blood clotting abnormalities, babies & infants. Precautions: Pregnancy, lactation, elderly. Interactions: Sulfonylureas, coumarins, methotrexate, probenecid, sulfinpyrazone, frusemide, rifampicin. Adverse Reactions: Allergic exanthema, drug fever, bronchospasm, lupus erythematosus-like syndrome, hepatitis, pancreatitis. Mesalazine 250 mg Suppository S a l o f a l k - Trade Name
A07EC02259S2001XX (A)

System: Gastro-Intestinal Indications: i) Infl ammatory bowel disease (patients who cannot tolerate or do not respond to Sulphasalazine) ii) Treatment of ulcerative proctitis. Dosage: Insert 1 g suppository in rectum dly or 3 - 6 suppository of 250 mg dly in divided doses, with last dose at bedti me. Contraindications: Severe hepatic & renal function disorders, active peptic ulcer, blood clotting abnormalities, babies & infants. Precautions: Pregnancy, lactation, elderly. Interactions: Sulfonylureas, coumarins, methotrexate, probenecid, sulfinpyraz one, frusemide, rifampicin. Adverse Reactions: Allergic exanthema, drug fever, bronchospasm, lupus erythematosus-like syndrome, hepatitis, pancreatitis. Mesalazine 1 g Suppository S a l o f a l k - Trade Name
A07EC02259S2002XX (A)

System: Gastro-Intestinal Indications: i) Inflammatory bowel disease (patients who cannot tolerate or do not respond to Sulphasalazine) ii) Treatment of ulcerative proctitis. Dosage: Insert 1 g suppository in rectum dly or 3 - 6 suppository of 250 mg dly in 29

divided doses, with last dose at bedtime. Contraindications: Severe hepatic & renal function disorders, active peptic ulcer, blood clotting abnormalities, babies & infants. Precautions: Pregnancy, lactation, elderly. Interactions: Sulfonylureas, coumarins, methotrexate, probenecid, sulfinpyrazone, frusemide, rifampicin. Adverse Reactions: Allergic exanthema, drug fever, bronchospasm, lupus erythematosus-like syndrome, hepatitis, pancreatitis. Mesalazine 250 mg Tablet Mesalazine 500 mg Tablet S a l o f a l k - Trade Name
A07EC02259T1001XX (A) A07EC02259T1002XX (A)NEDL

System: Gastro-Intestinal Indications: i) Inflammatory bowel disease (patients who cannot tolerate or do not respond to Sulphasalazine) ii) Ulcerative colitis iii) Crohn's disease Dosage: Adult : 250 - 500 mg 3 - 4 times dly for 3 - 6 wks. Child > 2 yrs with Crohn's disease : 20 - 30 mg/dly in divided doses. Contraindications: Severe hepatic & renal function disorders, active peptic ulcer, blood clotting abnormalities, babies & infants. Precautions: Pregnancy, lactation, elderly. Interactions: Sulfonylureas, coumarins, methotrexate, probenecid, sulfinpyrazone, frusemide, rifampicin. Adverse Reactions: Allergic exanthema, drug fever, bronchospasm, lupus erythematosus-like syndrome, hepatitis, pancreatitis. Pancreatic Enzymes Tablet
A09AA00000T1001XX (B)

System: Gastro-Intestinal Indications: Replacement or supplemental therapy for digestive disorders associated with exocrine pancreatic insufficiency. Dosage: 2 - 3 tab with each meal. The dose may need to be adjusted according to size, number and consistency of stools. Contraindications: Hypersensitivity reaction to the ingredients (porcine protein). Precautions: Obstruction of the bile ducts. Interactions: Acarbose, cimetidine, ciprofloxacin, folic acid, ranitidine. Adverse Reactions: Perioral & perianal irritation, skin rash, gastro-intestinal disturbance, hyperuricaemia, hyperuricosuria, uric acid crystalluria. Pancreatic Enzymes & Vitamins Tablet E n z y p l e x - Trade Name System: Gastro-Intestinal Indications: 30
A09AC00924T1001XX (B)NEDL

Replacement or supplemental therapy for digestive disorders associated with exocrine pancreatic insufficiency. Dosage: 1 - 2 tab with each meal. Contraindications: Hypersensitivity reaction to the ingredients (porcine protein). Precautions: Obstruction of the bile ducts. Interactions: Acarbose, cimetidine, ciprofloxacin, folic acid, ranitidine. Adverse Reactions: Perioral & perianal irritation, skin rash, gastro-intestinal disturbance hyperuricaemia, hyperuricosuria, uric acid crystalluria. Insulin Recombinant Neutral Human short-acting 100IU/ml Injection in 10ml vial A10AB01000P3001XX (B)APPL A c t r a p i d , H u m u l i n - Trade Name System: Endocrine Indications: Treatment of insulin dependent diabetes mellitus, also non insulin-dependent diabetes unresponsive to treatment to diet and or oral hypoglycaemia; hyperkalaemia; to assure proper utilisation of glucose and reduce glucosuria in non diabetic patients receiving parenteral nutrition. Dosage: Dose to be individualised. Contraindications: Hypoglyacemia, insulinoma. Precautions: Psychic stress, infection, pregnancy. Interactions: MAOIs, alcohol, corticosteroid, oral contraceptives. Adverse Reactions: Rare incidence of allergy & lipoatrophy. Insulin Recombinant Synthetic Human, short-acting 100 IU/ml Penfill and Refill A10AB01000P5001XX (A/KK) A c t r a p i d - Trade Name System: Endocrine Indications: Insulin-dependent diabetes mellitus, non insulin-dependent diabetes unresponsive to treatment to diet/ or oral hypoglycaemics; hyperkalaemia to assure proper utilisation of glucose and reduce glucosuria in non diabetic patients receiving parenteral nutrition. Dosage: Dose to be individualised. Contraindications: Hypoglyacemia, insulinoma. Precautions: Psychic stress, infection, pregnancy. Interactions: MAOIs, alcohol, corticosteroid, oral contraceptives. Adverse Reactions: Rare incidence of allergy & lipoatrophy. Insulin Recombinant Synthetic human, intermediate-acting 100 IU/ml Injection in10ml vial A10AC01000P3001XX (B) Hu m i l i n , I n s u l a t a r d - Trade Name System: Endocrine Indications: 31

Insulin-dependent diabetes mellitus, non insulin-dependent diabetes unresponsive to treatment to diet or oral hypoglycaemics; hyperkalaemia; to assure proper utilisation of glucose and reduce glucosuria in non diabetic patients receiving parenteral nutrition. Dosage: Dose to be individualised. Contraindications: Hypoglyacemia, insulinoma. Precautions: Psychic stress, infection, pregnancy. Interactions: MAOIs, alcohol, corticosteroid, oral contraceptives. Adverse Reactions: Rare incidence of allergy & lipoatrophy. Insulin Recombinant Synthetic Human, Intermediate-acting 100 IU/ml Penfill and Refill A10AC01000P5001XX (A) I n s u l a t a r d - Trade Name System: Endocrine Indications: Insulin-dependent diabetes mellitus, non insulin-dependent diabetes unresponsive to treatment to diet/ or oral hypoglycaemics; hyperkalaemia to assure proper utilisation of glucose and reduce glucosuria in non diabetic patients receiving parenteral nutrition. Dosage: Dose to be individualised. Contraindications: Hypoglyacemia, insulinoma. Precautions: Psychic stress, infection, pregnancy. Interactions: MAOIs, alcohol, corticosteroid, oral contraceptives. Adverse Reactions: Rare incidence of allergy & lipoatrophy. Insulin Recombinant Synthetic human, pre-mixed 100 IU/ml Injection in10ml vial A10AD01000P3001XX (B) M i x t a r d - Trade Name System: Endocrine Indications: Insulin-dependent diabetes mellitus, non insulin-dependent diabetes unresponsive to treatment to diet or oral hypoglycaemics; hyperkalaemia; to assure proper utilisation of glucose and reduce glucosuria in non diabetic patients receiving parenteral nutrition. Dosage: Dose to be individualised. Contraindications: Hypoglyacemia, insulinoma. Precautions: Psychic stress, infection, pregnancy. Interactions: MAOIs, alcohol, corticosteroid, oral contraceptives. Adverse Reactions: Rare incidence of allergy & lipoatrophy. Insulin Recombinant Synthetic Human, pre-mixed 100 IU/ml Penfill and Refill Mixtard
A10AD01000P5001XX (A)
- Trade Name

System: Endocrine Indications: 32

Insulin-dependent diabetes mellitus, non insulin-dependent diabetes unresponsive to treatment to diet/ or oral hypoglycaemics; hyperkalaemia to assure proper utilisation of glucose and reduce glucosuria in non diabetic patients receiving parenteral nutrition. Dosage: Dose to be individualised. Contraindications: Hypoglyacemia, insulinoma. Precautions: Psychic stress, infection, pregnancy. Interactions: MAOIs, alcohol, corticosteroid, oral contraceptives. Adverse Reactions: Rare incidence of allergy & lipoatrophy. Metformin HCl 500 mg Tablet Glucophage - Trade Name
A10BA02110T1001XX (B) NEDL APPL

System: Endocrine Indications: Diabetes mellitus. Dosage: 500 mg tds or 850 mg 12 hrly with food; max : 3 g dly in 3 divided doses. Contraindications: Diabetic coma, ketoacidosis, renal impairment, chronic liver disease, cardiac failure, hypoxaemia, history of lactic acidosis. Precautions: Dehydration, serious infection or trauma, patients undergoing surgery, pregnancy, lactation, children. Monitor serum B12 levels annually. Interactions: Alcohol, sulfonylureas, cimetidine, anticoagulants Adverse Reactions: Metallic taste, epigastric discomfort, nausea, vomiting, decreased vit. B12 absorption. Rarely, diarrhoea, anorexia. Glibenclamide 5 mg Tablet D a o n i l - Trade Name
A10BB01000T1001XX (B) NEDL APPL

System: Endocrine Indications: Diabetes mellitus. Dosage: Range : 2.5 - 15 mg dly. (with or immediately after breakfast). Initially 2.5 mg dly increasing by 2.5 mg required for metabolic control. Max : 15 mg dly. Contraindications: Type 1 Diabetes Mellitus, diabetic coma, severe renal or renal impairment, pregnancy Precautions: Cross-sensitivity to sulphonamides & its derivatives. Interactions: Alcohol, beta blockers, biguanides, MAOIs. Adverse Reactions: GI disturbance, blood dyscrasia. Chlorpropamide 250 mg Tablet D i a b e n e s e - Trade Name System: Endocrine
A10BB02000T1001XX (B) NEDL APPL

33

Indications: Type 2 Diabetes mellitus. Dosage: Initial dose : 250 - 500 mg daily. Maintenance : 100 - 375 mg daily. Contraindications: Juvenile or child onset DM, severe or unstable brittle diabetes, pregnancy. Precautions: Can cause hypoglycaemia especially in the elderly and patients with hepatic or renal insufficiency. Interactions: MAOIs, chloramphenicol, probenecid, alcohol. Adverse Reactions: Jaundice, disulfiram-like reactions. Gliclazide 80 mg Tablet Diamicron - Trade Name
A10BB09000T1001XX (A/KK) APPL

System: Endocrine Indications: Type II Diabetes mellitus. Dosage: Initially 40 - 80 mg dly. Total daily dose may vary from 80 - 320 mg orally. Adjust dose according to patient's individual response. Contraindications: Type 1 Diabetes, pregnancy, diabetic coma. Precautions: Hepatic and renal impairment. Interactions: Potentiate effect of hypoglycaemia with alcohol, sulphonamides, salicylates, phenylbutazone, beta blockers. Adverse Reactions: Nausea, headache, rashes, GI disturbance. Gliclazide 30mg Modified Release Tablet Diamicron MR - Trade Name
A10BB09000T5002XX (A*)

System: Endocrine Indications: Type 2 Diabetes. Dosage: One tablet daily, adjust according to response every 4 weeks; max. 120 mg dly. Contraindications: Type 1 diabetes. Severe renal or hepatic insufficiency, diabetic ketoacidosis, diabetic precoma. Pregnancy & lactation. Avoid concomitant treatment with miconazole preparation. Precautions: Hepatic and or renal impairment. Hypoglycaemia may occur with reduced dietary intake or too high doses. Interactions: Potentiates hyperglycaemia with danazol, chlorpromazine, glucocorticoids, progestogens, beta2 agonist. Potentiated hypoglycaemic effect with sulfonamides, salicylates, phenylbutazone, beta-blockers, alcohol, H2 antagonists, NSAIDs, ACE inhibitors, MAOIs, fluconazole, ketoconazole & miconazole. Diminished hypoglycaemic effect with thiazide diuretics, corticosteroids & oestrogens. Adverse Reactions: Nausea, headache, rashes & GI disturbances. Rarely, haematological disorders.

34

Acarbose 50 mg Tablet Glucobay - Trade Name

A10BF01000T1001XX (A/KK)

System: Endocrine Indications: Only for treatment of (i) NIDDM when diet therapy is insufficient. (ii) NIDDM in combination with existing conventional oral therapy where glycaemic control is inadequate. Dosage: Initially 50 mg dly, increase to tds up to 100 mg tds. Max. 200 mg tds. Contraindications: Patients < 18yrs, chronic intestinal disorders associated with distinct disturbances of digestion & absorption, conditions which may deteriorate as a result of increased intestinal gas formation, pregnancy, lactation, severe renal impairment. Precautions: Asymptomatic liver enzyme elevations especially at higher dosages. Interactions: Cholestyramine, intestinal absorbents, digestive enzymes. Adverse Reactions: Flatulence & bowel sounds, diarrhoea & abdominal pain. Rosiglitazone 8 mg Tablet A v a n d i a - Trade Name
A10BG02000T1001XX (A*)

System: Endocrine Indications: Diabetes mellitus with insulin resistant features; combined with sulphonylureas, metformin, acarbose and or insulin; delays introduction of insulin in type 2 diabetes mellitus already on maximal doses of two or more oral hypoglycaemic agents. Dosage: 4 mg once daily or in 2 divided doses; may be increased to 8 mg/day in 1-2 divided doses after 12 wk. Contraindications: Hepatic impairment, history of heart failure, combination with insulin (risk of heart failure), pregnancy and breast feeding, diabetic ketoacidosis, hypersensitivity to rosiglitazone product. Precautions: Active liver disease, alanine transaminase levels > 2.5 times upper limit of normal; CHF (class I-II), diabetes mellitus Type I, oedema, lack of adequate contraception in premenopausal anovulatory women. Interactions: Gemfibrozil. Adverse Reactions: Headache, anaemia, hepatotoxicity, weight gain, oedema, Repaglinide 2mg Tablet N o v o n o r m - Trade Name
A10BX02000T1001XX (A*)

System: Endocrine Indications: NIDDM where hyperglycaemia cannot be controlled by diet, weight reduction and exercise. May be used alone or with metformin. Dosage: 0.5 mg within 30 min. before main meal. If patients are transferred from another 35

oral hypoglycaemic agent. Start dose with 1 mg before each main meal. Max single dose: 4mg before each main meal. Max 16 mg/day. Contraindications: Type 1 diabetes, diabetic ketoacidosis with or without coma. Pregnancy, lactation. Children < 12 years. Severe hepatic impairment, concomitant therapy with medicinal products which are CYP3A4 inhibitors or inducers. Precautions: Patients > 75 yr, debilitated or malnourished patients, renal impairment. Interactions: Gemfibrozil, itraconazole. Adverse Reactions: Hypoglycaemia, transient visual disturbances, GI disturbances, hypersensitivity reactions of skin, arthralgia. Pre/Post-Natal Vitamin & Mineral Capsule
A11AA03903C1001XX (B)

System: Nutrition and Blood Disorder Indications: Vitamin and mineral supplement for use during pregnancy and lactation. Dosage: 1 tab dly. Contraindications: Hypersensitivity to product components. Precautions: Severe renal or liver failure. Interactions: No interaction found. Adverse Reactions: Hypervitaminosis. Pre/Post-Natal Vitamin & Mineral Tablet
A11AA03903T1001XX (B)

System: Nutrition and Blood Disorder Indications: A vitamin and mineral supplement for use during pregnancy and lactation. Dosage: 1 tab dly. Contraindications: Hypersensitivity to product components. Precautions: Severe renal or liver failure. Interactions: No interaction found. Adverse Reactions: Hypervitaminosis. Multivitamin Drops A b d e c - Trade Name
A11BA00901D5001XX (B) NEDL

System: Nutrition and Blood Disorder Indications: For prevention and treatment of vitamin deficiencies. Dosage: Abdec: 0.6 ml daily. Vidaylin: 1 dropperful daily. Contraindications: Hypersensitivity to product components. Precautions: Severe renal or liver failure. Interactions: No interaction found. Adverse Reactions: Hypervitaminosis.

36

Multivitamin Syrup

A11BA00901L9001XX (C) NEDL

System: Nutrition and Blood Disorder Indications: For prevention and treatment of vitamin deficiencies. Dosage: 5 ml daily. Contraindications: Hypersensitivity to product components. Precautions: Severe renal or liver failure. Interactions: No interaction found. Adverse Reactions: Hypervitaminosis. Multivitamin Injection P a r e n t r o v i t e - Trade Name
A11BA00901P3001XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: For prevention and treatment of vitamin deficiencies. Dosage: Initially 2 - 4 pairs IV 4 - 8 hrly, reducing to 1 pair IV dly. For less serious cases, 1 pair IV 1 - 2 times dly. Contraindications: Hypersensitivity to product components. Precautions: Severe renal or liver failure. Interactions: Pyridoxine will antagonise the therapeutic effect of L-dopa (should not be administered concurrently), vitamin B6 reduces the plasma levels of phenobarbitone and phenytoin, ascorbic acid increases plasma level of ethinyloestradiol. Adverse Reactions: Hypervitaminosis, high doses may induce paraesthesia and hypotension. Multivitamin Tablet
A11BA00901T1001XX (B) NEDL

System: Nutrition and Blood Disorder Indications: For prevention and treatment of vitamin deficiencies. Dosage: Dose : 1 - 2 tab daily. Contraindications: Hypersensitivity to product components. Precautions: Severe renal or liver failure. Interactions: No interaction found. Adverse Reactions: Hypervitaminosis. Vitamin A 50,000 IU Capsule System: Nutrition and Blood Disorder
A11CA01000C1001XX (B)

37

Indications: Children with measles malnutrition and serious infections. Category C can use this drug for Orang Asli & in Sabah. Dosage: i) 0-5 mths, 50,000 IU ii) 6-11 mths, 100,000 IU iii) 1-5 yrs, 200,000 IU. Frequency twice daily. Contraindications: Hypersensitivity to Vitamin A, hypervitaminosis A, pregnancy (dose exceeding RDA) Precautions: Pregnant women. Interactions: Cholestyramine decreases absorption of vitamin A,retinoids may have additive adverse effects,neomycin and mineral oil may also interfere with vitamin A absorption. Adverse Reactions: Massive overdose can cause rough skin,dry hair,enlarge liver and raised erythrocyte sedimentation rate and raised serum calcium and serum alkaline phosphatase concentrations. Vitamin A 100,000 IU Capsule
A11CA01000C1002XX (B)

System: Nutrition and Blood Disorder Indications: Children with measles malnutrition and serious infections. Category C can use this drug for Orang Asli & in Sabah. Dosage: i) 0-5 mths, 50,000 IU ii) 6-11 mths, 100,000 IU iii) 1-5 yrs, 200,000 IU. Frequency twice daily. Contraindications: Hypersensitivity to Vitamin A, hypervitaminosis A, pregnancy (dose exceeding RDA) Precautions: Pregnant women. Interactions: Cholestyramine decreases absorption of vitamin A,retinoids may have additive adverse effects,neomycin and mineral oil may also interfere with vitamin A absorption. Adverse Reactions: Massive overdose can cause rough skin,dry hair,enlarge liver and raised erythrocyte sedimentation rate and raised serum calcium and serum alkaline phosphatase concentrations. Vitamin A 200,000 IU Capsule
A11CA01000C1003XX (B)

System: Nutrition and Blood Disorder Indications: Children with measles malnutrition and serious infections. Category C can use this drug for Orang Asli & in Sabah. Dosage: i) 0-5 mths, 50,000 IU ii) 6-11 mths, 100,000 IU iii) 1-5 yrs, 200,000 IU. Frequency twice daily. Contraindications: Hypersensitivity to Vitamin A, hypervitaminosis A, pregnancy (dose exceeding RDA) Precautions: Pregnant women. 38

Interactions: Cholestyramine decreases absorption of vitamin A,retinoids may have additive adverse effects,neomycin and mineral oil may also interfere with vitamin A absorption. Adverse Reactions: Massive overdose can cause rough skin,dry hair,enlarge liver and raised erythrocyte sedimentation rate and raised serum calcium and serum alkaline phosphatase concentrations. Vitamin A & D (Cod Liver Oil)
A11CB00901L5001XX (C) NEDL

System: Nutrition and Blood Disorder Indications: Prevention of ricketts. Dosage: Not more than 10 ml daily, allowance being made for Vitamin D obtained from other sources. Contraindications: Persons with hypervitaminosis A, oral preparations are not indicated for treating Vitamin A deficiency in persons with malabsorption syndromes etiologic for this deficiency, hypercalcaemia, metastatic calcification, hypersensitivity to vitamin A, vitamin D toxicity and hypersensitivity . Precautions: Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration, pregnancy, patient with arteriosclerosis, heart disease or renal stones. Interactions: Phenobarbital, phenytoin, anticoagulants, cholestyramine, minocycline. Adverse Reactions: Hypercalcaemia, nephrotoxicity, nausea, vomiting, constipation, anaemia, polydipsia, polyuria, hypoprothrombinaemia, seizures, drowsiness, irritability, headache, insomnia, somnolence, severe depression, psychosis and chronic liver damage, gingivitis, hepatotoxicity, alopecia, osteoporosis. Vitamin A & D Concentrate 25,000units/0.6ml Liquid A11CB00901L5002XX (B)
NEDL

System: Nutrition and Blood Disorder Indications: Prevention of ricketts. Dosage: 0.06-0.6ml (2,500-25,000 U of Vit A and 250-2,500 U of D)dly, allowance being made for A & D obtained from other sources. Contraindications: Persons with hypervitaminosis A,oral preparations are not indicated for treating vitamin A deficiency in persons with malabsorption syndromes etiologic for this deficiency,hypercalcaemia, metastatic calcification, hypersensitivity to vitamin A, vitamin D toxicity and hypersensitivity . Precautions: Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration, pregnancy, patient with arteriosclerosis, heart disease or renal stones. Interactions: Phenobarbital, phenytoin, anticoagulants, cholestyramine, minocycline. 39

Adverse Reactions: Hypercalcaemia, nephrotoxicity, nausea, vomiting, constipation, anaemia, polydipsia, polyuria, hypoprothrombinaemia, seizures, drowsiness, irritability, headache, insomnia, somnolence, severe depression, psychosis and chronic liver damage, gingivitis, hepatotoxicity, alopecia, osteoporosis. Alfacalcidol 0.25 mcg Capsule R o c a l t r o l - Trade Name
A11CC03000C1001XX (A/KK) APPL

System: Nutrition and Blood Disorder Indications: To be used only for the treatment of: (1) renal osteodystrophy in patients on haemodialysis (2) post-thyroidectomy hypoparathyroidism (3) primary hypoparathyroidism (4) pseudohypoparathyroidism and (5) hypophosphatemic rickets/osteomalacia (6) post menopausal osteoporosis. Dosage: 0.5 - 1 mcg/day. Contraindications: Hypercalcaemia, metastatic calcification, vitamin D toxicity and hypersensitivity to calcitriol products. Precautions: Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration. Interactions: Antiepileptics and diuretics. Adverse Reactions: Hypercalcaemia, nausea, vomiti ng, polydipsia, polyuria. Alfacalcidol 1 mcg Capsule R o c a l t r o l - Trade Name
A11CC03000C1002XX (A/KK) APPL

System: Nutrition and Blood Disorder Indications: To be used only for the treatment of: (1) renal osteodystrophy in patients on haemodialysis (2) post-thyroidectomy hypoparathyroidism (3) primary hypoparathyroidism (4) pseudohypoparathyroidism and (5) hypophosphatemic rickets/osteomalacia (6) post menopausal osteoporosis. Dosage: 0.5 - 1 mcg/day. Contraindications: Hypercalcaemia, metastatic calcification, vitamin D toxicity and hypersensitivity to calcitriol products. Precautions: Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration. Interactions: Antiepileptics and diuretics. Adverse Reactions: Hypercalcaemia, nausea, vomiting, polydipsia, polyuria. Alfacalcidol 2 mcg/ml Drops O n e-A l p h a - Trade Name System: Nutrition and Blood Disorder
A11CC03000D5001XX (A*) NEDL

40

Indications: To be used only for the treatment of: (1) renal osteodystrophy in patients on haemodialysis (2) post-thyroidectomy hypoparathyroidism (3) primary hypoparathyroidism (4) pseudohypoparathyroidism and (5) hypophosphatemic rickets/osteomalacia. Dosage: Neonates and prematures: 50 -100 nanograms/kg daily. Child less than 20 kg : 50 nanograms/kg daily. Contraindications: Hypercalcaemia, metastatic calcification, vitamin D toxicity and hypersensitivity to calcitriol products. Precautions: Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration. Interactions: Antiepileptics and diuretics. Adverse Reactions: Hypercalcaemia, nausea, vomiting, polydipsia, polyuria. Alfacalcidol 2 mcg/ml Injection O n e-A l p h a - Trade Name
A11CC03000P3001XX (A*)

System: Nutrition and Blood Disorder Indications: For treatment of secondary and tertiary hyperparathyroidism. Dosage: 0.5-6 mcg/haemodialysis up to maximum of 12 mcg/week. Contraindications: Hypercalcaemia, metastatic calcification, vitamin D toxicity and hypersensitivity to calcitriol products. Precautions: Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration. Interactions: Antiepileptics and diuretics. Adverse Reactions: Hypercalcaemia, nausea, vomiting, polydipsia, polyuria. Calcitriol 0.25 mcg Capsule R o c a l t r o l - Trade Name
A11CC04000C1001XX (A/KK) APPL

System: Nutrition and Blood Disorder Indications: To be used only for the treatment of: (1) renal osteodystrophy in patients on haemodialysis (2) post-thyroidectomy hypoparathyroidism (3) primary hypoparathyroidism (4) pseudohypoparathyroidism and (5) hypophosphatemic rickets/osteomalacia (6) post menopausal osteoporosis. Dosage: 0.5-1 mcg/day. Contraindications: Hypercalcaemia, vitamin D toxicity, abnormal sensitivity to the effects of vit D , malabsorption syndrome. Precautions: Hypercalcaemia, renal function impairment and secondary hyperparathyroidism. Interactions: Cholestyramine, thiazides diuretics, magnesium-containing antacids. Adverse Reactions: Hypercalcaemia, nausea, vomiting, polydipsia and polyuria. 41

Calcitriol 1 mcg/ml. Injection Calcijex - Trade Name

A11CC04000P3001XX (A*)

System: Nutrition and Blood Disorder Indications: To be used only for the treatment of: (1) renal osteodystrophy in patients on haemodialysis (2) post-thyroidectomy hypoparathyroidism (3) primary hypoparathyroidism (4) pseudohypoparathyroidism and (5) hypophosphatemic rickets/osteomalacia. IV inj. or inj. through the catheter after haemodialysis. Dosage: Initially 0.5 mcg 3 times a week, increase if necessary in steps of 0.25-0.5 mcg at intervals of 2-4 wks. Usual dose: 0.5-3 mcg 3 times a week. Contraindications: Hypercalcaemia, metastatic calcification, vitamin D toxicity and hypersensitivity to calcitriol products. Precautions: Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration. Interactions: Antiepileptics and diuretics. Adverse Reactions: Hypercalcaemia, nausea, vomiting, polydipsia, polyuria. Calcitriol 2 mcg/ml Injection Calcijex - Trade Name
A11CC04000P3002XX (A*)

System: Nutrition and Blood Disorder Indications: To be used only for the treatment of: (1) renal osteodystrophy in patients on haemodialysis (2) post-thyroidectomy hypoparathyroidism (3) primary hypoparathyroidism (4) pseudohypoparathyroidism and (5) hypophosphatemic rickets/osteomalacia. IV inj. or inj. through the catheter after haemodialysis. Dosage: Initially 0.5 mcg 3 times a week, increase if necessary in steps of 0.25-0.5 mcg at intervals of 2-4 wks. Usual dose: 0.5-3 mcg 3 times a week. Contraindications: Hypercalcaemia, metastatic calcification, vitamin D toxicity and hypersensitivity to calcitriol products. Precautions: Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration. Interactions: Antiepileptics and diuretics. Adverse Reactions: Hypercalcaemia, nausea/vomiting, polydipsia, polyuria. Thiamine HCl 100 mg/ml Injection
A11DA01110P3001XX (B) NEDL

System: Nutrition and Blood Disorder Indications: i) For the prevention or treatment of Vitamin B1 deficiency syndromes including beri-beri and peripheral neuritis associated with pellagra. Ii) Wernicke-Korsakoff Syndrome:a manifestation of thiamine deficiency seen particularly in alcoholic. Dosage: i) Mild to chronic deficiency: 10 - 25 mg daily. Severe deficiency: 200 - 300 mg dly. ii) 500mg every 8 hrs for 2 days, followed by 100 mg bd daily until patient can 42

take oral dose. Contraindications: Hypersensitivity to thiamine or any component. Precautions: Use with caution with parenteral route (especially IV) of administration. Interactions: Alkaline solutions, bicarbonates, carbonates, citrates, erythromycin lactobionate, iron salts, methohexital, neutral solutions, alkaline barbiturate solutions eg phenobarbital, thiopental . Adverse Reactions: Pain on injection, contact dermatitis, chronic pigmented purpura. Thiamine Mononitrate 3 mg Tablet
A11DA01221T1001XX (C)APPL

System: Nutrition and Blood Disorder Indications: i) For the prevention or treatment of Vitamin B1 deficiency syndromes including beri-beri and peripheral neuritis associated with pellagra. ii) Wernicke-Korsakoff Syndrome. Dosage: i) Mild to chronic deficiency: 10 - 25 mg daily. Severe deficiency: 200 - 300 mg dly. ii) 500mg every 8hrs for 2 days, followed by 100mg bd daily until patient can take oral dose. Contraindications: Hypersensitivity to thiamine or any component. Precautions: Not known. Interactions: Alkaline solutions, bicarbonates, carbonates, citrates, erythromycin lactobionate, iron salts, methohexital, neutral solutions, alkaline barbiturate solutions eg phenobarbital, thiopental. Adverse Reactions: Contact dermatitis, chronic pigmented purpura, skin rash, itching. Thiamine Mononitrate 10 mg Tablet
A11DA01221T1002XX (C) NEDL APPL

System: Nutrition and Blood Disorder Indications: i) For the prevention or treatment of Vitamin B1 deficiency syndromes including beri-beri and peripheral neuritis associated with pellagra. Ii) Wernicke-Korsakoff Syndrome. Dosage: i) Mild to chronic deficiency: 10 - 25 mg daily. Severe deficiency: 200 - 300 mg dly. ii) 500 mg every 8 hrs for 2 days, followed by 100 mg bd daily until patient can take oral dose. Contraindications: Hypersensitivity to thiamine or any component. Precautions: Not known. Interactions: Alkaline solutions, bicarbonates, carbonates, citrates, erythromycin lactobionate, iron salts, methohexital, neutral solutions, alkaline barbiturate solutions eg phenobarbital, thiopental. Adverse Reactions: Contact dermatitis, chronic pigmented purpura, skin rash, itching. 43

Vitamin B1, B6, B12 Injection Neurobion - Trade Name

A11DB00901P3001XX (A)

System: Nutrition and Blood Disorder Indications: For deficiency or raised requirement of Vit B1, B6, B12. Dosage: Mild cases : 1 amp IM 2 - 3 times weekly. Severe cases : 1 amp dly. Contraindications: Not known. Precautions: Photolysis. Repeated injection at the same site should be avoided. Care should be exercised when administering to neonates, premature infants, infants and children. The course of nerves should be avoided for the site of injection. If the patient complains of pain or if blood reflux occurs when the needle is stuck, withdraw it immediately and try at a different site. Interactions: High vit. B6 dose decreases action of L-dopa. Adverse Reactions: Pain and induration at site of injection, headache, sweating or hot sensation. Vitamin B1, B6, B12 Tablet Neurobion - Trade Name
A11DB00901T1001XX (B)

System: Nutrition and Blood Disorder Indications: For deficiency or raised requirement of Vit B1, B6, B12. Dosage: 1 - 3 tabs tds swallowed unchewed. Contraindications: Patients treated withlevodopa. Precautions: Discontinue medication if there is no response after taking orally for several months. Interactions: High vit. B6 dose decreases action of L-dopa. Adverse Reactions: Anorexia, nausea or diarrhoea, skin rash and hypersensitivity. Vitamin E, B12, B6, Nicotinamide Tablet Fundamin -E - Trade Name
A11E000901T1001XX (A)

System: Nutrition and Blood Disorder Indications: To improve appetite & growth. Neurasthenia, nausea & vomiting in pregnancy, radiation sickness & neuritis due to isoniazide therapy & alcoholism. Dosage: 1 - 2 tab dly. Contraindications: Hypersensitivity to drug or any components. Precautions: Vitamin K deficiency, necrotizing enterocolitis. Interactions: High vit. B6 dose decreases action of L-dopa, anticoagulants, cholestyramine. Adverse Reactions: Thrombophlebitis, anorexia, nausea or diarrhoea, skin rash and hypersensitivity. 44

Vitamin B Complex 10 ml Injection

A11EX00901P3001XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: Prophylaxis and treatment of vitamin B deficiency. Dosage: 1 - 2 ml IM dly. Contraindications: Allergy to cobalamins, megaloblastic anaemia of pregnancy. Precautions: Not for treatment of pernicious anaemia or other megaloblastic anaemias where vit. B12 is deficient. Interactions: Pyridoxine reduces the effect of levodopa. Adverse Reactions: Risk of anaphylactic shock. Allergy to cobalamins, megaloblastic anaemia of pregnancy. Vitamin B Complex Tablet
A11EX00901T1001XX (C) NEDL APPL

System: Nutrition and Blood Disorder Indications: Dietary supplement. Dosage: 1 - 2 tab dly. Contraindications: Allergy to cobalamins, megaloblastic anaemia of pregnancy. Precautions: Not for treatment of pernicious anaemia or other megaloblastic anaemias where vit. B12 is deficient. Interactions: Pyridoxine reduces the effect of levodopa. Adverse Reactions: Peripheral neuropathies (long term administration of large doses of pyridoxine). Ascorbic Acid 500 mg/2 ml Injection
A11GA01000P3001XX (B)NEDL

System: Nutrition and Blood Disorder Indications: For prevention and treatment of scurvy. Dosage: Therapeutic: Not less than 250 mg daily in divided doses. Contraindications: Hypersensitivity to vitamin C products. Precautions: Use cautiously in patients with preexisting kidney stone disease, erythrocyte G6PD deficiency, haemochromatosis, thalassaemia, or sideroblastic anaemia and avoid rapid intravenous injections. Interactions: Antacids, aspirin, contraceptives combination, cyanocobalamin, deferoxamine, gentamicin, haloperidol, iron, levodopa, methotrexate, warfarin. Adverse Reactions: In large doses, GI disturbances, renal calcium oxalate calculi formation. Ascorbic Acid 50 mg Tablet System: Nutrition and Blood Disorder Indications: 45
A11GA01000T1001XX (C) APPL

Dietary supplement. Dosage: Prophylactic : 25 - 75 mg daily. Therapeutic: Not less than 250 mg daily in divided doses. Contraindications: Hypersensitivity to vitamin C products. Precautions: Use cautiously in patients with preexisting kidney stone disease, erythrocyte G6PD deficiency, haemochromatosis, thalassaemia, or sideroblastic anaemia and avoid rapid intravenous injections. Interactions: Antacids, aspirin, contraceptives combination, cyanocobalamin, deferoxamine, gentamicin, haloperidol, iron, levodopa, methotrexate, warfarin. Adverse Reactions: In large doses, GI disturbances, renal calcium oxalate calculi formation. Ascorbic Acid 1,000 mg Effervescent Tablet R e d o x o n - Trade Name
A11GA01000T 4001XX (A)

System: Nutrition and Blood Disorder Indications: Dietary supplement. Dosage: Therapeutic : 1 g daily. Intensive therapy: 1-2 g daily. Contraindications: Hypersensitivity to vitamin C products. Precautions: Use cautiously in patients with preexisting kidney stone disease, erythrocyte G6PD deficiency, haemochromatosis, thalassaemia, or sideroblastic anaemia and avoid rapid intravenous injections. Interactions: Antacids, aspirin, contraceptives combination, cyanocobalamin, deferoxamine, gentamicin, haloperidol, iron, levodopa, methotrexate, warfarin. Adverse Reactions: In large doses, GI disturbances, renal calcium oxalate calculi formation. Nicotinic Acid 50 mg Tablet Niacin - Trade Name
A11HA01000T1001XX (B)NEDL

System: Nutrition and Blood Disorder Indications: For prophylaxis and treatment of Vitamin B3 deficiency. Dosage: Prophylactic : 15 - 30 mg daily. Therapeutic : 50 - 250 mg daily. Max single dose : 200 mg. Max dose in 24 hrs : 800 mg. Contraindications: Active liver disease, active peptic ulcer disease, hypersensitivity to Niacin or any of its components. Precautions: Renal disease, history of liver disease, consumption of substantial quantities of alcohol, unstable angina, concurrent vasoconstrictors and concurrent anticoagulants. Predisposition to gout. Women have a greater hypolipidaemic response than men at equivalent doses. Pregnancy and lactation. Interactions: Aspirin, atorvastatin, colestipol, cholestyramine, fluvastatin, isoniazid, lovastatin, nicotine, simvastatin, ethanol and pravastatin. Adverse Reactions: Flushing with burning of the hands, ears and face, pruritis and rash, gastrointestinal upset,hypotension, 46

Diarrhoea, nausea, vomiting, abdominal pain, feeling of restlessness, headache, hypotension, rash, tingling, itching and dry skin. Pyridoxine HCl 50 mg/2 ml Injection
A11HA02110P3001XX (B) NEDL

System: Nutrition and Blood Disorder Indications: (i) Pyridoxine - dependent convulsions in infancy (ii) Sideroblastic Anaemia (iii)B6-deficient Anaemia in adult (iv) Prophylaxis to Peripheral Neuritis in Isoniazid therapy (v) Nausea & Vomiting of pregnancy & irradiation sickness Dosage: (i) 4 mg/kg dly for short periods. (ii) Up to 400 mg daily in divided doses. (iii) 50-150 mg dly in divided doses. (iv) Adult: 100 mg dly. (v) 20-100 mg dly. Contraindications: Hypersensitivity to pyridoxine or any component of preparation. Precautions: Pregnancy, lactation, neonatal seizures, concurrent treatment with levodopa. Interactions: levodopa, penicillamine, selegiline. Adverse Reactions: Peripheral sensory neuropathy, hypotonia, respiratory difficulties, nausea and other GI complaints, photosensitivity, vesicular lesions and bullous lesions. Pyridoxine HCl 10 mg (Vitamin B6)Tablet
A11HA02110T1001XX (B)NEDL

System: Nutrition and Blood Disorder Indications: (i) Pyridoxine - dependent convulsions in infancy. (ii) Sideroblastic anaemia. (iii)B6-deficient anaemia in adult. (iv) Prophylaxis to peripheral neuritis in isoniazid therapy (v) Nausea & vomiting of pregnancy & irradiation sickness. Dosage: (i) 4 mg/kg dly for short periods. (ii) Up to 400 mg daily in divided doses. (iii) 50-150 mg dly in divided doses. (iv) Adult: 100 mg dly. (v) 20-100 mg dly. Contraindications: Hypersensitivity to pyridoxine or any component of preparation. Precautions: Pregnancy, lactation, neonatal seizures, concurrent treatment with levodopa. Interactions: Levodopa, penicillamine, selegiline. Adverse Reactions: Peripheral sensory neuropathy, hypotonia, respiratory difficulties, nausea and other GI complaints, photosensitivity, vesicular lesions and bullous lesions. 47

Vitamin E 50 mg Tablet Natopherol - Trade Name

A11HA03000T1001XX (A)

System: Nutrition and Blood Disorder Indications: Prophylaxis and treatment of Vit.E deficiency. Dosage: Juvela: 1-2 tabs bd or tds. Natopherol: 200 iu dly. Contraindications: Hypersensitivity to drug or any components. Precautions: Vitamin K deficiency, necrotizing enterocolitis. Interactions: Anticoagulants, cholestyramine. Adverse Reactions: Thrombophlebitis. Riboflavine 3 mg Tablet
A11HA04000T1001XX (C) NEDL APPL

System: Nutrition and Blood Disorder Indications: For prevention and treatment of riboflavine deficiency. Dosage: Prophylactic: 1 - 4 mg daily. Therapeutic: 5 - 10 mg daily. Contraindications: Hypersensitivity to riboflavin products. Precautions: Riboflavin deficiency often occurs in the presence of other vitamin B deficiencies. High content of riboflavin and pyridoxine in some commercial infant formula. Interactions: Decreased absorption with probenecid. Adverse Reactions: Urine discoloration. Calcium Carbonate 500 mg Capsule
A12AA04121T1001XX (A/KK)

System: Nutrition and Blood Disorder Indications: To be used only for elemental calcium supplementation and phosphate binding activity in patients with chronic renal failure. Dosage: Initial dose : 2.5 g dly and increased up to 17 g dly. Contraindications: Not known. Precautions: Patients with renal impairment or dehydration and electrolyte imbalance as well as patients with a history of renal calculi. Interactions: Chlorothiazide, hydrochlorothiazide, levothyroxine, metolazone increase the risk of the milk-alkali syndrome i.e. hypercalcaemia, alkalosis and renal impairment. Adverse Reactions: Gastrointestinal irritation, constipation, flatulence, gastric hypersecretion and acid rebound, hypercalcaemia, alkalosis and renal dysfunction. Calcium Lactate 0.3 g Tablet System: Nutrition and Blood Disorder
A12AA05125T1001XX (C) NEDL APPL

48

Indications: For prophylaxis of calcium deficiency and treatment of chronic hypocalcaemia. Dosage: Adult :1 - 5 g dly in divided dose. Contraindications: Ventricular fibrillation during cardiac resuscitation, hypercalcaemia and injectable forms in existing digitalis toxicity. Precautions: Calcium enhances the effect of cardiac glycosides on the heart and may precipitate arrhythmias. Interactions: Allopurinol, aspirin, chlorothiazide, ciprofloxacin, digoxin, doxycycline, hydrochlorothiazide, itraconazole, ketoc onazole, levothyroxine, metolazone, minocycline, norfloxacin, ofloxacin, oxytetracycline, pefloxacin, tetracycline, ticlopidine, verapamil, zalcitabine. Adverse Reactions: Mild gastro-intestinal disturbances, bradycardia, arrhythmias. Calcium Chloride 1 g/10 ml Injection
A12AA07100P3001XX (B)NEDL

System: Nutrition and Blood Disorder Indications: For the treatment of electrolyte depletion and acute hypocalcaemia. Dosage: Adult : 500 mg - 2 g /dly. Child: 300 mg/kg body wt/dly in divided dose. By slow IV, IM route is not recommended. Contraindications: Ventricular fibrillation during cardiac resuscitation, hypercalcaemia, injectable forms in existing digitalis toxicity and calcium chloride should not be given by intramuscular injection. Precautions: Extravasation with calcium chloride is irritating to veins and may cause necrosis and sloughing. Interactions: Allopurinol, aspirin, chlorothiazide, ciprofloxacin, digoxin, doxycycline, hydrochlorothiazide, itraconazole, ketoconazole, levothyroxine, metolazone, minocycline, norfloxacin, ofloxacin, oxytetracycline, pefloxacin, tetracycline, ticlopidine, verapamil, zalcitabine. Adverse Reactions: Constipation, GI upset, hypertension, venous thrombosis, arrhythmias and acute cardiac function. Potassium Chloride 1 g/15 ml Mixture
A12BA01100L2101XX (C)

System: Nutrition and Blood Disorder Indications: Potassium depletion. Dosage: 1 g once dly or bd until serum potassium is restored. Contraindications: Acute dehydration, heat cramps,hyperkalaemia and severe renal disease (oliguria). Precautions: Severe renal impairment, cardiac disease, hyperkalaemia. Interactions: Potassium sparing diuretics, salt substitutes, ACE inhibitors. Adverse Reactions: Nausea, vomiting, gastrointestinal ulceration, ECG changes.

49

Potassium Chloride (Slow Release) 600 mg. Tablet S l o w-K

A12BA01100T5001XX (B) NEDL APPL
- Trade Name

System: Nutrition and Blood Disorder Indications: For the treatment and specific prevention of hypokalaemia. Dosage: Adult: 2-3 tab dly. Severe deficiency: 9-12 tab dly or according to the needs of the patient. Contraindications: Acute dehydration, heat cramps, hyperkalaemia, severe renal disease (oliguria). Precautions: Severe renal impairment, cardiac disease, hyperkalaemia. Interactions: Potassium sparing diuretics, salt substitutes, ACE inhibitors. Adverse Reactions: Nausea, vomiting, gastrointestinal ulceration, ECG changes. Potassium Citrate 3g/10 ml & Citric Acid Mixture
A12BA02955L2101XX (C) NEDL APPL

System: Genitourinary Indications: For systemic or urine alkalinization. Dosage: Adult : 10 ml tds well diluted with water. Child : up to 1 yr : 2.5 ml tds, 1 - 5 yrs : 5 ml tds, 6 - 12 yrs : 10 ml tds. To be taken well diluted with water. Contraindications: Severe renal impairment with oliguria, azotemia, or anuria, Addison's disease, adynamic episodica hereditaria, acute dehydration, heat cramps, severe myocardial damage, potassium citrate in patients with hyperkalemia, sodium citrate for patients on sodium restriction. Precautions: Conges tive heart failure, hypertension, pulmonary or peripheral oedema, toxaemia of pregnancy, monitor serum electrolytes, especially bicarbonate, in patients with renal disease, decreased urinary output, especially in the presence of hypocalcaemia. Interactions: Concurrent administration of potassium citrate with potassiumcontaining medications, angiotensin-converting enzyme inhibitors, or cardiac glycosides, concurrent administration with aluminum-based gels. Adverse Reactions: Hyperkalaemia, metabolic alkalosis, nausea, vomiting, diarrhoea. Polycitra Syrup
A12BA02955L9001XX (C) NEDL

System: Genitourinary Indications: For treatment of calcium and uric acid stones. Dosage: The usual dose of potassium citrate is 30 - 60 mEq/day orally in 3 or 4 doses with meals or within 30 min after meals. Adult : 15 ml tds well diluted with water. Contraindications: Severe renal impairment with oliguria, azotemia, or anuria, 50

Addison's disease, adynamic episodica hereditaria, acute dehydration, heat cramps, severe myocardial damage, potassium citrate in patients with hyperkalaemia, sodium citrate for patients on sodium restriction. Precautions: Congestive heart failure, hypertension, pulmonary or peripheral oedema, toxaemia of pregnancy, monitor serum electrolytes, especially bicarbonate, in patients with renal disease, decreased urinary output, especially in the presence of hypocalcaemia. Interactions: Concurrent administration of potassium citrate with potassiumcontaining medications, angiotensin-converting enzyme inhibitors, or cardiac glycosides,concurrent administration with aluminum-based gels,blood products containing citrate. Adverse Reactions: Hyperkalaemia, metabolic alkalosis, nausea, vomiting, diarrhoea. Oxymetholone 50 mg Tablet Anap o l o n - Trade Name
A14AA05000T1001XX (A)

System: Endocrine Indications: Anaemias caused by the administration of myelotoxic drugs; treatment of AIDSwasting syndrome. Dosage: Adult & children : 1 - 5 mg/kg daily in divided doses. The selected dose will depend on the severity of the condition. Contraindications: Hypersensitivity to oxymetholone products, male breast/prostate cancer, metastatic female breast cancer with hypercalcaemia, nephrosis/nephrotic phase of nephritis, known/suspected pregnancy, severe liver disease. Precautions: Mild hepatic dysfunction, congestive heart failure or hypertension, patients with coronary artery disease, previous myocardial infarction, or lipid-lipoprotein abnormalities. Renal function impairment, diabetes mellitus, benign prostatic hyperplasia, previous hypersensitivity to other androgens or anabolic steroids and children. Interactions: Dicumarol, warfarin. Adverse Reactions: Oedema, hypertension, virilization, nausea & vomiting , hepatotoxicity. Nandrolone Decanoate 25 mg/ml Injection D e c a -D u r a b o l i n - Trade Name
A14AB01135P3001XX (A)

System: Endocrine Indications: Anabolic therapy. Dosage: Adult: 25 - 50 mg every 3 wks. Child: Up to 12.5 mg every 3 wks. Contraindications: Hypersensitivity to nandrolone products, male breast/prostate cancer, metastatic female breast cancer with hypercalcaemia, nephrosis/nephrotic phase of nephritis, known/suspected pregnancy, severe liver disease. Precautions: Congestive heart failure or hypertension, Patients with coronary 51

artery disease, previous myocardial infarction, or lipid-lipoprotein abnormalities, hepatic or renal function impairment, diabetes mellitus, benign prostatic hypertrophy, breast- feeding period, lupus erythematosus, previous hypersensitivity to other androgens or anabolic steroids. Interactions: Increased toxicity : Oral anticoagulants, insulin, oral hypoglycaemic agents, adrenal steroids, ACTH. Adverse Reactions: Oedema, hypertension, virilization, hypoglycaemia, lipid abnormalities. Warfarin Sodium 1 mg Tablet Warfarin Sodium 2 mg Tablet C o u m a d i n - Trade Name
B01AA03520T1001XX (B) B01AA03520T1002XX (B) NEDL

System: Cardiovascular Indications: Treatment and prophylaxis of thrombo-embolic disorders. Dosage: Initially 10 mg dly for 2 days. Maintenance dose, 3 - 9 mg daily according to the INR (taken at the same time each day). Contraindications: Haemorrhagic tendencies, pregnancy, blood dyscrasias, hypersensitivity to warfarin products. Precautions: Severe to moderate hepatic or renal insufficiency, concomitant use of antiplatelet drugs or drugs with ulcerogenic activity. Surgery and dental extraction, congestive heart failure. Concurrent use with thrombolytic drugs, known or suspected protein C deficiency. Moderate to severe hypertension, severe diabetes, severe allergic or anaphylactic disorders. Patients with hyperor hypothyroidism may have a substantially altered response to warfarin. Avoid concurrent use with herbal medicines and limit Vitamin K rich vegetables. Interactions: Activity potentiated by cimetidine, clofibrate, co-trimoxazole, erythromycin, quinidine, phenylbutazone, sulfonamides, amiodarone, rifampicin, carbamazepine, phenytoin, azole antifungals, metronidazole. Drugs which may increase risk of bleeding including aspirin, NSAIDs; dipyridamole, clopidrogel, ticlopidine. Adverse Reactions: Haemorrhage; alopecia, fever, GI disorders, hypersensitivity reactions; `purple toes'. Occasionally skin necrosis (obese elderly patients). Warfarin Sodium 3 mg Tablet Warfarin Sodium 5 mg T ablet C o u m a d i n - Trade Name
B01AA03520T1003XX (B) NEDL B01AA03520T1004XX (B) NEDL

System: Cardiovascular Indications: Treatment and prophylaxis of thrombo-embolic disorders. Dosage: Initially 10 mg dly for 2 days. Maintenance dose, 3 - 10 mg daily according to the INR (taken at the same time each day). Contraindications: Haemorrhagic tendencies, pregnancy, blood dyscrasias, hypersensitivity to warfarin products. Precautions: Severe to moderate hepatic or renal insufficiency, concomitant 52

use of antiplatelet drugs or drugs with ulcerogenic activity. Surgery and dental extraction, congestive heart failure. Concurrent use with thrombolytic drugs, known or suspected protein C deficiency. Moderate to severe hypertension, severe diabetes, severe allergic or anaphylactic disorders. Patients with hyperor hypothyroidism may have a substantially altered response to warfarin. Avoid concurrent use with herbal medicines and limit Vitamin K rich vegetables. Interactions: Activity potentiated by cimetidine, clofibrate, co-trimoxazole, erythromycin, quinidine, phenylbutazone, sulfonamides, amiodarone, rifampicin, carbamazepine, phenytoin, azole antifungals, metronidazole. Drugs which may increase risk of bleeding including aspirin, NSAIDs; dipyridamole, clopidrogel, ticlopidine. Adverse Reactions: Haemorrhage; alopecia, fever, GI disorders, hypersensitivity reactions; `purple toes'. Occasionally skin necrosis (obese elderly patients). Heparin 1000 units/ml Injection Heparin 5000 units/ml Injection
B01AB01520P3001XX (B) NEDL APPL B01AB01520P3002XX (B) NEDL APPL

System: Cardiovascular Indications: i) Prophylaxis and treatment of venous thrombosis and pulmonary embolism. ii) Treatment of myocardial infarction and arterial embolism. iii) Prevention of clotting in arterial and heart surgery and for prevention of cerebral thrombosis. Dosage: i) By IV injection, loading dose of 5000 units (10,000 units in severe pulmonary embolism) followed by continuous infusion of 15 - 25 units/kg/hr. By SC injection (for DVT) of 15,000 units every 12 hours (laboratory monitoring on daily basis essential to adjust dose). Small adult or child, lower loading dose then, 15 - 25 units/kg/hr by IV infusion, or 250 units/kg every 12 hours by SC injection. ii) As i), for unstable angina and acute peripheral arterial occlusion. iii) Prophylaxis in general surgery, by SC injection, 5000 units 2 hr before surgery, then every 8 - 12 hr for 7 days or until patient is ambulant, during pregnancy (with monitoring), 5000-10000 units every 12 hours. An adjusted dose regimen may be used for major orthopaedic surgery or low molecular weight heparin may be selected. Contraindications: Hypersensitivity, in patients who are actively bleeding, or have blood dyscrasias, in patients with haemophilia or other blood disorders, and in cases where sufficient blood coagulation tests are not available. Precautions: Heparin should be used cautiously in patients with allergies since it is of animal origin, renal and hepatic disease. Hypertension during menstruation. Patients with indwelling catheters. Precaution must be taken if using long-term subcutaneous heparin in pregnant women and bacterial endocarditis. Interactions: Alprostadil, alteplase, aspirin, cefoperazone, clopidogrel, dextran, moxalactam, reteplase, urokinase, warfarin. Adverse Reactions: Haemorrhage, cutaneous necrosis, thrombocytopenia, anaphylaxis 53

Enoxaparin Sodium 20 mg Injection Enoxaparin Sodium 40 mg Injection Enoxaparin Sodium 60 mg Injection Clexane - Trade Name

B01AB05520P5001XX (A*) B01AB05520P5002XX (A*) B01AB05520P5003XX (A*)

System: Cardiovascular Indications: i) Prevention of Deep Vein Thrombosis(DVT) especially in perioperative and high risk surgical cases. ii) Treatment of DVT iii) Unstable angina and non Q wave Myocardial Infarction. Dosage: i) Prevention: Moderate risk, 20 mg SC approximately 2 hrs before surgery then 40 mg every 24 hrs for minimum 7 - 10 days. ii) Treatment: 1 mg/kg SC bd, usually for at least 5 days or until mobilization (should not exceed 10 days). iii) 1 mg/kg SC every 12 hrs, usually for 2 - 8 days. Contraindications: Active major bleeding, hypersensitivity to enoxaparin, heparin, thrombocytopenia due to enoxaparin, acute GI ulcer. Precautions: Carefully monitor patients for possible spinal or epidural bleeding and if neurological impairment is detected, treat immediately. Active or history of recent gastrointestinal ulceration and haemorrhage, bacterial endocarditis, bleeding diathesis. Concomitant therapy with agents that inhibit platelets. Congenital or acquired bleeding disorders. Do not give via intramuscular injection. Elderly patients and patients with renal insufficiency may experience delayed elimination of enoxaparin. Haemorrhagic stroke, post-op period following brain & spinal cord or ophthalmological surgery. Uncontrolled arterial hypertension. Use with extreme caution in patients with history of heparininduced thrombocytopenia. Diabetic retinopathy, low molecular weight heparins or unfractionated heparin cannot be used interchangeably, unit for unit. Interactions: Increased risk of haemorrhage when used with NSAIDs, ticlopidine, corticosteroids, dextran 40. May potentiate effects of oral anticoagulants. Vit K antagonists, anti-platelet drugs. Adverse Reactions: Haemorrhagic symptoms, thrombocytopenia (rare), haematomas & skin necrosis at injection site; skin allergies or systemic allergic reactions. Nadroparin Calcium 0.2 ml Injection Nadroparin Calcium 0.3 ml Injection Nadroparin Calcium 0.4 ml Injection Nadroparin Calcium 0.6 ml Injection F r a x i p a r i n e - Trade Name System: Cardiovascular
B01AB06390P5001XX B01AB06390P5002XX B01AB06390P5003XX B01AB06390P5004XX (A*) (A*) (A*) (A*)

54

Indications: i) Prevention of Deep Vein Thrombosis (DVT) especially in perioperative and high risk surgical cases. ii) Treatment of DVT iii) Unstable angina & non Q wave Myocardial infarction Dosage: i) Prevention; moderate risk, 0.3 ml SC units dly for at least 7 days or until the patient is ambulant; the first dose being given 2-4 hrs before the procedure. High risk: Continue treatment for at least 10 days. > 70 kg : 0.4 ml pre-op & until day 3 & 0.6 ml from day 4 onwards. 50 - 69 kg : 0.3 ml pre-op & until day 3 & 0.4 ml from day 4 onwards. < 50 kg : 0.2 ml pre-op & until day 3, & 0.3 ml from day 4 onwards. ii) Treatment : 2 daily inj 12 hrly > 100 kg : 1 ml/inj; 90 - 99 kg : 0.9 ml/inj ; 80 - 89 kg : 0.8 ml/inj; 70 - 79 kg : 0.7 ml/inj; 60 - 69 kg : 0.6 ml/inj; 50 - 59 kg : 0.5 ml/inj; 40 - 49 kg : 0.4 ml/inj. iii) 86 IU anti-Xa/kg SC bd w/aspirin (75-325 mg PO after loading dose of 160 325 mg) for 6 days until stabilisation with dose adjusted to body weight. High risk : Continue treatment for at least 10 days. > 70 kg : 0.4 ml pre-op & until day 3 & 0.6 ml from day 4 onwards. 50 - 69 kg : 0.3 ml pre-op & until day 3 & 0.4 ml from day 4 onwards. < 50 kg : 0.2 ml pre-op & until day 3, & 0.3 ml from day 4 onwards. Treatment : 2 daily inj 12 hrly >100 kg : 1 ml/inj; 90 99 kg : 0.9 ml/inj ; 80 - 89 kg : 0.8 ml/inj; 70 - 79 kg : 0.7 ml/inj; 60 - 69 kg : 0.6 ml/inj; 50 - 59 kg : 0.5 ml/inj; 40 - 49 kg : 0.4 ml/inj. Contraindications: Hypersensitivity to nadroparin, cerebrovascular haemorrhage or other active haemorrhage (except disseminated intravascular coagulation) . Cerebral aneurysm, severe and unc ontrolled hypertension (risk of cerebral haemorrhage). Precautions: Previous hypersensitivity to unfractionated heparin, patients with thrombocytopenia prior to therapy and recent childbirth. Peptic ulcer disease, renal impairment (dose reductions if severe), liver disease (alterations in haemostasis may affect response to nadroparin). Recent lumbar puncture. Vasculitis, concurrent use of aspirin (increased bleeding risk). Pericarditis or pericardial effusion. Interactions: NSAIDs, aspirin, oral anticoagulants, antiplatelet agents, dextrans. Adverse Reactions: Overt or concealed haemorrhage; rarely, severe thrombocytopenia, small haematoma, cutaneous necrosis at injection site; raised transaminases, hypoaldosteronism. Heparin Sodium 50 units in Sodium Chloride Injection Hepsal
- Trade Name

B01AB51930P3001XX (B)NEDL

System: Cardiovascular Indications: To maintain patency of peripheral venous catheters. Dosage: Flush with 5 ml (50 units) every 4 hours or as required. Contraindications: Hypersensitivity in patients who are actively bleeding or have blood dyscrasias, in patients with haemophilia or other blood disorders 55

and in cases where sufficient blood coagulation tests are not available. Precautions: Heparin should be used cautiously in patients with allergies since it is of animal origin, renal and hepatic disease. Hypertension during menstruation. Patients with indwelling catheters. Precaution must be taken if using long-term subcutaneous heparin in pregnant women. Bacterial endocarditis. Interactions: Alprostadil, alteplase, aspirin, cefoperazone, clopidogrel, dextran, moxalactam, reteplase, urokinase, warfarin Adverse Reactions: Haemorrhage, cutaneous necrosis, thrombocytopenia, anaphylaxis. Clopidogrel 75mg Tablet Plavix - Trade Name
B01AC04000T1001XX (A*)

System: Cardiovascular Indications: Reduction of atherosclerotic events (MI, stroke & vascular death) with artheroslerosis documented by recent stroke, recent MI or established peripheral arterial disease. Dosage: 75mg once daily. Contraindications: Active pathological bleeding such as peptic ulcer & intracranial haemorrhage, breast feeding. Precautions: Avoid for first few days after MI and for 7 days after ischaemic stroke; not recommended in unstable angina, coronary artery bypass grafting and percutaneous transluminal coronary angioplasty; patients at risk of increased bleeding from trauma, surgery or other pathological conditions; discontinue 7 days before elective surgery if antiplatelet effect not desirable, liver impairment, renal impairment, pregnancy. Interactions: Warfarin, aspirin, heparin, thrombolytics or NSAIDs. Adverse Reactions: GI bleeding, purpura, bruising haematoma, epistaxis, haematuria, ocular haemorrhage, intra cranial bleeding, abdominal pain, dyspepsia, gastritis & constipation, rash, pruritus. Ticlopidine HCl 250 mg Tablet T i c l i d - Trade Name
B01AC05110T1001XX (A/KK)

System: Cardiovascular Indications: As antiplatelet agent after: a) coronary bypass surgery or angioplasty. b) transient attack due to vertebral artery narrowing as evidenced by murmur on ascultation or angiogram. c) recurrent embolism due to neural thrombus where patients are not able to tolerate aspirin or aspirin compound (proven GIT bleeding/ erosion), or allergy to aspirin. d) maintenance of patency of access in patients on chronic haemodialysis. Dosage: 250 - 500 mg dly during meals. Contraindications: Hypersensitivity to ticlopidine or its components, patients 56

with active bleeding disorders. Neutropenia or thrombocytopenia, severe liver impairment. Precautions: Predisposition to bleeding, including gastric or duodenal ulcers. Underlying haematologic disorders. Concomitant oral anticoagulant therapy or nonsteroidal antiinflammatory agents (including aspirin). Liver disease, patients undergoing lumbar puncture or surgical procedure. Ticlopidine should be discontinued if the absolute neutrophil count falls below 1200/mm3 or if the platelet count falls below 80,000/mm3. If possible, ticlopidine should be discontinued 10 to 14 days prior to surgery. Interactions: Any drugs likely to produce coagulation. Adverse Reactions: Minor GI disorders. Rarely, cutaneous allergic manifestations, thrombocytopenia, cholestatic icterus and or rise in transaminases. Neutropenia and thrombocytopenia (monitor FBC weekly initially). Acetylsalicylic Acid 150 mg Tablet Aspirin - Trade Name
B01AC06000T1001XX (C)

System: Cardiovascular Indications: For secondary prevention of stroke and myocardial infarction. Dosage: 150 mg - 300 mg daily (chewed or dispersed in water). Maintenance dose, 75 mg dly. Contraindications: Bleeding disorders. Hypersensitivity to salicylate. Precautions: Dyspepsia, gastric mucosal lesions, haemorrhagic disorders, gout. Intolerant to aspirin. Renal or hepatic impairment, asthma and G6PD deficiency. Interactions: Alcohol, dipyridamole, metoclopramide, metoprolol, carbonic anhydrase inhibitors, corticosteroids, coumarin anticoagulants, sulphonylureas, methotrexate, phenytoin, valproic acid, probenecid, sulphinpyrazone. Adverse Reactions: Nausea, vomiting, dyspepsia, GI ulceration, haematemesis, malaena. Occasionally, hepatotoxicity. Acetylsalicylic Acid 100 mg, Glycine 45 mg Tablet B01AC06259T1001XX (A/KK) C a r d i p r i n - Trade Name System: Cardiovascular Indications: For conditions where modification of platelet behaviour is beneficial eg. transient ischaemic attacks, secondary prevention of myocardial infarct and for prophylaxis against stroke, vascular occlusion and deep vein thrombosis. Dosage: One tablet daily. Contraindications: Bleeding disorders. Hypersensitivity to salicylate. Precautions: Dyspepsia, gastric mucosal lesions, haemorrhagic disorders, gout, intolerant to aspirin, renal or hepatic impairment, asthma and G6PD deficiency Interactions: Alcohol, dipyridamole, metoclopramide, metoprolol, carbonic anhydrase inhibitors, corticosteroids, coumarin anticoagulants, sulphonylureas, 57

methotrexate, phenytoin, valproic acid, probenecid, sulphinpyrazone. Adverse Reactions: Nausea, vomiting, dyspepsia, GI ulceration, haematemesis, malaena. Occasionally, hepatotoxicity. Dipyridamole 75 mg Tablet P e r s a n t i n - Trade Name
B01AC07000T1001XX (B)APPL

System: Cardiovascular Indications: As an adjunct to oral anticoagulation/ antiplatelet therapy in the prophylaxis of cerebrovascular events. Dosage: 75 - 150 mg tds to be taken 1 hr before meals. Contraindications: Hypersensitivity to dipyridamole or tartrazine dye (25 mg tablets). Precautions: Patients with hypotension. Interactions: Adenosine, indomethacin,low molecular weight heparins,streptokinase, theophylline. Adverse Reactions: Dizziness, headache, rash, abdominal distress, exacerbation of angina pectoris. Tirofiban HCl 0.25 mg/ml Injection Aggrastat - Trade Name
B01AC17110L3001XX (A*)

System: Cardiovascular Indications: Unstable angina or non-ST segment elevation myocardial infarction with the following: elevated cardiac markers, refractory chest pain, ST-segment changes & thrombolysis in myocardial infarction (TIMI) risk score 4. Dosage: By IV infusion, 0.4 mcg/kg/min for 30 min, then 0.1 mcg/kg/min for at least 48 hrs & up to 108 hr. Contraindications: Abnormal bleeding within 30 days, stroke within 30 days or any history of haemorrhagic stroke, intracranial disease (aneurysm, neoplasm or arteriovenous malformation), severe hypertension, haemorrhagic diathesis, increased prothrombin time or INR, thrombocytopenia and breast-feeding. Precautions: Renal impairment, hepatic impairment, major surgery or severe trauma within 3 months, traumatic or protracted cardiopulmonary resuscitation, organ biopsy, recent bleeding including history of GI bleeding or genitourinary bleeding, platelet disorder or history of thrombocytopenia; platelet count < 150,000 cells/mm3. Interactions: Drugs that affect haemostasis (eg warfarin). Adverse Reactions: Bleeding manifestations, reversible thrombocytopenia, nausea, fever, headache. Streptokinase 1,500,000 IU Injection S t r e p t a s e - Trade Name System: Cardiovascular
B01AD01000P4001XX (A*) NEDL APPL

58

Indications: i) Acute Myocardial Infarction ii)Acute Pulmonary Embolism Dosage: i)1,500,000 units over 30 - 60 minutes. ii) 250,000 units by IV infusion over 30 min. then 100,000 units every hr. for up to 12 - 72 hours with monitoring of clotting factors. Contraindications: Hypersensitivity to streptokinase products, streptococcal infections within 6 months haemorrhage, CVA, surgery or trauma within 1 month, subacute bacterial endocarditis Precautions: Arterial invasive procedures should be avoided before and during treatment and invasive venous procedures should be performed carefully. Spontaneous bleeding from internal sites may occur. Concurrent use of anticoagulants with streptokinase is not recommended. Concurrent use of heparin may be required during intracoronary administration of streptokinase. Precaution must be taken during concurrent use of drugs that may alter platelet function (dextran, aspirin, indomethacin, phenylbutazone) and anticoagulants. Interactions: Aspirin, dipyridamole,eptifibatide, warfarin Adverse Reactions: Hypotension,bleeding,bronchospasm Urokinase 6000 iu Injection U r o k i n a s e - Trade Name
B01AD04000P4001XX (A)

System: Ophthalmology Indications: Thrombolysis in the eyes. Dosage: 5,000 - 10,000 Ploug units in 2 - 3 ml sterile saline. Contraindications: Hypersensitivity to urokinase products, CVA, internal bleeding , surgery or trauma within 10 days. Precautions: Surgery within 10 days. Intra arterial diagnostic procedure within 10 days. Ulcerative wounds. Recent trauma with possibility of internal injuries. Pregnancy and the 1st 10 days of the postpartum period. Ulcerative colitis, diverticulitis or an active bleeding lesion of the gastrointestinal or genitourinary tract. Interactions: Heparin, oral anticoagulants. Adverse Reactions: Bleeding, hypotension, epistaxis, bronchospasm. Tranexamic Acid 250 mg Capsule T r a n s a m i n - Trade Name
B02AA02000C1001XX (B) NEDL

System: Cardiovascular Indications: Haemorrhage associated with excessive fibrinolysis. Dosage: Adult: 1 - 1.5 g ( 15 - 25 mg/kg ) bd - qid. Child : 25 mg/kg/day bd - tds. Contraindications: Intravascular clotting process, disturbance of colour vision and subarachnoid haemorrhage. Precautions: Cardiovascular disease , cerebrovascular disease, concomitant 59

antifibrinolytic therapy . Concomitant therapy with oestrogens or thrombolytics . Renal impairment and transurethral prostatectomy (potential for intravesicular clotting). Interactions: Anti-inhibitor coagulant complex. Adverse Reactions: Nausea, vomiting ,diarrhoea ,hypotension,thrombosis. Tranexamic Acid 100 mg/ml Injection T r a n s a m i n , C y k l o k a p r o n - Trade Name
B02AA02000P3001XX (A)NEDL

System: Cardiovascular Indications: Haemorrhage associated with excessive fibrinolysis. Dosage: Adult : Slow IV 0.5 - 1 g ( 10 - 15 mg/kg) tds. Continuous infusion at a rate of 25 - 50 mg/kg daily. Child : IV 10 mg/kg/day bd - tds. Contraindications: Intravascular clotting process, disturbance of colour vision, subarachnoid haemorrhage. Precautions: Cardiovascular disease, cerebrovascular disease, concomitant antifibrinolytic therapy. Concomitant therapy with oestrogens or thrombolytics. Renal impairment and transurethral prostatectomy (potential for intravesicular clotting). Interactions: Anti-inhibitor coagulant complex. Adverse Reactions: Nausea, vomiting, diarrhoea, hypotension, thrombosis. Aprotinin 10,000 KIU/ml Injection Trasylol - Trade Name
B02AB01000P3001XX (A*)

System: Cardiovascular Indications: Only for Open Heart Surgery (extracorporeal circulation) Dosage: Initially 2 million KIU bolus followed by 2 million KIU in heart-lung machine followed by a Slow infusion of 500,000 KIU/hr until end of surgery. Child : 20,000 KIU/kg/day. Contraindications: Hypersensitivity to aprotinin products. Precautions: Previous exposure to aprotinin (increased risk of hypersensitivity),renal insufficiency. Interactions: Succinylcholine Adverse Reactions: MI, shock, kidney tubular necrosis, lung oedema,atrial fibrillation Synthetic Vitamin K1 1 mg/ml Injection K o n a k i o n - Trade Name
B02BA01000P3001XX (C) NEDL APPL

System: Nutrition and Blood Disorder Indications: Vitamin K deficiency in neonates. Dosage: 1 mg IM or IV. Contraindications: Hypersensitivity to Vitamin K, menadione (k3) 60

administration in glucose-6-phosphate dehydrogenase deficiency. Precautions: Intravenous or intramuscular administration only when necessary (risk of anaphylaxis) . Hypersensitivity reactions possible even at first administration . The anticoagulant action of heparin not counteracted by phytomenadione Vit. K. Interactions: Fatty foods,warfarin. Adverse Reactions: Anaphylactic reactions during intravenous administration, dermatitis at injection site, haemolytic anaemia. Synthetic Vitamin K1 10 mg/ml Injection K o n a k i o n - Trade Name
B02BA01000P3002XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: Haemorrhage associated with hypoprothrombinaemia caused by overdose of anticoagulants. Dosage: 0.5 - 20 mg slow IV, depending on seriousness of bleeding and INR. Contraindications: Hypersensitivity to Vitamin K, menadione (k3) administration in glucose-6-phosphate dehydrogenase deficiency. Precautions: Intravenous or intramuscular administration only when necessary (risk of anaphylaxis) . Hypersensitivity reactions possible even at first administration . The anticoagulant action of heparin not counteracted by phytomenadione Vit. K. Interactions: Fatty foods,warfarin Adverse Reactions: Anaphylactic reactions during intravenous administration, dermatitis at injection site, haemolytic anaemia. Synthetic Vitamin K1 Mixed Micelle 2 mg/0.2 ml Injection Konakion
B02BA01000P3004XX (B)NEDL
- Trade Name

System: Nutrition and Blood Disorder Indications: Prevention of bleeding in neonates. Dosage: Healthy neonate 2 mg orally at birth or soon after followed by 2 mg at 4 - 7 days. Exclusively breastfed baby, in addition, 2 mg orally at monthly intervals until end of breastfeeding period. Neonate at special risk, 1 mg IM/IV at birth or soon after if oral route is not suitable. Treatment : 1mg IV initially. Further doses depend on clinical picture and coagulation status. Contraindications: Hypersensitivity to Vitamin K, menadione (k3) administration in glucose-6-phosphate dehydrogenase deficiency. Precautions: Intravenous or intramuscular administration only when necessary (risk of anaphylaxis) . Hypersensitivity reactions possible even at first administration . The anticoagulant action of heparin not counteracted by phytomenadione Vit. K. Interactions: Fatty foods,warfarin. Adverse Reactions: Anaphylactic reactions during intravenous administration, dermatitis at injection site, haemolytic anaemia. 61

Factor VIII concentrate 270-300 units Injection B02BD02999P9901XX (A) NEDL APPL K o a t e - Trade Name System: Cardiovascular Indications: I)Replacement therapy in Haemophilia A by slow IV infusion. Dosage: Dose varies according to the patient and the circumstances of the bleeding. i)Mild to moderate: Usually a single dose of 10-15units/kg. ii)More serious haemorrhage/minor surgery:Initially 15 - 25 units/kg followed by 10 - 15 units/kg every 8 - 12 hrs if required. iii) Severe haemorrhage/major surgery: Initial : 40 - 50 units/kg followed by 20 - 25 units/kg every 8-12 hrs. Contraindications: Disseminated intravascular coagulation, underlying thrombosis. Precautions: Risk of thrombosis and transmission of infection. Interactions: No interaction found. Adverse Reactions: Allergic reactions (chills, urticaria, fever), headache, intravascular hemolysis. Factor IX concentrate 540-570 units Injection B02BD04000P9901XX (A) NEDL APPL Konyne - Trade Name System: Cardiovascular Indications: Replacement therapy in Haemophilia B by slow IV infusion. Dose varies according to the patient and the circumstances of the bleeding. Dosage: i) Mild haemorrhage: Initial dose of 30 units/kg body wt. ii)Moderate haemorrhage: Initial dose of 50 units/kg iii) Major haemorrhage/surgery: Initial dose of 75 - 100 units/kg. Half of these doses may be repeated after 18-24 hrs if necessary. Contraindications: Disseminated intravascular coagulation. Precautions: Risk of thrombosis. Interactions: No Interaction Found Adverse Reactions: Allergic reactions Factor IX concentrate with Factor VIII Inhibitor Bypassing activity Injection Feiba
B02BD06000P4001XX (A)
- Trade Name

System: Cardiovascular Indications: Haemophilia B patients with factor VIII inhibitors. Dosage: 50 - 100 units/kg body wt. 12 hrly for a period of 36 hrs. Contraindications: Disseminated intravascular coagulation, fibrinolysis. Precautions: Liver disease. Risk of thrombosis and transmission of infection. Interactions: No Interaction found. Adverse Reactions: Rapid infusion may cause headache, flushing, changes in blood pressure and pulse rate. 62

Factor VIIa (Recombinant)eptacog alfa (activated) 60 KIU (1.2 mg) Injection Novoseven
B02BD08000P4001XX (A*)
- Trade Name

System: Cardiovascular Indications: a) Inherited factor VII deficiency b) Inhibitor to coagulation factors VIII & IX in patients with Haemophilia, Christmas disease. c)Inhibitor to coagulation factors VIII & IX in patients with no history of haemophilia or Christmas disease. d) In refractory thrombocytopenia. e) In refractory Glanzmann disease. Dosage: 90 - 120 KIU/kg per dose every 2 hrs till bleeding stops. Most often bleeding stops with 2 - 3 doses. Contraindications: Known Hypersensitivity to mouse, hamster or bovine protein may be a contraindication to the use of NovoSeven . Precautions: Atherosclerotic disease, crush injury, septicaemia or disseminated intravascular coagulation, pregnancy and lactation . Interactions: Potential interaction between NovoSeven and coagulation factor concentrates is unknown. Simultaneous use of prothrombin complex concentrates, activated or not should be avoided. Adverse Reactions: Rash, itching, nausea, fever, headache, malaise, diaphoresis, changes in blood pressure,renal failure, cerebrovascular disorder, angina pectoris, atrial arrythmia, circulatory shock. Factor VIIa (Recombinant)eptacog alfa (activated) 240 KIU (4.8 mg) Injection Factor VIIa (Recombinant)eptacog alfa (activated) 120 KIU (2.4 mg) Injection Novoseven
B02BD08000P4003XX (A*)
- Trade Name

B02BD08000P4002XX (A*)

System: Cardiovascular Indications: a) Inherited factor VII deficiency b) Inhibitor to coagulation factors VIII & IX in patients with Haemophilia, Christmas disease c) Inhibitor to coagulation factors VIII & IX in patients with no history of haemophilia or Christmas disease d) In refractory thrombocytopenia e) In refractory Glanzmann disease Dosage: 90 - 120 KIU/kg per dose every 2 hrs till bleeding stops. Most often bleeding stops with 2 - 3 doses. Contraindications: Known hypersensitivity to mouse, hamster or bovine protein may be a contraindication to the use of NovoSeven . Precautions: Atherosclerotic disease, crush injury, septicaemia or disseminated intravascular coagulation, pregnancy and lactation . Interactions: Potential interaction between NovoSeven and coagulation factor 63

concentrates is unknown. Simultaneous use of prothrombin complex concentrates, activated or not should be avoided. Adverse Reactions: Rash, itching, nausea, fever, headache, malaise, diaphoresis, changes in blood pressure,renal failure, cerebrovascular disorder, angina pectoris, atrial arrhythmia, circulatory shock. Ferrous Fumarate 200 mg Tablet
B03AA02138T1001XX (C) NEDL APPL

System: Nutrition and Blood Disorder Indications: For the prevention and treatment of iron deficiency. Dosage: Prophylactic 200 mg dly. Therapeutic : 200 mg bd. Paed up to 6yrs : 80 - 140 mg bd. Contraindications: Haemochromatosis, haemolytic anaemia, known hypersensitivity to iron salts. Precautions: Avoid in patients with peptic ulcer, enteritis, or ulcerative colitis. Administration of iron for >6 mths should be avoided except in patients with continuous bleeding or menorrhagia. Interactions: Tetracycline, decreased tetracycline and iron effectiveness. Penicillamine, levodopa, methyldopa, ciprofloxacin, decreased penicillamine, levodopa, methyldopa, ciprofloxacin effectiveness. Dairy foods, decreased iron bioavailability. Aluminium, calcium or magnesium containing products, decreased iron effectiveness. Adverse Reactions: Abdominal cramps, nausea, vomiting, diarrhoea or constipation, dark stools, heartburn, temporary teeth staining and discolouration of urine. Ferric Ammonium Citrate 800 mg/10ml Paed Mixture B03AB06136L2101XX (C) System: Nutrition and Blood Disorder Indications: Prevention and treatment of iron-deficiency anaemias. Dosage: Paeds: Up to 1 yr: 5 ml up to 4 times dly; 1 - 5 yrs : 10 ml up to 4 times dly. To be taken well diluted with water. Contraindications: Hypersensitivity to ferric ammonium citrate products and intestinal perforation or obstruction. Precautions: A.Prior complications, including allergic phenomena, associated with the use of other iron-containing contrast agents (eg, ferumoxides, ferumoxtran) or other iron formulations B. Gastrointestinal symptoms prior to administration of ferric ammonium citrate (may be exacerbated) C. Recent history of hiatal hernia, oesophageal reflux, nausea, vomiting, or abdominal pain (may not be able to tolerate full doses of ferric ammonium citrate (FerriSeltz) D. Specific fluid intake restrictions (eg, congestive heart failure) E. Inflammatory bowel disease, or disorders associated with iron overload, such as haemosiderosis or chronic haemolytic anaemia with frequent blood 64

transfusions. F. Renal or hepatic insufficiency (the pharmacokinetics of oral ferric ammonium citrate have not been studied in these patients). G. The efficacy of ferric ammonium citrate for lower gastrointestinal MR imaging has not been adequately studied; image quality/diagnostic efficacy may be inferior compared to upper gastrointestinal imaging. H. Concurrent use of drugs which can increase or decrease gastrointestinal transit time Interactions: Decreased levodopa or methyldopa effectiveness. Adverse Reactions: Diarrhoea, nausea, abdominal cramps. Iron Dextran 50 mg Fe/ml Injection I m f e r o n - Trade Name
B03AC06000P3001XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: Severe iron deficiency anaemia. Dosage: An initial test dose of 0.5 ml should be given over the desired route. For severe iron deficiency anaemia, 1 - 2 ml dly by deep IM. Contraindications: Haemachromatosis, haemosiderosis, haemolytic anaemia, and all anaemias other than iron deficiency anaemia, hypersensitivity to product or any of its components and parenteral preparation is not for subcutaneous administration. Precautions: Anaphylaxis has occurred with parenteral iron dextran. Active or suspected infection. Iron dextran injection in patients with serious impairment in liver function. Iron dextran injection should not be used during the acute phase of infectious kidney disease. Interactions: Mycophenolate mofetil, decreased mycophenolate mofetil efficacy. Chloramphenicol, decreased iron effectiveness. Adverse Reactions: Anaphylactic reactions, chest pain ,hypertension ,urticaria, pruritus, rash ,abdominal pain, nausea, vomiting, diarrhoea, leucocytosis, arthralgias, arthritis, convulsions, seizures, headache, respiratory arrest, dyspnoea,haematuria. Cyanocobalamin 0.1 mg Injection
B03BA01000P3001XX (B)APPL

System: Nutrition and Blood Disorder Indications: i)Prophylaxis of anaemia ii)Uncomplicated pernicious anaemia or Vit B12 malabsorption Dosage: i)Prophylaxis of anaemia: 250 mcg - 1000 mcg IM every month. ii)Uncomplicated pernicious anaemia or Vit B12 malabsorption : Initial 100 mcg dly for 5 - 10 days followed by 100 - 200 mcg mthly until complete remission is achieved. Maintenance : 100 mcg mthly. Paed : 30 - 50 mcg dly for 2 or more wks (to a total dose of 1-5mg). Maintenance: 100mcg monthly to sustain remission. Contraindications: Hypersensitivity to any component of cyanocobalamin or hydroxocobalamin formulations, or to cobalt. 65

Precautions: Hereditary optic atrophy, vitamin B12 therapy can mask folic acid deficiency, hypokalaemia and risk of gastric cancer is higher in patients with pernicious anaemia. Interactions: Chloramphenicol, decreased haematologic response.Aminosalicylic acid, ascorbic acid, chloramphenicol, cimetidine, contraceptive combination, omeprazole, ranitidine. Adverse Reactions: Diarrhoea, urticaria, pruritus, skin rash, hypokalaemia, polycythemia vera, volume overload. Cyanocobalamin 1 mg Injection
B03BA01000P3002XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: i)Prophylaxis of anaemia ii)Uncomplicated pernicious anaemia or Vit B12 malabsorption Dosage: i)Prophylaxis of anaemia: 250 mcg - 1000 mcg IM every month. ii)Uncomplicated pernicious anaemia or Vit B12 malabsorption : Initial 100 mcg dly for 5 - 10 days followed by 100 - 200 mcg mthly until complete remission is achieved. Maintenance : 100 mcg mthly. Paed : 30 - 50 mcg dly for 2 or more wks (to a total dose of 1-5mg). Maintenance: 100mcg mthly to sustain remission. Contraindications: Hypersensitivity to any component of cyanocobalamin or hydroxocobalamin formulations, or to cobalt. Precautions: Hereditary optic atrophy, vitamin B12 therapy can mask folic acid deficiency, hypokalaemia and risk of gastric cancer is higher in patients with pernicious anaemia. Interactions: Chloramphenicol, decreased haematologic response, aminosalicylic acid, ascorbic acid, chloramphenicol, cimetidine, contraceptive combination, omeprazole, ranitidine. Adverse Reactions: Diarrhoea, urticaria, pruritus, skin rash, hypokalaemia, polycythemia vera, volume overload. Cyanocobalamin 10 mcg Tablet
B03BA01000T1001XX (B) NEDL

System: Nutrition and Blood Disorder Indications: Vitamin B12 deficiency of dietary origin. Dosage: 50 - 150 mcg dly. Child : 35 - 50 mcg bd. Macrocytic anaemia : 300 mcg dly. Contraindications: Hypersensitivity to any component of cyanocobalamin or hydroxocobalamin formulations, or to cobalt. Precautions: Hereditary optic atrophy, vitamin B12 therapy can mask folic acid deficiency, hypokalaemia and risk of gastric cancer is higher in patients with pernicious anaemia. Interactions: Chloramphenicol, decreased haematologic response. Adverse Reactions: Diarrhoea, urticaria, pruritus, skin rash, hypokalaemia, polycythemia vera, volume overload.

66

Folic Acid 5 mg Tablet

B03BB01000T1001XX (C) NEDL APPL

System: Nutrition and Blood Disorder Indications: i) For the prevention and treatment of folate deficiency states. ii)For the prevention of neural tube defect in the foetus. Dosage: i) Initial 5 mg dly x 4 mths or until haematopoietic response obtained. Maintenance: 5 mg every 1 - 7 days depending on underlying disease. Paed : up to 1 yr : 0.5 mg/kg/day, over 1 yr : as adult dose. ii) 5 mg dly to be given to pregnant women. Contraindications: Pernicious, aplastic or normocytic anaemias. Precautions: Resistance to treatment may occur with depressed haematopoiesis, alcoholism, deficiencies of other vitamins. Interactions: Phenytoin, primidone, para-aminosalicylic acid and sulfasalazine, oral contraceptives, chloramphenicol , pyrimethamine and dihydrofolate reductase inhibitors (eg, methotrexate, trimethoprim ). Adverse Reactions: Irritability , urticaria, pruritus. Erythropoietin Human Recombinant 1000 Units Prefilled Syringes Eprex
B03XA01000P5001XX (A*)
- Trade Name

System: Nutrition and Blood Disorder Indications: For the treatment of anaemia associated with chronic renal failure.Indications : Dialysis patients who are Hb < 8 g, exhibiting symptoms of anaemia although Hb > 8 g and pre-transplant cases. Dosage: 50 - 75 u/kg body wt. IV 2 - 3 times a wk or 4000 units SC wkly. Contraindications: Uncontrolled hypertension, hypersensitivity to human albumin, hypersensitivity to mammalian cell-derived products. Precautions: Increased incidence of thrombotic events, increased incidence of mortality in patients with cardiac disease, hypertension, seizures, resumption of menses in some female patients, exacerbation of porphyria, pregnancy. Interactions: Ace Inhibitors and Angiotensin-II Antagonists: antagonism of hypotensive effect;increased risk of hyperkalaemia. Adverse Reactions: Hypertension, headache, arthralgias. Erythropoietin Human Recombinant 2000 units Prefilled Syringes Erythropoietin Human Recombinant 3000 units Prefilled Syringes Erythropoietin Human Recombinant 4000 units Prefilled Syringes Eprex
- Trade Name

B03XA01000P5002XX (A)

B03XA01000P5003XX (A*)

B03XA01000P5004XX (A APPL)

System: Nutrition and Blood Disorder Indications: For the treatment of anaemia associated with chronic renal failure.Indications : 67

Dialysis patients who are Hb < 8 g, exhibiting symptoms of anaemia although Hb > 8 g and pre-transplant cases. Dosage: 50 - 75 u/kg body wt. IV 2 - 3 times a wk or 4000 units SC wkly. Contraindications: Uncontrolled hypertension, hypersensitivity to human albumin, hypersensitivity to mammalian cell-derived products. Precautions: Increased incidence of thrombotic events, increased incidence of mortality in patients with cardiac disease, hypertension, seizures, resumption of menses in some female patients, exacerbation of porphyria, pregnancy. Interactions: ACE inhibitors and Angiotensin-II Antagonist: antagonism of hypotensive effects increased risk of heperkalaemia. Adverse Reactions: Hypertension, headache, arthralgias. Human Albumin Injection
B05AA01000P3001XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: i) Acute hypovolemic shock ii) Hypoproteinaemia iii) Neonatal hyperbilirubinaemia Dosage: i) 25 g (adult) and 0.6 g/kg body wt.(child). ii) Max. daily dose of 2g iii) 1 g/kg before exchange transfusion. Dose is given at rate of 1 ml of 25% solution per min. Contraindications: Hypersensitivity to albumin or any component of the formulation; patients with severe anaemia or cardiac failure. Precautions: Use with caution in patients with hepatic or renal failure because of added protein load; rapid infusion of albumin solutions may cause vascular overload. Interactions: ACE inhibitors: May have increased risk of atypical reactions; withhold ACEIs for at least 24 hours prior to plasma exchanges using large volumes of albumin. Adverse Reactions: Cardiovascular: CHF precipitation, oedema, hypertension, hypervolemia, hypotension, tachycardia Central nervous system: Chills, fever, headache. Dermatologic: Pruritus, rash, urticaria. Gastrointestinal: Nausea, vomiting Respiratory: Bronchospasm, pulmonary oedema. Miscellaneous: Anaphylaxis Selected Plasma Protein 5 g/100 ml Injection P l a s m a n a t e - Trade Name System: Nutrition and Blood Disorder
B05AA02000P3001XX (B)NEDL

68

Indications: For treatment of shock due to burns, crushing injuries, abdominal emergencies and where there is a predominant loss of plasma fluids and red blood cells; emergency treatment of shock due to haemorrhage and in infants and small children in the initial therapy of shock due to dehydration and infection. Dosage: Adult: 250-500ml. Paed: Usual dose: 33ml/kg body wt at rate of 5-10ml/min. Contraindications: Cardiopulmonary bypass, CHF, increased blood volume, severe anaemia. Precautions: Monitor BP. Does not provide coagulation factors IV only. Interactions: Protein hydrolysates, solution with alcohol. Adverse Reactions: Hypotension, flushing, urticaria, back pain, headache, nausea. Modified Fluid Gelatin 4% Injection G e l a f u s i ne - Trade Name
B05AA06905L3001XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: For primary volume replacement in hypovolaemia, peri-operative stabilization of the circulation, haemodilution, extracorporeal circulation (haemodialysis and heart-lung machine) Dosage: Adult: 500 - 1500 ml. IV infusion. Contraindications: Not known Precautions: Use with caution in patients with cardiac disease. Interactions: No interaction found. Adverse Reactions: Hypersensitivity reactions, severe anaphylactoid. Hydroxyethyl Starch 6% Injection Haes -S t e r i l - Trade Name
B05AA07000L3001XX (B) NEDL

System: Nutrition and Blood Disorder Indications: Therapy & prophylaxis of volume deficiency & shock in connection with surgery, injuries, infections, burns, normovolemic haemodilution & therapeutic iso-or hypervolemic haemodilution. Dosage: 500 - 1500 ml. The rate of infusion may approach 20 ml/kg/hr in acute haemorrhagic shock; slower rates in burns and septic shock. Contraindications: Hypersensitivity to hydroxyethyl starch or any component of the formulation; severe bleeding disorders, renal failure with oliguria or anuria, or severe congestive heart failure; per the manufacturer, Hextend is also contraindicated in the treatment of lactic acidosis and in leukapheresis. Precautions: Anaphylactoid reactions have occurred. Interactions: No interaction found. Adverse Reactions: No information available.

69

Modified Polypeptides (Polygeline) 3.5% Injection B05AA10905L3001XX (B) NEDL H a e m a c e l - Trade Name System: Nutrition and Blood Disorder Indications: For primary volume replacement in hypovolaemia, peri-operative stabilization of the circulation, haemodilution, extracorporeal circulation (haemodialysis and heart-lung machine). Dosage: Adult: 500 - 1500 ml. IV infusion. Contraindications: Not known. Precautions: Use with caution in patients with cardiac disease. Interactions: No interaction found. Adverse Reactions: Hypersensitivity reactions, severe anaphylactoid. Amino Acids Injection V a m i n - Trade Name
B05BA01910P3001XX (A)APPL

System: Nutrition and Blood Disorder Indications: Source of amino acids in patients needing IV nutrition. Dosage: To be individualised 500 - 2,000 ml IV daily. Contraindications: Inborn errors of amino acid metabolism, irreversible liver damage, severe uraemia w/o dialysis Precautions: Impaired renal function, cardiac disease, K replacement therapy. Monitor liver function. Interactions: No interaction found. Adverse Reactions: GI upset, flushing, sweating, thrombophlebitis Fat Emulsion, High Calorie
B05BA02000L2001XX (A)

System: Nutrition and Blood Disorder Indications: To provide non-protein high calorie intake, orally. Dosage: According to the needs of the patient. Contraindications: Pathological hyperlipidaemia, severe liver damage and acute shock. Precautions: Renal insufficiency, uncompensated diabetes, certain forms of liver insufficiency (monitor liver function), metabolic disorders and sepsis. Interactions: No interaction found Adverse Reactions: Fever, hypertriglyceridaemia, shivering, chills and nausea/vomiting. Fat Emulsion 10% for IV Infusion I n t r a l i p i d - Trade Name System: Nutrition and Blood Disorder Indications: 70
B05BA02000L3001XX (A) APPL

To supply energy and essential fatty acids to patients needing IV nutrition; for patients with essential fatty acid deficiency who cannot maintain or restore normal essential fatty acid pattern by oral intake. Dosage: Adult: 2 - 3 g fat/kg/day. Infant: 0.5 - 1 g fat/kg/day. Contraindications: Pathological hyperlipidaemia, severe liver damage and acute shock. Precautions: Renal insufficiency, uncompensated diabetes, certain forms of liver insufficiency (monitor liver function), metabolic disorders and sepsis. Interactions: No interaction found. Adverse Reactions: Fever, hypertriglyceridaemia, shivering, chills and nausea/vomiting. Fat Emulsion 20% for IV Infusion I n t r a l i p i d - Trade Name
B05BA02000L3002XX (A)

System: Nutrition and Blood Disorder Indications: For parenteral nutrition preparations. To supply energy and essential fatty acids to patients needing IV nutrition; for patients with essential fatty acid deficiency who cannot maintain or restore normal essential fatty acid pattern by oral intake. Dosage: Adult : 2-3 g fat/kg/day. Infant : 0.5-1 g/kg/day up to 2 g/kg/day Contraindications: Pathological hyperlipidaemia, severe liver damage and acute shock. Precautions: Renal insufficiency, uncompensated diabetes, certain forms of liver insufficiency (monitor liver function), metabolic disorders and sepsis. Interactions: No interaction found. Adverse Reactions: Fever, hypertriglyceridaemia, shivering, chills and nausea/vomiting. Dextrose 30 % Injection
B05BA03000P3004XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: For fluid and carbohydrate replenishment, and treatment of hypoglycaemic coma. Dosage: According to the needs of the patient. Contraindications: Do not use concentrated solutions of dextrose in patients with: anuria, diabetic coma and hyperglycaemia, intracranial or intraspinal haemorrhage, delirium tremens in dehydrated patients and glucose-galactose malabsorption syndrome. Precautions: Diabetes mellitus or carbohydrate intolerance and hyperglycaemia may accentuate neurologic damage for an ischaemic insult. Patients at risk for cerebral ischaemia, acute stroke, impending cardiac arrest, or severe hypotension unless hypoglycaemia is suggested or until glucose is determined. Interactions: No interaction found. 71

Adverse Reactions: Thrombophlebitis, rebound hypoglycaemia, hypokalaemia, pulmonary embolism, right atrial thrombosis, extravasation. Dextrose 50 % Injection
B05BA03000P3005XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: For fluid and carbohydrate replenishment, and treatment of hypoglycaemic coma. Dosage: According to the needs of the patient. Contraindications: Anuria, diabetic coma and hyperglycaemia, intracranial or intraspinal haemorrhage, delirium tremens in dehydrated patients and glucosegalactose malabsorption syndrome. Precautions: Diabetes mellitus or carbohydrate intolerance and hyperglycaemia may accentuate neurologic damage for an ischaemic insult. Patients at risk for cerebral ischaemia, acute stroke, impending cardiac arrest, or severe hypotension unless hypoglycaemia is suggested or until glucose is determined. Interactions: No interaction found. Adverse Reactions: Thrombophlebitis, rebound hypoglycaemia, hypokalaemia, pulmonary embolism, right atrial thrombosis, extravasation. Dextrose 5 % Injection
B05BA03000P6001XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: For fluid and carbohydrate replenishment, and to provide temporary relief from the symptoms of cerebral oedema and for hypoglycaemic coma; according to the needs of the patient. Dosage: According to the needs of the patient. Contraindications: Do not use concentrated solutions of dextrose in patients with: anuria, diabetic coma and hyperglycaemia, intracranial or intraspinal haemorrhage, delirium tremens in dehydrated patients and glucose-galactose malabsorption syndrome. Precautions: Diabetes mellitus or carbohydrate intolerance and hyperglycaemia may accentuate neurologic damage for an ischaemic insult. Patients at risk for cerebral ischaemia, acute stroke, impending cardiac arrest, or severe hypotension unless hypoglycaemia is suggested or until glucose is determined. Interactions: No interaction found. Adverse Reactions: Local pain, vein irritation, thrombophlebitis, rebound hypoglycaemia, hypokalaemia. Dextrose 10 % Injection Dextrose 20 % Injection
B05BA03000P6002XX (B) NEDL A PPL B05BA03000P6003XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: For fluid and carbohydrate replenishment, and to provide temporary relief from 72

the symptoms of cerebral oedema and for hypoglycaemic coma; according to the needs of the patient. Dosage: According to the needs of the patient. Contraindications: Do not use concentrated solutions of dextrose in patients with: anuria, diabetic coma and hyperglycaemia, intracranial or intraspinal haemorrhage, delirium tremens in dehydrated patients and glucose-galactose malabsorption syndrome. Precautions: Diabetes mellitus or carbohydrate intolerance and hyperglycaemia may accentuate neurologic damage for an ischaemic insult. Patients at risk for cerebral ischaemia, acute stroke, impending cardiac arrest, or severe hypotension unless hypoglycaemia is suggested or until glucose is determined. Interactions: No interaction found. Adverse Reactions: Local pain, vein irritation, thrombophlebitis, rebound hypoglycaemia, hypokalaemia. Amino Acids, Glucose, Electrolytes & Lipid Injection B05BA10910P3001XX (A) V i t r i m i x - Trade Name System: Nutrition and Blood Disorder Indications: Source of amino acids in patients needing IV nutrition. Dosage: To be individualised 500 - 2,000 ml IV daily. Contraindications: Inborn errors of amino acid metabolism, irreversible liver damage, severe uraemia w/o dialysis. Precautions: Impaired renal function, cardiac disease, K replacement therapy. Monitor liver function. Interactions: No interaction found. Adverse Reactions: GI upset, flushing, sweating, thrombophlebitis. Amino Acids with Electrolytes Injection V a m i n - Trade Name
B05BA10910P3002XX (A)

System: Nutrition and Blood Disorder Indications: For parenteral nutrition, prophylaxis and therapy of protein deficiency due to increased protein loss and/or increased protein needs. Dosage: To be individualised 500 - 2,000 ml IV daily. Contraindications: Inborn errors of amino acid metabolism, irrev ersible liver damage, severe uraemia w/o dialysis. Precautions: Impaired renal function, cardiac disease, K replacement therapy. Monitor liver function. Interactions: No interaction found. Adverse Reactions: GI upset, flushing, sweating, thrombophlebitis.

73

Amino Acids with Glucose with Electrolytes Injection B05BA10910P3003XX (A)

NEDL

V a m i n G l u c o s e - Trade Name System: Nutrition and Blood Disorder Indications: Source of amino acids in patients needing IV nutrition. Dosage: To be individualised. Adult : 1 - 2 L per 24 hours. Child : 30 ml/kg body wt. in 24 hours. Electrolyte-free: Adult: Up to 1 L per 24 hours Contraindications: Patients with inborn errors of amino acid metabolism, irreversible liver damage and severe uraemia when dialysis facilities are not available. Precautions: Liver disease, renal impairment. Interactions: No interaction found. Adverse Reactions: Hyperammonaemia, encephalopathy, cholestasis, thrombophlebitis. Amino Acids with Glucose without Electrolytes Injection Vamin 14,Vamin 18
B05BA10910P3004XX (A)
- Trade Name

System: Nutrition and Blood Disorder Indications: Source of amino acids in patients needing IV nutrition. Dosage: To be individualised. Adult : 1 - 2 L per 24 hours. Child : 30 ml/kg body wt. in 24 hours. Electrolyte-free : Adult: Up to 1 L per 24 hours Contraindications: Patients with inborn errors of amino acid metabolism, irreversible liver damage and severe uraemia when dialysis facilities are not available. Precautions: Liver disease, renal impairment. Interactions: No interaction found. Adverse Reactions: Hyperammonemia, encephalopathy, cholestasis, thrombophlebitis. Amino Acids with Fat Emulsion Injection V i t r i m i x - Trade Name
B05BA10910P3005XX (A)NEDL

System: Nutrition and Blood Disorder Indications: For parenteral nutrition preparations. Dosage: 2 - 3 g fat/kg body wt daily. Contraindications: Thrombosis, severe hepatic & coagulation disorders, hyperlipidaemia, diabetes associated w/ ketosis, hypersensitivity. Precautions: Monitor patients hepatic function, blood lipid level, haemogram & blood coagulation regularly. Interactions: No information available Adverse Reactions: Phlebitis, bleeding, hepatic dysfunction, hypotension, 74

tachycardia, tachypnoea, dyspnoea, cyanosis, GI upsets, thirst, fever, chills, facial flush and oedema & a sensation of peculiar odor. Lactated Ringer's Solution 500ml Injection
B05BB01125P6001XX (B)

System: Nutrition and Blood Disorder Indications: In the treatment of acidosis. Dosage: A dose of up to 60 ml/kg body wt is required. For alkalinisation of urine: 30 ml/kg body wt. Rate of infusion should not exceed 300 ml/hr. Contraindications: Lactic acidosis, severe acidosis, hypernatraemia and conditions where sodium administration would be detrimental. Precautions: Metabolic or respiratory alkalosis, congestive heart failure, other sodium-retaining conditions, concurrent corticosteroids, conditions impairing lactate utilization (severe hepatic insufficiency, shock, beriberi, hypoxia) and during prolonged therapy, monitor fluid balance, electrolytes, acid-base balance. Interactions: No interaction found. Adverse Reactions: Anxiety, panic attacks, apprehension or fear, paraesthesias, tremors, dizziness, metabolic alkalosis, hypokalaemia. Compound Sodium Chloride (Ringers Solution) Injection
B05BB01905P6001XX (B)NEDL

System: Nutrition and Blood Disorder Indications: For replacement of extracellular fluid and supplying / replenishing of chloride. Dosage: According to the needs of the patient. Contraindications: Hypernatraemia or fluid retention, hypersensitivity, sodium chloride solutions with preservatives in newborns, for injection or flushing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks. Precautions: Congestive heart failure, circulatory insufficiency, kidney dysfunction, hypoproteinaemia, cirrhotic disease, hypervolemia, urinary tract obstruction, and patients receiving drugs that cause sodium retention, eg corticosteroids or corticotropin. Interactions: No interaction found. Adverse Reactions: Nausea, vomiting, diarrhoea, abdominal cramps, congestive heart failure, hypertension, tachycardia, fluid accumulation, irritability, restlessness, weakness, headache, dizziness, obtundation, convulsions. Dextrose 37.5 % & Electrolytes Injection System: Nutrition and Blood Disorder
B05BB02905P6001XX (A)

75

Indications: For carbohydrate replenishment. Dosage: According to the needs of the patient. Contraindications: Do not use concentrated solutions of dextrose in patients with: anuria, diabetic coma and hyperglycaemia, intracranial or intraspinal haemorrhage, delirium tremens in dehydrated patients and glucose-galactose malabsorption syndrome. Precautions: Diabetes mellitus or carbohydrate intolerance and hyperglycaemia may accentuate neurologic damage for an ischaemic insult. Patients at risk for cerebral ischaemia, acute stroke, impending cardiac arrest, or severe hypotension unless hypoglycaemia is suggested or until glucose is determined. Interactions: No interaction found. Adverse Reactions: Thrombophlebitis, rebound hypoglycaemia, hypokalaemia. Mannitol 10 % Injection (10 g/100 ml)
B05BC01000P3001XX (A) NEDL APPL

System: Cardiovascular Indications: Cerebral oedema. Dosage: Diuresis ; 50 - 200 g over 24 hrs, preceded by a test dose of 200 mg/kg by slow IV. Contraindications: Anuria, pulmonary oedema/congestion, severe CHF, intracranial bleeding. Precautions: Cardiopulmonary dysfunction, renal dysfunction. An in-line filter should be used during intravenous administration .Maintain proper fluid and electrolyte balance. Monitor urinary output. Renal dysfunction and solutions should be examined for crystals before use. Solutions of 15% and 20% should always be filtered. Interactions: Lithium toxicity (with diuretic induce hyponatraemia) Adverse Reactions: Hyperkalaemia, diarrhoea, renal failure. Mannitol 20 % Injection (20 g/100 ml)
B05BC01000P3002XX (A) NEDL APPL

System: Cardiovascular Indications: Cerebral oedema. Dosage: 1 g/kg by rapid IV infusion. Contraindications: Anuria, pulmonary oedema/congestion, severe CHF, intracranial bleeding. Precautions: Cardiopulmonary dysfunction, renal dysfunction. An in-line filter should be used during intravenous administration .Maintain proper fluid and electrolyte balance. Monitor urinary output. Renal dysfunction and solutions should be examined for crystals before use. Solutions of 15% and 20% should always be filtered. Interactions: Lithium toxicity (with diuretic induce hyponatraemia) 76

Adverse Reactions: Hyperkalaemia, diarrhoea, renal failure. Chlorhexidine Acetate 0.02 % Sterile Solution For Bladder Washout Hibitane
- Trade Name

B05CA02122H3001XX (C)NEDL

System: Genitourinary Indications: To wash out bladder before renal transplantation. Dosage: Used as bladder irrigation. Contraindications: Patients who have previously shown a hypersensitivity reaction to chlorhexidine. However, such reaction are extremely rare. Precautions: Avoid prolonged skin contact with alcoholic solution. Avoid contact with eyes, brain, meninges, middle ear & body cavities. For external use only. Interactions: No interaction found. Adverse Reactions: Occasionally, irritative skin reactions, extremely rare, generalised allergic reactions. Sodium Citrate 3.8% Solution
B05CB02136H3001XX (B)

System: Genitourinary Indications: Sterile solution for irrigation or washout of infected bladder. Dosage: Dose depending on clinical cases. Contraindications: Aluminium toxicity and heart failure. Precautions: Renal tubular acidosis, chronic diarrhoea syndromes, peripheral or pulmonary oedema, hypertension, toxemia of pregnancy. Interactions: Quinidine, antacids, especially those containing aluminium or sodium bicarbonate. Adverse Reactions: Metabolic alkalosis, hypernatraemia and diarrhoea. Sodium Citrate, Citric Acid Mixture 3 g/10 ml M i s t S o d C i t r a t e - Trade Name
B05CB02136L2101XX (B)

System: Genitourinary Indications: Citrates and citric acid solutions are used to correct the acidosis of certain renal tubular disorders, to treat metabolic acidosis, for long-term urine alkalinization, for prevention and treatment of uric acid and calcium kidney stones, and as nonparticulate neutralizing buffers. Dosage: Adult : 10 - 20 ml well diluted with water. Child : Up to 1 yr : 2.5 ml, 6 - 12 yrs : 10 ml. To be taken well diluted with water. Contraindications: Severe renal impairment with oliguria, azotemia, or anuria, Addison's disease, Adynamic episodica hereditaria, acute dehydration, heat cramps, severe myocardial damage, potassium citrate in patients with hyperkalaemia, sodium citrate for patients on sodium restriction. Precautions: Congestive heart failure,hypertension,pulmonary or peripheral 77

oedema,toxaemia of pregnancy, monitor serum electrolytes, especially bicarbonate, in patients with renal disease, decreased urinary output, especially in the presence of hypocalcaemia. Interactions: Concurrent administration of potassium citrate with potassiumcontaining medications, angiotensin-converting enzyme inhibitors, or cardiac glycosides,concurrent administration with aluminum-based gels,blood products containing citrate. Adverse Reactions: Hyperkalaemia,metabolic alkalosis,nausea, vomiting, diarrhoea. Sodium Citrate 0.3 M Solution
B05CB02136L9901XX (B)

System: Anaesthesia Indications: For use as an oral solution and prophylaxis for aspiration pneumonitis. Dosage: Dose depending on clinical cases.(30ml given 10 to 47 minutes before anaesthesia prior to elective cesarean surgery is effective antacid) Contraindications: Aluminium toxicity and heart failure. Precautions: Renal tubular acidosis, chronic diarrhoea syndromes, peripheral or pulmonary oedema, hypertension, toxaemia of pregnancy. Interactions: Quinidine, antacids, especially those containing aluminium or sodium bicarbonate. Adverse Reactions: Metabolic alkalosis, hypernatraemia and diarrhoea. Balanced Salt Solution PLUS (fortified with sodium bicarbonate, glucose & glutathione) B05CB10905L5001XX (A) B.S.S. - Trade Name System: Nutrition and Blood Disorder Indications: For irrigation during various surgical procedures of the eyes, ears, nose and/or throat according to standard format for each surgical procedure. To be used during 'extra capsular cataract extrac tion' operation or 'phaco emulsification' and also during vitrectomy. Dosage: Use as needed for foreign body removal, gonioscopy, general ophthalmic office procedure. Single use only. Contraindications: Hypersensitivity to any of the components of product. Precautions: Solution contains no preservatives and should not be reused. Interactions: No interaction found. Adverse Reactions: Ocular irritation. Continuous Ambulatory Peritoneal Dialysis Soln containing 1.5% Dextrose Continuous Ambulatory Peritoneal Dialysis Soln containing 4.25% Dextrose
B05CB10908H2003XX (B) B05CB10908H2001XX (B)

System: Nutrition and Blood Disorder Indications: For chronic renal diseases requiring dialysis and acute therapy -resistance renal 78

failure eg. prior to transfer to a dialysis centre. Dosage: Dose depending on clinical cases. Contraindications: No information available. Precautions: Abdominal sepsis, previous abdominal surgery, or severe inflammatory bowel disease. Dialysis solutions should be warmed to body temperature with dry heat because wet heat carries a risk of microbial contamination. Interactions: Generally, drugs of low molecular weight, high water solubility, low volume of distribution, low protein binding, and high renal clearance are most extensively removed by dialysis e.g. aminoglycosides. Adverse Reactions: Peritonitis, hernias, hyperglycaemia, protein malnutrition, and catheter complications. Long-term peritoneal dialysis results in progressive structural changes to the peritoneal membrane ultimately resulting in dialysis failure. Continuous Ambulatory Peritoneal Dialysis Soln containing 2.5% Dextrose
B05CB10908H2002XX (B)NEDL

System: Nutrition and Blood Disorder Indications: For chronic renal diseases requiring dialysis and acute therapy -resistance renal failure eg. prior to transfer to a dialysis centre. Dosage: Dose depending on clinical cases. Contraindications: No information available. Precautions: Abdominal sepsis, previous abdominal surgery, or severe inflammatory bowel disease. Dialysis solutions should be warmed to body temperature with dry heat because wet heat carries a risk of microbial contamination. Interactions: Generally, drugs of low molecular weight, high water solubility, low volume of distribution, low protein binding and high renal clearance are most extensively removed by dialysis e.g. aminoglycosides. Adverse Reactions: Peritonitis, hernias, hyperglycaemia, protein malnutrition and catheter complications. Long-term peritoneal dialysis results in progressive structural changes to the peritoneal membrane ultimately resulting in dialysis failure. Sodium Bicarbonate, Citric Acid, Sodium Citrate & Tartaric Acid - 4 g per sachet B05CB10955M4001XX (B) Ural - Trade Name System: Genitourinary Indications: For relieving of discomfort in mild UTI, symptomatic relief of dysuria to enchance the action to certain antibiotics especially some sulphonamides. In gout as urinary alkalinizers to prevent cystallisation of urates. Dosage: 4 - 8 g (1- 2 sachets) dissolved in a glass of cold water qid as prescribed. Contraindications: Renal failure or hyperthermia, in conjuction with hexamine 79

mandate or hexamine mandelate or haxamine hippurate,cardiac failure. Precautions: Patients on sodium restricted diet. Interactions: No interactions found. Adverse Reactions: Mild laxative effect, systemic alkalosis or hyperthermia with prolonged or excessive usage. Glycine 1.5% Irrigating Solution
B05CX03000H3001XX (A)

System: Genitourinary Indications: Isotonic irrigant used during urological surgery. Dosage: The dosage depends on the extent of the procedure and its duration. Contraindications: Anuric patients. Precautions: Hepatic impairment: since any absorption and consequent metabolism may cause hyperammonaemia cardiopulmonary or renal dysfunction. Interactions: No interaction found. Adverse Reactions: Systemic absorption can lead to disturbances of fluid and electrolyte balance and cardiovascular and pulmonary disorders. Peritoneal Dialysis with 1.5% Glucose Solution B05D000908H2001XX (B)NEDL APPL Peritoneal Dialysis with 4.25% Glucose Solution
B05D000908H2002XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: For chronic renal disease requiring dialysis and for acute renal failure. Dosage: Dose depending on clinical cases. Contraindications: Not known. Precautions: Abdominal sepsis, previous abdominal surgery, or severe inflammatory bowel disease. Dialysis solutions should be warmed to body temperature with dry heat because wet heat carries a risk of microbial contaminati on. Interactions: Generally, drugs of low molecular weight, high water solubility, low volume of distribution, low protein binding, and high renal clearance are most extensively removed by dialysis e.g. aminoglycosides. Dialysis-induced changes in fluids and electrolytes. Adverse Reactions: Peritonitis, hernias, hyperglycaemia, protein malnutrition, and catheter complications. Long-term peritoneal dialysis results in progressive structural changes to the peritoneal membrane ultimately resulting in dialysis failure. Electrolyte Solution Injection
B05XA00000P3001XX (A*)

System: Nutrition and Blood Disorder Indications: To be used only as a priming solution to prime the bypass circuit of the Heart Lung Machine. Dosage: 80

Not applicable. Contraindications: Not known. Precautions: Not known. Interactions: Not known. Adverse Reactions: Not known. Sodium Lactate 1/6 molar Injection
B05XA00125P3001XX (B)NEDL

System: Nutrition and Blood Disorder Indications: For use as alternative to sodium bicarbonate in the treatment of metabolic acidosis and to alkalinise urine; and for replacement of extracellular fluid loss. Dosage: The rate should not exceed 300 ml/hr in dose up to 60 ml/kg in the treatment of acidosis, and up to 30 ml/kg for alkalinisation of urine. Contraindications: Lactic acidosis, severe acidosis requiring immediate repletion of plasma bicarbonate, hypernatraemia and conditions where sodium administration would be detrimental. Precautions: Metabolic or respiratory alkalosis, congestive heart failure, other sodium-retaining conditions, concurrent corticosteroids, conditions impairing lactate utilisation (severe hepatic insufficiency, shock, beriberi, hypoxia) and during prolonged therapy. Interactions: No interaction found. Adverse Reactions: Anxiety, panic attacks, apprehension or fear, paraesthesias, tremors, dizziness, metabolic alkalosis, hypokalaemia. Potassium Chloride 1 g/10 ml Injection
B05XA01100P3001XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: For the correction of severe hypokalaemia and when sufficient potassium cannot be taken by mouth. Dosage: By slow IV infusion depending on the deficit or the daily maintenance requirements. 1g diluted in 500 ml normal saline or glucose and given slowly over 2-3 hours. Contraindications: Acute dehydration, heat cramps, hyperkalaemia, severe renal disease (oliguria). Precautions: Severe renal impairment, cardiac disease, hyperkalaemia. Interactions: Potassium sparing diuretics, salt substitutes, ACE inhibitors. Adverse Reactions: Nausea, vomiting, gastrointestinal ulceration, ECG changes. Sodium Bicarbonate 4.2% (0.5 mmol/ml) Injection B05XA02131P3001XX (B) System: Nutrition and Blood Disorder Indications: For acceleration of excretion in drug intoxication (where excretion of the drug into the urine is accelerated by elevated urine pH) and for acidosis. Dosage: IV infusion of 2 - 5 mmol/kg body wt. over a period of 4 - 8 hrs or according to 81

the needs of the patients. Contraindications: alkalosis, hypernatraemia, hy pocalcaemia, hypochloraemia, severe pulmonary oedema, unknown abdominal pain Precautions: renal impairment, peptic ulcer, congestive heart failure, oedema, cirrhosis Interactions: amphetamine,aspirin,chlorpropamide,dextroamphetamine,ephedrine,itraconazo le,ketoconazole,lithium,pseudoephedrine, flecainide, Adverse Reactions: GI cramps, flatulence, alkalosis Sodium Bicarbonate 8.4% (1 mmol/ml) Injection B05XA02131P3002XX (B) NEDL
APPL

System: Nutrition and Blood Disorder Indications: For acceleration of excretion in drug intoxication (where excretion of the drug into the urine is accelerated by elevated urine pH) and for acidosis. Dosage: According to the needs of the patient. In severe shock due to cardiac arrest: 50 ml IV. Contraindications: Alkalosis, hypernatraemia, hypocalcaemia, hypochloraemia, severe pulmonary oedema, unknown abdominal pain Precautions: Renal impairment, peptic ulcer, congestive heart failure, oedema, cirrhosis. Interactions: Amphetamine, aspirin, chlorpropamide, dextroamphetamine, ephedrine, itraconazole, ketoconazole, lithium, pseudoephedrine, flecainide. Adverse Reactions: GI cramps, flatulence, alkalosis. Sodium Chloride (Half Strength) 0.45% Injection B05XA03100P6001XX (B) NEDL
APPL

System: Nutrition and Blood Disorder Indications: For replenishing fluid and for restoring / maintaining the concentration of sodium and chloride ions. Dosage: 100 - 1000 ml IV or according to the needs of the patient. Contraindications: Hypernatraemia or fluid retention, hypersensitivity(ophthalmic products), sodium chloride solutions with preservatives in newborns, for injection or flushing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks. Precautions: Restrict intake in impaired renal function, cardiac failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy. Interactions: No interaction found. Adverse Reactions: Nausea, vomiting, diarrhoea, abdominal cramps, congestive heart failure, hypertension, tachycardia, fluid accumulation, irritability, restlessness, weakness, headache, dizziness, obtundation and convulsions. 82

Sodium Chloride 0.9% Injection

B05XA03100P6002XX (C) NEDL APPL

System: Nutrition and Blood Disorder Indications: For replenishing fluid and for restoring / maintaining the concentration of sodium and chloride ions. Dosage: 100 - 1000 ml IV or according to the needs of the patient. Contraindications: Hypernatraemia or fluid retention, hypersensitivity (ophthalmic products), sodium chloride solutions with preservatives in newborns, for injection or flushing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks. Precautions: Restrict intake in impaired renal func tion, cardiac failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy. Interactions: No interaction found. Adverse Reactions: Nausea, vomiting, diarrhoea, abdominal cramps, congestive heart failure, hypertension, tachycardia, fluid accumulation, irritability, restlessness, weakness, headache, dizziness, obtundation and convulsions. Sodium Chloride 3% Injection
B05XA03100P9901XX (B)NEDL

System: Nutrition and Blood Disorder Indications: Acute dilutional hyponatraemia. Dosage: According to the needs of the patient. Contraindications: Hypernatraemia or fluid retention, hypersensitivity(ophthalmic products), sodium chloride solutions with preservatives in newborns, for injection or flushing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks. Precautions: Restrict intake in impaired renal function, cardiac failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy. Interactions: During therapy with corticosteroids or ACTH there may be an increased retention of sodium and chloride.Decreased levels of lithium. Adverse Reactions: Nausea, vomiting, diarrhoea, abdominal cramps, congestive heart failure, hypertension, tachycardia, fluid accumulation, iritability, restlessness, weakness, headache, dizziness, obtundation, convulsions. Sodium Chloride 20% Injection
B05XA03100P9902XX (B)

System: Nutrition and Blood Disorder Indications: Addition of sodium electrolyte in parenteral nutrition bags especially in paediatrics / neonates with restricted fluid allowance. Dosage: According to the needs of the patient. Contraindications: Hypernatraemia or fluid retention, hypersensitivity 83

(ophthalmic products), sodium chloride solutions with preservatives in newborns, for injection or flushing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks. Precautions: Restrict intake in impaired renal function, cardiac failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy. Interactions: During therapy with corticosteroids or ACTH there may be an increased retention of sodium and chloride.Decreased levels of lithium. Adverse Reactions: Nausea, vomiting, diarrhoea, abdominal cramps, congestive heart failure, hypertension, tachycardia, fluid accumulation, irritability, restlessness, weakness, headache, dizziness, obtundation, convulsions. Sodium Chloride 0.18% with Dextrose 10% Injection B05XA03904P6001XX (B)
NEDL

System: Nutrition and Blood Disorder Indications: For replenishing fluid and energy and for restoring /maintaining the concentration of sodium and chloride ions. Dosage: According to the needs of the patient. Contraindications: Hypernatraemia or fluid retention, hypersensitivity (ophthalmic products), sodium chloride solutions with preservatives in newborns, for injection or flushing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks. Precautions: Restrict intake in impaired renal function, cardiac failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy. Diabetes mellitus or carbohydrate intolerance and hyperglycaemia may accentuate neurologic damage for an ischaemic insult. Patients at risk for cerebral ischaemia, acute stroke, impending cardiac arrest, or severe hypotension unless hypoglycaemia is suggested or until glucose is determined. Interactions: No interaction found. Adverse Reactions: Thrombophlebitis, rebound hypoglycaemia, hy pokalaemia, sodium accumulation and oedema. Sodium Chloride 0.45% with Dextrose 10% Injection B05XA03904P6002XX (B)
NEDL

System: Nutrition and Blood Disorder Indications: For replenishing fluid and energy and for restoring /maintaining the concentration of sodium and chloride ions. Dosage: According to the needs of the patient. Contraindications: Hypernatraemia or fluid retention, hypersensitivity (ophthalmic products), sodium chloride solutions with preservatives in newborns, for injection or flus hing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks. Precautions: Restrict intake in impaired renal function, cardiac failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy.Diabetes mellitus or carbohydrate intolerance and hyperglycaemia 84

may accentuate neurologic damage for an ischaemic insult. Patients at risk for cerebral ischaemia, acute stroke, impending cardiac arrest, or severe hypotension unless hypoglycaemia is suggested or until glucose is determined. Interactions: No interaction found. Adverse Reactions: Thrombophlebitis, rebound hypoglycaemia, hypokalaemia, sodium accumulation and oedema. Sodium Chloride 0.9% with Dextrose 5% Injection
B05XA03904P6003XX (C) NEDL APPL

System: Nutrition and Blood Disorder Indications: For replenishing fluid and energy and for restoring /maintaining the concentration of sodium and chloride ions. Dosage: According to the needs of the patient. Contraindications: Hypernatraemia or fluid retention, hypersensitivity (ophthalmic products), sodium chloride solutions with preservatives in newborns, for injection or flushing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks. Precautions: Restrict intake in impaired renal function, cardiac failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy. Interactions: No interaction found. Adverse Reactions: Thrombophlebitis, rebound hypoglycaemia, hypokalaemia, sodium accumulation and oedema. Sodium Chloride 0.18% with Dextrose 4.23% Injection
B05XA03904P6004XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: For replenishing fluid and energy and for restoring /maintaining the concentration of sodium and chloride ions. Dosage: According to the needs of the patient. Contraindications: Hypernatraemia or fluid retention, hypersensitivity (ophthalmic products), sodium chloride solutions with preservatives in newborns, for injection or flushing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks. Precautions: Restrict intake in impaired renal function, cardiac failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy. Diabetes mellitus or carbohydrate intolerance and hyperglycaemia may accentuate neurologic damage for an ischaemic insult. Patients at risk for cerebral ischaemia, acute stroke, impending cardiac arrest, or severe hypotension unless hypoglycaemia is suggested or until glucose is determined. Interactions: No interaction found. Adverse Reactions: Thrombophlebitis, rebound hypoglycaemia, hypokalaemia, sodium accumulation and oedema.

85

Sodium Chloride 0.45% with Dextrose 5% Injection B05XA03904P6005XX (B)

NEDL

System: Nutrition and Blood Disorder Indications: For replenishing fluid and energy and for restoring /maintaining the concentration of sodium and chloride ions. Dosage: According to the needs of the patient. Contraindications: Hypernatraemia or fluid retention, hypersensitivity (ophthalmic products), sodium chloride solutions with preservatives in newborns, for injection or flushing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks. Precautions: Restrict intake in impaired renal function, cardiac failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy. Interactions: No interaction found. Adverse Reactions: Thrombophlebitis, rebound hypoglycaemia, hypokalaemia, sodium accumulation and oedema. Magnesium Sulphate 50% Injection
B05XA05183P3001XX (C)NEDL

System: Nutrition and Blood Disorder Indications: For replacement therapy in magnesium deficiency, especially in acute hypomagnesaemia accompanied by signs of tetany. Dosage: Adult: IM 5-10 ml. Paed IM: 20-40 mg/kg body wt as a 20% solution. Hypomagnesaemia: 0.5-1 mmol/kg body wt up to 160 mmol Mg over to 5 days. Eclampsia: IV 4 g over up to 20 mins followied by IV infusion at rate of 1 g every hr. Recurrent seizures may require an additional IV bolus of 2 - 4 g. Contraindications: Heart block, myocardial damage. Precautions: Impaired renal function and those receiving digitalis glycosides. Pregnancy and lactation. Interactions: Additive central depressant effects with CNS depressants. Neuromuscular blocking agents, cardiac glycosides, nifedipine. Adverse Reactions: Hypotension, flushing, sweating, depression of reflexes, flaccid paralysis, hypothermia, circulatory collapse, depression of cardiac function, CNS depression. Potassium Hydrogen Phosphate 1.83 g/10 ml Injection
B05XA06170P3001XX (A)

System: Nutrition and Blood Disorder Indications: For the treatment and specific prevention of hy pokalaemia. Dosage: Initially : 2.5 -5 mg/kg body wt IV 6-8 hrly. Additional doses depend on new serum phosphate level and the patient clinical status. Max : 7.5 mg/kg body wt over 6-8 hrs. Contraindications: Renal insufficiency, renal failure, 86

hyperphosphataemia,hypocalcaemia, hyperkalaemia, hypernatraemia and Addison's disease. Precautions: Renal insufficiency, cardiac disease, metabolic alkalosis. Interactions: Aluminium and magnesium-containing antacids, sucralfate, potassium-sparing diuretics, salt substitutes, ACE inhibitors, digitalis. Adverse Reactions: Diarrhoea, nausea, stomach pain, flatulence, vomiting, bradycardia, hyperkalaemia, weakness, dyspnoea. Phosphate Solution containing Sod Acid Phosphate 1.936 g / 15 ml
B05XA09902L5001XX (A)

System: Nutrition and Blood Disorder Indications: To supply supplemental ionic phosphorus for correction of hypophosphataemia. Dosage: According to the needs of the patient. Contraindications: Renal insufficiency, renal failure, hyperphosphataemia, hypocalcaemia, hyperkalaemia, hypernatraemia and Addison's disease. Precautions: Mild-to-moderate renal impairment, cirrhosis, heart failure, other oedematous condition, intravenous phosphate therapy for hypophosphataemia is indicated only in life-threatening situations, concomitant use of antacids containing aluminum or magnesium should be avoided, hypomagnesaemia can occur during intravenous phosphate therapy of hypophosphataemia, patients with kidney stones may pass old stones during phosphate therapy and do not administer laxatives when nausea, vomiting or abdominal pain is present. Interactions: Antacids, incompatible with intravenous admixtures - dextran 12%, dextran in drextrose/sodium chloride and dextrose. Adverse Reactions: Severe hypotension, hypocalcaemia, extraskeletal calcification, hypomagnesaemia, diarrhoea and acute renal failure. Cardioplegia solution containing KCl, MgCl2 & Procaine HCl Injection
B05XA16934P3001XX (A*)

System: Cardiovascular Indications: For myocardial preservation(prevent myocardial damage) during cardiac surgery. Dosage: Dilute 20 ml to 1 L of Ringer soln (cooled to 2 -8 C prior to use). Initial rapid instillation into aortic root at 300 ml/m body surface area/min for 3 mins. Should myocardial activity persist or recur instill at 300ml/m body surface area/min for 2mins.Readminister every 30 mins or sooner if myocardial temperature reaches 18C or cardiac activity returns. Contraindications: Hypersensitivity to procaine. Precautions: Use in pregnancy and lactation. Interactions: Incompatible with aminophylline, barbiturates, magnesium sulphate, phenytoin sodium, sodium bicarbonate, amikacin, dobutamine and amphotericin. Adverse Reactions: Myocardial infarction, electrocardiographic abnormalities and arrhythmias including ventricular fibrillation. 87

Sodium Lactate Compound (Hartmanns Solution)

B05XA30125L9901XX (B) NEDL APPL

System: Nutrition and Blood Disorder Indications: For replacement of extracellular fluid. Dosage: Dose : 100-1000ml IV or according to the needs of the patient. Contraindications: Lactic acidosis, severe acidosis, hypernatraemia and conditions where sodium administration would be detrimental. Precautions: Metabolic or respiratory alkalosis, congestive heart failure, other sodium-retaining conditions, concurrent corticosteroids, conditions impairing lactate utilisation (severe hepatic insufficiency, shock, beriberi, hypoxia) and during prolonged therapy. Interactions: No interaction found. Adverse Reactions: Anxiety, panic attacks, apprehension or fear, paraesthesias, tremors, dizziness, metabolic alkalosis, hypokalaemia. Trace Elements and Electrolytes (Adult) Solution B05XA30905P3001XX (A*) A d d a m e l S o l u t i o n - Trade Name System: Nutrition and Blood Disorder Indications: Only to be used to cover daily loss of electrolyte and trace elements for patient on parenteral nutrition. Dosage: Add 10 ml to 1 L solution & infused over 6-8 hrs. Contraindications: Total biliary obstruction. Precautions: Impaired biliary or renal function, liver dysfunction (cholestasis),monitor serum aluminium in neonate. Interactions: No interation found. Adverse Reactions: No information available. Trace Elements and Electrolytes (Paed) Solution B05XA30905P3002XX (A*) P e d- el - Trade Name System: Nutrition and Blood Disorder Indications: Only to be used to cover daily loss of electrolyte and trace elements for patient on parenteral nutrition. Dosage: According to the needs of the patient. Contraindications: Fructose intolerance. Precautions: Impaired or immature biliary and or renal function, monitor serum aluminium in neonate. Interactions: No interation found. Adverse Reactions: No information available.

88

Haemodialysis Concentrate Solution

B05ZA00000H1001XX (A)

System: Nutrition and Blood Disorder Indications: For acute renal failure, chronic renal failure, overhydration, intoxication, adjustment of acid-base and electrolyte balance. Dosage: Dose depending on clinical cases. Contraindications: Not known. Precautions: Unstable cardiovascular disease or active bleeding. During haemodialysis and haemofiltration, heparin are required to prevent clotting of the blood in the extracorporeal circuit. Dialysis solutions should be warmed to body temperature with dry heat because wet heat carries a risk of microbial contamination. Interactions: Generally, drugs of low molecular weight, high water solubility, low volume of distribution, low protein binding and high renal clearance are most extensively removed by dialysis e.g. aminoglycosides. Dialysis-induced changes in fluids and electrolytes. Adverse Reactions: Nausea, vomiting, hypotension, muscle cramps, and air embolus. Effects related to vascular access include infection, thrombosis and haemorrhage.Long-term complications in dialysed patients, some of which may relate to renal failure itself, include haemodialysis-related amyloidosis, acquired cystic kidney disease and accelerated atherosclerosis. Dialysis dementia is a special hazard of aluminium overload. Haemodialysis Concentrate with Acetate Haemodialysis Concentrate with Bicarbonate
B05ZA00908H1001XX (A)APPL B05ZA00908H1002XX (A)APPL

System: Nutrition and Blood Disorder Indications: For acute renal failure, chronic renal failure, overhydration, intoxication, adjustment of acid-base and electrolyte balance. Dosage: Dose depending on clinical cases. Contraindications: Not known. Precautions: Unstable cardiovascular disease or active bleeding. During haemodialysis and haemofiltration, heparin are required to prevent clotting of the blood in the extracorporeal circuit. Dialysis solutions should be warmed to body temperature with dry heat because wet heat carries a risk of microbial contamination. Interactions: Generally, drugs of low molecular weight, high water solubility, low volume of distribution, low protein binding, and high renal clearance are most extensively removed by dialysis e.g. aminoglycosides. Dialysis-induced changes in fluids and electrolytes. Adverse Reactions: Nausea, vomiting, hypotension, muscle cramps, and air embolus. Effects related to vascular access include infection, thrombosis, and haemorrhage.Long-term complications in dialysed patients, some of which may relate to renal failure itself, include haemodialysis-related amyloidosis,acquired cystic kidney disease and accelerated atherosclerosis. Dialysis dementia is a 89

special hazard of aluminium overload. Digoxin 50 mcg/ml Elixir L a n o x i n - Trade Name

C01AA05000L1001XX (B) NEDL

System: Cardiovascular Indications: Heart failure, supraventricular arrhy thmias(particularly atrial fibrillation). Dosage: Child under 10 yrs : initially 10 - 20 mcg/kg qid, then on a maintenance dose of 10 - 20 mcg/kg dly. Contraindications: Hypersensitivity to digoxin and ventricular fibrillation. Precautions: Acute myocardial infarction, acute myocarditis, amyloid cardiomyopathy, AV block. Chronic constrictive pericarditis, electrolyte imbalance (eg. hypokalaemia, hypo- or hypercalcaemia, hypomagnesaemia), hypothyroidism, hypoxia, idiopathic hypertrophic subaortic stenosis. Renal disease, severe bradycardia, severe heart failure and pulmonary disease, ventricular tachycardia and Wolff-Parkinson-White syndrome. Interactions: Plasma concentration increased by quinidine, verapamil, nifedipine, amiodarone. Hypokalaemia may be associated with diuretics, lithium, carbenoxolone, corticosteroids. Antacids, neomycin may reduce serum level of digoxin. Adverse Reactions: Nausea, vomiting, anorexia, diarrhoea, abdominal pains, salivation, sweating; headache, facial pain, malaise, fatigue, drowsiness, depression, disorientation, mental confusion, delirium, hallucination, visual disturbance. Ventricular premature contraction. Digoxin 500 mcg/2 ml Injection L a n o x i n - Trade Name
C01AA05000P3001XX (A) NEDL

System: Cardiovascular Indications: Heart failure with atrial fibrillation, supraventricular arrhythmias (particularly atrial fibrillation). Dosage: Rapid digitilisation: Adult & child > 10 yr : Initially 0.75 - 1.5 mg, followed by 250 mcg 6 hrly until digitilisation is complete. Contraindications: Hypersensitivity to digoxin. Precautions: Acute myocardial infarction, acute myocarditis, amyloid cardiomyopathy, AV block. Chronic constrictive pericarditis, electrolyte imbalance (eg. hypokalaemia, hypo- or hypercalcaemia, hypomagnesaemia), hypothyroidism, hypoxia, idiopathic hypertrophic subaortic stenosis. Renal disease, severe bradycardia, severe heart failure and pulmonary disease, ventricular tachycardia and Wolff-Parkinson-White syndrome. Interactions: Plasma concentration increased by quinidine, verapamil, nifedipine, amiodarone. Hypokalaemia may be associated with diuretics, lithium, carbenoxolone, corticosteroids. Antacids, neomycin may reduce serum level of digoxin. Adverse Reactions: Nausea, vomiting, anorexia, diarrhoea, abdominal pains, salivation, sweating; headache, facial pain, malaise, fatigue, drowsiness, 90

depression, disorientation, mental confusion, delirium, hallucination, visual disturbance. Ventricular premature contraction. Digoxin 0.25 mg Tablet L a n o x i n - Trade Name
C01AA05000T1001XX (B)NEDL

System: Cardiovascular Indications: Heart failure , with atrial fibrillation, supraventricular arrhythmias (particularly, atrial fibrillation). Dosage: Rapid digitalisation, 1-1.5 mg in divided doses over 24 hours; less urgent digitalisation, 250-500 mcg dly (higher dose may be divided). Maintenance: 62.5 - 500 mcg dly (higher dose may be divided) according to renal fuction, and in atrial fibrillation, on heart-response; usual range :125 - 250 mcg dly (lower doses may be appropriate in the elderly). Contraindications: Hypersensitivity to digoxin. Precautions: Acute myocardial infarction, acute myocarditis, amyloid cardiomyopathy, AV block. Chronic constrictive pericarditis, electrolyte imbalance (eg. hypokalaemia, hypo- or hypercalcaemia, hypomagnesaemia), hypothyroidism, hypoxia, idiopathic hypertrophic subaortic stenosis. Renal disease, severe bradycardia, severe heart failure and pulmonary disease, ventricular tachycardia and Wolff-Parkinson-White syndrome. Interactions: Plasma concentration increased by quinidine, verapamil, nifedipine, amiodarone. Hypokalaemia may be associated with diuretics, lithium, carbenoxolone, corticosteroids. Antacids, neomycin may reduce serum level of digoxin. Adverse Reactions: Nausea, vomiting, anorexia, diarrhoea, abdominal pains, salivation, sweating; headache, facial pain, malaise, fatigue, drowsiness, depression, disorientation, mental confusion, delirium, hallucination, visual disturbance. Ventricular premature contractions, atrial or ventricular arrhythmias and conduction defects. Hypokalaemia. Digoxin 62.5 mcg Tablet L a n o x i n - Trade Name
C01AA05000T1002XX (B) NEDL APPL

System: Cardiovascular Indications: Heart failure, with atrial fibrillation, supraventricular arrhythmias (particularly, atrial fibrillation). Dosage: Rapid digitalisation, 1-1.5 mg in divided doses over 24 hours; less urgent digitalisation, 250-500 mcg dly (higher dose may be divided). Maintenance: 62.5 - 500 mcg dly (higher dose may be divided) according to renal fuction, and in atrial fibrillation, on heart-response; usual range :125 - 250 mcg dly (lower doses may be appropriate in the elderly). Contraindications: Hypersensitivity to digoxin. Precautions: Acute myocardial infarction, acute myocarditis, amyloid cardiomyopathy, AV block. Chronic constrictive pericarditis, electrolyte imbalance (eg. hypokalaemia, hypo- or hypercalcaemia, hypomagnesaemia), 91

hypothyroidism, hypoxia, idiopathic hypertrophic subaortic stenosis. Renal disease, severe bradycardia, severe heart failure and pulmonary disease, ventricular tachycardia and Wolff-Parkinson-White syndrome. Interactions: Plasma concentration increased by quinidine, verapamil, nifedipine, amiodarone. Hypokalaemia may be associated with diuretics, lithium, carbenoxolone, corticosteroids. Antacids, neomycin may reduce serum level of digoxin. Adverse Reactions: Nausea, vomiting, anorexia, diarrhoea, abdominal pains, salivation, sweating; headache, facial pain, malaise, fatigue, drowsiness, depression, disorientation, mental confusion, delirium, hallucination, visual disturbance. Ventricular premature contractions, atrial or ventricular arrhythmias and conduction defects. Hypokalaemia. Lignocaine 100 mg/ml Injection Lignocaine 500 mg/ml Injection X y l o c a r d - Trade Name
C01BB01110P3001XX (B) NEDL APPL C01BB01110P3002XX (B) NEDL APPL

System: Cardiovascular Indications: Ventricular Tachycardia and Ventricullar Fibrillation. To be diluted before use. Dosage: 50 - 100 mg IV as a bolus, repeated after 5 mins if necessary. Maintenance: 1 4 mg/min by IV infusion under ECG monitoring. Contraindications: Hypersensitivity to lidocaine or amide type of local anaesthetics. Precautions: Adams-Stokes syndrome, advanced heart failure. EKG monitoring for intravenous administration. Epidural anaesthesia; a test dose is recommended, heart block, hepatic disease, hypovolaemia, renal disease, severe degrees of sinoatrial, atrioventricular or intraventricular block. Shock, sinus bradycardia, spinal anaesthesia, severe haemorrhage, shock, heart block, local infection at injection site, septicaemia. Wolff-Parkinson-White syndrome. Interactions: Amiodarone, bupivacaine, cimetidine, propranolol, metoprolol and nadolol. Adverse Reactions: Nervousness, dizziness, paraesthesia, drowsiness, tinnitus, disorientation, blurred vision, tremor, convulsions, respiratory depression, hypotension, bradycardia. Flecainide Acetate 100 mg Tablet T r a m b o c o r - Trade Name
C01BC04122T1001XX (A*)

System: Cardiovascular Indications: i) Sustained monomorphic ventricular tachycardias ii)Preexcited atrial fibrillation associated with Wolff-Parkinson White Syndrome iii)Reciprocating Atrio-Ventricular tachycardias (AVT) associated with WolffParkinson White Syndrome iv) Supraventricular tachycardias due to Intra-Atrio Ventricular Nodul Reentry. Dosage: Ventricular arrhythmias: 100 mg bd, max. 200 mg bd (usually reserved for rapid 92

control or in heavily built patients), reduced after 3 - 5 days if possible. Supraventricular arrhythmias: 50 mg bd, increased if required to max of 150 mg bd. Contraindications: Cardiogenic shock, hypersensitivity to flecainide, preexisting second or third-degree AV block. Right bundle branch block when associated with left hemiblock (bifascicular block) unless a pacemaker is present. Precautions: Congestive heart failure (CHF), patients with a left ventricular ejection fraction (LVEF) less than 40% may be particularly susceptible to the adverse cardiac effects (ie, worsening CHF, proarrhythmia). Elderly patients. Electrolyte imbalance (eg, hypo- or hyperkalemia) . Hepatic disease, increased mortality; flecainide should not be initiated in post-myocardial infarction patients with asymptomatic or minimally symptomatic non-life threatening ventricular arrhythmias. Increased pacemaker threshold, proarrhythmic events; new or worsened arrhythmias, primarily at high serum levels . Renal disease . Sick sinus syndrome (Bradycardia-Tachycardia syndrome) and slowing of cardiac conduction. Interactions: May cause rise in plasma digoxin. Possible additive -ve inotropic effects of beta-blockers & other cardiac depressants. Enzyme inducers enhance elimination. Reduces flecainide dosage by 50% when given in the presence of amiodarone. Adverse Reactions: Giddiness, dizziness, lightheadedness, visual disturbances, nausea and vomiting. Proarrhythmia may occur in patients with structural heart disease and or significant left ventricular impairment. Amiodarone 150 mg/3 ml Injection C o r d a r o n e - Trade Name
C01BD01110P3001XX (A*)

System: Cardiovascular Indications: Arrhythmias when other drugs are contraindicated. Dosage: Initial infusion of 150 - 300 mg via large venous access over 20 - 120 minutes with ECG monitoring, followed by an infusion to a max. of 1.2 g in 24 hrs. Contraindications: Cardiogenic shock, hypersensitivity to amiodarone, second or third degree AV block (if no pacemaker is present). Severe sinus bradycardia and severe sinus-node dysfunction. Precautions: Acute myocardial infarction, particularly with IV administration, AV block, particularly with IV administration, bradycardia, particularly with IV administration. Cardiomegaly, particularly with IV administration, corneal microdeposits (impaired vision). Interactions: Antiarrhythmics, beta-blockers, stimulating laxatives, diuretics inducing hypokalaemia, systemic corticosteroids, tetracosactide, amphotericin B, digitalis, anticoagulants, phenytoin, general anaesthetic, cyclosporin. Adverse Reactions: Reversible corneal microdeposits; colored halos; hyper or hypothyroidism. Rarely, photosensitization and pigmentation, reversible diffuse interstitial pneumopathy or peripheral neuropathy.

93

Amiodarone 200 mg Tablet C o r d a r o n e - Trade Name

C01BD01110T1001XX (A*)

System: Cardiovascular Indications: Arrhythmias Dosage: 200 mg tds for 1 wk, then reduced to 200 mg bd for another wk. Maintenance dose, usually 200 mg dly or the minimum required to control the arrhythmia. Contraindications: Cardiogenic shock, hypersensitivity to amiodarone, second or third degree AV block (if no pacemaker is present). Severe sinus bradycardia and severe sinus-node dysfunction Precautions: Acute myocardial infarction, particularly with IV administration, AV block, particularly with IV administration, bradycardia, particularly with IV administration. Cardiomegaly, particularly with IV administration, corneal microdeposits (impaired vision). Interactions: Antiarrhythmics, beta-blockers, stimulating laxatives, diuretics inducing hypokalaemia, systemic corticosteroids, tetracosactide, amphotericin B, digitalis, anticoagulants, phenytoin, general anaesthetics, cyclosporin. Adverse Reactions: Reversible corneal microdeposits, colored halos, hyper or hypothyroidism. Rarely, photosensitization and pigmentation, reversible diffuse interstitial pneumopathy or peripheral neuropathy Isoprenaline HCl 0.2 mg/ ml Injection Isoprenaline HCl 1 mg/5 ml Injection I s u p r e l - Trade Name
C01CA02110P3001XX (B)NEDL C01CA02110P3002XX (B)NEDL

System: Cardiovascular Indications: Complete heart block (third-degree artrioventricular block) not responding to atropine, while waiting for cardiac pacing. Dosage: Initially 200mcg as subcutaneously or intramuscularly. 10 - 20 mcg by slow IV or 2 mg by IV infusion in dextrose according to patient's response. Contraindications: Angina pectoris, cardiac arrhythmia associated with tachycardia, Digitalis-induced tachycardia or heart block. Hypersensitivity to isoproterenol or other product ingredients and ventricular arrhythmia requiring inotropic therapy. Precautions: Cardiovascular disorders, especially coronary insufficiency, arrhythmias, hypertension, convulsive disorders, diabetes mellitus. Doses sufficient to raise the heart rate above 130 beats/minute. Hyperthyroidism, patients who are unusually responsive. Interactions: Isoprenaline & adrenaline may produce arrhythmias. Adverse Reactions: Nervousness, dizziness, headache, tachycardia, palpitations, angina, Adams-Stokes attacks, pulmonary eodema, hypertension, hypotension, ventricular arrhythmias, tachyarrhythmias, flushing and sweating.

94

Norepinephrine Bitartrate 4 mg/4 ml Injection (Noradrenaline acid tartrate) Levophed

C01CA03123P3001XX (A)
- Trade Name

System: Cardiovascular Indications: Septic shock and shock where peripheral vascular resistance is low. Dosage: Infuse and titrate to desired pressure response. Range : 0.05 - 0.5 mcg/kg/minute. Contraindications: Blood volume deficit. Precautions: Peripheral vascular thrombosis, concomitant cyclopropane and halothane anaesthesia, profound hypoxia. Coadministration with monoamine oxidase inhibitors (MOAIs) or tricyclic antidepressants. Sulfite allergy (seen more frequently in asthmatic than nonasthmatic patients). Interactions: MAOIs, tricyclic antidepressants Adverse Reactions: Occasionally, bradycardia; anxiety, transient headache. Plasma volume depletion (prolonged administration). Respiratory difficulty, ischemic injury. Dopamine HCl 40 mg/ml Injection I n t r o p i n - Trade Name
C01CA04110P3001XX (B) NEDL APPL

System: Cardiovascular Indications: Non-hypovolemic hypotension. Dosage: By IV infusion, initially 2.5 - 20 mcg/kg/min, adjusted according to response. Contraindications: Pheochromocytoma, tachyarrhythmias or ventricular fibrillation. Precautions: Angina pectoris, conditions such as hypovolaemia, hypoxia, hypercapnia, and acidosis should be corrected prior to administration of dopamine. Patients allergic to sulfite. Dopamine solutions may contain sodium metabisulfite. Patients receiving Monoamine Oxidase (MAO) inhibitors will exhibit enhanced dopamine effects. Patients with pre-existing vascular damage secondary to atherosclerosis, diabetes, Raynaud's disease or frostbite since dopamine can produce peripheral necrosis or gangrene. Interactions: Beta-blockers, cyclopropane or halogenated hydrocarbon, ergotamine, phenytoin. Adverse Reactions: Increased heart rate, blood pressure and ventricular ectopic activity. Nausea, headache, anginal pain, nonspecific chest pain, palpitations and shortness of breath. Dobutamine HCl 250 mg/20 ml Injection D o b u t r e x - Trade Name System: Cardiovascular Indications: Hypotension and heart failure. Dosage: 95
C01CA07110P3001XX (A*) APPL

By IV infusion, 2.5 - 40 mcg/kg/min, adjusted according to response. Contraindications: Hypersensitivity to dobutamine, idiopathic hypertrophic subaortic stenosis. Precautions: Arrhythmias, hypovolaemia . May be ineffective in patients who have recently received a beta-blocker, in such cases peripheral vascular resistance may increase. Monitor EKG and blood pressure constantly, serum potassium, pulmonary wedge pressure and cardiac output. Myocardial infarction and severe coronary artery disease. Interactions: Beta-blockers. Avoid cyclopropane or halogenated hydrocarbon anaesthesia. Adverse Reactions: Increased heart rate, blood pressure and ventricular ectopic activity. Nausea, headache, anginal pain, nonspecific chest pain, palpitations and shortness of breath. Hydroxynorephedrine (Metaraminol) 10mg/ml lnj C01CA09123P3001XX (B)NEDL A r a m i n e - Trade Name System: Cardiovascular Indications: Prevention and treatment of acute hypotensive state occuring with spinal anaesthesia and as adjunctive treatment of hypotension. Dosage: 2 - 10 mg SC or IM. 0.5 - 5 mg IV. Contraindications: Concomitant anaesthesia with cyclopropane or halothane, hypersensitivity to metaraminol or its sulfites. Precautions: Cirrhosis, concomitant digitalis, monoamine oxidase inhibitor or tricyclic antidepressant. Diabetes, excessive blood pressure response may precipitate acute pulmonary oedema, arrhythmias or cardiac arrest. Heart disease, hypertension hyperthyroidism. Prolonged administration may reduce venous return and cardiac output, with subsequent increase in workload of the heart. Sulfite sensitivity may be increased in patients with asthma. Use adequate blood volume expansion in conjunction with metaraminol to avoid perpetuation of the shock state. Interactions: MAOIs may potentiate the action of sympathomimetics. Digitalis, combination capable of causing ectopic arrhythmic activity. Adverse Reactions: May cause acute pulmonary oedema, cardiac arrhythmias and cardiac arrest due to rapidly induced hypertensive responses. May cause sinus or ventricular tachycardia or other arrhythmias, especially in patients with MI. Methoxamine HCl 20 mg/ml Injection V a s o x i n e - Trade Name
C01CA10110P3001XX (A*)

System: Cardiovascular Indications: Hypotension associated with the use of antihypertensive drugs and spinal anaesthesia and during cardio-pulmonary bypass. Dosage: 5 - 20 mg IM or by slow IV, 5 - 10 mg at 1 mg/minute. Contraindications: Hypersensitivity to methoxamine, severe hypertension, 96

local anaesthetics. Precautions: Bradycardia, concomitant ergot alkaloids, monoamine oxidase inhibitors, oxytoxic agents, tricyclic antidepressants or vasopressin, hyperthyroidism, myocardial disease, partial heart block, severe arteriosclerosis, sulfite sensitivity; greater in asthmatics. Interactions: Tricyclic antidepressants. Adverse Reactions: Headache, hypertension, tingling of the extremities, arrhythmias. Adrenaline Acid (Epinephrine) Tartrate 1 mg/ml Injection
C01CA24123P3001XX (B) NEDL APPL

System: Cardiovascular Indications: Cardiopulmonary resuscitation. Dosage: 0.5 -1 mg SC/IM. Contraindications: Cardiac dilatation, coronary insufficiency. During general anaesthesia with halogenated hydrocarbons or cyclopropane. In combination with local anaesthetics in fingers or toes, patients with organic brain damage. Intra-arterial injection. Precautions: Allow sufficient time to pass before or after administering another beta-agonist sympathomimetic to avoid additive effects. Avoid inadvertent administration of epinephrine in lieu of vitamin. Angina pectoris, cardiovascular disease, cerebrovascular insufficiency, chronic lung disease, concurrent use with cyclopropane or halogenated hydrocarbon anaesthetics may produce fatal ventricular arrhythmias . Epinephrine may produce a greater increase in heart rate, blood glucose, lactate, glycerol, and free fatty acids in diabetic patients with autonomic neuropathy than in diabetics without neuropathy. Elderly patients. Hypertension, hyperthyroidism, hypersensitivity to sympathomimetics. Interactions: Carvedilol, chlorpromazine, halothane, labetalol, moclobemide, nadolol, oxprenolol, propranolol, rocuronium, selegiline, timolol, tricyclic antidepressants. Adverse Reactions: Hypertension, nausea, vomiting, headache, arrhythmias. Glyceryl Trinitrate 5 mg Transdermal Patch Nitroderm TTS , Nitrodisc - Trade Name
C01DA02221M7001XX (A) NEDL

System: Cardiovascular Indications: Prophylaxis and treatment of angina, left ventricular failure. Dosage: Apply once daily to a site free of hair on the chest or on inner side of upper arm. Replace every 24 hours. Contraindications: Hypersensitivity to adhesives and organic nitrates. Increased intracranial pressure Precautions: Acute myocardial infarction (associated with hypertension and or tachycardia and or congestive heart failure. Alcohol use enhances hypotensive effects. Cerebral haemorrhage, gastric hypermotility (sustained release dosage form), head trauma, hyperthyroidism, hypertrophic cardiomyopathy, increased 97

intraocular pressure, postural hypotension, pregnancy and lactation. Withdraw gradually to avoid acute angina Interactions: Imipramine, atropine, nitrates and sildenafil . Adverse Reactions: Flushing, dizziness, tachycardia and throbbing headache. Large doses cause vomiting, restlessness, blurred vision, hypotension (which can be severe), syncope, and rarely cyanosis, and methaemoglobinaemia, impairment of respiration and bradycardia. Glyceryl Trinitrate 25 mg/5 ml Injection Nitro - b i d - Trade Name
C01DA02221P3001XX (A) NEDL APPL

System: Cardiovascular Indications: Prophylaxis and treatment of angina, left ventricular failure. Not for direct IV injection. Dosage: Initial 5 mcg/min delivered via infusion pump. Subsequent titration must be adjusted to clinical situation with dose increment becoming more cautious as partial response is seen. Contraindications: Constrictive pericarditis and organic nitrates. Increased intracranial pressure Precautions: Acute myocardial infarction (associated with hypertension, and or tachycardia, and or congestive heart failure . Alcohol use enhances hypotensive effects. Cerebral haemorrhage, gastric hypermotility (sustained release dosage form), head trauma, hyperthyroidism, hypertrophic cardiomyopathy, increased intraocular pressure, postural hypotension, pregnancy and lactation. Withdraw gradually to avoid acute angina Interactions: Imipramine, atropine, nitrates and sildenafil Adverse Reactions: Flushing, dizziness, tachycardia and throbbing headache. Large doses cause vomiting, restlessness, blurred vision, hypotension (which can be severe), syncope and rarely cyanosis and methaemoglobinaemia, impairment of respiration and bradycardia . Glyceryl Trinitrate 0.5 mg Tablet A n g i s e d - Trade Name
C01DA02221T1001XX (B) NEDL APPL

System: Cardiovascular Indications: Prophylaxis and treatment of angina, left ventricular failure. Dosage: 0.5 - 1 mg sublingually. Contraindications: Anaemia severe, early myocardial infarction and organic nitrates. Increased intracranial pressure Precautions: Acute myocardial infarction (associated with hypertension and or tachycardia and or congestive heart failure. Alcohol use enhances hypotensive effects. Cerebral haemorrhage, gastric hypermotility (sustained release dosage form), head trauma, hyperthyroidism, hypertrophic cardiomyopathy, increased intraocular pressure, postural hypotension, pregnancy and lactation. Withdraw gradually to avoid acute angina. Interactions: Imipramine, atropine, nitrates and sildenafil 98

Adverse Reactions: Flushing, dizziness, tachycardia and throbbing headache. Large doses cause vomiting, restlessness, blurred vision, hypotension (which can be severe), syncope and rarely cyanosis and methaemoglobinaemia, impairment of respiration and bradycardia . Isosorbide Dinitrate 1 mg/ml Injection Isoket - Trade Name
C01DA08221P3001XX (A)NEDL

System: Cardiovascular Indications: Prophylaxis and treatment of angina, left ventricular failure. Dosage: 2 - 10 mg/hr by IV infusion after dilution, higher doses up to 20 mg/hour may be required. Contraindications: Hypersensitivity to organic nitrates, anaemia, symptomatic hypotension. Precautions: Acute myocardial infarction (associated with hypertension and or tachycardia). Alcohol use enhances hypotensive effects. Cerebral haemorrhage. Dose to provide 10- to 12-hour drug-free intervals. Elderly (postural hypotension), head trauma, hyperthyroidism, hypertrophic cardiomyopathy, increased intraocular pressure, pericardial tamponade, postural hypotension. Pregnancy and lactation, restrictive cardiomyopathy and withdraw gradually to avoid acute angina. Interactions: Sildenafil, diazoxide. Hypotensive effects may be enhanced by alcohol, beta-blocker, antihypertensive and tricyclic antidepressant. Adverse Reactions: Headache, hypotension, tachycardia. Isosorbide Dinitrate 10 mg Tablet I s o r d i l - Trade Name
C01DA08221T1001XX (B) NEDL APPL

System: Cardiovascular Indications: Prophylaxis and treatment of i) angina ii) left ventricular failure. Dosage: i) 30 - 120 mg dly in divided doses. ii) 40 - 160 mg, up to 240 mg if required. In acute episodes: 5 - 10 mg sublingually. Contraindications: Hypersensitivity to organic nitrates, anaemia, symptomatic hypotension. Precautions: Acute myocardial infarction (associated with hypertension and or tachycardia). Alcohol use enhances hypotensive effects. Cerebral haemorrhage. Dose to provide 10 - 12-hour drug-free intervals. Elderly (postural hypotension), head trauma, hyperthyroidism, hypertrophic cardiomyopathy, increased intraocular pressure, pericardial tamponade, postural hypotension. Pregnancy and lactation, restrictive cardiomyopathy and withdraw gradually to avoid acute angina. Interactions: Sildenafil, diazoxide. Hypotensive effects may be enhanced by alcohol, beta-blocker, antihypertensive and tricyclic antidepressant. 99

Adverse Reactions: Headache, hypotension, tachycardia. Isosorbide Mononitrate 50 mg SR Capsule E l a n t a n - Trade Name
C01DA14221C2001XX (A)

System: Cardiovascular Indications: Long term treatment of coronary arterial disease and congestive heart failure, prophylaxis of anginal attacks, post treatment of myocardial infarction with persisting anginal symptoms. Dosage: 50 mg dly. Contraindications: Anaemia, head trauma, symptomatic hypotension, hyperthyroidism, hypersensitivity to organic nitrates. Precautions: Acute myocardial infarction (associated with hypertension and or tachycardia). Alcohol use enhances hypotensive effects. Cerebral haemorrhage. Dose to provide 10- to 12-hour drug-free intervals . Elderly (postural hypotension), head trauma, hyperthyroidism, hypertrophic cardiomyopathy, increased intraocular pressure, pericardial tamponade, postural hypotension . Pregnancy and lactation, restrictive cardiomyopathy and withdraw gradually to avoid acute angina. Interactions: Sildenafil, diazoxide. Hypotensive effects may be enhanced by alcohol, beta-blocker, antihypertensive and tricyclic antidepressant. Adverse Reactions: Headache, hypotension, tachycardia. Isosorbide-5-Mononitrate 30 mg SR Tablet Isosorbide-5-Mononitrate 60 mg SR Tablet I m d u r - Trade Name
C01DA14221T5001XX (A) C01DA14221T5002XX (A)

System: Cardiovascular Indications: Prophylaxis and treatment of angina pectoris. Dosage: 30 - 120 mg dly. Contraindications: Hypersensitivity to organic nitrates, anaemia, symptomatic hypotension. Precautions: Acute myocardial infarction (associated with hypertension, and/or tachycardia). Alcohol use enhances hypotensive effects. Cerebral haemorrhage. Dose to provide 10- to 12-hour drug-free intervals. Elderly (postural hypotension), head trauma, hyperthyroidism, hypertrophic cardiomyopathy, increased intraocular pressure, pericardial tamponade, postural hypotension. Pregnancy and lactation, restrictive cardiomyopathy and withdraw gradually to avoid acute angina. Interactions: Sildenafil, diazoxide. Hypotensive effects may be enhanced by alcohol, beta-blocker, antihypertensive and tricyclic antidepressant. Adverse Reactions: Headache, hypotension, tachycardia. Alprostadil 500 mcg/ml Injection P r o s t i n V R - Trade Name System: Cardiovascular 100
C01EA01000P3001XX (A*) NEDL

Indications: For treatment of congenital heart diseases which are ductus arteriosus dependent. Dosage: 0.05 - 0.1 mcg/kg/min by continuous IV infusion. Contraindications: Neonates with respiratory distress syndrome. Precautions: Concurrent anticoagulants, neonates with bleeding tendencies, spinal cord injury. Interactions: Heparin. Adverse Reactions: Bradycardia, fever, hypotension, tachycardia, neonatal apnoea, seizures. Adenosine 3 mg/ml Injection A d e n o c o r - Trade Name
C01EB10000P3001XX (A)

System: Cardiovascular Indications: Rapid conversion of paroxysmal supraventricular tachycardia to sinus rhythm. Dosage: Adult: 3 mg by rapid IV injection over 2 seconds; increasing to 6 and 12 mg at 1 - 2 minutes intervals, if patients do not respond. Child : 0.05 - 0.25 mg/kg IV (max : 3 mg) every 2 mins. Contraindications: Bradycardia, bronchoconstrictive or bronchospastic lung disease (eg. asthma). Hypersensitivity to adenosine, second-degree or thirddegree AV block (if no pacemaker is present), sinus node disease (ie sick sinus syndrome). Precautions: Avoid concomitant use of dipyridamole and methylxanthines (ie caffeine, theophylline) . Cardiac arrest, heart block, heart transplant patients, hypertension, hypotension, myocardial infarction. Proarrhythmic events; new rhythms, particularly at time of conversion and unstable angina. Interactions: Actions may be potentiated by dipyridamole and carbamazepine. Theophylline & caffeine inhibit its action. Adverse Reactions: Facial flush, dyspnoea, a feeling of thorasic constriction, nausea, lightheadedness, feeling of discomfort, sweating, palpitations, hyperventilation, head pressure, apprehension, blurred vision, burning sensation, bradycardia, chest pains, headache, dizziness, heaviness in arms, arm, back and neck pains; metallic taste. Trimetazidine 20 mg Tablet V a s t a r e l - Trade Name
C01EB15110T1001XX (A/KK) NEDL

System: Cardiovascular Indications: As adjuvant therapy for patients who are not good candidates for vascularization procedures, also for patients who are intolerant to Betablockers and or calcium channel blockers. Dosage: 20 mg tds. Contraindications: Concomitant administration with MAOIs. Precautions: Pregnancy especially first trimester, unstable angina, 101

hypertension, renal or hepatic insufficiency. Interactions: No interactions found. Adverse Reactions: Rare cases of GI disorders. Methyldopa 250 mg Tablet Aldomet - Trade Name
C02AB01110T1001XX (B) NEDL APPL

System: Cardiovascular Indications: Hypertension. Dosage: 250 mg bd - tds, gradually increased at intervals of 2 or more days. Max : 3 g/day. Elderly, 125 mg bd initially, gradually increased; max 2 g dly. Contraindications: Hypersensitivity to methyldopa, history of hepatitis, autonomic dysfunction, bilateral cardiovascular disease. Precautions: Avoid abrupt withdrawal, pre-existing postural hypotension or other signs of autonomic dysfunction, history of liver disease or dysfunction . Interactions: Antihypertensive drugs, lithium, MAOIs Adverse Reactions: Sedation (usually transient), headache, asthenia, oedema, drug fever, CNS, CVS, hepatic effects, endocrine and GI disturbances, allergic and dermatologic reactions. Bone marrow depression (usually reversible), haemolytic anaemia (stop drug), jaundice, involuntary choreoathetotic movements. Clonidine HCl 0.025 mg Tablet C a t a p r e s - Trade Name
C02AC01110T1001XX (A)

System: Emergency Indications: Detoxification of heroin addicti on in combination with Naltrexone. Dosage: 0.2 mg qid. Contraindications: Anticoagulant therapy (epidural dosing), bleeding site, hypersensitivity to clonidine or adhesive components. Precautions: Cerebrovascular disease, chronic renal failure, conduction disturbances, myocardial infarction, obstetric, post-partum or peri-operative pain management. Interactions: Acebutolol, betaxolol, carvedilol , labetalol, metoprolol, propranolol : exaggerated clonidine withdrawal response (acute hypertension). Cyclosporin : increased risk of cyclosporin toxicity (renal dysfunction, cholestasis, paraesthesias). Dothiepin : decreased antihypertensive effectiveness. Naloxone : hypertension. Adverse Reactions: Rebound hypertension, atrioventricular block, bradycardia, hypotension, depression, psychotic reactions, drowsiness, fatigue, irritability, vomiting, dry mouth, constipation, sexual dysfunction, hepatotoxicity and cutaneous reactions.

102

Prazosin HCl 1 mg Tablet Prazosin HCl 2 mg Tablet Prazosin HCl 5 mg Tablet M i n i p r e s s - Trade Name

C02CA01110T1001XX (B) NEDL APPL C02CA01110T1002XX (B) NEDL APPL C02CA01110T1003XX (B) NEDL APPL

System: Cardiovascular Indications: Hypertension. Dosage: 500 mcg bd - tds, the initial dose on retiring to bed at night (to avoid collapse); increased to 1 mg bd - tds after 3 - 7 days; further increased if necessary to max. 20 mg dly (in divided doses). Contraindications: Hypersensitivity to prazosin products or other quinazolines. Precautions: Dizziness, lightheadedness, orthostatic hypotension, syncope, fainting, and sudden loss of consciousness (First-dose effect). Interactions: Antihypertensive effects of other hypotension producing medications may be potentiated when used concomitantly. Antihypertensive effects of prazosin may be reduced when used concurrently with NSAIDs & sympathomimetics. Adverse Reactions: Dizziness, orthostatic hypotension, oedema, palpitations, urinary incontinence, angina, dyspnoea, priapism. Dihydralazine Methanesulphonate 25 mg Injection C02DB01196P3001XX (B)NEDL N e p r e s o l - Trade Name System: Cardiovascular Indications: Hypertensive crisis. Dosage: Adult, initially 6.25 mg by slow IV, repeat after 20-30 mins if necessary. May also be given by continuous IV infusion using 50 mg in 500 ml solution. Maintenance flow rate: Not more than 0.5 mg/min. Paeds, initially 0.1-0.5 mg/kg IV mg/kg over 1-2 mins, repeat every 30-90 mins as required. Max: 3.5mg/kg/day. Contraindications: Hypersensitivity to dihydralazine or hydralazine. Dissecting aortic aneurysm. Precautions: Coronary artery disease, history of cerebrovascular disease or stroke, renal insufficiency, hydralazine-induced systemic lupus erythematosus, may reduce the pressor responses to epinephrine. Interactions: Concomitant treatment with other vasodilators, calcium antagonists, ACE inhibitors, diuretics, antihypertensives, tricyclic antidepressants and major tranquillisers, as well as the consumption of alcohol, may potentiate the blood pressure-lowering effect. Adverse Reactions: Tachycardia, palpitation, anginal symptoms, headache, GI disturbances. SLE- like syndrome, skin rash, changes in blood count. Hepatitis, jaundice, arthralgia, peripheral neuritis, anxiety.

103

Hydralazine HCl 25 mg Tablet

C02DB02110T1001XX (A*)

System: Cardiovascular Indications: Moderate to severe hypertension Dosage: 25 mg bd, increased to a max of 50 mg bd. Contraindications: Hypersensitivity to hydralazine,CAD,history of CVD,dissecting aortic aneurysm Precautions: Coronary artery disease, history of cerebrovascular disease or stroke, renal insufficiency, hydralazine-induced systemic lupus erythematosus, may reduce the pressor responses to epinephrine. Interactions: Indomethacin,metoprolol, oxprenolol, propranolol Adverse Reactions: Lupus syndrome, tachycardia,peripheral neuropathy Minoxidil 5 mg Tablet L o n i t e n - Trade Name
C02DC01000T1001XX (A*)

System: Cardiovascular Indications: Severe hypertension. Dosage: Adults and children > 12 yrs : initially 5 mg (elderly 2.5 mg) dly in single or divided doses. May increase by 5 - 10 mg dly at intervals of 3 or more days until optimum control is achieved. Max 50 mg daily.<12 yrs: 0.2 mg/kg as a single or divided dose. Contraindications: Hypersensitivity to minoxidil products Precautions: Angina pectoris may be exacerbated, breast feeding period, cerebrovascular disease, cerebrovascular accident (recent), congestive heart failure (without adequate diuretic therapy), dialysis, fluid retention, impaired renal function, myocardial infarction Interactions: Combination with guanethidine may produce orthostatic hypotension. Adverse Reactions: Salt and water retention; tachycardia, pericardial effusion and tamponade; hypertrichosis. Occasionally, allergic rashes; GI effects; breast tenderness; thrombocytopenia, leucopenia. Sodium Nitroprusside 50 mg/5 ml Injection N i p r i d e - Trade Name System: Cardiovascular
C02DD01520P3001XX (A)

104

Indications: i) Hypertensive crisis and ii) Controlled hypotension in surgery. Dosage: i) By IV infusion, initially 0.5-1.5 mcg/kg/min, then adjusted before increasement of 0.5 mcg/kg/min every 5 mins within range 0.5-8 mcg/kg/min (lower doses in pts. already receiving other antihypertensives); stop if marked response not obtained with max dose in 10 minutes. Use only in infusion with 5 % Dextrose IV. ii) By IV infusion , max : 1.5 mcg/kg/min. Contraindications: Hypersensitivity to nitroprusside,anaemia, head trauma, symptomatic hypotension, encephalopathy, Precautions: Excessive hypotension, acute heart failure associated with reduced peripheral vascular resistance . Cyanide toxicity ,methaemoglobinemia ,NADH-methaemoglobin reductase deficiency , drug-induced (phenacetin, nitrites, nitrates, sulfonamides, dapsone, chlorates, chloroquine, primaquine, and phenazopyridine) . Pre-existing anaemia and or hypovolaemia. Interactions: Hypotensive effect potentiated by ganglion blockers, other antihypertensive agents, volatile liquid anaesthetics & other circulatory depressants. Adverse Reactions: Tachycardia, postural hypotension; nausea, retching, diaphoresis, apprehension, headache, restlessness, muscle twitching, retrosternal discomfort, palpitation, perspiration, dizziness, drowsiness, paraesthesial warmth, abdominal pain. Irritation and reddening at inj site. Chlorothiazide 500 mg Tablet Chlotride - Trade Name
C03AA04000T1001XX (B) NEDL APPL

System: Cardiovascular Indications: i) Diuretic ii) Hypertension. Dosage: i) 250 - 1000 mg dly in 1 or 2 divided doses ii) 250 - 500 mg dly. Contraindications: Hypersensitivity to chlorothiazide/thiazides or sulfas, anuria. Precautions: Avoid lithium. Diabetics may require increased amounts of insulin or oral hypoglycemic agents. Electrolyte imbalance (eg, hypokalaemia, hyponatraemia, hypomagnesaemia, hypercalcemia). Hepatic disease. Hyperuricemia. Lupus erythematosus. Postsympathectomy patients. May aggravate digitalis toxicity. May potentiate the effects of other antihypertensives. Renal disease (may precipitate azotemia). Interactions: Angiotensin converting enzyme inhibitors : postural hypotension (first dose). Chlorpropamide : decreased chlorpropamide effectiveness. Cholestyramine : decreased chlorothiazide effectiveness. Digitalis glycosides : digitalis toxicity (nausea, vomiting, arrhythmias). Lithium: increased lithium concentrations and lithium toxicity (weakness, tremor, excessive thirst, confusion). NSAIDs: decreased diuretic and antihypertensive efficacy. Adverse Reactions: Hypokalaemia, hyperuricemia, hyperglycaemia, hepatotoxicity. 105

Metolazone 5 mg Tablet D i u l o - Trade Name

C03BA08000T1001XX (A*)

System: Cardiovascular Indications: Oedema in congestive cardiac failure, nephrotic syndrome and impaired renal function. Dosage: Adult : 5 - 20 mg qid. Child : 0.05 -0.1 mg/kg qid Contraindications: Anuria, hepatic coma or precoma and hypersensitivity to metolazone. Precautions: Avoid concomitant lithium. Diabetics may require increased amounts of insulin or oral hypoglycemic agents . Electrolyte imbalance (eg, hypokalaemia, hyponatraemia, hypomagnesaemia), hepatic diseas, hyperuricemia, lupus erythematosus. May aggravate digitalis toxicity. May potentiate the effects of other antihypertensives. Orthostatic hypotension, severe renal disease (may precipitate azotemia), sensitivity reactions may occur with or without a history of allergy or asthma. Interactions: Angiotensin converting enzyme inhibitors, calcium carbonate, diazoxide, digitalis glycosides, lithium, Adverse Reactions: Dizziness, orthostatic hypotension, oedema, hypokalaemia, rash, nausea ,vomiting, cough. Frusemide 20 mg/2 ml Injection L a s i x - Trade Name
C03CA01000P3001XX (B) NEDL APPL

System: Cardiovascular Indications: Pulmonary Oedema Dosage: Initially 20 - 50 mg IM or slow IV (rate not exceeding 4 mg/min). Child : 0.5 - 1.5 mg/kg. Max : 20 mg dly. Contraindications: Anuria, hypersensitivity to frusemide, hepatic coma and pre-coma . Severe hypokalaemia, severe hyponatraemia, hypovolaemia with or without concomitant hypotension. Precautions: Alterations in blood glucose and glucose tolerance tests . Diabetes mellitus, electrolyte imbalance (eg, hypokalaemia, hyponatraemia) , fluid imbalance, dehydration, blood volume reduction with circulatory collapse, and possible vascular thrombosis and emboli may occur with excessive diuresis, especially in elderly patients. Gout or hyperuricemia. Hepatic disease (cirrhosis and ascites). Hypersensitivity to sulfonamides. Ototoxicity (hearing loss, tinnitus), avoid rapid injection, high doses, or concurrent administration of other ototoxic agents. If high- dose therapy is used, controlled intravenous infusion is recommended at a rate not to exceed 4 mg/min. Severe progressive renal disease (azotemia, oliguria). Systemic lupus erythematosus. Interactions: Activated charcoal ,amikacin, gentamicin, kanamycin , Angiotensin converting enzyme inhibitors ,aspirin , chloral hydrate ,digoxin steroids , NSAIDs . 106

Adverse Reactions: Hypokalaemia, hyperuricemia, hypotension, hyperglycaemia Frusemide 40 mg Tablet L a s i x - Trade Name
C03CA01000T1001XX (B) NEDL APPL

System: Cardiovascular Indications: Diuretic. Dosage: Adult: Initial 40 - 80 mg o.m., if required, can be increased to a max of 1 g/day in certain cases especially in chronic renal failure. Child : 1 - 3 mg/kg dly. Contraindications: Anuria, hypersensitivity to frusemide, hepatic coma and pre-coma . Severe hypokalaemia, severe hyponatraemia, hypovolaemia with or without concomitant hypotension. Precautions: Alterations in blood glucose and glucose tolerance tests . Diabetes mellitus, electrolyte imbalance (eg, hypokalaemia, hyponatraemia) , fluid imbalance, dehydration, blood volume reduction with circulatory collapse, and possible vascular thrombosis and emboli may occur with excessive diuresis, especially in elderly patients. Gout or hyperuricemia. Hepatic disease (cirrhosis and ascites). Hypersensitivity to sulfonamides. Ototoxicity (hearing loss, tinnitus),Systemic lupus erythematosus. Interactions: Activated charcoal ,amikacin, gentamicin, kanamycin , Angiotensin converting enzyme inhibitors ,aspirin , chloral hydrate ,digoxin steroids , NSAIDs . Adverse Reactions: Hypokalaemia, hyperuricemia, hypotension, hyperglycaemia. Frusemide 500 mg Tablet L a s i x - Trade Name
C03CA01000T1002XX (A*) NEDL

System: Cardiovascular Indications: Intended exclusively for patients with severely impaired glomerular filtration (GFR< 20 ml/min). Treatment of refractory oedema after combination diuretics have failed. Dosage: Initially 250 mg daily then increase in steps of 250 mg. Max : 2000 mg as a single dose. Contraindications: Anuria, hypersensitivity to frusemide, hepatic coma and pre-coma . Severe hypokalaemia, severe hyponatraemia, hypovolaemia with or without concomitant hypotension. Precautions: Alterations in blood glucose and glucose tolerance tests . Diabetes mellitus, electrolyte imbalance (eg, hypokalaemia, hyponatraemia) , fluid imbalance, dehydration, blood volume reduction with circulatory collapse, and possible vascular thrombosis and emboli may occur with excessive diuresis, especially in elderly patients. Gout or hyperuricemia. Hepatic disease (cirrhosis and ascites). Hypersensitivity to sulfonamides. Ototoxicity (hearing loss, tinnitus ) .Systemic lupus erythematosus. Interactions: Activated charcoal ,amikacin, gentamicin, kanamycin , 107

Angiotensin converting enzyme inhibitors ,aspirin , chloral hydrate ,digoxin steroids , NSAIDs . Adverse Reactions: Hypokalaemia, hyperuricemia, hypotension, hyperglycaemia. Bumetanide 0.5 mg/ml Injection B u r i n e x - Trade Name
C03CA02000P3001XX (A*)

System: Cardiovascular Indications: Severe nephrosis and refractory to Frusemide. Dosage: IV injection : 1 - 2 mg; repeated after 20 mins. IV infusion : 2 - 5 mg over 30 60 mins. Contraindications: Allergy to bumetanide products, anuria, severe electrolyte imbalance, hepatic coma. Precautions: Alterations in glucose metabolism, blood dyscrasias (thrombocytopenia), hepatic disease, hyperuricemia, hypokalaemia, hypovolaemia, ototoxicity, particularly potentiation of aminoglycoside ototoxicity; coadministration not recommended . Interactions: Amikacin, angiotensin converting enzyme inhibitors, digitoxin, digoxin, gentamicin, kanamycin, lithium, neomycin, netilmicin, nonsteroidal antiinflammatory agents, streptomycin, tobramycin. Adverse Reactions: Hypokalaemia, hyperuricemia, muscle cramps, arthralgias. Bumetanide 1 mg Tablet Bumetanide 5 mg Tablet B u r i n e x - Trade Name
C03CA02000T1001XX (A*) C03CA02000T1002XX (A*)

System: Cardiovascular Indications: For severe nephrosis and refractory to Frusemide. Dosage: 1 mg in the morning, repeat after 6 - 8 hrs if necessary. Up to 5 mg daily in severe cases. Contraindications: Allergy to bumetanide products, anuria, severe electrolyte imbalance, hepatic coma. Precautions: Alterations in glucose metabolism. Blood dyscrasias (thrombocytopenia). Hepatic disease. Hyperuricemia. Hypokalaemia. Hypovolaemia. Ototoxicity, particularly potentiation of aminoglycoside ototoxicity; coadministration not recommended. Interactions: Angiotensin converting enzyme inhibitors : postural hypotension (first dose). Digoxin : digoxin toxicity (nausea, vomiting, cardiac arrhythmias). Gentamicin : ototoxicity. Kanamycin : increased risk of ototoxicity (tinnitus). Adverse Reactions: Hypokalaemia, hyperuricemia, muscle cramps, arthralgias.

108

Spironolactone 25 mg Tablet A l d a c t o n e - Trade Name

C03DA01000T1001XX (B) NEDL APPL

System: Cardiovascular Indications: Oedema and ascites in cirrhosis of the liver, congestive heart failure. Dosage: Adult:100 - 200 mg dly in divided doses. Increase to 400 mg if required. Paed : initially 3 mg/kg dly in divided doses. Contraindications: Hypersensitivity, hyperkalemia, renal failure, anuria, patients receiving other potassium-sparing diuretics or potassium supplements. Precautions: Hyperkalaemia or progressive renal failure, impaired hepatic or renal function, diabetes mellitus, patients likely to develop acidosis. Pregnancy and lactation Interactions: Angiotensin converting enzyme inhibitors, cyclosporin : hyperkalemia. Aspirin : decreased spironolactone effectiveness. Digoxin : digoxin toxicity (nausea, vomiting, cardiac arrhythmias). NSAIDs : reduced diuretic effectiveness, hyperkalemia. Adverse Reactions: Headache, drowsiness, GI disturbances, including cramp and diarrhoea, ataxia, mental confusion, hirsutism, deepening of the voice, menstrual irregularities, impotence, skin rashes, hyponatraemia, hyperkalaemia. Amiloride HCl 5 mg & Hydrochlorothiazide 50 mg Tablet Moduretic
C03EA01900T1001XX (B) NEDL APPL
- Trade Name

System: Cardiovascular Indications: i) Diuretic as an adjunct to the management of oedematous states (ii) Hypertension. Dosage: (i) Initially 1 - 2 tab dly adjusted according to response. Max : 4 tabs daily. (ii) 1 -2 tabs dly as a single or divided dose. Contraindications: Hypersensitivity to Hydrochlorothiazide/amiloride or sulfonamides, hyperkalemia, anuria, renal failure. Precautions: Diabetes mellitus. Electrolyte imbalance, concomitant use of other diuretics can result in hyponatraemia and hypochloremia as well as increases in BUN levels. This is more frequent in patients with hepatic cirrhosis and ascites, metabolic alkalosis, or those with resistant oedema. Metabolic or respiratory acidosis. Interactions: Angiotensin converting enzyme inhibitors : postural hypotension (first dose). Carbamazepine : hyponatraemia. Chlorpropamide : decreased chlorpropamide effectiveness. Digitalis : digitalis toxicity (nausea, vomiting, arrhythmias). Corticosteroids : hypokalaemia and subsequent cardiac arrhythmias. NSAIDs : decreased diuretic and antihypertensive efficacy. Propranolol : hyperglycaemia, hypertriglyceridemia. Adverse Reactions: Hyperkalemia, rash, dizziness, headache, asthenia. 109

Pentoxifylline 400 mg Tablet T r e n t a l - Trade Name

C04AD03000T5001XX (A/KK) APPL

System: Cardiovascular Indications: Peripheral vascular disease. Dosage: 400 mg bd - tds. Contraindications: Cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction; pregnancy and breastfeeding. Precautions: Hypotension, coronary artery disease, renal impairment, severe hepatic impairment. Interactions: Increased risk of bleeding with ketorolac, possibly increased risk of bleeding with other NSAIDs. Adverse Reactions: GI effects, hypersensitivity reactions, dizziness , agitation, sleep disturbances, headache. Phenoxybenzamine 5 mg Capsule D i b e n y l i n e - Trade Name
C04AX02110C1001XX (A*)

System: Genitourinary Indications: i) Phaeochromocytoma ii) Urinary retention due to neurogenic bladder Dosage: i) Phaeochromocytoma- 10 mg dly, increased by 10 mg dly; usual dose 1 - 2 mg/kg dly in 2 divided doses. ii) Urinary retention due to neurogenic bladder- 10 mg bd. Contraindications: Any condition compromised by decreased blood pressure. Precautions: Cerebral or coronary arteriosclerosis,concomitant administration with substances that stimulate alpha and beta receptors; hypotension and tachycardia may be amplified,renal impairment,respiratory infection. Interactions: In patients currently on beta blockers, the first dose response (marked initial drop in blood pressure, particularly on standing) to an alpha-1 adrenergic blocking drug may be exaggerated.Phenoxybenzamine combined with methyldopa has led to total urinary incontinence. Concurrent administration of oxilofrine and alpha adrenergic blockers may lead to hypo- or hypertension with bradycardia. Adverse Reactions: Hypotension, sedation, Nausea and vomiting, sexual dysfunction,tachycardia. Phenoxybenzamine 100 mg/2 ml Injection D i b e n y l i n e - Trade Name System: Genitourinary
C04AX02110P3001XX (A*)

110

Indications: Only for the treatment of: i) urinary retention due to neurogenic bladder. ii) urinary retention due to benign prostatic hypertrophy. iii) hypertensive episodes associated with phaeochromocytoma. Dosage: IV infusion 1mg/kg dly in 200 ml sodium chloride 0.9% over at least 2 hrs. Do not repeat within 24 hrs. Contraindications: Any condition compromised by decreased blood pressure. Precautions: Cerebral or coronary arteriosclerosis,concomitant administration with substances that stimulate alpha and beta receptors; hypotension and tachycardia may be amplified,renal impairment,respiratory infection. Interactions: In patients currently on beta blockers, the first dose response (marked initial drop in blood pressure, particularly on standing) to an alpha-1 adrenergic blocking drug may be exaggerated.Phenoxybenzamine combined with methyldopa has led to total urinary incontinence. Concurrent administration of oxilofrine and alpha adrenergic blockers may lead to hypo- or hypertension with bradycardia. Adverse Reactions: Hypotension, sedation, nausea and vomiting, sexual dysfunction, tachycardia. Bismuth Subgallate & Benzyl Benzoate Ointment C05AX02931G5001XX (B) NEDL Anusol - Trade Name System: Gastro-Intestinal Indications: For relief of itching, burning and soreness in haemorrhoids and minor rectal inflammation. Also in minor skin irritation, itching and chaffing. Dosage: Apply once or bd and after a bowel movement; do not use for longer than 7 days. Child : not recommended. Contraindications: Hypersensitivity to any component of preparation. Precautions: Do not use for longer than 7 days; child not recommended. Interactions: No interaction found. Adverse Reactions: Local irritation. Bismuth Subgallate & Benzyl Benzoate Suppository Anusol
- Trade Name

C05AX02931S2001XX (C) NEDL APPL

System: Gastro-Intestinal Indications: For relief of pruritus, burning and soreness in patients with haemorrhoids and perianal conditions. Dosage: Insert 1 supp. night and morning after bowel movements; do not use for longer than 7 days. Contraindications: Hypersensitivity to any component of preparation. Precautions: Not for prolongrd use. Use in children is not recommended. Interactions: No known drug interactions. 111

Adverse Reactions: Local irritation. Lignocaine, Aluminium Acetate, Zinc Oxide & Hydrocortisone Ointment Xyloproct
- Trade Name

C05AX03931G5001XX (A/KK) NEDL

System: Gastro-Intestinal Indications: Anorectal pain, pruritis, inflammation and irritation. Dosage: Apply once or bd; Not for prolonged use. Contraindications: Hypersensitivity to local anaesthetics or to other components of the product. Precautions: Children < 12 yr; traumatised mucosa, sepsis in anorectal region or suspected herpes simplex infection. Interactions: With large doses of lidocaine; risk of additional systemic toxicity in patients receiving other local anaesthetics. Adverse Reactions: Dry skin, pruritus, irritation, transient burning/stinging & atrophy of anal skin. Lignocaine, Aluminium Acetate, Zinc Oxide & Hydrocortisone Suppository Xyloproct
C05AX03931S2001XX (A/KK) NEDL
- Trade Name

System: Gastro-Intestinal Indications: Anorectal pain, pruritis, inflammation and irritation. Dosage: 1 suppository to be used once or twice a day. Not for prolonged use. Contraindications: Hypersensitivity to local anaesthetics or to other components of the product. Precautions: Children < 12 yr, traumatised mucosa or sepsis in anorectal region or suspected herpes simplex infection. Interactions: With large doses of lidocaine, risk of additional systemic toxicity in patients receiving other local anaesthetics. Adverse Reactions: Dry skin, pruritus, irritation, transient burning/stinging. Tribenoside & Lignocaine Cream P r o c t o - g l y v e n o l - Trade Name
C05AX05999G1001XX (A) NEDL

System: Gastro-Intestinal Indications: External and internal haemorrhoids. Dosage: Apply thinly bd. Contraindications: Hypersensitivity to the active substance. Precautions: Pregnancy, lactation. Interactions: No interaction found. Adverse Reactions: Slight burning sens ation, pain, increased intestinal motility. 112

Tribenoside & Lignocaine Suppository P r o c t o - g l y v e n o l - Trade Name

C05AX05999S2001XX (A) NEDL

System: Gastro-Intestinal Indications: External and internal haemorrhoids. Dosage: Insert 1 on or bd or tds. Contraindications: Hypersensitivity to the active substance. Precautions: Pregnancy, lactation. Interactions: No interaction found. Adverse Reactions: Slight burning sensation, pain, increased intestinal motility. Sodium Tetradecyl Sulphate 1 % Injection Sodium Tetradecyl Sulphate 3 % Injection T r o m b o v a r - Trade Name
C05BB04183P3001XX (A*) C05BB04183P3002XX (A*) NEDL

System: Gastro-Intestinal Indications: Sclerotherapy of oesophageal varices, haemorrhoids and varicose veins. Dosage: 0.5-2 mL into the submucosal layer at the base of the oesophageal varix or the haemorrhoid; several injections may be given at different sites, max. total injected 10-15 mL of 1% per treatment. Contraindications: Large or inaccessible varicose veins, febrile illness, phlebitis. Precautions: Patients with history of allergy, pregnancy, lactation. Interactions: Avoid any combination in the injection. Adverse Reactions: Pain, urticaria and ulceration at the site of injection, embolisms, headache, nausea, vomiting, esophageal perforation, allergic reactions (including anaphylaxis). Diosmin 450 mg & Hesperidin 50 mg Tablet Daflon - Trade Name
C05CA53931T1001XX (A/KK)

System: Gastro-Intestinal Indications: i) Haemorrhoids ii) Chronic Venous insufficiency Dosage: i) Acute attack : 6 tab dly for the first 4 days, then 4 tab dly in 2 divided doses for 3 days and 2 tab thereafter. ii)2 tab dly with meals. Contraindications: Hypersensitivity to any component of preparation. Precautions: Lactation. Interactions: No known drug interactions. Adverse Reactions: Minor GI disturbances. 113

Tribenoside 400 mg Capsule G l y v e n o l - Trade Name

C05CX01000C1001XX (A)

System: Cardiovascular Indications: External and internal haemorrhoids. Inflammatory and varicose disorders of the vein, including haemorrhoids. Dosage: 400 mg bd. Contraindications: Hypersensitivity to the active substance & auxiliaries. Precautions: Pregnancy & lactation. Interactions: No interaction found. Adverse Reactions: GI upsets, skin rash. Propranolol HCl 1 mg/ml Injection Inderal - Trade Name
C07AA05110P3001XX (A) NEDL

System: Cardiovascular Indications: Arrhythmias and thyrotoxicosis crisis. Dosage: Slow IV injection in a dose of 1 mg over 1 minutes, repeated if necessary every 2 minutes until a max. of 10 mg has been given in conscious patients and 5 mg in patients under anaesthesia. Child : 25 - 50 mcg/kg slow IV with appropriate monitoring. Contraindications: Bronchial asthma or chronic obstructive pulmonary disease , cardiogenic shock, hypersensitivity to propranolol . Overt cardiac failure, second and third degree AV block and severe sinus bradycardia. Precautions: Anaesthesia/surgery (myocardial depression) . Avoid abrupt withdrawal, gradual withdrawal over a period of 1 to 2 weeks is recommended. Bronchospastic disease , cerebrovascular insufficiency , congestive heart failure , diabetes mellitus, hepatic disease. Interactions: Alpha-1 adrenergic blockers ,aluminum carbonate, basic aluminum hydroxide, aluminum phosphate, amiodarone, chlorpromazine, cimetidine, clonidine, cocaine, digoxin, dihydroergotamine, dihydropyridine calcium channel blockers, diltiazem, disopyramide. Adverse Reactions: Bronchospasm ,bradycardia ,depression. Propranolol HCl 10 mg Tablet Inderal - Trade Name
C07AA05110T1001XX (A)NEDL

System: Cardiovascular Indications: Dysrythmias, tachycardia, hypertrophic obstructive cardiomyopathy (For cardiologist only). Dosage: 10 - 40 mg tds - qid. Contraindications: Hypersensitivity to propranolol, asthma, bradycardia, 2nd and 3rd degree AV block, cardiogenic shock overt cardiac failure, obstructive airway disease. 114

Precautions: Pregnancy and breast feeding Interactions: Alpha-1 adrenergic blockers,amiodarone,chlorpromazine,cimetidine,clonidine, cocaine, digoxin, dihydroergotamine,dihydropyridine, calcium channel blockers, diltiazem, disopyramide, epinephrine, ergotamine, flecainide, flunarizine, fluvoxamine, frusemide, risk of lignocaine toxicity increased. Adverse Reactions: Bronchospasm, bradycardia, depression, nausea, vomiting, dizziness, CNS effects, muscle cramps, fluid retention, skin rashes, dry mouth. Propranolol HCL 40 mg Tablet Inderal - Trade Name
C07AA05110T1002XX (B) NEDL APPL

System: Cardiovascular Indications: i)Hypertension ii) Angina iii)Myocardial Infarct iv)Cardiac arrhythmia v)Portal hypertension vi)Migraine vii) Thyrotoxicosis Dosage: i)Initial dose of 40-80 mg bd increased as required to a usual range of 160-320 mg dly (some may require up to 640 mg dly). Paeds: Initial doses of 1mg/kg in divided doses, can be increased to 2-4mg/kg/day in divided doses. ii)Initial dose of 40mg 2-3 times daily. Maintenance 120-240mg daily. iii)40mg 4 times daily for 2-3 days then 80mg twice daily, beginning 5-21 days after infarction. iv)10-40mg 3-4 times daily . v)Initially 40mg twice daily. The dose may be increased as required up to 160mg twice daily. vi)Initial prophylaxis dose :40mg 2-3 times daily. The dose may be increased at weekly intervals up to 160mg daily. vii) (adjunct): 10-40mg 3-4 times daily. Contraindications: Hypersensitivity to propranolol, asthma, bradycardia, 2nd and 3rd degree AV block, cardiogenic shock overt cardiac failure, obstructive airway disease. Precautions: Avoid abrupt withdrawal, bronchospastic disease, congestive heart failure, diabetes, hepatic disease, peripheral vascular disease, renal disease, myasthenia gravis, pregnancy, breast feeding. Interactions: Alpha-1 adrenergic blockers,amiodarone,chlorpromazine,cimetidine,clonidine, cocaine, digoxin, dihydroergotamine,dihydropyridine, calcium channel blockers, diltiazem, disopyramide, epinephrine, ergotamine, flecainide, flunarizine, fluvoxamine, frusemide, risk of lignocaine toxicity increased. Adverse Reactions: Bronchospasm, bradycardia, depression, nausea, vomiting, dizziness, CNS effects, muscle cramps, fluid retention, skin rashes, dry mouth. 115

Sotalol HCl 80 mg Tablet Sotalol HCl 160 mg Tablet Sotacor - Trade Name

C07AA07110T1001XX (A*) C07AA07110T1002XX (A*)

System: Cardiovascular Indications: Ventricular tachyarrythmias Dosage: 80 - 160 mg bd. Contraindications: Hypersensitivity to sotalol products, asthma, bradycardia, 2nd and 3rd degree AV block overt cardiac failure, cardiogenic shock, congenital or acquired long QT syndromes Precautions: Anaesthesia/surgery (myocardial depression). Avoid abrupt withdrawal; gradual withdrawal over a period of 1 to 2 weeks is recommended. Bronchospastic disease, concomitant use with other drugs that prolong the QT interval, congestive heart failure (doses of 3 milligrams/kg or greater should not be administered by bolus infusion), diabetes mellitus, electrolyte imbalance (ie, hypokalaemia, hypomagnesaemia), hyperthyroidism/thyrotoxicosis, peripheral vascular disease, renal disease, underlying conduction disturbances (eg, sick sinus syndrome). Interactions: May potentiate initial insulin hypoglycaemic effects. Affected by class I antiarrhythmics, quinidine, disopyramide, tricyclic antidepressants. Adverse Reactions: Occasionally, dyspnoea, tiredness, dizziness, headache, fever, excessive bradycardia and/or hypotension. Metoprolol Tartrate 50 mg Tablet Metoprolol Tartrate 100 mg Tablet Betaloc - Trade Name
C07AB02123T1001XX (B) C07AB02123T1002XX (B) NEDL APPL

System: Cardiovascular Indications: Hypertension, angina, myocardial infarction,arrhythmias. Dosage: Initially 50 mg dly, maintenance 100 - 200 mg dly in 1 - 2 doses. Max 400 mg daily. Contraindications: Allergy to metoprolol products, bradycardia, 2nd and 3rd degree AV block overt cardiac failure, cardiogenic shock. Precautions: Pregnancy, breast feeding. Interactions: Alpha-1 adrenergic blockers,amiodarone,chlorpromazine,chlorprothixene,cimetidine, clonidine,digoxin,dihydropyridine, calcium channel blockers,diltiazem,flunarizine,fluoxetine, fluvoxamine, hydralazine,hypoglycemic agents,lidocaine,methyldopa. Adverse Reactions: Lassitude, gastrointestinal and sleep pattern disturbances; rarely, non-specific skin reactions and coldness of extremities.

116

Atenolol 50 mg Tablet Atenolol 100 mg Tablet T e n o r m i n - Trade Name

C07AB03000T1001XX (B)NEDL C07AB03000T1002XX (B) NEDL APPL

System: Cardiovascular Indications: Hypertension, angina pectoris, myocardial infarction and arrhythmias. Dosage: 50 - 100 mg dly. Contraindications: Allergy to atenolol products, bradycardia, 2nd and 3rd degree AV block overt cardiac failure, cardiogenic shock Precautions: Anaesthesia/surgery (myocardial depression) . Avoid abrupt withdrawal; gradual withdrawal over a period of 1 to 2 weeks is recommended. Bronchospastic disease, congestive heart failure, diabetes mellitus, hyperthyroidism/thyrotoxicosis . Patients receiving clonidine - discontinue atenolol several days prior to withdrawal of clonidine. Peripheral vascular and renal disease. Interactions: Clonidine, catecholamine-depleting agents, beta-blockers Adverse Reactions: Occasionally, CHF, AV block, bradycardia, bronchospasm, dizziness, vertigo, nausea, fatigue, diarrhoea. Bisoprolol Fumarate 2.5 mg Tablet Bisoprolol Fumarate 5 mg Tablet C o n c or - Trade Name
C07AB07000T1001XX (A) C07AB07000T1002XX (A)

System: Cardiovascular Indications: Treatment of stable moderate to severe congestive cardiac failure, in addition to ACEI's and diuretics. Dosage: 1.25 mg once daily to 5 - 10 mg daily. Contraindications: Hypersensitivity, cardiac failure, pulmonary oedema, pregnancy, severe asthma or severe COPD, hypotension. Precautions: Avoid abrupt withdrawal, congestive heart failure, diabetes mellitus, hyperthyroidism, liver and renal impairment. Interactions: Prazosin, digoxin, amiodarone, ACEI, antidiabetic agent, calcitriol, cholestyramine, clonidine. Adverse Reactions: Arrythmia, bradycardia, chest pain, oedema, hypotension, dizziness, headache, fatique, diarrhoea, nausea, impotency, cough, rhinitis. Esmolol HCl 10 mg/ml Injection Esmolol HCl 250 mg/ml Injection Brevibloc - Trade Name System: Cardiovascular
C07AB09110P3001XX (A*) C07AB09110P3002XX (A*)

117

Indications: Perioperative tachycardia and hypertension. Dosage: Perioperative tachycardia and hypertension, by IV infusion, usually within range of 50 - 200 mcg/kg/min. Contraindications: Hypersensitivity to esmolol products, bradycardia, heart block, overt cardiac failure, cardiogenic shock. Precautions: Anaesthesia/surgery (myocardial depression), atrial fibrillation (hypotension occurs more frequently in these patients), avoid abrupt withdrawal; gradual withdrawal over a period of 1 to 2 weeks is recommended. Bronchospastic disease, cerebrovascular insufficiency, congestive heart failure, diabetes mellitus . Due to the potency and rapid onset of clinical effects, small initial doses are recommended; the infusion rate should be controlled carefully, preferably with a volumetric infusion pump . Elderly patients (hypotension occurs more frequently in these patients), hyperthyroidism/thyrotoxicosis, myasthenic conditions, peripheral vascular disease, postoperative patients (hypotension occurs more frequently in these patients) and renal disease. Interactions: Catecholamine-depleting drugs. Concomitant use with verapamil (caution in patients with depressed myocardial function). Adverse Reactions: Hypotension, dizziness, somnolence, confusions headache, agitation, fatigue; nausea and vomiting. Labetalol HCl 100 mg/20 ml Injection T r a n d a t e - Trade Name
C07AG01110P3001XX (B)

System: Cardiovascular Indications: Severe Hypertension Dosage: Adult : 50 mg IV over 1 min. Max: 200 mg. Contraindications: Hypersensitivity to labetalol products, bradycardia, asthma/obstructive airway disease, cardiogenic shock, heart block overt cardiac failure Precautions: Anaesthesia/surgery, including when used in cases to control bleeding (myocardial depression) . Avoid abrupt withdrawal; gradual withdrawal over a period of 1 to 2 weeks is recommended. Bronchospastic disease, congestive heart failure, diabetes mellitus . Interactions: Alpha-1 adrenergic blockers,amiodarone, bepridil,cimetidine,clonidine,digoxin,dihydropyridine, calcium channel blockers, diltiazem,enflurane,epinephrine, flunarizine,halothane, hypoglycemic agents, imipramine,isoflurane,lidoflazine methyldopa, verapamil Adverse Reactions: Hypotension ,bradycardia nausea, vomiting Labetalol HCl 100 mg Tablet Labetalol HCl 200 mg Tablet T r a n d a t e - Trade Name System: Cardiovascular
C07AG01110T1001XX (B) NEDL APPL C07AG01110T1002XX (B)NEDL

118

Indications: Severe hypertension. Dosage: Adult: 100 mg (50 mg in elderly) dly with food, increased at intervals of 14 days to usual dose of 200 mg bd; up to 400 mg bd (3 - 4 divided doses if higher dose). Max: 2.4 g dly. Contraindications: Hypersensitivity to labetalol products, bradycardia, asthma/obstructive airway disease, cardiogenic shock, heart block overt cardiac failure. Precautions: Anesthesia/surgery, including when used in cases to control bleeding (myocardial depression). Avoid abrupt withdrawal; gradual withdrawal over a period of 1 to 2 weeks is recommended. Bronchospastic disease, congestive heart failure, diabetes mellitus (it can mask prominent hypoglycaemic symptoms). Interactions: Alpha-1 adrenergic blockers, amiodarone, cimetidine, clonidine, digoxin, dihydropyridine, calcium channel blockers, diltiazem, enflurane, epinephrine, flunarizine, halothane, hypoglycemic agents, imipramine, isoflurane, lidoflazine methyldopa, verapamil. Adverse Reactions: Hypotension, bradycardia nausea, vomiting. Carvedilol 6.25 mg Tablet Carvedilol 25 mg Tablet Dilatrend - Trade Name
C07AG02000T1001XX (A*) C07AG02000T1002XX (A*)

System: Cardiovascular Indications: Treatment of stable moderate to severe congestive cardiac failure, in addition to ACEI's and diuretics. Dosage: 3.125 mg bd for 2 wks, then 6.25 mg bd for 2 wks, then 12.5 mg bd for 2 wks then 25 mg bd (titrated up to the highest tolerated level). Contraindications: Asthma or COPD, cardiogenic shock, hypersensitivity to carvedilol products, 2nd/3rd degree AV block, severe sinus bradycardia sick sinus syndrome. Precautions: Anaesthesia/surgery, including when used in cases to control bleeding (myocardial depression) . Avoid abrupt withdrawal; gradual withdrawal over a period of 1 to 2 weeks is recommended. Bronchospastic disease, congestive heart failure, diabetes mellitus. Interactions: Hypotensive effects potentiated by adrenergic neurone-blocking drugs, catecholamine depletors, CNS depressants, diuretics & vasodilators. Action decreased by rifampicin. Concurrent administration with cardiac glycosides may cause a sharp drop in heart rate . Adverse Reactions: Dizziness, headache, tiredness, gastrointestinal disorders, flu-like symptoms. Amlodipine Besylate 5 mg Tablet Amlodipine Besylate 10 mg Tablet Norvasc - Trade Name System: Cardiovascular 119
C08CA01197T1001XX (A) C08CA01197T1002XX (A) NEDL

Indications: Hypertension. Dosage: 5 mg once dly. Max : 10 mg. Contraindications: Hypersensitivity to amlodipine, symptomatic hypotension, persistent dermatologic reactions, congestive heart failure. Precautions: Angina (exacerbation) during initiation of treatment; with dosage increases; during beta-blocker withdrawal; taper slowly prior to calcium channel blocker therapy. Aortic stenosis (reduc ed myocardial oxygenation with druginduced hypotension), congestive heart failure. Interactions: Cyclosporin, fluconazole,itraconazole,ketoconazole, vardenafil. Adverse Reactions: Headache, dizziness, gingival hyperplasia, tachycardia, peripheral oedema. Felodipine 5 mg Tablet Felodipine 10 mg Tablet P l e n d i l - Trade Name
C08CA02000T1001XX (A/KK) C08CA02000T1002XX (A/KK) NEDL

System: Cardiovascular Indications: Hypertension. Dosage: Initiate at 5 mg once dly. Usual dose, 5 - 10 mg once dly in the morning. Contraindications: Hypersensitivity to felodipine or other calcium channel blockers, symptomatic hypotension, peripheral vascular disease, persistent dermatologic reactions, cardiovascular arterial disease and congestive haeart failure. Precautions: Rarely precipitate significant hypotension which can lead to myocardial ischaemia. Interactions: Beta-adrenergic blockers, cyclosporin, fluconazole, itraconazole, ketoconazole ,magnesium, oral anticoagulants, phenobarbital and saquinavir. Adverse Reactions: Transient: Flushing, headache, palpitations, dizziness, fatigue. Ankle swelling (appears to be dose-related). Mild gingival hyperplasia. Nifedipine 10 mg Capsule Adalat - Trade Name
C08CA05000C1001XX (B) NEDL

System: Cardiovascular Indications: Hypertension, angina. Dosage: 10 - 30 mg tds. Max : 120 - 180 mg/day Contraindications: Hypersensitivity to nifedipine , symptomatic hypotension, persistent dermatologic reactions, CHF. Precautions: Angina (exacerbation) during initiation of treatment; with dosage increases; during beta-blocker withdrawal; taper slowly prior to calcium channel blocker therapy. Chronic renal insufficiency, combination therapy with betablockers (with left ventricular dysfunction), congestive heart failure, gastrointestinal hypermotility (extended release dose forms) and obstruction (extended release dose forms) . Hypotension (with initial therapy; combination 120

beta-blocker therapy), liver function; isolated transaminase elevation usually mild and transient; hepatocellular injury may occur, peripheral oedema (confounding physical findings in congestive failure), persistent dermatologic reactions induced by calcium antagonists have progressed to erythema multiforme or exfoliative dermatitis. Interactions: Beta-adrenergic blockers, cimetidine, digoxin, diltiazem, fluconazole, itraconazole, ketoconazole, magnesium, oral anticoagulants, phenytoin, quinidine, rifampin, saquinavir, vincristine, Adverse Reactions: Peripheral oedema, headache, dizziness, tachycardia. Nifedipine 10 mg Tablet Adalat - Trade Name
C08CA05000T1001XX (B) NEDL APPL

System: Cardiovascular Indications: Hypertension, angina. Dosage: Initial dose of 10 mg twice daily . Usual range 10 - 30 mg tds. Max : 120 - 180 mg/day Contraindications: Hypersensitivity to nifedipine , symptomatic hypotension, persistent dermatologic reactions, CHF Precautions: Angina (exacerbation) during initiation of treatment; with dosage increases; during beta-blocker withdrawal; taper slowly prior to calcium channel blocker therapy. Chronic renal insufficienc, combination therapy with betablockers (with left ventricular dsfunction Interactions: Beta-adrenergic blockers, cimetidine, digoxin, diltiazem, fluconazole, itraconazole, ketoconazole, magnesium, oral anticoagulants, phenytoin, quinidine, rifampin, saquinavir, vincristine, Adverse Reactions: Peripheral oedema, headache, dizziness, tachycardia Nimodipine 10 mg/50 ml Infusion Solution N i m o t o p - Trade Name
C08CA06000L3001XX (A*)

System: Cardiovascular Indications: Subarachnoid Haemorrhage. Dosage: 2 mg/hr. IV for 7 days followed by oral at 60 mg every 4 hrs for 14 days Contraindications: Hypersensitivity to nimodipine Precautions: Cardiovascular surgery; increased risk of bleeding and mortality . Impaired liver function (dosage adjustment) . May cause hypotension. Interactions: Potentiates effects of antihypertensives. IV beta-blockers (avoid). Possible increase of nimodipine blood concentration with cimetidine. Possible decrease of nimodipine efficacy with rifampicin. Nephrotoxic drugs, monitor renal function. Adverse Reactions: Severe BP lowering. GI disturbances. In addition for infusion: deterioration of renal function, disturbances of heart rhythm, phlebitis, increase of liver enzymes.

121

Nimodipine 30 mg Tablet N i m o t o p - Trade Name

C08CA06000T1001XX (A*)

System: Cardiovascular Indications: Subarachnoid Haemorrhage. Dosage: 2 mg/hr. IV for 7 days followed by oral at 60 mg every 4 hrs for 14 days Contraindications: Hypersensitivity to nimodipine Precautions: Cardiovascular surgery, increased risk of bleeding and mortality . Impaired liver function .May cause hypotension. Interactions: Potentiates effects of antihypertensives. IV beta-blockers (avoid). Possible increase of nimodipine blood concentration with cimetidine. Possible decrease of nimodipine efficacy with rifampicin. Nephrotoxic drugs, monitor renal function. Adverse Reactions: Severe BP lowering. GI disturbances. In addition for infusion: deterioration of renal function, disturbances of heart rhythm, phlebitis, increase of liver enzymes. Verapamil HCl 5 mg/2 ml Injection Isoptin - Trade Name
C08DA01110P3001XX (A/KK) NEDL

System: Cardiovascular Indications: Supraventricular tachycardia. Dosage: 5 mg by slow IV. The dose can be repeated after 5 - 10 mins. Recommended max. total dose : 15 mg. Contraindications: Atrial fibrillation or flutter associated with : i) Accessory bypass tract (Wolff-Parkinson-White, Lown-Ganong-Levine) ii) Short PR syndromes. Cardiogenic shock, concurrent intravenous beta-blocker therapy, congestive heart failure. Precautions: Angina (exacerbation) during initiation of treatment; with dosage increases; during beta-blocker withdrawal; taper slowly prior to calcium channel blocker therapy. AV block (first degree). Avoid abrupt withdrawal; hypertensive crisis/rebound. Combination therapy with beta-blockers (with left ventricular dysfunction). Digital ischaemia, ulceration or gangrene. Gastrointestinal hypermotility (extended release dose forms) and obstruction (extended release dose forms). Hypotension, idiopathic hypertrophic cardiomyopathy (especially with pulmonary artery wedge pressure over 20 mmHg and or left ventricular outflow obstruction). Impaired liver and renal function. Neuromuscular transmission defects ; respiratory depression. Persistent dermatologic reactions induced by calcium antagonists have progressed to erythema multiforme or exfoliative dermatitis. Discontinue calcium antagonist treatment in this setting. Severe left ventricular dysfunction. Interactions: Effects enhanced by beta-blockers, antiarrhythmics or inhalation anaesthetic. May intensify effects of other antihypertensives. Lithium (attenuated by verapamil, enhanced neurotoxicity). Increases plasma level of cyclosporin, theophylline, digoxin, carbamazepine. 122

Adverse Reactions: Constipation, dizziness, nausea or vertigo, headache, hypotension, ankle oedema, flushing, fatigue, nervousness, paraesthesia; bradycardiac arrhythmias, CHF, dyspnoea, raised prolactin levels, single cases of galactorrhoea, myalgia, arthralgia; allergic skin reactions; purpura, photosensitisation dermatitis, gynaecomastia, reversible increase in transaminases and or alkaline phosphatase; gingival hyperplasia, tachycardia, palpitations, impotence, tinnitus, tremor. Verapamil HCl 40 mg Tablet Isoptin - Trade Name
C08DA01110T1001XX (A) NEDL APPL

System: Cardiovascular Indications: i) Supraventricular tachyarrhythmias (SVT) prophylaxis ii) angina. Dosage: Adult : 40 - 80 mg tds - qid. In oral long term therapy, a dly dose of 480 mg should not be exceeded. Contraindications: Atrial fibrillation or flutter associated with : i) Accessory bypass tract (Wolff-Parkinson-White, Lown-Ganong-Levine), ii) Short PR syndromes. Cardiogenic shock, concurrent intravenous beta-blocker therapy, congestive heart failure. Precautions: Angina (exacerbation) during initiation of treatment; with dosage increases; during beta-blocker withdrawal; taper slowly prior to calcium channel blocker therapy. AV block (first degree). Avoid abrupt withdrawal; hypertensive crisis/rebound. Combination therapy with beta-blockers (with left ventricular dysfunction). Digital ischaemia, ulceration or gangrene . Gastrointestinal hypermotility (extended release dose forms) and obstruction (extended release dose forms). Hypotension, idiopathic hypertrophic cardiomyopathy (especially with pulmonary artery wedge pressure over 20 mmHg and or left ventricular outflow obstruction). Impaired liver and renal function. Neuromuscular transmission defects, respiratory depression. Persistent dermatologic reactions induced by calcium antagonists have progressed to erythema multiforme or exfoliative dermatitis. Discontinue calcium antagonist treatment in this setting. Severe left ventricular dysfunction. Interactions: Increased risk of myocardial depression with beta-blockers or inhalation anaesthetic. May increase plasma digoxin concentration & plasma cyclosporin concentration. Adverse Reactions: Increased effect by anaesthetic, non-depolarising muscle relaxants, prior administration of suxamethonium, aminoglycoside and polypeptide antibiotics, diuretics, beta-adrenergic blockers, thiamine, MAOIs, quinidine, protamine, imidazole, metronidazole, alpha-adrenergic blockers. Decreased effect by neostigmine, corticosteroids, noradrenaline, theophylline, azathioprine, KCl, NaCl, edrophonium. Diltiazem HCl 30 mg Tablet Herbesser - Trade Name System: Cardiovascular
C08DB01110T1001XX (B) APPL

123

Indications: Treatment of angina pectoris in the following cases: i) inadequate response or intolerance to beta-blockers and Isosorbide dinitrate. ii) contraindication to beta-blockers. iii) coronary artery spasm. Dosage: 60 mg tds (elderly initially bd); increased if necessary to 360 mg dly. Contraindications: Acute myocardial infarction with pulmonary congestion, atrial fibrillation or flutter (IV dose forms): i) Accessory bypass tract (WolffParkinson-White, Lown-Ganong-Levine) ii) Short PR syndromes. Hypersensitivity to this or other calcium channel blocker. Precautions: AV block (first degree), combination therapy with beta-blockers (with left ventricular dysfunction), congestive heart failure, gastrointestinal hypermotility (extended release dose forms), gastrointestinal obstruction (extended release dose forms), hypotension, impaired liver function (reduced metabolism, enhanced response). Impaired renal function. Paroxysmal supraventricular tachycardia conversion, persistent dermatologic reactions induced by calcium antagonists have progressed to erythema multiforme or exfoliative dermatitis. Interactions: Aspirin, beta-adrenergic blockers, carbamazepine, cimetidine, cisapride, cyclosporin, digitoxin, digoxin, enflurane, lithium, lovastatin, methylprednisolone, midazolam, nifedipine, oral anticoagulants, phenytoin, quinidine, rifampin, saquinavir, simvastatin. Adverse Reactions: Headache, dizziness, peripheral oedema, gingival hyperplasia, AV block, bradycardia. Captopril 12.5 mg Tablet Captopril 25 mg Tablet C a p o t e n - Trade Name
C09AA01000T1001XX (B)NEDL C09AA01000T1002XX (B) NEDL APPL

System: Cardiovascular Indications: Hypertension, heart failure, acute myocardial infarction and diabetic nephropathy. Dosage: Initially, 6.25 mg bd and gradually increased to 50 mg tds. Max : 150 mg tds. Contraindications: Angioedema induced by other angiotensin converting enzyme (ACE) inhibitors during prior exposure. Anuric renal failure during prior exposure to ACE inhibitors. Hypersensitivity to this or any other ACE inhibitor. Pregnancy (second and third trimester pregnancy). Precautions: Anaphylaxis during lipid apheresis with dextran sulfate membranes and during hymenoptera desensitization, angioedema; discontinue if laryngeal stridor or angioedema of the face, tongue, or glottis is observed, aortic stenosis, breast feeding period, cough, impaired renal function. Interactions: May increase serum K with K-sparing diuretics. Hypotensive effects enhanced by diuretics. Antihypertensive effect diminished by indomethacin, salicylates, NSAIDs. Adverse Reactions: Rash, pruritus, flushing; angioedema; loss of taste perception; stomatitis; GI irritation and abdominal pain; leucopenia; cough. 124

Enalapril 5 mg Tablet Enalapril 10 mg Tablet Enalapril 20 mg Tablet R e n i t e c - Trade Name

C09AA02253T1001XX (B) NEDL APPL C09AA02253T1002XX (B) C09AA02253T1003XX (B)NEDL

System: Cardiovascular Indications: i) Congestive heart failure. ii) Essential hypertension. iii) Hypertension in patients with chronic renal failure. Dosage: i) 2.5 mg dly under close medical supervision, usual maintenance dose 20 mg dly in 1-2 divided doses. ii) 5 mg once dly. iii) Initially 2.5 mg dly (usual maintenance dose of 20 mg dly;) Max: 40 mg once daily. Contraindications: Angioedema induced by other angiotensin converting enzyme (ACE) inhibitors. Hypersensitivity to this or any other angiotensin converting enzyme inhibitor. Pregnancy (second and third trimesters particularly). Precautions: Anaphylaxis during lipid apheresis with dextran sulfate membranes and during hymenoptera desensitization, angioedema; discontinue if laryngeal stridor or angioedema of the face, tongue or glottis is observed, aortic stenosis, breast feeding period and cough and impaired renal function. Interactions: May have additive effects with other antihypertensives, potassium supplement, potassium-sparing diuretics or potassium-containing salt substitutes. Increased lithium level. Adverse Reactions: Dizziness, headache, diarrhoea, fatigue, asthenia, cough, orthostatic hypotension; hyperkalaemia; angioneurotic oedema (discontinue therapy). Perindopril 4 mg Tablet C o v e r s y l - Trade Name
C09AA04000T1001XX (B)

System: Cardiovascular Indications: Hypertension and cardiac failure. Dosage: Initially 2 mg dly; up to a max. of 8 mg dly. Contraindications: Angioedema induced by other angiotensin converting enzyme (ACE) inhibitors. Hypersensitivity to this or any other angiotensin converting enzyme inhibitor. Pregnancy (second and third trimesters particularly). Precautions: Anaphylaxis during lipid apheresis with dextran sulfate membranes and during hymenoptera desensitization, angioedema; discontinue if laryngeal stridor or angioedema of the face, tongue or glottis is observed, aortic stenosis, breast feeding period, cough, hepatic dysfunction, hyperkalaemia, potassium supplements, potassium sparing diuretics, renal disease, diabetes, hypotension, congestive heart failure, elderly and volume125

depletion (diuretics, dialysis, gastrointestinal disease). Neutropenia : autoimmune diseases, collagen vascular disease, febrile illness and immunosuppressant drug therapy. Proteinuria. Renal insufficiency, renal artery stenosis (solitary kidney or bilateral disease) . Surgery/anaesthesia (excessive hypotension correctable with fluids). Interactions: Potassium supplements or Potassium-sparing diuretics may induce hyperkalaemia especially in renal failure. Neuroleptics or imipraminelike antidepressants increase risk of postural hypotension. Serum lithium concentrations may rise during lithium therapy. Adverse Reactions: Gastrointestinal disorders; dizziness, headaches, mood and or sleep disorders, asthenia; taste disorder; cramps, localized skin rashes; dry cough; angioneurotic oedema. Ramipril 2.5 mg Tablet Ramipril 5 mg Tablet T r i t a c e - Trade Name
C09AA05000T1001XX (A) C09AA05000T1002XX (A)

System: Cardiovascular Indications: Hypertension, congestive heart failure, post myocardial infarction, diabetic nephropathy, non-diabetic proteinuria. Dosage: Initial dose of 1.25 mg once daily. Double dose at 1 - 2 weeks intervals. Usual range 2.5 - 5 mg once daily. Max : 10 mg daily. Contraindications: Hypersensitive to ACE inhibitors and in known or suspected renovascular diseases, aortic stenosis or outflow tract obstruction and in pregnancy. Precautions: Patients receiving diuretics, first dose may cause hypotension, on a low-salt diet, on dialysis, dehydrated or with heart failure. Interactions: Enhanced hypotensive effects by alcohol, alprostadil, anaesthetics. Adverse Reactions: Renal impairment, pacreatitis, angioedema, blood dyscrasia. Losartan 50 mg Tablet C o z a a r - Trade Name
C09CA01500T1001XX (A*)

System: Cardiovascular Indications: Patients intolerant of ACE inhibitors, only in the treatment of i) Hypertension with heart failure. ii) Hypertension in diabetics with proteinuria or nephropathy. Dosage: Usually 50 mg once dly; if necessary increased after several wks to 100 mg once dly. Contraindications: Hypersensitivity to losartan, pregnancy. Precautions: Angioedema (associated with aspirin and or penicillin allergy); discontinue with laryngeal stridor or angioedema of the face, tongue or glottis. Aortic or mitral valve stenosis, biliary cirrhosis or biliary obstruction, coronary artery disease, elderly. 126

Interactions: Fluconazole, lithium, rifampicin. Adverse Reactions: Angioedema, headache, dizziness, cough. Valsartan 80 mg Tablet D i o v a n - Trade Name
C09CA03000T1001XX (A*)

System: Cardiovascular Indications: Hypertension in patients who cannot tolerate ACE inhibitor because of cough. Dosage: 80 mg dly. May be increased to 160 mg dly or add a diuretic. Contraindications: Hypersensitivity to valsartan products, pregnancy, renal artery stenosis and aspirin/ penicillin allergy. Precautions: Angioedema (associated with aspirin and or penicillin allergy); discontinue with laryngeal stridor or angioedema of the face, tongue or glottis. Aortic or mitral valve stenosis, biliary cirrhosis or biliary obstruction, coronary artery disease and elderly. Interactions: Fluconazole, lithium, rifampicin. Adverse Reactions: Headache, dizziness, viral infection, upper respiratory tract infection, coughing, diarrhoea, fatigue, rhinitis, sinusitis, back pain, abdominal pain, nausea, pharyngitis and arthralgia. Irbesartan 150mg Tablet Irbesartan 300mg Tablet A p r o v e l - Trade Name
C09CA04000T1001XX (A*) C09CA04000T1002XX (A*)

System: Cardiovascular Indications: Essential hypertension, diabetic nephropathy (only for patients who cannot tolerate ACEIs because of cough). Dosage: 150 mg to 300 mg daily. Contraindications: Hypersensitivity, pregnancy. Precautions: Angioedema (present or past) breastfeeding period, excessive hypotension, hepatic or renal impairment, hyperkalemia, hypertrophic cardiomyopathy, stenosis, aortic or mitral valve stenosis, surgery/anaesthesia. Interactions: Liquorice, lithium, yohimbine. Adverse Reactions: Diarrhoea, dyspepsia/heart burn, fatigue headache, URI, angioedema of the face, lips or throat. Telmisartan 40 mg Tablet Telmisartan 80 mg Tablet Micardis - Trade Name
C09CA07000T1001XX (A*) C09CA07000T1002XX (A*)

System: Cardiovascular Indications: Hypertension in patients who cannot tolerate an ACE inhibitor because of cough. Dosage: 40 - 80 mg / day. Contraindications: Hypersensitivity to telmisartan products, pregnancy and 127

renal artery stenosis. Precautions: Angioedema (associated with aspirin and or penicillin allergy), discontinue with laryngeal stridor or angioedema of the face, tongue or glottis. Aortic or mitral valve stenosis, biliary cirrhosis or biliary obstruction, coronary artery disease and elderly. Interactions: Digoxin, heparin, warfarin, lithium, potassium-sparing diuretics, potassium supplements and other antihypertensive agents. Adverse Reactions: Headache, dizziness and cough. Losartan Potassium 50 mg & Hydrochlorothiazide 12.5 mg Tablet Hyzaar
C09DA01935T1001XX (A*)
- Trade Name

System: Cardiovascular Indications: Hypertension(only for patients who cannot tolerate ACEIs because of cough). Dosage: 1 tab once dly. May be increased to 2 tabs once dly. Contraindications: Anuria, hypersensitivity to hydrochlorothiazide, losartan or sulfonamides, pregnancy. Precautions: Angioedema (associated with aspirin and or penicillin allergy), avoid lithium, biliary cirrhosis or biliary obstruction, breast feeding period, diabetes mellitus, electrolyte imbalance, renal function impairment, geriatrics, hyperuricaemia or gout, hypotension, intravascular volume and salt-depleted, liver disease, may aggravate digitalis toxicity, postsympathectomy patients, pregnancy, renal artery stenosis, solitary kidney, renal impairment, sensitivity reactions may occur with or without a history of allergy or asthma, systemic lupus erythematosus. Interactions: Angiotensin converting enzyme inhibitors, calcitriol, chlorpropamide, cholestyramine, corticotropin, cortisone, diazoxide, digitalis glycosides, diuretics, droperidol, hydrocortisone, indomethacin, liquorice, lithium, methotrexate, methylprednisolone, prednisolone, propranolol, tolbutamide, triamcinolone. Adverse Reactions: Oedema, palpitations, asthenia, dizziness, fatigue, headache, electrolyte abnormalities, abdominal pain, diarrhoea, nausea, bronchitis, cough, pharyngitis, sinusitis, upper respiratory infection, skin rash, back pain, hepatitis. Losartan Potassium 100 mg & Hydrochlorothiazide 25 mg Fortzaar
C09DA01935T1002XX (A*)
- Trade Name

System: Cardiovascular Indications: Hypertension(only for patients who cannot tolerate ACEIs because of cough). Dosage: 1 tab. daily. Contraindications: Anuria ,hypersensitivity to hydrochlorothiazide, losartan or sulfonamides, pregnancy. Precautions: Angioedema (associated with aspirin and or penicillin allergy), 128

avoid lithium, biliary cirrhosis or biliary obstruction, breast feeding period, diabetes mellitus, electrolyte imbalance, renal function impairment, geriatrics, hyperuricaemia or gout, hypotension, intravascular volume and salt-depleted, liver disease, may aggravate digitalis toxicity postsympathectomy patients, pregnancy, renal artery stenosis, solitary kidney, renal impairment, sensitivity reactions may occur with or without a history of allergy or asthma, systemic lupus erythematosus. Interactions: Angiotensin converting enzyme inhibitors, calcitriol, chlorpropamide, cholestyramine, corticotropin, cortisone, diazoxide, digitalis glycosides, diuretics, droperidol, hydrocortisone, indomethacin, liquorice, lithium, methotrexate, methylprednisolone, prednisolone, propranolol, tolbutamide, triamcinolone. Adverse Reactions: Oedema, palpitations, asthenia, dizziness, fatigue, headache, electrolyte abnormalities, abdominal pain, diarrhoea, nausea, bronchitis, cough, pharyngitis, sinusitis, upper respiratory infection, skin rash, back pain, hepatitis. Valsartan 80 mg, Hydrochlorothiazide 12.5 mg Tablet Co -D i o v a n
C09DA03935T1001XX (A*)
- Trade Name

System: Cardiovascular Indications: Hypertension. Dosage: 1 tab once dly. May be increased to 2 tabs once dly. Contraindications: Hypersensitivity to varsartan and pregnancy. Precautions: Angioedema (associated with aspirin and or penicillin allergy), discontinue with laryngeal stridor or angioedema of the face, tongue or glottis. Aortic or mitral valve stenosis, biliary cirrhosis or biliary obstruction, coronary artery disease and elderly. Interactions: Combination with other antihypertensives, lithium, K-Sparing diuretics, K-Supplements. Adverse Reactions: Angioedema, headache, dizziness, cough. Simvastatin 10 mg Tablet Simvastatin 20 mg Tablet Simvastatin 40 mg Tablet Z o c o r - Trade Name
C10AA01000T1001XX (A/KK) C10AA01000T1002XX (A)APPL C10AA01000T1003XX (A*)

System: Cardiovascular Indications: CHD and hypercholesterolaemia patient to reduce risk of total mortality by reducing coronary death,reduce risk of non-fatal myocardial infarction,reduce risk for undergoing myocardial revascularization procedures and slow the progression of coronary atherosclerosis, including development of new lesions and new total occlusions. Dosage: 5 - 40 mg dly at bedtime. Contraindications: Hypersensitivity to simvastatin products, active liver 129

disease, pregnancy and nursing women Precautions: Heavy alcohol use, history of liver disease. Discontinue therapy if serum transaminase levels rise to 3 times upper limit of normal and are persistent . May cause myopathy and renal failure due to rhabdomyolysis . Concomitant administration of fibrates, nicotinic acid, immunosuppressives including cyclosporin, macrolide antibiotics (erythromycin, clarithromycin), itraconazole and ketoconazole, or nefazodone may increase the risk of myopathy. Interactions: Antacids,antibacterials,anticoagulant,antifungals,antivirals,ciclosporin. Adverse Reactions: Abdominal pain, flatulence, constipation, asthenia and headache. Rarely hepatitis, hypersensitivity syndrome Lovastatin 20 mg Tablet M e v a c o r - Trade Name
C10AA02000T1001XX (A/KK)

System: Cardiovascular Indications: CHD and hypercholesterolaemia to reduce risk of total mortality by reducing coronary death, reduce risk of non-fatal myocardial infarction, reduce risk for undergoing myocardial revascularization procedures and slow the progression of coronary atherosclerosis, including development of new lesions and total occlusions. Dosage: 20 - 80 mg dly at bedtime Contraindications: Pregnancy, liver disease, hypersensitivity to lovastatin and nursing women Precautions: Heavy alcohol use. history of liver disease . Discontinue therapy if serum transaminase levels rise to 3 times upper limit of normal and are persistent. This class of drug has been known to cause myopathy and renal failure due to rhabdomyolysis. Concomitant administration of fibrates, niacin, cyclosporin or erythromycin may increase the risk of myopathy. Interactions: Use with caution with coumarin anticoagulants & with immunosuppressive drugs, gemfibrozil or niacin (as a lipid lowering agent) or erythromycin. Itraconazole. Adverse Reactions: GI upsets, headache, skin rashes, fatigue, pruritis, dry mouth, sleep disorders . Rarely, hepatitis, hypersensitivity syndrome, erythema multiforme, toxic epidermal necrolysis. Pravastatin Sodium 20 mg Tablet P r a v a c h o l - Trade Name
C10AA03520T1001XX (A)

System: Cardiovascular Indications: Primary hypercholesterolaemia intolerant or not responsive to other forms of therapy. Dosage: 10 - 20 mg once dly at bedtime, may increase to 40 mg/day at bedtime. Contraindications: Hypersensitivity to pravastatin, liver disease, pregnancy or lactation 130

Precautions: Heavy alcohol use, history of liver disease. Discontinue therapy if serum transaminase levels rise to 3 times upper limit of normal and are persistent . May cause myopathy and renal failure due to rhabdomyolysis .Concomitant administration of fibrates, nicotinic acid, immunosuppressives including cyclosporin, macrolide antibiotics (erythromycin, clarithromycin), itraconazole and ketoconazole, may increase the risk of myopathy. Interactions: Cholestyramine, ciprofibrate, colestipol, cyclosporin, erythromycin, fenofibrate, gemfibrozil , niacin. Adverse Reactions: Mild, transient: Rash, myalgia, headache, non-cardiac chest pain, nausea, vomiting, diarrhoea, fatigue. Atorvastatin 40 mg Tablet Atorvastatin 20 mg Tablet Lipitor - Trade Name
C10AA05000T1001XX (A*) C10AA05000T1002XX (A*)

System: Cardiovascular Indications: Adjunct to diet for lowering total cholesterol, low density lipoprotein, apolipoprotein, beta and total triglyceride levels in patients with : i) Primary hypercholesterolaemia ii) Mixed dyslipidaemia iii) Heterozygous and homozygous familial hypercholesterolaemia. Dosage: Starting dose: 10 mg once dly.( Range: 10 - 80 mg once dly). Contraindications: Liver disease ,hypersensitivity to atorvastatin, pregnant or nursing women. Precautions: Heavy alcohol use, history of liver disease . Discontinue therapy if serum transaminase levels rise to 3 times upper limit of normal and are persistent. This class of drug has been known to cause myopathy and renal failure due to rhabdomyolysis. Concomitant administration of fibrates, niacin, cyclosporin or erythromycin may increase the risk of myopathy. Interactions: Risk of myopathy increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, niacin or azole antifungals. Decreased atorvastatin plasma conc with oral antacid suspensions containing Mg & Al hydroxides, & colestipol. Adverse Reactions: GI disturbances, headache, myalgia, asthenia, insomnia, angioneurotic oedema, muscle cramps, myosti tis, myopathy, cholestatic jaundice, peripheral neuropathy, pruritus. Gemfibrozil 300 mg Capsule L o p i d - Trade Name
C10AB04000C1001XX (A/KK) APPL

System: Cardiovascular Indications: Hyperlipidaemia not responding to measures like diet control, regular exercise etc. Dosage: Adult : 1200 mg/day in 2 divided doses, 30 minutes before breakfast and dinner.Dose range from 0.9-1.5g dly. Contraindications: Hypersensitivity to gemfibrozil, gallbladder disease / biliary cirrhosis, severe liver/kidney disease 131

Precautions: Cholelithiasis, concomitant use of anticoagulants and hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (lovastatin, simvastatin) may cause an increased risk of rhabdomyolysis . Diabetes, hypothyroidism, not recommended in type IIa hyperlipidaemic patients. Should be used only after diet, exercise, and weight loss attempts have failed in obese patients. Interactions: Increases plasma concentration of warfarin. Severe myositis & myoglobinuria when used with statins Adverse Reactions: Dizziness, chest pain, fatigue, rash, pruritis, dermatitis, urticaria, pain in extremities, abdominal & epigastric pain, diarrhoea, vomiting, flatulence, gout, headache, paraesthesia, blurred vision. Cholestyramine resin 4 mg Questran light - Trade Name
C10AC01000M4001XX (A)

System: Cardiovascular Indications: i)Adjunct therapy in elevated LDL-cholesterol. ii)Pruritus associated with partial biliary obstruction. iii)Diarrhoea due to bile acid malab-sorption. Dosage: Child: 50 - 150 mg/ kg 6 - 8 hourly oral. Adult: 4 g orally to maintenance of 8 16 g daily in 2 doses. Contraindications: Complete biliary obstruction, hyperlipidaemia type III, IV or V. Hypersensitivity to bile-sequestering resins. Precautions: Increased bleeding tendency may dev elop due to hypoprothrombinaemia from vit K deficiency, may interfere with fat absorption, absorption of fat soluble vitamins may be decreased & pre-existing constipations. Interactions: Amiodarone, cephalexin, chlorothiazide, diclofenac, digitoxin, digox in, entacapone, frusemide, hydrochloro-thiazide, leflunomide, meloxicam, methotrexate, metronidazole, mycophenolate mofetil, pravastatin, raloxifene, valproic acid, warfarin. Adverse Reactions: Abdominal discomfort, bleeding tendencies due to hypoprothrombinaemia, constipation, flatulence, nausea & vomiting. Nicotinic Acid 500 mg Tablet Niacin - Trade Name
C10AD02000T1001XX (B) NEDL

System: Cardiovascular Indications: Hyperlipidaemia not responding to measures like diet control, weight reduction in the obese and regular exercise. Caution patient about possible flushing, dizziness and palpitations which may occasionally need aspirin about 30 min before the dose. Dosage: 100 - 200 mg tds, gradually increased over 2 - 4 wks to 1 - 2g tds with or after meals. Contraindications: Active liver disease, active peptic ulcer disease, hypersensitivity to Niacin or any of its components. 132

Precautions: Renal disease, history of liver disease, consumption of substantial quantities of alcohol, unstable angina, concurrent vasoconstrictors and concurrent anticoagulants . Predisposition to gout . Women have a greater hypolipidaemic response than men at equivalent doses.Pregnancy and lactation. Interactions: Aspirin, atorvastatin, colestipol, cholestyramine, fluvastatin, isoniazid, lovastatin, nicotine, simvastatin, ethanol and pravastatin. Adverse Reactions: Flushing with burning of the hands, ears and face, pruritis, and rash , gastrointestinal upset,hypotension.Diarrhoea, nausea, vomiting, abdominal pain, feeling of restlessness, headache, hypotension, rash, tingling, itching, and dry skin. Ezetimibe 10mg tablet E z e t r o l - Trade Name
C10AX09000T1001XX (A*)

System: Cardiovascular Indications: i) Co-administration with statins for patients who have CHD or are CHD equivalent, or familial hypercholesterolaemia with target LDL-C not achieved by maximum dose of statins. ii) Monotherapy in patients with documented biochemical intolerance to stains. Dosage: Patient >=10 yr: 10mg once daily. Contraindications: Avoid co-administration with fibrates. Hypersensitivity to ezetimibe, active liver disease or persistently elevated liver enyzymes. Precautions: Child under 10 yrs old, moderate to severe hepatic insufficency, myopathy, pregnancy and lactation. Interactions: Cholestyramine, fibrates, cyclosporin. Adverse Reactions: Abdominal pain arthralgia, back pain, cough, diarrhoea, fatigue, headache, sinusitis. Nystatin 100,000 units/g Cream Mycostatin - Trade Name
D01AA01000G1001XX (C) NEDL APPL

System: Dermatology Indications: Prevention and treatment of cutaneous infections caused by Candida albicans. Dosage: Apply liberally to affected area bd or as required. After lesion has disappeared continue treatment for 10 days to prevent relapses. Nail infection: Cut nails as short as possible. Apply cream once daily until growth of new nail has set in. Contraindications: Hypersensitivity to nystatin. Precautions: Pregnancy. Interactions: No interaction found. Adverse Reactions: Skin irritation. Nystatin 100,000 units/g Ointment Mycostatin - Trade Name System: Dermatology Indications: 133
D01AA01000G5001XX (C)

Prevention and treatment of cutaneous or mucocutaneous infections caused by Candida albicans. Dosage: Apply liberally to affected area bd or as required. After lesion has disappeared continue treatment for 10 days to prevent relapses. Nail infection: Cut nails as short as possible. Apply cream once daily until growth of new nail has set in. Contraindications: Hypersensitivity to nystatin. Precautions: Pregnancy. Interactions: No interaction found. Adverse Reactions: Skin irritation. Clotrimazole 1 % Cream C a n e s t e n - Trade Name
D01AC01000G1001XX (B) NEDL

System: Dermatology Indications: Cutaneous candidiasis, Tinea corporis, Tinea cruris, Tinea pedis and Tinea versicolor. Dosage: Rub in gently onto affected and surrounding skin bd-tds; continuing for 14 days after lesions have healed. Contraindications: Hypersensitivity to clotrimazole. Precautions: Hypersensitivity to clotrimazole. Interactions: No interaction found. Adverse Reactions: Skin reactions, contact dermatitis, pruritis. Clotrimazole 1 % Solution C a n e s t e n - Trade Name
D01AC01000L6001XX (A)NEDL

System: Dermatology Indications: Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis & tinea versicolor. Dosage: Apply gently onto affected and surrounding skin area bd-tds continuing for 14 days after lesions have healed. Contraindications: Hypersensitivity to any component. Precautions: Infant and child: not to use more than once daily. Interactions: No interaction found. Adverse Reactions: Stinging, skin rash, blistering, burning, peeling, redness or other sign of skin irritation not present before using this medicine. Miconazole Nitrate 2 % Powder Daktarin - Trade Name System: Dermatology
D01AC02221F2001XX (A) NEDL

134

Indications: Skin infections caused by dermatophytes or Candida. Dosage: Dust powder over infected area once daily or bd. Contraindications: Children less than 2 yr. Precautions: 1st trimester of pregnancy, lactation. Interactions: No interaction found. Adverse Reactions: Ocassional skin irritation or sensitivity. Miconazole 2 % Cream Daktarin - Trade Name
D01AC02221G1001XX (B) NEDL

System: Dermatology Indications: i) Fungal infections: Tinea pedis, Tinea corporis, Tinea capitis and other dermatophyte infections caused by Trichophyton and Epidermophyton species. ii) Antifungal agent that has been in various candida infections including vaginal candidiasis. Dosage: i) Skin Infection: Apply sparingly and rub gently onto affected area once daily or bd continuing for 10 days after lesions have healed. ii) Apply twice daily continuing for 10 days after lesions have healed Contraindications: Children less than 2 yr. Hypersensitivity to manizole products. Precautions: 1st trimester of pregnancy, lactation. Local sensitization or irritation, to discontinue use. Interactions: No interaction found. Adverse Reactions: Ocassional skin irritation or sensitivity, contact dermatitis, vaginal burning due to cream base. Tioconazole 1 % Cream. T r o s y d - Trade Name
D01AC07000G1001XX (A*) NEDL

System: Dermatology Indications: Fungal infections resistant to antifungal drugs such as miconazole and clotrimazole. Dosage: Gently massage into the affected & surrounding area once daily - bd. Contraindications: Hypersensitivity to tioconazole and midazole antifungal agents. Precautions: Not for ophthalmic use. Interactions: No interaction found. Adverse Reactions: Local irritation, burning, rash, erythema, itching and headache. Ketoconazole 2 % Shampoo N i z o r a l - Trade Name System: Dermatology Indications: 135
D01AC08000L5201XX (A)NEDL

Resistant dandruff only. Dosage: Apply twice weekly for 2 - 4 weeks. Prophylaxis : Once every 1 - 2 weeks. Contraindications: Known hypersensitivity to ketoconazole products. Precautions: After prolonged treatment with topical corticosteroids. Interactions: Concurrent use with ethanol may result in a disulfiram-like reaction (flushing, vomiting, increased respiratory rate, tachycardia). Adverse Reactions: Local irritation, pruritus, alopecia and photosensitivity. Sodium Thiosulphate 10-20% Solution
D01AE00181L9901XX (C)

System: Dermatology Indications: Fungicides. For the treatment of pityriasis versicolor. Dosage: Apply to all affected parts of the body and face with a brush after a bath once dly or bd. Contraindications: Hypersensitivity to sodium thiosulphate or any component of the formulation. Precautions: Discontinue topical use if irritation or sensitivity occurs, rapid IV infusion has caused transient hypotension. Interactions: No interaction found. Adverse Reactions: Hypotension, coma, psychosis, confusion, contact dermatitis, local irritation, neuromuscular & skeletal weakness, tinnitus, diarrhoea (following large accidental ingestion). Salicylic Acid 2 - 10 % Cream
D01AE12000G1001XX (C)

System: Dermatology Indications: Seborrhoeic dermatitis, scalp psoriasis and hyperkeratotic skin conditions. Dosage: Apply sparingly to the affected area bd-tds. Contraindications: Hypersensitivity to salicylic acid. Age less than 2 yrs, diabetes, with impaired circulation. Precautions: Avoid contact with eyes and mucous membranes. Interactions: No interaction found. Adverse Reactions: Local irritation. Salicylic Acid 2 - 10 % Ointment
D01AE12000G5001XX (C)

System: Dermatology Indications: Seborrhoeic dermatitis, scalp, psoriasis and hyperkeratotic skin disorders. Dosage: Apply sparingly to the affected area bd - tds. Contraindications: Hypersensitivity to salicylic acid. Age less than 2 yrs, diabetes with impaired circulation. Precautions: Avoid contact with eyes and mucous membranes. Interactions: No interaction found. 136

Adverse Reactions: Local irritation. Salicylic Acid 20 % Ointment

D01AE12000G5002XX (C)

System: Dermatology Indications: Plantar warts. Dosage: Apply sparingly to the affected area bd - tds. Wash with cleanser 2 - 3 times per day. Contraindications: Hypersensitivity to salicylic acid. Age less than 2 yrs, diabetes, with impaired circulation. Precautions: Avoid contact with eyes and mucous membranes. Interactions: No interaction found. Adverse Reactions: Local irritation. Salicylic Acid 2% Lotion
D01AE12000L6001XX (B) NEDL

System: Dermatology Indications: Seborrhoeic dermatitis, scalp, psoriasis and hyperkeratotic skin conditions. Dosage: Apply sparingly to affected area bd-tds. Wash with cleanser 2 - 3 times per day. Contraindications: Hypersensitivity to salicylic acid. Age less than 2 yrs, diabetes with impaired circulation. Precautions: Avoid contact with eyes and mucous membranes. Interactions: No interaction found. Adverse Reactions: Local irritation. Benzoic Acid Compound Half Strength (Paed) Ointment Whitfield's
D01AE12952G5001XX (C)
- Trade Name

System: Dermatology Indications: Tinea infections of the skin. Dosage: Apply sparingly to affected area once dly or bd. Contraindications: Hypersensitivity to any component. Diabetes impaired circulation. Precautions: Contact with the eyes, mouth, and other mucous membranes should be avoided. Interactions: No interaction found. Adverse Reactions: Local irritation. Benzoic Acid Compound Ointment Whitfields - Trade Name System: Dermatology
D01AE12952G5002XX (C) NEDL APPL

137

Indications: Tinea infections of thickened skin of palms and soles. Dosage: Apply sparingly to affected area once dly or bd. Contraindications: Hypersensitivity, use in children less than 2 yrs, diabetes impaired circulation. Precautions: Contact with the eyes, mouth, and other mucous membranes should be avoided. Interactions: No interaction found. Adverse Reactions: Local irritation. Salicylic Acid, Starch, Zinc Oxide Paste L a s s a r ' s - Trade Name
D01AE12952G6001XX (C)

System: Dermatology Indications: Use as a protective or base. Dosage: Apply the paste liberally and carefully to the lesions bd. Contraindications: Hypersensitivity to any component. Precautions: Contact with the eyes, mouth, and other mucous membranes should be avoided. Interactions: No interaction found. Adverse Reactions: Local irritation. Amorolfine 5 % Nail Lacquer Loceryl - Trade Name
D01AE16110L5001XX (A*)

System: Dermatology Indications: Fungal nail infections. Dosage: Apply to affected nail once or sometimes twice a week after filing and cleansing; allow to dry, treat finger nail for 6 mths, toe nail for 9 - 12 mths (review at intervals of 3 mths). Contraindications: Hypersensitivity to amorolfine. Precautions: Avoid contact with eyes, previous hypersensitivity or intolerance to other topical antifungal agents. Interactions: No interaction found. Adverse Reactions: Slight transient burning sensation. Griseofulvin Syrup F u l c i n - Trade Name System: Antiinfectives
D01BA01000L9001XX (B)

138

Indications: Dermatophyte infections. Dosage: Child : up to 1 yr : 62.5 mg bd, 1 - 5 yrs : 62.5 mg tds, 6 - 12 yrs : 125 mg bd - tds. Contraindications: Established porphyria, hepatocellular failure, SLE & related conditions, pregnancy. Precautions: Ability to drive & operate machinery may be impaired. Lactation. May damage sperm cells - male should not father childn w/in 6 mth of treatment. Interactions: Absorption reduced by barbiturates. Effectiveness reduced by liver enzyme inducing drugs. Decreases anticoagulant effect of warfarin. Reduces effectiveness of oral contraceptive. Enhancement of effects of alcohol. Adverse Reactions: Urticarial reactions, rashes, headache, gastrointestinal disturbances, dizziness, fatigue, granulocytopenia, leucopenia, photosensitivity, precipitation of SLE & related conditions, erythema multiforme, toxic epidermal necrolysis & related conditions, peripheral neuropathy, confusion with impaired coordination and oral candidiasis. Griseofulvin (Ultramicrosize 125 mg =250 mg Microsize) Tablet Fulcin
D01BA01000T1001XX (B) NEDL APPL
- Trade Name

System: Antiinfectives Indications: Dermatophyte infections of the skin, scalp, hair and nails, where topical therapy has failed or inappropriate. Dosage: Adult: 500 mg dly up to 1 g dly in divided doses, Child : 10 mg/kg dly in divided doses or as a single dose. Contraindications: Established porphyria, hepatocellular failure, SLE & related conditions, pregnancy. Precautions: Ability to drive & operate machinery may be impaired. Lactation. May damage sperm cells - male should not father childn within 6 mth of treatment. Interactions: Absorption reduced by barbiturates. Effectiveness reduced by liver enzyme inducing drugs. Decreases anticoagulant effect of warfarin. Reduces effectiveness of oral contraceptive. Enhancement of effects of alcohol. Adverse Reactions: Urticarial reactions, rashes, headache, gastrointestinal disturbances, dizziness, fatigue, granulocytopenia, leucopenia, photosensitivity, precipitation of SLE & related conditions, erythema multiforme, toxic epidermal necrolysis & related conditions, peripheral neuropathy, confusion with impaired coordination and oral candidiasis.

139

Terbinafine HCl 250 mg Tablet L a m i s i l - Trade Name

D01BA02110T1001XX (A*)

System: Antiinfectives Indications: Fungal infections especially onchomycosis caused by dermatophytes. Dosage: 250 mg once a day x 6 weeks for fingernails: 12 weeks for toenails. Contraindications: Hypersensitivity to terbinafine. Precautions: Severe liver or renal dysfunction (creatinine clearance less than 50 ml/min or serum creatinine of more than 300 mol/L) should receive a lower dose. Pregnancy and lactation. Interactions: Induce metabolism (eg, rifampicin) and may be inhibited by drugs which inhibit cytochrome P-450 (eg, cimetidine). Adverse Reactions: Gastrointestinal symptoms, skin reactions, headache, dizziness, vertigo, lymphocytopenia, and visual disturbance. Zinc Oxide Cream
D02AB00000G1001XX (C) NEDL

System: Dermatology Indications: Skin protective in various skin conditions such as nappy rash, eczema and problem skin. Dosage: Apply tds or as required. Contraindications: Weeping dermatoses. Precautions: Hypersensitivity to any component. Avoid contact with eyes. Not to be applied over deep or puncture wounds, infections or lacerations. Interactions: No interaction found. Adverse Reactions: Hypersensitivity to any component. Zinc Oxide Ointment
D02AB00240G5001XX (C) NEDL

System: Dermatology Indications: Skin protective in various skin conditions such as nappy rash and eczema. Dosage: Apply tds or as required. Contraindications: Weeping dermatoses. Precautions: Hypersensitivity to any component. Avoid contact with eyes. Not to be applied over deep or puncture wounds, infections or lacerations. Interactions: No interaction found. Adverse Reactions: Hypersensitivity to any component. Hypoallergenic Ambiphilic Base Cream S u p r a c r e a m - Trade Name
D02AC00000G1001XX (A)

System: Dermatology Indications: Supportive therapy for the symptomatic treatment of mild chronic dermatitis and 140

eczema; and in connection with treatment of all skin diseases undergoing corticosteroid therapy. Dosage: Apply to the affected area once dly - bd. Contraindications: Not known. Precautions: Avoid contact with eyes and other mucous membranes. Interactions: No interaction found. Adverse Reactions: No information available. Paraffin, White Soft Paraffin, Yellow Soft Vaseline - Trade Name
D02AC00000G5001XX (C) APPL D02AC00000G5002XX (C) NEDL APPL

System: Dermatology Indications: Xerosis and ichthyosis. Dosage: Apply to the affected area. Contraindications: Hypersensitivity to any component. Precautions: Avoid exposure to fire. Interactions: No interaction found. Adverse Reactions: Hypersensitivity to any component. Emulsificants Ointment
D02AC00952G5001XX (C)

System: Dermatology Indications: Xerosis and ichthyosis. Dosage: Use as a soap and emollient. Contraindications: Hypersensitivity to any component. Precautions: Should not be used before phototherapy or in phototesting procedures. Interactions: No interaction found. Adverse Reactions: No information available. Carbamide (Urea) 10 % Cream C a l m u r i d - Trade Name
D02AE01000G1001XX (B)

System: Dermatology Indications: Contact irritant dermatitis, infantile eczemas, acute and chronic allergic eczemas, icthyosis, hyperkeratotic. Dosage: Apply sparingly and rub into affected area bd - tds and when required after cleansing skin. Contraindications: Hypersensitivity to urea or any component. Precautions: Avoid contact with eyes, discontinue use if oral inflammation persists or worsens. Use with caution on inflammed skin or exudative lesions : irritation may results. 141

Interactions: No interaction found. Adverse Reactions: Skin irritation, rash and ischaemic skin necrosis. Aqueous Cream
D02AX00000G1001XX (C) NEDL

System: Dermatology Indications: Dry skin. Dosage: As a soap or apply to the skin as an emollient cream. Contraindications: Not known. Precautions: It should not be used before phototherapy or in phototesting procedures. Interactions: No interaction found. Adverse Reactions: No information available. Lanolin
D02AX00000G5001XX (C) NEDL

System: Dermatology Indications: As an emollient. Dosage: Apply to the affected area . Contraindications: Hypersensitivity to lanolin. Precautions: Avoid contact with eyes. Not to be applied over deep or puncture wounds, infections or lacerations. Interactions: No interaction found. Adverse Reactions: Possible allergic reaction to material if inhaled, ingested or in contact with skin. Red Petroleum, Zinc Oxide & 2-Ethoxyethyl P-Methoxy Cinnamate Ointment RV Paque
D02BA00952G5001XX (A)
- Trade Name

System: Dermatology Indications: Total sunblock. Dosage: Apply in uniformly thin film to areas requiring light protection. Reapply after swimming, heavy perspiration & towelling dry. Contraindications: Hypersensitivity to any component. Precautions: Avoid contact with eyes. Interactions: No interaction found. Adverse Reactions: Hypersensitivity to any component. Sunscreen 5 - 20 % w/w Cream System: Dermatology Indications: Photodermatitis. Dosage: 142
D02BA02000G1001XX (B)

Apply to exposed areas at least 30 minutes prior to solar exposure; reapply after swimming, prolonged perspiration and after 2 hrs of continuos sun exposure. Contraindications: Hypersensitivity to a particular sunscreen agent. Precautions: Allergic to benzocaine, procaine, paraphenylenediamina (found in hair dyes), thiazide diuretics, sulfonamides aniline, or methylparaben may also be allergic to sunscreen containing PABA or PABA esters. Interactions: Antagonise antibacterial effect of sulfonamides. Adverse Reactions: Contact dermatitis and miliaria. Protein Free Haemodialysate 10 % Jelly S o l c o s e r y l - Trade Name
D03AX00000G4001XX (A)

System: Dermatology Indications: Trophic lesions in patients with arterial occlusive disease and with chronic venous insufficiency; burn injuries, impaired wound healing, decubital ulcers; and skin ulcer caused by irradiation. Dosage: Apply 3 - 5 times daily. Contraindications: Hypersensitivity to any component. Precautions: Burning sensation after application of jelly. Interactions: No interaction found. Adverse Reactions: Allergic skin reactions. Protein Free Haemodialysate 5 % Ointment S o l c o s e r y l - Trade Name
D03AX00000G5001XX (A) NEDL

System: Dermatology Indications: Trophic lesions in patients with arterial occlusive disease and with chronic venous insufficiency; burn injuries, impaired wound healing, decubitus ulcers; and skin ulcer caused by irradiation. Dosage: Apply 3 - 5 times daily. Contraindications: Hypersensitivity to any component. Precautions: Burning sensation after application. Interactions: No interaction found. Adverse Reactions: Allergic skin reactions. Protein Free Haemodialysate Dental Adhesive Paste D03AX00000G6001XX (A) S o l c o s e r y l - Trade Name System: Ear, Nose and Oropharynx Indications: Painful and inflammatory affliction on the oral mucosa, gums and lips, teething pain, denture pressure sores, oral and maxillofacial surgery and dressing after scaling. Dosage: Apply to lesions 3 - 5 times daily. Contraindications: Hypersensitivity to any component. 143

Precautions: Burning sensation after application. Interactions: No interaction found. Adverse Reactions: No information available. Protein Free Haemodialysate Injection S o l c o s e r y l - Trade Name
D03AX00000P3001XX (A)

System: Miscellaneous Indications: For peripheral arterial occlusive disease gangrene and other trophic lesions, cerebrovascular disease, chronic venous insufficiency, severe burns, irradiation lesions, impaired wound healing, arteriosclerotic, diabetic angiopathies and myocardial infarct. Dosage: Arteriosclerotic & diabetic angiopathies: 4 - 6 ml IM, IV or IA daily for first 2 wks, after which the dose may be reduced. Myocardial infarct: 4ml daily for 1 - 2 wks. Contraindications: Hypersensitivity to any component. Precautions: Pregnancy, lactation. Interactions: No interaction found. Adverse Reactions: No information available. Calamine Cream
D04AX00000G1001XX (C) NEDL APPL

System: Dermatology Indications: Prickly heat or insect bites. Dosage: Apply to the affected area as required. Contraindications: Not known. Precautions: Avoid contact with eyes and other mucous membranes. Interactions: No interaction found. Adverse Reactions: Rash or irritation. Calamine Oily Lotion
D04AX00000L6001XX (C)

System: Dermatology Indications: Prickly heat, insect bites and for temporary relief of itching and pain. Dosage: Apply to the affected area 1 - 3 times a day. Shake well before application. Contraindications: Not known. Precautions: Avoid contact with eyes and other mucous membranes. Do not use on children under 2 yrs of age without consulting a physician. Interactions: No interaction found. Adverse Reactions: Rash or irritation. Calamine Lotion System: Dermatology Indications: 144
D04AX00000L8001XX (C) NEDL APPL

Prickly heat or insect bites. Dosage: Apply to the skin as required and allow to dry 1-3 times a day. Contraindications: Not known. Precautions: Avoid contact with eyes and other mucous membranes. Interactions: No interaction found. Adverse Reactions: Rash or irritation. Calamine with 0.5 % Phenol Cream
D04AX00952G1001XX (C)

System: Dermatology Indications: For use as a mild astringent. Dosage: Apply to the affected area as required. Contraindications: Pregnancy, paediatrics and geriatrics. Precautions: Aviod contact with eyes and other mucous membranes. Do not use on children under 2 years without consulting a physician. Interactions: No interaction found. Adverse Reactions: Rash or irritation. Calamine with 0.25 - 0.5 % Menthol Lotion
D04AX00952L6001XX (C)

System: Dermatology Indications: Prickly heat or insect bites. Dosage: Apply to the skin as required and allow to dry 1 - 3 times a day. Contraindications: Not known. Precautions: Avoid contact with eyes and other mucous membranes. Do not use on children under 2 years without consulting a physician. Interactions: No interaction found. Adverse Reactions: Rash or irritation. Calamine with 2 - 6 % Precipitated Sulphur Lotion D04AX00952L6002XX (C) System: Dermatology Indications: Acne vulgaris. Dosage: Apply to the skin as required and allow to dry 1 - 3 times a day. Contraindications: Not known. Precautions: Avoid contact with eyes and other mucous membranes. Do not use on children under 2 years without consulting a physician. Interactions: No interaction found. Adverse Reactions: Rash or irritation. Coal Tar 1- 9 % Ointment System: Dermatology Indications: 145
D05AA00000G5001XX (B)

Dandruff, seborrhoeic dermatitis, atopic dermatitis, eczema and psoriasis. Dosage: Apply sparingly to the affected area 1-3 times dly starting with low strength preparations. Contraindications: Absence of beneficial use when used previously. Presence of folliculitis and acne vulgaris . Active or inflammed psoriasis, weeping eczema, erythrodermic and generalized pustular psoriasis, photosensitivity . Precautions: Avoid contact with eye, mucous membranes or broken skin. Interactions: No interaction found. Adverse Reactions: Skin ulcerations, hypersensitivity reactions including and contact dermatitis. The use of ultraviolet light and coal tar may produce or aggravate, folliculitis, erythema and a smarting. Coal Tar 20 % Solution
D05AA00000L5201XX (B) APPL

System: Dermatology Indications: Dandruff, seborrhoeic dermatitis, atopic dermatitis, eczema and psoriasis. Dosage: Use 100 ml in a bath. Contraindications: Presence of folliculitis and acne vulgaris . Active or inflammed psoriasis, weeping eczema, erythrodermic and generalized pustular psoriasis, photosensitivity . Precautions: Do not apply to acutely inflammed skin. Avoid contact with eyes and do not apply coal tar preparations (other than bath emulsions) to genital or rectal areas. Interactions: No interaction found Adverse Reactions: Skin ulcerations,hypersensitivity reactions including allergic contact dermatitis, aggravations of status varicosus. The use of ultraviolet light and coal tar may produce or aggravate herpes lesions keratocystomatosis,Folliculitis ,erythema and a smarting reaction. Cocois Co. Ointment
D05AA00946G5001XX (B)

System: Dermatology Indications: Scalp psoriasis and severe seborrhoeic dermatitis. Dosage: Rub a small amount into the scalp gently. Contraindications: Hypersensitivity to any of its ingredients. Precautions: Avoid eyes, mucosa, genital, rectal areas, broken or inflammed skin. Interactions: No interaction found. Adverse Reactions: Dermatitis, folliculitis Coal Tar and Salicylic Acid (various concentrations) Ointment
D05AA00946G5002XX (B) NEDL

System: Dermatology

146

Indications: Dandruff, seborrhoeic dermatitis, atopic dermatitis, eczema and psoriasis. Dosage: Apply to the affected areas. Contraindications: Skin infection Precautions: Avoid contact with eyes, mucous membranes or broken skin. Avoid exposure to sun or strong artificial light.Should not be used for acute or pustular psoriasis or on inflammed skin. It stains skin, hair, some fabrics, plastics, and enamel. Interactions: No interaction found. Adverse Reactions: Local irritation Coal Tar 1- 6 % in Betamethasone 17 - Valerate 0.01 % Ointment
D05AA00946G5003XX (B)

System: Dermatology Indications: Dandruff, seborrhoeic dermatitis, atopic dermatitis, eczema and psoriasis. Dosage: Apply to the affected areas. Contraindications: Hypersensitivity to any of its ingredients. Precautions: Avoid eyes, mucosa, genital, rectal areas, broken or inflammed skin. Interactions: No interaction found. Adverse Reactions: Dermatitis, folliculitis. Tar, Coal Tar & Oleyl Alcohol Liquid P o l y t a r - Trade Name
D05AA00952L5001XX (A/KK)

System: Dermatology Indications: Dandruff, seborrhoeic dermatitis and atopic dermatitis. Dosage: Massage into wet hair, rinse and repeat. Use once or twice wkly. Contraindications: Folliculitis and acne vulgaris, weeping eczema, erythrodermic, generalized pustular psoriasis and photosensitivity. Precautions: Do not apply to acutely inflammed skin. Avoid contact with eyes, do not apply coal tar preparations (other than bath emulsions) to genital or rectal areas. Interactions: No interaction found. Adverse Reactions: Skin ulcerations and hypersensitivity reactions including allergic contact dermatitis, the use of ultraviolet light and coal tar may produce or aggravate, folliculitis erythema and a smarting reaction. Dithranol 0.1 - 5 % in Vaseline /Ointment System: Dermatology
D05AC01000G5001XX (A)

147

Indications: Short contact treatment for plaque psoriasis and alopecia areata. Dosage: Use as short contact. Apply for not more than hr then wash off. Apply carefully to lesions. Contraindications: Use on the face and genitals. Should not be used for acute or pustular psoriasis or on inflammed skin. Precautions: Irritant to the eyes and mucous membranes. Interactions: No interaction found. Adverse Reactions: May cause a burning sensation especially on perilesional skin. Dithranol 1 % in Lassars Paste
D05AC01000G6001XX (A)

System: Dermatology Indications: Treatment of quiescent or chronic psoriasis of the skin, scalp and alopecia areata. Dosage: Apply liberally and carefully to the lesions with a suitable applicator. A dressing may be applied. Contraindications: Use on the face and genitals. Should not be used for acute or pustular psoriasis or on inflammed skin. Precautions: Irritant to the eyes and mucous membranes. Interactions: No interaction found. Adverse Reactions: May cause a burning sensation especially on perilesional skin. Methoxsalen 0.1 % Paint M e l a d i n i n e - Trade Name
D05AD02000L7001XX (A)NEDL

System: Dermatology Indications: Psoriasis and Vitiligo. Dosage: Apply 2 - 3 times a week according to patient's tolerance and should be used at least 1 hour before UV or solar irradiation. To be diluted with alcohol to 1/4 1/2 concentrate for the first 2 wks. Contraindications: History of idiosyncratic reactions to psoralens ,history of light sensitive disease states (lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, albinism). History of melanoma. Precautions: Patients with hepatic insufficiency. Protect eyes & skin against complementary sun exposure after controlled UV irradiation. Interactions: Methoxsalen may increase the levels/effects of CYP1A2 substrates include aminophylline, fluvoxamine, mexiletine, mirtazapine, ropinirole, theophylline, and trifluoperazine. Methoxsalen may also increase the levels/effects of CYP2A6 substrates include dexmedetomidine and ifosfamide. Methoxsalen serum concentrations may be increased if taken with food. Avoid 148

furocoumarin-containing foods (limes, figs, parsley, celery, cloves, lemon, mustard, carrots). Adverse Reactions: Pruritus, erythema, nausea, nervousness, vertigo, depression, dizziness, headache, malaise, loss of muscle coordination, leg cramps Calcipotriol 50 mcg/g Cream D a i v o n e x - Trade Name
D05AX02000G1001XX (A*)

System: Dermatology Indications: Only for the treatment of Psoriasis Vulgaris. Dosage: Apply to the affected skin lesions bd. Maintenance therapy may be achieved with less frequent application. The wkly dose should not exceed 100 g. Contraindications: Hypersensitivity to any constituents of the Calcipotriol. Disorders of calcium metabolism. Precautions: Should not be used on the face since the formulation may give rise to irritation of the facial skin. Careful handwashing after use is recommended. Interactions: No interaction found Adverse Reactions: Transient local irritation & very rarely, facial dermatitis may occur, hypercalcemia. Calcipotriol 50 mcg/g Ointment D a i v o n e x - Trade Name
D05AX02000G5001XX (A*) NEDL

System: Dermatology Indications: Only for the treatment of Psoriasis Vulgaris. Dosage: Apply to the affected skin lesions bd. Maintenance therapy may be achieved with less frequent application. The wkly dose should not exceed 100 g. Contraindications: Hypersensitivity to any constituents of the Calcipotriol. Disorders of calcium metabolism. Precautions: Should not be used on the face since the ointment formulation may give rise to irritation of the facial skin. Careful handwashing after use is recommended. Interactions: No interaction found Adverse Reactions: Transient local irritation & very rarely, facial dermatitis may occur, hypercalcemia. Calcipotriol 50 mcg/ml Scalp Solution D i a v o n e x - Trade Name
D05AX02000L9901XX (A*)

System: Dermatology Indications: Only for the treatment of Psoriasis Vulgaris. Dosage: Apply to the affected skin lesions bd. Weekly maintenance therapy may be achieved with less frequent application. The wkly dose should not exceed 100 149

g. Contraindications: Hypersensitivity to any constituents of the Calcipotriol. Disorders of calcium metabolism. Precautions: Should not be used on the face since the formulation may give rise to irritation of the facial skin. Careful handwashing after use is recommended. Interactions: No interaction found. Adverse Reactions: Transient local irritation & very rarely, facial dermatitis may occur and hypercalcemia. Trioxsalen 5 mg Tablet T r i s o r a l e n - Trade Name
D05BA01000T1001XX (A)

System: Dermatology Indications: Vitiligo. Dosage: 5 - 10 mg dly, 2 - 4 hours before exposure to sunlight. To increase pigmentation: 10 mg dly, 2 hours prior to UV irradiation. Contraindications: Porphyria ,concomitant photosensitizing drugs, children 12 yrs and under, leukoderma of infection, acute lupus erythematosus. Precautions: Overdose and or overexposure may result in serious burning and blistering. Interactions: Concurrent use of trioxsalen and furocoumarin foods may result in severe burns. Adverse Reactions: GI discomfort ,severe sunburn (high dose), phototoxicity. Methoxsalen 10 mg Tablet M e l a d i n i n e - Trade Name
D05BA02000T1001XX (A)NEDL

System: Dermatology Indications: Protection before exposure to sunlight, psoriasis and vitiligo Dosage: 0.2 - 0.6 mg/kg/body weight.For repigmentation of larger lesions (greater than 6 cm sq) : 20 mg/day 2 hr before exposure. Take with food or milk. Contraindications: History of idiosyncratic reactions to psoralens ,history of light sensitive disease states (lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, albinism). History of melanoma. Precautions: Breast feeding, ,exposure to sunlight or UVA radiation,ocular changes ,patients with a history of previous arsenic exposure should be observed for signs of carcinoma,patients with a history of previous radiation therapy or Grenz ray therapy should be observed for signs of carcinoma, pregnancy ,special care should be taken during concomitant administration of photosensitizing agents ,tartrazine sensitivity. Interactions: Phenytoin may reduce effectiveness of methoxsalen. Adverse Reactions: Erythema, pruritus,headache, dizziness, fatigue nausea, skin pain ,hepatotoxicity , precancerous changes. 150

Acitretin 10 mg Capsule N e o t i g a s o n - Trade Name

D05BB02000C1001XX (A*) NEDL

System: Dermatology Indications: Only for the treatment of generalised pustular and or erythrodermic psoriasis, pityriasis rubra pilaris, Darier's Disease, Icthyosiform Erythrodermas - Bullous and non-bullous forms, extensive naevus verrucosus, extensive psoriasis. Dosage: Adult: initially 25-30 mg daily for 2-4 wks, then adjusted according to response, usually within range 25-50 mg dly for further 6-8 wks (max: 75 mg daily). Paed: 500 mcg/kg daily occasionally up to 1 mg/kg daily to a max. 35 mg daily for limited periods. Contraindications: Pregnancy & lactation; liver & kidney insufficiency; hypervitaminosis A; excessively elevated blood lipid values. Precautions: Long-term treatment, diabetes, obesity, alcoholism, disturbances of lipid metabolism. Interactions: Oral contraceptives, progestogen may result in loss of contraceptive effectiveness.Ethanol may result in a prolonged risk of teratogenicity. Possible hypervitaminosis with vitamin A. Reduces protein binding of phenytoin. Adverse Reactions: Symptoms of hypervitaminosis A; localized but reversible hair loss; thinning & scaling of the skin; paronychia, muscle & joint pain. Acitretin 25 mg Capsule N e o t i g a s o n - Trade Name
D05BB02000C1002XX (A*)

System: Dermatology Indications: Only for the treatment of Generalised Pustular and/or Erythrodermic Psoriasis, Pityriasis Rubra Pilaris, Darier's Disease, Icthyosiform Erythrodermas - Bullous and Non-bullous forms, Extensive Naevus Verrucosus, Extensive psoriasis. Dosage: Adult: initially 25-30 mg daily for 2-4 wks, then adjusted according to response, usually within range 25-50 mg dly for further 6-8 wks (max: 75 mg daily). Paed: 500 mcg/kg daily (occasionally up to 1 mg/kg daily to a max. 35 mg daily for limited periods. Contraindications: Pregnancy & lactation; liver & kidney insufficiency; hypervitaminosis A; excessively elevated blood lipid values. Precautions: Long-term treatment; diabetes, obesity, alcoholism, disturbances of lipid metabolism. Interactions: Oral contraceptives, Progestogen may result in loss of contraceptive effectiveness.Ethanol may result in a prolonged risk of teratogenicity.Possible hypervitaminosis with vit A. Reduces protein binding of phenytoin. Adverse Reactions: Symptoms of hypervitaminosis A; localized but reversible hair loss; thinning & scaling of the skin; paronychia, muscle & joint pain.

151

Chlortetracycline 1 - 3 % Cream

D06AA02000G1001XX (B)

System: Dermatology Indications: Bacterial skin infections. Dosage: Apply directly to affected area twice dly as required for 1 - 2 wks. Contraindications: Hypersensitivity to chlortetracycline or to any agents in the tetracycline class. Precautions: Photosensitivity. Interactions: No interaction found. Adverse Reactions: Erythema, maculopapular lesions and phototoxicity. Fusidic Acid 2 % Cream F u c i d i n - Trade Name
D06AX01000G1001XX (A) NEDL

System: Dermatology Indications: Skin infections caused by staphylococci, streptococci, corynebacterium minutissumun and other sodium fusidate-sensitive organisms. Dosage: Apply to affected area bd - tds. Contraindications: Infections caused by non -susceptible organisms in particular Pseudomonas aeruginosa. Precautions: Avoid contact with eyes and other mucous membranes. Interactions: No interaction found Adverse Reactions: Rashes, irritation, pruritus & contact dermatitis. Sodium Fusidate 2 % Ointment F u c i d i n - Trade Name
D06AX01520G5001XX (A) NEDL

System: Dermatology Indications: Skin infections caused by staphylococci, streptococci, corynebacterium minutissumun and other sodium fusidate-sensitive organisms. Dosage: Apply sparingly to affected area bd - tds. Contraindications: Infection caused by non-susceptable organism in particular Pseudomonas aeruginosa. Precautions: Avoid contact with eyes and other mucous membranes. Interactions: No interaction found Adverse Reactions: Rash, irritation, pruritus, contact dermatitis. Fusidic Acid 2 % in Betamethasone Valerate 0.1 % Cream Fucicort
D06AX01948G1001XX (A/KK) NEDL
- Trade Name

System: Dermatology

152

Indications: Eczemas with secondary bacterial infections. Dosage: Apply bd - tds. Contraindications: Primary bacterial, viral & fungal skin infections. Precautions: Avoid long term continuous therapy, avoid contact with eyes. Pregnancy & lactation. Interactions: No interaction found Adverse Reactions: Mild stinging, irritation, rash. Neomycin 0.5 % Cream.
D06AX04256G1001XX (B) NEDL APPL

System: Dermatology Indications: Infections of the skin due to susceptible organisms. Dosage: Apply sparingly to affected area up to 3 times dly. ( For short term use; 1 - 2 wks ) Contraindications: Hypersensitivity to neomycin or other aminoglycosides. Precautions: Superinfection may occur on prolonged use .Renal impairment. Interactions: No interaction found Adverse Reactions: Skin sensitization or contact dermatitis. The sensitivity disappears when treatment is discontinued Neomycin 0.5 % Ointment
D06AX04256G5001XX (B) NEDL

System: Dermatology Indications: Infections of the skin due to susceptible organisms. Dosage: Apply sparingly to affected area up to 3 times dly. ( For short term use ; 1- 2 wks ) Contraindications: Hypersensitivity to neomycin or other aminoglycosides. Precautions: Superinfection may occur on prolonged use .Renal impairment. Interactions: No interaction found Adverse Reactions: Skin sensitization or contact dermatitis. The sensitivity disappears when treatment is discontinued Gentamicin 0.1 % Cream G a r a m y c i n - Trade Name
D06AX07183G1001XX (A*) NEDL

System: Dermatology Indications: For localised infections . Dosage: Apply bd - tds. Contraindications: Hypersensitivity to gentamicin or other aminoglycosides. Precautions: Discontinue if irritation or sensitization occurs Interactions: No interaction found Adverse Reactions: Avoid prolonged use. 153

Mupirocin 2% Cream Bactro b a n - Trade Name

D06AX09000G1001XX (A)

System: Dermatology Indications: Skin infection by Staphylococcus aureus (including MRSA),Staph. epidermidis and beta-haemolytic streptococcus. Dosage: 2 - 3 times a day Contraindications: Hypersensitivity to mupirocin products. Precautions: Not for ophthalmic or intranasal use.Use with caution if there is evidence of moderate or severe renal impairment. Interactions: Avoid products with polyethylene glycol on open wounds. Adverse Reactions: Stinging or burning, pruritus. Mupirocin 2 % Ointment B a c t r o b a n - Trade Name
D06AX09000G5001XX (A) NEDL

System: Dermatology Indications: For MRSA infections only. Dosage: Adult & Child : Apply up to three times dly for 3 - 5 days. Contraindications: Hypersensitivity to mupirocin products. Precautions: Not for ophthalmic or intranasal use.Use with caution if there is evidence of moderate or severe renal impairment. Interactions: Avoid products with polyethylene glycol on open wounds. Adverse Reactions: Stinging or burning, pruritus. Silver Sulphadiazine 1 % Cream Flamazine - Trade Name
D06BA01199G1001XX (B) NEDL APPL

System: Dermatology Indications: Prevention and treatment of infections in severe burns, leg ulcers where infections may prevent healing and for the prophylaxis of infections in skin grafting. Dosage: Burns : Apply 3 mm thick layer bd with sterile applicator. Leg ulcer; apply at least 3 times a week. Contraindications: Hypersensitivity to silver or to silver sulphadiazine, Pregnant women at or near term (increased kernicterus). Preterm infants or newborns during first two months. Precautions: Those allergic to sulfonamides may show cross-sensitivity to silver sulfadiazine, Hemolysis may occur with glucose-6-phosphate deficiency. Accumulation may occur in renal or hepatic insufficiency. Interactions: Concomitant cimetidine therapy may increase the likelihood of causing leucopenia in silver sulfadiazine-treated burn patients. Adverse Reactions: Transient leucopenia has occurred with topical silver, haemolytic anaemia, probable febrile reaction, irritation, itching, and burning at 154

the application site , argyria, hyperpigmentation. Acyclovir 5 % Cream Z o v i r a x - Trade Name

D06BB03000G1001XX (A*) NEDL

System: Dermatology Indications: Herpes simplex infections of the skin, including initial and recurrent labial and genital herpes simplex infections. Dosage: Apply every 4 hrs for 5 - 10 days Contraindications: Hypersensitivity to acyclovir or valacyclovir. Precautions: Application to mucous membranes,pregnancy, lactation. Should not be used in the eyes. Interactions: No interaction found Adverse Reactions: Transient burning or stinging or erythema, mild drying or flaking of the skin. Podophyllum 10 - 20 % Paint
D06BB04000L7001XX (B) NEDL

System: Dermatology Indications: External genital warts. Dosage: Apply 2 - 3 drops carefully to lesion after protecting surrounding area with vaseline. Wash off after 6 hrs or if feel burning sensation and repeat 2-3 times weekly or once weekly . Contraindications: Pregnancy, use on bleeding warts, moles, birthmarks and concomitant steroid therapy. Precautions: Sensitive parts of the body.Caustic to healthy skin. Keep away from eyes. Interactions: No interaction found. Adverse Reactions: Inflammation of the surrounding skin may occur, in which case treatment should be suspended. Hydrocortisone 1 % Cream
D07AA02000G1001XX (B) NEDL APPL

System: Dermatology Indications: Inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Dosage: Apply sparingly to affected area bd-tds until condition improve, then reduce frequency. Contraindications: Fungal & bacterial infections,TB of the skin, viral disease of the skin,acne vulgaris, rosacea, perioral dermatitis. Hypersensitivity to hydrocortisone. Precautions: Prolonged use in infants & children, ulceration at infection site; diabetes mellitus. Interactions: No interaction found Adverse Reactions: Local atrophic skin changes, impaired skin healing. 155

Hydrocortisone 1 % Ointment

D07AA02000G5001XX (B) NEDL APPL

System: Dermatology Indications: Inflammatory and pruritic manifestations of corticoid responsive dermatoses. Dosage: Apply sparingly to affected area bd - tds until condition improve then reduce frequency. Contraindications: Fungal & bacterial infections,TB of the skin, viral disease of the skin,acne vulgaris, rosacea, perioral dermatitis. Hypersensitivity to hydrocortisone. Precautions: Prolonged use in infants & children, ulceration at infection site, diabetes mellitus. Interactions: No interaction found Adverse Reactions: Local atrophic skin changes, impaired skin healing. Clobetasone Butyrate 0.05 % Cream E u m o v a t e - Trade Name
D07AB01255G1001XX (A/KK) NEDL

System: Dermatology Indications: Eczema and dermatitis of all types. Dosage: Apply up to bd - tds. Contraindications: Skin lesions caused by viral, fungal & bacterial infections. Hypersensitivity to clobetasone or other corticosteroids. Precautions: Infants & child; prolonged & continuous use; pregnancy. Discontinue if sec ondary infection develops, avoid prolonged application to face. Interactions: No interaction found Adverse Reactions: Hypersensitivity to clobetasone or other corticosteriods. Transient adrenal suppression. Pigmentation changes & hypertrichosis. Clobetasone Butyrate 0.05 % Ointment E u m o v a t e - Trade Name
D07AB01255G5001XX (A/KK)

System: Dermatology Indications: Eczema and dermatitis of all types. Dosage: Apply up to bd - tds. Contraindications: Skin lesions caused by viral, fungal & bacterial infections. Hypersensitivity to clobetasone or other corticosteroids. Precautions: Infants & child; prolonged & continuous use; pregnancy. Discontinue if secondary infection develops, avoid prolonged application to face. Interactions: No interaction found Adverse Reactions: Hypersensitivity to clobetasone or other corticosteriods. Transient adrenal suppression. Pigmentary changes & hypertrichosis. 156

Betamethasone 17 - Valerate 0.01 - 0.05 % Cream D07AC01256G1001XX (B) NEDL B e t n o v a t e - Trade Name System: Dermatology Indications: Eczemas, prurigo nodularis, limited psoriasis in appropriate in sites. Dosage: Apply sparingly to affected area bd - tds then reduced to once dly when improvement occurs. Contraindications: Viral diseases, bacteria and fungal infection, acne, rosacea & perioral dermatitis. Hypersensitivity to betamethasone products. Precautions: Extensive or prolonged use ,pregnancy,infant & children < 4 yr. Avoid contact with eyes. Use in patients 12 years of age younger. Interactions: No interaction found Adverse Reactions: Local skin atrophy, striae, systemic hypercorticism, folliculitis, hypertrichosis,acneiform eruptions, hypopigmentation & allergic contact dermatitis. Betamethasone 17 - Valerate 0.1 % Cream D07AC01256G1002XX (A) NEDL APPL B et n o v a t e - Trade Name System: Dermatology Indications: Eczemas, prurigo nodularis, psoriasis (excluding widespread plaque psoriasis). Dosage: Apply sparingly to affected area bd - tds then reduced to once dly when improvement occurs. Contraindications: Viral diseases, bacteria and fungal infection, acne, rosacea & perioral dermatitis. Hypersensitivity to betamethasone products. Precautions: Extensive or prolonged use ,pregnancy,infant & children < 4 yr. Avoid contact with eyes. Use in patients 12 years of age younger. Interactions: No interaction found Adverse Reactions: Local skin atrophy, striae. systemic hypercorticism, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation and allergic contact dermatitis. Betamethasone 17 - Valerate 0.01 - 0.05 % Ointment D07AC01256G5001XX (B)
NEDL

Betnovate

- Trade Name

System: Dermatology Indications: Eczema, prurigo nodularis, limited psoriasis in appropriate in sites. Dosage: Apply sparingly to affected area bd - tds then reduced to once dly when improvement occurs. Contraindications: Viral diseases, bacteria and fungal infection, acne, rosacea & perioral dermatitis. Hypersensitivity to betamethasone products. Precautions: Extensive or prolonged use ,pregnancy,infant & children < 4 yr. Avoid contact with eyes. Use in patients 12 years of age younger. 157

Interactions: No interaction found Adverse Reactions: Local skin atrophy, striae. systemic hypercorticism, folliculitis, hypertrichosis,acneiform eruptions, hypopigmentation, prioral & allergic contact dermatitis. Betamethasone 17 - Valerate 0.1 % Ointment D07AC01256G5002XX (A) NEDL B e t n o v a t e - Trade Name System: Dermatology Indications: Eczema, prurigo nodularis, psoriasis (excluding widespread plaque psoriasis). Dosage: Apply sparingly to affected area bd - tds then reduced to once dly when improvement occurs. Contraindications: Viral diseases, bacteria and fungal infection, acne, rosacea & perioral dermatitis. Hypersensitivity to betamethasone products. Precautions: Extensive or prolonged use ,pregnancy,infant & children < 4 yr. Avoid contact with eyes. Use in patients 12 years of age younger. Interactions: No interaction found Adverse Reactions: Local skin atrophy, striae. systemic hypercorticism, folliculitis, hypertrichosis,acneiform eruptions, hypopigmentation, prioral & allergic contact dermatitis. Clobetasol Propionate 0.05 % Cream D e r m o v a t e - Trade Name
D07AD01133G1001XX (A) NEDL

System: Dermatology Indications: More resistant dermatoses eg. psoriasis, recalcitrant eczemas, lichen planus, discoid lupus erythematosus and other conditions which do not respond satisfactorily to less potent steroids. Dosage: Apply sparingly once dly or bd, changing to lower potency therapy as soon as condition is controlled. Max:50 g/week. Contraindications: Rosacea,acne vulgaris, skin lesions caused by viral, fungal & bacterial infections. Hypersensitivity to clobetasol or other corticosteroid. Precautions: Infants & child; prolonged & continuous use; pregnancy ,avoid contact with eyes. Do not use for greater than 2 consecutive weeks or with occlusive dressing. Interactions: No interaction found Adverse Reactions: Local atrophic skin changes, hypercorticism, burning, stinging, irritation and adrenal suppression. Clobetasol Propionate 0.05 % Ointment D e r m o v a t e - Trade Name
D07AD01133G5001XX (A)

System: Dermatology Indications: More resistant dermatoses eg. psoriasis, recalcitrant eczemas, lichen planus, discoid lupus erythematosus and other conditions which do not respond 158

satisfactorily to less potent steroids. Dosage: Apply sparingly once dly or bd, changing to lower potency therapy as soon as condition is controlled. Max:50 g/week. Contraindications: Rosacea,acne vulgaris, skin lesions caused by viral, fungal & bacterial infections. Hypersensitivity to clobetasol or other corticosteroid. Precautions: Infants & child; prolonged & continuous use; pregnancy ,avoid contact with eyes. Do not use for greater than 2 consecutive weeks or with occlusive dressing. Interactions: No interaction found Adverse Reactions: Local atrophic skin changes, hypercorticism, burning, stinging, irritation and adrenal suppression. Hydrocortisone 1 % & Neomycin 0.5 % Cream D07CA01952G1001XX (B) NEDL APPL System: Dermatology Indications: Inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Dosage: Apply to affected part bd-tds (occasionally may cause sensitisation to Neomycin). Contraindications: Viral diseases, bacteria and fungal infection, acne, rosacea & perioral dermatitis. Precautions: Extensive or prolonged use, pregnancy, infant & children < 4 yr. Avoid contact with eyes. Interactions: No interaction found Adverse Reactions: Dry skin,pruritus, irritation, mild to moderate transient burning/stinging and allergic contact dermatitis. Neomycin 0.5 % in Betamethasone 17 - Valerate 0.01 % Cream Neomycin 0.5 % in Betamethasone 17 - Valerate 0.1 % Cream B e t n o v a t e -N
- Trade Name

D07CC01947G1001XX (B)

D07CC01947G1002XX (A) NEDL

System: Dermatology Indications: Treatment of the following conditions where bacterial infection is present or likely to occur: eczemas, prurigo nodularis, psoriasis (excluding widespread plaque psoriasis), neurodermatoses, anal and genital intertrigo. Dosage: Apply sparingly to affected area bd - tds. (May cause sensitisation to Neomycin. Use with caution) Contraindications: Hypersensitivity to any of its component. Precautions: Superinfection may occur on prolonged use .Renal impairment Interactions: No interaction found Adverse Reactions: Skin sensitization or contact dermatitis. The sensitivity disappears when treatment is discontinued. 159

Neomycin 0.5 % in Betamethasone 17 - Valerate 0.01 % Ointment Neomycin 0.5 % in Betamethasone 17 - Valerate 0.1 % Ointment B e t n o v a t e -N
- Trade Name

D07CC01947G5001XX (B)

D07CC01947G5002XX (A) NEDL

System: Dermatology Indications: Treatment of the following conditions where bacterial infection is present or likely to occur: eczemas, prurigo nodularis, psoriasis (excluding widespread plaque psoriasis), neurodermatoses, anal and genital intertrigo. Dosage: Apply sparingly to affected area bd - tds. (May cause sensitisation to Neomycin. Use with caution). Contraindications: Hypersensitivity to any of its component. Precautions: Superinfection may occur on prolonged use .Renal impairment Interactions: No interaction found Adverse Reactions: Skin sensitization or contact dermatitis. The sensitivity disappears when treatment is discontinued. Salicylic Acid 1 - 2 % in Hydrocortisone 1 % Ointment
D07XA01952G5001XX (B) NEDL

System: Dermatology Indications: Seborrhoeic capitis. Dosage: Apply to affected areas. Contraindications: Hypersensitivity, use in children less than 2 years, diabetes with impaired circulation. Precautions: Avoid contact with eyes and other mucous membranes. Interactions: No interaction found. Adverse Reactions: Local irritation. Mometasone Furoate 0.1% Cream Elomet - Trade Name
D07XC03139G1001XX (A*)

System: Dermatology Indications: Steroid responsive dermatosis and vitiligo. Used where a potent steroid is required for short duration not more than 6 weeks. Dosage: Apply once daily to affected areas. Contraindications: Hypersensitivity to mometasone. Precautions: Systemic absorption may be increased if extensive body surface are treated. Long term use in infant and children. Avoid contact with eyes, pregnancy, lactation. Interactions: CYP3A4. Adverse Reactions: Burning, pruritus, skin atrophy, paraesthesia, tingling/stinging. 160

Copper Sulphate Crystal

D08A000183F9901XX (C) NEDL

System: Dermatology Indications: Wounds. Dosage: The tip of the crystal should be moistened by dipping in water and applied carefully to the lesion. Contraindications: Dermal hypersensitivity reactions. Precautions: Skin exposure may result in severe irritation. Interactions: No interaction found. Adverse Reactions: Severe irritant contact dermatitis and may produce systemic toxicity, especially if applied to injured skin as occurred when copper sulfate was previously used in burn treatment. Chlorinated Lime Solution & Buffered Acetate Solution Eusol -T
- Trade Name

D08A000999G9901XX (C)

System: Dermatology Indications: Wound or ulcer . Dosage: Apply to affected areas undiluted as a cleansing agent. Contraindications: Patients who have previously shown a hypersensitivity reaction. Precautions: Topically applied hypochlorites may dissolve blood clots and cause bleeding. Interactions: No interaction found. Adverse Reactions: Skin irritation. Acriflavine 0.1% Lotion
D08AA03000L6001XX (C) NEDL APPL

System: Dermatology Indications: Infected skin, lesions, cuts, abrasions, wounds and burns. Dosage: Apply undiluted tds to the affected part . Contraindications: Hypersensitivity to acriflavine compound. Precautions: Prolonged application, may stain skin, hair & fabric. Interactions: No interaction found. Adverse Reactions: Hypersensitivity to acriflavine compound. Aluminium Acetate 5 % Lotion System: Dermatology
D08AB00122L6001XX (A*)

161

Indications: Weeping eczema. Dosage: Use undiluted freshly prepared as soaks. Contraindications: Broken or irritated skin Precautions: Hypersensitivity to any component. Interactions: No interaction found Adverse Reactions: Hypersensitivity to any component. Chlorhexidine Gluconate 5 % Solution H i b i t a n e - Trade Name
D08AC02137L9901XX (C)NEDL

System: Dermatology Indications: i) Preoperative skin disinfection ii) Wounds or burns iii) Emergency disinfection of instruments. Dosage: i) & iii) I : 10 in 70 % Alcohol ii) 1 : 100 Contraindications: Hypersensitivity to any of its components. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: Mucosal irritation (discontinue if desquamation), reversible brown staining of teeth, parotid gland swelling. Chlorhexidine Gluconate 4% Scrub H i b i s c r u b - Trade Name
D08AC02137M9901XX (C) NEDL APPL

System: Dermatology Indications: Surgical hand scrub, pre-op skin prep. Dosage: Surgical hand disinfection: Apply 5ml to clean hands & forearms for 1 min. Rinse & repeat with another 5ml for a further 2 mins & then rinse & dry. General skin disinfection: Apply appropriate quantity to wet area & scrub for 1 min. Rinse thoroughly & dry. Contraindications: Hypersensitivity to chlorhexidine gluconate or any component of the formulation. Precautions: For external use only. Avoid contact w/ eyes & middle ear. Interactions: No interaction known. Adverse Reactions: Occasionally; irritative skin reactions, extremely rare; generalised allergic reactions. Chlorhexidine Gluconate 5% Soln 1:10 in 70%alcohol with lanolin as emollient D08AC52137L9901XX (C)NEDL H i b i s o l - Trade Name System: Dermatology Indications: To be used undiluted for hand and skin disinfections. 162

Dosage: Pre-op surgical hand disinfection: Spread 5ml throughly over both hands and forearms, rubbing vigorously. When dry apply a further 5ml & repeat procedure. Antiseptic hand disinfection on the ward: Spread 3ml throughly over the hands & wrist rubbing vigorously until dry. Disinfection of patient's skin: Prior to surgery, apply to a sterile swab & rub thouroughly over the operation site for a minimum of 2 mins. Contraindications: Hypersensitivity to chlorhexidine gluconate or any component of the formulation. Precautions: Avoid contact with eyes, brain meninges, body cavities, middle ear. Not for injection. Avoid prolonged skin contact. Allow to dry before proceeding. Interactions: No interaction found. Adverse Reactions: Occasionally, irritative skin reactions; extremely rare, generalised allergic reactions. Phenol 80 % w/w Liquid
D08AE03000L5001XX (C) NEDL APPL

System: Dermatology Indications: As disinfectant. Dosage: Use in various dilutions. Contraindications: Hypersensitivity. Precautions: Solutions containing phenol should not be applied to large areas of skin or large wounds since sufficient phenol may be absorbed to give rise to toxic symptoms. Phenol should not be used as a throat spray in patients with epiglottitis, or in children age under six years. Interactions: No interaction found. Adverse Reactions: Dermatitis and depigmentation appear to be the most common adverse effects. Diaphoresis may develop with systemic toxicity. Triclosan 2 % w/w Emulsion. Phisohex - Trade Name
D08AE04000L2001XX (A) NEDL

System: Dermatology Indications: Acne, pimples and minor skin infections. Dosage: Use tds - qid when the skin problem is active and daily after the problem has cleared up. Contraindications: Hypersensitivity to any component. Precautions: Avoid contact with eyes. Interactions: No interaction found. Adverse Reactions: Hypersensitivity to any component. Povidone Iodine 7.5% (eqvt. to 0.75% iodine) Scrub D08AG02000L9901XX (B)
NEDL

System: Dermatology Indications: 163

As preoperative scrub for hands and skin. Pre-op scrubbing by operating personnel. Dosage: Spread 5 ml over both hands and rub thoroughly for about 5 mins. Rinse thoroughly. Repeat if desired. Pre-op use on patient : Apply scrub and rub thoroughly for about 5 mins. Rinse off using a sterile gauze saturated with water. Contraindications: Hypersensitivity to iodine or any component of the formulation. Precautions: Highly toxic if ingested; sodium thiosulfate is the most effective chemical antidote; avoid contact with eyes; use with caution in infants and nursing women. Interactions: No interaction found. Adverse Reactions: Dermatologic: Rash, pruritus Local: Local oedema <1%; Systemic absorption in extensive burns causing iododerma, metabolic acidosis, renal impairment. Povidone Iodine 10% (eqvt. to 1% iodine) Solution D08AG02000L9902XX (B) NEDL System: Dermatology Indications: As a disinfectant. Dosage: Paint the area once or twice daily and allow to dry. Contraindications: Hypersensitivity to iodine or any component of the formulation. Precautions: Highly toxic if ingested; sodium thiosulfate is the most effective chemical antidote; avoid contact with eyes; use with caution in infants and nursing women. Interactions: No interaction found. Adverse Reactions: Dermatologic: Rash, pruritus; Local: Local oedema <1%; Systemic absorption in extensive burns causing iododerma, metabolic acidosis, renal impairment. Iodine 2.5 % Solution
D08AG03000L9901XX (C)

System: Dermatology Indications: Wound dressing. Dosage: Apply to skin undiluted once daily or bd without dressing. Contraindications: Hypersensitivity to iodine. Precautions: Hypersensitivity to iodine. Interactions: No interaction found. Adverse Reactions: Skin or mucous membrane irritation. Benzalkonium 0.01 % Cream Drapolene - Trade Name System: Dermatology Indications: 164
D08AJ01000G1001XX (B) NEDL APPL

Prevention and treatment of nappy rash. Dosage: Wash and dry baby's bottom. Apply by spreading the cream evenly paying particular attention to the fold of the skin, after every nappy change. Contraindications: Hypersensitivity to benzalkonium products. Precautions: May be adsorbed by contact lenses (do not use while lenses in). Interactions: No interaction found. Adverse Reactions: Dermatitis. Cetrimide 0.5 % Cream C e t a v l o n - Trade Name
D08AJ04000G1001XX (C)

System: Dermatology Indications: As shampoo and cleanser. Dosage: Apply to affected area. Contraindications: Hypersensitivity to cetrimide. Precautions: Hypersensitivity may occur if prolonged and repeated applications. Contact with the eyes, brain, meninges, and middle ear should be avoided. Cetrimide should not be used in body cavities or as an enema. Solutions of quaternary ammonium compounds should not be used for disinfection of soft contact lenses. Aqueous solutions of cetrimide or other quartenary ammonium disinfectants may be susceptible to contamination with microorganisms. To reduce this risk, a sterilised preparation should be used or where necessary, solutions must be freshly prepared at the recommended concentration and appropriate measures should be taken to prevent contamination during storage or dilution. Interactions: No interaction found. Adverse Reactions: Hypersensitivity to cetrimide after prolonged & repeated applications. Cetrimide 1 - 2 % Lotion. C e t a v l o n - Trade Name
D08AJ04000L6001XX (C)

System: Dermatology Indications: As shampoo and cleanser. Dosage: Apply to affected area. Contraindications: Hypersensitivity to cetrimide. Precautions: Hypersensitivity may occur if prolonged and repeated applications. Contact with the eyes, brain, meninges, and middle ear should be avoided. Cetrimide should not be used in body cavities or as an enema. Solutions of quaternary ammonium compounds should not be used for disinfection of soft contact lenses. Aqueous solutions of cetrimide or other quartenary ammonium disinfectants may be susceptible to contamination with microorganisms. To reduce this risk, a sterilised preparation should be used or where necessary, solutions must be freshly prepared at the recommended concentration and appropriate measures should be tak en to prevent 165

contamination during storage or dilution. Interactions: No interaction found. Adverse Reactions: Hypersensitivity to cetrimide after prolonged & repeated applications. Silver Nitrate 0.5 % Lotion
D08AL01221L6001XX (B) NEDL

System: Dermatology Indications: For use as antiseptic. Dosage: Apply undiluted to affected area for a limited period. Contraindications: Hypersensitivity to silver nitrate or any component of the formulation. Precautions: Hypersensitivity to silver nitrate or any component. Interactions: No interaction known. Adverse Reactions: Frequency not defined. Burning and skin irritation, staining of the skin. Benzoin Compound Tincture
D08AX00000L5001XX (C) NEDL

System: Dermatology Indications: Infected skin, lesions, cuts, abrasions, wounds and burns. Dosage: Apply undiluted to the skin. Apply to affected area 1 or 2 times daily. Duration therapy , may be weeks to months depending on the infection being treated. Contraindications: Hypersensitivity to any of its compound. Precautions: May result in mild irritation at the site of application. Interactions: No interaction found Adverse Reactions: Allergic reaction and dermatologic effects. Hydrogen Peroxide 20 vol Solution
D08AX01241L9901XX (C) NEDL

System: Dermatology Indications: Skin disinfection, particularly cleansing and deodorising wounds and ulcers Dosage: Children & Adults: Topical: 1.5% to 3% solution for cleansing wounds. Contraindications: Should not be used in abscesses Precautions: Large or deep wounds; avoid normal skin; bleaches fabric Interactions: No interaction found Adverse Reactions: Dermatologic: Bleaching effect on hair, irritating burn. Local: irritation of the buccal mucous membrane. Potassium Permanganate 1:10,000 Solution
D08AX06362L9901XX (C)

System: Dermatology Indications: Cleansing and deodorising suppurative eczematous reactions and wounds. Dosage: 166

As soaks or wet dressing 1 - 3 times dly or as required. Contraindications: Hypersensitivity to any component. Precautions: Avoid contact with eyes and other mucous membranes. Interactions: No interaction found. Adverse Reactions: Irritant to tissues and stain skin brown. Potassium Permanganate 1:20,000 Solution
D08AX06362L9902XX (B)

System: Dermatology Indications: Cleansing and deodorising suppurative eczematous reactions and wounds. Dosage: As a bath dly - bd or as required. Contraindications: Hypersensitivity to any component. Precautions: Avoid contact with eyes and other mucous membranes. Interactions: No interaction found. Adverse Reactions: Irritant to tissues and stain skin brown. Alcohol 70% Solution
D08AX08000L9901XX (C) NEDL

System: Dermatology Indications: Use as antiseptic and disinfectant. Dosage: Apply to the skin undiluted or when needed/required. Contraindications: Not known. Precautions: Pregnancy, nursing mothers, elderly. Interactions: Chlorpropamide, metronidazole, cefoperazone, cefoperazone/sulbactam and cefotaxime. Adverse Reactions: Mental impairment, gastro-intestinal disturbances, severe effec ts include respiratory depression, coma and death. Framycetin Sulphate 1 % impregnated in sterile gauze dressing S o f r a -t u l l e
D09AA01183M6001XX (A) NEDL
- Trade Name

System: Dermatology Indications: Wounds, burns, ulcers and other secondary infec ted skin conditions. Dosage: If necessary, the lesion should first be cleansed, then a single layer of impregnated gauze is applied & covered with a suitable dressing. If the lesion exudes profusely, change the dressings at least once dly. Contraindications: Hypersensitivity to framycetin products. Precautions: Prolonged use of framycetin may result in overgrowth of nonsusceptible organisms. Interactions: No interaction found Adverse Reactions: Neuromuscular blockade and respiratory paralysis, contact dermatitis, nephrotoxicity, ototoxicity. 167

Sulphur 5 - 10 % Ointment.

D10AB02000G5001XX (C)

System: Dermatology Indications: Scabies, seborrhoeic condition and acne. Dosage: Apply sparingly to affected area. Contraindications: Hypersensitivity to sulphur or sulphonamides. Precautions: Avoid contact with eyes & mucous membranes. Application to irritated or abraded skin. Discontinue use if signs of sensitization develop. Interactions: No interaction found Adverse Reactions: Topical application of sulphur can cause skin irritation and dermatitis has been reported following repeated application. Sulphur 2 % & Salicylic Acid 2 % Cream
D10AB02951G1001XX (C)

System: Dermatology Indications: Acne vulgaris and seborrhoeic dermatitis. Dosage: When used in scalp disorders, a small amount of cream should be rubbed gently into the roots of the hair. When used in skin disorders, the cream should be applied sparingly to the affected area. Apply once dly or eod until noticeable improvement, then once or twice a week. Contraindications: Hypersensitivity, use in children less than 2 yrs, diabetes with impaired circulation. Precautions: Avoid contact with eyes and other mucous membranes. Interactions: Concomitant topical use of sulphur and mercurial compounds can lead to the generation of hydrogen sulphide which has a foul odour and may stain the skin black. Adverse Reactions: Local irritation and dermatitis. Tretinoin 0.05 % Cream Tretinoin 0.1 % Cream R e t i n-A - Trade Name
D10AD01000G1001XX (A) NEDL D10AD01000G1002XX (A) NEDL

System: Dermatology Indications: Acne vulgaris and recalcitrant cases of acne (comedonal type). Dosage: Apply thinly to the affected area once dly or bd. Avoid exposure to sunlight. Duration of treatment : 8 - 12 wks is required before any noticeable response. Contraindications: Acute dermatitis, rosacea. Hypersensitivity to tretinoin or parabens. Precautions: Exposure to sunlight including sunlamp should be minimized. Avoid contact with eyes, mouth, angle of the nose & mucous membrane. Eczema, sunburn, pregnancy & lactation.Special caution is indicated in cases of simultaneous treatment with other preparations. Interactions: No interaction found. Adverse Reactions: Erythema, oedema, blistering; hypopigmentation or 168

hyperpigmentation, sensitivity to sunlight. Tretinoin 0.01% Gel R e t i n-A - Trade Name

D10AD01000G3001XX (A) NEDL

System: Dermatology Indications: Acne vulgaris, recalcitrant cases of acne (comedonal type). Dosage: Apply thinly to the affected area once dly or bd. Avoid exposure to sunlight. Duration of treatment : 8 - 12 wks. is required before any noticeable response. Contraindications: Acute dermatitis, rosacea, hypersensitivity to tretinoin or parabens. Precautions: Exposure to sunlight including sunlamp should be minimized. Avoid contact with eyes, mouth, angle of the nose & mucous membrane. Eczema, sunburn, pregnancy & lactation.Special caution is indicated in case of simultaneous treatment with other preparations. Interactions: No interaction found. Adverse Reactions: Erythema, oedema, blistering; hypopigmentation or hyperpigmentation, sensitivity to sunlight. Benzoyl Peroxide 5 % Gel Benzoyl Peroxide 10 % Gel Panoxyl - Trade Name
D10AE01241G3001XX (B) NEDL D10AE01241G3002XX (B) NEDL

System: Dermatology Indications: Mild, to moderate and maintenance therapy for acne vulgaris. Dosage: Apply sparingly once dly or bd. Contraindications: Hypersensitivity to benzoyl peroxide products Precautions: Avoid contact with eyes, mouth & other mucous membranes. May bleach dyed clothing & fabrics. Avoid unnecessary sun exposure. Interactions: No interaction found Adverse Reactions: Burning/stinging contact dermatitis ,redness . Azelaic Acid 20 % Cream S k i n o r e n - Trade Name
D10AX03000G1001XX (A*) NEDL

System: Dermatology Indications: Acne vulgaris. Dosage: Apply bd. Treatment should not exceed 6 mths. Contraindications: Hypersensitivity to propylene glycol and azelaic acid products. Precautions: Avoid contact with eyes. May cause hypopigmentation. Should not use with occlusive dressings or wrappings. Interactions: No interaction found Adverse Reactions: Occasionally, local skin irritation, pruritus, tingling feeling, burning/stinging. 169

Isotretinoin 10 mg Capsule Isotretinoin 20 mg Capsule R o a c c u t a n e - Trade Name

D10BA01000C1001XX (A*) D10BA01000C1002XX (A*) NEDL

System: Dermatology Indications: Only for treatment of i) Severe nodulo-cystic acne. ii) Acne conglobata . iii) Acne fulminans. iv) Severe acne vulgaris failing conventional treatment WARNING: TH IS DRUG IS TERATOGENIC. Dosage: Initially : 0.5 mg/kg body wt with food once daily or two divided doses.. Maintenance : 0.1 - 1 mg/kg body wt dly. Contraindications: Pregnancy & lactation. Hepatic or renal insufficiency. Hypervitaminosis A. Patients with excessively elevated blood lipid values. Concomitant tetramycin therapy. Hypersensitivity to isotretinoin products or paraben. Precautions: Diabetes, obesity, alcoholism, disturbances of lipid metabolism and childbearing potential. Interactions: Concurrent use with vitamin A intensifies symptoms of hypervitaminosis A. Doxycycline, minocycline, tetracycline may result in pseudotumour cerebri. Ethanol - a disulfiram-like reaction. Food - Increases its bioavailability. Adverse Reactions: Dry mucosa; dermatitis facialis, pruritus, sweating. Occasionally, reversible alopecia, muscle & joint pain. Rarely, inflammatory bowel disease; hyperuricaemia; benign intracranial hypertension, visual disturbances & photosensitivity reactions. Haematuria/proteinuria, hirsutism, pancreatitis, lymphadenopathy. Selenium Sulphide 2.5 % Shampoo S e l s u n - Trade Name
D11AC03180L5201XX (A/KK) NEDL

System: Dermatology Indications: Tinea versicolor Dosage: Apply on the affected skin and leave it for 10 - 30 min dly then wash off; for 1-2 wks and then wash off. Alternatively leave it overnight then wash off, repeat once wkly for 6 wks. Contraindications: Acute inflammation or exudation, broken skin. Precautions: Avoid contact with eyes, mucous membranes, inflamed or broken skin, or to extensive areas of the skin. Interactions: No interaction found Adverse Reactions: Oiliness or dryness of hair & scalp; hair discoloration, cutaneous sensitization and alopecia.

170

Sodium Lauryl Sulphate Shampoo Teepol - Trade Name

D11AC30183L5201XX (C)

System: Dermatology Indications: Skin cleanser and has bacteriostatic action against gram-positive bacteria. Dosage: Use as shampoo. Contraindications: Hypersensitivity to any component. Precautions: Avoid contact with eyes and other mucous membranes. Interactions: No interaction found Adverse Reactions: No information available. Salicylic Acid, Lactic Acid and Oxypolyethoxydodicane Solution Collomack
D11AF00952L9901XX (A/KK)
- Trade Name

System: Dermatology Indications: Hardened skin, corns, collosities and warts. Dosage: One drop to be applied to the affected area bd. Contraindications: hypersensitivity ,use in children less than 2 yrs, diabetes impaired circulation. Precautions: Avoid contact with eyes and mucous membranes. Interactions: Concurrent use with varicella vaccine may result in an enhanced risk of developing Reye's syndrome. Adverse Reactions: local irritation Magnesium Sulphate 45 % Paste
D11AX05183G6001XX (C) NEDL

System: Dermatology Indications: Inflammatory skin conditions such as boils and carbuncles. Dosage: Apply under dressing. Contraindications: Hypersensitivity to magnesium sulfate Precautions: Avoid contact with eyes and other mucous membranes. Interactions: No interaction found Adverse Reactions: Prolonged or repeated use may damage the surrounding skin. Nystatin 100,000 units pessary Mycostatin - Trade Name System: Obstetrics, Gynaecology
G01AA01000S1001XX (B) NEDL APPL

171

Indications: Vaginal moniliasis. Dosage: Dosage : 100,000 - 200,000 units pessary at bedtime for 2 weeks. Contraindications: Hypersensitivity to nystatin products. Precautions: Not intended for ophthalmic use,to treat systemic mycoses. If hypersensitivity develops, discontinue use. Interactions: No interaction found. Adverse Reactions: Irritation and pain of the vulvovaginal areas. Tetracycline HCI 100 mg & Amphotericin B 50 mg Pessary Talsutin
G01AA03953S1001XX (A)NEDL
- Trade Name

System: Obstetrics, Gynaecology Indications: Monillia, trichomonas and bacterial vaginal infection. Dosage: Dosage : 1 pessary to be inserted high up into the vagina twice daily. Treatment to continue even during menstruation. Contraindications: Hypersensitivity, pregnancy. Precautions: Pregnancy, venereal disease with suspected co-existing syphilis. Therapy may result in overgrowth of non-susceptible organism including fungi. Interactions: No interations found. Adverse Reactions: Superinfection, burning & itching (hypersensitive individual). Clotrimazole 100mg Pessary C a n es t e n - Trade Name
G01AF02000S1001XX (B)

System: Obstetrics, Gynaecology Indications: Vaginal candidiasis Dosage: 200 mg pessary dly for 3 days. Recurrent cases : 100 mg pessary dly for 6 days. Refractory cases : 100 mg pessary for 14 days. Contraindications: Hypersensitivity to Clotrimazole Precautions: Monitor hepatic function in patients with pre-existing hepatic impairment,not for ophthalmic use and vaginal use in pregnant patients should be supervised by a physician. Interactions: Concurrent use with betamethasone may result in increased susceptibility to skin infection or enhanced organism growth. Concurrent use with tacrolimus may increase plasma concentration of tacrolimus and cause toxicity(nephrotoxicity, hyperglycaemia, hyperkalaemia). Adverse Reactions: Nausea and vomiting ,transient elevation in contact dermatitis. Tioconazole 6.5% Vaginal Ointment G y n o- T r o s y d - Trade Name System: Obstetrics, Gynaecology 172
G01AF08000G5001XX (A)

Indications: Vulvaginal candidiasis. Dosage: Apply 4.6 g prior to bedtime as a single dose therapy, therapy may extend to 7 days. Contraindications: Hypersensitivity to tioconazole or miconazole products. Precautions: Diabetes, pregnancy, HIV or AIDS. Interactions: No interactions found. Adverse Reactions: Burning, rash, erythema, itching. Tioconazole 100mg Vaginal Tablet G y n o- T r o s y d - Trade Name
G01AF08000S1001XX (A)

System: Obstetrics, Gynaecology Indications: Vulvovaginal candidiasis. Dosage: Insert nightly on retiring for 3-6 or 14 days. Contraindications: Hypersensitivity to tioconazole or miconazole products. Precautions: Diabetes, pregnancy, HIV or AIDS. Interactions: No interactions found. Adverse Reactions: Burning, rash, erythema, itching. Policresulen 360mg/g Concentrate A l b o t h y l - Trade Name
G01AX03900L9901XX (A)

System: Obstetrics, Gynaecology Indications: Local treatment of cervical and vaginal inflammation & tissue damage eg. discharge due to bacterial, trichomonal & fungal infections. Protrusions of endocervical mucosa (erosion), haemostasis following biopsy or excision of uterine polyps. Dosage: For cauterization, undiluted once or twice weekly whilst for vaginal douches, to be diluted 1 part concentrate to 5 parts of water. Contraindications: Concomitant use of other topical agents in treating the affected areas. Precautions: 1st trimester of pregnancy. Interactions: No interactions found. Adverse Reactions: Occasionally, mild local discomfort at beginning of treatment which disappears on discontinuation. Policresulen 90 mg Vaginal pessary A l b o t h y l - Trade Name System: Obstetrics, Gynaecology
G01AX03900S1001XX (A)

173

Indications: Local treatment of inflammation or infection and tissue damage of vagina and cervix (eg. discharge due to to bacterial, trichomonal and fungal infections, pressure sores from pressaries), condylomata acuminate. Dosage: Protrusions of endocervical murcosa (erosion), haemostasis following biopsy or uterine polyps, 90 mg supp. intravaginally on alternate days. Contraindications: Concomitant use of other topical agents in treating the affected areas. Precautions: First trimester of pregnancy. Interactions: No interactions found. Adverse Reactions: Occasionally, mild local discomfort at beginning of treatment which disappears on discontinuation. Ergometrine Maleate 0.5 mg/ml Injection
G02AB03253P3001XX (C+) NEDL

System: Obstetrics, Gynaecology Indications: Prevention and treatment of postpartum and postabortal haemorrhage due to uterine atony. Dosage: IM 200 - 1000 mcg and IV 250 - 500 mcg. Contraindications: Induction of labour, in cases of threatened spontaneous abortion, and in patients with a history of hypersensitivity or idiosyncratic reactions. Precautions: Exacerbations of porphyria. Not recommended for routine use prior to delivery of the placenta. Patients with heart disease, hepatic dysfunction, hypertension, mitral valve stenosis, obliterative vascular disease, renal impairment, sepsis or venoarterial shunts. Hyperstimulation of the uterus during labor. Patients with calcium deficiency. Interactions: Combined use of delavirdine and ergometrine may cause elevated ergometrine serum concentration. Avoid concomitant use with antivirals like indinavir,saquinavir etc. Adverse Reactions: Nausea and vomiting, abdominal pain, diarrhoea, headache, dizziness, tinnitus, chest pain , palpitations, bradycardia, dyspnoea, hypertension, hypersensitivity reactions and ergotism has been reported. Cardiovascular effects, including arrhythmias and myocardial infarction and bronchospasm. Ergometrine Maleate 0.5mg Tablet M e t r i n a - Trade Name
G02AB03253T1001XX (C+)

System: Obstetrics, Gynaecology Indications: Prevention and treatment of postpartum and postabortal haemorrhage due to uterine atony. Dosage: 0.5 - 1 mg. Contraindications: Induction of labour, in cases of threatened spontaneous abortion, and in patients with history of hypersensitivity or idiosyncratic 174

reations. Precautions: Exacerbations of porphyria. Not recommended for routine use prior to delivery of the placenta. Patients with heart disease, hepatic dysfunction, hypertension, mitral valve stenosis, obliterative vascular disease, renal impairment, sepsis or venoarterial shunts. Hyperstimulation of the uterus during labour. Patients with calcium deficiency. Interactions: Combined use of delavirdine and ergometrine may cause elevated ergometrine serum concentration. Avoid concomitant use with antivirals like indinavir,saquinavir etc. Adverse Reactions: Nausea and vomiting, abdominal pain, diarrhoea, headache, dizziness, tinnitus, chest pain, palpitations, bradycardia, dyspnoea, hypertension, hypersensitivity reactions and ergotism has been reported. Cardiovascular effects, including arrhythmias and myocardial infarction and bronchospasm. Oxytocin 5 units & Ergometrine Maleate 0.5mg/ml Injection Syntometrine
- Trade Name

G02AC01900P3001XX (C+) NEDL APPL

System: Obstetrics, Gynaecology Indications: i) Prevention & treatment of post partum haemorrhage. ii) Management of 3rd stage of labour. Dosage: i) Dose : 1 ml IM, may be repeated after 2 hrs. Should not exceed 3 ml within 24hrs. ii) For routine management of third stage of labour, 1 ml IM following delivery of the anterior shoulder or immediately after delivery of the child. Contraindications: Pregnancy, labour (except second stage following delivery of the anterior shoulder), severe hypertension, pre-eclampsia, eclampsia, severe disorders of cardiac, hepatic or renal function, occlusive vascular disease, sepsis. Precautions: Hypertension, cardiac, hepatic or renal disease. Should not be given until after delivery of child & in multiple births not until the last child has been delivered. Interactions: Vasoconstrictors, prostaglandins, halothane anaesthesia. Adverse Reactions: Gastrointestinal upsets, abdominal pain, headache, dizziness, skin rashes. Rarely hypertension, bradycardia, cardiac arrthymias, chest pain, anaphylactoid reactions. Dinoprost (Prostaglandin F2) 5 mg/ml Injection P r o s t i n F 2 - Trade Name System: Obstetrics, Gynaecology
G02AD01000P3001XX (A)

175

Indications: Induction of labour. Dosage: 0.0025 mg/min infused IV as solution containing 0.015 mg/ml for at least 30 min. For termination of pregnancy during 2nd trimester. 8ml is injected slowly into the amniotic sac. Contraindications: Cardiac/pulmonary/renal/hepatic disease, hypersensitivity to dinoprostone products, history of caesarean section/traumatic delivery, cephalopelvic disproportion, fetal distress. Precautions: Hypertension, syncope, convulsions and intrauterine foetal deaths. Interactions: Ergonovine, methylergonovine, oxytocin. Adverse Reactions: Vasoconstriction, hypotension and syncope, vasomotor reactions, chest pains, arrhythmias, vasospasm, seizures, galactorrhoea, nausea, vomiting, uterine laceration, bronchoconstriction. Dinoprostone (Prostagladine E2) 3mg Vaginal Tablet G02AD02000S1001XX (A)
APPL

P r o s t i n E 2 - Trade Name System: Obstetrics, Gynaecology Indications: Induction of labour by vagina. Dosage: 3 mg vaginal tablet to be inserted high into the posterior formix. A second 3 mg tablet may be inserted after 6-8 hrs if labour is not established. Max 6 mg. Contraindications: Hypersensitivity to dinosprostone, pelvic inflammatory disease, extrauterine pregnancy, cephalopelvic disproportion, fetal distress, placenta previa, hypertonic or hyperactive uterine patterns, unexplained vaginal bleeding during current pregnancy. Precautions: Glaucoma elevated IOP, asthma or history of asthma. Cephalopelvic relationships carefully evaluated prior to use. During use, uterine activity, fetal status and progression of cervical dilatation evaluated at frequent intervals. In patients with history of hypertonic uterine. Interactions: History of caesarean section or major uterine surgery; cephalopelvic disproportion, pre-existing fetal distress, history of difficult labour & or traumatic delivery. Adverse Reactions: GI upsets,uterine hypercontractility with or without fetal bradycardia, rapid cervical dilatation with low Apgar score, headache. Dinoprostone (Prostagladin E2) 0.5mg Tablet P r o s t i n E 2 - Trade Name
G02AD02000T1001XX (A)

System: Obstetrics, Gynaecology Indications: (i) Induction of labour, as an abortifacient, (ii) Postpartum haemorrhage (iii) Uterine atony. Dosage: By mouth, 0.5mg followed by 0.5 - 1mg (max 1.5mg) at hourly intervals. Contraindications: Hypersensitivity to dinoprostone, pelvic inflammatory 176

disease, extrauterine pregnancy, cephalopelvic disproportion, foetal distress, placenta previa, hypertonic or hyperactive uterine patterns, unexplained vaginal bleeding during current pregnancy. Precautions: Glaucoma elevated IOP, asthma or history of asthma. Cephalopelvic relationships carefully evaluated prior to use. During use,uterine activity, fetal status and the progression of cervical dilatation evaluated at frequent intervals. In patients with history of hypertonic uterine contractility or tetanic uterine contractions, recommended that the uterine activity and state of fetus be monitored throughout labour. Possible uterine rupture where high tone myometrial contractions are sustained. Interactions: History of caesarean section or major uterine surgery; cephalopelvic disproportion, pre-existing fetal distress, history of difficult labour & or traumatic delivery. Adverse Reactions: GI upsets, uterine hypercontractility with or without fetal bradycardia, rapid cervical dilatation with low Apgar score, headache. Gemeprost (Prostagladin E1 Synthetic Analogue) 1 mg Pessary Cervagem
G02AD03000S1001XX (A)
- Trade Name

System: Obstetrics, Gynaecology Indications: Inducing abortion in the first trimester. Dosage: Cervical dilatation: 1 pessary 3 hrly before surgery to a max of 5 pessaries over 24 hrs. Contraindications: Hypersensitivity to Gemeprost or other prostagladin derivatives. Acute pelvic inflammatory disease and uterine scars. Induction of labour or cervical softening at term. Precautions: Suction and curettage equipment must be available when Gemeprost-induced abortion is incomplete. Patients with history of asthma. Acute vaginitis. Ulcerative colitis,cardiovascular disease,renal or hepatic disease. Patients with hypertension or hypotension. Interactions: No interactions found. Adverse Reactions: Vaginal bleeding,mild uterine pain, GI disturbances,headche,muscle weakness,dizziness,flushing,chills,backache,dyspnoea,chest pain,palpitations and mild pyrexia. Anapylactic reactions (rare). Carboprost Tromethamine 250 mcg. Injection H e m a b a t e - Trade Name System: Obstetrics, Gynaecology
G02AD04999P3001XX (A*)

177

Indications: Postpartum haemorrhage refractory to oxytocin. Dosage: Adult : by deep IM inj., 250 mcg ; may repeat at 15-90 min. intervals to a total dose of 2 mg (8 doses), followed by subsequent doses of 250 mcg at intervals of 1.5 to 3.5 hours. Dosage may be increased to 500mcg/dose if contractility is inadequate. Contraindications: Hypersensitivity to prostagladin, acute pelvic inflammatory disease, cardiac, renal, pulmonary, or hepatic disease. Precautions: Glaucoma, elevated IOP, asthma or history of asthma. Interactions: No interaction found. Adverse Reactions: Nausea, vomiting and diarrhoea, paraesthesia, fever/chills, dystonia, breast tenderness, hyperthermia and flushing, bronchospasm, cardiovascular collapse. Copper 250 mm2 Intrauterine Device M u l t i l o a d M L C u - Trade Name
G02BA02000M9001XX (B)

System: Obstetrics, Gynaecology Indications: Contracepti on. Dosage: One unit intrauterine device to be inserted into the uterine cavity on the last day of the menstrual flow or in the first days afterwards. It is advised that the Multiload Cu 250 devices are replaced every 3 years. Contraindications: Pregnancy, ectopic pregnancy or predisposing factors, malformations or distortions of uterus or cervix, active pelvic inflammatory disease (PID), presence or history of venereal disease, infected abortion within 3 months, undiagnosed vaginal bleeding, coagulopathy, treatment with anticoagulant, disorders of copper -related. Precautions: Nulliparity, recent history of PID, epilepsy, medical diathermy of abdominal & sacral area, valvular heart disease, anaemia, severe dysmenorrhoea, uterine scars, endometrial polyps or endometriosis. Treatment with corticosteroids or NSAIDs. Interactions: No interactions found. Adverse Reactions: Uterine cramps & or abdominal pain, syncope, bradycardia, other neurovascular episodes during or immediately after insertion or removal of IUDs, breakthrough bleeding, prolongation of menstruation, dysmenorrhoea, back & leg pain, dyspareunia, pelvic inflammatory disease (PID), abnormal vaginal discharge, perforated uterus or cervix, spontaneous abortion, septicaemia, ectopic pregnancy. Urticarial allergic skin reactions. Copper 375 mm2 Intrauterine Device M u l t i l o a d M L C u - Trade Name
G02BA02000M9002XX (B)

System: Obstetrics, Gynaecology Indications: Contraception. Dosage: One unit intrauterine device to be inserted into the uterine cavity on the last 178

day of the menstrual flow or in the first days afterwards. It is advised that the Multiload Cu 375 devices are replaced every 5 years. Contraindications: Pregnancy, ectopic pregnancy or predisposing factors, malformations or distortions of uterus or cervix, active pelvic inflammatory disease (PID), presence or history of venereal disease, infected abortion within 3 months, undiagnosed vaginal bleeding, coagulopathy, treatment with anticoagulant, disorders of copper -related. Precautions: Nulliparity, recent history of PID, epilepsy, medical diathermy of abdominal & sacral area, valvular heart disease, anaemia, severe dysmenorrhoea, uterine scars, endometrial polyps or endometriosis. Treatment with corticosteroids or NSAIDs. Interactions: No interactions found. Adverse Reactions: Uterine cramps & or abdominal pain, syncope, bradycardia, other neurovascular episodes during or immediately after insertion or removal of IUDs, breakthrough bleeding, prolongation of menstruation, dysmenorrhoea, back & leg pain, dyspareunia, pelvic inflammatory disease (PID), abnormal vaginal discharge, perforated uterus or cervix, spontaneous abortion, septicaemia, ectopic pregnancy. Urticarial allergic skin reactions. Levonorgestrel releasing intrauterine system M i r e n a - Trade Name
G02BA03000P1001XX (A*)

System: Obstetrics, Gynaecology Indications: Contraception.(Initial release rate of 20mcg/24hrs) Dosage: One unit IUD to be inserted into the uterine cavity within 7 days of the onset of menstruation or immediately after first trimester abortion. Postpartum insertion should be postponed until 6 weeks after delivery. One unit IUD is effective for 5 years. Contraindications: Active hepatic disease, active thrombophlebitis or thromboembolic disorders, haemorrhagic diathesis, carcinoma of the breast, pregnancy, undiagnosed abnormal uterine bleeding, undiagnosed abnormal genital bleeding, history of idiopathic intracranial hypertension, hypersensitivity. Precautions: Discontinue treatment if crescendo migraine or other symptoms indicating transient cerebral ischaemia, exceptionally severe headache, jaundice, marked increase of BP, unexplained loss of vision or other symptoms of retinal thrombosis occurs. Hormone dependent neoplasia including breast cancer, malignancies affecting the blood or leukaemias, severe arterial disease eg stroke or MI. Diabetics. In recurrent endometriosis, pelvic infections or if an acute infection does not respond to treatment within a few days, perforation, accidental pregnancy. Not a contraceptive of choice during lactation. Interactions: No interaction found. Adverse Reactions: Menstrual changes, lower abdominal pain, acne or other skin problems, backpain, mastalgia, headache, vaginal discharge, mood changes, nausea, edema, weight gain, decreas ed libido, sweating, hair loss, greasy hair, ectopic pregnancy, Pelvic Inflammatory Disease (PID), perforation of uterine wall, enlarged follicles may develop.

179

Ritodrine HCI 50 mg/5ml Injection Y u t o p a r - Trade Name

G02CA01110P3001XX (A)

System: Obstetrics, Gynaecology Indications: Prevention of preterm labour. Dosage: Dose : IV 0.05 mg/min to be gradually increased by 0.05 mg/min every 10-15 mins. IM inj : 10mg 4-6 hrly. Continue treatment for 12-48 hrs after ceased contraction. Contraindications: Antepartum haemorrhage due to any cause but particularly placenta praevia & abruption placenta. Eclampsia & severe pre-eclampsia, intra-uterine foetal deaths, chorioamnionitis, maternal cardiac disorder, hyperthyroidism and uncontrolled hypertension. Precautions: Patients with potential cardiac risks & cardiac abnormalities. Careful monitoring of patients with suspected cardiac disorder. Occult cardiac disease may be unmasked. Diabetics or those receiving potassium-depleting diuretics. Monitor patient's state of hydration, avoid fluid over load. Interactions: Corticosteroids , general anaesthesia. Other sympathomimetic amines, beta-adrenergic blocking drugs, anaesthesia used in surgery. Adverse Reactions: Pulmonary oedema (several cases reported with fatal results). Maternal and fetal heart can increase. Frenquently : nausea, vomiting, tremors, headache, erythema, nervousness, restlessness, jitterness, emotional upset, anxiety or malaise. Infrequently cardiac symptoms eg. chest pain or tightness with or without ECG abnormalities & cardiac arrhythmias. Impaired liver function. Ritodrine HCI 10 mg Tablet Y u t o p a r - Trade Name
G02CA01110T1001XX (A)

System: Obstetrics, Gynaecology Indications: Prevention of preterm labour. Dosage: 10 mg 30 min. before termination of IV, repeated every 2 hours for 24 hours, followed by 10 - 20 mg every 4 - 6 hours. Max. 120 mg daily. Contraindications: Antepartum haemorrhage due to any cause but particularly placenta praevia & abruption placenta. Eclampsia & severe pre-eclampsia, intra-uterine foetal deaths, chorioamnionitis, maternal cardiac disorder, hyperthyroidism and uncontrolled hypertension. Precautions: Patients with potential cardiac risks & cardiac abnormalities. Careful monitoring of patients with suspected cardiac disorder. Occult cardiac disease may be unmasked. Diabetics or those receiving potassium-depleting diuretics. Monitor patient's state of hydration, avoid fluid over load. Interactions: Corticosteroids, general anaesthesia. Other sympathomimetic amines, beta-adrenergic blocking drugs, anaesthesia used in surgery. Adverse Reactions: Pulmonary oedema (several cases reported with fatal results). Maternal and fetal heart can increase. Frenquently : nausea, vomiting, tremors, headache, erythema, nervousness, restlessness, jitterness, emotional 180

upset, anxiety or malaise. Infrequently cardiac symptoms eg. chest pain or tightness with or without ECG abnormalities & cardiac arrhythmias. Impaired liver function. Bromocriptine Mesylate 2.5 mg Tablet P a r l o d e l - Trade Name
G02CB01196T 1001XX (A/KK) NEDL APPL

System: Endocrine Indications: i) Hypogonadism / Galactorrhoea ii) Acromegaly Dosage: i) Initially 1 - 1.25 mg at bedtime increased gradually, usual dose: 7.5 mg dly in divided doses. Max. 30 mg dly. ii) 1.25 - 2.5 mg at bedtime for 3 days & may be increased by 1.25 - 2.5 mg every 3 - 7 days up to 30 mg a day in divided doses. Contraindications: Hypersensitivity to bromocriptine products, toxaemia of pregnancy, hypertension in post-partum & during puerperium. Precautions: Nursing mothers, children under 15-years-old, peptic ulcer disease, post- partum, puerperal women with high BP, CAD, psychic disorders, concomitant use of other ergot alkaloid. Fertility may be restored (contraception needed), malignancy excluded before use for benign breast disease, acromegalic patients with history of peptic ulceration. Interactions: Bromperidol may result in decreased therapeutic efficacy. Clarithromycin -elevations in serum levels of bromocriptine. Inhibit cyclosporin metabolism. Erythromycin - significantly increase the bioavailability of bromocriptine. Thioridazine - result in interference of the prolactin lowering effects of bromocriptine. Bromocriptine, may decrease the metabolism of sirolimus, tacrolimus -increase plasma concentrations of sirolimus and tacrolimus. Adverse Reactions: Hypotension,peripheral vasoconstriction, dyskinesias, fatigue, nausea, vomiting, constipation, drowsiness, confusion, psychomotor excitation, hallucinations, dyskinesias, dryness of the mouth, leg cramps, allergic skin reactions. On prolonged treatment, reversible pallor of fingers and toes. Bromocriptine Mesylate 5 mg Tablet P a r l o d e l - Trade Name
G02CB01196T1002XX (A/KK)

System: Endocrine Indications: i) Hypogonadism / Galactorrhoea ii) Acromegaly Dosage: i) Initially 1 - 1.25 mg at bedtime increased gradually, usual dose: 7.5 mg dly in divided doses. Max. 30 mg dly. ii) 1.25 - 2.5 mg at bedtime for 3 days & may be increased by 1.25 - 2.5 mg every 3 - 7 days up to 30 mg a day in divided doses. Contraindications: Hypersensitivity to bromocriptine products, toxaemia of pregnancy, hypertension post-partum & during puerperium. 181

Precautions: Nursing mothers, children under 15-years-old, peptic ulcer disease, post- partum, puerperal women with high BP, CAD, psychic disorders, concomitant use of other ergot alkaloid. Fertility may be restored (contraception needed), malignancy excluded before use for benign breast disease, acromegalic pts with history of peptic ulceration. Interactions: Bromperidol may result in decreased therapeutic efficacy. Clarithromycin-elevations in serum levels of bromocriptine. Inhibit cyclosporin metabolism. Erythromycin - significantly increase the bioavailability of bromocriptine. Thioridazine - result in interference of the prolactin lowering effects of bromocriptine. Bromocriptine, may decrease the metabolism of sirolimus, tacrolimus -increase plasma concentrations of sirolimus and tacrolimus. Adverse Reactions: Hypotension, peripheral vasoconstriction, dyskinesias, fatigue, nausea, vomiting, constipation, drowsiness, confusion, psychomotor excitation, hallucinations, dyskinesias, dryness of the mouth, leg cramps, allergic skin reactions. On prolonged treatment, reversible pallor of fingers and toes. Bromocriptine Mesylate 10 mg Tablet P a r l o d e l - Trade Name
G02CB01196T1003XX (A/KK)

System: Endocrine Indications: i) Hypogonadism / Galactorrhoea ii) Acromegaly Dosage: i) Initially 1 - 1.25 mg at bedtime increased gradually, usual dose: 7.5 mg dly in divided doses. Max. 30 mg dly. ii) 1.25 - 2.5 mg at bedtime for 3 days & may be increased by 1.25 - 2.5 mg every 3 - 7 days up to 30 mg a day in divided doses. Contraindications: Hypersensitivity to bromocriptine products, toxaemia of pregnancy, hypertension post-partum & during puerperium. Precautions: Nursing mothers, children under 15-years-old, peptic ulcer disease, post- partum, puerperal women with high BP, CAD, psychic disorders, concomitant use of other ergot alkaloid. Fertility may be restored (contraception needed), malignancy excluded before use for benign breast disease, acromegalic patients with history of peptic ulceration. Interactions: Bromperidol may result in decreased therapeutic efficacy. Clarithromycin -elevations in serum levels of bromocriptine. Inhibit cyclosporin metabolism. Erythromycin - significantly increase the bioavailability of bromocriptine. Thioridazine - result in interference of the prolactin lowering effects of bromocriptine. Bromocriptine, may decrease the metabolism of sirolimus, tacrolimus -increase plasma concentrations of sirolimus and tacrolimus. Adverse Reactions: Hypotension, peripheral vasoconstriction, dyskinesias, fatigue, nausea, vomiting, constipation, drowsiness, confusion, psychomotor excitation, hallucinations, dy skinesias, dryness of the mouth, leg cramps, allergic skin reactions. On prolonged treatment, reversible pallor of fingers and toes. 182

Desogestrol 150 mcg & Ethinyloestradiol 30 mcg Tablet Marvelon

G03AB05954T1001XX (C)
- Trade Name

System: Obstetrics, Gynaecology Indications: Contraception. Dosage: One tablet daily for 21 days; subsequent courses repeated after 7 day interval (during which withdrawal bleeding occurs). Contraindications: Thromboembolic disorders, CAD, breast/ endometrial cancer, estrogen-dependent neoplasia, undiagnosed abnormal vaginal bleeding, cholestatic jaundice of pregnancy, hepatic adenomas/carcinomas, known/suspected pregnancy. Precautions: Gastrointestinal disease (impaired absorption of oral contraceptive steroids in the small bowel due to inflammatory disease, diarrhoea, ileostomy or jejunoileal bypass may result in contraceptive failure). Severe varicose veins, hepatic cell adenoma, latent or overt cardiac failure, renal dysfunction, epilepsy, migraine, hypertension, diabetes, smoking, surgery or prolonged immobilization. Interactions: Irregular bleeding and reduced efficacy with anticonvulsant, barbiturates, tetracyclines, rifampicin, activated charcoal, certain laxatives, antidiabetic drugs. Monitor patients receiving alprazolam therapy for an increased response to the benzodiazepine. Adverse Reactions: Thromboembolic disease, hypertension, myocardial infarct, gall bladder disease, nausea, vomiting, migraine. Norethisterone 0.35 mg Tablet Noriday - Trade Name
G03AC01000T1001XX (C)

System: Obstetrics, Gynaecology Indications: Contraception. Dosage: Dose : One tablet daily starting on the first day of the menstrual bleeding. Contraindications: Hypersensitivity,breast carcinoma, liver disease or dysfunction, pregnancy, incomplete abortion, abnormal and undiagnosed vaginal bleeding, active/history of thromboembolic disease, thrombophlebitis, hypercoagulable state . Cerebral vascular or coronary artery diseases. Precautions: Gastrointestinal disease (impaired absorption of oral contraceptive steroids in the small bowel due to inflammatory disease, diarrhoea, ileostomy, or jejunoileal bypass may result in contraceptive failure). Interactions: Effectiveness may be reduced by antibiotics, phenytoin, carbamazepine, barbiturates, rifampicin. Adverse Reactions: GI distress, oedema,menstrual disorders,dermatologic effects,nausea,fatique,depression,acne,hirsutism,breast tenderness,thromboembolic phenomena,galactorrhoea,decreased glucose tolerance,anaphylaxis,corticoid-like reaction (high doses). 183

Norethisterone Enanthate 200 mg/ml Injection Noristerat - Trade Name

G03AC01257P3001XX (B)

System: Obstetrics, Gynaecology Indications: Contraception. Dosage: By deep IM injection only. First injection is within first 5 days of the cycle. The next 3 injections are given at 8 weeks interval after which the injection interval should be extended to 12 weeks. Contraindications: Pregnancy, thromboembolic diseases, hypertension, acute and severe chronic liver disease, existing or treated breast or uterine cancers, severe diabetes with vascular changes, history of or existing liver tumours, disturbances of lipid metabolism, history of herpes of pregnancy, idiopathic jaundice. Precautions: Benign and rarely, malignant liver tumours which may lead to life-threatening intra-abdominal haemorrhage have been observed. If severe upper abdominal complaints, liver enlargement or signs of intra- abdominal haemorrhage occur, a liver tumour should be considered. Porphyria, diabetes, smoking, age, sickle-cell anaemia, history of phlebitis or thromboembolic diseases,impaired liver function, history of extrauterine pregnancy if one tube is missing. Interactions: Action may be impaired by barbiturates, phenylbutazone, hydantoins, rifampicin & ampicillin. Adverse Reactions: Nausea, headache, dizziness, depressive moods, spotting, breakthrough bleeding, amenorrhoea, rarely weight gain. Medroxyprogesterone Acetate 150 mg/3ml Injection G03AC06122P3001XX (B) P r o v e r a / F a r l u t a l - Trade Name System: Obstetrics, Gynaecology Indications: Prevention of pregnancy and to provide long term contraception. Dosage: To be administered every 3 monthly. Contraindications: Thromboembolic disorders,liver disease, breast/genital cancer, undiagnosed abnormal vaginal bleeding, known/suspected pregnancy, hypersensitivity to medroxyprogesterone products. Precautions: Depression, epilepsy, migraine, asthma, diabetes, cardiac or renal dysfunction, fluid retention,thromboembolic disorders, cerebral apoplexy. Interactions: Concurrent use with aminoglutethimide may result in decreased medroxyprogesterone efficacy. Concurrent use with nevirapine may result in loss of contraceptive efficacy. Concurrent use with succinylcholine may result in prolongation of neuromuscular blockade. Adverse Reactions: GI distress, oedema, menstrual disorders, dermatologic effects.

184

Testosterone Enanthate 250 mg/ml Injection T e s t o v i r o n -Depot - Trade Name

G03BA03257P3001XX (A*)

System: Endocrine Indications: Only for treatment of male infertility, protein deficiency during convalescence after surgery and wasting disorder. In women, supplementary therapy of progressive mammary carcinoma. Dosage: By IM only. Hypogonadism 250 mg every 2-3 weeks. To maintain an adequate androgenic effect 250 mg every 3-6 weeks. Potency disorders 250 mg every 4 weeks. Male climateric disorders: 250 mg every 3-4 weeks. Repeated 6-8 weeks courses at 2-3 months interval. Aplastic anaemia: 250 mg 2-3 times/week. Contraindications: Hypersensitivity to testosterone, males with breast carcinoma, androderm therapy has not been evaluated in women and must not be used in women. Testosterone may cause foetal harm. Extensive cardiac, hepatic, or renal disease. History of or existing hepatic tumour. Precautions: Geriatric patient, healthy males with delayed puberty, benign prostatic hyperthrophy, priapism and or excessive sexual stimulation may develop, oligospermia may occur with prolonged administration or excessive dosage. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage, a liver tumour should be taken into consideration. Development of hypercalcaemia in female patients (stop treatment). Interactions: An increased risk of cyclosporin toxicity (renal dysfunction, cholestasis, paraesthesias), concurrent use with dicumarol may result in bleeding. Adverse Reactions: Oedema, signs of virilisation in women, inhibition of spermatogenesis. Oestradiol Valerate 1 mg Tablet P r o g y n o v a - Trade Name
G03CA03256T1002XX (A*)

System: Obstetrics, Gynaecology Indications: Oestrogen replacement therapy - only those who cannot tolerate Premarin. Dosage: 1 mg daily continuously or 21 day regimen with 1 week of tablet free interval. Contraindications: Severe liver disease, breast cancer(except metatastic disease), oestrogen-dependent neoplasia, known/suspected pregnancy, undiagnosed abnormal vaginal bleeding, thromboembolic disorders. Precautions: Associated with adverse lipoprotein metabolism, impairment of glucose tolerance, possible enhancement of mitotic activity in breast epithelial tissue. Hypercoagulability, familial hyperlipoproteinaemia, fluid retention, uterine bleeding and mastodynia, impaired liver function and aspirin hypersensitivity (tartazine dye). Interactions: Barbiturates, phenylbutazone, hydantoins, rifamcipin & ampicillin may impair action of the drug. Requirements for oral antidiabetics & insulin can 185

change. Adverse Reactions: Headache, nausea, hypertension, MI, thromboembolism, vaginal bleeding, breast tension, increase in body weight. Conjugated Oestrogens 0.625mg/g cream P r e m a r i n - Trade Name
G03CA57000G1001XX (A) NEDL

System: Obstetrics, Gynaecology Indications: Atrophic vaginitis and post menopausal atrophic urethritis. Dosage: Intravaginally or topically 2 - 4 g daily depending on severity of condition. Total dose not exceeding 4 g. Administration should be cyclic, with 3 wks on conjugated oestrogens and one week off. Oestrogens should be used for the shortest duration possible when treating atrophic vaginitis. Every 3 to 6 months attempts should be made to taper or discontinue therapy, and conjugated oestrogens should be titrated to give the lowest possible dosage to control symptoms. Contraindications: Oestrogen-dependent neoplasia, known/suspected pregnancy, undiagnosed abnormal vaginal bleeding, thromboembolic disorders, neuro-ophthalmologic vascular disease, breast cancer (except metastatic disease therapy). Precautions: Systemic absorption may occur. Precautions as for oral premarin should be considered. Interactions: No interactions found. Adverse Reactions: Nausea, abdominal cramp, oedema, rash. Conjugated Oestrogens 0.625 mg Tablet P r e m a r i n - Trade Name
G03CA57000T1001XX (A)NEDL

System: Obstetrics, Gynaecology Indications: i) Osteoporosis. ii) Female hypoestrogenism. iii) Vasomotor symptoms/atrophic vaginitis & urethritis. Dosage: i) 0.625 mg daily. ii) 0.3 - 1.25 mg daily. iii) 0.3 - 1.25 mg daily. Contraindications: Oestrogen-dependent neoplasia, known/suspected pregnancy, undiagnosed abnormal vaginal bleeding. Precautions: Familial hyperlipoproteinaemia, uterine bleeding and mastodynia, uterine fibroids, impaired liver function, fluid retention, hypocalcaemia and renal insufficiency, addition of a progesterone for seven or more days of a cycle of oestrogen administration have reported a lowered incidence of endometrial hyperplasia, gall bladder disease, patient who have been treated for endometrial carcinoma, endometriosis, patient with pre-existing hypertension, fibrocystic disease of the breast, migraine headache, uterine leiomyoma. Interactions: Rifampicin may reduce effectiveness. Adverse Reactions: Nausea, endometrial cancer (postmenopausal), oedema, 186

weight changes, breast changes, headache migraine, steepening of corneal curvature, changes in libido, change in menstrual flow, vomiting, aggravation of porphyria, cholestatic jaundice, alopecia, breakthrough bleeding, spotting, amenorrhoea, bloating, dizziness. Conjugated Oestrogens 1.25 mg Tablet P r e m a r i n - Trade Name
G03CA57000T1002XX (A)NEDL

System: Obstetrics, Gynaecology Indications: i) Osteoporosis. ii) Female hypoestrogenism. iii) Vasomotor symptoms/atrophic vaginitis & urethritis. Dosage: i) 0.625 mg daily. ii) 0.3 - 1.25 mg daily. iii) 0.3 - 1.25 mg daily. Contraindications: Oestrogen-dependent neoplasia, known/suspected pregnancy, undiagnosed abnormal vaginal bleeding. Precautions: Familial hyperlipoproteinaemia, uterine bleeding and mastodynia, uterine fibroids, impaired liver function, fluid retention, hypocalcaemia and renal insufficiency, addition of a progesterone for seven or more days of a cycle of estrogen administration have reported a lowered incidence of endometrial hyperplasia, gall bladder disease, patient who have been treated for endometrial carcinoma, endometriosis, patient with pre-existing hypertension, fibrocystic disease of the breast, migraine headache, uterine leiomyoma. Interactions: Rifampicin may reduce effectiveness. Adverse Reactions: Nausea, endometrial cancer (postmenopausal), oedema, weight changes, breast changes, headache migraine, steepening of corneal curvature, changes in libido, change in menstrual flow, vomiting, aggravation of porphyria, cholestatic jaundice, alopecia, breakthrough bleeding, spotting, amenorrhoea, bloating, dizziness. Conjugated Oestrogens 0.3 mg Tablet P r e m a r i n - Trade Name
G03CA57000T1003XX (A)NEDL

System: Obstetrics, Gynaecology Indications: i) Osteoporosis. ii) Female hypoestrogenism. iii) Vasomotor symptoms/atrophic vaginitis & urethritis. Dosage: i) 0.625 mg daily. ii) 0.3 - 1.25 mg daily. iii) 0.3 - 1.25 mg daily. Contraindications: Oestrogen-dependent neoplasia, known/suspected pregnancy, undiagnosed abnormal vaginal bleeding. Precautions: Familial hyperlipoproteinaemia, uterine bleeding and mastodynia, uterine fibroids, impaired liver function, fluid retention, hypocalcaemia and renal insufficiency, addition of a progesterone for seven or more days of a cycle of 187

oestrogen administration have reported a lowered incidence of endometrial hyperplasia, gall bladder disease, patient who have been treated for endometrial carcinoma, endometriosis, patient with pre-existing hypertension, fibrocystic disease of the breast, migraine headache, uterine leiomyoma. Interactions: Rifampicin may reduce effectiveness. Adverse Reactions: Nausea, endometrial cancer (postmenopausal), oedema, weight changes, breast changes, headache migraine, steepening of corneal curvature, changes in libido, change in menstrual flow, vomiting, aggravation of porphyria, cholestatic jaundice, alopecia, breakthrough bleeding, spotting, amenorrhoea, bloating, dizziness. Medroxyprogesterone Acetate 5mg Tablet G03DA02122T1001XX (B) NEDL APPL Medroxyprogesterone Acetate 10mg Tablet G03DA02122T1002XX (B)NEDL P r o v e r a / F a r l u t a l - Trade Name System: Obstetrics, Gynaecology Indications: i) Secondary amenorrhoea. ii) Abnormal uterine bleeding due to hormonal imbalance. Dosage: i) 5-10mg daily for 5-10 days. To produce optimum secretory transformation 10 mg daily for 10 days. ii) 5-10mg daily for 5-10 days on day 15-21 of menstrual cycle. Optimum secretory transformation 10 mg daily for 10 days from day 15 of the cycle. Contraindications: Thromboembolic disorders, liver disease, known or suspected malignancy of breast/genital organs, undiagnosed abnormal vaginal bleeding, known/suspected pregnancy, hypersensitivity to medroxyprogesterone products. Precautions: Depression, diabetes, epilepsy, migraine, asthma. Interactions: Aminoglutethimide, rifampicin. Adverse Reactions: GI distress, oedema, menstrual disorders, dermatologic effects, nausea, fatique, depression, acne, hirsutism, breast tenderness, thromboembolic phenomena, galactorrhoea, decreased glucose tolerance, anaphylaxis, corticoid-like reaction (high doses). Hydroxyprogesterone Caproate 250mg/ml Injection G03DA03128P2001XX (A) Proluton -Depot - Trade Name System: Endocrine Indications: Habitual and threatened abortion. Dosage: 250 - 500 mg once wkly by IM injection. Contraindications: Sensitivity to hydroxyprogesterone, carcinoma of the breast (known or suspected), undiagnosed genital bleeding, missed abortion, history of thrombophlebitis & thromboembolic disorders, history of cerebral apoplexy, genital malignancy, liver tumours, history of herpes of pregnancy. Precautions: Asthma, migraine, epilepsy, cardiac dysfunction, renal dysfunction, history of psychic depression, hepatic and endocrine tests maybe altered during treatment. Benign & rarely malignant liver tumour which may 188

lead to life-threatening intra-abdominal haemorrhage had been observed. Interactions: Requirements for oral antidiabetics & insulin can change. Adverse Reactions: Oedema, thrombophlebitis, mental depression, weight changes, abdominal cramps, anorexia, bloating, nausea, vomiting, cervical secretions, mentrual disorders, cholestatic jaundice, pulmonary embolism, rash. Dydrogesterone HCI 10 mg Tablet D u p h a s t o n - Trade Name
G03DB01110T1001XX (A/KK)

System: Obstetrics, Gynaecology Indications: i) Dysmenorrhoea. ii) Endometriosis. iii) Dysfunctional uterine bleeding (to arrest & to prevent bleeding). iv) Threatened abortion. v) Habitual abortion. vi) Post menopausal complaints (hormone replacement therapy in combination with oestrogen). Dosage: i) 10 mg bd from day 5 - 25 of cycle. ii) 10 mg bd - tds from day 5 - 25 of the cycle or continuously. iii) To arrest bleeding :10 mg bd with an oestrogen once daily for 5 - 7 days , To prevent bleeding : 10 mg bd with an oestrogen once daily from day 11 - 25 of the cycle. iv) 40 mg at once, then 10mg 8hrly until symptoms remit. v) 10 mg bd until 20th week of pregnancy. vi) 10-20 mg daily during last 12-14 days of each cycle. Contraindications: Breast and genital cancers, abnormal vaginal bleeding. Precautions: Pregnancy. Interactions: Enzyme-inducing drugs such as carbamazepine, griseofulvin, phenobarbitone, phenytoin and rifampicin may enhance the clearance of progesterone. Progesterone may inhibit cyclosporin metabolism leading to increased plasma-cyclosporin. Adverse Reactions: Breakthrough bleeding, altered liver function, angioedema, haemolytic anaemia. Tibolone 2.5mg Tablet Livial - Trade Name
G03DC05000T1001XX (A*)

System: Obstetrics, Gynaecology Indications: Complaints resulting from natural or surgical menopause and in cases at high risk for breast carcinomas where general hormone replacement therapy is contraindicated. Dosage: Dose: 2.5 - 5mg dly. Contraindications: Hypersensitivity to tibolone, breast cancer (known or suspected), oestrogen-dependent neoplasms, cerebrovascular disease, history of stroke, arterial disease, thromboembolic disorders, history of cholestatic 189

jaundice, hepatic tumours (benign or malignant),abnormal vaginal bleeding. Precautions: Women with hormone dependent tumours, cardiovascular or cerebrovascular disorders including thrombophlebitis, thromboembolic processes or a history of these conditions, undiagnosed vaginal bleeding and severe liver disorders. Liver disease. Patients with hypercholesterolaemia and impaired glucose tolerance. Stop tibolone 4 weeks before elective surgery when prolonged immobilisation after surgery is likely. Interactions: Phenytoin, carbamazepine, and rifampicin may enchance the metabolism of tibolone and thus reduce its activity. Adverse Reactions: Endometrial hyperplasia and endometrial carcinoma (rare), change in body weight, vaginal bleeding, GI upsets, changes in liver parameters, increased facial hair growth and pre-tibial oedema. Oestradiol 1 mg & Norethisterone Acetate 0.5 mg Tablet Activelle
G03FA01122T1001XX (A*)
- Trade Name

System: Obs tetrics, Gynaecology Indications: Hormone replacement therapy for oestrogen deficiency symptoms in women > 1 year after menopause and prevention of osteoporosis in post menopausal women. Dosage: 1 tablet/day without interruption. Contraindications: Pregnancy & lactation, cancer of the breast, hormone dependent tumour, deep vein thrombosis, acute or chronic liver disease. Precautions: History of thrombosis, hypertension, diabetes, liver disorder, endometriosis. Interactions: Barbiturates, phenytoin, carbamazepine, ketoconazole. Adverse Reactions: Breast tenderness, headache, abdominal pain, nausea, flatulence, breast enlargement. Oestradiol Valerate 2mg & Norgestrel 0.5mg Tablet (calender pack x 21 Tablets) G03FA10953T1001XX (B) Progyluton - Trade Name System: Obstetrics, Gynaecology Indications: Pre & post menopausal syndrome, primary & secondary amenorrhea; menstrual irregularities. Deficiency symptoms after oophorectomy or radiological castration for noncarcinomatous disease. Dosage: Start on the 5th day of menstrual cycle - 1 tab daily x 21 days then stop for 7 days. If patient forgets dose at usual time,it should be taken within following 12 hrs. Contraindications: Known or suspected pregnancy, including use for missed abortion or as a diagnostic test for pregnancy. Oestrogen or progestin may cause foetal harm when administered to a pregnant woman. Known or suspected cancer of the breast. Known or suspected oestrogen -dependent neoplasm. 190

Precautions: Asthma, epilepsy, migraine, hypertension, cardiac or renal dysfunction, endometrial hyperplasia, metabolic bone diseases, endometrial cancer, breast cancer, gall bladder disease, pancreatitis, lactation. , surgery, liver disorders,enlargement of uterine fibromyomata. Interactions: Rifampicin, barbiturates, phenytoin, rifampicin, phenylbutazone,ampicillin. Requirements for oral antidiabetics & insulin can change. Adverse Reactions: Changes in vaginal bleeding pattern, change in amount of cervical secretion, premenstrual-like-syndrome, cystitis-like-syndrome, increase in size of uterine leiomyomata, vaginal candidiasis, amenorrhoea, changes in cervical erosion, nausea, cholestic jaundice, changes in appetite, vomiting, abdominal cramps, bloating, increased incidence of gall bladder disease, pancreatitis. Headache, dizziness, mental depression, nervousness, migraine. Increase or decrease in weight, oedema, changes in libido, fatigue, backache, reduced carbohydrate tolerance, aggravation of porphyria, pyrexia, anaphylactoid reactions. Conjugated Oestrogen 0.625mg (28 Tablet) & Medroxyprogesterone 5 mg (14 Tablet) G03FB06954T1001XX (A) P l e n t i v a C y c l e 5 - Trade Name System: Obstetrics, Gynaecology Indications: Cyclic continuous regular bleed Hormone Replacement Therapy for woman with uterus. Dosage: Conjugated oestrogens 0.625mg to be taken daily for 28 days and medroxyprogesterone acetate 5 mg to be taken on days 15 through 28. Contraindications: Known or suspected pregnancy, including use for missed abortion or as a diagnostic test for pregnancy. Oestrogen or progestin may cause fetal harm when administered to a pregnant woman. Known or suspected cancer of the breast. Known or suspected oestrogen-dependent neoplasm. Precautions: Asthma, epilepsy, migraine, hypertension, cardiac or renal dysfunction, endometrial hyperplasia, metabolic bone diseases, endometrial cancer, breast cancer, gall bladder disease, pancreatitis, lactation. Surgery,liver disorders, enlargement of uterine fibromyomata. Interactions: Rifampicin may reduce effectiveness. Adverse Reactions: Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, change in amount of cervical secretion, pre-menstrual-like-syndrome, cystitis-like-syndrome, increase in size of uterine leiomyomata, vaginal candidiasis, amenorrhoea, changes in cervical erosion. Nausea, cholestatic jaundice, changes in appetite, vomiting, abdominal cramps, bloating, increased incidence of gall bladder disease, pancreatitis. Headache, dizziness, mental depression, nervousness, migraine. Increase or decrease in weight, oedema, changes in libido, fatigue, backache, reduced carbohydrate tolerance, aggravation of porphyria, pyrexia, anaphylactoid reactions, anaphylaxis. Conjugated Oestrogens 0.625mg (28 Tablets) & Medroxyprogesterone 191

Acetate 5 mg (28 Tablets) P l e n t i v a 5 - Trade Name

G03FB06954T1002XX (A)

System: Obstetrics, Gynaecology Indications: Combined continuous no bleed Hormone Replacement Therapy for woman with uterus. Dosage: To be taken simultaneously once daily. Contraindications: Known or suspected pregnancy, including use for missed abortion or as a diagnostic test for pregnancy. Oestrogen or progestin may cause fetal harm when administered to a pregnant woman. Known or suspected cancer of the breast. Known or suspected oestrogen-dependent neoplasm. Precautions: Asthma, epilepsy, migraine, hypertension, cardiac or renal dysfunction, endometrial hyperplasia, metabolic bone diseases, endometrial cancer, breast cancer, gall bladder disease, pancreatitis, lactation. Surgery,liver disorders, enlargement of uterine fibromyomata. Interactions: Rifampicin may reduce effectiveness. Adverse Reactions: Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, change in amount of cervical secretion, pre-menstrual-like-syndrome, cystitis-like-syndrome, increase in size of uterine leiomyomata, vaginal candidiasis, amenorrhoea, changes in cervical erosion. Nausea, cholestatic jaundice, changes in appetite, vomiting, abdominal cramps, bloating, increased incidence of gall bladder disease, pancreatitis. Headache, dizziness, mental depression, nervousness, migraine. Increase or decrease in weight, oedema, changes in libido, fatigue, backache, reduced carbohydrate tolerance, aggravation of porphyria, pyrexia, anaphylactoid reactions, anaphylaxis. Conjugated Oestrogen & Medrogestone Tablets (calendar pack of 31 Tablets) G03FB06954T1003XX (A) P r e m p a k - Trade Name System: Obstetrics, Gynaecology Indications: Moderate to severe vasomotor symptoms associated with menopause; osteoporosis, atrophic vaginitis, atrophic urethritis, female hypoestrogenism. Dosage: Given cylicly: 0.625 mg conjugated oestrogen tab daily for 21 days plus 5 mg medrogestone tab dly on days 12-21, followed by 7 tab - free days. Contraindications: Known or suspected pregnancy, including use for missed abortion or as a diagnostic test for pregnancy. Oestrogen or progestin may cause fetal harm when administered to a pregnant woman. Known or suspected cancer of the breast. Known or suspected oestrogen-dependent neoplasm. Precautions: Asthma, epilepsy, migraine, hypertension, cardiac or renal dysfunction, endometrial hyperplasia, metabolic bone diseases, endometrial cancer, breast cancer, gall bladder disease, pancreatitis, lactation. Surgery, liver disorders, enlargement of uterine fibromyomata. 192

Interactions: Rifampicin may reduce effectiveness. Adverse Reactions: Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, change in amount of cervical secretion, pre-menstrual like syndrome, cystitis-like syndrome, increase in size of uterine leiomyomata, vaginal candidiasis, amenorrhoea, changes in cervical erosion. Nausea, cholestatic jaundice, changes in appetite, vomiting, abdominal cramps, bloating, increased incidence of gall bladder disease, pancreatitis. Headache, dizziness, mental depression, nervousness, migraine, increase or decrease in weight, oedema, changes in libido, fatigue, backache, reduced carbohydrate tolerance, aggravation of porphyria, pyrexia, anaphylactoid reactions, anaphylaxis. Levonorgestrel 150 mcg & Ethinyloestradiol 30 mcg Tablet Rigevidon
G03FB09954T1001XX (C)
- Trade Name

System: Obstetrics, Gynaecology Indications: Contraception. Dosage: Dose : One tablet daily for 21 days from first day of the cycle, followed by 7 tabfree days. Contraindications: Thromboembolic disorders, cardiovascular disease, breast/endometrial cancer, oestrogen-dependent neoplasia, undiagnosed abnormal vaginal bleeding, cholestatic jaundice of pregnancy, hepatic adenomas/ carcinomas, known/suspected pregnancy. Precautions: Age, smoking, gall bladder disease, diabetes, hypertension, epilepsy, migraine, cardiac or renal dysfunction, history of depression, uterine fibroids, lactation. Gastrointestinal disease (impaired absorption of oral contraceptive steroids in the small bowel due to inflammatory disease). Interactions: Effectiveness may be reduced by antibiotics, phenytoin, carbamazepine, barbiturates, rifampicin. Adverse Reactions: Thromboembolic disease, hypertension, gall bladder disease, nausea, vomiting, migraine. Chorionic Gonadotrophin Human (HCG) 5000 IU Injection Pregnyl
G03GA01000P4001XX (A*)
- Trade Name

System: Obstetrics, Gynaecology Indications: Treatment of infertile women to induce ovulation, and as a luteal support in controlled ovarian hyperstimulation cycles. Dosage: Induction of ovulation: Female : 5000 - 10,000 units one day following last dose of menotropin. Up to 3 repeat injections of 5000 units each may be given within the following 9 days to prevent insufficiency corpus luteum. Contraindications: Androgen dependent neoplasia, prior allergic reaction to chorionic gonadotrophin, active thrombophlebitis. Precautions: Use of human gonadotrophin, either to induce ovulation or as a 193

luteal support, may increase the risk of ovarian hyperstimulation syndrome (OHSS). Interactions: When used with gonadotrophins (FSH), ovarian hyperstimulation syndrome, enlargement of ovarian cysts, or rupture of ovarian cysts and multiple births may occur. Adverse Reactions: Thromboembolism, oedema, headache, irritability, restlessness, depression and tiredness.Salt and fluid retention. Pain at injection site. Skin rashes. Chorionic Gonadotrophin Human (HCG) 10,000 IU Injection Pregnyl
G03GA01000P4002XX (A*)
- Trade Name

System: Obstetrics, Gynaecology Indications: Treatment of infertile women to induce ovulation, and as a luteal support in controlled ovarian hyperstimulation cycles. Dosage: Induction of ovulation: Female : 5000 - 10,000 units one day following last dose of menotropin. Up to 3 repeat injections of 5000 units each may be given within the following 9 days to prevent insufficiency corpus luteum. Contraindications: Androgen dependent neoplasia, prior allergic reaction to chorionic gonadotrophin, active thrombophlebitis. Precautions: Use of human gonadotrophin, either to induce ovulation or as a luteal support, may increase the risk of ovarian hyperstimulation syndrome (OHSS). Interactions: When used with gonadotrophins (FSH), ovarian hyperstimulation syndrome, enlargement of ovarian cysts, or rupture of ovarian cysts and multiple births may occur. Adverse Reactions: Thromboembolism, oedema, headache, irritability, restlessness, depression and tiredness. Salt and fluid retention. Pain at injection site. Skin rashes. Follicle-Stimulating Hormone (FSH) Human Urinary 150 IU & Luteinizing Hormone (LH) Human 150IU G03GA02954P4002XX (A*) P e r g o n a l - Trade Name System: Obstetrics, Gynaecology Indications: For anovulation in infertility where clomiphene has failed. To be used in conjuction with Human Chorionic Gonadotrophin. They are used mainly for women undergoing in vitro fertilization. Dosage: SC or IM Injection according to patient's response. Contraindications: Undiagnosed abnormal vaginal bleeding, intracranial bleeding, adrenal/thyroid disorders, preexisting ovarian cysts/ enlargement, primary ovarian/testicular failure, pituitary tumor, pregnancy. Precautions: Discontinue if the ovaries become enlarged or abdominal pain occurs. Special care should be exercised to monitor for pregnancy. During ovulation induction therapy and for a two-week period after therapy, patients 194

should be examined every other day for signs of excessive ovarian stimulation. Multiple births can occur. Interactions: No interaction found. Adverse Reactions: Adnexal torsion (with ovarian enlargement), ovarian cysts, flu-like symptoms, pulmonary/vascular complications. Follitropin Alpha (FSH Recombinant) 75IU Injection G03GA05000P3001XX (A*) Gonal F - Trade Name System: Obstetrics, Gynaecology Indications: Infertility treatment in anovulatory women who have been unresponsive to treatment with clomiphene citrate. Stimulation of follicular development for intra-uterine cycles Stimulation of follicular development in assisted reproductive technology in the management of infertility. Dosage: To be individualized. Give in multiples of 75iu. Contraindications: Pregnancy, lactation, ovarian enlargement or cyst not due to polycystic ovarian disease, gynaecological haemorrhages of unknown aetiology, ovarian, uterine or mammary carcinoma tumours of the hypothalamus & pituitary gland. Precautions: Evaluate patient for hypothyroidism, adrenocortical deficiency, hyperprolactinaemia & pituitary or hypothalamic tumours before starting therapy. Interactions: Other ovulation stimulation agents may potentiate the follicular response whereas concurrent use in GnRH agonist- induced pituitary desensitization may increase the dosage of Gonal-F needed to elicit an adequate ovarian response. Adverse Reactions: Fever, arthralgia, pain in lower abdominal region, nausea, vomiting and weight gain, ovarian hyperstimulation syndrome (OHSS), multiple pregnancy. Follitropin Beta (Recombinant Human FSH) 50IU Injection Puregon
G03GA06000P3001XX (A*)
- Trade Name

System: Obstetrics, Gynaecology Indications: Infertility treatment in anovulatory women who have been unresponsive to treatment with clomiphene citrate. Stimulation of follicular development for intra-uterine insemination cycles. Stimulation of follicular development in asssisted reproductive technology in the management of infertility. Dosage: To be individualized. Give in multiples of 50 iu. Starting dose can be 50 iu - 200 iu daily. It can be a step-up regime or a step-down, depending on the protocol and the ovarian response. Contraindications: Pregnancy, lactation, ovarian enlargement or cyst not due to polycystic ovarian disease, gynaecological haemorrhages of unknown 195

aetiology, ovarian, uterine or mammary carcinoma, tumours of the hypothalamus and pituitary gland. Precautions: Presence of uncontrolled non-gonadal endocrinopathies should be excluded. Interactions: Concomitant use with clomiphene citrate may enhance the follicular response. A higher dose may be needed after pituitary desensitization induced by a GnRH agonist. Adverse Reactions: Ovarian hyperstimulation, bruising, pain, redness, swelling & itching, ectopic pregnancy, multiple gestations, arteriothromboembolism. Clomiphene Citrate 50 mg Tablet C l o m i d - Trade Name
G03GB02136T1001XX (A) NEDL

System: Obstetrics, Gynaecology Indications: Anovulatory infertility. Dosage: 50 mg dly from 2nd - 6th or 5th - 9th day of menstrual cycle. Increase dose gradually by increments of 50mg if there is no response until a dosage of 200mg daily is achieved. Contraindications: Pregnancy, uncontrolled thyroid or adrenal dysfunction, liver disease, abnormal uterine bleeding, ovarian cysts, organic intracranial lesion. Precautions: Pelvic examination prior to initial treatment, ophthalmological evaluation in patients developing visual symptoms, multiple pregnancies can occur, ovarian hyperstimulation syndrome and abnormal ovarian enlargement may occur. Interactions: Danazol - results in inhibition of response to clomiphene. Ethinyl estradiol - results in suppression of response to ethinyl estradiol. When used concomitantly with gonadorelin acetate gonadotrophins (FSH), it may increase the risk of ovarian hyperstimulation syndrome (OHSS). Adverse Reactions: Blurred vision, vasomotor flushing, abdominal pain and ovarian enlargement (which may be part of the ovarian hyperstimulation syndrome). Cyproterone Acetate 50 mg Tablet A n d r o c u r - Trade Name
G03HA01122T1001XX (A*) APPL

System: Haematology/Oncology Indications: Carcinoma of prostate. Dosage: i) After orchidectomy, 100mg od or bd. ii) If used together with LHRH agonists, the initial dose is 100mg bd for 5 7 days before the start of LHRH agonist, then 100 mg bd for 3 4 weeks together with the LHRH agonist. Contraindications: Pregnancy, lactation, thromboembolic disorders, liver disease, severe diabetes with vascular changes. Precautions: Monitor liver function. 196

Interactions: Oral antidiabetics, insulin. Adverse Reactions: Tiredness, liver dysfunction, gynaecomastia. Cyproterone Acetate 2.0 mg & Ethinyloestradiol 0.035 mg Tablet Diane 35
G03HB01954T1001XX (A*)
- Trade Name

System: Obstetrics, Gynaecology Indications: Contraception. Dosage: One tablet daily for 21 days from the first day of the cycle, followed by 7 tabfree days. Contraindications: Pregnancy, lactation, severe disturbances of liver function, history of idiopathic jaundice or severe pruritus during pregnancy, previous or existing liver tumours, malignant diseases (not prostatic carcinoma), thromboembolic disorders, acute liver disease, hypersensitivity. Precautions: Diabetes, hypertension, varicose veins, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, chorea minor, history of phlebitis. Benign and rarely, malignant liver tumours which may lead to life-threatening intraabdominal haemorrhage have been observed. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be taken into consideration. Interactions: Barbiturates, phenylbutazone, hydantoins, rifampicin and ampicillin may impair the action of the drug. Requirements for oral antidiabetics & insulin can change. Adverse Reactions: Hepatotoxicity, anaemia, myocardial ischaemia, oedema, thromboembolic disease, headache, gastric upsets, nausea, breast tension, changes in body weight & libido, intermenstrual bleeding, depressive mood, chloasma, fluid retention. Danazol 100 mg Capsule Danazol 200 mg Capsule Ladogal - Trade Name
G03XA01000C1001XX (A/KK) NEDL APPL G03XA01000C1002XX (A/KK) NEDL APPL

System: Endocrine Indications: i) Endometriosis and gynaecomastia. ii) Menorrhagia. iii) Prophylaxis of hereditary angioedema. Dosage: i) 200 - 800 mg dly for max. of 9 mths. ii) 200 mg daily for 12 wks. iii) 400 mg daily. Reduce to 200 mg daily after 2 mths attack-free period. Contraindications: Undiagnosed abnormal vaginal bleeding, hepatic/ renal/cardiac dysfunction. Precautions: Haemophilia, epilepsy, migraine, or cardiac or renal dysfunction, require careful observation. Periodic liver function tests should be performed, exacerbation of acute intermittent porphyria. Interactions: Coadministration of oral anticoagulants has resulted in a 197

prolonged prothrombin time and haemorrhages. Carbamazepine - significant increases in carbamazepine levels which resulted in toxicity. Clomiphene result in inhibition of response to clomiphene. Cyclosporin- increased cyclosporin blood levels and toxicity. Sirolimus, Tacrolimus- decrease the metabolism, causing increased plasma concentrations of sirolimus and tacrolimus. Adverse Reactions: Hepatic dysfunction, weight gain, acne, menstrual disturbances. Gestrinone 2.5 mg Capsule D i m e t r i o s e - Trade Name
G03XA02000C1001XX (A)

System: Endocrine Indications: Treatment of endometriosis for patients who cannot tolerate Danazol. Dosage: 1 cap twice/week, initially dose should be given on the 1st day of menstruation, 2nd on the 4th day, continue treatment for 6 mths. Contraindications: Pregnancy, lactation, severe cardiac, renal or hepatic insufficiency, metabolic & or vascular disorders during previous oestrogen and or progestogen therapy. Precautions: Haemophilia, epilepsy, migraine or cardiac or renal dysfunction, require careful observation. Periodic liver function tests should be performed, exacerbation of acute intermittent porphyria. Interactions: Efficacy may be reduced by antiepileptic drugs, rifampicin and oral contraceptives. Adverse Reactions: May inhibit ovulation and menstrual irregularities suc h as breakthrough bleeding, androgenic side-effects include acne, oily skin, fluid retention, weight gain, hirsutism and voice change. Headache, gastrointestinal disturbances, increased liver enzyme values, altered libido, hot flushes, decreased breast size, nervousness, change in appetite, muscle cramp and depression may also occur. Raloxifene HCl 60mg Tablet E v i s t a - Trade Name
G03XC01110T1001XX (A*)

System: Obstetrics, Gynaecology Indications: Prevention and treatment of post menopausal osteoporosis. Dosage: 1 tablet daily. Contraindications: Women with child bearing potential, active thromboembolic disorder, pregnancy. Precautions: Elderly, excessive exercise, hypoglycaemia, breast cancer. Interactions: Ampicillin & Cholestyramine decrease Raloxifene absorption. Adverse Reactions: Has been associated with increased risk of thromboembolism (DVT, PE) and superficial thrombophlebitis. Hot flushes and leg cramps.

198

Flavoxate HCL 100 mg Tablet U r i s p a s - Trade Name

G04BD02110T1001XX (A)NEDL

System: Genitourinary Indications: Urinary frequency and incontinence, dysuria, urgency, bladder spasm due to catheterisation. Dosage: Adult : 200 mg tds. Child : under 12 yrs not recommended. Contraindications: Pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, GI haemorrhage, obstructive uropathies of the lower urinary tract, children < 12 yrs. Precautions: Pregnancy & lactation; suspected glaucoma. May affect ability to drive or operate machinery. Interactions: Other antimuscarinic drugs. Adverse Reactions: GI disturbances, vertigo, headache, mental confusion especially in elderly, drowsiness, fatigue & nervousness; tachycardia & palpitations, urticaria, eosinophilia & hyperpyrexia. Oxybutynin Chloride 5 mg Tablet D i t r o p a n - Trade Name
G04BD04110T1001XX (A*)

System: Genitourinary Indications: For the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (ie urgency, frequency, urinary leakage, urge incontinence, dysuria). Dosage: Adult : Initially 2.5 - 5 mg bd-tds increased if necessary to max. 5 mg qid. Elderly : Initially 2.5 - 3 mg bd, increased to 5 mg bd according to response and tolerance. Child over 5 yrs, neurogenic bladder instability : 2.5 - 3 mg bd increased to 5 mg bd (max. 5 mg tds). Contraindications: Glaucoma, GIT obstruction, paralytic ileus, intestinal atony, megacolon, toxic megacolon, ulcerative colitis, severe colitis, myasthenia gravis, obstructive uropathy, unstable cardiovascular status in acute haemorrhage. Precautions: High temperature, elderly, autonomic neuropathy, ileus, ulcerative colitis, hyperthyroidism, chronic heart disease, prostatic hypertrophy, reflux oesophagitis. Interactions: Side effects enhanced by antidepressants, antipsychotics, antihistamine, anti -Parkinsonian drugs. Adverse Reactions: Dry mouth, blurred vision, tachycardia, dizziness, impotence, allergic reactions. Tolterodine L-Tartrate 1 mg Tablet Tolterodine L-Tartrate 2 mg Tablet D e t r u s i t o l - Trade Name System: Genitourinary 199
G04BD07123T1001XX (A*) G04BD07123T1002XX (A*)

Indications: Treatment of overactive bladder with symptoms of urinary, frequency or urge incontinence. Dosage: Adult : 2 mg bd. In case of troublesome side effects, may reduce to 1 mg bd. Contraindications: Urinary retention, uncontrolled narrow angle glaucoma, toxic megacolon, myasthenia gravis. Pregnancy and lactation. Precautions: Significant bladder outlet obstruction, GI obstruction disorders, renal disease, hepatic disease, autonomic neuropathy, hiatus hernia, concomitant treatment with CYP3A4 inhibitors. Interactions: Erythromycin, clarithromycin, metoclopramide, cisapride. Adverse Reactions: Mild to moderate antimuscarinic effects, dryness of mouth, dyspepsia, reduc ed lacrimation. Papaverine HCl 30 mg/ml Injection
G04BE02110P3001XX (A)

System: Genitourinary Indications: Therapy adjunct of vasospastic. Dosage: 30 - 120 mg slow IM or IV. Maybe repeated 3 hourly if necessary. Contraindications: Complete AV block. Precautions: Glaucoma, Parkinson's disease, pregnancy. Interactions: Effects slightly potentiated by CNS depressants and synergism when used with morphine. May interfere with the therapeutic effect of levodopa in patients with Parkinson's disease. Adverse Reactions: Nausea, constipation, diarrhoea, abdominal distress, anorexia, facial flushing, headache, drowsiness, skin rash, sweating, dry mouth or throat, pruritus, vertigo, hypotension or slight BP increase, increase depth of respiration. Doxazosin Mesylate 1 mg Tablet Doxazosin Mesylate 2 mg Tablet C a r d u r a - Trade Name
G04CA00196T1001XX (A*) G04CA00196T1002XX (A*)

System: Genitourinary Indications: Only for treatment of Benign Prostatic Hyperplasia. NOT TO BE USED FOR TREATMENT OF HYPERTENSION. Dosage: 1 mg dly, may go up to 8 mg/day. Elderly: Initial 0.5 mg once dly. Contraindications: Hypersensitivity to doxazosin products or other quinazolines. Precautions: Pregnancy,lactation,impaired liver function. Interactions: In patients currently on beta blockers, the first dose response (marked initial drop in blood pressure, particularly on standing) to an alpha-1 adrenergic blocking drug may be exaggerated. Adverse Reactions: Hypotension,vertigo,headache,fatigue,postural dizziness,oedema and asthenia. 200

Doxazosin Mesylate 4 mg Tablet C a r d u r a - Trade Name

G04CA00196T1003XX (A*)

System: Genitourinary Indications: Only for treatment of Benign Prostatic Hyperplasia. NOT TO BE USED FOR TREATMENT OF HYPERTENSION. Dosage: 1 mg dly, may go up to 8 mg/day. Elderly: Initial 0.5 mg once dly. Contraindications: Hypersensitivity to doxazosin products or other quinazolines. Precautions: Pregnancy,lactation,impaired liver function. Interactions: In patients currently on beta blockers, the first dose response (marked initial drop in blood pressure, particularly on standing) to an alpha-1 adrenergic blocking drug may be exaggerated. Adverse Reactions: Hypotension,vertigo,headache,fatigue,postural dizziness,oedema and asthenia. Alfuzosine HCl 10mg Tablet X a t r a l X L - Trade Name
G04CA01110T1001XX (A*)

System: Genitourinary Indications: Treatment of functional symptoms related with benign prostatic hypertrophy (BPH). Dosage: 2.5 mg tds, max. 10 mg daily. Elderly initially 2.5 mg bd. Contraindications: Orthostatic hypotension, hepatic insufficiency, severe renal insufficiency (CLcR <30 ml/min), intestinal occlusion. Avoid combination with alpha blockers. Precautions: Elderly, coronary insufficiency, discontinue in the event of recurrence or exacerbation of angina, may impair ability to drive or operate machinery. Interactions: Alpha blockers & other antihypertensives. Adverse Reactions: G1 disturbances, vertigo, malaise dizziness, headache. Rarely orthostatic hypotension, syncope, tachycardia, palpitations, chest pain, asthenia, drowsiness, oedema, flushing, dry mouth, rash, pruritis. Terazosin HCl 1 mg Tablet Terazosin HCl 2 mg Tablet Terazosin HCl 5 mg Tablet H y t r i n - Trade Name System: Genitourinary
G04CA03110T1001XX (A*) NEDL G04CA03110T1002XX (A*) NEDL G04CA03110T1003XX (A* NEDL)

201

Indications: Only for treatment of Benign Prostatic Hyperplasia. Not to be used for treatment of hypertension. Dosage: Initially 1 mg at night, increased in a stepwise fashion to 2 mg, 5 mg or 10 mg once dly. Contraindications: Hypersensitivity to terazosin products or other quinazolines. Precautions: Carcinoma of the prostate and benign prostatic hyperplasia may cause the same symptoms. Prostate cancer should be ruled out prior to treatment. Dizziness, lightheadedness, orthostatic hypotension, syncope ("firstdose" effect). Interactions: In patients currently on beta blockers, the first dose response (marked initial drop in blood pressure, particularly on standing) to an alpha-1 adrenergic blocking drug may be exaggerated. Concomitant therapy with ibuprofen and antihypertensive agents has been reported to result in increases in blood pressure and interference with blood pressure control. Adverse Reactions: Tachycardia, dizziness, syncope, headache and asthenia. Finasteride 5 mg Tablet Proscar - Trade Name
G04CB01000T1001XX (A*)

System: Genitourinary Indications: Treatment & control of benign prostatic hyperplasia. Dosage: 5 mg/day as a single dose. Clinical responses occur within 12 wks - 6 mths of initiation of therapy. Long-term administration is recommended for maximal response. Contraindications: Hypersensitivity to finasteride products, known or suspected pregnancy. Precautions: Patients should be screened for prostatic carcinoma, hepatic dysfunction, patients with a large residual urinary volume or a severely diminished urinary flow rate should be monitored for obstructive uropathy and may not be candidates for finasteride therapy, crushed tablets should not be handled by a woman when she is pregnant or may potentially be pregnant because of the possibility of absorption and the subsequent potential risk to the male foetus. Interactions: No interactions found. Adverse Reactions: Sexual dysfunction, breast tenderness/ enlargement. Synthetic ACTH (Tetracosactrin Acetate) 250 mcg/ml Injection Synacthen
H01AA02000P3001XX (A) NEDL
- Trade Name

System: Endocrine Indications: To test adrenocortical function. Dosage: 202

250 mcg/ml injection (stat) Contraindications: Patients having had any type of allergic reaction to either natural adrenocorticotropin hormone or cosyntropin. Avoid injections containing benzyl alcohol in neonates. Precautions: Due to side effects or potentially fatal allergic reactions, therefore, patients should be monitored for at least one hour after administration in a controlled setting. Discontinue treatment by reducing the dosage gradually. Interactions: Risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones and corticosteroids. Adverse Reactions: Excessive weight gain, diarrhoea, increased susceptibility to infections due to immune suppression, worsening of mental state with either dejection or excessive nervousness, acne, menstrual discharges, electrolyte and calcium abnormalities, hypertension. Vasopressin 20 units/ml Injection P i t r e s s i n - Trade Name
H01BA01000P3001XX (A)

System: Endocrine Indications: i) Pituitary Diabetes Insipidus ii) Oesophageal variceal bleeding. Dosage: i) 5 - 20 units SC or IM every 4 hrs. ii) 20 units in 100 - 200 ml 5 % dextrose saline over 15 min as infusion which may be repeated after at intervals of 1 - 2 hrs. Max : 4 doses. Contraindications: Hypersensitivity to vasopressin products,chronic nephritis with nitrogen retention. Precautions: Patients who cannot tolerate rapid retention of extracellular water, patients with epilepsy, migraine, asthma, and heart failure. Patients with vascular disease, especially disease of coronary arteries. Avoid use of excessive doses, since this may cause undesirable side effects which may be alarming to the patient. IV administration should be used only for emergency treatment of gastrointestinal haemorrhage. Interactions: No interactions found Adverse Reactions: Tremor,sweating,vertigo,metabolic acidosis, nausea, vomiting. Desmopressin 100 mcg/ml Nasal Spray Minirin - Trade Name
H01BA02122A4101XX (A) NEDL APPL

System: Endocrine Indications: Diabetes Insipidus and Primary Nocturnal Enuresis. Dosage: Adult : 10 - 40 mcg/day in 1 - 2 divided doses. Child : 10 - 20 mcg/day in 1 - 3 doses. Contraindications: Hypersensitivity to desmopressin products, Children under 3 months of age, Type IIB von Willebrand's disease. Precautions: In patients with hemophilia A, particularly elderly, with coronary 203

artery insufficiency and/or hypertensive cardiovascular disease (may cause HPT), CAD (increased risk of thrombosis),fluid and electrolyte imbalance. May cause hypotension in post-bypass patients. Hyponatraemia and seizures are possible. Changes in nasal mucosa (scarring, oedema, or other disease) may cause erratic or unreliable absorption of nasal desmopressin. Interactions: Concomitant desmopressin acetate and glyburide therapy has resulted in inhibition of desmopressin's effects. Adverse Reactions: Flushing, headache, nausea, hypertension, hypotension, palpitation, anaphylaxis. Desmopressin Acetate 4 mcg/ml Injection Minirin - Trade Name
H01BA02122P3001XX (A) NEDL

System: Endocrine Indications: i) Control of Diabetes Insipidus. ii) Haemostasis in peri-operative situations Dosage: i) Control of Diabetes Insipidus- Adult : 1 - 4 mcg IV od - bd, child > 1 yr : 0.4 - 1 mcg IV od - bd, < 1 yr : 0.2 - 0.4 mcg IV od - bd. ii) Haemostasis in peri-operative situations- 0.3 mcg/kg IV Contraindications: Hypersensitivity to desmopressin products, cardiac insufficiency, children under 3 mths of age with hemophilia A, Type IIB von Willebrand's. Precautions: Elderly patients with coronary artery insufficiency and/or hypertensive cardiovascular disease (may cause HPT), CAD (increased risk of thrombosis),fluid and electrolyte imbalance, may cause hypotension. Interactions: Concomitant desmopressin acetate and glyburide therapy has resulted in inhibition of desmopressin's effects. Adverse Reactions: Flushing, headache, nausea. Desmopressin 0.1mg Tablet Minirin - Trade Name
H01BA02122T1001XX (A)NEDL

System: Endocrine Indications: i)Central diabetes insipidus ii)Primary nocturnal enuresis. iii)Treatment of nocturia associated with nocturnal polyuria in adult. Dosage: i) Adult & child 0.1mg tds. Maintenance: 0.3-0.6mg daily. ii) Adult & child over 5 yrs, 0.2mg at bed time; withdraw for 1 week for assessment after 3 mths. iii) Initially 0.1 mg on. May be increased to 0.2 mg and 0.4 mg by dose escalar. Contraindications: Habitual & psychogenic polydypsia. For renal concentration capacity test: cardiac insufficiency & other conditions requiring treatment with diuretics. For haemostatic use: unstable angina pectoris, decompensated cardiac insufficiency, von Willebrand's disease type II B. Precautions: Avoid fluid overload in the very young & the elderly, conditions characterised by fluid & or electrolyte imbalance & those at risk for increased intracranial pressure. Caution in renal concentration capacity testing for 204

children < 1yr. In haemostatic use, avoid fluid overload in patient taking diuretics. Interactions: Magnitude but not the duration of response may be augmented by indomethacin. Adverse Reactions: Transient headache, nausea, stomach pain, epistaxis & fatigue, transient fall in BP with reflex tachycardia & facial flushing. Rarely dizziness. Desmopressin 0.2mg Tablet Minirin - Trade Name
H01BA02122T1002XX (A)NEDL

System: Endocrine Indications: i)Central diabetes insipidus. ii)Primary nocturnal enuresis. iii)Treatment of nocturia associated with nocturnal polyuria in adult. Dosage: i)Adult & child 0.1 mg tds. Maintenance: 0.3-0.6mg daily. ii)Adult & child over 5 yrs, 0.2 mg at bed time; withdraw for 1 week for assesment after 3 mths. iii)Initially 0.1 mg on.May be increased to 0.2 mg and 0.4 mg by dose escalar. Contraindications: Habitual & psychogenic polydypsia. For renal concentration capacity test: cardiac insufficiency & other conditions requiring treatment with diuretics. For haemostatic use: unstable angina pectoris, decompensated cardiac insufficiency, von Willebrand's disease type II B. Precautions: Avoid fluid overload in the very young & the elderly, conditions characterised by fluid and or electrolyte imbalance & those at risk for increased intracranial pressure. Caution in renal concentration capacity testing for children < 1yr. In haemostatic use, avoid fluid overload in patient taking diuretics. Interactions: Magnitude but not the duration of response may be augmented by indomethacin. Adverse Reactions: Transient headache, nausea, stomach pain, epistaxis & fatigue, transient fall in BP with reflex tachycardia & facial flushing. Rarely dizziness. Terlipressin 1 mg Injection G l y p r e s s i n - Trade Name
H01BA04000P4001XX (A*)

System: Endocrine Indications: Acute oesophageal variceal bleeding. Dosage: 2 mg IV bolus over 1 min. Maintenance : 1 - 2 mg IV bolus 4 - 6 hrly until bleeding is controlled; up to 24 - 36 hrs. Contraindications: Pregnancy. Precautions: Asthma, hypertension, advanced arteriosclerosis, coronary insufficiency, cardiac arrhythmias, renal insufficiency. Interactions: No interactions found. Adverse Reactions: Fibrinolysis, bradycardia, facial pallor, increased BP and 205

ECG changes, peripheral vasoconstriction may occur, increased intestinal peristalsis, stool urgency and possible stool incontinence may occur, uterine contractions, bronchial constriction may occur. Oxytocin 10 units/ml Injection P i t o c i n - Trade Name
H01BB02000P3001XX (B) NEDL APPL

System: Obstetrics, Gynaecology Indications: Induction of labour. Dosage: Dose : IV Infusion : 1-4 milliunits/min ; increase by 1-2 milliunits every 15-30 min until contraction pattern has been established ; max dose should not exceed 20 milliunits/min. Also postpartum uterine atony. Contraindications: Significant cephalopelvic disproportion, fetal malpresentation, placenta praevia, placental abruption, grand multiparity, history of major uterine surgery including caesarean section, severe toxaemia, severe cardiovascular disorders. Precautions: For induction or enhancement only as IV infusion, careful monitoring of fetal heart rate and uterine contractions are required. Interactions: Prostaglandins, inhalation anaesthetics, vasoconstrictor agents. Adverse Reactions: Gastrointestinal upsets, water intoxication resulting from large amounts of solution or too rapid infusion, cardiac arrhythmias. Octreotide 0.1 mg/ml Injection S a n d o s t a t i n - Trade Name
H01CB02110P3001XX (A) NEDL APPL

System: Gastro-Intestinal Indications: i) Relief of symptms associated with neuroendocrine tumours (carcinoids) ii) Reduce pancreatic exocrine secretions during / following pancreatic surgery and in acute pancreatitis. iii) Bleeding oesophageal varices Dosage: i) 100 - 200 micro-gm tds ii) 50-100 micro-gm tds for 5 to 7 days iii) 25-50 micro-gm/hr for 24-48 hrs Contraindications: Hypersensitivity to Octreotide Precautions: Growth hormone secreting pituitary tumours (can expand & cause space occupying effects) insulinomas (exaggerate hypoglycaemia), diabetes, pregnancy & lactation. Interactions: Cyclosporin Adverse Reactions: Local reaction & discomfort at inj. site. Anorexia, nausea, vomiting, crampy abdominal pain, abdominal bloating, flatulence, loose stools, diarrhoea, steatorrhea, bradycardia, arrhythmias, hyperglycamia, hypoglycemia. Octreotide 0.05mg/ml Injection S a n d o s t a t i n - Trade Name System: Gastro-Intestinal 206
H01CB02110P3002XX (A)APPL

Indications: i) Relief of symptms associated with neuroendocrine tumours (carcinoids) ii) Reduce pancreatic exocrine secretions during / following pancreatic surgery and in acute pancreatitis. iii) Bleeding oesophageal varices Dosage: i) 100 - 200 micro-gm tds ii) 50-100 micro-gm tds for 5 to 7 days iii) 25-50 micro-gm/hr for 24-48 hrs Contraindications: Hypersensitivity to octreotide. Precautions: Growth hormone secreting pituitary tumours (can expand & cause space occupying effects) insulinomas (exaggerate hypoglycaemia), diabetes, pregnancy & lactation. Interactions: Reduces absorbtion of cyclosporin, cimetidine. Increases bioavailability of bromocriptine. Adverse Reactions: Local reaction & discomfort at inj. site. Anorexia, nausea, vomiting, crampy abdominal pain, abdominal bloating, flatulence, loose stools, diarrhoea, steatorrhea, bradycardia, arrhythmias, hyperglycamia, hypoglycemia. Fludrocortisone Acetate 0.1 mg Tablet F l o r i n e f - Trade Name
H02AA02122T1001XX (A)NEDL

System: Endocrine Indications: As an adjunct to glucocorticoids in the management of primary adrenocortical insufficiency in Addison's disease and treatment of salt-losing adrenogenital syndrome. Dosage: 0.1 mg dly. Contraindications: Hypersensitivity,systemic fungal infection. Precautions: Discontinue treatment by reducing the dosage gradually. Interactions: Spironolactone - result in a paradoxical dose-related increase in urinary potassium excretion.Loop diuretic - excessive potassium loss . Risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones and corticosteroids. Adverse Reactions: Fluid & electrolyte disturbances,muscle weakness, peptic ulcer. Betamethasone 0.5 mg Tablet Celestone - Trade Name
H02AB01000T1001XX (A)

System: Endocrine Indications: Suppression of inflammatory and allergic disorders, congenital adrenal hyperplasia, cerebral oedema. Dosage: 0.5 - 9 mg daily in divided doses. Child : 0.5 - 7.5 mg/m2/day divided every 6 12 hrs. Contraindications: Systemic infection (unless specific antimicrobial therapy 207

given). Precautions: Discontinue treatment by reducing the dosage gradually. Interactions: CYP3A3/4 enzyme substrate, phenytoin, phenobarbital, potassium-depleting diuretics. Skin test antigens, immunizations: Betamethasone may decrease response. Adverse Reactions: Fluid & electrolyte disturbances, muscle weakness, peptic ulcer, Cushing's syndrome. Betamethasone Sodium Phosphate 4mg/ml Injection H02AB01162P3001XX (B) Celestone - Trade Name System: Endocrine Indications: Pre-op & in serious trauma or illness, shock, as adjunctive therapy in rheumatoid disorders, ocular, dermatologic & resp allergic & inflammatory states. Dosage: Usual intravenous doses are up to 9mg/day of the sodium phosphate salt only. Children, IM: 0.5-7.7mg base/m2/day divided every 6-12 hours. Adolescent & Adult, IM: 0.6-9mg divided every 12-24 hrs. Contraindications: Systemic fungal infection. Precautions: Discontinue treatment by reducing the dosage gradually. Interactions: No interaction found Adverse Reactions: Fluid & electrolyte disturbances, muscle weakness, peptic ulcer. Dexamethasone 0.5 mg Tablet Decadron - Trade Name
H02AB02000T1001XX (A)NEDL

System: Endocrine Indications: Croup, septic shock, cerebral oedema, and respiratory distress syndrome including status asthmaticus. Dosage: 0.5 - 9 mg dly, depending upon the disease being treated. Up to 15 mg dly in severe disease. Contraindications: Hypersensitivity, systemic fungal infection Precautions: Discontinue treatment by reducing the dosage gradually. Interactions: Barbiturates, phenytoin, rifampin may decreases dexamethasone effects; Dexamethasone decreases effect of salicylates, vaccines, toxoids. Increased effect: Salmeterol: The addition of salmeterol has been demonstrated to improve response. Adverse Reactions: Fluid & electrolyte disturbances, muscle weakness, peptic ulcer. Dexamethasone Sodium Phosphate 8 mg/2 ml Injection Decadron
H02AB02162P3001XX (B) NEDL APPL
- Trade Name

System: Endocrine Indications: 208

Croup, septic shock, cerebral oedema, and respiratory distress syndrome including status asthmaticus. Dosage: Initially 0.5 - 2.0 mg IM,IV or infusion dly, depending upon the disease being treated. Contraindications: Hypersensitivity. Systemic fungal infections. Precautions: During periods of stress.Mask the signs of infection and decrease resistance to infection. Discontinue treatment by reducing the dosage gradually. Interactions: Barbiturates, phenytoin, rifampicin may decrease dexamethasone effects; dexamethasone decreases effect of salicylates, vaccines, toxoids. Increased effect: Salmeterol: The addition of salmeterol has been demonstrated to improve response. Adverse Reactions: Fluid & electrolyte disturbances,muscle weakness, peptic ulcer. Methylprednisolone Sodium Succinate 0.5 g Injection H02AB04520P4001XX (A)
NEDL

S o l u -M e d r o l

- Trade Name

System: Endocrine Indications: Suppression of inflammatory and allergic disorders, cerebral oedema, immunosuppression treatment of haematological & oncological disorders treatment of shock states & endocrine disorders. Dosage: 15 - 30 mg/kg dly. Contraindications: Hypersensitivity,systemic fungal infection. Precautions: Discontinue treatment by reducing the dosage gradually. Interactions: Decreased effect: Phenytoin, phenobarbital, rifampicin increases clearance of methylprednisolone. Potassium depleting diuretics enhance potassium depletion. Increased toxicity: Skin test antigens, immunizations decrease response of methylprednisolone. Adverse Reactions: Fluid & electrolyte disturbances,muscle weakness, peptic ulcer. Methylprednisolone Sodium Succinate 1 g Injection H02AB04520P4002XX (A)
NEDL

S o l u -M e d r o l

- Trade Name

System: Endocrine Indications: Suppression of inflammatory and allergic disorders, cerebral oedema, immunosuppression treatment of haematological & oncological disorders treatment of shock states & endocrine disorders. Dosage: 15 - 30 mg/kg dly. Contraindications: Hypersensitivity,systemic fungal infection. Precautions: Discontinue treatment by reducing the dosage gradually. Interactions: Decreased effect: Phenytoin, phenobarbital, rifampicin increase clearance of methylprednisolone. Potassium depleting diuretics enhance 209

potassium depletion. Increased toxicity: Skin test antigens, immunizations decrease response of methylprednisolone. Adverse Reactions: Fluid & electrolyte disturbances,muscle weakness, peptic ulcer. Prednisolone 3 mg/5 ml Syrup P r e d n i s o n e - Trade Name
H02AB06000L9001XX (B) NEDL

System: Endocrine Indications: i) Replacement therapy for primary and secondary adrenocortical insufficiency ii) Adrenogenital syndrome iii) Other therapy. Dosage: i) Replacement therapy for primary and secondary adrenocortical insufficiency: 5 - 25 mg daily in divided doses ii) Adrenogenital syndrome: 10 - 20 mg/m2 body surface daily in divided doses. Iii) Other therapy - 5 - 30 mg daily . Child : 0.5 - 2 mg/kg/day in divided doses every 6 - 8 hrs or as a single daily. Contraindications: Hypersensitivity and systemic fungal infection. Precautions: Discontinue treatment by reducing the dosage gradually. Interactions: Phenytoin, phenobarbital, rifampin increase clearance of methylprednisolone. Potassium depleting diuretics enhance potassium depletion. Skin test antigens and immunizations decrease response. Increase circulating glucose level and may need adjustment of insulin or oral hypoglycemics. Adverse Reactions: Fluid & electrolyte disturbances, muscle weakness and peptic ulcer. Prednisolone 5 mg Tablet P r e d n i s o n e - Trade Name
H02AB06000T1001XX (B) NEDL APPL

System: Endocrine Indications: i) Replacement therapy for primary and secondary adrenocortical insufficiency ii) Adrenogenital syndrome iii) Other therapy Dosage: i) Replacement therapy for primary and secondary adrenocortical insufficiency5 - 25 mg daily in divided doses ii) Adrenogenital syndrome- 10 - 20 mg/m2 body surface daily in divided doses. Iii) Other therapy - 5 - 30 mg daily . Child : 0.5 - 2 mg/kg/day in divided doses every 6 - 8 hrs or as a single daily. Contraindications: Hypersensitivity and systemic fungal infection. Precautions: Discontinue treatment by reducing the dosage gradually. Interactions: Decreased effect : Phenytoin, phenobarbital, rifampicin increases 210

clearance of prednisolone. Potassium depleting diuretics enhance potassium depletion. Increased toxicity : Skin test antigens Immunizations decrease response. Increase circulating glucose level and may need adjustment of insulin or oral hypoglycemics. Adverse Reactions: Fluid & electrolyte disturbances, muscle weakness and peptic ulcer. Triamcinolone Acetonide 10 mg/ml Injection Kenacort - Trade Name
H02AB08351P3001XX (A)

System: Endocrine Indications: Inflammation of joints, bursae & tendon sheaths. Dosage: Smaller joints: 2.5 - 5 mg and larger joints: 5 -15 mg. Treatment should be limited to 1 mg/inj. site to prevent cutaneous atrophy. Contraindications: Systemic fungal infection, unstable or infected joints, lactation. Precautions: Intercurrent infection, hypothyroidism, cirrhosis, active or latent TB, renal insufficiency, cardiac failure, diabetes, glaucoma, myasthenia gravis, pregnancy. Interactions: Phenytoin, phenobarbitone, rifampicin, diuretics, anticholinesterases, salicylates. Adverse Reactions: Local atrophy, post injection flare, pigmentation changes, sodium & fluid retention, peptic ulcer, impaired wound healing, purpura, striae, increased ocular/intracranial pressure with cushingnoid state, growth retardation. Triamcinolone Acetonide 40 mg/ml Injection Kenacort -A - Trade Name
H02AB08351P3002XX (A/KK)

System: Endocrine Indications: Allergies, dermatoses & rheumatoid arthritis. Dosage: 40-80 mg deep into the gluteal muscle. Contraindications: Systemic fungal infection, unstable or infected joints, lactation. Precautions: Intercurrent infection, hy pothyroidism, cirrhosis, active or latent TB, renal insufficiency, cardiac failure, diabetes, glaucoma, myasthenia gravis, pregnancy. Interactions: Phenytoin, phenobarbitone, rifampicin, diuretics, anticholinesterases, salicylates. Adverse Reactions: Local atrophy, post injection flare, pigmentation changes, sodium & fluid retention, peptic ulser, impaired wound healing, purpura, striae, increased ocular/intracranial pressure with cushingnoid state, growth retardation. 211

Hydrocortisone 10 mg Tablet

H02AB09000T1001XX (B)

System: Endocrine Indications: Glucocorticoid replacement therapy in primary or secondary adrenal insufficiencies and long term management of congenital adrenal hyperplasia in children. Dosage: Adult : 20 - 30 mg dly in divided doses. Child : 10 - 30 mg dly in divided doses. Contraindications: Hypersensitivity, systemic fungal infection Precautions: Discontinue treatment by reducing the dosage gradually. Interactions: Concurrent use of barbiturates, carbamazepine, phenytoin, primidone, or rifampicin may enhance the metabolism and reduce the effects of systemic corticosteroids. Oral contraceptives or ritonavir may increase plasma concentrations of corticosteroids. Adverse Reactions: Fluid & electrolyte disturbances, muscle weakness, peptic ulcer. Hydrocortisone Sodium Succinate 100 mg Injection S o l u -Cortef
H02AB09520P4001XX (B) NEDL APPL
- Trade Name

System: Endocrine Indications: Conditions responsive to systemic or local glucocorticoid injection therapy especially in emergencies. Dosage: 50 - 500 mg dly by IV, SC, IM or rectal drip. Contraindications: Hypersensitivity, systemic fungal infection. Precautions: Discontinue treatment by reducing the dosage gradually. Interactions: Concurrent use of barbiturates, carbamazepine, phenytoin, primidone, or rifampicin may enhance the metabolism and reduce the effects of systemic corticosteroids. Oral contraceptives or ritonavir may increase plasma concentrations of corticosteroids. Adverse Reactions: Fluid & electrolyte disturbances,muscle weakness, peptic ulcer. Cortisone Acetate 5mg Tablet Cortef - Trade Name
H02AB10122T1002XX (B)

System: Endocrine Indications: For salt losing congenital adrenal hyperplasia in newborn and paediatric patients. Dosage: 20-30 mg/m2 daily. Doses may be divided with two-thirds in the morning and one-third late in the afternoon. Contraindications: Hypersensitivity , systemic fungal infection. Precautions: Discontinue treatment by reducing the dosage gradually. Interactions: Concurrent use with phenobarbital and phenytoin may result in 212

decreased corticosteriods effectiveness. Concurrent use with aspirin may result in an increased risk of gastrointestinal ulceration and subtherapeutic aspirin serum concentration. Adverse Reactions: Fluid & electrolyte disturbances, muscle weakness, peptic ulcer. L-Thyroxine Sodium 0.1 mg Tablet O r o x i n e - Trade Name
H03AA01520T1001XX (B) NEDL APPL

System: Endocrine Indications: i) Hypothyroidism ii) Cretinism Dosage: Hypothyroidism: Adult : 0.05 - 0.1 mg/day increased every 2 -4 wks by 0.05 mg. Maintenance : 0.1 - 0.3 mg/day. Child : 0.05 - 0.1 mg/day increased by 0.025 mg every 3 wks according to response. Cretinism : 0.01 - 0.025 mg/day increased gradually. Maintenance : 0.1 - 0.2 mg/ Contraindications: Thyrotoxicosis. Precautions: Predisposition to adrenal insufficiency from other causes, elderly, cardiovascular disease. Interactions: No interaction found. Adverse Reactions: Palpitation, cramps, arrhythmia. Propylthiouracil 50 mg Tablet
H03BA02000T1001XX (B)NEDL

System: Endocrine Indications: Palliative treatment of hypothyroidism as an adjunct to ameliorate hyperthyrodism in preparation for surgical treatment or radioactive iodine therapy and in the management of thyrotoxic crisis. Dosage: Child : Initial 5 - 7 mg/kg/day in divided doses every 8 hrs. Maintenance :1/3 to 2/3 of the initial dose in divided doses every 6 -8 hrs. Adult : initial dose : 300 - 450 mg daily in divided doses every 8 hrs. Maintenance : 100 - 150 mg daily in divided doses every 8 - 12 hrs. Contraindications: Lactation. Precautions: Renal impairment. Interactions: No interaction found. Adverse Reactions: Gastric distress, headache, nausea, skin rash. Carbimazole 5 mg Tablet N e o -m e r c a z o l e - Trade Name System: Endocrine
H03BB01000T1001XX (B) NEDL A PPL

213

Indications: Hyperthyroidism. Dosage: Initially 10 - 60 mg dly in divided doses. Maintenance : 5 - 20 mg dly. Contraindications: May be given to pregnancy mothers, treatment should be discontinued 3-4 wks before delivery. Infants should not breast fed by mothers taking carbimazole. Precautions: Liver disorders, pregnancy, breast feeding. Interactions: Concurrent use of digoxin and carbimazole may result in decreased peak serum levels of digoxin. Antithy roid drugs, by reducing the extent of hyperthyroidism, decrease the metabolism of clotting factors and thus reduce the effects of oral anticoagulants. Adverse Reactions: Nausea, mild GI disturbance, rashes, bone marrow supression. Potassium Iodide Mixture
H03CA00200L2101XX (B)APPL

System: Endocrine Indications: Pre-operative management of hyperthyroidism and thyrotoxicosis. Dosage: Children & adult : 50 - 250 mg 3 times/day. Contraindications: Hypersensitivity to iodine or any component of the formulation; hyperkalaemia; pulmonary oedema; impaired renal function; hyperthyroidism; iodine-induced goiter; pregnancy. Precautions: Prolonged use can lead to hypothyroidism, cystic fibrosis patients have an exaggerated response, can cause acne flare-ups, can cause dermatitis, use with caution in patients with a history of thyroid disease, Addison's disease, cardiac disease, myotonia congenita, tuberculosis, acute bronchitis. Interactions: Concurrent use with ACE Inhibitors may lead to hyperkalaemia, cardiac arrhythmias or cardiac arrest. Concurrent use with diuretics or potassium-sparing diuretic may lead to hyperkalaemia, cardiac arrhythmias or cardiac arrest. Lithium may cause additive hypothyroid. Adverse Reactions: Irregular heart beat, confusion, tiredness, fever, skin rash, goiter, salivary gland swelling/tenderness, thyroid adenoma, swelling of neck/throat, myxedema, lymph node. Iodine & Potassium Iodide Solution L u g o l ' s S o l u t i o n - Trade Name
H03CA00200L9901XX (B)

System: Endocrine Indications: i) Pre-operative treatment of thyrotoxicosis. ii)Thyrotoxicosis crisis. Dosage: i) 1 ml daily in divided doses. ii) 2 - 3 ml dly Contraindications: Breast feeding. Precautions: Should not be used for long term treatment. Pregnancy, 214

lactation, children. Interactions: Concomitant used with lithium may result in hypothyroidism and decrease the effects of oral anticoagulants. Adverse Reactions: Hypersensitivity reactions, headache, lacrimation. Glucagon (Lyophilised) 1 mg/ml Injection G l u c a g o n - Trade Name
H04AA01000P4001XX (B)

System: Endocrine Indications: Management of hypoglycaemia. Dosage: 0.5 - 1 mg by SC, IM or IV. Repeat in 20 mins if necessary. Contraindications: Glucagonoma, insulinoma, phaeochromocytoma. Precautions: Patients with marked depletion of liver glycogen stores. Interactions: No interaction found. Adverse Reactions: GI upset, hypersensitivity. Synthetic Salmon Calcitonin 50IU Nasal Spray Miacalcic - Trade Name
H05BA01000A4101XX (A*)

System: Endocrine Indications: Osteoporosis. Dosage: 200 units daily. Contraindications: Hypersensitivity to calcitonin. Precautions: Pregnancy, lactation, caution when driving vehicles or operating machine. Should not be given to children more than a few weeks. Possibility of systemic allergic reactions exists. Interactions: Ketoprofen inhibited the calciuric and uricosuric effects calcitonin. Calcitonin caused a significant decrease in the mean values of lithium plasma levels. Adverse Reactions: Rhinitis, ulcerative rhinitis, sinusitis, epitaxis, flushing, dizziness, headache, GI disturbances, musculoskeletal pain, pharyngitis, fatigue, dysgeusia. Rarely, hypertension, vomiting, arthralgia, cough, oedema, flu-like symptoms, abnormal vision. Synthetic Salmon Calcitonin 50 IU Injection Miacalcic - Trade Name
H05BA01000P3001XX (A*)

System: Endocrine Indications: Acute hypercalcaemia. Dosage: 5 - 10 units/kg daily (in 1 -2 divided doses)to 400 units every 6-8 hrs adjusted according to clinical and biochemical response (no additional benefit with over 8 units/kg every 6 hrs). 5-10 units/kg by slow IV over at least 6 hrs. Contraindications: Hypersensitivity to calcitonin. Precautions: Pregnancy, lactation, caution when driving vehicles or operating 215

machinery. Interactions: Ketoprofen inhibited the calciuric and uricosuric effects calcitonin. Calcitonin caused a significant decreased in the mean values of lithium plasma levels. Adverse Reactions: Nausea, vomiting, flushing, chills, dizziness, polyuria. Rarely, local hypersensitivity reactions, anaphylactoid-like reactions. Synthetic Salmon Calcitonin 100 IU Injection Miacalcic - Trade Name
H05BA01000P3002XX (A*)

System: Endocrine Indications: Acute hypercalcaemia. Dosage: 5-10 IU/kg/day SC/IM (in 1-2 divided doses) to 400 units ev ery 6-8 hrs adjusted according to clinical and biochemical response (no additional benefit with over 8 units/kg every 6 hrs). 5-10 units/kg slow IV over at least 6 hrs. Contraindications: Hypersensitivity to calcitonin. Precautions: Pregnancy, lactation, caution when driving vehicles or operating machinery. Interactions: Ketoprofen inhibited the calciuric and uricosuric effects calcitonin. Calcitonin caused a significant decrease in the mean values of lithium plasma levels. Adverse Reactions: Nausea, vomiting, flushing, chills, dizziness, polyuria. Rarely, local hypersensitivity reactions, anaphylactoid-like reactions. Doxycycline 100 mg Capsule V i b r a m y c i n - Trade Name
J01AA02000C1001XX (B) NEDL APPL

System: Antiinfectives Indications: Infections due to susceptible organisms. Dosage: 200 mg on the first day followed by 100 mg dly. Severe infections: 200 mg dly. Contraindications: Hypersensitivity to tetracyclines, porphyria, pregnancy, lactation, child< 12 yrs. Precautions: Lactation, myasthenia gravis, hepatic or renal impairment. Interactions: Anticoagulants, penicillin, antacids, ferum. Adverse Reactions: GI distress, anorexia, maculopapular & erythematous rash, tooth discolouration in children. Doxycycline 5 mg/ml Syrup Vib r a m y c i n - Trade Name
J01AA02000L9001XX (A)

System: Antiinfectives Indications: Infections due to susceptible organisms. Dosage: Child < 45 kg body weight : 4.4 mg/kg body wt on first day, then 2.2 - 4.4 mg/kg/day. Contraindications: Hypersensitivity to tetracyclines, porphyria, pregnancy, 216

lactation, child< 12 yrs. Precautions: Lactation, myasthenia gravis, hepatic or renal impairment. Interactions: Anticoagulants, penicillin, antacids, ferum. Adverse Reactions: GI distress, anorexia, maculopapular & erythematous rash, tooth discolouration in children. Doxycycline 100 mg Injection V i b r a m y c i n - Trade Name
J01AA02000P4001XX (A) NEDL

System: Antiinfectives Indications: Infections due to susceptible organisms. Dosage: 100 - 200 mg dly by IV infusion. Contraindications: Hypersensitivity to tetracyclines, porphyria, pregnancy, lactation, child< 12 yrs. Precautions: Lactation, myasthenia gravis, hepatic or renal impairment. Interactions: Anticoagulants, penicillin, antacids, ferum. Adverse Reactions: GI distress, anorexia, mac ulopapular & erythematous rash, tooth discolouration in children. Doxycycline 100 mg Tablet V i b r a m y c i n - Trade Name
J01AA02000T1001XX (B) NEDL

System: Antiinfectives Indications: Infections due to susceptible organisms. Dosage: Adult : 200 mg on the first day followed by 100 mg dly. Severe infections : 200 mg dly. Contraindications: Hypersensitivity to tetracyclines, porphyria, pregnancy, lactation, child< 12 yrs. Precautions: Lactation, myasthenia gravis, hepatic or renal impairment. Interactions: Anticoagulants, penicillin, antacids, ferum. Adverse Reactions: GI distress, anorexia, maculopapular & erythematous rash, tooth discolouration in children. Tetracycline HCl 250 mg Capsule A c h r o m y c i n - Trade Name
J01AA07110C1001XX (B) NEDL APPL

System: Antiinfectives Indications: Infections caused by susceptible pathogens. Dosage: Adult : 250 mg 6 hrly, increased in severe infections to 500 mg every 6 8 hrs for 1 month or more. Contraindications: Hypersensitivity, patients with severe renal impairment, pregnancy, childn < 8 yr. , premature & newborn infant. Precautions: Liver impairment, myasthenia gravis, lactation. Interactions: Absorption reduced by antacids, milk. Potentiates action of anticoagulants & sulfonylureas. 217

Adverse Reactions: GI upsets, superinfection, hepatic & renal toxicity, photosensitivity. Rarely, neutropenia, haemolytic anaemia,thrombopenia, raised intracranial pressure. May exacerbate existing SLE. Tetracycline HCl 250 mg Tablet A c h r o m y c i n - Trade Name
J01AA07110T1001XX (B)

System: Antiinfectives Indications: Infections caused by susceptible pathogens. Dosage: Adult : 250 mg 6 hrly, increased in severe infections to 500 mg every 6 - 8 hrs for 1 month or more. Contraindications: Hypersensitivity, patients with severe renal impairment, pregnancy, childn < 8 yr. , premature & newborn infant. Precautions: Liver impairment, myasthenia gravis, lactation. Interactions: Absorption reduced by antacids, milk. Potentiates action of anticoagulants & sulfonylureas. Adverse Reactions: GI upsets, superinfection, hepatic & renal toxicity, photosensitivity. Rarely, neutropenia, haemolytic anaemia,thrombopenia, raised intracranial pressure. May exacerbate existing SLE. Minocycline 50 mg Capsule M i n o c i n - Trade Name
J01AA08110C1001XX (A*)

System: Antiinfectives Indications: As second-line treatment for leprosy only Dosage: 100 mg dly 6 - 18 mths. Contraindications: Hypersensitivity. Last half of pregnancy, infants, child <= 8 yr. Precautions: Overgrowth of susceptible organisms,renal impairment. Use in conjunction with penicillins. Interactions: Oral absorption is impaired by antacids containing Al, Mg. Adverse Reactions: GI disorders. Maculopapular & erythematous rashes, photosensitivity, tooth discoloration, hypersensitivity reactions. Minocycline 100 mg Capsule M i n o c i n - Trade Name
J01AA08110C1002XX (A*)

System: Antiinfectives Indications: As second-line treatment for leprosy only Dosage: 100 mg dly 6 - 18 mths. Contraindications: Hypersensitivity. Last half of pregnancy, infants, child <= 8 yr. Precautions: Overgrowth of susceptible organisms,renal impairment. Use in conjunction with penicillins. Interactions: Oral absorption is impaired by antacids containing Al, Mg. 218

Adverse Reactions: GI disorders. Maculopapular & erythematous rashes, photosensitivity, tooth discoloration, hypersensitivity reactions. Chloramphenicol 250 mg Capsule C h l o r o m y c e t i n - Trade Name
J01BA01126C1001XX (B) NEDL APPL

System: Antiinfectives Indications: Treatment of typhoid, paratyphoid fevers, bronchopneumonia and enteric infection. Dosage: Adult : 500 mg qds or 50 mg/kg dly in 4 divided doses IM, IV/SC. Child : 25 - 100 mg/kg/day in 4 divided doses. Contraindications: Hypersensitivity to chloramphenicol. Precautions: Avoid prolong treatment or use in minor infections. Liver impairment. Uraemic patients, infants, pregnancy, active immunisation. Interactions: Bone marrow depressants, enhance effects of coumarin anticoagulants & warfarin, phenytoin & some hypoglycaemic agents. Adverse Reactions: Aplastic anaemia. Haemolytic anaemia in G6PD deficiency. Grey syndrome, bleeding, peripheral & optic neuritis, hypersensitivity reaction & erythema multiforme. Chloramphenicol 125 mg/5 ml Suspension C h l o r o m y c e t i n - Trade Name
J01BA01126L8001XX (B) NEDL

System: Antiinfectives Indications: Typhoid fever, salmonella infections, meningitis, cholera ,anaerobic and rickettsial infections. Dosage: Paed :25 - 50 mg/kg/day in 4 divided doses. Contraindications: Hypersensitivity to chloramphenicol. Precautions: Avoid prolong treatment or use in minor infections.Liver impairment.Uraemic patients, infants, pregnancy, active immunisation. Interactions: Bone marrow depressants, enhance effects of coumarin anticoagulants & warfarin, phenytoin. Adverse Reactions: Aplastic anaemia.Haemolytic anaemia in G6PD deficiency.Grey syndrome, bleeding, peripheral & optic neuritis, hypersensitivity reaction & erythema multiforme. Chloramphenicol Sodium Succinate 1 g Injection Chloromycetin
- Trade Name

J01BA01520P4001XX (B) NEDL APPL

System: Antiinfectives

219

Indications: Treatment of typhoid, paratyphoid fevers, bronchopneumonia and enteric infection. Dosage: Adult:1.5 - 3 g dly in divided doses IM, IV/SC. Child:25 -100 mg/kg/day in divided doses. Contraindications: Hypersensitivity, pregnancy and lactation, anaemia, porphyria. Precautions: Repeated courses & chronic treatment,infants, impaired liver or kidney function.Frequent haematological examination recommended. Interactions: Phenobarbitone & rifampicin may reduce the plasma concentration.Drugs which potentially depress bone marrow function.May potentiate actions of phenytoin, sulfonylureas & anticoagulants. Adverse Reactions: Depression of bone marrow leading to agranulocytosis,thrombocytopenia purpura, leucopenia & aplastic anaemia.Peripheral & optic neuritis, erythema multiforme GI disorders, urticaria, dry mouth & blurred vision. Ampicillin Trihydrate 125 mg/5 ml Suspension. J01CA01012F2101XX (B) NEDL APPL P e n b r i t i n - Trade Name System: Antiinfectives Indications: Treatment of susceptible bacterial infections (nonbeta-lactamase-producing organisms). Dosage: Child : 50 - 100 mg/kg/day qid. Under 1 yr : 62.5 - 125 mg qid., 1 - 10 yrs : 125 - 250 mg qid. Contraindications: Hypersensitivity to penicillins Precautions: Hypersensitivity to cephalosporins. Severe renal dysfunction. Interactions: Bacteriostatic drugs, anticoagulants. Adverse Reactions: Diarrhoea, indigestion. Occasionally rashes. Ampicillin Sodium 500 mg Injection P e n b r i t i n - Trade Name
J01CA01520P4001XX (B) NEDL APPL

System: Antiinfectives Indications: Treatment of susceptible bacterial infections (non beta-lactamase-producing organisms); meningitis. Dosage: 250 - 500 mg IM/IV every 4 - 6 hrs, higher doses in meningitis. Max : 400 mg/kg/day, child < 10 yr, half adult dose. Contraindications: Hypersensitivity to penicillins Precautions: Hypersensitivity to cephalosporins.Chronic treatment requires assessment of renal,hepatic & haematopoietic functions.Renal impairment,lymphatic leukaemia. Interactions: Excretion impaired by probenecid.Increased risk of skin rashes with allopurinol.May decrease effectiveness of oral contraceptives and atenolol. Adverse Reactions: GI disturbances,skin rashes,pruritis,urticartia, 220

fever,anaphylaxis,blood disorders, superinfection. Amoxycillin 250 mg Capsule A m o x i l - Trade Name

J01CA04012C1001XX (B) NEDL APPL

System: Antiinfectives Indications: Infections caused by susceptible strains of gram +ve and gram -ve organisms. Dosage: Adult: 250 - 500 mg tds. Child : 20 - 40 mg/kg/day in divided doses 8 hrly. Contraindications: Hypersensitivity to penicillins. Precautions: Hypersensitivity to cephalosporins, renal or hepatic impairment, superinfection. Interactions: Aminoglycosides, oral contraceptives. Adverse Reactions: Diarrhoea, indigestion, urticarial or erythematous rash, hepatitis, cholestatic jaundice. fever,anaphylaxis,blood disorders, superinfection. Amoxycillin Trihydrate 125mg/5ml syrup
J01CA04012F1001XX (B)

System: Antiinfectives Indications: Infections caused by susceptible strains of gram +ve and gram -ve organisms. Dosage: Children to 10yrs : 125 mg every 8hrs. Contraindications: Hypersensitivity to penicillins. Precautions: Hypersensitivity to cephalosporins, renal or hepatic impairment, superinfection. Interactions: Aminoglycosides, oral contraceptives. Adverse Reactions: Diarrhoea, indigestion, urticarial or erythematous rash, hepatitis, cholestatic jaundice. Bacampicillin 400 mg Tablet P e n g l o b e - Trade Name
J01CA06000T1001XX (B) NEDL APPL

System: Antiinfectives Indications: Infections caused by ampicillin-sensitive gram+ve & gram-ve microorganisms. Dosage: Adult: 400 mg bd. Severe infection : 800 mg bd. Contraindications: Hypersensitivity to penicillins. Precautions: Hypersensitivity to cephalosporins, renal or hepatic impairment, superinfection Interactions: Aminoglycosides, oral contraceptives. Adverse Reactions: Diarrhoea, indigestion, urticarial or erythematous rash, hepatitis, cholestatic jaundice. Piperacillin Sodium 2 g Injection P i p r a c i l - Trade Name System: Antiinfectives 221
J01CA12520P4001XX (A) NEDL APPL

Indications: Infections due to Pseudomonas aeruginosa. Dosage: Adult: 100 - 150 mg/kg IM/IV in divided doses. Increase to 200 - 300 mg/kg in severe infections & at least 16 g in life-threatening infections. Single dose over 2 g, IV route only. Child : 50 mg/kg/dose 6 - 8 hrly. Contraindications: Hypersensitivity to piperacillin products/penicillins and or cephalosporins. Precautions: Infants, elderly, renal impairment, chronic heart failure, hypersensitivity to cephalosporins. Interactions: Methotrexate, probenecid, typhoid vaccine, vecuronium. Adverse Reactions: Allergic reactions including rashes, fever, urticaria, pruritis, anaphy laxis, gastrointestinal disturbances, glossitis, stomatitis, convulsions, coagulants & blood disorders, superinfection. Piperacillin Sodium 4 g Injection P i p r a c i l - Trade Name
J01CA12520P4002XX (A) NEDL APPL

System: Antiinfectives Indications: Infec tions due to Pseudomonas aeruginosa. Dosage: Adult: 100 - 150 mg/kg IM/IV in divided doses. Increase to 200 - 300 mg/kg in severe infections & at least 16 g in life-threatening infections. Single dose over 2 g: IV route only. Child : 50 mg/kg/dose 6 - 8 hrly. Contraindications: Hypersensitivity to piperacillin products/penicillins and/or cephalosporins. Precautions: Infants, elderly, renal impairment, chronic heart failure, hypersensitivity to cephalosporins. Interactions: Methotrexate, probenecid, typhoid vaccine, vecuronium. Adverse Reactions: Allergic reactions including rashes, fever, urticaria, pruritis, anaphylaxis, gastrointestinal disturbances, glossitis, stomatitis, convulsions, coagulants & blood disorders, superinfection. Benzylpenicillin 1 mega unit (600 mg) Injection J01CE01702P4001XX (B) NEDL APPL System: Antiinfectives Indications: i) Infections caused by susceptible organisms. ii) Infective endocarditis. Dosage: i) Adult: 600 - 1200 mg IM 4 times dly, increased if necessary in more serious infections. Child : 50 - 100 mg/kg body weight dly IV in 2 - 4 divided doses. ii) Adult : 7.2 g daily by slow IV infusion in 6 divided doses. Contraindications: History of anaphylaxis, accelerated (e.g., hives) or serum sickness reaction to previous penicillin administration. Precautions: Allergic diathesis, bronchial asthma. Severe cardiopathies, hypovolaemia, epilepsy and renal or hepatic damage. Interactions: Bacteriostatic antibiotics, anti-inflammatory, antirheumatics, antipyretics, probenecids, oral contraceptives 222

Adverse Reactions: Hypersensitivity reactions, GI disturbances, eosinophilia, haemolytic anaemia, leucopenia, agranulocytosis. Convulsions in the presence of severely reduced renal function, epilepsy, meningitis or cerebral oedema or during cardiopulmonary bypass procedure. Benzylpenicillin 5 mega units (3 g) Injection J01CE01702P4002XX (B) NEDL APPL System: Antiinfectives Indications: i)Infections caused by susceptible organisms. ii)Infective endocarditis. Dosage: i)Adult: 600 - 1200 mg IM 4 times dly, increased if necessary in more serious infections. Child : 50 -100 mg/kg body weight dly IV in 2 - 4 divided doses. ii)Adult: 7.2 g daily by slow IV in 6 divided doses. Contraindications: History of anaphylaxis, accelerated (e.g., hives) or serum sickness reaction to previous penicillin administration. Precautions: Allergic diathesis, bronchial asthma. Severe cardiopathies, hypovolaemia, epilepsy and renal or hepatic damage. Interactions: Bacteriostatic antibiotics, anti-inflammatory, antirheumatics, antipyretics, probenecids, oral contraceptives Adverse Reactions: Hypersensitivity reactions, GI disturbances, eosinophilia, haemolytic anaemia, leucopenia, agranulocytosis. Convulsions in the presence of severely reduced renal function, epilepsy, meningitis or cerebral oedema or during cardiopulmonary bypass procedure. Phenoxymethyl Penicillin 125 mg/5 ml Syrup P e n i c i l l i n V - Trade Name
J01CE02520F2101XX (C) NEDL

System: Antiinfectives Indications: Treatment or prophylaxis of infections caused by susceptible organisms. Dosage: Child : Up to 1 yr: 62.5 mg 6 hrly; 1 - 5 yrs : 125 mg 6 hrly; 6 - 12 yrs : 250 mg 6 hrly. Contraindications: Hypersensitivity to penicillin. Precautions: Use cautiously in patients with penicillin or cephalosporin hypersensitivity reactions or asthma. Haematological & renal function test required on long-term treatment. Not for trivial infection. Renal or hepatic impairment. Interactions: Antirheumatics & antipyretics inhibit excretion. Neomycin may cause malabsorption. Adverse Reactions: Skin rashes, anaphylaxis, urticaria, fever, joint pain. Haemolytic anaemia, blood disorders, gastrointestinaI distress & superinfection. Phenoxymethyl Penicillin 125 mg Tablet P e n i c i l l i n V - Trade Name System: Antiinfectives 223
J01CE02520T1001XX (C) NEDL APPL

Indications: i) Treatment or prophylaxis of infections caused by susceptible organisms. ii) Prophylactic, rheumatic fever. Dosage: i) Treatment or prophylaxis of infections caused by susceptible organisms Adult : 500 - 750 mg 6 hrly. Child; up to 1 yr : 62.5 mg, 1 - 5 yrs : 125 mg , 6 - 12 yrs : 250 mg. Duration - 6 hrly. ii) Prophylactic, rheumatic fever- Adult : 125 - 250 mg bd. Child : 25 - 50 mg/kg in divided doses every 6 - 8 hrs. Max : 3 g/day. Contraindications: Hypersensitivity to penicillin. Precautions: Use cautiously in patients with penicillin or cephalosporin hypersensitivity reactions or asthma. Haematological & renal function test required on long-term treatment. Not for trivial infection. Renal or hepatic impairment. Interactions: Antirheumatics & antipyretics inhibit excretion. Neomycin may cause malabsorption. Adverse Reactions: Skin rashes, anaphylaxis, urticaria, fever, joint pain. Haemolytic anaemia, blood disorders, gastrointestinal distress & superinfection. Phenoxymethyl Penicillin 250 mg Tablet P e n i c i l l i n V - Trade Name
J01CE02520T1002XX (C) NEDL

System: Antiinfectives Indications: i)Treatment or prophylaxis of infections caused by susceptible organisms. ii) Prophylactic, rheumatic fever. Dosage: i) Treatment or prophylaxis of infections caused by susceptible organisms Adult : 500 - 750 mg 6 hrly. Child; up to 1 yr : 62.5 mg, 1 - 5 yrs : 125 mg , 6 - 12 yrs : 250 mg. Duration - 6 hrly. ii) Prophylactic, rheumatic fever- Adult : 125 - 250 mg bd. Child : 25 - 50 mg/kg in divided doses every 6 - 8 hrs. Max : 3 g/day. Contraindications: Hypersensitivity to penicillin. Precautions: Use cautiously in patients with penicillin or cephalosporin hypersensitivity reactions or asthma. Haematological & renal function test required on long-term treatment. Not for trivial infection. Renal or hepatic impairment. Interactions: Antirheumatics & antipyretics inhibit excretion. Neomycin may cause malabsorption. Adverse Reactions: Skin rashes, anaphylaxis, urticaria, fever, joint pain. Haemolytic anaemia, blood disorders, gastrointestinal distress & superinfection. Benzathine Penicillin 2.4 mega units Injection (1.8 g) Penadur L.A.
J01CE08702P4001XX (B) NEDL APPL
- Trade Name

System: Antiinfectives

224

Indications: (i) Treatment of mild to moderately severe infections due to Penicillin Gsensitive organisms. (ii) Treatment of syphillis Dosage: (i) Adult : 1.2 mega units IM (ii) For syphillis : 2.4 mega units weekly for 1-3 weeks Contraindications: Hypersensitivity to penicillins & cephalosporins. Severe pneumonia, empyema, sepsis, pericarditis, meningitis, peritonitis or arthritis requiring high dose of penicillin levels, bronchial asthma. Precautions: Diabetes. Not for SC, IV or intralumbarly or into body cavities. Impaired renal function, infants, elderly, hypersensitivity to cephalosporins. Interactions: Bacteriostatic antibiotics, anti-inflammatory, antirheumatics, antipyretics, probenec ids, oral contraceptives. Adverse Reactions: Allergic reactions, glossitis, stomatitis, haemolytic anaemia,leucopenia, thrombocytopenia, agranulocytosis, neuropathy, nephropathy, Jarisch-Herxheimer reactions secondary to bacteriolysis. Procaine Benzylpenicillin Aqueous 3 mega units (3 g) Injection
J01CE09702P4001XX (B)

System: Antiinfectives Indications: Treatment of infections due to Penicillin G sensitive organisms. Dosage: Adult : 300,000 - 900,000 units ( 300 - 900 mg) IM dly. Child : Up to 1 yr : 150 mg IM dly. 1 - 5 yrs : 300 mg IM dly. 6 - 12 yrs : 600 mg IM dly. Contraindications: History of anaphylactic, accelerated allergic (eg, hives) or serum sickness reactions to previous penicillin administration. Hypersensitivity to procaine. Precautions: History of penicillin or cephalosporin hypersensitivity reactions. Histories of significant allergies and or asthma. Inadvertent intra-arterial administration or injection into or near major peripheral nerves or blood vessels. Interactions: Probenecid, bacteriostatic antibacterials such as chloramphenicol and tetracyclines, anticoagulants, methotrexate and oral contraceptives. Adverse Reactions: Hypersensitivity reactions, especially skin rashes, anaphylaxis, haemolytic anaemia and neutropenia, prolongation of bleeding time and defective platelet function, convulsions and other signs of CNS toxicity (encephalopathy has followed intrathecal administration and can be fatal) and electrolyte disturbances. Procaine Benzylpenicillin Aqueous 4 mega units (4 g) Injection
J01CE09702P4002XX (B) NEDL APPL

System: Antiinfectives Indications: 225

Treatment of infections due to Penicillin G sensitive organisms. Dosage: Adult : 300,000 - 900,000 units (300 - 900 mg) IM dly. Child : Up to 1 yr : 150 mg IM dly. 1 - 5 y rs : 300 mg IM dly. 6 - 12 yrs : 600 mg IM dly. Contraindications: History of anaphylactic, accelerated allergic (eg, hives) or serum sickness reactions to previous penicillin administration. Hypersensitivity to procaine. Precautions: History of penicillin or cephalosporin hypersensitivity reactions. Histories of significant allergies and or asthma. Inadvertent intra-arterial administration or injection into or near major peripheral nerves or blood vessels. Interactions: Probenecid, bacteriostatic antibacterials such as chloramphenicol and tetracyclines, anticoagulants, methotrexate and oral contraceptives. Adverse Reactions: Hypersensitivity reactions, especially skin rashes, anaphylaxis, haemolytic anaemia and neutropenia, prolongation of bleeding time and defective platelet function, convulsions and other signs of CNS toxicity (encephalopathy has followed intrathecal administration and can be fatal), and electrolyte disturbances. Cloxacillin Sodium 250 mg Capsule Orbenin - Trade Name
J01CF02520C1001XX (B) NEDL APPL

System: Antiinfectives Indications: Treatment of susceptible bacterial infections, notably penicillinase-producing staphylococci. Dosage: Adult : 250 - 500 mg every 6 hours. Child : 2 - 10 yrs : 250 mg qid; < 2 yrs : 125 mg qid. Contraindications: Hypersensitivity to cloxacillin products/penicillins Precautions: Renal impairment. Neonates born of mothers hypersensitive to penicillin. Hypersensitivity to cephalosporins. Interactions: Probenecid impairs renal excretion. Decreases anticoagulant effect. Adverse Reactions: Occasional rashes, GI upsets, anaphylaxis. Cloxacillin Sodium 125 mg/5 ml Suspension J01CF02520L8001XX (B) NEDL APPL Orbenin - Trade Name System: Antiinfectives Indications: Treatment of susceptible bacterial infections, notably penicillinase-producing staphylococci. Dosage: Child : Under 1 yr : 62.5 - 125 mg 6 hrly. 1 - 5 yrs: 125 - 250 mg 6 hrly. Contraindications: Hypersensitivity to cloxacillin products/penicillins Precautions: Renal impairment. Neonates born to mothers hypersensitive to 226

penicillin. Hypersensitivity to cephalosporins. Interactions: Probenecid impairs renal excretion. Decreases anticoagulant effect. Adverse Reactions: Occasional rashes, GI upsets, anaphylaxis. Cloxacillin Sodium 250 mg Injection Orbenin - Trade Name
J01CF02520P4001XX (B) APPL

System: Antiinfectives Indications: Treatment of susceptible bacterial infections, notably penicillinase-producing staphylococci infections. Dosage: Adult : IM 250 mg 4 - 6 hrly, IV 500 mg 4 - 6 hrly. Severe infections : Doses may be doubled. Child : <2 yrs : quarter adult dose, 2 - 10 yrs : half adult dose. Contraindications: Hypersensitivity to cloxacillin products/penicillins Precautions: Hypersensitivity to cephalosporins. Jaundiced neonates, impaired renal function. Avoid subconjunctival injection or use in eye drops. Interactions: Tetracycline, oestrogen-containing oral contraceptives. Adverse Reactions: Fever, rash, nausea, vomiting, diarrhoea, hepatotoxicity, anaphylaxis. Cloxacillin Sodium 500 mg Injection Orbenin - Trade Name
J01CF02520P4002XX (B) NEDL APPL

System: Antiinfectives Indications: Treatment of susceptible bacterial infections, notably penicillinase-producing staphylococci infections. Dosage: Adult : IM 250 mg 4 - 6 hrly, IV 500 mg 4 - 6 hrly. Severe infections : Doses may be doubled. Child : <2 yrs : quarter adult dose, 2 - 10 yrs : half adult dose. Contraindications: Hypersensitivity to cloxacillin products/penicillins Precautions: Hypersensitivity to cephalosporins. Jaundiced neonates. Impaired renal function. Avoid subconjunctival injection or use in eye drops. Interactions: Tetracycline, oestrogen-containing oral contraceptives. Adverse Reactions: Fever, rash , nausea, vomiting, diarrhoea, hepatotoxicity, anaphylaxis. Ampicillin & Sulbactam 250 mg/5 ml Suspension Unasyn Susp. - Trade Name
J01CR01961F2101XX (A)

System: Antiinfectives Indications: Treatment of susceptible bacterial infections Dosage: Adult: 375-750mg db. Child > 30 kg - adult dose, < 30 kg : 25 - 50 mg/kg/day in 2 divided doses. Contraindications: History of allergic reaction to any penicillins. 227

Precautions: Overgrowth of non-susceptible organism. Check periodically for organ system dysfunction during prolong therapy. Interactions: No interactions found. Adverse Reactions: GI disturbances, phlebitis, skin rashes, itching, blood disorders, anaphylaxis and superinfection. Ampicillin & Sulbactam 750 mg Injection U n a s y n - Trade Name
J01CR01961P4001XX (A) NEDL

System: Antiinfectives Indications: Treatment of susceptible bacterial infections. Dosage: Adults: 1.5 - 12 g/day in divided doses 6 - 8 hrly. Max : 4 g Sulbactam. Child: 150 mg/kg/day 6 - 8 hrly. Prophylaxis: 1.5 - 3 g at induction of anaesthesia. May be repeated 6 - 8 hrly. Contraindications: History of allergic reaction to any penicillins. Precautions: Overgrowth of non-susceptible organism. Check periodically for organ system dysfunction during prolong therapy. Interactions: Concurrent use with oral contraceptives may result in decreased contraceptive effectiveness. Adverse Reactions: GI disturbances, phlebitis, skin rashes, itching, blood disorders, anaphylaxis and superinfection. Ampicillin & Sulbactam 1.5 g Injection U n a s y n - Trade Name
J01CR01961P4002XX (A) NEDL

System: Antiinfectives Indications: Treatment of susceptible bacterial infections. Dosage: Adults: 1.5 - 12 g/day in divided doses 6 - 8 hrly. Max : 4 g Sulbactam. Child: 150 mg/kg/day 6 - 8 hrly. Prophylaxis: 1.5 - 3 g at induction of anaesthesia. May be repeated 6 - 8 hrly. Contraindications: History of allergic reaction to any penicillins. Precautions: Overgrowth of non-susceptible organism. Check periodically for organ system dysfunction during prolong therapy. Interactions: Concurrent use with oral contraceptives may result in decreased contraceptive effectiveness. Adverse Reactions: GI disturbances, phlebitis, skin rashes, itching, blood disorders, anaphylaxis and superinfection. Ampicillin & Sulbactam 375 mg Tablet U n a s y n - Trade Name
J01CR01961T1001XX (A)

System: Antiinfectives Indications: Treatment of susceptible bacterial infections . Dosage: Adult and child > 30 kg: 375 - 750 mg bd. Max : 3 g dly. Contraindications: History of allergic reaction to any penicillins. 228

Precautions: Overgrowth of non-susceptible organism. Check periodically for organ system dysfunction during prolong therapy. Interactions: No interactions found. Adverse Reactions: GI disturbances, phlebitis, skin rashes, itching, blood disorders, anaphylaxis and superinfection. Amoxycillin/Clavulanate 228 mg/5 ml Syrup A u g m e n t i n - Trade Name
J01CR02961F2102XX (A/KK)

System: Antiinfectives Indications: Infections caused by susceptible organisms. Dosage: Moderate infections: Child: 7-12 yr 10 ml, 2-6 yr 5 ml. Severe infections: 2-6 yr 10 ml. Contraindications: Hypersensitivity to ampicillin/penicillin/sulbactam products. History of penicillin-associated cholestatic jaundice/hepatic dysfunction. Precautions: Renal impairment, severe hepatic dysfunction Interactions: Aminoglycosides, anti-coagulants, oral contraceptives. Adverse Reactions: Diarrhoea, pseudomembraneous colitis, indigestion, GI upsets, increased liver enzyme. Amoxycillin & Clavulanic Acid 600 mg Injection J01CR02961P4001XX (A) NEDL Amoxycillin & Clavulanic Acid 1.2 g Injection J01CR02961P4002XX (A) NEDL A u g m e n t i n - Trade Name System: Antiinfectives Indications: Infections caused by susceptible organisms. Dosage: Adult & child > 12 yrs, mild to moderate infections : 0.6 - 1.2 g by IV or intermittent infusion 6 - 8 hrly. Contraindications: Hypersensitivity to ampicillin/penicillin/sulbactam products. History of penicillin-associated cholestatic jaundice/hepatic dysfunction. Precautions: Pregnancy, breast-feeding period, renal/liver failure, pseudomembranous colitis. Interactions: Aminoglycosides, anti-coagulants. Adverse Reactions: Diarrhoea, pseudomembraneous colitis, GI upsets, increased liver enzyme, urticaria and erythematous multiforme, StevenJohnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, transient leucopenia, thrombocytopenia, haemolytic anaemia. Amoxycillin & Clavulanic Acid 375 mg Tablet Augmentin
J01CR02961T1001XX (A/KK) NEDL APPL
- Trade Name

System: Antiinfectives

229

Indications: Infections caused by susceptible organisms. Dosage: Adult: 375 - 750 mg tds. Max: 3 g dly. Contraindications: Hypersensitivity to ampicillin/penicillin/sulbactam products. History of penicillin-associated cholestatic jaundice/hepatic dysfunction. Precautions: Renal impairment, severe hepatic dysfunction Interactions: Aminoglycosides, anti-coagulants, oral contraceptives. Adverse Reactions: Diarrhoea, pseudomembraneous colitis, indigestion, GI upsets, increased liver enzyme. Piperacillin 4g & Tazobactam 500mg Injection Taz o c i n 4 . 5 g - Trade Name
J01CR05961P3001XX (A*)

System: Antiinfectives Indications: Febrile neutropenia, lower respiratory infection and severe sepsis. Dosage: - Adult and children > 12 yrs:- 4.5 g 8 hrly. - Renal insufficiency: CrCL 20 -80 ml/min: 4.5 g 8 hrly. CrCL <20ml/min: 4.5g 12 hrly - Neutropenia adult and children >12yrs, >50kg: 4.5g 6 hrly in combination with aminoglycoside - Children with normal renal function & < 50kg : 90mg/kg 6 hrly in combination with aminoglycosides. Contraindications: Hypersensitivity to penicillin, cephalosporin. Precautions: Bleeding manifestations, neuromuscular excitability in renal impairment, increased risk of fever and rash in cystic fibrosis, patients requiring sodium restriction. Not to use in children who do not have neutropenia. Interactions: Methotrexate, probenecid ,vecuronium. Adverse Reactions: Allergic reaction, diarrhoea, nausea & vomiting, headache, injection site reactions, rash, pruritus, anaphylaxis. Cephalexin Monohydrate 250 mg Capsule Cephalexin Monohydrate 500 mg Capsule C e p o r e x - Trade Name
J01DA01010C1001XX (B) APPL J01DA01010C1002XX (B)

System: Antiinfectives Indications: i) Respiratory tract infection, urinary tract infection ii) Complicated, recurrent or chronic infections, bronchitis iii)Pneumonia. Dosage: i) 250 mg 6 hly. ii) 250 - 500 mg 6 hrly. iii) 1 - 1.5 g tds or qid. Max: 6 g/day. Contraindications: Hypersensitivity to cephalosporins. Precautions: Hypersensitivity to penicillins, renal impairment, superinfection. Interactions: Concurrent treatment with high doses of cephalosporins & aminoglycosides or potent diuretics may adversely affect renal function. 230

Probenecid may increase or prolong plasma level & toxicity of cephalosporins. Adverse Reactions: GI disturbances, overgrowth of non-susceptible organisms, hypersensitivity reactions, reversible neutropenia. Cephalexin Monohydrate 125 mg/5 ml Syrup Cephalexin Monohydrate 250 mg/5 ml Syrup C e p o r e x - Trade Name
J01DA01010F2101XX (B) NEDL J01DA01010F2102XX (B) NEDL

System: Antiinfectives Indications: Respiratory tract infections,ear, nose and throat infections, urinary tract infections, obstetric and gynaecologic infections. Dosage: Child : 25 - 100 mg/kg daily in divided doses. Max : 4 g dly. Contraindications: Hypersensitivity to cephalosporins. Precautions: Hypersensitivity to penicillins, renal impairment, superinfection. Interactions: Concurrent treatment with high doses of cephalosporins & aminoglycosides or potent diuretics may adversely affect renal function. Probenecid may increase or prolong plasma level & toxicity of cephalosporins. Adverse Reactions: GI disturbances, overgrowth of non-susceptible organisms, hypersensitivity reactions, reversible neutropenia. Cephalexin Monohydrate 250 mg Tablet C e p o r e x - Trade Name
J01DA01010T1001XX (B) APPL

System: Antiinfectives Indications: i) Respiratory tract infection, urinary tract infection ii) Complicated, recurrent or chronic infections, bronchitis iii)Pneumonia. Dosage: Adult: i) 250 mg 6 hrly. ii) 250 - 500 mg 6 hrly. iii) 1 - 1.5 g tds - qid. Max: 6 g/day. Contraindications: Hypersensitivity to cephalosporins. Precautions: Hypersensitivity to penicillins, renal impairment, superinfection. Interactions: Concurrent treatment with high doses of cephalosporins & aminoglycosides or potent diuretics may adversely affect renal function. Probenecid may increase or prolong plasma level & toxicity of cephalosporins. Adverse Reactions: GI disturbances, overgrowth of non-susceptible organisms, hypersensitivity reactions, reversible neutropenia. Cephalexin Monohydrate 500 mg Tablet C e p o r e x - Trade Name System: Antiinfectives
J01DA01010T1002XX (B) NEDL

231

Indications: i) Respiratory tract infection, urinary tract infection ii) Complicated, recurrent or chronic infections, bronchitis iii)Pneumonia. Dosage: Adult: i) 250 mg 6 hrly. ii) 250 - 500 mg 6 hrly. iii) 1 - 1.5 g tds - qid. Max: 6 g/day. Contraindications: Hypersensitivity to cephalosporins. Precautions: Hypersensitivity to penicillins. Renal impairment. Superinfection. Interactions: Concurrent treatment with high doses of cephalosporins & aminoglycosides or potent diuretics may adversely affect renal function. Probenecid may increase or prolong plasma level & toxicity of cephalosporins. Adverse Reactions: GI disturbances; overgrowth of non-susceptible organisms; Hypersensitivity reactions, Rarely, reversible neutropenia. Cefuroxime Axetil 125 mg/5 ml Suspension Zinnat - Trade Name
J01DA06233F2101XX (A) NEDL

System: Antiinfectives Indications: Infections caused by susceptible organisms. Dosage: 250 mg bd for otitis media, for other infections 125 mg bd. Contraindications: Hypersensitivity to cephalosporins. Precautions: Anaphylactic reaction to penicillins. Interactions: Aminoglycosides, typhoid vaccine. Adverse Reactions: GI disturbances occasionally pseudomembraneous colitis, hypersensitivity reactions, eosinophilia, headache, superinfection. Cefuroxime Axetil 125 mg Tablet Zinnat - Trade Name
J01DA06233T1001XX (A)

System: Antiinfectives Indications: i) Upper respiratory tract, GUT, skin & soft tissue infections, pyelonephritis. ii) Urinary tract infection. Dosage: i) Adult : 250 mg bd. Pneumonia : 500 mg bd. ii) Adult : 125 mg bd. Child : 125 mg bd. Contraindications: Hypersensitivity to cephalosporins. Precautions: Anaphylactic reaction to penicillins. Interactions: Aminoglycosides, typhoid vaccine. Adverse Reactions: GI disturbances occasionally pseudomembraneous colitis, hypersensitivity reactions, eosinophilia, headache, superinfection. Cefuroxime Axetil 250 mg Tablet Zinnat - Trade Name System: Antiinfectives 232
J01DA06233T1002XX (A/KK) NEDL APPL

Indications: i) Upper respiratory tract, GUT, skin & soft tissue infections, pyelonephritis. ii) Urinary tract infection. Dosage: i) Adult : 250 mg bd. Pneumonia : 500 mg bd. ii) Adult : 125 mg bd. Child : 125 mg bd. Contraindications: Hypersensitivity to cephalosporins. Precautions: Anaphylactic reaction to penicillins. Interactions: Aminoglycosides, typhoid vaccine. Adverse Reactions: GI disturbances occasionally pseudomembraneous colitis, hypersensitivity reactions, eosinophilia, headache, superinfection. Cefuroxime Sodium 250 mg Injection Cefuroxime Sod 750 mg Injection Cefuroxime Sod 1.5 g Injection Zinacef - Trade Name
J01DA06520P4001XX (A) NEDL J01DA06520P4002XX (A) NEDL APPL J01DA06520P4003XX (A) NEDL APPL

System: Antiinfectives Indications: Infections caused by susceptible organisms, surgical prophylaxis. Dosage: Adult : 750 mg 6 - 8 hrs IM or IV. Severe infections : 1.5 g tds - qid IV. Child : 30 - 200 mg/kg/day in 2 - 4 divided doses. Contraindications: Hypersensitivity to cephalosporins. Precautions: Anaphylactic reaction to penicillins, concurrent treatment with potent diuretics. Renal impairment. Interactions: Probenecid, aminoglycosides, live typhoid vaccine. Adverse Reactions: Hypersensitivity , GI disturbances including pseudomembraneous colitis, haematological changes, superinfection, transient pain at IM inj site, thrombophlebitis (IV inj). Cefaclor 500 mg Capsule C e c l o r , D i s t a c l o r - Trade Name
J01DA08000C1002XX (A) NEDL

System: Antiinfectives Indications: Infections caused by susceptible organisms including Staphylococcus aureus and H. Influenzae, treatment of sinusitis and infections involving the respiratory tract, skin and skin structure, bone and joint, and urinary tract. Dosage: Adult: 250 mg tds for 10 days. For severe infections, double dosage. Max: 4 g dly. Child : 20 - 40 mg/kg body wt. dly in 3 divided doses. Max : 1 g dly. Contraindications: Hypersensitivity to cephalosporins. Precautions: Penicillin-sensitive patients, impaired renal function. Interactions: Probenecid, anticoagulants, bacteriostatic antibiotics may reduce cephalosporin effectiveness. Adverse Reactions: Blood disorders, GI disturbances, CNS effects, allergic skin reactions.

233

Cefaclor 125 mg/5 ml Suspension C e c l o r , D i s t a c l o r - Trade Name

J01DA08000F2101XX (A)

System: Antiinfectives Indications: Infections caused by susceptible organisms including Staphylococcus aureus and H. Influenzae, treatment of sinusitis and infections involving the respiratory tract, skin and skin structure, bone and joint, and urinary tract. Dosage: 20 - 40 mg/kg body wt dly in 3 divided doses. Max : 1 g dly. Contraindications: Hypersensitivity to cephalosporins. Precautions: Penicillin-sensitive patients, impaired renal function. Interactions: Probenecid, anticoagulants, bacteriostatic antibiotics may reduce cephalosporin effectiveness. Adverse Reactions: Blood disorders, GI disturbances, CNS effects, allergic skin reactions. Cefaclor 375 mg Tablet C e c l o r , D i s t a c l o r - Trade Name
J01DA08010T1001XX (A)

System: Antiinfectives Indications: Infections caused by susceptible organisms including Staphylococcus aureus and H. Influenzae, treatment of sinusitis and infections involving the respiratory tract, skin and skin structure, bone and joint, and urinary tract. Dosage: 20 - 40 mg/kg body wt dly in 3 divided doses. Max : 1 g dly. Contraindications: Hypersensitivity to cephalosporins. Precautions: Penicillin-sensitive patients, impaired renal function. Interactions: Probenecid, anticoagulants, bacteriostatic antibiotics may reduce cephalosporin effectiveness. Adverse Reactions: Blood disorders, GI disturbances, CNS effects, allergic skin reactions. Cefotaxime 500 mg Injection Cefotaxime 1 g Injection C l a f o r a n - Trade Name
J01DA10520P4001XX (A) APPL J01DA10520P4002XX (A) APPL

System: Antiinfectives Indications: Infections due to gram-negative bacteria. Dosage: Adult : 1 g 12 hrly (up to 12 g/day in severe cases). Child : 50 - 200 mg/kg/day in 2 - 4 divided doses. Contraindications: Hypersensitivity to cephalosporins. Precautions: Hypersensitivity to penicillins, pregnancy. Interactions: Aminoglycosides, typhoid vaccine. Adverse Reactions: Thrombocytopenia, eosinophilia, leucopenia, hypersensitivity reactions, GI effects, anaphylactic shock(rare). 234

Ceftazidime 250 mg Injection Fortum - Trade Name

J01DA11520P4001XX (A) NEDL

System: Antiinfectives Indications: Severe gram negative bacterial infections. Dosage: Adult : 1 g 8 hrly or 2 g 12 hrly. In severe infections : 2 g 8 hrly. Child : 25 200 mg/kg/day in 2 - 3 divided doses. Contraindications: Hypersensitivity to cephalosporins. Precautions: Hypersensitivity to penicillins, renal impairment. Interactions: Aminoglycosides, chloramphenicol, live typhoid vaccine. Adverse Reactions: GI upsets, CNS effects, phlebitis or thrombophlebitis at the IV injection site, pain and/or inflammation after IM injection, very rarely hypersensitivity reactions. Transient haematologicals changes. Ceftazidime 500 mg Injection Fortum - Trade Name
J01DA11520P4002XX (A)

System: Antiinfectives Indications: Severe gram negative bacterial infections. Dosage: Adult : 1 g 8 hrly or 2 g 12 hrly. In severe infections : 2 g 8 hrly. Child : 25 200 mg/kg/day in 2 - 3 divided doses. Contraindications: Hypersensitivity to cephalosporins. Precautions: Hypersensitivity to penicillins, renal impairment. Interactions: Aminoglycosides, chloramphenicol, live typhoid vaccine. Adverse Reactions: GI upsets, CNS effects, phlebitis or thrombophlebitis at the IV injection site, pain and/or inflammation after IM injection, very rarely hypersensitivity reactions. Transient haematologicals changes. Ceftazidime 1 g Injection Fortum - Trade Name
J01DA11520P4003XX (A) APPL

System: Antiinfectives Indications: Severe gram negative bacterial infections. Dosage: Adult : 1 g 8 hrly or 2 g 12 hrly. In severe infections : 2 g 8 hrly. Child : 25 - 200 mg/kg/day in 2 - 3 divided doses. Contraindications: Hypersensitivity to cephalosporins. Precautions: Hypersensitivity to penicillins, renal impairment. Interactions: Aminoglycosides, chloramphenicol, live typhoid vaccine. Adverse Reactions: GI upsets, CNS effects, phlebitis or thrombophlebitis at the IV injection site, pain and/or inflammation after IM injection, very rarely hypersensitivity reactions. Transient haematologicals changes.

235

Ceftazidime 2 g Injection Fortum - Trade Name

J01DA11520P4004XX (A) NEDL APPL

System: Antiinfectives Indications: Severe gram negative bacterial infections. Dosage: Adult : 1 g 8 hrly or 2 g 12 hrly. In severe infections : 2 g 8 hrly. Child : 25 - 200 mg/kg/day in 2 - 3 divided doses. Contraindications: Hypersensitivity to cephalosporins. Precautions: Hypersensitivity to penicillins, renal impairment. Interactions: Aminoglycosides, chloramphenicol, live typhoid vaccine. Adverse Reactions: GI upsets, CNS effects, phlebitis or thrombophlebitis at the IV injection site, pain and/or inflammation after IM injection, very rarely hypersensitivity reactions. Transient haematologicals changes. Ceftriaxone 0.25 g Injection R o c e p h i n - Trade Name
J01DA13520P4001XX (A/KK)

System: Antiinfectives Indications: i) Gonorrhoea ii) Chancroid. Dosage: i) 250 mg by deep IM Inj. and ii) single IM inj. 250 mg only. For severe infection up to 100 mg/kg/day. Contraindications: Hypersensitivity to penicillins. Precautions: Previous hypersensitivity to penicillins, anaphylactic shock, severe renal & hepatic failure, pregnancy. Interactions: Aminoglycosides, cyclosporin, typhoid vaccine. Adverse Reactions: GI upsets, haematological changes, skin reactions, coagulation disorders, phlebitis, agranulocytosis, renal precipitations. Ceftriaxone 0.5 g Injection R o c e p h i n - Trade Name
J01DA13520P4002XX (A)

System: Antiinfectives Indications: Infections caused by susceptible organisms. Dosage: Adult : 1 - 2 g once dly. Severe infection : 2 - 4 g once dly. Infant and Child , 3 wks - 12 yrs : 20 - 80 mg/kg body wt dly. Child with body weight 50 kg or more : adult dose. Neonate up to 2 wks : 20 - 50 mg/kg body wt dly, not to exceed 50 mg/kg. Contraindications: Hypersensitivity to penicillins. Precautions: Previous hypersensitivity to penicillins, anaphylactic shock, severe renal & hepatic failure, pregnancy. Interactions: Aminoglycosides, cyclosporin, typhoid vaccine. Adverse Reactions: GI upsets, haematological changes, skin reactions, coagulation disorders, phlebitis, agranulocytosis, renal precipitations. 236

Ceftriaxone 1g Injection R o c e p h i n - Trade Name

J01DA13520P4003XX (A) APPL

System: Antiinfectives Indications: Infections caused by susceptible organisms. Dosage: Adult : 1 - 2 g once dly. Severe infection : 2 - 4 g once dly. Infant and Child , 3 wks - 12 yrs : 20 - 80 mg/kg body wt dly. Child with body weight 50 kg or more : adult dose. Neonate up to 2 wks : 20 - 50 mg/kg body wt dly, not to exceed 50 mg/kg. Contraindications: Hypersensitivity to penicillins. Precautions: Previous hypersensitivity to penicillins. Anaphylactic shock, severe renal & hepatic failure, pregnancy. Interactions: Aminoglycosides, cyclosporin, typhoid vaccine. Adverse Reactions: GI upsets, haematological changes, skin reactions, coagulation disorders, phlebitis, agranulocytosis, renal precipitations. Cefepime 500 mg Injection M a x i p i m e - Trade Name
J01DA24110P4001XX (A*)

System: Antiinfectives Indications: Febrile neutropenia, septicaemia, lower respiratory tract infection, urinary tract infection, skin and skin structure infections, gynaecologic and intra-abdominal infections. Dosage: Adult : 1 - 2 g bd for most infections. For severe infections including febrile neutropenia : 2 g tds. Child : 25 - 50 mg/kg tds. Contraindications: Hypersensitivity to cephalosporins, penicillins or other beta-lactam antibiotics. Precautions: Hypensensitivity, pseudomembranous colitis & superinfection may occur. Discontinue therapy if allergic reaction occurs. Pregnancy, lactation. Children less than 13yrs. Interactions: Aminoglycosides, typhoid vaccine, frusemide. Adverse Reactions: Headache, colitis, diarrhoea, dyspepsia, local reactions, phlebitis, pain or inflammation, rash. Cefepime 1 g Injection Maxipi m e - Trade Name
J01DA24110P4002XX (A*)

System: Antiinfectives Indications: Febrile neutropenia, septicaemia, lower respiratory tract infection, urinary tract infection, skin and skin structure infections, gynaecologic and intra-abdominal infections. Dosage: Adult : 1 - 2 g bd for most infections. For severe infections including febrile neutropenia : 2 g tds. Child : 25 - 50 mg/kg tds. Contraindications: Hypersensitivity to cephalosporins, penicillins or other 237

beta-lactam antibiotics. Precautions: Hypensensitivity, pseudomembranous colitis & superinfection may occur. Discontinue therapy if allergic reaction occurs. Pregnancy, lactation. Children less than 13yrs. Interactions: Aminoglycosides, typhoid vaccine, frusemide. Adverse Reactions: Headache, colitis, diarrhoea, dyspepsia, local reactions, phlebitis, pain or inflammation, rash. Cefoperazone 500mg & Sulbactam 500mg Injection J01DA32000P4001XX (A) Sulferazon - Trade Name System: Antiinfectives Indications: i) Treatment of infections due to multi-drug resistance pathogens producing Blactamase ii) Treatment of infections caused by Acinetobacter spp. Dosage: Adult : 1 - 2 g bd. Child : 40 - 80 mg/kg/day. Contraindications: Known allergy to penicillins or cephalosporins. Precautions: Hepatic dysfunction & concomitant renal impairment, ingestion of alcoholic beverages; overgrowth of nonsusceptible organisms. Interactions: Aminoglycosides, heparin, typhoid vaccine, warfarin. Adverse Reactions: Diarrhoea, nausea , vomiting, maculopapular rash, urticaria; eosinophilia; drug fever. Cefoperazone Sodium 500 mg Injection C e f o b i d - Trade Name
J01DA32520P4001XX (A) NEDL APPL

System: Antiinfectives Indications: Infections due to gram-negative bacteria. Dosage: Adult : 1 - 2 g bd IM or IV. By IV, adult dose may be doubled. Max : 16 g daily in divided doses. Child : 50 - 200 mg/kg/day in 2 - 4 divided doses. Contraindications: Previous hypersensitvity to cephalosporin. Precautions: Penicillin-sensitive patients, severe biliary obstruction, severe hepatic disease or coex isting renal dysfunction. Interactions: Aminoglycosides, heparin, typhoid vaccine, warfarin. Adverse Reactions: Hypersensitivity reactions eg. Rash, urticaria, fever, neutropenia (reversible), hypothrombinaemia, GI effects & local reactions, vit K deficiency. Cefoperazone Sodium 1 g Injection C e f o b i d - Trade Name System: Antiinfectives
J01DA32520P4002XX (A) NEDL APPL

238

Indications: Infections due to gram-negative bacteria. Dosage: Adult : 1 - 2 g bd IM or IV. By IV, adult dose may be doubled. Max : 16 g daily in divided doses. Child : 50 - 200 mg/kg/day in 2 - 4 divided doses. Contraindications: Previous hypersensitvity to cephalosporin. Precautions: Penicillin-sensitive patients, severe biliary obstruction, severe hepatic disease or coexisting renal dysfunction. Interactions: Aminoglycosides, heparin, typhoid vaccine, warfarin. Adverse Reactions: Hypersensitivity reactions eg. Rash, urticaria , fever, neutropenia(reversible), hypothrombinaemia, GI effects & local reactions, vit K deficiency. Cefoperazone Sodium 2 g Injection C e f o b i d - Trade Name
J01DA32520P4003XX (A)

System: Antiinfectives Indications: Infections due to gram-negative bacteria. Dosage: Adult : 1 - 2 g bd IM or IV. By IV, adult dose may be doubled. Max : 16 g daily in divided doses. Child : 50 - 200 mg/kg/day in 2 - 4 divided doses. Contraindications: Previous hypersensitvity to cephalosporin. Precautions: Penicillin-sensitive patients, severe biliary obstruction, severe hepatic disease or coexisting renal dysfunction. Interactions: Aminoglycosides, heparin, typhoid vaccine, warfarin. Adverse Reactions: Hypersensitivity reactions eg. Rash, urticaria , fever, neutropenia (reversible), hypothrombinaemia, GI effects & local reactions, vit K deficiency. Meropenem 500 mg IV Injection Meropenem 1g Injection M e r o n e m - Trade Name
J01DH02000P4001XX (A*) J01DH02000P4002XX (A*)

System: Antiinfectives Indications: 1. Emperical treatment for presume infections in patients (adult & children) with febrile neutropenia, used as monotherapy or in combination with anti -virals or antifungal agent. 2. Septicaemia 3. Serious infections in renal impaired patients. Dosage: Adult: 0.5 - 1g tds Child: 10 - 20 mg/kg tds (except meningitis 40 mg/kg) Contraindications: Hypersensitivity to meronem, carbapenems, penicillins or other b-lactam antibiotics. Precautions: History of hypersensitivity to carbapenems or other beta-lactam antibiotics. Monitor transaminase & bilirubin levels when used in hepatic disease. Not recommended for MRSA infections. Consider diagnosis of pseudomembranous colitis in patients who develop diarrhoea. Critically ill 239

patients with P. aeruginosa infection. Pregnancy and lactation. Interactions: Probenecid, Valproic acid. Adverse Reactions: Local inj site reactions, rash, pruritus, urticaria, nausea, vomiting, diarrhoea, headache, paraesthesia, oral & vaginal candidiasis, reversible thrombocytopenia, eosinophilia, thrombocytopenia, neutropenia. Imipenem 250 mg & Cilastatin 250 mg Injection J01DH51961P4001XX (A*) APPL T i e n a m - Trade Name System: Antiinfectives Indications: Severe infections caused by susceptible pathogens especially useful in infections involving ESBL organisms. Not to be used for prophylaxis. Dosage: Based on type or severity of infection, susceptibility of pathogen(s) and patient condition including body wt and renal function. Adult : 1 - 2 g dly in 3 - 4 divided doses. Max : 50 mg/kg/day or < 4 g dly. Infusion rate : <500 mg dose over 20 - 30 mins, >500 mg dose over 40 - 60 mins. Child : 15 - 30 mg/kg/dose, infusion at 6 - 12 hrly intervals depending on age. Max : 2 g/day. Contraindications: Hypersensitivity to amide-type local anaesthetic. Severe shock/heart block. Precautions: Dosage adjustment in patients with renal insufficiency. Partial cross allergenicity with other beta-lactam antibiotics. History of GI disease. Caution in patients with CNS disorders and or compromised renal function in whom accumulation of drug could occur. If CNS symptoms occur, dosage should be decreased or discontinued. Usage during pregnancy, lactation and children < 3 month or paediatrics patients with impaired renal function. Interactions: Ganciclovir. Adverse Reactions: Thrombophlebitis, pain, erythema & tenderness following injection. Rash, urticaria, pruritus, GI disturbances, pseudomembranous colitis, haematological disturbances, increase in liver enzymes, taste perversion. Myoclonic activity, seizures, psychic disturbances, confusional states. Imipenem 500 mg & Cilastatin 500 mg Injection J01DH51961P4002XX (A*) APPL T i e n a m - Trade Name System: Antiinfectives

240

Indications: Severe infections caused by susceptible pathogens especially useful in infections involving ESBL organisms. Not to be used for prophylaxis. Dosage: Based on type or severity of infection, susceptibility of pathogen(s) and patient condition including body wt and renal function. Adult : 1 - 2 g dly in 3 - 4 divided doses. Max : 50 mg/kg/day or < 4 g dly. Infusion rate : <500 mg dose over 20 - 30 mins, >500 mg dose over 40 - 60 mins. Child : 15 - 30 mg/kg/dose infusion at 6 - 12 hrly intervals depending on age. Max : 2 g/day. Contraindications: Hypersensitivity to amide-type local anaesthetic. Severe shock/heart block. Precautions: Dosage adjustment in patients with renal insufficiency. Partial cross allergenicity with other beta-lactam antibiotics. History of GI disease. Caution in patients with CNS disorders and or compromised renal function in whom accumulation of drug could occur. If CNS symptoms occur, dosage should be decreased or discontinued. Usage during pregnancy, lactation and children < 3 month or paediatrics patients with impaired renal function. Interactions: Ganciclovir. Adverse Reactions: Thrombophlebitis, pain, erythema & tenderness following inj. Rash, urticaria, pruritus, GI disturbances, pseudomembranous colitis, haematological disturbances, increase in liver enzymes, taste perversion. Myoclonic activity, seizures, psychic disturbances,confusional states. Trimethoprim 100 mg Tablet A l p r i m - Trade Name
J01EA01000T1001XX (B)

System: Antiinfectives Indications: Treatment of urinary tract infections due to susceptible pathogens. Dosage: Adult : 200 mg dly in 1 or 2 divided doses or 300 mg dly as a single dose. Acute infection : 200 mg bd. Child : 6 - 12 yrs : 100 mg bd ; 6 mths -5 yrs : 50 mg bd. Contraindications: Hypersensitivity to trimethoprim or any component, megaloblastic anaemia due to folate deficiency. Precautions: Renal/hepatic impairment, folate deficiency, elderly and malnourished patients or with possible folate deficiency, nursing woman. Interactions: Increased effect, toxicity or levels of phenytoin, increased myelosuppression with methotrexate, may increase levels of digoxin. Adverse Reactions: Rash, pruritus, exfoliative dermatitis, nausea, vomiting, anorexia, and infrequent hematologic reactions (thrombocytopenia, leucopenia, and megaloblastic anaemia) with chronic high dose. Trimethoprim 300 mg Tablet A l p r i m - Trade Name System: Antiinfectives
J01EA01000T1002XX (B) NEDL

241

Indications: Treatment of urinary tract infections due to susceptible pathogens. Dosage: Adult : 200 mg dly in 1 or 2 divided doses or 300 mg dly as a single dose. Acute infection : 200 mg bd. Child : 6 - 12 yrs : 100 mg bd ; 6 mths -5 yrs : 50 mg bd. Contraindications: Hypersensitivity to trimethoprim or any component, megaloblastic anaemia due to folate deficiency. Precautions: Renal/hepatic impairment, folate deficiency, elderly and malnourished patients or with possible folate deficiency, nursing woman. Interactions: Increased effect, toxicity or levels of phenytoin, increased myelosuppression with methotrexate, may increase levels of digoxin. Adverse Reactions: Rash, pruritus, exfoliative dermatitis, nausea, vomiting, anorexia, and infrequent hematologic reactions (thrombocytopenia, leucopenia and megaloblastic anaemia) with chronic high dose. Sulphamethoxazole 200 mg & Trimethoprim 40 mg/5ml Suspension Bactrim
J01EE01961L8001XX (B) NEDL
- Trade Name

System: Antiinfectives Indications: Infections caus ed by susceptible pathogens Dosage: Child < 12 yrs : TM 6 mg & SMZ 30 mg/kg/day, divided into 2 equal doses. Child > 12 yrs : Standard dose : 10 ml diluted & infused bd. Severe infections : 15 ml diluted & infused bd. Contraindications: Marked liver parenchymal damage, severe renal impairment, pregnancy, hypersensitivity. Use with caution in premature babies or full-term infants in the neonatal period. Precautions: Haematological disorders, elderly, pregnancy, lactation, G6PD deficiency, folate deficiency, impaired renal function. Haematological disorders, elderly, pregnancy, lactation, G6PD deficiency, folate deficiency, impaired renal function. Interactions: Increased incidence of thrombocytopenia with thiazide diuretics in elderly. May require dosage reduction of warfarin & phenytoin. May displace methotrexate from plasma protein binding sites. Increased risk of venticular arrhythmias with amiodarone. Adverse Reactions: GI upsets, stomatitis, glossitis and skin rashes, tinnitus, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome, leucopenia, neutropenia, thrombocytopenia, agranulocytosis, megaloblastic anaemia, pancytopenia or purpura, hyperkalaemia. Sulphamethoxazole 400 mg & Trimethoprim 80 mg Injection B a c t ri m
- Trade Name

J01EE01961P3001XX (A) NEDL

System: Antiinfectives

242

Indications: i) Severe or complicated infections when oral therapy is not feasible. ii) Treatment and prophylaxis of PCP in immunocompromised patients. Dosage: i) Adult : 960 mg bd increased to 1.44 g bd in sev ere infections. Child : 36 mg/kg daily in 2 divided doses increased to 54 mg/kg/day in severe infections. ii) Treatment : Adult & Child over 4 wks : 120 mg/kg/day PO/IV infusion in 2 4 divided doses for 14 days. Prophylaxis :Adult : 960 mg od or 960 mg on alternate days ( 3 times a wk) or 960 mg bd on alternate days (3 times a wk). Child; 6 wks - 5 mths : 120 mg bd on 3 consecutive days or 7 days per wk; 6 mths - 5 yrs : 240 mg; 6 - 12 yrs : 480 mg. Contraindications: Marked liver parenchymal damage; severe renal impairment; pregnancy, hypersensitivity. Use with caution in premature babies or full-term infants in the neonatal period. Precautions: Haematological disorders; elderly; pregnancy; lactation; G6PD deficiency, folate deficiency, impaired renal function. Interactions: Increased incidence of thrombocytopenia with thiazide diuretics in elderly. May require dosage reduction of warfarin & phenytoin. May displace methotrexate from plasma protein binding sites. Increased risk of venticular arrhythmias with amiodarone. Possible megaloblastic anaemia with high dose of pyrimethamine. Adverse Reactions: GI upsets, stomatitis; glossitis & skin rashes; tinnitus; erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome; leucopenia, neutropenia, thrombocytopenia, agranulocytosis, megaloblastic anaemia, pancytopenia or purpura, hyperkalaemia, hypoglycaemia. Sulphamethoxazole 400 mg & Trimethoprim 80 mg Tablet Bactrim
J01EE01961T1001XX (A) NEDL APPL
- Trade Name

System: Antiinfectives Indications: i)Severe or complicated infections due to susceptible infection. ii)Treatment and prophylaxis of PCP in immunocompromised patients. Dosage: i)Adult:1-3 tablet bd. ii)Treatment: Adult & Child over 4 wks : 120 mg/kg/day in 2 - 4 divided doses for 14 days. Prophylaxis :Adult : 960 mg od or 960 mg on alternate days ( 3 times a wk) or 960 mg bd on alternate days (3 times a wk). Child; 6 wks - 5 mths : 120 mg bd on 3 consecutive days or 7 days per wk; 6 mths - 5 yrs : 240 mg; 6 - 12 yrs : 480 mg. Contraindications: Marked liver parenchymal damage; severe renal impairment; pregnancy, hypersensitivity, use with caution in premature babies or full-term infants in the neonatal period. Precautions: Haematological disorders; elderly; pregnancy; lactation; G6PD deficiency, folate deficiency, impaired renal function. Interactions: Increased incidence of thrombocytopenia with thiazide diuretics in elderly. May require dosage reduction of warfarin & phenytoin. May displace methotrexate from plasma protein binding sites. Increased risk of venticular 243

arrhythmias with amiodarone. Adverse Reactions: GI upsets, stomatitis; glossitis & skin rashes; tinnitus; erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome; leucopenia, neutropenia, thrombocytopenia, agranulocytosis, megaloblastic anaemia, pancytopenia or purpura, hyperkalaemia and hypoglycaemia. Erythromycin Lactobionate 500 mg Injection E r y t h r o c i n - Trade Name
J01FA01129P3001XX (A*) NEDL

System: Antiinfectives Indications: Only for treatment of: i) certain forms of meningitis ii) septicaemia not responding to usual antibiotics iii) mycoplasma pneumonia iv) infection with gram-positive organisms (e.g. tetanus, streptococcal infection) associated with Penicillin allergy, only when oral erythromycin cannot be given. Dosage: Adult : 15 - 20 mg/kg/day 6 hrly or 500 mg - 1 g 6hrly, or given as a continuous infusion over 24 hours (Max. 4 g/day). Child : 20 - 50 mg/kg/day in 3 - 4 divided doses. Contraindications: Hypersensitivity , porphyria. Precautions: Hepatic impairment, myasthenia gravis. Interactions: Can increase plasma concentration of warfarin, theophylline, carbamazepine, cyclosporin, possibly phenytoin. Combination with ergotamine increases risk of peripheral ischaemia. Caution when taken with terfenadine or astemizole. Adverse Reactions: Phlebitis; mild allergic reaction; liver dysfunction with or without jaundice. Erythromycin Ethylsuccinate 200 mg/5 ml Suspension J01FA01238F2101XX (B)
APPL

Erythrocin

- Trade Name

System: Antiinfectives Indications: Treatment of susceptible bacterial infections. Dosage: Child : mild to moderate infection, 30 - 50 mg/kg/day in equally divided doses every 6 hours. For more severe infection this dose may be doubled. Doses may be given bd - tds a day. Contraindications: Hypersensitivity, porphyria. Precautions: Hepatic impairment, myasthenia gravis. Interactions: Can increase plasma concentration of warfarin, theophylline, carbamazepine, cyclosporin, possibly phenytoin. Combination with ergotamine increases risk of peripheral ischaemia. Caution when taken with terfenadine or astemizole. Adverse Reactions: Abdominal discomfort, mild allergic reaction; liver dysfunction with or without jaundice; reversible hearing loss.

244

Erythromycin Ethylsuccinate 400 mg/5 ml Suspension J01FA01238F2102XX (B)

NEDL

Eryped

- Trade Name

System: Antiinfectives Indications: Treatment of susceptible bacterial infections. Dosage: Child : mild to moderate infection, 30 - 50 mg/kg/day in equally divided doses every 6 hours. For more severe infection this dose may be doubled. Doses may be given bd - tds a day. Contraindications: Hypersensitivity, porphyria. Precautions: Hepatic impairment, myasthenia gravis. Interactions: Can increase plasma concentration of warfarin, theophylline, carbamazepine, cyclosporin, possibly phenytoin. Combination with ergotamine increases risk of peripheral ischaemia. Caution when taken with terfenadine or astemizole. Adverse Reactions: Abdominal discomfort, mild allergic reaction; liver dysfunction with or without jaundice; reversible hearing loss. Erythromycin Ethylsuccinate 400 mg Tablet E E S - Trade Name
J01FA01238T1001XX (B) NEDL

System: Antiinfectives Indications: Treatment of susceptible bacterial infections. Dosage: Adult : 400 - 800 mg bd. Child: 30 - 50 mg/kg/day in 2 - 4 divided doses. Contraindications: Hypersensitivity, porphyria. Precautions: Hepatic impairment, myasthenia gravis. Interactions: Can increase plasma concentration of warfarin, theophylline, carbamazepine, cyclosporin, possibly phenytoin. Combination with ergotamine increases risk of peripheral ischaemia. Caution when taken with terfenadine or astemizole. Adverse Reactions: Abdominal discomfort, mild allergic reaction; liver dysfunction. Erythromycin Stearate 250 mg Tablet E r y t h r o c i n - Trade Name
J01FA01258T1001XX (B) NEDL APPL

System: Antiinfectives Indications: Infections due to susceptible organism. Dosage: Adult : 250 - 500 mg 6 hrly. Child: 30 - 50 mg/kg/day in 4 divided doses. Contraindications: Hypersensitivity, porphyria. Precautions: Hepatic impairment, myasthenia gravis. Interactions: Can increase plasma concentration of warfarin, theophylline, carbamazepine, cyclosporin, possibly phenytoin. Combination with ergotamine increases risk of peripheral ischaemia. Caution when taken with terfenadine or 245

astemizole. Adverse Reactions: Abdominal discomfort, mild allergic reaction; liver dysfunction. Clarithromycin Granules 125 mg/5 ml K l a c i d - Trade Name
J01FA09000F1001XX (A*)

System: Antiinfectives Indications: Treatment of complicated respiratory tract infections not responding to standard macrolides. Dosage: Child, body wt < 8 kg : 7.5 mg/kg twice dly, 8 -11 kg ( 1 - 2 yrs) 62.5 mg twice dly; 12 - 19 kg (3 - 6 yrs) 125 mg twice dly, 20 - 29 kg (7 - 9 yrs) 187.5 mg twice dly; 30 - 40 kg (10 - 12 yrs) 250 mg twice dly. Contraindications: Known hypersensitivity to macrolides. Patients receiving terfenadine therapy with pre-existing cardiac abnormalities or electrolyte disturbances. Precautions: Impaired hepatic function & moderate to severe renal impairment. Interactions: Modest increase of circulating theophylline or carbamazepine levels. May potentiate effects of warfarin or digoxin. May alter metabolism of terfenadine resulting in increased levels of terfenadine. Inhibition of metabolism with ritonavir. Adverse Reactions: Nausea, dyspepsia, abdominal pain & diarrhoea. Headache & skin rash. Reversible hearing loss. Alteration of sense of smell with taste perversion. Glossitis, stomatitis, oral monilia, tounge discoloration, tooth discoloration (reversible). Clarithromycin 500 mg Injection K l a c i d - Trade Name
J01FA09000P3001XX (A*)

System: Antiinfectives Indications: Only for i) Treatment of complicated respiratory tract infection not responding to standard macrolides. ii) Eradication of H.Pylori infection. Dosage: 1 g daily in 2 divided doses. Contraindications: Known hypersensitivity to macrolides. Patients receiving terfenadine therapy with pre-existing cardiac abnormalities or electrolyte disturbances. Precautions: Impaired hepatic function & moderate to severe renal impairment. Interactions: Modest increase of circulating theophylline or carbamazepine levels. May potentiate effects of warfarin or digoxin. May alter metabolism of terfenadine resulting in increased levels of terfenadine. Inhibition of metabolism with ritonavir. Adverse Reactions: Nausea, dyspepsia, abdominal pain & diarrhoea. 246

Headache & skin rash. Reversible hearing loss. Alteration of sense of smell with taste perversion. Glossitis, stomatitis, oral monilia, tounge discoloration, tooth discoloration (reversible). Clarithromycin 250 mg Tablet K l a c i d - Trade Name
J01FA09000T1001XX (A*)

System: Antiinfectives Indications: Only for i) treatment of complicated respiratory tract infection not responding to standard macrolides , ii) eradication of Helicobacter Pylori infection. Dosage: (i) & (ii) 250 - 500 mg bd. Up to 6 - 14 days. Contraindications: Known hypersensitivity to macrolides. Patients receiving terfenadine therapy with pre-existing cardiac abnormalities or electrolyte disturbances. Precautions: Impaired hepatic function & moderate to severe renal impairment. Interactions: Modest increase of circulating theophylline or carbamazepine levels. May potentiate effects of warfarin or digoxin. May alter metabolism of terfenadine resulting in increased levels of terfenadine. Inhibition of metabolism with ritonavir. Adverse Reactions: Nausea, dyspepsia, abdominal pain & diarrhoea. Headache & skin rash. Reversible hearing loss. Alteration of sense of smell with taste perversion. Glossitis, stomatitis, oral monilia, tounge discoloration, tooth discoloration (reversible). Azithromycin 200 mg/5 ml Granules Zithromax - Trade Name
J01FA10011F1001XX (A*)

System: Antiinfectives Indications: Treatment of complicated respiratory tract infections not responding to standard macrolides Dosage: Child : 10 mg/kg dly for 3 days / alternatively, given for 5 days with a single 10 mg/kg dose on day 1, then 5 mg/kg on days 2 - 5. Contraindications: Known hypersensitivity to azithromycin or any of the macrolides Precautions: Moderate or severerenal impairment; liver impairment; pregnancy & lactation. Interactions: Antacids. Ergot derivatives. Monitor patientson concurrent warfarin, digoxin or cyclosporin. Adverse Reactions: Nausea, abdominal discomfort, vomiting, flatulence, diarrhoea & loose stools. Hearing impairment, interstitial nephritis, , acute renal failure, abnormal liver function, dizziness/vertigo, convulsions, headache, somnolence.

247

Azithromycin 500mg Injection Zithromax - Trade Name

J01FA10011P4001XX (A*)

System: Antiinfectives Indications: Only for treatment of severe atypical pneumonia. Dosage: i) 500 mg once daily for 3 days. ii) Uncomplicated genital chlamydial infections and non-gonococcal urethritis, 1 g as a single dose Contraindications: Known hypersensitivity to azithromycin or any of the macrolides. Precautions: Moderate or severe renal impairment, liver impairment, pregnancy & lactation. Interactions: Antacids, ergot derivatives. Monitor patients on concurrent warfarin, digoxin or cyclosporin. Adverse Reactions: Nausea, abdominal discomfort, vomiting, flatulence, diarrhoea & loose stools. Hearing impairment, interstitial nephritis, , acute renal failure, abnormal liver function, dizziness & vertigo, convulsions, headache, somnolence. Azithromycin 250 mg Tablet Zithromax - Trade Name
J01FA10011T1001XX (A*)

System: Antiinfectives Indications: i) Treatment of complicated respiratory tract infection not responding to standard macrolides. ii) Adult treatment of uncomplicated genital infections due to Chlamydia Trichomatis or susceptible Neisseria Gonorrhoea iii) Prophylaxis against Mycobacterium Avium Complex in patients with advanced HIV. Dosage: i) 500 mg dly for 3 days. ii) 1 g as a single dose. iii) 1 g weekly Contraindications: Known hypersensitivity to azithromycin or any of the macrolides Precautions: Moderate or severe renal impairment, liver impairment, pregnancy & lactation. Interactions: Antacids, Ergot derivatives. Monitor patients on concurrent warfarin, digoxin or cyclosporin. Adverse Reactions: Nausea, abdominal discomfort, vomiting, flatulence, diarrhoea & loose stools. Hearing impairment, interstitial nephritis, , acute renal failure, abnormal liver function, dizziness & vertigo, convulsions, headache, somnolence. Clindamycin HCl 300 mg Capsule L i n c o c i n - Trade Name System: Antiinfectives
J01FF01110C1001XX (A*)

248

Indications: i) Skin and soft tissue infections, bone & joint infections. ii) Cerebral toxoplasmosis. Dosage: i) 150-300 mg every 6 hours; up to 450 mg every 6 hours in severe infections; child, 3-6 mg/kg every 6 hr. ii) 600 mg 6 hrly for 6 wks. Contraindications: Hypersensitivity to clindamycin or lincomycin. Patients with diarrhoea. Precautions: History of GI disease, severe renal & hepatic impairment. Interactions: Antagonism with erythromycin. Adverse Reactions: Diarrhoea occasionally with acute colitis (discontinue), abdominal pain, GI upsets, skin reactions, jaundice, hematopoietic changes. Clindamycin Phosphate 150 mg/ml Injection L i n c o c i n - Trade Name
J01FF01162P3001XX (A*)

System: Antiinfectives Indications: i) Skin and soft tissue infections, bone & joint infections. ii) Cerebral toxoplasmosis. Dosage: i) Adult : 0.6 - 2.7 g daily (in 2 - 4 divided doses); up to 4.8 g daily; Child over 1 month, 15 - 25 mg/kg/day or 350 mg/m2/day in 3 - 4 divided doses. ii) 1200 mg every 6 hrs for 3 wks followed by 300 mg orally every 6 hrs for another 3 wks. Contraindications: Hypersensitivity to clindamycin or lincomycin. Patients with diarrhoea. Precautions: New borns & infants; impaired hepatic or renal function; diarrhoea. Patients receiving neuromuscular blockers. Interactions: Antagonism with erythromycin. Adverse Reactions: Diarrhoea, occasionally associated with severe colitis, skin reactions, jaundice, haematopoietic changes. Local irritation, pain at IM inj site. Thrombophlebitis may occur with IV injection. Rarely, cardiopulmonary arrest & hypotension following too rapid IV administration. Streptomycin Sulphate 1 g Injection
J01GA01183P4001XX (B) NEDL APPL

System: Antiinfectives Indications: Tuberculosis Dosage: 0.5 - 1 g IM of Streptomycin base daily, or at longer intervals, cumulative dose should not exceed 100 g. Contraindications: Hypersensitivity to other aminoglycosides. Precautions: Renal & hepatic impairment. Elderly, poor oral & parenteral nutrition. Pregnancy & lactation. Interactions: Used with blood substitutes & diuretics intensify nephrotoxicity & ototoxicity. Possible inhibition of respiration with anaesthetics or muscle relaxants. 249

Adverse Reactions: Ototoxicity, nephrotoxicity, shock, vit K & vit B deficiency, Steven-Johnson syndrome. Gentamicin 7.5 mg Beads S e p t o p a l - Trade Name
J01GB03183P1001XX (A) NEDL

System: Antiinfectives Indications: Treatment of chronic osteomyelitis of post- traumatic, post- operative or hematogenous origin. Dosage: 7.5 - 22.5 mg chains to fill affected cavity. Contraindications: Established gentamicin intolerance. Precautions: Not known Interactions: No interaction found. Adverse Reactions: Toxic side-effects are not anticipated since after use of Septopal chains only extremely low gentamicin concentrations are found in serum. Gentamicin Sulphate 5 mg/ml Injection G a r a m y c i n - Trade Name
J01GB03183P3001XX (B)

System: Antiinfectives Indications: Infections due to susceptible organisms. Dosage: Adult : 0.8 - 3 mg/kg/day 8 hrly IM or IV. Sev ere cases: Up to 5 mg/kg/day 8 hrly. Child: 2.5 - 3.5 mg/kg/dose 8 hrly IM or IV. Infants/neonates : 2.5 mg/kg/day 12 hrly for the first week, then 8 hrly thereafter. Contraindications: Known hypersensitivity. Patients with pre-existent vestibular & or cochlear disease. Administration of other ototoxic and/or nephrotoxic antibiotics. Pregnancy & lactation. Precautions: Pregnancy, patients with reduced renal function, myasthenia gravis or Parkinson. Interactions: Concurrent or sequestial administration with potent antidiuretics, anaesthetics, neuromuscular blockers, other aminoglycosides, polymyxin, amphotericin B, mannitol, cephalosporins. Adverse Reactions: Vestibular & auditory toxicity, renal toxicity, neuromuscular blockade, superinfection. Gentamicin Sulphate 20 mg/2 ml Injection G a r a m y c i n - Trade Name
J01GB03183P3002XX (B) NEDL

System: Antiinfectives Indications: Infections due to susceptible organisms. Dosage: Adult : 0.8 - 3 mg/kg/day 8 hrly IM or IV. Severe cases: Up to 5 mg/kg/day 8 hrly. Child: 2.5 - 3.5 mg/kg/dose 8 hrly IM or IV. Infants/neonates : 2.5 mg/kg/day 12 hrly for the first week, then 8 hrly thereafter. Contraindications: Known hypersensitivity. Patients with pre-existent 250

vestibular & or cochlear disease. Administration of other ototoxic or nephrotoxic antibiotics. Pregnancy & lactation. Precautions: Pregnancy, patients with reduced renal function, myasthenia gravis or Parkinson. Interactions: Concurrent or sequestial administration with potent antidiuretics, anaesthetics, neuromuscular blockers, other aminoglycosides, polymyxin, amphotericin B, mannitol, cephalosporins. Adverse Reactions: Vestibular & auditory toxicity, renal toxicity, neuromuscular blockade, superinfection. Gentamicin Sulphate 80 mg/2 ml Injection G a r a m y c i n - Trade Name
J01GB03183P3003XX (B) NEDL APPL

System: Antiinfectives Indications: Infections due to susceptible organisms. Dosage: Adult : 3 - 5 mg/kg/day 8 hrly IM or IV. Severe cases: Up to 5 mg/kg/day 8 hrly. Child : 2.5 - 3.5 mg/kg/dose 8 hrly IM or IV. Contraindications: Known hypersensitivity. Patients with pre-existent vestibular & or cochlear disease. Administration of other ototoxic and/or nephrotoxic antibiotics. Pregnancy & lactation. Precautions: Pregnancy. Patients with reduced renal function, myasthenia gravis or Parkinson. Interactions: Concurrent or sequestial administration with potent antidiuretics, anaesthetics, neuromuscular blockers, other aminoglycosides, polymyxin, amphotericin B, mannitol, cephalosporins. Adverse Reactions: Vestibular & auditory toxicity, renal toxicity, neuromuscular blockade, superinfection. Kanamycin 1 g Injection
J01GB04183P4001XX (A*) NEDL

System: Antiinfectives Indications: i) Treatment of gonorrhoea and neonatal meningitis ii) Treatment of TB patients who require reserved second line drugs but have no pre-existing renal complications. Dosage: i) Adult : 1 - 2 g daily IM in 1 - 2 equally divided doses. Child : 15 mg/kg/day in divided doses every 8 - 12 hrs. ii) Adult : 1 - 2 g daily IM in 1 - 2 equally divided doses twice a week or 1 g once daily 3 days a week. Contraindications: Hypersensitivity to other aminoglycosides. Precautions: Renal impairment, elderly, poor oral or parenteral nutrition. Pregnancy & lactation. Interactions: Use with blood substitute or diuretics aggravates ototoxicity & nephrotoxicity. Respiratory depression with anaesthetics or muscle relaxants Adverse Reactions: Ototoxicity, nephrotoxicity. Rarely, shock, vit K & vit B deficiency. 251

Amikacin 100 mg/2 ml Injection Amikacin 500 mg/2 ml Injection Amikacin 250 mg/2 ml Injection A m i k i n - Trade Name

J01GB06183P3001XX (A) J01GB06183P3002XX (A) NEDL APPL J01GB06183P3003XX (A) NEDL APPL

System: Antiinfec tives Indications: Infections due to susceptible organisms. Dosage: Adult: (IM or IV) : 15 mg/kg/day 12 hrly for 7 - 10 days. Max : 1.5 g daily. Child : 15 mg/kg/day 12 hrly. Max : 1.5 g/day. Neonates : Initial loading dose of 10 mg/kg followed by 15 mg/kg/day 12 hrly. Contraindications: Hypersensitivity Precautions: Myasthenia gravis, renal impairment, pregnancy & lactation Interactions: Potentiation of toxicity in combination with loop diuretics, cephalothin, vancomycin, cyclosporin. Prolongs action of neuromuscular blockers. Increased risk of resp. depression with either halothane, methoxyflurane & neuromuscular blockers. Adverse Reactions: Ototoxicity & nephrotoxicity, rarely skin rash, fever, paraesthesia, athralgia, anaemia, hypotension Netilmicin Sulph 50 mg/2 ml Injection Netilmicin Sulph 100 mg/2ml Injection Netilmicin Sulph 150 mg/2 ml Injection N e t r o m y c i n - Trade Name
J01GB07183P3001XX (A) APPL J01GB07183P3002XX (A) J01GB07183P3003XX (A APPL)

System: Antiinfectives Indications: Systemic Infections Dosage: Adult : 4 - 6.5 mg/kg/day IM or IV in 2 - 3 equally divided doses for 7 - 14 days. Max : 7.5 mg/kg/day. Child : 5 - 7.5 mg/kg/day 8 - 12 hrly depending on gestation and age. Max : 7.5 mg/kg/day. Contraindications: Known allergy to penicillins or cephalosporins Precautions: Renal impairment; neuromuscular disorder eg myasthenia gravis or Parkinson, hypocalcaemia. Pregnancy & lactation. Good hydration during treatment required. Interactions: Toxicity potentiated by other ototoxic & nephrotoxic drugs. May potentiate actions of neuromuscular blockers. Adverse Reactions: Nephrotoxicity , neurotoxicity( auditory & vestibular toxicity); local reactions; GI effects , fever; blood coagulation abnormalities. Ofloxacin 200 mg Injection Rifocin - Trade Name
J01MA01000P4001XX (A)

System: Antiinfectives Indications: Sequential therapy for UTI and Pyelonephritis Dosage: 200 mg IV bd. for 3 - 5 days follow with 200 mg tab bd for 3 - 5 days as 252

maintenance dose (if necessary). Contraindications: Hypersensitivity. Childn. Pregnancy & lactation. Precautions: Patient with severe nephropathy, convulsions, elderly Interactions: Antacids may reduce absorption. Adverse Reactions: Shock, anaphylactoid symptom, Lyell's syndrome, rhabdomyolysis, tendon disorders, agranulocytosis, interstitial pneumonia, pseudomembranous colitis, anaemia, GI distress, headache, dizziness, sleep disturbances, hepatic & hematologic disorders.Drug Interaction Antacids may reduce absorption. Ofloxacin 100 mg Tablet T a r i v i d - Trade Name
J01MA01000T1001XX (A*)

System: Antiinfectives Indications: i) As second-line treatment of leprosy ii) as second-line treatment for tuberculosis and multidrug resistant tuberculosis (MDR-TB) iii) Sequential therapy for UTI and Pyelonephritis Dosage: i) 400 mg/day ii)400 mg b.d. iii ) 200 mg tablet bd Contraindications: Hypersensitivity, children, pregnancy & lactation. Precautions: Patient w/ severe nephropathy, convulsions, elderly. Interactions: Antacids may reduce absorption. Adverse Reactions: Shock, anaphylactoid symptom, Lyell's syndrome, rhabdomyolysis, tendon disorders, agranulocytosis, interstitial pneumoniac, pseudomembranous colitis, anaemia, GI distress, headache, dizziness, sleep disturbances, hepatic & hematologic disorders. Ciprofloxacin 100 mg / 50 ml Injection Ciprobay - Trade Name
J01MA02000P3001XX (A)NEDL

System: Antiinfectives Indications: Treatment of infections due to susceptible bacterial strains. Dosage: Uncomplicated infections of the kidneys and lower and upper urinary tract for adults : 200 mg/day. Acute gonorrhoea and acute uncomplicated cystitis in women can be treated with a single infusion of 100 mg. Other infections: 400 mg/day Contraindications: Hypersensitivity to ciprofloxacin or other quinolones. Children, adolescents, pregnancy & lactation. Precautions: Epilepsy, CNS damage. Interactions: Mineral-containing antacids reduce absorption of ciprofloxacin. May increase theophylline plasma levels. Concomitant intake w/ NSAIDs can lead to convulsion. Transient rise of serum creatinine w/ cyclosporin. Effects of warfarin are intensified. 253

Adverse Reactions: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain, flatulence, anorexia, dizziness, headache, tiredness, agitation, trembling, very rarely, insomnia, peripheral paralgesia, sweating, unsteady gait, convulsions, increase in intracranial pressure, anxiety states, nightmares, confusion, depression, hallucinations, impaired taste & smell, visual disturbances, tinnitus, transitory impairment of hearing, especially at high frequencies, skin reactions. Ciprofloxacin 200 mg / 100 ml Injection Ciprobay - Trade Name
J01MA02000P3002XX (A)

System: Antiinfectives Indications: Treatment of infections due to susceptible bacterial strains. Dosage: Uncomplicated infections of the kidneys and lower and upper urinary tract for adults : 200 mg/day. Acute gonorrhoea and acute uncomplicated cystitis in women can be treated with a single infusion of 100 mg. Other infections: 400 mg/day Contraindications: Hypersensitivity to ciprofloxacin or other quinolones. Children, adolescents, pregnancy & lactation. Precautions: Epilepsy, CNS damage. Interactions: Mineral-containing antacids reduce absorption of ciprofloxacin. May increase theophylline plasma levels. Concomitant intake w/ NSAIDs can lead to convulsion. Transient rise of serum creatinine w/ cyclosporin. Effects of warfarin are intensified. Adverse Reactions: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain, flatulence, anorexia, dizziness, headache, tiredness, agitation, trembling, insomnia, peripheral paralgesia, sweating, unsteady gait, convulsions, increase in intracranial pressure, anxiety states, nightmares, confusion, depression, hallucinations, impaired taste & smell, visual disturbances, tinnitus, transitory impairment of hearing, especially at high frequencies, skin reactions. Ciprofloxacin 250 mg Tablet Ciprofloxacin 500 mg Tablet Ciprobay - Trade Name
J01MA02000T1001XX (A) NEDL J01MA02000T1002XX (A)

System: Antiinfectives Indications: Treatment of infections due to susceptible bacterial strains. Dosage: Adult : 125 - 750 mg bd. Acute gonorrhoea: a single dose of 250 mg. Contraindications: Hypersensitivity to ciprofloxacin or other quinolones. Children, adolescents, pregnancy & lactation. Precautions: Epilepsy, CNS damage. Interactions: Mineral-containing antacids reduce absorption of ciprofloxacin. May increase theophylline plasma levels. Concomitant intake w/ NSAIDs can lead to convulsion. Transient rise of serum creatinine w/ cyclosporin. Effects of warfarin are intensified. Adverse Reactions: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain, 254

flatulence, anorexia, dizziness, headache, tiredness, agitation, trembling, insomnia, peripheral paralgesia, sweating, unsteady gait, convulsions, increase in intracranial pressure, anxiety states, nightmares, confusion, depression, hallucinations, impaired taste & smell, visual disturbances, tinnitus, transitory impairment of hearing, especially at high frequencies, skin reactions. Pefloxacin 400 mg Tablet L e x i n o r - Trade Name
J01MA03000T1001XX (A) NEDL

System: Antiinfectives Indications: i) Infections due to gram-positive and gram-negative pathogens. ii) Uncomplicated UTI, chancroid gonococcal urethritis Dosage: Adult i) 800 mg/day in 2 divided doses. ii) 800 mg stat. Contraindications: G6PD deficiency. Allergy to drugs of the quinolone group. Childn < 15 yr. ,pregnancy, lactation,.history of tendon lesions, tendinitis or tendon rupture. Precautions: Avoid exposure to sunlight or ultra violet light. Adjust dosage in severe hepatic insufficiency. Interactions: Efficacy reduced by aluminium based antacids. May potentiate theophylline effects. Coumarin (monitor clotting times). Adverse Reactions: GI disturbances, muscle & or joint pains. Neurological disturbances. With high dose, thrombocytopenia may occur. Photosensitivity, tendinitis, ruptures of the Achilles tendon. Pefloxacin 400 mg Injection P e f l a c i n e - Trade Name
J01MA03196P3001XX (A)APPL

System: Antiinfectives Indications: Infections due to gram-positive and gram-negative pathogens. Dosage: Administered as a slow ( one hour ) intravenous perfusion, after diluting the contents of the 400 mg in 250 ml 5% glucose ( two perfusions daily, morning and evening ). Contraindications: G6PD deficiency. Allergy to drugs of the quinolone group. Children < 15 yr, pregnancy, lactation, history of tendon lesions, tendinitis or tendon rupture. Precautions: Avoid exposure to sunlight or Ultra violet light. Adjust dosage in severe hepatic insufficiency. Interactions: Efficacy reduced by Aluminium based antacids. May potentiate theophylline effects. Coumarin (monitor clotting times). Adverse Reactions: GI disturbances, muscle & or joint pains. Neurological disturbances. With high dose, thrombocytopenia may occur. Photosensitivity, tendinitis, ruptures of the Achilles tendon.

255

Vancomycin HCl 500 mg Injection V a n c o c i n - Trade Name

J01XA01110P4001XX (A*)APPL

System: Antiinfectives Indications: Only for the treatment of MRSA and CAPD peritonitis. Dosage: 500 mg over at least 60 mins every 6 hours or 1 g over at least 100 minutes every 12 hours. Neonate up to 1 week, 15 mg/kg initially, then 10 mg/kg every 12 hours. Infant 1- 4 wks, 15 mg/kg initially then 10 mg/kg every 8 hours. Child over 1 month, 10 mg/kg every 6 hours. Contraindications: Known hypersensitivity to this antibiotic. Precautions: Rapid infusion-related reactions. Hearing loss, renal impairment, pregnancy & lactation. Interactions: Increased risk of ototoxicity w/ loop diuretics, aminoglycosides. Increased risk of nephrotoxicity w/ aminoglycosides & cephalosporins. Adverse Reactions: Thrombophlebitis, febrile reactions w/ rigor during administration, nephrotoxicity, ototoxicity. Fusidic Acid 50 mg/ml Suspension F u c i d i n - Trade Name
J01XC01000L8001XX (A*)

System: Antiinfectives Indications: Treatment of infections caused by staphylococcal especially Methicillin Resistant Staphylococcus aureus (MRSA). Dosage: Adult : 15 ml tds. Child and infant : 1 ml/kg body wt dly in 3 - 4 divided doses , 1 - 5 yrs : 5 ml tds, 5 - 12 yrs : 10 ml tds. Contraindications: Hypersensitivity to fusidic acid and or its salts. Precautions: Hepatic insufficiency. Pregnancy & lactation. Interactions: No interactions found. Adverse Reactions: GI disturbances (dyspepsia, nausea, vomiting) Fusidic Acid 500 mg Injection F u c i d i n - Trade Name
J01XC01520P4001XX (A*) APPL

System: Antiinfectives Indications: Treatment of severe staphylococcal infec tions especially MRSA. To be used in combination therapy only Dosage: Adult: 500 mg tds diluted to 250 - 500 ml infused slowly over 2 hrs. Max : 2 g dly. Child and infants : 20 mg/kg/day divided into 3 equal doses infused slowly over 2 - 4 hrs. Contraindications: Hypersensitivity to fusidic acid and or its salts. Precautions: Hepatic insufficiency; pregnancy & lactation. Interactions: No interactions found. Adverse Reactions: Reversible jaundice, thrombophlebitis 256

Fusidic Acid 250 mg Tablet F u c i d i n - Trade Name

J01XC01520T1001XX (A*)

System: Antiinfectives Indications: Treatment of infections caused by susceptible organisms esp. Staphylococcal infections especially MRSA. Dosage: Adult : 500 mg tds, skin and soft tissue infection : 250 - 500 mg bd. Contraindications: Hypersensitivity to fusidic acid and or its salts. Precautions: Hepatic insufficiency. Pregnancy & lactation. Interactions: No interactions found. Adverse Reactions: GI disturbances (dyspepsia, nausea, vomiting) Metronidazole 500 mg/100 ml Injection Metrogyl - Trade Name
J01XD01110L3001XX (A) NEDL APPL

System: Antiinfectives Indications: Anaerobic infections Dosage: Adult : 500 mg IV infusion 8 hrly. Child : 7.5 mg/kg body wt every 8 hrs. Contraindications: Hypersensitivity to metronidazole Precautions: If administered for > 10 days, haematological tests are recommended. Re-administer immediately after haemodialysis. Caution in patient w/ active disease of CNS except for brain abscess or hepatic encephalopathy. Pregnancy & lactation. Interactions: Alcohol,warfarin,phenobarbitone,lithium,phenytoin,cimetidine. Adverse Reactions: GIT disturbances,urticaria, angioedema, drowsiness, dizziness, headache, ataxia, skin rashes, pruritus, darkening of urine,peripheral neuropathy or transient epileptiform seizures ,leucopenia, anaphylaxis. Metronidazole 200 mg/5 ml Suspension Flagyl - Trade Name
J01XD01110L8001XX (B)

System: Antiinfectives Indications: Anaerobic Infection. Dosage: Child : 7.5 mg/kg tds for 7 days. Contraindications: Hypersensitivity to metronidazole Precautions: Caution in patient with active disease of CNS except for brain abscess of hepatic encephalopathy. Interactions: Alcohol,warfarin,phenobarbitone,lithium,phenytoin,cimetidine. Adverse Reactions: Unpleasant taste in mouth, furry tongue, GIT disturbances,urticaria, angioedema,drowsiness, dizziness, headache, ataxia, skin rashes, pruritus, darkening of urine,peripheral neuropathy or transient epileptiform seizures ,leucopenia. 257

Metronidazole 0.5 g Suppository Flagyl - Trade Name

J01XD01110S2001XX (B)

System: Antiinfectives Indications: Anaerobic infection. Dosage: Adult : 1 g rectally 8 hrly for 3 days, then 1 g 12 hrly if treatment must continue (not > 7 days). Paed : 7.5 mg/kg 8 hrly. Prophylaxis: > 12 yrs: 1 g rectally 2 hrs before surgery, repeated 8 hrly till oral medication can be given. Contraindications: Hypersensitivity to metronidazole. Precautions: Not known. Interactions: No interactions found. Adverse Reactions: GIT disturbanc es, urticaria, angioedema, drowsiness, dizziness, headache, ataxia, skin rashes, pruritus, darkening of urine. Peripheral neuropathy or transient epileptiform seizures (prolonged therapy), leucopenia. Rarely, anaphylaxis. Metronidazole 1 g Suppository Flagyl - Trade Name
J01XD01110S2002XX (B)

System: Antiinfectives Indications: Anaerobic infection. Dosage: Adult : 1 g rectally 8 hrly for 3 days, then 1 g 12 hrly if treatment must continue (not > 7 days). Paed : 7.5 mg/kg 8 hrly. Prophylaxis: > 12 yrs: 1 g rectally 2 hrs before surgery, repeated 8 hrly till oral medication can be given. Contraindications: Hypersensitivity to metronidazole. Precautions: Not known. Interactions: No interactions found. Adverse Reactions: GIT disturbances, urticaria, angioedema, drowsiness, dizziness, headache, ataxia, skin rashes, pruritus, darkening of urine, peripheral neuropathy or transient epileptiform seizures (prolonged therapy), leucopenia. Rarely, anaphylaxis. Metronidazole 200 mg Tablet Flagyl - Trade Name
J01XD01110T1001XX (B) NEDL APPL

System: Antiinfectives Indications: Anaerobic infections Dosage: 800 mg initially followed by 400 mg 8 hrly . Child : 7.5 mg/day tds. Contraindications: Hypersensitivity to metronidazole Precautions: Caution in patient with active disease of CNS except for brain abscess or hepatic encephalopathy,pregnancy and lactation. Interactions: Alcohol,warfarin,phenobarbitone,lithium,phenytoin,cimetidine. Adverse Reactions: Unpleasant taste in mouth, furry tongue, GIT disturbances,urticaria, angioedema,drowsiness, dizziness, headache, ataxia, 258

skin rashes, pruritus, darkening of urine,peripheral neuropathy or transient epileptiform seizures ,leucopenia. Tinidazole 500 mg Tablet F a s i g y n - Trade Name
J01XD02000T1001XX (B)

System: Antiinfectives Indications: i) Amoebiasis ii) Urogenital Trichomoniasis & Giardiasis Dosage: i) Amoebiasis- Adult : 2 g as a single dose for 2 - 3 days. Child : 50 - 60 mg/kg daily for 3 days. Sexual partners should be treated concomitantly with the same dose. ii) Urogenital Trichomoniasis & Giardiasis- Adult : 2 g as a single d ose (repeated once if necessary). Child : single dose Contraindications: History of blood dyscrasias, patients with active organic neurological disorders, 1st trimester of pregnancy & lactation. Precautions: If abnormal neurological signs develop, discontinue therapy. Interactions: No interaction found. Adverse Reactions: Neurological disturbances, GI disturbances, anorexia & metallic taste, hypersensitivity, rarely, leucopenia, headache, tiredness, furry tongue, dark urine. Nitrofurantoin 100mg Tablet Furadantin - Trade Name
J01XE01000T1002XX (B)

System: Antiinfectives Indications: Uncomplicated lower urinary tract infections. Dosage: Dose : Children > 1 mnth/kg/day in divided doses every 6 hrs ; max 400 mg/day. Chronic therapy : 1-2 mg/kg/day in divided doses every 12-24 hrs; max 100 mg/day/kg. Adults : 50-100 mg/dose every 6 hrs. Prophylaxis/chronic therapy : 50-100 mg/dose at bedtime. Contraindications: Creatinine clearence less than 40-50 ml/minute. Pregnancy at terms. Infants less than I months of age. Prostate infection in elderly men. Precautions: Pregnancy,lactation,glucose-6-phosphate deficiency (G6PD),lung disease,peripheral neuropathy. Interactions: Concurrent use with norfloxacin may result in antogonism of antibacterial effect of norfloxacin. Adverse Reactions: Pulmonary,hypersensitivity,haemolytic anaemia,peripheral neuropathy. Linezolid 2mg/ml Injection Zyvox - Trade Name
J01XX08000P3001XX (A)

System: Antiinfectives Indications: MRSA patient with severe sepsis requiring intensive care and not clinically 259

responding to vancomycin. Dosage: 600 mg bd for 10 -14 days. Contraindications: Hypersensitivity to linezolid. Precautions: Monitor FBC in patients with pre-existing myelosuppression, increased bleeding risk or who receive medications that may decrease haemoglobin levels, platelet count or who received linezolid for more than 2 weeks. Interactions: Citalopram, dopamine, epinephrine, escitalopram, fluoxetine, fluvoxamine, sertraline, venlafaxine, pseudoephedrine, tramadol. Adverse Reactions: Hypertension, headache, insomnia, thrombocytopaenia, myelosuppression, optic and peripheral neuropathy. Amphotericin B 50 mg for Injection F u n g i z o n e - Trade Name
J02AA01801P4001XX (A) APPL

System: Antiinfectives Indications: Systemic fungal infections. Dosage: Adult : 0.25 mg/kg/day by IV infusion, gradually increase if tolerated to 1 mg/kg/day. Max. in severe cases : 1.5 mg/kg dly or on alternate days. For neonates, lower doses are recommended. Contraindications: Pregnancy. Precautions: Avoid rapid infusion, renal impairment. Hepatic & renal function tests, blood count & plasma electrolyte monitoring are required. Interactions: Corticosteroids, nephrotoxic antibiotics and antineoplastics. Adverse Reactions: Fever, headache, anorexia, weight loss, GI disturbances, malaise, epigastric pain, dyspepsia, generalized pain, anaemia, abnormal renal function. Rarely cardiovascular toxicity, haematologic reactions, neurologic reactions, liver failure. Miconazole 10 mg/ml Injection Daktarin - Trade Name
J02AB01221P3001XX (A)

System: Ophthalmology Indications: For preparation of eye drops for use in cases of fungal corneal infection. Dosage: Accordingly to needs of the patient. Contraindications: Hypersensitivity to miconazole products. Hepatic impairment. Precautions: Pregnancy & breastfeeding, avoid in porphyria. Interactions: Cyclosporin, phenytoin, warfarin. Adverse Reactions: Thrombophlebitis, nausea & vomiting, cardiotoxicity, hyponatraemia, pruritus. Ketoconazole 200 mg Tablet N i z o r a l - Trade Name System: Antiinfectives 260
J02AB02000T1001XX (A/KK) NEDL

Indications: i) Pityriasis versicolor ii) Systemic mycosis (other skin mycoses) iii) Nail infections Dosage: i) 200 mg with meal once dly for 14 days. ii) 200 - 400 mg dly for 4 wks - 12 mths. iii) 200 - 400 mg dly for 6 - 12 mths. Max 400 mg dly. Contraindications: Liver disease, recovery phase of hepatitis, known hypersensitivity. Precautions: Adrenal insufficiency or borderline adrenal function, prolonged periods of stress, pregnancy & lactation. Interactions: Antacids, H2 receptor antagonist, antimuscarinic agents, alcohol, warfarin, prednisolone, quinidine, cyclosporin, phenytoin, rifampicin. Adverse Reactions: GI disturbances; pruritus; elevated liver function tests. Rarely, acute allergic reactions, hepatitis, gynaecomastia. Fluconazole 50 mg Capsule D i f l u c a n - Trade Name
J02AC01000C1001XX (A)

System: Antiinfectives Indications: i) Oropharyngeal candidiasis, atrophic oral candidiasis associated with dentures, other candidal infections of mucosa ii) Tinea pedis, corporis,cruris, versicolor and dermal candidiasis iii) Invasive candidal & cryptococcal infections (including meningitis) iv) Prevention of relapse of cryptococcal meningitis in AIDS patients after completion of primary therapy v) Prevention of fungal infections in immunocompromised patients considered at risk as a consequence of HIV infections or neutropenia following cytotoxic chemotherapy, radiotherapy or bone marrow transplant Dosage: i) Oropharyngeal candidiasis: 50-100 mg daily for 7-14 day (Max. 14 days) except in severely immunocompromised patients. Atrophic oral candidiasis associated with dentures : 50 mg daily for 14 days. Other candidal infections of mucosa : 50 - 100 mg daily for 14-30 days. Child :3-6 mg/kg on first day then 3 mg/kg daily (every 72 hrs in Neonate up to 2 wks old, every 48 hrs in neonate 2-4 wks old ). ii) 50 mg daily for 2-4 wks, max. 6 wks. iii) 400 mg initially then 200-400 mg daily for 6-8 wks. Child: 6-12 mg/kg daily (every 72 hrs in Neonate up to 2 wks old, every 48 hrs in neonate 2-4 wks old ). iv) 100 - 200 mg daily. v) 50-400 mg daily. Child: 3-12 mg/kg daily (every 72 hrs in Neonate up to 2 wks old, every 48 hrs in neonate 2-4 wks old). Contraindications: Known hypersensitivity to fluconazole or to related azole compounds. Precautions: Pregnancy, lactation. Interactions: Warfarin, oral sulfonylureas, phenytoin, rifampicin, cyclosporin, theophylline, cisapride. Adverse Reactions: Nausea, abdominal pain, diarrhoea, flatulence; rash.

261

Fluconazole 100 mg Capsule D i f l u c a n - Trade Name

J02AC01000C1002XX (A) NEDL APPL

System: Antiinfectives Indications: i) Oropharyngeal candidiasis, atrophic oral candidiasis associated with dentures, other candidal infections of mucosa ii) Tinea pedis, corporis,cruris, versicolor and dermal candidiasis iii) Invasive candidal & cryptococcal infections (including meningitis) iv) Prevention of relapse of cryptococcal meningitis in AIDS patients after completion of primary therapy v) Prevention of fungal infections in immunocompromised patients considered at risk as a consequence of HIV infections or neutropenia following cytotox ic chemotherapy, radiotherapy or bone marrow transplant Dosage: i)50-100 mg daily for 7-14 day (Max. 14 days) except in severely immunocompromised patients. Atrophic oral candidiasis associated with dentures : 50 mg daily for 14 days. Other candidal infec tions of mucosa : 50 100 mg daily for 14-30 days. Child :3-6 mg/kg on first day then 3 mg/kg daily (every 72 hrs in Neonate up to 2 wks old, every 48 hrs in neonate 2-4 wks old ). ii)50 mg daily for 2-4 wks, max. 6 wks. iii)400 mg initially then 200-400 mg daily for 6-8 wks. Child: 6-12 mg/kg daily (every 72 hrs in Neonate up to 2 wks old, every 48 hrs in neonate 2-4 wks old ). iv)100 - 200 mg daily. v) 50-400 mg daily. Child: 3-12 mg/kg daily (every 72 hrs in Neonate up to 2 wks old, every 48 hrs in neonate 2-4 wks old). Contraindications: Known hypersensitivity to fluconazole or to related azole compounds. Precautions: Pregnancy, lactation. Interactions: Warfarin, oral sulfonylureas, phenytoin, rifampicin, cyclosporin, theophylline, cisapride. Adverse Reactions: Nausea, abdominal pain, diarrhoea, flatulence; rash. Fluconazole 2 mg/ml Injection D i f l u c a n - Trade Name
J02AC01000L3001XX (A)

System: Antiinfectives Indications: i) Oropharyngeal candidiasis, atrophic oral candidiasis associated with dentures, other candidal infections of mucosa ii) Tinea pedis, corporis,cruris, versicolor and dermal candidiasis iii) Invasive candidal & cryptococcal infections (including meningitis) iv) Prevention of relapse of cryptococcal meningitis in AIDS patients after completion of primary therapy v) Prevention of fungal infections in immunocompromised patients considered at risk as a consequence of HIV infections or neutropenia following cytotoxic chemotherapy, radiotherapy or bone marrow transplant Dosage: i)50-100 mg daily for 7-14 day (Max. 14 days) except in severely 262

immunocompromised patients. Atrophic oral candidiasis associated with dentures : 50 mg daily for 14 days. Other candidal infections of mucosa : 50 100 mg daily for 14-30 days. Child :3-6 mg/kg on first day then 3 mg/kg daily (every 72 hrs in Neonate up to 2 wks old, every 48 hrs in neonate 2-4 wks old ). ii)50 mg daily for 2-4 wks, max. 6 wks. iii)400 mg initially then 200-400 mg daily for 6-8 wks. Child: 6-12 mg/kg daily (every 72 hrs in Neonate up to 2 wks old, every 48 hrs in neonate 2-4 wks old ). iv)100 - 200 mg daily. v) 50-400 mg daily. Child: 3-12 mg/kg daily (every 72 hrs in Neonate up to 2 wks old, every 48 hrs in neonate 2-4 wks old). Contraindications: Known hypersensitivity to fl uconazole or to related azole compounds. Precautions: Pregnancy, lactation. Interactions: Warfarin, oral sulfonylureas, phenytoin, rifampicin, cyclosporin, theophylline, cisapride. Adverse Reactions: Nausea, abdominal pain, diarrhoea, flatulence; rash. Itraconazole 100 mg Capsule Sporanox - Trade Name
J02AC02000C1001XX (A*)

System: Antiinfectives Indications: i)Dermatomycosis including Pityriasis versicolor ii) Oral Candidosis iii)Palmar Tinea manus and plantar Tinea pedis iv) Fingernail onychomycosis v) Toenail onychomycosis vi) Vulvovaginal candidosis Dosage: i) 200 mg once dly for 7 days. ii) 100 mg daily for 15 days iii) 200 mg bd for 7 days iv) 200 mg bd for 1 wk/mth v) 200 mg bd for 1 wk/mth for 3 mths vi) 200 mg morning and evening for 1 day or 200 mg once daily for 3 days. Contraindications: Pregnancy, hypersensitivity. Precautions: Lactation, history of liver or renal disease, children, decreased gastric acidity, risk of heart failure. Interactions: Rifampicin & phenytoin reduce oral bioavailability of itraconazole. Inhibits metabolism of warfarin, digoxin, terfenadine, cyclosporin A, astemizole, cisapride, oral midazolam. Adverse Reactions: GI disturbances, headache. Itraconazole 10 mg/ml Oral Solution Sporanox - Trade Name System: Antiinfectives
J02AC02000L9901XX (A*)

263

Indications: Treatment of i) oral or oesophageal candidiasis ii) fluconazole resistant and/or oesophageal candidiasis Dosage: i) 200 mg dly in 2 intakes, or in 1 intake, for 1 wk. If no response after 1 wk, continue treatment for another wk. ii) Fluconazole resistant or oesophageal candidiasis- 100 - 200 mg bd for 2 wks. If no response after 2 wks continue treatment for another 2 wks. The 400 mg daily dose should not be used for >14 days. Contraindications: Pregnancy, hypersensitivity. Precautions: Lactation, history of liver or renal disease, children, decreased gastric acidity. Interactions: Rifampicin & phenytoin reduce oral bioavailability of itraconazole. Inhibits metabolism of warfarin, digoxin, terfenadine, cyclosporin A, astemizole, cisapride, oral midazolam. Adverse Reactions: GI disturbances, headache. Flucytosine 2.5 g/250 ml Injection A n c o t i l - Trade Name
J02AX01000L3001XX (A*)NEDL

System: Antiinfectives Indications: Treatment of systemic fungal infection. Dosage: Adult : 100 - 200 mg/kg daily in 4 divided doses by IV infusion over 20 40 mins not more than 7 days. For neonates, used primarily with Amphotericin. Contraindications: Patients with a hypersensitivity to flucytosine. Precautions: Renal impairment or failure and patients with existing bone marrow depression. Interactions: Concurrent use with Zidovudine may result in hematologic toxicity (neutropenia). Adverse Reactions: Leucopenia, thrombocytopenia, headache, drowsiness, confusion, hallucinations, nausea, vomiting, diarrhoea, elevated liver function tests, and cutaneous reactions. Flucytosine 500 mg Tablet A n c o t i l - Trade Name
J02AX01000T1001XX (A*) NEDL

System: Antiinfectives Indications: Only for the treatment of fungal meningitis. Dosage: Adult : 50 - 100 mg/kg/day in 4 divided doses. 250 mg/kg/day have been recommended in severe infection. Contraindications: Patients with a hypersensitivity to flucytosine. Precautions: Renal impairment or failure and patients with existing bone marrow depression. Interactions: Concurrent use with Zidovudine may result in hematologic 264

toxicity (neutropenia). Adverse Reactions: Leucopenia, thrombocytopenia, headache, drowsiness, confusion, hallucinations, nausea, vomiting, diarrhoea, elevated liver function tests, and cutaneous reactions. Cycloserine 250 mg Capsule
J04AB01000C1001XX (A*)

System: Antiinfectives Indications: Multi-Drug Resistance Tuberculosis treatment failure. (For respiratory physicians ). Dosage: Adult : Initial : 250 mg every 12 hrs for 14 days, then administer 0.5 - 1 g daily in 2 divided doses for 18 - 24 mths (max. daily dose : 1 g). Child : 10 - 20 mg/kg/day in 2 divided doses up to 1 g/day for 18 - 24 mths. Contraindications: Severe renal impairment, epilepsy, depression, severe anxiety, psychotic states, alcohol dependence Precautions: Reduce dose in renal impairment, monitor haematological, renal, hepatic function, breast feeding, pregnancy Interactions: Alcohol, antiepileptic Adverse Reactions: Vertigo, nausea, convulsion, psychosis, rashes Rifampicin 150 mg Capsule R i f a d i n - Trade Name
J04AB02000C1001XX (B) NEDL APPL

System: Antiinfectives Indications: Only for (i)tuberculosis patients, (ii)leprosy and (iii)prophylaxis for meningococcal meningitis. Dosage: i) Tuberculosis - Adults : 450 - 600 mg as a single morning dose. Child : 10 - 20 mg/kg body wt daily in 1 - 2 doses. Directly observed therapy (DOT) : 10 mg/kg twice wkly or 3 times/wk. Max : 600 mg. (ii) Leprosy - 600 mg/day. (iii) Prophylaxis for meningococcal meningitis - 600 mg bd for 2 days. Contraindications: Hypersensitivity and jaundice patient. Precautions: Alcoholism, pati ents w/ impaired liver function, pregnancy, lactation. Interactions: May reduce the activity of anticoagulant, corticosteroids, cyclosporin, digitalis, oral contraceptives, oral hypoglycemics. Adverse Reactions: Flushing, itching, GI reactions, pseudomembranous colitis, hepatitis, thrombocytopenia, muscle weakness. Flu syndrome may occur w/ intermittent dosage regimens. May produce a reddish discoloration of body fluids. Rifampicin 300 mg Capsule R i f a d i n - Trade Name System: Antiinfectives
J04AB02000C1002XX (B) NEDL APPL

265

Indications: Only for (i)tuberculosis patients, (ii)leprosy and (iii)prophylaxis for meningococcal meningitis. Dosage: i) Tuberculosis - Adults : 450 - 600 mg as a single morning dose. Child : 10 - 20 mg/kg body wt daily in 1 - 2 doses. Directly observed therapy (DOT) : 10 mg/kg twice wkly or 3 times/wk. Max : 600 mg. (ii) Leprosy - 600 mg/day. (iii) Prophylaxis for meningococcal meningitis - 600 mg bd for 2 days. Contraindications: Hypersensitivity and jaundice patient. Precautions: Alcoholism, patients w/ impaired liver function, pregnancy, lactation. Interactions: May reduce the activity of anticoagulant, corticosteroids, cyclosporin, digitalis, oral contraceptives, oral hypoglycemics. Adverse Reactions: Flushing, itching, GI reactions, pseudomembranous colitis, hepatitis, thrombocytopenia, muscle weakness. Flu syndrome may occur w/ intermittent dosage regimens. May produce a reddish discoloration of body fluids. Rifampicin 100 mg/5 ml Syrup Rif a d i n - Trade Name
J04AB02000L9001XX (A)

System: Antiinfectives Indications: Tuberculosis and leprosy. Dosage: Child : 20 mg/kg body wt dly in 1 - 2 doses. Up to 1 yr : 10 mg/kg body wt in a single dly dose. Contraindications: Hypersensitivity and jaundice patient. Precautions: Patients with impaired liver function, pregnancy, lactation. Interactions: May reduce the activity of anticoagulant, corticosteroids, cyclosporin, digitalis preparations, oral contraceptives, oral hypoglycemics. Adverse Reactions: Flushing, itching, GI reactions, pseudomembranous colitis, hepatitis, thrombocytopenia, muscle weakness. Flu syndrome may occur w/ intermittent dosage regimens. May produce a reddish discoloration of body fluids. Isoniazid 100 mg Tablet Isoniazid 400 mg Tablet
J04AC01000T1001XX (B) NEDL APPL J04AC01000T1002XX (B) NEDL APPL

System: Antiinfectives Indications: i) Tuberculosis ii) Tuberculous meningitis Dosage: i) Tuberculosis - Adult : 5 mg/kg daily for 6 mths. Max. 300 mg dly. Child : 5 - 10 mg/kg/day (max : 300 mg dly). ii) Tuberculous meningitis- 15 - 20 mg/kg dly. Contraindications: Acute liver disease & previous isoniazid-associated hepatitis. Precautions: Severe renal dysfunction, chronic liver disease and daily users of 266

alcohol, associated with a higher incidence of isoniazid hepatitis. Interactions: Inhibits metabolism of antiepileptics (carbamazepine, ethosuximide and phenytoin) and diazepam , reduced plasma concentration of ketoconazole and increased theophylline plasma concentration. Adverse Reactions: Peripheral neuropathy and hepatotoxicity. Pyrazinamide 500 mg Tablet
J04AK01000T1001XX (B) NEDL APPL

System: Antiinfectives Indications: Tuberculosis. Dosage: Adults : 20 - 35 mg/kg daily in 3 - 4 divided doses. Max : 3 g daily. Child : 20 - 35 mg/kg daily (max : 3 g daily). Contraindications: Porphyria, severe liver damage, acute liver disease, pregnancy, lactation. Precautions: Slightly impaired liver function, hyperuricaemia, arthralgia, renal insufficiency, diabetes mellitus. Interactions: Concurrent use of pyrazinamide and zidovudine may result in decreased efficacy of pyrazinamide. Adverse Reactions: Liver toxicity depending on treatment duration & concomitant therapy. Transient increase in serum transminase levels, acute yellow atrophy of the liver. Nausea, vomiting, anorexia, diarrhoea, abdominal pain. Hyperuricaemia may occur w/ dosages > 2 g/day. Ethambutol HCl 200 mg Tablet Ethambutol HCl 400 mg Tablet M y a m b u t o l - Trade Name
J04AK02110T1001XX (B) J04AK02110T1002XX (B) NEDL

System: Antiinfectives Indications: Tuberculosis. Dosage: Adult : Initial treatment - 15 mg/kg as a single dly dose. Retreatment: 25 mg/kg/day as a single dose. To be administered concurrently with one other antituberculous drug. After 60 days, decrease dose to 15 mg/kg as a single dose. Child: Retreatment: 25 mg/kg daily for 60 days then 15 mg/kg. Contraindications: Optic neuritis; history of previous adverse effects with ethambutol. Precautions: Reduced visual acuity. Reduced dosage in impaired renal function. May precipitate attack of gout. Ocular examination is recommended. Interactions: No interactions found. Adverse Reactions: Generally well tolerated but may provoke reversible retrobulbar neuritis with a reduction of visual acuity, central scotoma & greenred colour blindness. Rarely, allergic rashes, GI disturbances, jaundice, peripheral neuritis, confusion, hallucinations, joint pain, fever, malaise, headache, dizziness, anorexia & abdominal pain.

267

Rifampicin, Dapsone & Clofazimine M B C o m b i - Trade Name

J04AM02961T9901XX (B)

System: Antiinfectives Indications: For the treatment of leprosy and tuberculosis. Dosage: Rifampicin : 600mg once-monthly, Dapsone: 100mg daily, Clofazimine: 300mg once-monthly and 50mg daily (or 100mg on alternate days). Contraindications: Hypersensitivity to rifampicin, dapsone and clofazimine. Precautions: Patients with impaired liver function, pregnancy, lactation. Interactions: May reduce the activity of anticoagulant, corticosteroids, cyclosporin, digitalis, oral contraceptives, oral hypoglycemics. Adverse Reactions: Nausea, vomiting, anorexia; headache; dizziness, tachycardia, nervousness, insomnia, skin disorders, agranulocytosis, peripheral neuritis, psychosis, hemolysis, methaemoglobinemia; hypersensitivity reactions. Clofazimine 50 mg Capsule L a m p r e n e - Trade Name
J04BA01000C1001XX (B) APPL

System: Antiinfectives Indications: i) Previously untreated leprosy patients ii) Leprosy patients resistant to sulphones iii)Suppression of lepra reactions Dosage: i) Adult : 100 mg eod or 50 mg dly after food. Max : 200 mg/day. Child : 1 - 2 mg/kg/day. Max : 100 mg/day ii) 100 mg dly. iii) 200 - 300 mg usually effective. Treatment with minimum suppression dose continued for at least 6 mths. Contraindications: Hypersensitivity to clofazimine products Precautions: Avoid treatment if possible in patients with abdominal pains, diarrhoea, liver or kidney damage. Treatment w/ daily doses > 100 mg; not to be used for > 3 mth. Persistent diarrhoea or vomiting; patient should be hospitalised. Pregnancy, lactation. Interactions: Concurrent use of phenytoin and clofazimine may result in reduced phenytoin serum concentrations and loss of phenytoin efficacy. Adverse Reactions: Reversible reddish to dark brown discoloration, nonspecific skin reactions, GI effects including eosinophilic enteropathy. Clofazimine 100 mg Capsule L a m p r e n e - Trade Name System: Antiinfectives
J04BA01000C1002XX (B) APPL

268

Indications: i) Previously untreated leprosy patients ii) Leprosy patients resistant to sulphones iii)Suppression of lepra reactions Dosage: i) Adult : 100 mg eod or 50 mg dly after food. Max : 200 mg/day. Child : 1 - 2 mg/kg/day. Max : 100 mg/day ii) 100 mg dly. iii) 200 - 300 mg usually effective. Treatment with minimum suppression dose continued for at least 6 mths. Contraindications: Hypersensitivity to clofazimine products Precautions: Avoid treatment if possible in patients with abdominal pains, diarrhoea, liver or kidney damage. Treatment w/ daily doses > 100 mg; not to be used for > 3 mth. Persistent diarrhoea or vomiting; patient should be hospitalised. Pregnancy, lactation. Interactions: Concurrent use of phenytoin and clofazimine may result in reduced phenytoin serum concentrations and loss of phenytoin efficacy. Adverse Reactions: Reversible reddish to dark brown discoloration, nonspecific skin reactions, GI effects including eosinophilic enteropathy. Dapsone 100 mg Tablet
J04BA02000T1001XX (B) NEDL APPL

System: Antiinfectives Indications: i)Leprosy ii) Dermatitis Herpetiformis Dosage: i) Adult : 6 - 10 mg/kg wkly (around 50 - 100 mg dly). Child : 1 - 2 mg/kg/day. Max : 100 mg/day ii) Adult : 50 - 400 mg dly. Contraindications: Severe anaemia. Precautions: Cardiac, pulmonary, hepatic or renal disease, pregnancy, lactation. Interactions: Rifampicin increases plasma clearance of dapsone. Excretion decreased by probenecid. Adverse Reactions: Nausea, vomiting, anorexia; headache; dizziness, tachycardia, nervousness, insomnia, skin disorders, agranulocytosis, peripheral neuritis, psychosis, hemolysis, methaemoglobinemia; hypersensitivity reactions. Acyclovir 200 mg/5 ml Suspension A c i c l o v i r - Trade Name System: Antiinfectives
J05AB01000L8001XX (A*)

269

Indications: i)Mucocutaneous Herpes Simplex infection in immunocompromised and AIDS patients ii)Primary and recurrent Varicella Zoster Infection in immunocompromised and AIDS patients iii) Severe Kaposi Varicella Eruption (Eczema herpeticum ) iv) Severe primary HSV infections ( eg. Neonatal herpes, encephalitis, eczema herpeticum , genital herpes, gingival stomatitis, vaginal delivery with maternal vulva herpes) v) Severe and complicated varicella infection (eg. Encephalitis, purpura fulminans) vi) Severe zoster infection in paediatrics ( eg.Encephalitis, purpura fulminans, immunocompromised patients and facial, sacral and motor zoster) Dosage: i) Adult : initially 400 mg 5 times daily for 5 days. Child < 2 yrs : 200 mg 4 times daily, Child > 2 yrs : 400 mg 4 times daily. ii), iii) and iv) Adult : 200 400mg 4 times daily. Child : < 2 yrs, half adult dose; >2 yrs, adult dose. v) Adult : 800 mg 5 times dly for 7 days vi) Adult : 20 mg/kg (max : 800 mg ) qid for 5 days , Child <2 yrs, 200 mg qid, 2-5 yrs : 400 mg qid, >6 yrs : 800 mg qid. Contraindications: Patients known to be hypersensitive to acyclovir. Precautions: Patients with preexisting neurologic, renal, or hepatic impairment, dehydrated patient, elderly and lactation. Interactions: Increased mean half-life & plasma concentration with probenecid. Adverse Reactions: Skin rashes; GI effects; Fatigue. Acyclovir 250 mg Injection Z o v i r a x - Trade Name
J05AB01000P4001XX (A*)APPL

System: Antiinfectives Indications: Treatment and prophylaxis of herpes simplex in immunocompromised, severe initial genital herpes and Varicella -Zoster. Dosage: i) Adult : 5 mg/kg by IV infusion 8 hrly for 5 days, doubled to immunocompromised and in simplex encephalitis ( usually given for 10 days in encephalitis) ; max : 10 g/kg IV 8 hrly . Neonate up to 3 mths, Herpes Simplex : 10 mg/kg 8 hrly for 10 days; Child , 3 mths - 12 yrs Herpes simplex or Varicella Zoster : 250 mg/m2 8 hrly for 5 days, doubled to 500 mg/m2 8 hrly for varicella-zoster in the immunocompromised and in simplex encephalitis ( usually given for 10 days in encephalitis). Contraindications: Patients known to be hypersensitive to acyclovir. Precautions: In patients receiving Zovirax IV at higher doses, specific care regarding renal function should be taken, particularly when patients are dehydrated or have any renal impairment. Interactions: Increased mean half-life & plasma concentration with probenecid. Adverse Reactions: Skin rashes; GI effects,neurological reactions (IV infusion). 270

Acyclovir 800 mg Tablet Acyclovir - Trade Name

J05AB01000T1002XX (A/KK)

System: Antiinfectives Indications: i)Mucocutaneous Herpes Simplex infection in immunocompromised and AIDS patients ii)Primary and recurrent Varicella Zoster Infection in immunocompromised and AIDS patients iii) Severe Kaposi Varicella Eruption (Eczema herpeticum ) iv) Severe primary HSV infections ( eg. Neonatal herpes, encephalitis, eczema herpeticum , genital herpes, gingival stomatitis, vaginal delivery with maternal vulva herpes) v) Severe and complicated varicella infection (eg. Encephalitis, purpura fulminans) vi) Severe zoster infection in paediatrics ( eg.Encephalitis, purpura fulminans, immunocompromised patients and facial, sacral and motor zoster) Dosage: i) Adult : initially 400 mg 5 times daily for 5 days. Child < 2 yrs : 200 mg 4 times daily, Child > 2 yrs : 400 mg 4 times daily. ii), iii) and iv) Adult : 200 400mg 4 times daily. Child : < 2 yrs, half adult dose; >2 yrs, adult dose. v) Adult : 800 mg 5 times dly for 7 days vi) Adult : 20 mg/kg (max : 800 mg ) qid for 5 days , Child <2 yrs, 200 mg qid, 2-5 yrs : 400 mg qid, >6 yrs : 800 mg qid. Contraindications: Patients known to be hypersensitive to acyclovir. Precautions: Patients with preexisting neurologic, renal, or hepatic impairment, dehydrated pati ent, elderly and lactation Interactions: Increased mean half-life & plasma concentration with probenecid. Adverse Reactions: Skin rashes; GI effects; Fatigue Acyclovir 200 mg Tablet Z o v i r a x - Trade Name
J05AB01000T4001XX (A/KK) APPL

System: Antiinfectives Indications: i)Mucocutaneous Herpes Simplex infection in immunocompromised and AIDS patients ii)Primary and recurrent Varicella Zoster Infection in immunocompromised and AIDS patients iii) Severe Kaposi Varicella Eruption (Eczema herpeticum ) iv) Severe primary HSV infections ( eg. Neonatal herpes, encephalitis, eczema herpeticum , genital herpes, gingival stomatitis, vaginal delivery with maternal vulva herpes) v) Severe and complicated varicella infection (eg. Encephalitis, purpura fulminans) vi) Severe zoster infection in paediatrics ( eg.Encephalitis, purpura fulminans, immunocompromised patients and facial, sacral and motor zoster) Dosage: i) Adult : initially 400 mg 5 times daily for 5 days. Child < 2 yrs : 200 mg 4 times daily, Child > 2 yrs : 400 mg 4 times daily. ii), iii) and iv) Adult : 200 271

400mg 4 times daily. Child : < 2 yrs, half adult dose; >2 yrs, adult dose. v) Adult : 800 mg 5 times dly for 7 day s vi) Adult : 20 mg/kg (max : 800 mg ) qid for 5 days , Child <2 yrs, 200 mg qid, 2-5 yrs : 400 mg qid, >6 yrs : 800 mg qid. Contraindications: Patients known to be hypersensitive to acyclovir. Precautions: Patients with preexisting neurologic, renal, or hepatic impairment, dehydrated patient, elderly and lactation. Interactions: Increased mean half-life & plasma concentration with probenecid. Adverse Reactions: Skin rashes; GI effects; Fatigue Ribavirin 200 mg Capsule Rebetol - Trade Name
J05AB04000C1001XX (A*)

System: Antiinfectives Indications: For the treatment of chronic hepatitis C (in combination with interferon alfa2a/2b). Dosage: Adult <75 kg : 400 mg in the morning, then 600 mg in the evening; >75 kg : 600 mg in the morning, then 600 mg in the evening. Contraindications: Pregnancy, severe cardiac disease, including unstable or uncontrolled cardiac disease in previous 6 months, haemoglobinopathies. Precautions: Exclude pregnancy before treatment, effective contraception essential during treatment and for 4 months after treatment in women and for 7 months after treatment in men, routine monthly pregnancy test. Interactions: Zidovudine, stavudine. Adverse Reactions: Haemolytic anaemia, reticulocytosis, nausea vomiting, abdominal pain, hyperuricemia, rhinitis. Ganciclovir Sodium 250 mg Capsule C y m e v e n e - Trade Name
J05AB06520C1001XX (A*)

System: Antiinfectives Indications: Treatment of Cytomegalovirus Retinitis Dosage: 1 g tds with food or 500 mg 6 times dly with food. Contraindications: Pregnancy, lactation. Patients w/ neutrophil count < 500 cells/mcL. Precautions: Pre-existing cytopenias. Maintain adequate hydration of patients. Impaired renal function. Avoid driving and operating machinery. Interactions: Probenecid reduces clearance of ganciclovir. zidovudine, imipenem-cilastatin. Adverse Reactions: Fever, rash, leucopenia, thrombocytopenia, anaemia, decreased blood sugar. Ganciclovir Sodium 546 mg/10 ml Injection C y m e v e n e - Trade Name System: Antiinfectives 272
J05AB06520P3001XX (A*)NEDL

Indications: Treatment of Cytomegalovirus (CMV) disease in immunocompromised patients, prevention of CMV disease during immunosuppressive therapy following organ transplant. Dosage: Initial : 5 mg/kg infused over 1 hr 12 hrly for 14 - 21 days (CMV Retinitis treatment) or 7 - 14 days (CMV disease prevention). Long term maintenance : 6 mg/kg daily for 5 days/wk or 5 mg/kg dly for 7 days/wk. Contraindications: Pregnancy, lactation, patients with neutrophil count less than 500 cells/mcL. Precautions: Pre-existing cytopenias. Maintain adequate hydration of patients. Impaired renal function. High pH (9-11) of reconstituted soln. Interactions: Probenecid reduces clearance of ganciclovir, zidovudine, imipenem-cilastatin. Adverse Reactions: Fever, rash, leucopenia, thrombocytopenia, anaemia, decreased blood sugar. Indinavir Sulphate 400 mg Capsule C r i x i v a n - Trade Name
J05AE02183C1001XX (A*)

System: Antiinfectives Indications: i) Post-exposure prophylaxis (PEP) among healthcare workers in high-risk HIV occupational exposure. ii) For therapy as part of combination antiretroviral treatment on adult HIV patients (HAART). Dosage: Adult: 800 mg every 8 hrs. Child (investigational): 500 mg/m2 every 8 hrs (patients with smaller body surface area (BSA) may require lower doses of 300 - 400 mg/m2 every 8 hrs). Contraindications: Breast feeding, known hypersensitivy to this compound. Precautions: Nephrolithiasis, acute haemolytic anaemia, hyperglycaemia, pregnancy, lactation, hyperlipidaemia. Interactions: Ketoconazole, rifampicin, cisapride, astemizole. Adverse Reactions: Asthenia/fatigue, abdominal pain, dry mouth, flatulence, lymphadenopathy. Ritonavir 100 mg Capsule Norvir - Trade Name
J05AE03000C1001XX (A*)

System: Antiinfectives Indications: Progressive or advanced HIV infection in combination with other antiretroviral agents. Criteria for use: a) Clinical AIDS, b) CD4 <350 cells or c) Viral load > 10,000 copies/ml. Dosage: Adult : initially 300 mg bd, increase by 100 mg bd increments to 600 mg bd. For older child who can swallow soft gelatin cap; 250 mg/m2 bd for 2 days, if tolerate 400 mg/m2 bd onwards. Contraindications: Hypersensitivity, breast feeding, severe hepatic 273

impairment. Precautions: Hepatic impairment. Interactions: Decreased plasma concentration with phenobarbital, carbamazepine, dexamethasone and phenytoin. Adverse Reactions: Asthenia, GI & neurological disturbances, anorexia, taste perversion. Ritonavir 80 mg/ml Solution Norvir - Trade Name
J05AE03000L9901XX (A*)

System: Antiinfectives Indications: Progressive or advanced HIV infection in combination with other antiretroviral agents. Criteria for use: a) Clinical AIDS, b) CD4 <350 cells or c) Viral load > 10,000 copies/ml. Dosage: Adults : 400 - 600 mg bd. Child : 250 - 400 mg/m2 bd. Contraindications: Hypersensitivity, breast feeding, severe hepatic impairment. Precautions: Hepatic impairment. Interactions: Decreased plasma concentration with phenobarbital, carbamazepine, dexamethasone and phenytoin. Adverse Reactions: Asthenia, GI & neurological disturbances, anorexia, taste perversion. Lopinavir 133.3mg & Ritonavir 33.3 mg Capsule K a l e t r a - Trade Name
J05AE06964C1001XX (A)

System: Antiinfectives Indications: As second line protease inhibitor if intolerant to indinavir/ ritonavir as part of HAART regimen. Dosage: 3 capsules twice daily Contraindications: Hypersensitivity Precautions: Hepatic impairment, renal impairment, haemophilia, pregnancy, diabetes, pancreatitis. Interactions: Antiarrhythmias, anticonvulsant, antihistamines, benzodiazepines, calcium channel blockers, cisapride, clarithromycin, dexamethasone, disulfiram, didanosine. Adverse Reactions: dyslipidaemia, hyperglycaemia, hypercholesterolemia, increased triglycerides, diarrhoea, nausea, headache, pain, insomnia. Lopinavir/Ritonavir Oral Solution K a l e t r a - Trade Name
J05AE06964L9901XX (A)

System: Antiinfectives Indications: Management of patients with asymptomatic and symptomatic (early or advanced) HIV Infection with CD4 cell counts <50 cubic mm. Dosage: 274

12 mg/kg BD for those 7 - 15 kg and 10mg/kg BD for those 15-40 kg taken with food, up to a maximum dose of 400/100 mg in children greater than 40 kg (5 ml or 3 capsule) twice daily. Contraindications: Hypersensitivity, concomitant use with drugs that are highly dependent on CYP3A or CYP2D6 for clearance. Precautions: Hepatic impaiment, renal impairment, haemophilia, pregnancy, diabetes, pancreatitis. Interactions: Antiarrhy thmias, anticonvulsant, antihistamines, benzodiazepines, calcium channel blockers, cisapride, clarithromycin, dexamethasone, disulfiram, didanosine. Adverse Reactions: dyslipidaemia, hyperglycaemia, hypercholesterolemia, increased triglycerides, diarrhoea, nausea, headache, pain, insomnia. Zidovudine 100 mg Capsule Retrovir - Trade Name
J05AF01000C1001XX (A*) NEDL

System: Antiinfectives Indications: i) Management of patients with asymptomatic and symptomatic (early or advanced) HIV infections with CD4 cell counts < 500 cu. mm. ii) Neonatal prophylaxis. Dosage: i) Adult : 500 - 600 mg/day in 2 - 3 divided doses. Child > 3 mths : 360 - 480 mg/m2 dly in 3 - 4 divided doses; max. 200 mg every 6 hours. ii) 2 mg/kg 6 hrly within 12 hr after birth up to 6 wk. Contraindications: Abnormally low neutrophil cell count (< 0.75 x 109/L) or abnormally low Hb levels (< 7.5 g/dL). Precautions: Monitor carefully haematological parameters. If anaemia or myelosuppression occurs dose adjustments are suggested. Patients with preexisting bone marrow compromise. Pregnancy & lactation. Interactions: Chronic paracetamol use, potentially nephrotoxic or myelosuppressive drugs, probenecid. Adverse Reactions: Anaemia, neutropenia, leucopenia, nausea, headache, rash, abdominal pain, fever, myalgia, paraesthesia, vomiting, insomnia & anorexia, asthenia, malaise, somnolence, diarrhoea, dizziness, sweating, dyspnoea, dyspepsia, flatulence, bad taste, chest pain, loss of mental acuity, anxiety, urinary frequency, depression, generalised pain, chills, cough, urticaria, pruritus & flu-like syndrome. Zidovudine 1% Injection Retrovir - Trade Name
J05AF01000L3001XX (A)

System: Antiinfectives Indications: To reduce the rate of maternal-foetal transmission of HIV in: i) HIV-positive pregnant women over 14 weeks of gestation. ii) their newborn infants. Dosage: i) 100 mg 5 times daily until beginning of labour. During labour, by IV infusion initially 2 mg/kg over 1 hr followed by continuous IV infusion at 1 mg/kg/hr until 275

delivery. ii) 2 mg/kg orally every 6 hrs within 12 hr after birth. If unable to receive oral dose, then 1.5 mg/kg IV infused over 30 min. every 6 hr. Contraindications: Abnormally low neutrophil cell count (< 0.75 x 109L) or abnormally low Hb levels (< 7.5 g/dL). Precautions: Monitor carefully haematological parameters. If anaemia or myelosuppression occurs dose adjustments are suggested. Patients with preexisting bone marrow compromise. Pregnancy & lactation. Interactions: Chronic paracetamol use, potentially nephrotoxic or myelosuppressive drugs, probenecid. Adverse Reactions: Anaemia, neutropenia, leucopenia, nausea, headache, rash, abdominal pain, fever, myalgia, paraesthesia, vomiting, insomnia & anorexia. Asthenia, malaise, somnolence, diarrhoea, dizziness, sweating, dyspnoea, dyspepsia, flatulence, bad taste, chest pain, loss of mental acuity, anxiety, urinary frequency, depression, generalised pain, chills, cough, urticaria, pruritus & flu-like syndrome. Zidovudine 10 mg/ml Syrup Retrovir - Trade Name
J05AF01000L9001XX (A*) NEDL

System: Antiinfectives Indications: i) Management of patients with asymptomatic and symptomatic (early or advanced) HIV infections with CD4 cell counts < 500 cu. mm. ii) Neonatal prophylaxis. Dosage: i) Adult : 500 - 600 mg/day in 2 - 3 divided doses. Child > 3 mths : 360 - 480 mg/m2 dly in 3 - 4 divided doses; max. 200 mg every 6 hours. ii) 2 mg/kg 6 hrly within 12 hr after birth up to 6 wk. Contraindications: Abnormally low neutrophil cell count (< 0.75 x 109/L) or abnormally low Hb levels (< 7.5 g/dL). Precautions: Monitor carefully haematological parameters. If anaemia or myelosuppression occurs dose adjustments are suggested. Patients with preexisting bone marrow compromise. Pregnancy & lactation. Interactions: Chronic paracetamol use, potentially nephrotoxic or myelosuppressive drugs, probenecid. Adverse Reactions: Anaemia, neutropenia, leucopenia, nausea, headache, rash, abdominal pain, fever, myalgia, paraesthesia, vomiting, insomnia & anorexia. Asthenia, malaise, somnolence, diarrhoea, dizziness, sweating, dyspnoea, dyspepsia, flatulence, bad taste, chest pain, loss of mental acuity, anxiety, urinary frequency, depression, generalised pain, chills, cough, urticaria, pruritus & flu-like syndrome. Zidovudine 300 mg Tablet Retrovir - Trade Name System: Antiinfectives
J05AF01000T1001XX (A*)

276

Indications: i. Management of patients with asymptomatic and symptomatic (early or advanced) HIV infections with CD4 cell counts< 500 cu. mm. ii. HIV positive pregnant mothers . Dosage: Adult : 500 - 600 mg dly in 2 - 3 divided doses. Contraindications: Abnormally low neutrophil cell count (< 0.75 x 109/L) or abnormally low Hb levels (< 7.5 g/dL). Precautions: Monitor carefully haematological parameters. If anaemia or myelosuppression occurs dose adjustments are suggested. Patients w/ preexisting bone marrow compromise. Pregnancy & lactation. Interactions: Chronic paracetamol use, potentially nephrotoxic or myelosuppressive drugs, probenecid. Adverse Reactions: Anaemia, neutropenia, leucopenia, nausea, headache, rash, abdominal pain, fever, myalgia, paraesthesia, vomiting, insomnia & anorexia, asthenia, malaise, somnolence, diarrhoea, dizziness, sweating, dyspnoea, dyspepsia, flatulence, bad taste, chest pain, loss of mental acuity, anxiety, urinary frequency, depression, generalised pain, chills, cough, urticaria, pruritus & flu-like syndrome. Didanosine 2 g Oral Solution. (ddI) Videx - Trade Name
J05AF02000F2101XX (A*)NEDL

System: Antiinfectives Indications: Patients with advanced HIV infection. Dosage: Adult : Patient baseline weight >60 kg : 200 mg bd, weight < 60 kg : 125 mg bd. Child : 8 mths and over : 120 mg/m2 bd , 2 wks - 8 mths : 100 mg/m2 bd Contraindications: Hypersensitivity to didanosine. Precautions: Peripheral neuropathy, history of pancreatitis, lactic acidosis, renal impairment, phenylketonuria, pregnancy & lactation. Interactions: Co-administration with drugs that are known to cause peripheral neuropathy or pancreatitis may increase the risk of those toxicities. Drugs which can be affected by stomach acidity should be administered at least 2 hours prior to administration of didanosine. Adverse Reactions: Pancreatitis, peripheral neuropathy, rash, pruritis, asthenia, headache, nausea/vomiting, abdominal pain, diarrhoea, chills, fever, pain, retinal depigmentation, optic neuritis, anorexia, dyspepsia, flatulence, parotid gland enlargement, anthralgia, myopathy, hypoglycaemia & hyperglycaemia , rhabdomyolysis. Didanosine 25 mg Tablet (ddI) Videx - Trade Name System: Antiinfectives Indications: Patients with advanced HIV infection. Dosage: 277
J05AF02000T2001XX (A*)NEDL

Adult : Patient baseline weight >60 kg : 200 mg bd, weight < 60 kg : 125 mg bd or 300 mg dly. Child : 8 mths and over : 120 mg/m2 bd, 2 wks - 8 mths : 100 mg/m2 bd. Contraindications: Hypersensitivity to didanosine. Precautions: Peripheral neuropathy, history of pancreatitis, lactic acidosis, renal impairment, phenylketonuria, pregnancy & lactation. Interactions: Co-administration with drugs that are known to cause peripheral neuropathy or pancreatitis may increase the risk of those toxicities. Drugs which can be affected by stomach acidity should be administered at least 2 hours prior to administration of didanosine. Adverse Reactions: Pancreatitis, peripheral neuropathy, rash, pruritis, asthenia, headache, nausea, vomiting, abdominal pain, diarrhoea, chills, fever, pain, retinal depigmentation, optic neuritis, anorexia, dyspepsia, flatulence, parotid gland enlargement, anthralgia, myopathy, hypoglycaemia & hyperglycaemia, rhabdomyolysis. Didanosine 100 mg Tablet (ddI) Videx - Trade Name
J05AF02000T2002XX (A*)NEDL

System: Antiinfectives Indications: Patients with advanced HIV infec tion. Dosage: Adult : Patient baseline weight >60 kg : 200 mg bd, weight <60 kg : 125 mg bd or 300mg daily. Child : 8 mths and over : 120 mg/m2 bd, 2 wks - 8 mths : 100 mg/m2 bd Contraindications: Hypersensitivity to didanosine. Precautions: Peripheral neuropathy, history of pancreatitis, lactic acidosis, renal impairment, phenylketonuria, pregnancy & lactation. Interactions: Co-administration with drugs that are known to cause peripheral neuropathy or pancreatitis may increase the risk of those toxicities. Drugs which can be affected by stomach acidity should be administered at least 2 hours prior to administration of didanosine. Adverse Reactions: Pancreatitis, peripheral neuropathy, rash, pruritis, asthenia, headache, nausea, vomiting, abdominal pain, diarrhoea, chills, fever, pain, retinal depigmentation, optic neuritis, anorexia, dyspepsia, flatulence, parotid gland enlargement, anthralgia, myopathy, hypoglycaemia & hyperglycaemia , rhabdomyolysis. Zalcitabine 0.75 mg Tablet H i v i d - Trade Name System: Antiinfectives
J05AF03000T1001XX (A*)

278

Indications: i) Monotherapy for Zidovudine-intolerant patients or failures in advanced HIV infection ii) Combination therapy with Zidovudine in advanced HIV infection (CD4 cell counts <300 cu mm). Dosage: i) Adult : 0.75 mg 8 hrly. ii) 0.75 mg concomitantly with 200 mg Zidovudine 8 hrly. Contraindications: Hypersensitivity to zalcitabine or its excipients. Precautions: Peripheral neuropathy, hepatic or renal impairment, history of pancreatitis. Interactions: Drugs with potential to cause peripheral neuropathy, pancreatitis or which are nephrotoxic. Adverse Reactions: Peripheral neuropathy, oral ulcers, nausea, dysphagia, anorexia, diarrhoea, abdominal pain, vomiting, constipation, rash, pruritus, sweating, headache, dizziness, myalgia, arthralgia, weight loss, fatigue, fever, rigors, chest pain, pharyngitis. Stavudine 30 mg Capsule Zerit - Trade Name
J05AF04000C1001XX (A*)

System: Antiinfectives Indications: Treatment of adults with advanced HIV infection in combination with other anti retroviral agents. Criteria: I) Clinical AIDS ii) CD4 < 350 cells or iii) Viral load > 10,000 copies /ml. Dosage: Child < 30 kg : 15 mg bd, > 30 kg : 30 mg bd. Adult > 60 kg : 40 mg bd ; < 60 kg : 30 mg bd Contraindications: Hypersensitivity Precautions: Pregnancy, lactation, history of peripheral neuropathy. Interactions: Zidovudine, doxorubicin. Adverse Reactions: Peripheral neuropathy, pancreatitis, headache, malaise, lactic acidosis. Stavudine 40 mg Capsule (d4T) Zerit - Trade Name
J05AF04000C1002XX (A*)

System: Antiinfectives Indications: Treatment of adults with advanced HIV infection in combination with other anti retroviral agents. Criteria: I) Clinical AIDS ii) CD4 < 350 cells or iii) Viral load > 10,000 copies / ml. Dosage: Child < 30 kg : 15 mg bd, > 30 kg : 30 mg bd. Adult > 60 kg : 40 mg bd ; < 60 kg : 30 mg bd Contraindications: Hypersensitivity Precautions: Pregnancy, lactation, history of peripheral neuropathy. Interactions: Zidovudine, doxorubicin. Adverse Reactions: Peripheral neuropathy, pancreatitis, headache, malaise, 279

lactic acidosis. Stavudine 1 mg/ml Solution Zerit - Trade Name

J05AF04000L5001XX (A*)

System: Antiinfectives Indications: Treatment of adult & children > 5 month of age with HIV infection. Dosage: Children > 30 kg: adult dosing < 30kg: 1 mg/kg 12 hrly. Contraindications: Hypersensitivity. Precautions: Pregnancy, lactation, history of peripheral neuropathy. Interactions: Zidovudine, doxorubicin. Adverse Reactions: Peripheral neuropathy, pancreatitis, headache, malaise, lactic acidosis. Lamivudine 10 mg/ml Oral Solution (3TC) 3 T C - Trade Name
J05AF05000L9901XX (A*)

System: Antiinfectives Indications: Used in combination with Zidovudine for the treatment of HIV infected adults and children (3 months and above). Dosage: Adult : 150 mg bd + Zidovudine 300 mg bd. Child : 4 mg/kg bd + Zidovudine 360 - 720 mg/m2 per day. Contraindications: Abnormally low neutrophil counts (< 0.75 x 109/L) or abnormally low haemoglobin levels (< 7.5 g/dL or 4.65 mmol/L). Precautions: Moderate to severe renal impairment, advanced cirrhotic liver disease, pregnancy, lactation. Interactions: Trimethoprim causes an increase in lamivudine plasma levels. Adverse Reactions: Malaise, fatigue, upper abdominal pain, rash, paraesthesia, headache, nausea & vomiting, diarrhoea & fever. Lamivudine 100 mg Tablet Zeffix - Trade Name
J05AF05000T1001XX (A*)

System: Antiinfectives Indications: Treatment of patients > 16 yr with chronic Hepatitis B & evidence of Hepatitis B virus replication. Dosage: 100 mg once dly. Contraindications: Abnormally low neutrophil counts (< 0.75 x 109/L) or abnormally low haemoglobin levels (< 7.5 g/dL or 4.65 mmol/L). Precautions: Moderate to severe renal impairment, advanced cirrhotic liver disease, pregnancy, lactation. Interactions: Trimethoprim causes an increase in lamivudine plasma levels. Adverse Reactions: Malaise, fatigue, upper abdominal pain, rash, paraesthesia, headache, nausea & vomiting, diarrhoea & fever. 280

Lamivudine 150 mg Tablet (3TC) 3 T C - Trade Name

J05AF05000T1002XX (A*)

System: Antiinfectives Indications: Used in combination with other antiretroviral drugs for the treatment of HIV infected adults and children (3 months and above). Dosage: Adult : 150 mg bd and Zidovudine 300 mg bd. Child : 4 mg/kg bd and Zidovudine 360 - 720 mg/m2 per day. Contraindications: Abnormally low neutrophil counts (< 0.75 x 109/L) or abnormally low haemoglobin levels (< 7.5 g/dL or 4.65 mmol/L). Precautions: Moderate to severe renal impairment, advanced cirrhotic liver disease, pregnancy, lactation Interactions: Trimethoprim causes an increase in lamivudine plasma levels. Adverse Reactions: Malaise, fatigue, upper abdominal pain, rash, paraesthesia, headache, nausea & vomiting, diarrhoea & fever. Zidovudine 300 mg Tablet & Lamivudine 150 mg Tablet Combivir
J05AF30964T1001XX (A*)
- Trade Name

System: Antiinfectives Indications: Management of HIV infected adults and children more than 12 years of age with progressive immunodeficiency. Dosage: 1 tablet bd. Contraindications: Hypersensitivity. Patients with abnormally low neutrophil counts (< 0.75 x 109), or abnormally low haemoglobin levels (< 7.5 g/dL or 4.65 mmol/L). Precautions: Advanced cirrhotic liver disease due to chronic hepatitis B infection. Severe hepatic or renal impairment. Monitor haematological parameters. Interactions: Trimethoprim, phenytoin, paracetamol, aspirin, codeine, morphine, indomethacine, ketoprofen, naproxen, oxazepam, lorazepam, cimetidine, clofibrate, dapsone, & isoprinosine, potentially nephrotoxic or myelosuppressive drugs, ribavirin. Adverse Reactions: Headache, malaise, fatigue, GI effects, upper abdominal pain, fever, rash, pancreatitis, peripheral neuropathy, leucopenia, neutropenia, anaemia, thrombocytopenia. Nevirapine 200 mg Tablet
J05AG01000T1001XX (A)

System: Antiinfectives Indications: Treatment of HIV infection in combination with other antiretroviral agents. Dosage: 200 mg once daily for first 14 days then 200 mg twice daily. Contraindications: Hypersensitivity to Nevirapine or any component of the 281

formulation, breast feeding, severe hepatic impairment. Precautions: Hepatic impairment, history of chronic hepatitis, hepatic disease, pregnancy. Interactions: Methadone, rifampicin, ketoconazole, other antivirals such as saquinaxir, indinavir, st. john's wort, warfarin. Adverse Reactions: Hepatitis, hepatic failure (life threatening), hepatotoxicity, severe skin reaction, headache, fatique, diarrhoea, nausea, rash, fat redistribution. Efavirenz 50 mg Capsule S t o c r i n - Trade Name
J05AG03000C1001XX (A*)

System: Antiinfectives Indications: Combination therapy for HIV infections with a protease inhibitor and or Nucleoside Reverse Transcriptase Inhibitors(NRTIs). Dosage: Child : according to body wt., 13 - 15 kg : 200 mg dly, 15 - 20 kg : 250 mg, 20 25 kg : 300 mg, 25 - 32.5 kg : 350 mg, 32.5 - 40 kg : 400 mg, > 40 kg and adult : 600 mg dly. Contraindications: Hypersensitivity, concomitant terfenadine, cisapride, midazolam, triazolam and ergot derivatives. Precautions: Pregnancy, lactation and renal impairment. Interactions: Indinavir, ritonavir, rifampicin, warfarin, sertaline and clarithromycin. Adverse Reactions: Rash, dizziness, nausea, headache & fatigue. Efavirenz 100 mg Capsule Efavirenz 200 mg Capsule S t o c r i n - Trade Name
J05AG03000C1002XX (A*) J05AG03000C1003XX (A*)

System: Antiinfectives Indications: Combination therapy for HIV infections with a protease inhibitor and/or NRTIs. Dosage: Child : according to body wt., 13 - 15 kg : 200 mg dly, 15 - 20 kg : 250 mg, 20 25 kg : 300 mg, 25 - 32.5 kg : 350 mg, 32.5 - 40 kg : 400 mg, > 40 kg and adult : 600 mg dly. Contraindications: Hypersensitivity, concomitant terfenadine, cisapride, midazolam, triazolam and ergot derivatives. Precautions: Pregnancy, lactation and renal impairment. Interactions: Indinavir, ritonavir, rifampicin, warfarin, sertaline and clarithromycin. Adverse Reactions: Rash, dizziness, nausea, headache & fatigue. Efavirenz 600 mg Tablet S t o c r i n - Trade Name
J05AG03000T1001XX (A*)

System: Antiinfectives Indications: For anti -retroviral therapy in adult as part of Highly Active Antiretroviral Therapy 282

(HAART). Dosage: 600 mg daily. Contraindications: Hypersensitivity, concomitant terfenadine, cisapride, midazolam, triazolam and ergot derivatives. Precautions: Pregnancy, lactation, renal impairment. Interactions: Indinavir, ritonavir, rifampicin, clarithromycin. Adverse Reactions: Rash, dizziness, nausea, headache & fatigue. Tetanus Antitoxin, 1500 units/ml in Injection
J06AA02000P3001XX (B)

System: Immunological Products and Vaccines Indications: Tetanus. Dosage: Prophylaxis: 1500 units SC or IM, or 3000 units if wound is heavily contaminated. Two further doses may be given at weekly intervals. Treatment: Should be given as early as possible in doses of up to 100,000 units IM. Further doses of 25,000-50,000. Contraindications: Not known. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: Anaphylaxis and serum sickness if source is equine. Antivenene Malaysian Pit Viper Injection
J06AA03000P3001XX (B) NEDL APPL

System: Emergency Indications: Bitten by pit viper. Dosage: Reconstitute content for the vial with 5ml sterile pyrogen-free distilled water. Administer by IV infusion 200ml of Normal Saline over a period of 1-2hrs. Contraindications: Hypersensitivity to any component of the formulation, unless the benefits outweigh the risks and appropriate management for anaphylaxis is available. Precautions: Sensitivity testing should be performed before the administration. Interactions: No interaction found. Adverse Reactions: Chest pain, hypotension, chills, nervousness, cellulitis, bruising, pruritus, rash, urticaria, anorexia, nausea, coagulation disorder, back pain, circumoral paraesthesia, general paraesthesia, myalgia, asthma, cough, dyspnoea, sputum increased, wheezing, allergic reaction, serum sickness, subcutaneous nodule, wound infection, anaphylaxis, serum sickness. Antivenene Serum (Cobra) Injection System: Emergency Indications: Bitten by cobra. Dosage: 283
J06AA03000P3002XX (B) NEDL APPL

IM, IV or SC : 1 - 2 vials for mild case. Larger doses for moderate to severe cases. Contraindications: Not known. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: No information available. Antivenene Serum (Sea snake) 1000 units/26.3ml Injection
J06AA03000P3003XX (B) NEDL APPL

System: Emergency Indications: Bitten by sea snake Dosage: 1000 units by IV infusion over 1/2 to 1 hr. In severe cases 3000-10000 units may be required. Contraindications: Not known. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: No information available. Mixed Gas-Gangrene Antitoxin 25,000 units/5 ml Injection
J06AA05000P3001XX (B)

System: Immunological Products and Vaccines Indications: Mixed gas-gangrene Dosage: Prophylactic: 25,000 units IM or IV. Therapeutic: not less than 75,000 units IV. Contraindications: Not known Precautions: Not known Interactions: No interaction found Adverse Reactions: Anaphylaxis and serum sickness if source is equine Hyperimmune Gamma Globulin Injection G a m m a- 1 6 - Trade Name System: Immunological Products and Vaccines
J06BA02000P3001XX (A) APPL

284

Indications: (i) Hypogammaglobulinaemia & other deficiency states (ii) Severe refractory idiopathic thrombocytopenia purpura (platelet< 20,000) with internal bleeding, particularly CNS (iii) Septicaemia in immunocompromised patients or patients not responding to antibiotics. (iv) Chronic lymphocytic leukaemia not responding to conventional therapy. Dosage: (i) 50 mg/kg body wt dly for 5 days, then 25 - 50 mg/kg wkly for maintenance according to the severity of the condition. (ii) 400 mg/kg daily for 5 days with a further dose of 400mg/kg as required. (iii) Septicaemia in immunocompromised patients or patients not responding to antibiotics. (iv) 250mg/kg per month Contraindications: Anaphylactic or severe systemic response to human Ig. Selective IgA deficiencies who have known antibody against IgA. Precautions: Pregnancy Interactions: Live virus vaccines. Adverse Reactions: Local reaction at injection site, allergic reaction, headache, malaise, fever, chest tightness, back pain Anti RhD Gamma Globulin 250 mcg/2 ml Injection (500 units=100 mcg) Rhogam
- Trade Name

J06BB01000P3001XX (B) NEDL APPL

System: Immunological Products and Vaccines Indications: Prevention of Rh(D) sensitisation, by IM inj, to Rhesus negative woman after delivery of rhesus-positive infant. Dosage: 50 - 100 mcg within 72 hours after incompatible blood transfusion: 25 mcg (125 units) per ml transfused blood, up to 1000 mcg. Contraindications: RhD +ve mother Precautions: Never administer by IV or to infant. IgA deficiency. Hypersensitivity to thiomersal or human Ig. Interactions: Live virus vaccines. Adverse Reactions: Pain at inj site.Slight temperature elevation. Antitetanus Human Immunoglobulin 250 Units/Vial H y p e r -Tet
- Trade Name

J06BB02000P3001XX (B) NEDL APPL

System: Immunological Products and Vaccines Indications: Passive immunization against tetanus. Dosage: Prophylaxis of tetanus : IM 250 - 500 units. Treatment of tetanus: IM 150 units/kg. Contraindications: HIV patients. Precautions: Known intolerence to blood or blood derivatives. 285

Interactions: Never administer tetanus toxoid and Tetanus Immunoglobulin (TIG) in same syringe (toxoid will be neutralized); toxoid may be given at a separate site; concomitant administration with T-dependant antigen (Td) may decrease its immune response, especially in individuals with low prevaccination antibody titers. Adverse Reactions: Pain, tenderness, erythema at injection site, fever (mild), urticaria, angioedema, muscle stiffness, anaphylaxis reaction, sensitization to repeated injections. Hepatitis B Immunoglobulin (Human) Injection J06BB04000P3001XX (A) NEDL H y p e r h e p / H e p a b i g - Trade Name System: Immunological Products and Vaccines Indications: i) For post-exposure prophylaxis of hepatitis B ii) Prophylaxis against recurrence of hepatitis B infection in chronic hepatitis B post liver transplantation. Dosage: i) Recommended dose in adult and child > 10 years : A single dose of 500 units IM within 48 hours and not more than 1 week after exposure. ii) Different regimens depending on HBV DN A positivity. Contraindications: Selective IgA deficiencies. Precautions: Extreme hypogammaglobulinaemia, severe thrombocytopenia, bleeding disorders. Interactions: Live vaccines. Adverse Reactions: Local reaction at injection site, headache, malaise, fever, nephrotic syndrome. Antirabies Immunoglobulin (Human) 300 iu/2ml Imogam Rabies - Trade Name
J06BB05000P3001XX (B)

System: Immunological Products and Vaccines Indications: Treatment of rabies. Dosage: 20 iu/kg; half by IM and half by infiltration around the wound. Contraindications: Severe febrile infection, acute disease, progressive chronic disease, hypersensitivity to any of the ingredients of the vaccine. Precautions: Allergy to neomycin. Interactions: Corticosteroids and immunosuppressor. Adverse Reactions: Minor local reactions, systemic reactions, hypersensitivity reaction, neuropathy. Palivizumab 100mg Injection Synagis - Trade Name System: Antiinfectives
J06BB16000P3001XX (A*)

286

Indications: For the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in paediatric patients at high risk of RSV disease. Dosage: 15 mg/kg IM once a month during season of RSV risk. Contraindications: Hypersensitivity to humanised monoclonal antibodies. Precautions: Should be given with caution to patients with thrombocytopenia or any coagulation disorder. Injection should be given within 6 hrs after reconstitution. Interactions: Carcinogenesis, mutagenesis and reproductive toxicity studies have not been performed. Adverse Reactions: Fever, nervousness, diarrhoea, vomiting, rhinitis, cough, wheeze, pain, rash, leucopenia, abnormal liver function tests. Cholera Vaccine
J07AE01000P3001XX (B) NEDL

System: Immunological Products and Vaccines Indications: Immunisation of cholera. Dosage: Prophylactic, adult : 1st dose of 0.5 ml SC/IM followed after 1 - 4 wks by a 2nd dose of 1ml. Child; 1-5 year: 0.1 ml (1st dose), 0.3 ml (2nd dose). Child; 5-10 years: 0.3 ml (1st dose), 0.5ml (2nd dose). Contraindications: Infants less than 6 months of age. Revaccination is not advisable if serious reaction to the vaccine has occurred. Precautions: Avoid administration to immunosuppressed patients, use in pregnant women only when necessary. Interactions: Yellow fever vaccine. Adverse Reactions: Tachycardia and hypotension, neurologic disorders, anaphylaxis and hypersensitivity reactions, malaise, low-grade-fever, generalized aches and pains, urticaria. Diphtheria Antitoxin 20,000 units/10 ml Injection J07AF01000P3001XX (B) NEDL System: Immunological Products and Vaccines Indications: Diphtheria. Dosage: Therapeutic : 10,000 - 30,000 units IM or IV. Increase to 40,000 - 100,000 units in severe cases. Doses up to 30,000 units may be given IM. Prophylaxis is no longer use. Contraindications: Not known. Precautions: Sensitivity testing should be performed before the administration. Interactions: No interaction found. Adverse Reactions: Anaphylaxis, serum sickness.

287

Haemophilus Influenzae Type B Conjugate 10 mcg Vaccine A c t -H i b

J07AG01000P4001XX (A)
- Trade Name

System: Immunological Products and Vaccines Indications: Immunisation of infants against Hib. Dosage: 0.5 ml. Contraindications: Allergy to one of the vaccine constituents, particularly to tetanus protein. Precautions: Presence of fever or acute infection. Interactions: No interaction found. Adverse Reactions: No information available. Adsorbed Diptheria, Tetanus, Pertussis and Conjugated Haemophilus Type B 10 mcg Vaccine J07AG52000P3001XX (C) T e t r a m u n e / T E T R A c t -Hib - Trade Name System: Immunological Products and Vaccines Indications: Immunisation of children against Hib infections, diphteria, tetanus and pertassis. Dosage: 0.5 ml IM injection. Contraindications: Evolving encephalopathy with or without convulsions. Discontinue vaccination on subjects who exhibit strong reaction within 48 hr. Precautions: Presence of fever or acute infection. Do not administer this product intravascularly. Interactions: No interaction found. Adverse Reactions: Pain, erythema or nodule at injection site. Febrile reaction (38 - 39 C) up to 48 hr. Rarely, high fever (>40 C), high pitch crying syndrome, convulsions, encephalopathy, shock. Meningococcal A, C, Y, W135 Vaccine Injection J07AH04000P4001XX (B) NEDL APPL System: Immunological Products and Vaccines Indications: Immunisation against meningococcal diseases caused by Neisseria meningitidis Group A, Group C, Group Y or Group W-135. Dosage: Prophylaxis: 0.5 ml SC. Contraindications: Hypersensitivity to any component of the form. Precautions: Infants < 18 month have a lower rate of seroconversion to C, Y and W135. Interactions: Decreased effect with administration of immunoglobulin within 1 month. Adverse Reactions: Temporary hyperthermia & mild erythema at injection site. 288

Diphtheria-Pertussis-Tetanus Vaccine Injection J07AJ52963P3001XX (C) NEDL APPL Triple antigen - Trade Name System: Immunological Products and Vaccines Indications: Prophylactic immunisation against diphtheria, pertussis and tetanus. Dosage: By deep SC or IM injection : 3 doses each of 0.5 or 1 ml with intervals of 6 - 8 wks and 4 - 6 mths respectively between the doses. Booster 1 and 5 years after primary immunisation. Contraindications: Any neurological disease, strong reaction to a previous pertussis vaccine injection : fever > 40c, shrieking syndrome, convulsions, shock happening within 48 hrs of injection. Precautions: Allergy to streptomycin. Interactions: No interaction found. Adverse Reactions: Pain, erythema or nodule at the injection site. Pneumococcal Vaccine (Polyvalent) Pneumo 23 - Trade Name
J07AL01000P3001XX (A)

System: Immunological Products and Vaccines Indications: Prevention of pneumococcal infections in high risk subjects from the age of 2 years including patient with a history of splenectomy or scheduled splenectomy. Dosage: Primary injection: 1 single inj (0.5ml) only. Booster: Must not be given within 5 years except in very high risk patient who received the vaccine while under immunosuppressive treatment. Contraindications: Marked reaction after a previous injection. Precautions: Pregnancy. Interactions: No interaction found. Adverse Reactions: Hypersensitivity. Tetanus Toxoid Injection ATT - Trade Name
J07AM01000P3001XX (C) NEDL APPL

System: Immunological Products and Vaccines Indications: Immunization against tetanus infection. Dosage: IM/deep SC, 0.5 ml at 2 mths followed by 2nd dose after 4 weeks and third dose after another 4 weeks. Booster every 10 years. Contraindications: Not known. Precautions: Not recommended for children < 2 years. Interactions: No Interaction found. Adverse Reactions: Local reaction, fever, headache and malaise starting a few hours after injection and lasting for 1 or 2 days, hypersensitivity reactions. 289

Diphtheria-Tetanus Vaccine Injection D o u b l e a n t i g e n - Trade Name

J07AM51963P3001XX (C) NEDL APPL

System: Immunological Products and Vaccines Indications: Immunisation against diphtheria and tetanus. Dosage: Prophylactic: 2 or 3 doses by deep SC or IM injection, 0.5 or 1 ml. Each 2nd dose at 4 - 6 wks then 4 - 6 mths. Booster at 4 - 6 years. Contraindications: Not known. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: Pain, erythema or nodule at the injection site. BCG.Freeze-dried Vaccine Injection
J07AN01000P4001XX (C) NEDL APPL

System: Immunological Products and Vaccines Indications: For the prevention of tuberculosis. Dosage: Prevention of tuberculosis : 0.1 ml by intradermal inj. Infant under 3 months : 0.05 ml. Contraindications: Congenital or acquired cell mediated immune deficiencies(including HIV), patients with systemic corticosteroid/immunosuppresive treatment, malignant condition, pyrexia, generalised infected dermatoses, organ abnormalities. Precautions: Children born to HIV positive mothers, pregnancy. Interactions: No interaction found. Adverse Reactions: Superficial, self healing ulceration. Typhoid Vaccine Injection
J07AP02000P3001XX (B) NEDL APPL

System: Immunological Products and Vaccines Indications: Typhoid immunisation are advised for travellers to countries where sanitation standards may be poor and for laboratory workers handling spesimens from suspected cases. Dosage: 2 doses (0.5 ml/dose) are given by SC or IM injection. Preferable 4 - 6 weeks apart. Reinforcing dose may be given every 3 yrs. Contraindications: Not known. Precautions: Not recommended for children < 2 years. Interactions: No interaction found. Adverse Reactions: Local reaction, fever, headache and malaise starting a few hours after injection and lasting for 1 or 2 days. Hypersensitivity reactions. Hepatitis B Vaccine Injection B -H e p a v a c - Trade Name
J07BC01000P4001XX (B) NEDL APPL

System: Immunological Products and Vaccines 290

Indications: Immunisation against all subtypes of Hepatitis B virus. Dosage: Adults & paeds over 10 yrs : 3 doses of 1 ml each. Newborn & paeds up to 10 yrs: 3 doses of 0.5 ml each. Infants born to HBsAg positive mothers: 3 doses of 0.5 ml each. Second dose to be given after 1 mth and booster dose after 6 mths. Contraindications: Hypersensitivity to any of the components. Precautions: Pregnancy, immunodeficiency and or receiving immunosuppresant therapy, severely compromised cardiopulmonary status. Interactions: No interaction found. Adverse Reactions: Fatigue, malaise, nausea, diarrhoea, reactions at injection site. Hepatitis A, Inactivated vaccine 160 antigen units Injection Avaxim
J07BC02000P5001XX (A)
- Trade Name

System: Immunological Products and Vaccines Indications: Vaccination against hepatitis A especially in those at risk of exposure to hepatitis A virus such as i) Visitors ii) Chronic hepatitis B and C patient iii) Those requiring vaccination against hepatitis A. Dosage: 0.5 ml per injection. Adult & child > 15 yr : A single primary dose followed by a booster dose 6 - 12 mth later. Child 2 - 15 yr : A single primary dose followed by a booster dose 6 mth later. Contraindications: Fever, acute illness, chronic progressive disease, hypersensitivity. Precautions: Hepatic disease, hypersensitivity to neomycin, avoid IV route of administration. Interactions: Immunosuppressants. Adverse Reactions: Fatique, fever, headache, muscle or joint pain & GI upset. Mild reversible rise in liver enzymes. Measle's Vaccine (Live Attenuated) Injection J07BD01000P4001XX (C) NEDL APPL System: Immunological Products and Vaccines Indications: Prophylaxis against measles and to prevent development of infection (if given within 72 hours of contact). Dosage: By SC or IM injection, 0.5 ml as a single dose at 9-12 months of age. Contraindications: Congenital or acquired cell mediated immune deficiencies(including HIV), children born to HIV positive mothers. Precautions: Hypersensitivity to egg protein & allergy to neomycin. Interactions: No interaction found. Adverse Reactions: Hyperthermia, mild mobiliform skin lesion. 291

Polio Oral Vaccine P o l i o r a l - Trade Name

J07BF01000D5001XX (C) NEDL APPL

System: Immunological Products and Vaccines Indications: Immunization against poliomyelitis. Dosage: 3 doses given orally plus boosters. Contraindications: Congenital or acquired cell mediated immune deficiencies(including HIV), active malignant disease, pregnancy. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: Rare, paralysis due to reversion of viral attenuation. Rabies Human Diploid Cell Vaccine (Lyophilised) Injection Imorab
J07BG01000P4001XX (B) NEDL
- Trade Name

System: Immunological Products and Vaccines Indications: Pre-exposure and post-exposure vaccination against rabies. Dosage: Prophylaxis: 3 dose (1ml each) schedule on days 0, 7 and 28 booster dose after every 3-4 years. Post exposure prophylaxis : use after attack of a potential rabid animal: 1 dose on days 0, 3, 7, 14, 30. In previously vaccinated individuals 2 doses on day 0, 3. Contraindications: Pregnancy, acute febrile illness. Precautions: Allergy to neomycin. Interactions: Corticosteroids, immunosuppressives. Adverse Reactions: Erythema of injection site, fever with mild asthenia. Rubella Virus Vaccine (Live Attenuated) Injection
J07BJ01000P3001XX (C) NEDL APPL

System: Immunological Products and Vaccines Indications: Immunization against rubella (German measles). Dosage: 0.5 ml SC as a a single dose. Contraindications: Congenital or acquired cell mediated immune deficiencies (including HIV), children born to HIV positive mothers and pregnancy. Precautions: Pregnancy must be avoided for 1 month after rubella vaccination. Interactions: Immunoglobulin or blood products containing immunoglubulin. Adverse Reactions: Mild lymph node enlargement and joint manifestations. Measles, Mumps & Rubella Vaccine Live M- M- R - Trade Name System: Immunological Products and Vaccines Indications: 292
J07BJ51963P4001XX (C)

For immunisation of children against measles, mumps and rubella. Dosage: Subcutaneous or by intramuscular injection, 0.5 ml. Contraindications: Children with untreated malignant disease or altered immunity and those receiving immunosuppressive drugs or radiotherapy or high-dose corticosteroids, allergies to neomycin, kanamycin, child who received another live vaccine by injection within 3 weeks. Precautions: Not suitable for prophylaxis following exposure to mumps or rubella since the antibody response to the mumps and rubella components is too slow for effective prophylaxis. Interactions: No interaction found. Adverse Reactions: Malaise, fever, rash may occur following first dose of MMR vaccine. Varicella Virus Vaccine Live 1350 PFU/0.5 ml Injection J07BK00000P4001XX (A) Varivax - Trade Name System: Immunological Products and Vaccines Indications: Health staff at high risk of contracting varicella and transmitting it to at risk patients. Health staff working with a) children b) pregnant women c) transplant, cancer and immunocompromised patients. Dosage: Adult & child 13yrs or more: Two 0.5 ml SC injection 4 - 8 weeks apart. 12 mths-12 yrs:0.5ml SC as a single dose. Contraindications: Hypersensitivity to any component including gelatin. Blood dyscrasias, leukaemia, lymphoma, malignant neoplasms affecting bone marrow or lymphatic system. Immunodeficiency, active untreated TB, febrile respiratory illness or other active infections. History of anaphylactoid reaction to neomycin. Individuals receiving immunosupressive therapy. Precautions: Avoid salicylates for 6 weeks & avoid pregnancy for 3 months after vaccination. Defer vaccination for 5 months or more following blood/plasma transfusion/administration of immunoglobulin/varicella zoster immune globuline. Following administration of the vaccine, any immunoglobulin should not be given for 2 months thereafter unless its use outweighs the benefit of vaccination. Avoid close contact with susceptible high risk individuals. Interactions: Salicylates, corticosteroids, immunosuppressants. Adverse Reactions: Redness and pain at injection site, upper & lower respiratory illness, cough, irritability or nervousness, fatigue, disturbed sleep, vomiting, otitis, diaper rash, contact rash, headache, mild GI upset, myalgia, arthralgia, lymphadenopathy. Varicella Virus Vaccine Live Attenuated Injection J07BK01000P4001XX (A*) Okavax - Trade Name System: Immunological Products and Vaccines

293

Indications: Prevention of varicella infection in transplant patient. Dosage: 0.5 ml SC (one dose). Contraindications: Reinforcement therapy for leukaemia or extensive therapy using strong immunosuppressives. Acute myelogenous leukaemia or malignant lymphoma. Precautions: Discontinue maintenance chemotherapy equal or less than 1 wk prior to injection & recommence therapy after equal or more than 1 wk after injection. Malignant solid tumours, women of child-bearing potential should practise adequate contraceptive measures 1 mth prior to vaccination & 2 mth after vaccination. Cardiovascular, kidney, liver, haematological or developmental abnormalities. History of seizures, diagnosed immunodeficiency states, abnormal immune system function. Concomitant immunosupressive therapy. Vaccine may not effective in patients receiving blood or gammaglobulin preparation within 3 mth prior to vaccination. Other live viral vaccines should only be given equal or more than 4 wks after Okavax. Interactions: Transfusion and administration of Gamma-Globulin Preparations: The vaccine may not be effective in those receiving blood or gamma-globulin preparation within 3 mth before vaccination. Vaccination of such individuals should be delayed until equal or more than 3 mth has elapsed. For those receiving high dose gamma-globulin therapy, ie equal or more than 200 mg/kg, eg patients with Kawasaki disease or acute immune thrombocytopenic purpura (ITP), vaccination should be delayed until equal or more than 6 mths has elapsed. If gamma-globulin is administered within 14 days after administration of the vaccine, the vaccine may not be effective. Such individuals should be revaccinated equal or more than 3 mths after the initial vaccination. Other live vaccine preparations: Those receiving other live vaccines, eg oral polio, measles, mumps, rubella, BCG or yellow fever vaccine, are advised to wait until equal or more than 4 wks has elapsed before being vaccinated. Incompatibilities: The vaccine should not be mixed with other vaccines or medications in the same syringe. Adverse Reactions: Fever, rash, urticaria, erythema, pruritus. Rarely, local reaction, anaphylactoid symptoms. Cyclophosphamide 200 mg Injection Cyclophosphamide 1 g Injection E n d o x a n - Trade Name
L01AA01000P4001XX (A) NEDL APPL L01AA01000P4002XX (A)

System: Haematology/Oncology Indications: i) Solid tumours (adult and paediatric), leukaemia, non-Hodgkins lymphoma, multiple myeloma. ii) Severe lupus nephritis (Class III and IV), iii) Other systemic vasculitis iv) Systemic Lupus Erythematosus, rheumatoid arthritis, polyarteritis nodosa,wegener granulomatosis. v) Pemphigus vulgaris. Dosage: i) Adult: 600 - 750 mg/m2 IV once every 3 wks as part of combination regime. 294

Paeds: Dose variable depending on disease and protocol. Range 600 mg/m2 to 2 g/m2 infusion over 1 hour to 6 hours (lower doses can be given as bolus). Care with pre and posthydration. Mesna to be given with doses > 1gm/m2. Higher doses are used in haematopoetic stem cell transplant-refer to specific protocols. ii) 750mg/m2 BSA monthly for 18 months iii) 750mg/m2 BSA monthly for 6 months. Dose can be adjusted up to 1,000mg/m2 BSA to achieve adequate leucocyte suppression iv) 500-1000mg intravenously (Regime varies according to indication). Starting dose may be given fortnightly then at monthly intervals followed by 3 monthly intervals. v) 500mg infusion on the 2nd day of the dexamethasone-cyclophosphamide pulsed regime, the cycle is repeated every 4 weeks up to 6 cycles or till remission followed by oral cyclophosphamide. Contraindications: Hypersensitivity to cyclophosphamide. Pregnancy, lactation. Precautions: Myelosuppression, renal/hepatic impairment, elderly patients. Interactions: Doxorubicin, cimetidine, thiazide diuretics. Succinyl choline, halothane, nitruous oxide. Increased bone marrow depression with allopurinol, barbiturates, phenytoin, corticosteroids, chlorophenicol, interferon alfa. Radiotherapy, live vaccines. Adverse Reactions: Myelosuppression, sterility, syndrome of inappropriate ADH secretion, hemorrhagic cystitis, fibrosis of bladder, alopecia, nausea and vomiting, anorexia, diarrhoea, headache, rash, flushing of face. Adverse reactions with high doses of cyclophophamide include heart failure and interstitial pneumonitis. Cyclophosphamide 50 mg Tablet E n d o x a n - Trade Name
L01AA01000T1001XX (A) NEDL

System: Haematology/Oncology Indications: i) Solid tumours, leukemia,lymphoma, autoimmune disorders, autoimmune bullous diseases, connective tissue disease, pyoderma gangrenosum. ii) For severe lupus nephritis (Class III & IV), systemic vasculitis and steroid resistant/dependent nephrotic syndrome. iii) SLE, Rheumatoid arthritis, Polyarteritis nodosa, Wegener Granulomatosis. Dosage: i) Adult : 50 - 100 mg/day. Monitor FBC, liver function, urine microscopy and renal function. Paed : Up to 1 yr : 10 - 20 mg daily; 1-5 yrs; 30 - 50 mg daily; 6 12yrs : 50 - 100 mg dly. ii)Dose: 2 mg/kg/day for 3-4 months. iii)Dose : 1 - 1.5 mg/kg/day orally in divided doses. Contraindications: Hypersensitivity to cyclophosphamide. Pregnancy, lactation. Precautions: Myelosuppression, renal/hepatic impairment, elderly patients. Interactions: Doxorubicin, cimetidine, thiazide diuretics. Radiotherapy, live vaccines. Succinyl choline, halothane, nitrous oxide. Increased bone marrow depression with allopurinol, barbiturates, phenytoin, corticosteroids, chlorophenicol, interferon alfa. 295

Adverse Reactions: Myelosuppression, sterility, syndrome of inappropriate ADH secretion, hemorrhagic cystitis, fibrosis of bladder, alopecia, nausea and vomiting, anorexia, diarrhoea, headache, rash, flushing of face. Chlorambucil 5 mg Tablet L e u k e r a n - Trade Name
L01AA02000T1001XX (A) NEDL

System: Haematology/Oncology Indications: Low grade lymphoma, chronic lymphocytic leukemia. Ovarian cancer. Dosage: 6 mg/m2 orally 7 - 14 days in 4 - 6 weekly cycles (usually not more than 10 mg daily). Contraindications: Hypersensitivity to chlorambucil, pregnancy. Precautions: Myelosuppression. Monitor blood counts..History of seizures. If generalised skin rash develops during treatment, to stop therapy to avoid progressing to erythema multiforme, toxic epidermal necrolysis or StevensJohnson syndrome. Interactions: Cyclosporin, phenobarbital, phenytoin Allopurinol. Live vaccines. Adverse Reactions: Myelosuppression, azoospermia/amenorrhea, rash, allergic reactions, seizures, nausea and vomiting, diarrhoea, stomatitis, interstitial pneumonitis, pulmonary fibrosis, transient elevation of liver enzymes, secondary malignancies. Melphalan 2 mg Tablet A l k e r a n - Trade Name
L01AA03000T1001XX (A)

System: Haematology/Oncology Indications: i) Multiple myeloma ii) neuroblastoma, rhabdomyosarcoma iii) Recurrent neuroblstoma (Palliative) Dosage: i) 8-10 mg/m2 for 4 days every 4 weeks. ii) 10-35 mg/m2 once every month For dose regimes, refer to protocols. Contraindications: Lactation, pregnancy, hypersensitivity to mephalan, severe myelosuppression Precautions: Use in caution in renal impairment and elderly. Dose adjustment with blood count. To be taken on empty stomach. Interactions: Cyclosporin, steroid, cemethidine. Adverse Reactions: Bone marrow depression, mild GI effects, diarrhoea , pulmonary fibrosis, interstitial pnuemonitis, alopecia, syndrome of inappropriate ADH secretion, secondary malignancy. Ifosfamide 1 g Injection Holoxan - Trade Name System: Haematology/Oncology Indications: 296
L01AA06000P4001XX (A*) APPL

i) Solid tumours ii) Leukaemia, lymphoma. Dosage: i) 1.2 - 2.4 g/m2/day for 3 - 7 days as a 30 - 120 minute infusion. Alternatively, can also be given as a single high dose, eg. 5 g/m2 in a 24 hour infusion. Cycles may be repeated every 3 - 4 weeks. ii) Paeds : 400 3000 mg/m2/day for 3 - 5 days according to protocol. iii) Refer to protocols. Contraindications: Hypersensitivity to ifosfamide, pregnancy, lactation. Severe myelosupression. Precautions: Brain metastases, electrolyte imbalance, hepatic and renal impairment. Hydration required. Renal function should be checked prior to administration.Co-administration with Mesna, which is a urothelial protective agent is mandatory. Interactions: Phenobarbital, carbamazepine, phenytoin. Adverse Reactions: Alopecia, myelosuppresion, nausea and vomiting, diarhoea, mucositis, transient abnormalities of liver enzymes, acute hepatocellular injury ( not common at standard doses) , erythematous rash, pruritis, pigmentary changes, photosensitivity, acute renal failure (high dose), headache, drowsiness, dizziness, encephalopathy/acute confusion (high dose). Busulphan 2 mg Tablet Myleran - Trade Name
L01AB01000T1001XX (A) NEDL

System: Haematology/Oncology Indications: i) Chronic myeloid leukaemia (CML) and other myeloproliferative diseases ii) Haemopoietic stem cell transplant (HSCT) - refer to specific protocols. Dosage: i)Adult : Initial : 2 - 4 mg daily. Maintenance : 0.5 - 2 mg dly. Stop when WBC < 20 x 109/L. Paed : 60 mcg/kg body weight dly. ii) Paed: Induction 60mcg/kg body wt dly (max 4mg) if leucocytes >20,000/mm3 and platelets >100,000/mm3. Maintenance 10-30mcg/kg(max 2mg daily) Contraindications: Hypersensitivity to Busulphan. Pregnancy and lactation. Precautions: Monitor blood counts during therapy. Caution in patients given radiotherapy or cytotoxic drug therapy recently Interactions: Itraconazole,paracetamol, live vaccines Adverse Reactions: Myelosuppression, cataracts, hyperpigmentation, diffuse intersititial pulmonary fibrosis, GI disturbances, veno-occlusive disease, gynaecomastia, convulsions, impaired fertility and gonadal function, endocardial fibrosis, adrenal suppression, secondary malignancy. Dacarbazine 100 mg Injection
L01AX04000P4001XX (A*)

System: Haematology/Oncology Indications: i) Malignant melanoma, sarcomas, neuroblastomas and other childhood solid tumours, ii) Hodgkin's Disease. Dosage: 297

i) 250 mg/m2 for 5 days, may be repeated every 3 wks. ii) 375 mg/m2 IV every 2 wks. Contraindications: Hypersensitivity to dacarbazine products, lactation. Precautions: Renal or hepatic impairment, bone marrow depression. Pregnancy. Avoid extravasation. Interactions: Drugs that induce hepatic P450 enzymes (eg phenobarbital, phenytoin)may lead to decreased efficacy. Increased risk of infection by the live vaccine. Adverse Reactions: Nausea, vomiting, myelosuppression, flu-like symptoms, alopecia, rash, photosensitivity, vesicant, paresthesias, ataxia, lethargy, headache, confusion, seizures, anaphylactic reactions, elevtion of liver enzymes. Methotrexate 50 mg Injection
L01BA01520P3001XX (A) NEDL APPL

System: Haematology/Oncology Indications: i) Solid tumours. ii) Gestational trophoblastic disease iii) Acute leukaemia/lymphomas iv) Rheumatoid arthritis, psoriatic arthropathy, severe / erythrodermic psoariasis Dosage: i) 50 mg/m2 once every 2 - 3 wks in combination with other drugs. ii) 50 mg IV Day 1, 3, 5, 9 every 3 wks. For high risk gestational trophoblastic disease, use 100 mg/m2 as part of EMA-CO regime. iii) High dose regimes: 500-3000 mg/m2 per dose may be used, employing the 500 mg preparations. Paed: CNS prophylaxis for acute leukaemia 2 gm/m2 over 24 hrs with folinic acid rescue, 3 doses for B- cell lineage. 4 doses for T lineage all every 3 weeks. relapse ALL: 1 gm/m2 over 36 hrs with folinic acid rescue every 3 weeks for 9 doses, maintenance: 50mg/m2 every 2 weeks. Bcell lymphoma: 3 gm/m2 over 3 hrs with folinic acid rescue for three doses. Methotrexate level monitoring recommended when using high dose regimens. The 500 mg strength is not for intrathecal use. Dosage for Intrathecal (IT) treatment and prophylaxis in leukaemia: <1 year : 5mg, 1-2 years:7.5mg, 2-3 years:10mg, >3 years:12.5mg. IT preparation must be clearly stated/verified. ENSURE THAT PREPARATION IS SUITABLE FOR INTRATHECAL USE. iv) Dose used by rheumatologist: 10-15mg IM injection or oral weekly. Dose used by dermatologist: 10-25 mg IM inj weekly. Contraindications: Severe myelosuppression, serious renal and liver disorders. Hypersensitivity to methotrexate , pregnancy, lactation. Precautions: Patients with a creatinine clearance of less than 60 ml/min, impaired renal function, pleural effusion, ascitis and poor nutritional status should not receive high-dose methotrexate. High-dose or intrathecal methotrexate therapy must NOT be formulated with diluents containing preservatives. High-dose methotrexate therapy requires the use of leucovorin rescue. Myelosuppression, acute or chronic hepatotoxicity (elevated transaminases, fibrosis, cirrhosis), pulmonary toxicity (dry cough, pneumonitis). Women of child-bearing potential, gastrointestinal toxicity (vomiting, diarrhoea, stomatittis), tumour lysis syndrome in patients with rapidly growing tumors, severe and sometimes fatal skin reactions, potentially fatal infections 298

(especially Pneumocystis carinii pneumonia), neurotoxicity (leukoencephalophaty, seizures), care should be taken in handling the body fluids of persons receiving antineoplastic agents. Interactions: NSAIDs, nephrotoxic drugs, sulphonamides, folic acid, warfarin, 5-fluorouracil, cytosine arabinoside, L asparaginase, omeprazole, hepatotoxic drugs (eg. Sulphasalazine), cyclosporin, corticosteroids. Adverse Reactions: Myelosuppression, interstitial pneumonitis, Nausea and vomiting, diarrhoea, mucositis, transient abnormalities in the serum levels of liver enzymes, erythematous rash, pruritis, pigmentation, photosensitivity, acute renal failure, drowsiness, dizziness, Alopecia, cirrhosis with chronic methotrexate therapy, demyelinating encephalopathy, acute cerebral dysfunction, acute chemical arachnoiditis (after intrathecal administration). Methotrexate 500 mg/20 ml Injection
L01BA01520P3002XX (A)

System: Haematology/Oncology Indications: i) Solid tumours. ii) Gestational trophoblastic disease. iii) Acute leukemias,lymphomas. Dosage: i) 50 mg/m2 once every 3 wks in combination with other drugs. (For this dose, use the 50 mg preparation.) ii) 50 mg IV Day 1, 3, 5, 9 every 3 wks. For high risk gestational trophoblastic disease, use 100 mg/m2 as part of EMA-CO regime. iii) High dose regimes: 500-3000 mg/m2 per dose may be used, employing the 500 mg preparations. Paed: CNS prophylaxis for acute leukaemia 2 gm/m2 over 24 hrs with folinic acid rescue, 3 doses for B-cell lineage. 4 doses for Tlineage all every 3 weeks. Relapse ALL: 1 gm/m2 over 36 hrs with folinic acid rescue every 3 weeks for 9 doses, maintenance: 50mg/m2 every 2 weeks. Bcell lymphoma: 3 gm/m2 over 3 hrs with folinic acid rescue for three doses. Methotrexate level monitoring recommended when using high dose regimens. THE 500MG STRENGTH IS NOT FOR INTRATHECAL USE. Contraindications: Pregnancy, lactation, severe myelosuppression, serious renal and liver disorder. Precautions: Patients with a creatinine clearance of less than 60 ml/min, impaired renal function, pleural effusion, ascitis or poor nutritional status should not receive high-dose methotrexate. High-dose or intrathecal methotrexate therapy must NOT be formulated with diluents containing preservatives. Highdose methotrexate therapy requires the use of leucovorin rescue. Myelosuppression, acute or chronic hepatotoxicity (elevated transaminases, fibrosis, cirrhosis), pulmonary toxicity (dry cough, pneumonitis). Women of child-bearing potential, gastrointestinal toxicity (vomiting, diarrhoea, stomatittis), tumour lysis syndrome in patients with rapidly growing tumors, severe and sometimes fatal skin reactions, potentially fatal infections (especially Pneumocystis carinii pneumonia), neurotoxicity (leukoencephalophaty, seizures), care should be taken in handling the body fluids of persons receiving antineoplastic agents. Interactions: NSAIDs, salicylates, nephrotoxic drugs, sulphonamides decrease renal tubular secretion, tetracyclines, folic acid, warfarin, 5-fluorouracil, cytosine 299

arabinoside. When used together with NSAIDS may risk sev ere myelosuppression and GI toxicity, alcohol, aminophenazone, amiodarone, amitriptyline, etoposide, cisplatin, antibiotics, cyclosporin, cytosine arabinoside. Adverse Reactions: Myelosuppression, nausea, vomiting, diarrhoea, mucositis, transient abnormalities in serum levels of liver enzymes, acute hepatocellular injury (not common at standard dose), erythematous rash, pruritis, pigmentary changes, photosensitivity, acute renal failure (high dose), headache, drowsiness, dizziness, acute confusion (high dose) interstitial pneumonitis, myelosuppression. Methotrexate Sod 2.5 mg Tablet
L01BA01520T1001XX (A) NEDL

System: Haematology/Oncology Indications: i) Acute lymphoblastic leukaemiaand acute promyelocytic leukemia (maintenance) ii) Extensive plaque psoriasis, erythrodermic psoriasis, pustular psoriasis, Reiter's syndrome, connective tissue disease. Dosage: i) Adult: 20 mg/m2 wkly. Paed: 20 30 mg/m2 wkly according to protocol. ii) Relapsed ALL: 100 mg/m2/day for 5 days 6 weekly according to protocol. iii) Dose used by dermatologist: 5-25mg weekly. Liver biopsy after cumulative dose of 1.5 gramand repeat liver biopsy with additional gram received. Maximum cumulative dose is 4 gram. Monitor FBC, renal and liver function. iv) Rheumatoid arthritis, psoriatic arthropathy: dose used by rheumatologist: 2.5 mg/wk orally starting dose, increasing to 7.5 - 20 mg/wkly. Contraindications: Pregnancy, lactation, severe myelosuppression, serious renal and liver impairment, increase risk of toxicity in the presence of third space fluid (pleural effusion, ascites). Precautions: Impaired renal function, pleural effusion, ascitis, poor nutritional status, Myelosuppression, acute or chronic hepatotoxicity (elevated transaminases, fibrosis, cirrhosis), pulmonary toxicity (dry cough, pneumonitis), nephrotoxicity with high-dose therapy, patients with a creatinine clearance of less than 60 ml/min should not receive high-dose methotrexate, high-dose or intrathecal methotrexate therapy must not be formulated with diluents containing preservatives,women of child-bearing potential, gastrointestinal toxicity (vomiting, diarrhoea, stomatitis), tumour lysis syndrome in patients with rapidly growing tumors, severe and sometimes fatal skin reactions, potentially fatal infections (especially Pneumocystis carinii pneumonia), neurotoxicity (leukoencephalopathy, seizures), high-dose methotrexate therapy will generally require the use of leucovorin rescue, care should be taken in handling the body fluids of persons receiving antineoplastic agents. Interactions: Alcohol, aminophenazone, amiodarone, amitriptyline, antibiotics, cisplatinum, cyclosporin, cytosine arabinoside, diclofenac, etoposide, etretinate, 5-fluorouracil, nsaids, salicylates, nephrotoxic drugs, sulfonamides, tetracyclines, teniposide, warfarin, folic acid. Adverse Reactions: Myelosuppression, nausea, vomiting, diarrhoea, mucositis, transient abnormalities in serum levels of liver enzymes, acute hepatocellular injury (not common at standard dose), erythematous rash, pruritis, pigmentary changes, photosensitivity, acute renal failure (high dose), 300

headache, drowsiness, dizziness, acute confusion (high dose) interstitial pneumonitis, myelosuppression, interstitial pneumonitis. Mercaptopurine 50 mg Tablet P u r i- N e t h o l - Trade Name
L01BB02000T1001XX (A) NEDL A PPL

System: Haematology/Oncology Indications: i) Langerhan's cell histocytosis ii) Acute lymphoblastic leukaemia. iii) APML (maintenance). Dosage: Adult: Maintenance therapy: 60 - 75 mg/m2 body surface area once dly. Adjust doses depending on peripheral blood counts. Paed: 2.5 mg/kg body wt. or 25 100 mg/m2 body surface area once dly according to protocol. Refer to protocols. Contraindications: Lactation, pregnancy, severe bone marrow suppression, severe liver disease, hypersensitivity to mercaptopurine. Precautions: Dose reduction with an abnormal liver or renal function. Myelosuppression (temporarily discontinue treatment with an abnormally large fall in any formed blood element), inherited deficiency of the enzyme thioguanine methyltransferase(TPMT), hepatotoxicity, reduce dosage when administered with allopurinol, pregnancy. Take on an empty stomach. Interactions: Allopurinol, methotrexate Warfarin, decreased anticoagulant effectiveness, sulfasalazine. Adverse Reactions: Bone marrow depression, nausea and vomiting, hepatotoxicity, rash, hyperpigmentation, hyperuricaemia. Thioguanine 40 mg Tablet Lanvis - Trade Name
L01BB03000T1001XX (A)

System: Haematology/Oncology Indications: For acute leukaemia and chronic granulocytic leukaemia. Dosage: Refer to specific protocols. Usually 100 mg/m2 for 5 - 7 days (AML) or up to 2 weeks (CML for accelerated/advanced disease). Paed: 40 60 mg/m2 daily according to protocol. Contraindications: Hypersensitivity to thioguanine. Pregnancy, lactation. Precautions: Caution in renal or hepatic impairment. Interactions: Busulphan. Adverse Reactions: Myelosuppression, mucositis, diarrhoea, hepatotoxicity, transient renal toxicity, nausea and vomiting. Fludarabine phosphate 50 mg Injection F l u d a r a - Trade Name System: Haematology/Oncology
L01BB05162P4001XX (A*)

301

Indications: Refractory acute leukaemias, chronic lymphocytic leukaemias, indolent low grade lymphomas. Dosage: 25 - 30 mg/m2 daily for 5 consecutive days in every 28 days. May be administered up to the achievement of a maximal response (usually 6 cycles) and then the drug should be discontinued. As a conditioning regime for mini-transplant, refer to protocols. Contraindications: Hypersensitivity to fludarabine. Pregnancy, lactation. Precautions: Measure creatinine clearance for renal impaired patients & those over 70 years old. Caution in the elderly, pre-existing severe myelosuppression and CNS disease. Avoid pregnancy during treatment and for at least 6 months after stopping therapy. Avoid live vaccines during and after treatment. Interactions: Cytarabine, cyclophosphamide, cisplatin, mitoxantrone. Effectiveness may be reduced by dipyridamole and other inhibitors of adenosine uptake. Increased risk of fatal lung toxicity when used together with deoxycoformycin. Adverse Reactions: Myelosuppression, fever, anorexia, chills, infection, malaise, fatigue, nausea, vomiting, immunosuppression, hypersensitivity skin reaction, neurotoxicity with high doses. Cytarabine (Cytosine Arabinoside) 40 mg Injection L01BC01000P4001XX (A) Cytosar - Trade Name System: Haematology/Oncology Indications: Lymphoma, leukaemia. Dosage: Standard doses 100-200mg/m2 daily over 7-10 days. Paed: Dose variable depending on disease and protocol. Range from 100 mg/m2 to 3 g/m2 bd. May be given as SC, IV bolus or infusion. Intrathecal dose: <1yr : 15mg, 1 - 2 yrs: 20 mg, 2 - 3 yr: 25mg, >3 yr: 30 mg. (ENSURE THAT PREPARATION IS SUITABLE FOR INTRATHECAL USE) Contraindications: Hypersensitivity to cytarabine products. Pregnancy, lactation. Precautions: Renal and hepatic impairment. Patients over 50 yrs old ( for high dose therapy), pregnancy and lactation. Pre-existing drug-induced bone marrow suppression, leukocyte and platelet counts should be monitored daily, bone marrow examinations should be performed periodically, hepatic impairment, women of childbearincg age, infants, severe GI, CNS and pulmonary toxicity when using high dose schedules. Interactions: Increased cytotoxicity when radiotherapy, alkylating agents, methotrexate and purine analogues are given together with cytarabine. Increased ototoxicity if used concurrently with cisplatin. Adverse Reactions: Myelosuppresion, alopecia, fever, mucositis, nausea and vomiting ,rash , neurotoxicity, headache, dizziness, somnolence, photophobia, cerebellar toxicity, pneumonitis, pulmonary oedema, conjunctivitis, hepatic dysfunction. Cytarabine (Cytosine Arabinoside) 100 mg Injection L01BC01000P4002XX (A) 302

NEDL

Cytosar

- Trade Name

System: Haematology/Oncology Indications: Lymphoma, leukaemia. Dosage: Standard doses 100-200mg/m2 daily over 7-10 days. Higher doses for intensification/consolidation: 1000 - 3000 mg/m2 dly over 3 - 5 days depending on specific protocols. Paed: Dose variable depending on disease and protocol. Range from 100 mg/m2 to 3 g/m2 bd. May be given as SC, IV bolus or infusion. Intrathecal dose: <1yr: 15mg, 1 - 2 yrs: 20 mg, 2 - 3 yr: 25mg, >3 yr: 30 mg. (ENSURE THAT PREPARATION IS SUITABLE FOR INTRATHECAL USE). Contraindications: Hypersensitivity to cytarabine products. Pregnancy, lactation. Precautions: Renal and hepatic impairment. Patients over 50 yrs old (for high dose therapy), pregnancy and lactation. Pre-existing drug-induced bone marrow suppression, leukocyte and platelet counts should be monitored daily, bone marrow examinations should be performed periodically, hepatic impairment, women of childbearing age, infants, severe GI, CNS and pulmonary toxicity when using high dose schedules. Interactions: Increased cytotoxicity when radiotherapy, alkylating agents, methotrexate and purine analogues are given together with cytarabine. Increased ototoxicity if used concurrently with cisplatin. Adverse Reactions: Myelosuppresion, alopecia, fever, mucositis, nausea and vomiting ,rash , neurotoxicity, headache, dizziness, somnolence, photophobia, cerebellar toxicity, pneumonitis, pulmonary oedema, conjunctivitis, hepatic dysfunction. Cytarabine (Cytosine Arabinoside) 500 mg Injection L01BC01000P4003XX (A) Cytosar - Trade Name System: Haematology/Oncology Indications: Haematopoietic stem cell transplantation. Higher doses for intensification/ consolidation. Dosage: 1000 - 3000 mg/m2 daily over 3 - 5 days depending on specific protocols. Contraindications: Hypersensitivity to cytarabine products. Pregnancy, lactation. Precautions: Renal and hepatic impairment. Patients over 50 yrs old (for high dose therapy), pregnancy and lactation. Pre-existing drug-induced bone marrow suppression, leukocyte and platelet counts should be monitored daily, bone marrow examinations should be performed periodically, hepatic impairment, women of childbearing age, infants, severe GI, CNS and pulmonary toxicity when using high dose schedules. Interactions: Increased cytotoxicity when radiotherapy, alkylating agents, methotrexate and purine analogues are given together with cytarabine. Increased ototoxicity if used concurrently with cisplatin. 303

Adverse Reactions: Myelosuppresion, alopecia, fever, mucositis, nausea and vomiting ,rash , neurotoxicity, headache, dizziness, somnolence, photophobia, cerebellar toxicity, pneumonitis, pulmonary oedema, conjunctivitis, hepatic dysfunction. Cytarabine (Cytosine Arabinoside) 1g Injection Cytosar - Trade Name
L01BC01000P4004XX (A)

System: Haematology/Oncology Indications: Haematopoietic stem cell transplantation. High dose for intensification/consolidation. Dosage: High doses for intensification/consolidation: 1000 - 3000 mg/m2 daily over 3 - 5 days depending on specific protocols. Contraindications: Hypersensitivity to cytarabine products. Pregnancy, lactation. Precautions: Seroid eyedrops & pyridoxine prophylaxis given during administration. Renal and hepatic impairment. Patients over 50 yrs old (for high dose therapy), pregnancy and lactation. Pre-existing drug-induced bone marrow suppression, leukocyte and platelet counts should be monitored daily, bone marrow examinations should be performed periodically, hepatic impairment, women of childbearing age, infants, severe GI, CNS and pulmonary toxicity when using high dose schedules. Interactions: Increased cytotoxicity when radiotherapy, alkylating agents, methotrexate and purine analogues are given together with cytarabine. Increased ototoxicity if used concurrently with cisplatin. Adverse Reactions: Myelosuppresion, alopecia, fever, mucositis, nausea and vomiting ,rash , neurotoxicity, headache, dizziness, somnolence, photophobia, cerebellar toxicity, pneumonitis, pulmonary oedema, conjunctivitis, hepatic dysfunction. Fluorouracil 250 mg/5 ml Injection 5- FU - Trade Name
L01BC02000P4001XX (A*) NEDL APPL

System: Haematology/Oncology Indications: Cancers of gastro-intestinal tract, breast & pancreas, head and neck. Ophtalmological indication: trabeculectomy. Dosage: 600 mg/m2 IV in combination with other cytotoxic agents, repeated every 3 wks; or 300 - 450 mg/m2 IV slow bolus dly for 5 days in combination with biological response modifiers, repeated every 4 wks, or 3000 - 3750 mg/m2 as a continuous infusion over 5 days in combination with a platinum compound every 3 to 4 wks. Contraindications: Hypersensitivity to fluorouracil, pregnancy, lactation. Precautions: Caution in ischaemic heart disease, renal or hepatic dysfunction, elderly. Previous pelvic irradiation, previous treatment with alkylating agents, Discontinue upon development of unexpected grade 3 or 4 stomatitis, oesophagopharyngitis, diarrhoea, myelosuppression, or neurologic toxicities. 304

Interactions: Leucovorin, warfarin, methotrexate, thymidine. Adverse Reactions: Myelosuppression, mucositis, pigmentation of infused vein, somnolence, confusion, ataxia, fits, encephalopathy, changes in ECG, chest pain, nausea and vomiting, diarrhoea, photosensitivity, hand foot syndrome. Fluorouracil 100 mg Tablet 5- FU - Trade Name
L01BC02000T1001XX (A) NEDL APPL

System: Haematology/Oncology Indications: Colorectal cancer. Dosage: 200 - 300 mg dly in 1-3 divided doses. Contraindications: Hypersensitivity to fluorouracil, pregnancy, lactation. Precautions: Caution in ischaemic heart disease, renal or hepatic dysfunction, elderly. Previous pelvic irradiation, previous treatment with alkylating agents, Discontinue upon development of unexpected grade 3 or 4 stomatitis, oesophagopharyngitis, diarrhoea, myelosuppression, or neurologic toxicities. Interactions: Leucovorin, warfarin, methotrexate, thymidine. Adverse Reactions: Myelosuppression, mucositis, pigmentation of infused vein, somnolence, confusion, ataxia, fits, encephalopathy, changes in ECG, chest pain, nausea and vomiting, diarrhoea, photosensitivity, hand foot syndrome. Gemcitabine HCl 200 mg Injection G e m z a r - Trade Name
L01BC05110P4001XX (A*)

System: Haematology/Oncology Indications: i) Locally advanced or metastatic non-small cell lung cancer ii) Locally advanced or metastatic pancreatic cancer Dosage: i) Alone or with cisplatin in locally advanced or metastasic NSCLC: 1000mg/m2 D1 & 8 every 3 weeks or 1000 mg/m2 D1, D8, D15 every 4 weeks. ii) Locally advanced or metastatic pancreatic cancer: Initially 1000mg/m2 weekly for 7 weeks followed by 1 week rest. Subsequent cycles 1000mg/ m2 weekly for 3 weeks followed by 1 week rest. Contraindications: Hypersensitivity to gemcitabine. Pregnancy, lactation. Precautions: Caution in hepatic dysfunction, myelosuppression, renal impairment. Avoid prolonging infusion times more than 60 minutes. Interactions: Increased risk of infection by live vaccines. Cisplatin, etoposide, radiotherapy. Adverse Reactions: Flu-like symptoms, proteinuria, nausea, vomiting, myelosuppression, oral soreness, rash, pruritus, elevation of liver enzymes, haematuria, dyspnoea, allergic reactions, myalgia, alopecia, diarrhoea, haemolytic uraemic syndrome, adult respiratory distress syndrome.

305

Gemcitabine HCl 1g Injection G e m z a r - Trade Name

L01BC05110P4002XX (A*)

System: Haematology/Oncology Indications: i) Locally advanced or metastatic non-small cell lung cancer ii) Locally advanced or metastatic pancreatic cancer Dosage: i) Alone or with cisplatin in locally advanced or metastasic NSCLC: 1000mg/m2 D1 & 8 every 3 weeks or 1000 mg/m2 D1, D8, D15 every 4 weeks. ii) Locally advanced or metastatic pancreatic cancer: Initially 1000mg/m2 weekly for 7 weeks followed by 1 week rest. Subsequent cycles 1000mg/m2 weekly for 3 weeks followed by 1 week rest. Contraindications: Hypersensitivity to gemcitabine. Pregnancy, lactation. Precautions: Caution in hepatic dysfunction, myelosuppression, renal impairment. Avoid prolonging infusion times more than 60 minutes. Interactions: Increased risk of infection by live vaccines. Cisplatin, etoposide, radiotherapy. Adverse Reactions: Flu-like symptoms, proteinuria, nausea, vomiting, myelosuppression, oral soreness, rash, pruritus, elevation of liver enzymes, haematuria, dyspnoea, allergic reactions, myalgia, alopecia, diarrhoea, haemolytic uraemic syndrome, adult respiratory distress syndrome. Capecitabine 500 mg Tablet X e l o d a - Trade Name
L01BC06000T1001XX (A*)

System: Haematology/Oncology Indications: Metastatic Breast Cancer (i) Refractory to Taxanes (ii) Elderly and poor performance status patients. Metastatic Colon Cancer (i) First line in elderly and poor performance status patients. (ii) Third line chemotherapy after failure with Irinotecan. Dosage: 2500mg/m2 administered daily for 2 weeks followed by 1 week rest.Regime repeated on 3 weekly basis. Administered orally in two divided doses daily. Contraindications: Hypersensitivity to capecitabine, fluouracil or any component of formulation, severe renal impairment, pregnancy, lactation. Precautions: Patient with bone marrow suppresion, poor nutritional status, elderly patients (>80 years), hepatic or renal dysfunction. Interactions: Warfarin Adverse Reactions: Myelosuppression, oedema, fatigue, fever, abdominal pain, palmar-plantar erythrodysesthesia, dermatitis, nausea & vomiting, stomatitis, anorexia, diarrhoea, constipation, paraesthesia. Vinblastine Sulphate 10 mg Injection V e l b e - Trade Name System: Haematology/Oncology 306
L01CA01183P3002XX (A) NEDL

Indications: Hodgkin's disease, choriocarcinoma, non-small cell lung cancer, Langerhan's cell histiocytosis. Dosage: Adult: Lung cancer - 6 mg/m2 (max 10 mg) on Day 1. Hodgkin's disease- refer to protocol. Paed: Usual wkly dose: 6 mg/m2 wkly or 3 wkly depending on protocol. Contraindications: Hypersensitivity to vinblastine. Pregnancy, lactation. Intrathecal administration of vinblastine is FATAL. NOT FOR INTRATHECAL USE. Precautions: Infection, leukopenia. Pre-existing myelosuppression, hepatic dysfunction or neurotoxicity. Avoid extravasation. Interactions: Mitomycin C, Phenytoin. Drugs which inhibit cytochrome P450 enzymes. Adverse Reactions: Myelosuppression, nausea, vomiting, anorexia, generalized fatigue, constipation, alopecia, dermatitis, vesicant, neurotoxicity, syndrome of inappropriate secretion of anti-diuretic hormone, transient elevation of liver enzymes, hypersensitivity. Vincristine Sulphate 1 mg Injection Oncovin - Trade Name
L01CA02183P3001XX (A) NEDL APPL

System: Haematology/Oncology Indications: i) Solid tumours ii) Gestational trophoblastic disease iii) Non Hodgkins lymphoma iv) Multiple myeloma v) Acute lymphoblastic leukemia. Dosage: i) Adult: 1.4 mg/m2 (max 2mg) ii) Refer to protocol. iii) 1.4 mg/m2 (max 2mg) i.v. bolus every 3 weeks iv) 0.4 mg/m2 (absolute dose) infusion over 24 hours Days 1 4 every 4 weeks v) Refer to protocol. Paeds: 1mg/m2 to 2mg/m2 wkly according to protocol (0.05 mg/kg for infants < 10kg). Contraindications: Hypersensitivity to vincristine. Pregnancy, lactation,Charcot-Marie-Tooth syndrome. Fatal if given intrathecally. NOT FOR INTRATHECAL USE. Precautions: Pre-existing neuropathy or neuromuscular disease. Dose adjustment needed if impaired liver function, elderly patients. Avoid extravasation. Interactions: If used together with L-asparaginase, L-asparaginase should be given 12-24 hours after vincristine injection. Digoxin, paclitaxel, cisplatin, methotrexate, nifedipine, etoposide, isoniazid, melphalan, metronidazole, verapamil, phenytoin. Adverse Reactions: Sensorimotor neuropathy, autonomic neuropathy (severe constipation, ileus, urinary retention and incontinence), cranial nerve dysfunction (hoarseness,diplopia, facial weakness) myelosuppression, 307

alopecia. Vesicant, rash, abdominal pain, SIADH, hypersensitivity, pain in jaws, bone, limb or parotid gland, depression, confusion, nausea/vomiting/diarrhoearare, myelosupression usually mild. Vinorelbine 10 mg Injection N a v e l b i n e - Trade Name
L01CA04000P4001XX (A*)

System: Haematology/Oncology Indications: i) First line treatment in non-small cell lung cancer in combination with Cisplatin/Ifosfomide. ii) Selected cases of metastatic breast cancer. INTRATHECAL ADMINISTRATION OF VINORELBINE IS FATAL. Dosage: 25 - 30 mg/m2. (intravenous) Refer to protocols. Contraindications: Pregnancy, lactation, granulocytopenia. NOT for Intrathecal administration. Precautions: Hypersensitivity to vinorelbine. Pre-existing myelosupression, neuropathy, liver or renal insufficiency, cachexia, ulcer on skin. Avoid extravasation. Drugs that inhibit drug metabolism via hepatic cytochrome P450 system. Dose reduction in abnormal liver function. Interactions: Phenytoin, cisplatin, mitomycin C. Adverse Reactions: Myelosupression esp. Granulocytopenia, peripheral neuropathy, nausea, vomiting, diarrhoea, mucositis, alopecia. Diminished marrow reserve, constipation, paralytic ileus, anorexia, elevation of liver enzymes, vesicant, SIADH, fatigue. Vinorelbine 50 mg Injection N a v e l b i n e - Trade Name
L01CA04000P4002XX (A*)

System: Haematology/Oncology Indications: i) First line treatment in non-small cell lung cancer in combination with Cisplatin/Ifosfomide. ii) Selected cases of metastatic breast cancer. Dosage: 25 - 30 mg/m2 iv weekly (Refer to protocols). Contraindications: Pregnancy, lactation, granulocytopenia. NOT for Intrathecal administration. Precautions: Hypersensitivity to vinorelbine. Pre-existing myelosupression, neuropathy, liver or renal insufficiency, cachexia, ulcer on skin. Avoid extravasation. Drugs that inhibit drug metabolism via hepatic cytochrome P450 system. Dose reduction in abnormal liver function. Interactions: Phenytoin, cisplatin, mitomycin C. Adverse Reactions: Myelosupression esp. Granulocytopenia, peripheral neuropathy, nausea, vomiting, diarrhoea, mucositis, alopecia. Diminished marrow reserve, constipation, paralytic ileus, anorexia, elevation of liver enzymes, vesicant, SIADH, fatigue.

308

Etoposide 25 mg Capsule V e p e s i d - Trade Name

L01CB01000C1001XX (A*)

System: Haematology/Oncology Indications: i) Palliative treatment of children with neuroblastoma, germ cell tumour, leukaemia. ii) Elderly patients with AML and myelodysplasia (palliative). Dosage: i) 50 mg/m2 in 2 divided doses/day for 21 days. Rest 1 week and restart. Usually for 6 courses. ii) 50 mg dly for 21 days every 28 days, or 100 mg dly for 14 days every 3 wks. Contraindications: Hypersensitivity to podophyllins, Severe hepatic dysfunction, pregnancy, lactation. Precautions: Use with caution in hepatic or renal impairment, myelosuppression. Interactions: Cyclosporin, calcium antagonists, methotrexate, warfarin. Increased risk of infection by the live vaccine. Adverse Reactions: Myelosuppression, nausea and vomiting, alopecia, hypersensitivity reaction, radiation recall reaction, secondary malignancy. Etoposide 100 mg Capsule V e p e s i d - Trade Name
L01CB01000C1002XX (A*) NEDL

System: Haematology/Oncology Indications: i) For palliative treatment of children with neuroblastoma, germ cell tumour, leukaemia ii) For elderly patients with AML and myelodysplasia (palliative). Dosage: i) 50 mg/m2 in 2 divided doses/day for 21 days. Rest 1 week and restart. Usually for 6 courses. ii) 50 mg dly for 21 days every 28 days, or 100 mg dly for 14 days every 3 wks. Doses for indications: refer to specific protocols. Contraindications: Hypersensitivity to podophyllins, severe hepatic dysfunction, pregnancy, lactation. Precautions: Use with caution in hepatic or renal impairment, myelosuppression. Interactions: Cyclosporin, calcium antagonists, methotrexate, warfarin. Increased risk of infection by the live vaccine. Adverse Reactions: Myelosuppression, nausea and vomiting, alopecia, hypersensitivity reaction, radiation recall reaction, secondary malignancy. Etoposide 100 mg/5 mg Injection V e p e s i d - Trade Name System: Haematology/Oncology
L01CB01000P3001XX (A*) NEDL

309

Indications: i) For treatment of children with solid tumours, JMML & Langerhan cell histiocytosis ii) Leukemia, lymphoma iii) Testicular cancer, Lung cancer, gestational trophoblastic disease, gastric cancer, sarcoma. Dosage: i) Paeds: IV 60-150mg/m2/day for 3-5 days every 3-6 weeks depending on protocols. ii) Maintenance or palliative chemotherapy for elderly AML, consolidation therapy for ALL, Stem cell mobilization (Refer to protocol). iii) 100 mg/m2 i.v. days 1-5 every 3 weeks, or 100 120 mg/m2 days 1-3 every 3 weeks. (Refer to protocols). Contraindications: Hypersensitivity to podophyllins, severe hepatic dysfunction, pregnancy, lactation. Precautions: Use with caution in hepatic or renal impairment, myelosuppression. Administer intravenously over 30 to 60 minutes to reduce risk of hypotension. Anaphylaxis following intravenous administration to be anticipated and treated appropriately. Interactions: Cyclosporin, calcium antagonists, methotrexate, warfarin. Increased risk of infection by the live vaccine. Adverse Reactions: Myelosuppression, nausea and vomiting, alopecia, hypersensitivity reaction, local inflammatory reaction at site of injection, radiation recall reaction, secondary malignancy. Paclitaxel 30 mg/5 ml Injection Paclitaxel 100 mg Injection T a x o l / A n z a t a x - Trade Name
L01CD01000P3001XX (A*) L01CD01000P3002XX (A*)

System: Haematology/Oncology Indications: i) Treatment of recurrent breast cancer, after failure of anthracycline-based chemotherapy ii) Primary adjuvant therapy in advanced ovarian cancer. Dosage: 175 mg/m2 IV (3 hours infusion) repeated 3 wkly (To be used only in a tertiary oncology unit or after clearance by an oncologist in writing). Contraindications: History of hypersensitivity reaction to paclitaxel or Cremophor EL (polyoxyethylated castor oil) or any component of preparation. Pregnancy, lactation. Precautions: Severe neutropaenia, severe hepatic impairment. Caution in patients with ischaemic heart disease, myocardial infarction and conduction defects. Refer to protocol for prophylactic medication and procedures against hypersensitivity reactions. Interactions: Radiotherapy, phenytoin, phenobarbital, ketoconazole, doxorubicin. Taxane to be given first when used in combination with platinum analogue. Increased risk of infection by live vaccines. Adverse Reactions: Alopecia, myelosuppression, neutropenia, peripheral neuropathy, arrhythmias, hypotension, hypersensitivity reactions, arthralgia, myalgia. 310

Docetaxel 20mg/0.5ml Injection concentrate Docetaxel 80mg/2ml Injection concentrate T a x o t e r e - Trade Name

L01CD02000P3001XX (A*) L01CD02000P3002XX (A*)

System: Haematology/Oncology Indications: i) Breast cancer patient who: a) relapsed less than 6 mths after the end of adjuvant anthracycline-basedchemotherapy b) have relapsed after receiving anthracycline-based chemotherapy for metastatic breast cancer c) demonstrated resistance to anthracycline-based chemotherapy d)performance status WHO 2 or less e) have visceral disease, eg, liver metastases. f) acceptable bone marrow reserve. ii)Patients with non-small cell lung cancer: a) who have progressive disease less than 6 mths after the end of platinumbased chemotherapy, or b) who have progressive disease while on platinum-based chemotherapy, c) good performance status (WHO score of 2 or less), d) have at least a good partial response to initial platinum-based chemotherapy, e) acceptable bone marrow reserve. Dosage: 60 - 75 mg/m2 every 3 weeks. Refer to protocols. Drug must be delivered only in a tertiary oncology centre or clearance must be obtained from an oncologist in writing. Contraindications: Hypersensitivity to docetaxel or Polysorbate 80; neutrophil count less than 1500 cells/mm3. Pregnancy, lactation. Precautions: All patients should receive premedication with corticosteroids against hypersensitivity reactions. Monitor blood counts, liver function tests. Avoid extravasation. Interactions: Increased risk of infection by the live vaccine. Drugs which affect liver cytochrome P450 enzyme system may affect the antitumour and toxic effects of docetaxel. Less toxicity if taxanes given before platinum compounds if combination of taxane and platinum is used. Adverse Reactions: Fluid retention syndrome, hypersensitivity reactions. rash, alopecia, oedema, peripheral neuropathy, myelosuppression, elev ation of liver enzymes, nausea, vomiting, stomatitis, diarrhoea, fatigue, weakness. Actinomycin D (Dactinomycin) 500 mcg/ml Injection L01DA01110P4001XX (A)
NEDL

Cosmegen

- Trade Name

System: Haematology/Oncology Indications: i) For solid tumours ii) Gestational trophoblastic disease Dosage: 311

i) Adult: 500 mcg IV dly for max of 5 days. Child: 1.5 mg/m2 once every 3 wks (if weight < 10 kg, 50 mcg/kg) ii) 500 mcg IV on Days 2, 4, 6, 8, 10, repeat every 7 - 10 days. Or 500 mcg IV bolus on Days 1 and 2, repeat every 15 days. Contraindications: Pregnancy, lactation, chickenpox or herpes zoster infection. Precautions: Avoid extravasation. Concomitant radiation therapy may exaggerate dactinomycin toxicity. Interactions: Live vaccines may result in an increase risk of infection, radiation therapy, halothane. Adverse Reactions: Mylosuppression,nausea,vomiting,mucositis,alopecia,rash,radiation recall reactions,hepatitis. Malaise, fatigue, fever,myalgia, gastrointestinal, haematologic and dermatologic effects. Doxorubicin HCl 10 mg Injection A d r i a m y c i n - Trade Name
L01DB01110P4001XX (A) NEDL APPL

System: Haematology/Oncology Indications: i) Solid tumours, leukaemia, non-Hodgkin's lymphoma ii) Leukaemia (ALL induction) iii) Multiple myeloma Dosage: i) 30 - 75 mg/m2 IV as a single dose at 21- day intervals. ii) 25 - 45 mg/m2 once a wk for the first 4 wks during induction or re-induction phase (refer to specific protocol). Caution: Total cumulative dose of doxorubicin must not exceed 550 mg/m2 due to risk of cardiotoxicity. Paed: 30mg/m2/dose over 6 - 24 hours for 1 - 2 days. Need to check cardiac function closely by echocardiography every cumulative dose of 100mg/m2 to max. 360mg/m2. iii) 9 mg/m2 over 24 hours infusion for 4 days at monthly intervals. Contraindications: Hypersensitivity to doxorubicin, marked myelosuppression induced by previous chemotherapy or radiotherapy. Previous treatment with tolerance doses of anthracyclines, significantly impaired cardiac function, angina pectoris, cardiac arrhythmias or recent myocardial infarction. Precautions: Cardiac failure, heart disease, hypertension. Previous radiotherapy to chest, elderly. Avoid in pregnancy and lactation. Avoid extravasation. Interactions: Live vaccines, phenytoin, radiation therapy, mitomycin C, 6mercaptopurine, cyclophosphamide, 5-fluorouracil, cyclosporin, digoxin, paclitaxel, phenobarbital, trastuzumab. Adverse Reactions: Alopecia, myelosuppression, mucositis, diarrhoea, hyperpigmentation of skin and nails, arrhythmias, congestive heart failure, nausea, vomiting,discolouration of urine, palmar-plantar erythrodysethesia, pericardial effusion,cardiomyopathy, radiation recall reactions, second malignancy.

312

Doxorubicin HCl 50 mg Injection A d r i a m y c i n - Trade Name

L01DB01110P4002XX (A) NEDL

System: Haematology/Oncology Indications: i) Solid tumours,leukaemia, non-Hodgkin's lymphoma ii) Leukaemia(ALL induction) iii) Multiple myeloma Dosage: i) 30 - 75 mg/m2 IV as a single dose at 21- day intervals . ii) 25 - 45 mg/m2 once a wk for the first 4 wks during induction or re-induction phase (refer to specific protocol). Caution: Total cumulative dose of doxorubicin must not exceed 550 mg/m2 due to risk of cardiotoxicity. Paed : 30mg/m2/dose over 6 24 hours for 1 - 2 days. Need to check cardiac function closely by echocardiography every cumulative dose of 100mg/m2 to max. 360mg/m2. iii) 9 mg/m2 over 24 hours infusion for 4 days at monthly intervals. Contraindications: Hypersensitivity to doxorubicin, marked myelosuppression induced by previous chemotherapy or radiotherapy. Previous treatment with tolerance doses of anthracyclines, significantly impaired cardiac function, angina pectoris, cardiac arrhythmias or recent myocardial infarction. Precautions: Cardiac failure, heart disease, hypertension. Previous radiotherapy to chest, elderly. Avoid in pregnancy and lactation. Avoid extravasation. Interactions: Live vaccines, phenytoin, radiation therapy, mitomycin C, 6mercaptopurine, cyclophosphamide, 5-fluorouracil, cyclosporin, digoxin, paclitaxel, phenobarbital, trastuzumab. Adverse Reactions: Alopecia, myelosuppression, mucositis, diarrhoea, hyperpigmentation of skin and nails, arrhythmias, congestive heart failure, nausea, vomiting,discolouration of urine, palmar-plantar erythrodysethesia, pericardial effusion,cardiomyopathy, radiation recall reactions, second malignancy. Daunorubicin HCl 20 mg Injection C e r u b i d i n - Trade Name
L01DB02110P4001XX (A*) NEDL

System: Haematology/Oncology Indications: i) Acute myeloblastic leukaemia (AML) ii) Acute lymphoblastic leukemia (ALL). Dosage: i) 45 - 60 mg/m2 IV daily for 3 - 5 days. ii) 25 - 45 mg/m2 once a wk for first 4 wks during induction phase. Caution : Total cumulative dose of daunorubicin and doxorubicin must not exceed 500 mg/m2 due to risk of cardiotoxicity. Paeds; 30-45mg/m2/dose infusion over 6 hours. Schedule depends on protocol. Need to check cardiac function closely by echocardiography every cumulative dose of 100mg/m2 to max. 360mg/m2. Contraindications: Hypersensitivity to daunorubicin. Pregnancy, lactation, preexisting myelosupression, congestive cardiac failure, arrhythmias, or previous 313

treatment with high cumulative doses of anthracyclines. Precautions: Hepatic impairment. Previous radiotherapy to chest. Avoid extravasation. Interactions: Increased risk of infection by live vaccines. Adverse Reactions: Alopecia, radiation recall reactions. Hyperpigmentation of nails. Myelosuppression. Nausea, vomiting, mucositis, diarrhoea, hepatic/renal impairment, Discolouration of urine. ECG abnormalities, congestive cardiac failure. Epirubicin 10 mg Injection Epirubicin 50 mg Injection Pharmorubicin, Adriamycin
L01DB03000P4001XX (A*) APPL L01DB03000P4002XX (A*) APPL
- Trade Name

System: Haematology/Oncology Indications: Breast cancer, Non-Hodgkin's lymphoma, Leukaemia(ALL induction). Dosage: 60 - 100 mg/m2 body area injected IV in 3 - 5 min, repeated at 21 day intervals. Paed: 50 mg/m2 over 6 hrs. Schedule depends on protocol. Contraindications: Hypersensitivity to anthracyclines, severe cardiac impairment, recent myocardial infarct, severe liver dysfunction, pregnancy, lactation. Precautions: Pre-existing cardiac disease, renal or liver impairment, previous radiotherapy, elderly patients. Avoid extravasation. Avoid cumulative doses beyond 900 mg/m2. Interactions: Cimetidine, cyclophophamide, 5-fluorouracil, live vaccines. Adverse Reactions: Myelosuppression, nausea, vomiting, cardiotoxicity (arrhythmias, conduction disturbances, myopericarditis syndrome, dilated cardiomyopathy, congestive cardiac failure), alopecia, mucositis, vesicant, rash, hyperpigmentation of skin and nails, radiation recall reaction, discolouration of urine. Idarubicin 5 mg Injection Idarubicin 10 mg Injection Zavedos - Trade Name
L01DB06000P4001XX (A*) L01DB06000P4002XX (A*)

System: Haematology/Oncology Indications: i) Acute promyelocytic leukaemia ii) Relapse AML (with sibling match) iii) AML, ALL (salvage therapy) Dosage: i) Induction phase: 12 mg/m2 IV slow bolus on Days 3, 5 and 7. Consolidation phase, month 1: 12mg/m2 IV on Days 1 and 2. Repeat monthly for 3 courses. ii) 12mg/m2 D1-3 iii) 12mg/m2 D1-3 as part of FLAG-IDA regimen Contraindications: Hypersensitivity to idarubicin and other anthracyclines. Pregnancy, lactation. Precautions: Risk for cardiotoxicity increased in elderly, hypertension, heart disease, previous treatment with anthracyclines, previous chest radiotherapy. 314

Cumulative doses > 150mg/m2 are associated with decreased left ventricular ejection fraction. Monitor cardiac function. Caution against sun exposure. Avoid extravasation. Anticipate and prevent tumour lysis syndrome. Caution with abnormal liver function tests. Interactions: Probenecid, sulfinpyrazone, heparin. Live vaccine, other myelosuppressants. Adverse Reactions: Cardiotoxicity , myelosuppression, nausea, vomiting, diarrhoea, mucositis, alopecia, rash, photosensitivity, hyperpigmentation, vesicant, discolouration of urine. Mitoxantrone 20mg / 10ml Injection N o v a n t r o n e - Trade Name
L01DB07110P3001XX (A*)

System: Haematology/Oncology Indications: Acute leukaemia, elderly patients with AML, relapsed / resistant acute leukaemia, NHL. Dosage: 10 - 12 mg/m2 IV dly for 3 days, in combination with other cytotoxic agents. Refer to protocol. Paed: 5 10 mg/m2 dly for 3-5 days according to protocol. Contraindications: Hypersensitivity to mitoxantrone products. Precautions: Cardiac effects (decreased left ventricular ejection fraction), irreversible congestive heart failure, patients previously treated with athracyclines, previous mediastinal radiotherapy), hepatic insufficiency(results in decreased clearance of mitoxantrone), extravasation, intra-arterial and intrathecal injection should be avoided (neuropathy and neurotoxicity reported), pregnanacy (may cause fetal harm), severe myelosuppression pregnancy, lactation, clinically significant decrease in LVEF, vesicant drug which can cause tissue ulceration, necrosis and sloughing. Interactions: Increased risk of infection by the live vaccine. Adverse Reactions: Myelosuppression, nausea, vomiting, stomatitis, alopecia, hepatoxicity, congestive cardiac failure , constipation, diarrhoea, arrhythmias, discolouration of urine and other secretions, alopecia, secondary malignancy, fatigue, fever, headache, amenorrhoea, abdominal pain. Bleomycin HCl 15 mg Injection B l e o c i n - Trade Name
L01DC01110P4001XX (A) NEDL APPL

System: Haematology/Oncology Indications: Squamous cell carcinoma, germ cell tumours, lymphomas. Routes: SC, IM, IV (either as bolus or as infusion over 24 hours), Intra-arterial, Intra-pleural. Dosage: 15 - 60 mg weekly in divided doses, or 10 - 20 mg/m2 once or twice weekly, or 10 mg/m2 slow bolus in 15 minutes D1 & D15 Max : 400 mg. Paed: 10 - 15 mg/m2 over 6 hours every 3 - 4 weeks. Contraindications: Hypersensitivity to bleomycin, severe pulmonary disease, 315

pregnancy, lactation. Precautions: Beware of increased risk of pulmonary fibrosis in elderly patients (> 70 years), if radiotherapy has been given to the chest, if cumulative lifetime doses of bleomycin are exceeded, or if high concentrations of oxygen is given after bleomycin therapy. Monitor lung function. Risk of anaphylatic reaction is higher in patients with lymphoma receiving bleomycin. Reconstitute in 0.9% sodium chloride or sterile water. Should not reconstitute in dextrose-containing solutions. Interactions: Phenothiazines, cisplatinum, radiotherapy. Adverse Reactions: Erythema, hyperpigmentation of skin, nail changes, mucositis, chills, fever, pneumonitis, pulmonary fibrosis, Raynauds phenomenon. Mitomycin-C 10 mg Injection Mitomycin -C - Trade Name
L01DC03000P4001XX (A*) APPL

System: Haematology/Oncology Indications: i) GI, lung, breast, cervical cancers. ii) Bladder tumours iii) Opthalmological conditions:conjunctival squamous neoplasia,squamous cell carcinoma of conjunctiva, trabeculectomy. Dosage: i) 10 - 20 mg/m2 BSA given as a single dose through a running IV infusion repeated every 6 - 8 wks. The whole schedule may be repeated depending on the bone marrow . ii) 10 - 40 mg dly or every other day. (intravesical) iii) 0.4 mg topicaly as a single application for opthalmological conditions, duration: 1 to 3 minutes. Contraindications: Thrombocytopenia, coagulation disorders, pregnancy, lactation , hypersensitivity to mitomycin, hepatotoxicty. Precautions: Bleeding tendency, radiotherapy. Interactions: Vinblastine, Vince alkaloids may increase risk of cardiotoxicity when given together with mitomycin C. Adverse Reactions: Nephrotoxicity,delayed myelosupression, nausea and vomiting, alopecia, CHF, fever, Haemolytic uraemic syndrome-risk increase when cumulative dose > 50mg/m2, interstitial pneumonitis. Cisplatin (Cis-Platinum) 10 mg Injection Cisplatin (Cis-Platinum) 50 mg Injection P l a t i n u l - Trade Name
L01XA01000P3001XX (A) APPL L01XA01000P3002XX (A) NEDL APPL

System: Haematology/Oncology Indications: Germ cell tumours,ovarian tumours, adult solid tumours, lymphomas. Dosage: Germ cell tumours : 20 mg/m2 dly for 5 days every 3 wks for 3 - 4 courses. Ovarian tumours: 75 mg/m2 once every 3 wks as part of combination therapy or 100 mg/m2 IV once every 3 wks as a single agent. Baseline creatinine 316

clearance, pretreatment hydration and forced diuresis are mandatory. Paeds: 100mg/m2 over 6 hrs once every 3 weeks. Lymphomas: Refer to protocols. Contraindications: Hypersensitivity to cisplatin/platinum-containing products, pre-exisiting renal insufficiency, myelosuppression, hearing impairment. Pregnancy, lactation. Precautions: Monitor blood counts, renal and neurologic function. Protect from light. Materials used to prepare/administer cisplatin should not contain aluminium. Mandatory pre-hydration and post- hydration with mannitol diuresis. Interactions: Sodium thiosulphate. Bleomycin. If platinum compound is used with taxane, to be given after taxane. Adverse Reactions: Acute renal failure, chronic renal insufficiency, myelosupression, nausea and vomiting, ototoxicity, peripheral neuropathy, autonomic neuropathy, electrolyte disturbances (eg hypokalemia, hypomagnesemia). Carboplatin 150 mg Injection Carboplatin 450 mg Injection P a r a p l a t i n - Trade Name
L01XA02000P4001XX (A*) L01XA02000P4002XX (A*)

System: Haematology/Oncology Indications: Adult solid tumours, paediatric tumours. Salvage therapy for lymphoma. Dosage: 360 - 400 mg/m2 BSA, by IV infusion over 15 mins to 1 hr on Day 1 every 4 wks. Alternatively, prescription may be based on Area Under Curve (AUC) calculations. Paed: 500-600 mg/m2 over 1 hr once every 3 weeks. Salvage regimes in lymphomas - refer to specific protocols. Contraindications: Hypersensitivity to cisplatin/ platinum products or mannitol, pregnancy, lactation. Precautions: Myelosuppression, renal impairment. Monitor blood counts and renal function. Do not use infusion sets or needles containing aluminium. Interactions: Nephrotoxic and ototoxic drugs,phenytoin. If platinum compound is used with taxane, to be given after taxane. Increased risk of infection by live vaccines. Adverse Reactions: Myelosuppression, alopecia, mucositis, electrolyte disturbances, nausea and vomiting, nephrotoxicity , ototoxicity, peripheral neuropathy.

317

(space intentionally left blank)

Oxaliplatin 50mg Injection E l o x a t i n - Trade Name

L01XA03000P4001XX (A*)

System: Haematology/Oncology Indications: Only for patients with colorectal cancer who: i) have relapsed within 6 mths after the end of adjuvant chemotherapy with 5fluorouracil-based regime; ii) have progressive disease despite 5-fluorouracil chemotherapy for advanced disease; iii) good performance status (WHO of 2 or less) The treatment must be given in a tertiary oncology centre or have clearance in writing by an oncologist.. Dosage: 85 mg/m2 IV repeated every 2 weeks. Contraindications: Hypersensitivity to oxaliplatin, pregnancy lactation. Precautions: Presence or history of peripheral neuropathy, preexisting renal or hepatic impairment, significant bone marrow suppression may cause pulmonary fibrosis. Interactions: Drugs with potential neurological toxicity, docetaxel, paclitaxel, aminoglycosides. Adverse Reactions: Anaphylactic, anaemia, dyspnea, febrile neutropaenia, thrombpcytopaenia, fatigue, fever, nausea, diarrheoa. Procarbazine HCl 50 mg Capsule N a t u l a n - Trade Name
L01XB01110C1001XX (A) NEDL

System: Haematology/Oncology Indications: Lymphomas. Dosage: 100 mg/m2 (max 150 mg) orally on Days 1 to 14, in combination with other cytotoxic drugs. Paed: 100mg/m2 per day for one week every 4 weeks. (Check with protocol) Contraindications: Hypersensitivity to procarbazine. Pregnancy, lactation, inadequate bone marrow reserve. Precautions: Severe renal/hepatic impairment Intake of alcohol or tyramine 318

containing foods may cause disulfiram-like reaction. Concomitant CNS repressants may result in CNS depression. Concomitant chemotherapy or radiation; wait one month or longer before giving procarbazine. Discontinue promptly if any of the following occur: diarrhoea, CNS effects, leucopaenia, thrombocytopaenia, stomatitis, bleeding or hypersensitivity reaction. Concurrent use with tricyclic antidepressant may give rise to CNS excitati on. Renal impairment, hepatic dysfunction. Interactions: Pethidine, amitriptyline, dothiepin, neurotoxicity, carbamazepine, pseudoephedrine, ephedrine, levodopa, live vaccines, rotavirus vaccine, fluoxetine, sertraline, venlafaxine, methotrexate, ethanol, hypertension, headache, increased risk of infection by the live vaccine. CNS toxicity or serotonin syndrome. Tyramine foods increase blood pressure. Adverse Reactions: Myelosuppression , hypertension, headache, nausea,vomitting, hypersensitivity reaction, flu-like syndrome, paraesthesias, neuropathies, confusion, interstitial pnuemonitis, second malignancy, amenorrhea, azoospermia. Rituximab 500 mg/50 ml Injection M a b t h e r a - Trade Name
L01XC02000P3001XX (A*)

System: Haematology/Oncology Indications: i) Treatment of patients with relapsed or chemo-resistant low grade or follicular B-cell Non-Hodgkin's lymphoma. ii) Adjunctive therapy with combination chemoagents for aggressive NHL. Dosage: i) 375 mg/m2 body surface area administered as an IV infusion through a dedicated line once weekly for 4 weeks. ii) Combination with CHOP as 375mg/m2 BSA once every 3 to 4 weeks. Contraindications: Type 1 hypertensensitivity or anaphytic reactions to murine proteins or any component of the formulation, breast feeding. Precautions: Hypersensitivity reaction may be severe, caution in patient receiving cardiotoxic chemotherapy,history of cardiovascular disease.pregnancy.Monitor for tumour lysis syndrome. Use with caution in heart disease and monitor for infusion-related events. Medication for treatment of hypersensitivity must be available for immediate use during administration. Interactions: Cisplatin, live vaccines, rotavirus vaccines. Adverse Reactions: Angina, cardiac arrythmias, lymphophenia, fever, chills, rigor, angioedema, nausea, rash, headache, dizziness, renal toxicity, hypotension, bronchospasm, mucocutaneous reactions, arrhythmias, chest pain, cough, rhinitis, dyspnoea. L-Asparaginase 10,000 IU Injection L e u n a s e - Trade Name System: Haematology/Oncology Indications: i) Acute lymphoblastic leukemia. ii) Non-hodgkins lymphoma. Dosage: 319
L01XX02000P3001XX (A*) NEDL APPL

i) 5,000 iu/m2 for 10 days during induction; 10,000 iu/m2 also used with high dose methotrexate rescue in consolidation phase of ALL. ii) Paed : 5,000 25,000 iu/m2 per dose depending on protocol. Contraindications: Hypersensitivity to L-Asparaginase, history of pancreatitis. Precautions: Haematologic, renal and hepatic dysfunction, pregnancy. Monitor for severe allergic reactions, caution in underlying coagulopathy. Interactions: Vincristine, cyclophosphamide, methotrexate, steroids. Adverse Reactions: Hypersensitivity reactions ( urticaria, chills, fever, anaphylaxis), hyperglycaemia, lethargy, depression, confusion, coagulopathy, anorexia, mild nausea and vomiting, acute pancreatitis, coma, myelosuppression (usually mild), hepatic dysfunction, renal dysfunction, somnolence, hallucination. Hydroxyurea 500 mg Capsule H y d r e a - Trade Name
L01XX05000C1001XX (A)

System: Dermatology Indications: i)Solid tumours ii) Chronic myelocytic leukaemia and myeloproliferative disease iii)Severe psoriasis eg. Extensive plaque psoriasis, erythrodermic psoriasis, pustular psoriasis -as third line therapy. Dosage: i)Intermittent therapy : 80 mg/kg orally as a single dose every 3rd day. Continuous therapy : 20 - 30 mg/kg orally as a single dose dly. Concomitant therapy with irradiation : 80 mg/kg orally as a single dose every 3rd day.(administration of hydroxyurea should be started at least 7 day s before initiation of irradiation and continued during radiotherapy as well). ii)Continuous therapy (20 - 30 mg/kg orally as a single dose daily, therapy should be interrupted if the white blood cell count drops below 2500/mm3, or the platelet count below 100,000/mm3. iii) 500 mg tds. Contraindications: Severe bone marrow depression , pregnancy, lactation, hypersensitivity to hydroxyurea products. Precautions: Hydroxyurea is mutagenic and clastogenic. Correct anaemia prior to initiating hydroxyurea therapy . Exacerbation of postirradiation erythema. Elderly patients, marked renal dysfunction, impairment of fertility. Interactions: Didanosine and or stavudine (in HIV-infected patients), fatal and nonfatal pancreatitis, hepatotoxicity, and peripheral neuropathy. Live vaccines, rotavirus vaccine, fluorouracil,methotrexate,cytarabine. Adverse Reactions: Myelosupression, GI disturbances, Hyperpigmentation, facial erythema, diffuse maculopapular rash, headache, drowsiness, confusion ,transient renal function abnormalities. All-Trans Retinoic Acid 10 mg Capsule V e s a n o i d - Trade Name System: Haematology/Oncology
L01XX14000C1001XX (A*)

320

Indications: Acute promyelocytic leukaemia. Dosage: Induction :45 mg/m2 daily for 30 - 90 days. Maintenance :45 mg/m2 daily for 2 wks every 3 months. Refer to protocols. Contraindications: Hypersensitivity to retinoids, pregnancy, breastfeeding. Precautions: Avoid pregnancy during and for at least 1 month after stopping treatment. Monitor haematological, coagulation profile,liver function test, serum lipid levels. To be used with caution in pre-existing hypertriglyceridaemia, diabetes mellitus, obesity. Anticipate and treat retinoic acid syndrome. Interactions: Concurrent use with drugs which inhibit hepatic cytochrome P450 enzyme system, eg ketoconazole, cimetidine, cyclosporin, diltiazem, erythromycin, rifampicin, verapamil. may increase risk of toxicity. .Use together with vitamin A supplements may result in increase in toxicity. Adverse Reactions: Headache, fever, weakness, fatigue, nausea, vomiting, dry skin, rash, peripheral oedema, mycosiss, conjunctivitis, hypotension, hypertension, arrhythmias, heart failure, flushing, dizziness, anxiety, depression, paresthesias, confusion, pseudotumour cerebri, gastrointestinal bleeding, abdominal pain, diarrhea, constipation, retinoic acid syndrome, bone pain, muscle pain, joint pain, increase in serum triglycerides and cholesterol. Irinotecan HCl Trihydrate 40 mg/2 ml Injection Irinotecan HCl Trihydrate 100mg/5ml Injection C a m p t o - Trade Name
L01XX19110P3001XX (A*) L01XX19110P3002XX (A*)

System: Haematology/Oncology Indications: Only for patients with colorectal cancer who : i) have relapsed within 6 mths after the end of adjuvant chemotherapy with 5fluorouracil-based regime. ii) have progressive disease despite 5-fluorouracil chemotherapy for advanced disease, iii) good performance status (WHO of 2 or less) The treatment must be given in a tertiary oncology centre or have clearance in writing by an oncologist. Dosage: In combination therapy (for previously untreated patients) : 180 mg/m2 once every 2 weeks as an IV infusion over 90 mins followed by infusion with folinic acid and 5-fluorouracil. In monotherapy (for previously treated patients): 350 mg/m2 administered as an intravenous infusion over 90 minutes period once every 3 weeks. Contraindications: Hypersensitivity to irinotecan, pregnancy & lactation. Precautions: Diarrhoea (early or late) must be treated adequately with delay of subsequent cycle until recovery. Antiemetic premedication is recommended. Avoid extravasation. Caution with myelosuppression. Patients over 65 years old, patients who have previously received pelvic / abdominal radiation and with poor performance status have increased risk of bone marrow suppression and diarrhoea. Interactions: Increased risk of infection by the live vaccine. Adverse Reactions: Myelosuppression, diarrhoea (early or late), nausea, 321

vomiting, alopecia, dyspnoea, weakness. Medroxyprogesterone Acetate 500 mg/2.5 ml Injection Provera/Farlutal
- Trade Name

L02AB02122P3002XX (A)

System: Haematology/Oncology Indications: i) Palliative treatment of endometrial carcinoma ii) Palliative treatment of prostatic carcinoma Dosage: i) IM 300 mg three times/week for 2 months, 300 mg two times/week for 1 month, 300 mg once a week for 1 month and 300 mg monthly thereafter. ii) 0.5 g weekly or twice weekly IM. Contraindications: Hypersensitivity to medroxyprogesterone, thrombophlebitis, undiagnosed vaginal bleeding, impaired liver function, pregnancy. Precautions: Examination of breast, pelvis and PAP smear before starting treatment. Diabetes, history of depression, cardiac dysfunction. Interactions: Aminoglutethimide. Adverse Reactions: Vaginal bleeding, cholestatic jaundice, depression, fluid retension, weight gain, hirsutism, acne, visual abnormalities. Medroxyprogesterone Acetate 500 mg Tablet P r o v e r a / F a r l u t a l - Trade Name
L02AB02122T1001XX (A) NEDL

System: Haematology/Oncology Indications: Breast carcinoma, Endometrial carcinoma, renal carcinoma. Dosage: 200-500mg orally daily. Contraindications: Hypersensitivity to medroxyprogesterone, thrombophlebitis, undiagnosed vaginal bleeding, impaired liver function, pregnancy. Precautions: Examination of breast, pelvis and PAP smear before starting treatment. Diabetes, history of depression, cardiac dysfunction. Interactions: Aminoglutethimide. Adverse Reactions: Vaginal bleeding, cholestatic jaundice, depression, fluid retension, weight gain, hirsutism, acne, visual abnormalities. Medroxyprogesterone Acetate 100 mg Tablet P r o v e r a / F a r l u t a l - Trade Name
L02AB02122T1002XX (A)

System: Haematology/Oncology Indications: Breast carcinoma, Endometrial carcinoma, renal carcinoma. Dosage: 200-500mg orally daily. Contraindications: Hypersensitivity to medroxyprogesterone, thrombophlebitis, undiagnosed vaginal bleeding, impaired liver function, pregnancy. 322

Precautions: Examination of breast, pelvis and PAP smear before starting treatment. Diabetes, history of depression, cardiac dysfunction. Interactions: Aminoglutethimide. Adverse Reactions: Vaginal bleeding, cholestatic jaundice, depression, fluid retension, weight gain, hirsutism, acne, visual abnormalities. Leuprolide Acetate 3.75 mg Injection Lucrin Depot - Trade Name
L02AE02122P2001XX (A*)

System: Endocrine Indications: i)Endometriosis ii)Hormonal therapy in advanced prostate cancer Dosage: i)3.75 mg mthly for 3 - 6 months. ii)3.75 mg IM or SC inj. monthly. Contraindications: Pregnancy,hypersensitivity to leuprolide products/GnRH agonists. Precautions: Undiagnosed abnormal vaginal bleeding,congestive heart failure or other conditions requiring sodium restriction,history of thromboembolism or cardiovascular disease,metastatic vertebral lesions,urinary tract obstruction,osteoporosis,breast feeding,reversible bone loss. Interactions: No interaction found Adverse Reactions: Hot flashes,vaginal haemorrhage,bone pain, nausea, vomiting,peripheral oedema,GI disturbances,dizziness,headache,paraes thesia,CHF,oedema,thrombophlebitis, breast tenderness,impotence,increases/decreases in certain hormone levels. Goserelin 3.6 mg Depot Injection Zoladex - Trade Name
L02AE03000P2001XX (A)

System: Endocrine Indications: Prostate cancer,endometriosis,leiomyoma uteri and assissted production,breast cancer in premenopausal & perimenopausal women suitable for hormonal manipulation. Dosage: 3.6 mg depot injection every 28 days. Contraindications: Pregnancy/breastfeeding, hypersensitivity to goserelin products Precautions: Initially may increase bone pain, increase serum testosterone levels, and worsen symptoms of prostatic cancer.Isolated cases of spinal cord compression and renal impairment from ureteral obstruction have occurred.History of prior treatment that may have resulted in bone mineral density loss or patients with increased risk factors for decreased bone mineral density. Interactions: No interaction found. Adverse Reactions: Bone pain, hot flashes, gynecomastia, impotence, breakthrough bleeding. 323

Triptorelin 3.75 mg. Injection D e c a p e p t y l - Trade Name

L02AE04000P2001XX (A)

System: Endocrine Indications: Endometriosis, leiomyoma uteri and assisted reproduction. Dosage: 3 .75mg IM Inj. every 4 wks.Period of treatment should not ex ceed 6 mths. Contraindications: Hypersensitivity reaction,pregnancy. Precautions: Prostatic carcinoma patients with impending spinal cord compression or severe urinary tract disorders,exacerbation of premenstrual syndrome ,renal insufficiency.Bone loss during long-term therapy in women with endometriosis or uterine leiomyoma. Interactions: No interactions found. Adverse Reactions: Palpitations,headache,sleep disturbances,tiredness, emotional lability, tremors, and dizziness.In men,hot flushes,impotence,loss of libido,rarely gynaecomastia.Depot inj. causes increased enzyme activity & thrombophlebitis.Breakthrough bleeding in women. Tamoxifen Citrate 20 mg Tablet N o l v a d e x - Trade Name
L02BA01136T1001XX (A) NEDL APPL

System: Haematology/Oncology Indications: Breast cancer. Dosage: 20 mg daily. Contraindications: Hypersensitivity to Tamoxifen. Pregnancy and lactation. Precautions: Caution in patients with leukopenia, thrombocytopenia, retinopathy or with family/past history of hypercoagulable states or thromboembolic disease. Pelvic examination should be carried out for patients on long term use of tamoxifen. Interactions: Warfarin, allopurinol, cyclosporin, bromocriptine. Adverse Reactions: Menopausal symptoms, fluid retention, peripheral oedema, nausea, vomiting, myelosuppression, tumour flare, endometrial hyperplasia, polyps and small risk of endometrial cancer. Flutamide 250 mg Tablet F u g e r e l - Trade Name
L02BB01000T1001XX (A*)

System: Haematology/Oncology Indications: Metastatic prostatic carcinoma. Dosage: 250 mg tds. Contraindications: Hypersensitivity to flutamide, severe hepatic impairment. Precautions: Monitor liver function. Interactions: Warfarin. Adverse Reactions: Diarrhoea, cystitis, hot flushes, hepatotoxicity, drowsiness, confusion, depression, anxiety, decreased libido, impotence, 324

gynaecomastia, discolouration of urine. Bicalutamide 50 mg Tablet Casodex - Trade Name

L02BB03000T1001XX (A*)

System: Haematology/Oncology Indications: Advanced prostate cancer in combination with LHRH analogue therapy or surgical castration. Dosage: 50 mg to 150 mg once daily. Contraindications: Hypersensitivity to bicalutamide. Pregnancy. Precautions: GI disturbances, hot flushes, pain. Use with caution if there is moderate to severe live impairment. Monitor liver function clinically and biochemically. Interactions: Enhanced effects of warfarin. Adverse Reactions: Hot flashes, breast tenderness, gynaecomastia, hepatic impairment, heart failure, angina pectoris. Aminoglutethimide 250 mg Tablet O r i m e t e n e - Trade Name
L02BG01000T1001XX (A*)

System: Haematology/Oncology Indications: Only for the treatment of hormone-responsive breast cancer. Dosage: 0.5 - 1 g/day. With hydrocortisone 30 mg/day or cortisone acetate 37.5 mg/day to prevent adrenal insuffiency. Contraindications: Porphyria, pregnancy, hypersensitivity to aminoglutethimide. Precautions: Monitor BP, adrenal and thyroid function. Periodic blood counts. May impair ability to drive and operate machinery. Not recommended in lactation. Interactions: Increased metabolism of synthetic glucocorticoids, warfarin and other oral anticoagulants, theophylline, medroxyprogesterone and oral antidiabetics. Adverse Reactions: Drowsiness, lethargy, ataxia, fever, skin rashes and GI disturbances.Bone-marrow depression, with leucopenia, thrombocytopenia, agranulocytosis, or severe pancytopenia . Adrenal insufficiency and other endocrine disturbances including hypothyroidism, and virilisation. Orthostatic hypotension. Anastrozole 1 mg Tablet Arimidex - Trade Name System: Haematology/Oncology
L02BG03000T1001XX (A*)

325

Indications: Treatment of hormone responsive metastatic or locally advanced breast cancer after failure of tamoxifen. Dosage: 1 mg daily Contraindications: Hypersensitivity to anastrazole, pregnancy. Not indicated for premenopausal women. Precautions: Hyperlipidemia. Interactions: Oestrogens, tamoxifen. Adverse Reactions: Hot flashes, asthenia, peripheral edema, vaginal bleeding, deep vein thrombosis, arthralgia, backpain, cough, dypsnea, headache, nausea, rash, hypercholesterolaemia. Letrozole 2.5 mg Tablet F e m a r a - Trade Name
L02BG04000T1001XX (A*)

System: Haematology/Oncology Indications: Treatment of hormone responsive metastatic or locally advance breast cancer after failure of Tamoxifen. Dosage: 2.5 mg dly. Contraindications: Hypersensitivity to letrozole. Pregnancy, lactation. Precautions: Impaired liver function. Only to be used in postmenopausal women. Interactions: Not reported. Adverse Reactions: Headache, nausea, fatigue, arthralgia, musculoskeletal pain, hot flushes. Filgrastim (G-CSF) 30 MU/ml Injection N e u p o g e n - Trade Name
L03AA02000P3001XX (A*) APPL

System: Haematology/Oncology Indications: i) Prophylactic and therapeutic use in chemotherapy -induced leucopenia ii) Haemopoeitic stem cell transplantation (HSCT)/Stem cell harvesting Dosage: i) Adult: SC or IV 5 mcg/kg/day. Initiation: 24 - 72 hrs after chemotherapy. Duration: Until a clinically adequate neutrophil recovery is achieved (absolute neutrophil count of at leas t 0.5 x 109/L on 2 consecutive days.) ii) Refer to protocol. Contraindications: Hypersensitivity to filgrastim and E. coli-derived products. Precautions: Do not administer within 24 hours before or after the administration of cytotoxic chemotherapy; avoid the simultaneous use of chemotherapy and radiation therapy with filgrastim. If dilution is required, use Dextrose 5%, not saline. If concentration is less than 15 mcg/ml, adsorption to plastic materials can be prevented with addition of albumin (1 ml of 5% ). Interactions: Vincristine, Topotecan, steroids, lithium. Adverse Reactions: Chest pain, fever, hypersensitivity reaction, fluid retention, alopecia. Bone pain, flu-like symptoms, nauseu and vomiting, splenic 326

rupture-rare, adult respiratory distress syndrome, sickle cell crisis. Molgramostim 150 mcg Injection Molgramostim 300 mcg Injection Molgramostim 400 mcg Injection Leucomax - Trade Name
L03AA03000P4001XX (A*) L03AA03000P4002XX (A*) L03AA03000P4003XX (A*)

System: Haematology/Oncology Indications: i) As secondary prophylaxis and therapeutic use against chemotherapy induced leucopaenia according to clinicians discretion ii) Haemopoietic stem cell transplantation(HSCT). Dosage: SC or IV 250 mcg/m2/day. Initiation: 24 to 72 hrs after chemotherapy Duration: Until a clinically adequate neutrophil recovery is achieved. Contraindications: Myeloid malignancies, pregnancy. Precautions: Pre-existing pulmonary disease, autoimmune disease, children under 18 years of age, GM-CSF reduces the myelotoxicity but not the overall toxicity of chemotherapy drugs; therefore its use for increasing chemotherapy dose intensity is not recommended. Interactions: Drugs highly bound to albumin. Adverse Reactions: Fever, GI disturbances, dyspnoea, rash, fatigue, musculoskeletal pain. Interferon Alpha - 2a 3 MIU Injection I n t r o n -A - Trade Name
L03AB04000P3001XX (A*) NEDL APPL

System: Drugs Affecting Immune Responds Indications: For the treatment of i) Hairy Cell Leukaemia ii) Chronic Myelogenous Leukaemia iii) AIDS related Kaposi's Sarcoma iv) Chronic Hepatitis B v) Chronic Hepatitis C vi)Haemangiomas especially those with life-threatening complications. Dosage: i)2 MIU SC or IM 3 times a wk. ii) Patient > 18 yrs : 3 - 9 MIU 3 - 5 times a wk; or daily depending on response. iii) Patient>18yrs. Initially escalating dose to 18-36 MIU SC/IM for 10-12 wks. Maintenance : up to 36 MIU 3 times wkly iv)2.5-5MIU/m2 SC 3 times weekly for 4-6mths. Children:up to 10 MIU/m2 BSA v)3MIU for 12months. Contraindications: Dec ompensated hepatic disease, immunosuppressed transplant. Precautions: Pregnancy, lactation, severe myelosuppression, cardiovascular disease. Interactions: Inhibit metabolism of theophylline. Adverse Reactions: Flu-like symptoms, fatigue. 327

Interferon Alpha-2a 4.5MIU Injection Roferon -A - Trade Name

L03AB04000P3002XX (A*)

System: Drugs Affecting Immune Responds Indications: For the treatment of i) Hairy Cell Leukaemia ii) Chronic Myelogenous Leukaemia iii) AIDS related Kaposi's Sarcoma iv) Chronic Hepatitis B v) Chronic Hepatitis C vi)Haemangiomas especially those with life-threatening complications. Dosage: i)2 MIU SC or IM 3 times a wk. ii) Patient > 18 yrs : 3 - 9 MIU 3 - 5 times a wk; or daily depending on response. iii) Patient>18yrs. Initially escalating dose to 18-36 MIU SC/IM for 10-12 wks. Maintenance : up to 36 MIU 3 times wkly iv)2.5-5MIU/m2 SC 3 times weekly for 4-6mths. Children:up to 10 MIU/m2 BSA v)3MIU for 12months. Contraindications: Decompensated hepatic disease, immunosuppressed transplant. Precautions: Pregnancy, lactation, severe myelosuppression, CV disease. Interactions: Inhibit metabolism of theophylline Adverse Reactions: Flu-like symptoms, fatigue. Interferon Alfa-2b 18 MIU Multidose Injection Pen Interferon Alfa-2b 30 MIU Multidose Injection Pen I n t r o n -A - Trade Name
L03AB05000P5001XX (A) L03AB05000P5002XX (A)

System: Drugs Affecting Immune Responds Indications: For the treatment of i) Hairy Cell Leukaemia ii) Chronic Myelogenous Leukaemia iii) AIDS related Kaposi's Sarcoma iv) Chronic Hepatitis B v) Chronic Hepatitis C vi)Haemangiomas especially those with life-threatening complications. Dosage: i)2 MIU SC or IM 3 times a wk. ii) Patient > 18 yrs : 3 - 9 MIU 3 - 5 times a wk; or daily depending on response. iii) Patient>18yrs. Initially escalating dose to 18-36 MIU SC/IM for 10-12 wks. Maintenance : up to 36 MIU 3 times wkly iv)2.5-5MIU/m2 SC 3 times weekly for 4-6mths. Children:up to 10 MIU/m2 BSA v)3MIU for 12months. Contraindications: Decompensated hepatic disease, immunosuppressed transplant. 328

Precautions: Pregnancy, lactation, severe myelosuppression, cardiovascular disease. Interactions: Inhibit metabolism of theophylline. Adverse Reactions: Flu-like symptoms, fatigue. Interferon Beta-1a 22 mcg R e b i f - Trade Name
L03AB07000P5001XX (A*)

System: Neurology Indications: Multiple sclerosis of the relapsing remitting type with 2 or more relapses within the last 2 years. Dosage: 22 mcg 3 times weekly. Contraindications: Hypersensitivity, severe renal & liver failure, children less 6 yrs, pregnancy, lactation psychiatric disorders. Precautions: Angina, CHF or arrhythmia, severe renal & hepatic failure, severe myelosuppression, depression. Interactions: ACE inhibitors, warfarin, zidovudine, antiepileptics, antidepressant. Adverse Reactions: Irritation at injection site. Headache, fatigue, fever, pain, chills, depression, dizziness, nausea, abdominal pain, urinary tract infection, leucopenia. Interferon Beta-1a 44 mcg R e b i f - Trade Name
L03AB07000P5002XX (A*)

System: Neurology Indications: Multiple sclerosis of the relapsing remitting type with 2 or more relapses within the last 2 years. Dosage: 44 mcg 3 times weekly. Contraindications: Hypersensitivity, severe renal & liver failure, children less 6 yrs, pregnancy, lactation psychiatric disorders. Precautions: Angina, CHF or arrhythmia, severe renal & hepatic failure, severe myelosuppression, depression. Interactions: ACE inhibitors, warfarin, zidovudine, antiepileptics, antidepressant. Adverse Reactions: Irritation at injection site. Headache, fatigue, fever, pain, chills, depression, dizziness, nausea, abdominal pain, urinary tract infection, leucopenia. Pegyinterferon Alpha-2b 50mcg Injection Pegyinterferon Alpha-2b 80mcg Injection Pegyinterferon Alpha-2b 100mcg Injection Pegyinterferon Alpha-2b 120mcg Injection Pegyinterferon Alpha-2b 150mcg Injection P e g- Intron - Trade Name System: Drugs Affecting Immune Responds 329
L03AB10000P5001XX L03AB10000P5002XX L03AB10000P5003XX L03AB10000P5004XX L03AB10000P5005XX (A*) (A*) (A*) (A*) (A*)

Indications: Treatment of chronic hepatitis C *Criteria used as guide prior to selection of patients for treatment include Viral load and HCV genotype. Dosage: 1.5mg/kg/week plus ribavirin (800-1200mg per day depending on body weight, viral load and HCV genotype for 6-12 months. Contraindications: Hypersensitivity autoimmune hepatitis, decompensated liver disease, pregnancy, severe psychiatric disorder. Precautions: Renal or hepatic impairment, diabetes, CHF,MI, arrhythmias, pregnancy, lactation. Interactions: ACE inhibitors, fluorouracil, mephalan, prednisolone, theophylline, warfarin, zidovudine, didanosine. Adverse Reactions: Headache, fatigue, insomnia, depression, dizziness, alopecia, pruritus, dermatitis, nausea, vomiting, abdominal pain, neutropenia, anaemia, dyspnoea. Peginterferon Alpha-2a 180 mcg Prefilled Syringe L03AB11000P5001XX (A*) Pegasys - Trade Name System: Drugs Affecting Immune Responds Indications: Treatment of chronic hepatitis C usually in combination with ribavirin. *Important to establish HCV genotype & viral load where combination treatment is advocated. Dosage: 180 mcg weekly with ribavirin 800 mg daily for 24 weeks in patients in genotype 2 & 3 and 180 mcg weekly with ribavirin (1000 - 1200mg) for 48 weeks for those with genotype 1 & 4. 135 mg dose may be used for patients who cannot tolerate the 180 mcg dose. Contraindications: Hypersensitivity, autoimmune hepatitis, decompensated liver disease, pregnancy, severe psychiatric disorder. Precautions: Chronic liver disease, cardiovascular disease, history of autoimmune disease, diabetes mellitus, hypo or hyperthyroidism, renal impairment, pregnancy, breast feeding, geriatric patient. Interactions: ACE inhibitors, fluorouracil, mephalan, prednisolone, theophylline, warfarin, zidovudine, didanosine. Adverse Reactions: Headache, fatigue, insomnia, depression, dizziness, alopecia, pruritus, dermatitis, nausea, vomiting, abdominal pain, neutropenia, anaemia, dyspnoea. Peginterferon Alpha-2a 135 mcg Prefilled Syringe L03AB11000P5002XX (A*) Pegasys - Trade Name System: Drugs Affecting Immune Responds Indications: Treatment of chronic hepatitis C usually in combination with ribavirin. *Important to establish HCV genotype & viral load where combination treatment is advocated. Dosage: 330

180 mcg weekly with ribavirin 800 mg daily for 24 weeks in patients in genotype 2 & 3 and 180 mcg weekly with ribavirin (1000 - 1200mg) for 48 weeks for those with genotype 1 & 4. 135 mg dose may be used for patients who cannot tolerate the 180 mcg dose. Contraindications: Hypersensitivity autoimmune hepatitis, decompensated liver disease, pregnancy, severe psychiatric disorder. Precautions: Chronic liver disease, cardiovascular disease, history of autoimmune disease, diabetes mellitus, hypo or hyperthyroidism, renal impairment, pregnancy, breast feeding, geriatric patient. Interactions: ACE inhibitors, fluorouracil, mephalan, prednisolone, theophylline, warfarin, zidovudine, didanosine. Adverse Reactions: Headache, fatigue, insomnia, depression, dizziness, alopecia, pruritus, dermatitis, nausea, vomiting, abdominal pain, neutropenia, anaemia, dyspnoea. BCG 81 mg/3 ml I m m u c y s t - Trade Name
L03AX03000P3001XX (A*)

System: Haematology/Oncology Indications: Superficial bladder cancer. Dosage: 81 mg intravesically once weekly for 6 weeks, followed by treatments at 3, 6, 12, 18, and 24 months after initial treatment. Contraindications: Hypersensitivity to BCG vaccine. Patients with positive tuberculin tests, AIDS, immunocompromised status, burns. Precautions: Asthmatic patients, Immunogenic material can result in astmatic attacks or anaphylaxis. The person preparing the product should wear gloves, mask and gown. Discarded containers, syringes and other equipment used for handling the vaccine should be sterilised before disposal. BCG (intravesical) should not be administered if there is indication that catherisation has been traumatic. BCG should not be administered earlier than 7 days following transurethral resection. Urine voided in the first 6 hours following intravesical BCG instillation should be handled as infection waste. Interactions: Concurrent use with antimicrobial therapy and immunosuppressive agents may impair efficacy of BCG. Adverse Reactions: Flu-like syndrome, chemical cystitis, urinary tract infection, nausea, vomiting, anorexia. Cyclosporin 25 mg Capsule Microemulsion Cyclosporin 100 mg Capsule Microemulsion S a n d i m m u n N e o r a l - Trade Name
L04AA01000C1001XX (A*) NEDL L04AA01000C1002XX (A*) NEDL

System: Drugs Affecting Immune Responds Indications: Only for: i) Patients in whom donor specific transplantation cannot be carried out and in young children to minimise side-effects of steroids. ii) Follow-up cases of bone marrow transplant iii) Patients with severe rheumatoid Arthritis not responding to other second line 331

drugs. iv) Patients with idiopathic nephrotic syndrome who are steroid toxic or poor response to cyclophosphamide. v) Severe aplastic anemia, pure red cell aplasia vi) Cases of recalcitrant psoriasis and atopic eczema vii) Treatment of chronic ocular inflammatory disorders/uveitis Dosage: i & ii) Initially 12.5 - 15 mg/kg/day, beginning on the day before transplant. Maintenance approx 12.5 mg/kg/day for 3 - 6 mths before being tapered off to zero by 1yr of transplantation. iii) 3mg/kg/day in 2 divided doses for first 6 wks. May increased gradually to max.5mg/kg.Treatment withdrawn if no response after 3mths. iv) Adult: 5mg/kg/day in 2 divided doses. Paed: 6mg/kg/day in 2 divided doses.Patients with permitted levels of kidney failure, the starting dose must not >2.5mg/kg/day. v) 12mg/kg/day. vi) 2.5mg/kg/day in 2 divided doses increasing if there is no improvement after 4 weeks by 0.5 -1mg/kg/month up to max. 5mg/kg/day. vii) 5mg/kg/day in 2 divided doses, may increase to 7mg/kg/day in resistant cases. Maintenance: Less than 5mg/kg/day especially during remission. Contraindications: Hypersensitivity to cyclosporin, or any other component. Rheumatoid arthritis or psoriasis patients with abnormal renal function, uncontrolled hypertension, malignancies, uncontrolled infections in rheumatoid arthritis patients; primary or secondary immunodeficiency in rheumatoid arthritis patients; psoriasis patients receiving PUVA (psoralen plus ultraviolet A) or UVB (ultraviolet B) therapy, methotrexate or other immunosuppressants, coal tar, radiation therapy. Precautions: Liver and renal function, hypertension, malignancies. Neoral and Sandimmun are not bioequivalent - dosage adjustments and increased monitoring needed . Interactions: Etoposide, statins,vaccines, immunosuppressive drugs except corticosteroids, live vaccines, nephrotoxic drugs,rifampicin,NSAIDs, hepatic enzyme inducers. Adverse Reactions: Nephrotoxicity, hepatotoxicity, gum hyperplasia, hypertension, neurotoxicity, convulsions, increased malignancy risk. Cyclosporin 100 mg/ml Drink Solution Sandimmum Neoral - Trade Name System: Drugs Affecting Immune Responds
L04AA01000L5002XX (A*) NEDL

332

Indications: Only for : i) Patients in whom donor specific transplantation cannot be carried out and in young children to minimise side-effects of steroids. ii) Follow-up cases of bone marrow transplant iii)Patients with severe Rheumatoid arthritis not responding to other second line drugs. iv) Patients with idiopathic nephrotic syndrome who are steroid toxic or poor response to cyclophosphamide. v)Severe aplastic anaemia, pure red cell aplasia vi)Cases of recalcitrant psoriasis and atopic eczema Dosage: i & ii) Initially 12.5 - 15 mg/kg/day, beginning on the day before transplant. Maintenance approx 12.5 mg/kg/day for 3 - 6 mths before being tapered off to zero by 1yr of transplantation. iii) 3mg/kg/day in 2 divided doses for first 6 wks. May increased gradually to max.5mg/kg.Treatment withdrawn if no response after 3mths. iv) Adult: 5mg/kg/day in 2 divided doses. Paed: 6mg/kg/day in 2 divided doses.Patients with permitted levels of kidney failure, the starting dose must not >2.5mg/kg/day. v) 12mg/kg/day. vi) 2.5mg/kg/day in 2 divided doses increasing if there is no improvement after 4 weeks by 0.5 -1mg/kg/month up to max. 5mg/kg/day. Contraindications: Hypersensitivity to cyclosporin, or any other component. Rheumatoid arthritis or psoriasis patients with abnormal renal function, uncontrolled hypertension, malignancies, uncontrolled infections in rheumatoid arthritis patients; primary or secondary immunodeficiency in rheumatoid arthritis patients; psoriasis patients receiving PUVA (psoralen plus ultraviolet A) or UVB (ultraviolet B) therapy, methotrexate or other immunosuppressants, coal tar, radiation therapy. Precautions: Liver and renal function, hypertension, malignancies. Neoral and Sandimmun are not bioequivalent - dosage adjustments and increased monitoring needed. Interactions: Etoposide, statins,vaccines, immunosuppressive drugs except corticosteroids, live vaccines, nephrotoxic drugs,rifampicin,NSAIDs, hepatic enzyme inducers. Adverse Reactions: Nephrotoxicity, hepatotoxicity, gum hyperplasia, hypertension, neurotoxicity, convulsions, increased malignancy risk. Cyclosporin 50 mg/ml Injection Sandimmum - Trade Name
L04AA01000P3001XX (A*)

System: Drugs Affecting Immune Responds Indications: i) Post bone marrow transplant ii) Solid organ transplant Dosage: i) 3 - 5 mg/kg/day until tolerate orally. ii) 2 - 3 mg/kg/day for recipients who are unable to take orally. Contraindications: Hypersensitivity to cyclosporin, or any other component. Rheumatoid arthritis or psoriasis patients with abnormal renal function, 333

uncontrolled hypertension, malignancies, uncontrolled infections in rheumatoid arthritis patients; primary or secondary immunodeficiency in rheumatoid arthritis patients; psoriasis patients receiving PUVA (psoralen plus ultraviolet A) or UVB (ultraviolet B) therapy, methotrexate or other immunosuppressants, coal tar, radiation therapy. Precautions: Liver and renal function, hypertension, malignancies. Neoral and Sandimmun are not bioequivalent - dosage adjustments and increased monitoring needed . Interactions: Etoposide, statins,vaccines, immunosuppressive drugs except corticosteroids, live vaccines, nephrotoxic drugs,rifampicin,NSAIDs, hepatic enzyme inducers. Adverse Reactions: Nephrotoxicity, hepatotoxicity, gum hyperplasia, hypertension, neurotoxicity, convulsions, increased malignancy risk. Muromonab-CD3 5 mg Injection O r t h o c l o n e O K T 3 - Trade Name
L04AA02000P3001XX (A*) APPL

System: Drugs Affecting Immune Responds Indications: Only for the treatment of severe acute rejection in kidney transplant patient. For severe acute graft-versus-host disease (GVHD) not responding to high dose steroids. Dosage: Adult & child >30kg: 5 mg dly for 10-14 days. Child =< 30kg 2.5mg dly for 10 - 14 days. Contraindications: Hypersensitivity to muromonab, anti-mouse antibody titres >= 1:1000, heart failure, fluid overload, hypertension, seizures, pregnancy, lactation. Precautions: Fever, cerebrovascular disease, neurological problems, concomitant drugs that affect the CNS, underlying vascular disease and history of thrombosis. Interactions: Azathioprine,corticosteroids,cyclosporin,indomethacine. Adverse Reactions: Cytokine release syndrome, anaphylaxis, respiratory distress, haematopoietic effects, neuro-psychiatric events, encephalopathy. Antilymphocyte/Antithymocyte Immunoglobulin (from Horse) Injection Atgam
L04AA03000P3001XX (A*)
- Trade Name

System: Immunological Products and Vaccines Indications: i) To be used when conventional anti -rejection therapy is not successful ii) Treatment of aplastic anaemia not responding to oxymethalone after 3 months, in which there is persistent pancytopenia with repeated attacks of septicaemia and bleeding. iii) Severe aplastic anaemia with the following parameters: a) Granulocyte < 0.5x109/L b) Platelet < 20x109/L c) Reticulocyte < 20x109/L iv) As a conditioning regime prior to transplant. v) Graft-versus-host disease treatment. Dosage: 334

10 - 30 mg/kg body wt dly. Slow IV infusion (over at least 4 hours) diluted in 250 - 500 ml Normal Saline. For Graft versus host disease treatment:40mg/kg/day. Contraindications: Hypersensitivity, acute viral illness. Precautions: Perform test dose, prophylactic platelet transfusion before and after infusion. Sodium and fluid overload. Monitor for allergic reactions and serum sickness. Interactions: Live vaccines, increased risk of infection. Adverse Reactions: Severe and unremitting thrombocytopenia or leucopenia, generalized rash, tachycardia, dyspnoea, hypotension, anaphylaxis. Antithymocyte Immunoglobulin (from Rabbit) Injection
L04AA04000P3001XX (A*)

System: Immunological Products and Vaccines Indications: i) To be used when conventional anti -rejection therapy is not successful (patients who do not respond to horse serum) ii) Treatment of aplastic anaemia not responding to oxymetholone after 3 months, in which there is persistent pancytopenia with repeated attacks of septicaemia and bleeding. iii) Severe aplastic anaemia. iv) Graft-versus -host disease treatment. Dosage: Antirejection therapy: 2.5-5mg/kg/day. Contraindications: Hypersensitivity Precautions: Monitor for allergic reactions, perform test dose, prophylactic platelet transfusion before and after infusion and monitor fluid overload. Interactions: Live vaccines Adverse Reactions: Leucopenia, nausea, vomiting, dizziness,headache, fever,chills Tacrolimus 1 mg Capsule Prograf - Trade Name
L04AA05000C1001XX (A*)

System: Drugs Affecting Immune Responds Indications: i) Primary immunosuppressant agent for all solid organ transplantation. ii) Rescue therapy for rejection. Dosage: i)0.2 mg/kg/day in 2 divided doses. ii)0.3 mg/kg/day in 2 divided doses. Contraindications: Hypersensitivity to tacrolimus products, pregnancy and lactation. Precautions: Renal or hepatic insufficiency, monitor blood glucose levels, increased risk of infections and possibly lymphoma, hyperkalemia, hypertension, myocardial hypertrophy and neurotoxicity. Interactions: Aminoglycosides, cisplatin, amphotericin B, additive or synergistic renal function impairment. Spironolactone, hyperkalaemia. NSAIDs, acute renal failure. Live vaccines, risk of infection in immunocompromised 335

hosts; reduced effectiveness of vaccine. Fluconazole, nifedipine, diltiazem, clarithromycin, erythromycin, chloramphenicol, increased risk of tacrolimus toxicity (nephrotoxicity, hyperglycaemia, hyperkalemia). Adverse Reactions: Hypertension, angina, tachycardia, pleural and pericardial effusion, hypotension, arrhythmias, ventricular or septal hypertrophy, cardiomyopathy, gastro-intestinal disturbances, headache, tremor, dizziness, anxiety, confusion and infection. Tacrolimus 5 mg Capsule Prograf - Trade Name
L04AA05000C1002XX (A*)

System: Drugs Affecting Immune Responds Indications: i) Primary immunosuppressant agent for all solid organ transplantation. ii) Rescue therapy for rejection. Dosage: i)0.2 mg/kg/day in 2 divided doses. ii)0.3 mg/kg/day in 2 divided doses. Contraindications: Hypersensitivity to tacrolimus products, pregnancy and lactation. Precautions: Renal or hepatic insufficiency, monitor blood glucose levels, increased risk of infections and possibly lymphoma, hyperkalemia, hypertension, myocardial hypertrophy and neurotoxicity. Interactions: Aminoglycosides, cisplatin, amphotericin B, additive or synergistic renal function impairment. Spironolactone, hyperkalaemia. NSAIDs, acute renal failure. Live vaccines, risk of infection in immunocompromised hosts; reduced effectiveness of vaccine. Fluconazole, nifedipine, diltiazem, clarithromycin, erythromycin, chloramphenicol, increased risk of tacrolimus toxicity (nephrotoxicity, hyperglycaemia, hyperkalemia). Adverse Reactions: Hypertension, angina, tachycardia, pleural and pericardial effusion, hypotension, arrhythmias, ventricular or septal hypertrophy, cardiomyopathy, gastro-intestinal disturbances, headache, tremor, dizziness, anx iety, confusion and infection. Tacrolimus 5mg/ml Injection Prograf - Trade Name
L04AA05000P3001XX (A*)

System: Drugs Affecting Immune Responds Indications: i) Primary immunosuppressant agent for all solid organ transplantation. ii) Rescue therapy for rejection. Dosage: i)0.2 mg/kg/day in 2 divided doses. ii)0.3 mg/kg/day in 2 divided doses. Contraindications: Hypersensitivity to tacrolimus products, pregnancy and lactation. Precautions: Renal or hepatic insufficiency, monitor blood glucose levels, increased risk of infections and possibly lymphoma, hyperkalemia, hypertension, myocardial hypertrophy and neurotoxicity. Interactions: Aminoglycosides, cisplatin, amphotericin B, additive or 336

synergistic renal function impairment. Spironolactone, hyperkalaemia. NSAIDs, acute renal failure. Live vaccines, risk of infection in immunocompromised hosts; reduced effectiveness of vaccine. Fluconazole, nifedipine, diltiazem, clarithromycin, erythromycin, chloramphenicol, increased risk of tacrolimus toxicity (nephrotoxicity, hyperglycaemia, hyperkalemia). Adverse Reactions: Hypertension, angina, tachycardia, pleural and pericardial effusion, hypotension, arrhythmias, ventricular or septal hypertrophy, cardiomyopathy, gastro-intestinal disturbances, headache, tremor , dizziness, anxiety, confusion and infection. Mycophenolate Mofetil 250 mg tablet Cellcept - Trade Name
L04AA06236T1001XX (A*)

System: Drugs Affecting Immune Responds Indications: i)Propylaxis of renal allograft rejection in high risk patients (eg high PRA, second transplant etc),patients who are unable to tolerate Azathioprine. ii)Treatment of refractory rejection. Dosage: i)Initially 250 mg orally within 72 hours following transplantation. Dose of 1g bd is recommended in renal transplant patients. Paed : 40 mg/kg/day. ii)1.5g bd. Contraindications: Hypersensitivity to mycophenolate mofetil and mycophenolic acid, pregnancy. Precautions: Full blood count weekly for 4 wks, then twice a month for 2 months, then monthly in the first year. Elderly, active serious gastro-intestinal disease, delayed graft function. Avoid exposure to sunlight. Bone marrow suppression. Interactions: Antacids, cholestyramine, decreased mycophenolate mofetil efficacy. Acyclovir, ganciclovir, increased plasma concentrations of acyclovir. Iron, decreased mycophenolate mofetil efficacy. Adverse Reactions: Myelosuppression, hypertension, infection, diarrhoea, nausea and vomiting, constipation, abdominal pain, dyspepsia, dizziness, insomnia, headache, tremor, leucopenia, anaemia, thrombocytopenia, leucocytosis, polycythaemia, electrolyte imbalances. Mycophenolate Mofetil 500 mg tablet Cellcept - Trade Name System: Drugs Affecting Immune Responds
L04AA06236T1002XX (A*)

337

Indications: Propylaxis of renal allograft rejection in high risk patients (eg high PRA, second transplant etc), patients who are unable to tolerate Azathioprine. ii)Treatment of refractory rejection. Dosage: i)Initially 250 mg orally within 72 hours following transplantation. Dose of 1g bd is recommended in renal transplant patients. Paed : 40 mg/kg/day. ii)1.5g bd. Contraindications: Hypersensitivity to mycophenolate mofetil and mycophenolic acid, pregnancy. Precautions: Full blood count wkly for 4 wks, then twice a month for 2 months, then monthly in the first yr. Elderly, active serious gastro-intestinal disease, delayed graft function. Avoid exposure to sunlight. Bone marrow suppression. Interactions: Antacids, cholestyramine, decreased mycophenolate mofetil efficacy. Acyclovir, ganciclovir, increased plasma concentrations of acyclovir. Iron, decreased mycophenolate mofetil efficacy. Adverse Reactions: Myelosuppression, hypertension, infection, diarrhoea, nausea / vomiting, constipation, abdominal pain, dyspepsia, dizziness, insomnia, headache, tremor, leucopenia, anaemia, thrombocytopenia, leucocytosis, polycythaemia, electrolyte imbalances. Basiliximab 20 mg Injection Simulect - Trade Name
L04AA09000P3001XX (A*)

System: Drugs Affecting Immune Responds Indications: Prophylaxis of acute organ rejection in de novo renal transplantation. Dosage: Adult & child 2 years and above & 35kg or more:20 mg /dose. 2 years or more but less than 35kg:10mg/dose. First dose given within 2 hrs before start of transplantation and second dose 4th day after transplant. Contraindications: Not known. Precautions: Pregnancy, avoid breast- feeding for 4 months after the last dose. Interactions: No interaction found. Adverse Reactions: Constipation, UTI pain, nausea, peripheral oedema, hypertension, anaemia, headache hyperkalemia, hypercholesterol, surgical wound complication, weight gain, increased serum creatinine, hypophosphataemia diarrhoea, upper respiratory tract infection, hypertrichosis, rhinitis, fever, viral infection, sepsis. Leflunomide 10 mg Tablet Leflunomide 20 mg Tablet Leflunomide 100 mg Tablet A r a v a - Trade Name System: Rheumatology
L04AA13000T1001XX (A*) L04AA13000T1002XX (A*) L04AA13000T1003XX (A*)

338

Indications: Persistent active rheumatoid arthritis. Dosage: i)Loading dose:100mg/daily for 3 days followed by 10 mg - 20 mg/day ii)without loading dose: 10 mg - 20 mg/day. Contraindications: Severe immunodeficiency state,serious infection,hepatic impairment,severe hypoproteinaemia,pregnancy,lactation,significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia. Precautions: Renal impairment, anaemia, leucopenia, thrombocytopenia, history of tuberculosis. Interactions: Other antirheumatic or immuno-suppressive agents, alcohol, phenytoin, warfarin, tolbutamide. Adverse Reactions: GI disturbances, anorexia, oral mucosa ulceration, elevation of liver parameters, headache, dizziness, paraesthesias, increase BP,weight loss, increase hair loss, eczema, dry skin. Azathioprine 50 mg Tablet I m u r a n - Trade Name
L04AX01000T1001XX (A) NEDL APPL

System: Drugs Affecting Immune Responds Indications: i)Acute leukaemia ii)Immunosuppressive agent Dosage: i) 1-4mg/kg/day ii) 1.5-2mg/kg/day Contraindications: Hypersensitivity, pregnancy, previous alkylating agents such as cyclophosphamide, chlorambucil, melphalan (risk of neoplasms). Precautions: Chronic immunosuppression ,increases risk of neoplasm, hematologic toxicity, mutagenicity. bleeding or bruising or signs of infection,bone marrow suppression. Interactions: ACEI,Angiotensin II Antagonist,warfarin, allopurinol, live vaccines,antibacterial. Adverse Reactions: GI disturbances, myelosuppression, pancreatitis, drug fever. Azathioprine 50 mg Injection I m u r a n - Trade Name
L04AX01520P4001XX (A) NEDL

System: Drugs Affecting Immune Responds Indications: Transplantation. Dosage: 1 - 4 mg/kg/day. Dose adjusted to haematological reaction. The contents of each vial should be dissolved in not less than 5 ml of water for injection. The solution must be given slowly (not less than 1min) and then flushed through with at least 50ml of physiological saline or glucose saline. Contraindications: Hypersensitivity, pregnancy, previous alkylating agents such as cyclophosphamide, chlorambucil, melphalan (risk of neoplasms). 339

Precautions: Chronic immunosuppression ,increases risk of neoplasm, hematologic toxicity, mutagenicity. bleeding or bruising or signs of infection,bone marrow suppression. Interactions: ACEI,Angiotensin II Antagonist,warfarin, allopurinol, live vaccines,antibacterial. Adverse Reactions: GI disturbances, myelosuppression, pancreatitis, drug fever. Indomethacin 25 mg Capsule I n d o c i d - Trade Name
M01AB01000C1001XX (B) NEDL APPL

System: Analgesics Indications: Pain and inflammation in rheumatic disease Dosage: 50 - 200 mg daily in divided doses, with food. Child not recommended. Contraindications: Hypersensitivity, rhinitis, urticaria, asthma, or allergic reactions to aspirin or other anti-inflammatory agents, use of supp contraindicated in patients with recent rectal bleeding or proctitis, pregnancy, lactation. Precautions: Active or previous history of gastrointestinal ulceration, bleeding, or perforation. History of renal/liver dysfunction or coagulation defects. Hypertension or cardiac conditions aggravated by fluid retention and oedema. May aggravate depression/psychiatric disorders. Interactions: Salicylates, anticoagulant drugs, probenecid, methotrexate, cyclosporin, lithium, diuretics, digoxin, B-blockers, captopril. Adverse Reactions: GI disturbances, headache, vertigo, depression, epigastric disease, GI bleeding. Diclofenac Sodium 75mg/3ml Injection Voltaren - Trade Name
M01AB05520P3001XX (A)

System: Analgesics Indications: Pain and inflammation in rheumatic disease. Dosage: 75mg once daily (2 times daily in severe cases) for not more than 2 days. Contraindications: Hypersensitivity to diclofenac or any component of the formulation, aspirin or other NSAIDs, asthma, rhinitis, porphyria, pregnancy (3rd trimester). Precautions: Patient with CHF, dehydration, hypertension, decreased renal or hepatic function, active GIT ulceration or bleeding, pre-existing asthma. Interactions: ACE inhibitors, angiotensin II antagonists, anticoagulants, cholestyramine and colestipol, ticlopidine, aspirin. Adverse Reactions: Pruritus, rash, contact dermatitis, pain,dry skin, exfoliation, paraesthesia, constipation, diarrhoea.

340

Diclofenac Sodium 12.5 mg Suppository Voltaren - Trade Name

M01AB05520S2001XX (A)

System: Analgesics Indications: Pain and inflammation in rheumatic disease and juvenile arthritis Dosage: 75 - 150 mg daily in divided doses. Child 1 - 12 years,Juvenile arthritis; 12.5mg - 25 mg daily. Contraindications: Patients with history of hypersensitivity to aspirin/other NSAIDs, lactation. Precautions: Previous history of gastrointestinal ulceration, bleeding, or perforation. Renal dysfunction. Hypertension or cardiac conditions aggravated by fluid retention and oedema. History of liver dysfunction, coagulation defects. Interactions: Increases plasma concentration of warfarin, lithium, & methotrexate. May reduce effects of diuretics & beta blockers. May alter plasma concentration of sulfonylureas. Adverse Reactions: Occasionally GI disorders, headache, dizziness, vertigo, rash. Diclofenac Sodium 25 mg Suppository Voltaren - Trade Name
M01AB05520S2002XX (A)

System: Analgesics Indications: Pain and inflammation in rheumatic disease and juvenile arthritis Dosage: 75 - 150 mg daily in divided doses. Paed: Juvenile arthritis, 1 - 3 mg/kg Contraindications: Patients with history of hypersensitivity to aspirin/other NSAIDs, lactation. Precautions: Previous history of gastrointestinal ulceration, bleeding, or proforation. Renal dysfunction. Hypertension or cardiac conditions aggravated by fluid retention and oedema. History of liver dysfunction, coagulation defects. Interactions: Increases plasma concentration of warfarin, lithium, & methotrexate. May reduce effects of diuretics & beta blockers. May alter plasma concentration of sulfonylureas. Adverse Reactions: Occasionally GI disorders, headache, dizziness, vertigo, rash. Diclofenac Sodium 50 mg Tablet Voltaren - Trade Name
M01AB05520T1001XX (B)

System: Analgesics Indications: Pain and inflammation in rheumatic disease. Dosage: Adults: Initial dose of 150 mg daily. Mild or long term: 75 - 150 mg dly in 2 to 3 divided doses after food. Paeds, 1 yr and above : 1 - 3 mg/kg body wt. daily. Contraindications: Hypersensitivity, rhinitis, urticaria, asthma, or allergic reactions to aspirin or other anti-inflammatory agents. 341

Precautions: Previous history of gastrointestinal ulceration, bleeding, or perforation. Renal dysfunction. Hypertension or cardiac conditions aggravated by fluid retention and oedema. History of liver dysfunction, coagulation defects. Interactions: Increases plasma concentration of warfarin, lithium & methotrexate. May reduce effects of diuretics & beta blockers. May alter plasma concentration of sulfonylureas. Adverse Reactions: Epigastric pain, GI disturbances, slight dizziness. Ketorolac Tromethamine 30 mg/ml Injection T o r a d o l - Trade Name
M01AB15239P3001XX (A*)

System: Analgesics Indications: Short term management of moderate to severe postoperative pain. Dosage: Adult : By IM/IV inj.(over not less than 15 sec.) Initially 15 mg 4 - 6 hrly. Max: 90 mg dly. Contraindications: Asthma, hypovolaemia, dehydration, hystory of peptic ulcer or coagulation disorders,hypersensitivity or other NSAIDs and aspirin or other prostaglandin synthesis inhibitors.GI bleeding, cerebrovascular bleeding, diathesis. Precautions: Active hepatitis and cholestasis, conditions predisposing to GI toxicity, conditions predisposing to or exacerbated by fluid retention, renal impairment, elderly. Interactions: ACEIs : decreased antihypertensive and natriuretic effects. Aspirin, NSAIDs : enhanced gastrointestinal adverse effects (peptic ulcers, gastrointestinal bleeding and or perforation) and possible increase in serum ketorolac levels. Beta-adrenergic block. Adverse Reactions: Bronchospasm, dyspnoea,GI disturbances, GI ulceration. Piroxicam 10 mg Tablet F e l d e n e - Trade Name
M01AC01000T4001XX (A/KK)

System: Rheumatology Indications: i) Rheumatoid arthritis , osteoarthritis, ankylosing spondylitis. ii) Acute musculoskeletal disorders. iii)Acute gout. Dosage: Dose: i) Rheumatoid arthritis; 20 mg daily, maintenance 10-30 mg daily, in single or divided doses. ii) Acute musculoskeletal disorders; 40 mg daily in single or divided doses for 2 days, then 20 mg daily for 7-14 days. iii)Acute gout; 40 mg initially, then 40 mg daily in single or divided doses for 4-6 days. Contraindications: Active pepic ulceration, allergy provoked by aspirin or NSAIDs. Precautions: Upper gastrointestinal disease, compromised cardiac function, 342

hypertension, renal disease. Interactions: Diuretics, anti -coagulant, sulphonylureas, captopril, phenytoin, digoxin, highly protein bound drugs. Adverse Reactions: Gastrointestinal disorders, flatulence, insomnia, pharyngitis, sinusitis, dizziness, vertigo, hearing disturbance, photos ensitivity, blood disorder, fluid retention, renal failure, hepatic impairment, StevenJohnson syndrome, allergic reactions, chest pain, oedema, hot flushes,flu-like symptoms. Gastric side effects are lesser with this drug as compared to other NSAIDs, swollen eyes, blurred vision, skin rash & pruritus. Meloxicam 7.5mg Tablet Mobic - Trade Name
M01AC06000T1001XX (A/KK)

System: Rheumatology Indications: Only for patients not responding to other NSAIDs in the treatment of i) painful osteoarthritis ii) rheumatoid arthritis. Dosage: i) initially 7.5 mg daily. May be increased to 15 mg daily. ii) initially 15 mg daily. May be reduced to 7.5 mg daily. Max 15 mg daily. Child under 12 years not recommended. Contraindications: active peptic ulceration, severe hepatic insuficiency, pregnancy, lactation. Precautions: history of GI disease, patients receiving anticoagulant treatment, liver cirrhosis, dehydration. Interactions: anticoagulants, lithium, diuretics, antihypertensives, cholestyramine, cyclosporin, intrauterine devices. Adverse Reactions: dyspepsia, nausea, abdominal pain, pruritis, skin rash,constipation. Ibuprofen 200 mg Tablet B r u f e n - Trade Name
M01AE01000T1001XX (B) NEDL APPL

System: Analgesics Indications: Pain and inflammation in rheumatic disease. Dosage: Adult : 200 - 400 mg tds after food, max. 2.4 g daily. Child : 20-30 mg/kg body wt dly in divided doses. Contraindications: Patients with history of hypersensitivity to aspirin/other NSAIDs and lactation. Precautions: Patients with active or severe peptic ulceration, pregnancy and history of bronchial asthma. Interactions: Coumarin-type anticoagulants, aspirin or NSAIDs, digitalis glycosides, lithium, methotrexate, diuretics, cefoperazone, , valproic acid, cyclosporin, gold compound, other nephrotic medications, probenecid. Adverse Reactions: Peptic ulceration, GI bleeding, headache, dizziness, nervousness, skin rash, pruritus, tinnitus, oedema depression, drowsiness, 343

insomnia, blurred vision, hypersensitivity, impairment of renal function, thrombocytopenia. Naproxen 250 mg Tablet N a p r o s y n - Trade Name
M01AE02000T1001XX (A/KK) APPL

System: Rheumatology Indications: i) Rheumatic arthritis, osteoarthritis and ankylosing spondylitis ii)Acute gout iii)Muscular skeletal disorder, dysmenorrhoea Dosage: i) 0.5-1 g dly in 2 divided doses. ii)750 mg initially then 250 mg 8 hrly. iii) 500 mg initially then 250 mg every 6 - 8 hour as required. Contraindications: Hypersensitivity, allergic reactions to aspirin or other antiinflammatory agents, acute peptic ulceration. Precautions: Active or previous history of gastrointestinal ulceration, bleeding or perforation. History of renal or liver dysfunction or coagulation defects. Hypertension or cardiac conditions aggravated by fluid retention and oedema, dehydration, diuretics, pregnancy and breast feeding. Interactions: Lithium, methotrexate, diuretics,B-blockers, warfarin, sulfonylureas, captopril, phenytoin, digoxin. Adverse Reactions: GI disturbances, vertigo, GI ulceration, dizziness, vertigo, hearing disturbance, photosensitivity, blood disorder, fluid retention, renal failure, hepatic impairment, Steven-Johnson syndrome. Naproxen 25 mg/ml Suspension N a p r o s y n - Trade Name
M01AE02520L8001XX (A)

System: Rheumatology Indications: Juvenile arthritis. Dosage: Child. over 5 years: 10 mg/kg. dly in 2 divided doses. Contraindications: Hypersensitivity, rhinitis, urticaria, asthma, or allergic reactions to aspirin or other anti-inflammatory agents. Precautions: Active or previous history of gastrointestinal ulceration, bleeding, or perforation. History of renal or liver dysfunction or coagulation defects. Hypertension or cardiac conditions aggravated by fluid retention and oedema. Interactions: Probenecid, methotrexate, beta blockers, lithium, frusemide, anticoagulants, sulfonylureas. Adverse Reactions: GI disturbances, vertigo, GI ulceration Naproxen Sodium 275 mg Tablet System: Rheumatology
M01AE02520T1001XX (A)

344

Indications: i)Rheumatic arthritis, osteoarthritis and alkylosing spondylitis. ii) Acute gout. iii)Muscular skeletal disorder and dysmenorrhoea. Dosage: i) 0.5 - 1 g dly in 2 divided doses. ii) 750 mg initially then 250 mg 8 hrly. iii) 500 mg initially then 250 mg every 6 - 8 hour as required. Contraindications: Active peptic ulcer, active inflammatory GIT diseases. NSAID-induced syndrome of asthma, rhinitis, urticaria. Precautions: GIT bleeding, impaired renal function. Interactions: Probenecid, methotrexate, beta blockers, lithium, frusemide, anticoagulants, sulfonylureas. Adverse Reactions: Abdominal discomfort, epigastric distress, GI reactions, peptic ulceration. Skin rash, pruritus, insomnia, visual disturbance, headache, nausea, peripheral oedema, tinnitus, vertigo. Prolongs bleeding time. Ketoprofen 100mg Slow Release Capsule O r u v a i l - Trade Name
M01AE03000C2001XX (A/KK)APPL

System: Analgesics Indications: Pain and inflammation in rheumatic disease. Dosage: 100-200 mg dly with food. Child not recommended. Contraindications: Active peptic ulceration, history of recurrent peptic ulcer or chronic dyspepsia, asthma, allergy provoked by aspirin or NSAIDs. Precautions: Renal impairment. Interactions: NSAIDs, methotrexate, highly protein bound drugs. Adverse Reactions: GI disturbances, headache, drowsiness, oedema. Ketoprofen 100 mg/2ml Injection Orudis - Trade Name
M01AE03000P3001XX (A*)

System: Analgesics Indications: To be used only in treatment of acute inflammatory conditions. Dosage: By deep IM into gluteal muscle, 50-100 mg every 4 hrs. Max. 200 mg in 24 hrs. for up to 3 days. Child not recommended. Contraindications: Active peptic ulceration, history of recurrent peptic ulcer or chronic dyspepsia, asthma, alergy provoked by aspirin or NSAIDs. Precautions: Renal impairment. Interactions: NSAIDs, methotrexate, highly protein bound drugs. Adverse Reactions: GI disturbances, headache, drowsiness, oedema. Mefenamic Acid 250 mg Capsule Ponstan - Trade Name System: Analgesics Indications: 345
M01AG01000C1001XX (B) NEDL APPL

Mild to moderate pain. Dosage: Adult: 250 - 500 mg tds after meals. Child over 6 mths: 6.5 - 25 mg/kg dly tds qid for not longer than 7 days except in juvenile arthritis. Contraindications: GI ulceration or inflammatory bowel disease, renal/hepatic impairment. Precautions: Elderly, renal impairment, asthmatic sensitive to NSAIDs or salicylates, pregnancy. Interactions: Alendronate, ACEIs, antacids, beta-adrenergic blockers, calcium channel blocker, cyclosporin, diuretics, methotrexate, sulphonylureas, warfarin. Adverse Reactions: Diarrhoea, skin rash, allergic, glomerulonephritis, nonoliguric renal failure, thrombocytopenia, reversible haemolytic anaemia. Mefenamic Acid 250 mg Tablet Ponstan - Trade Name
M01AG01000T1001XX (B) NEDL APPL

System: Analgesics Indications: Mild to moderate pain. Dosage: Adult: 250 - 500 mg tds after meals. Child over 6 months: 6.5 - 25 mg/kg dly tds - qid for not longer than 7 days except in juvenile arthritis. Contraindications: GI ulceration or inflammatory bowel disease, renal/hepatic impairment. Precautions: Elderly, renal impairment, asthmatic sensitive to NSAIDs or salicylates, pregnancy. Interactions: Alendronate, ACEIs, antacids, beta-adrenergic blockers, calcium channel blocker, cyclosporin, diuretics, methotrexate, sulphonylureas, warfarin. Adverse Reactions: Diarrhoea, skin rash, allergic, glomerulonephritis, nonoliguric renal failure, thrombocytopenia, reversible haemolytic anaemia. Celecoxib 200 mg Capsule Celebrex - Trade Name
M01AH01000C1001XX (A*)

System: Rheumatology Indications: i) Osteoarthritis ii) Rheumatoid Arthritis iii) Acute pain Dosage: i) Adults : 200 mg once daily. ii) 200 mg bd. iii) 400mg as a single dose on first day followed by 200mg once daily on subsequent days. Contraindications: Hypersensitivity to celecoxib, allergic-type reaction to sulfonamides, allergic reactions to aspirin or other nonsteroidal anti inflammatory agents. Precautions: Hypertension or cardiac conditions aggravated by fluid retention and oedema, liver/renal dysfunction, elderly, children < 18yr, pregnancy, lactation. Interactions: Diuretics, anti -coagulant, sulphonylureas, captopril, phenytoin, digoxin,fluconazole, lithium,antacids, aspirin, glucocorticoids. Adverse Reactions: GI disorders, flatulence, insomnia, pharyngitis, sinusitis, dizziness, vertigo, hearing disturbance, photosensitivity, blood disorder, fluid 346

retention, renal failure, hepatic impairment, Steven-Johnson syndrome, allergic reactions, chest pain, oedema, hot flushes, flu-like symptoms. Gastric side effects are lesser with this drug as compared to other NSAIDs. Etoricoxib 90 mg Tablet A r c o x i a - Trade Name
M01AH05000T1001XX (A*)

System: Rheumatology Indications: i)Acute and chronic treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis. ii)Treatment of acute gouty arthritis. Dosage: OA: 60 mg once daily RA: 90 mg once daily. Acute gouty arthritis: 120 mg once daily. Contraindications: Patients who experienced asthma, urticaria or allergic type of reaction after taking aspirin or NSAIDs, acute peptic ulcer, severe renal or hepatic disease. Precautions: Bleeding disorders, mild or moderate liver disease, mild or moderate renal impairment , hypertension and recent myocardial infarct. Interactions: Warfarin, ACE inhibitors, lithium, methotrexate, oral contraceptives, rifampicin, aspirin, SSRIs. Adverse Reactions: Small increase in blood pressure, increased risk of thrombotic complication, headache, dizziness, fatigue, insomnia, nausea, vomiting, diarrhoea, heartburn, taste disturbance, decreased appetite and flatulence. Etoricoxib 120 mg Tablet A r c o x i a - Trade Name
M01AH05000T1002XX (A*)

System: Rheumatology Indications: i)Acute and chronic treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis. ii)Treatment of acute gouty arthritis. Dosage: OA: 60 mg once daily RA: 90 mg once daily. Acute gouty arthritis: 120 mg once daily. Contraindications: Patients who experienced asthma, urticaria or allergic type of reaction after taking aspirin or NSAIDs, acute peptic ulcer, severe renal or hepatic disease. Precautions: Bleeding disorders, mild or moderate liver disease, mild or moderate renal impairment, hypertension and recent myocardial infarction. Interactions: Warfarin, ACE inhibitors, lithium, methotrexate, oral contraceptives, rifampicin, aspirin, SSRIs. Adverse Reactions: Small increase in blood pressure, increased risk of thrombotic complication, headache, dizziness, fatigue, insomnia, nausea, vomiting, diarrhoea, heartburn, taste disturbance, decreased appetite and flatulence. 347

D-Penicillamine 0.25 g Capsule C u p r i m i n e - Trade Name

M01CC01000C1001XX (A) NEDL

System: Emergency Indications: i) Treatment of severe lead poisoning, it is used as adjunctive treatment following initial treatment with another chelating agent. May also be used as sole therapy in the treatment of asymptomatic patients with moderately elevated blood concentrations. ii) Wilson Disease: to aid in elimination of copper ions. Dosage: i)1.5 - 2 g dly in divided doses before food; max: 2 g dly for a year. Maintenance : 0.75 - 1 g dly. ii) Initially 500 mg dly in divided doses, slowly maintenance over 3 mths; maintenance : 1.25 g dly. Contraindications: Penicillamine-related aplastic anaemia/agranulocytosis, hypersensitivity to penicillamine producs, myasthenia gravis, pregnancy, lactation. Precautions: Allergy to penicillin, concomitant gold therapy, antimalarial, cytotoxic drug, renal dysfunction. Interactions: Alluminium hydroxide or phosphate, magnesium carbonate,or hydroxide or oxide or trisilicate, iron, decreased penicillamine effectiveness, digoxin, decreased digoxin effectiveness. Adverse Reactions: Nausea, vomiting, myelosuppression, taste disorders, proteinuria. Turpentine & Oleic Acid Liniment L i n i m e n t A l b a - Trade Name
M02A000952L4001XX (C) NEDL

System: Analgesics Indications: Rheumatic pains and stiffness Dosage: The liniment should be applied to the skin with considerable friction. Contraindications: Not Known. Precautions: Not Known. Interactions: No Interaction found. Adverse Reactions: Hypersensitivity reactions and local irritation. Ingestion:local burning and gastrointestinal upset, coughing and choking, pulmonary oedema, excitement, coma, fever, tachycardia, liver damage, haematuria, and albuminuria. Ketoprofen 2.5% Gel Orudis - Trade Name
M02AA10000G3001XX (A)

System: Analgesics Indications: AS a short term treatment for traumatic lesions, sprains, tendinitis, oedema, bruises. Dosage: 348

Apply twice dly. Maximum 20 g dly. Contraindications: Avoid in patient with exudative dermatoses, eczema, sores, & infected skin. Do not apply to the mucous membranes or eyes. Precautions: Avoid in children < 5 yrs. Should skin rash occurs after gel application, treatment should be stopped. Interactions: No interaction found. Adverse Reactions: Pruritus and localised erythema Ketoprofen 30mg Transdermal Plaster K e t o t o p - Trade Name
M02AA10000M7001XX (A)

System: Analgesics Indications: Treatment of signs & symptoms of arthritis deformans, periarthritis humeroscapularis, tendinitis, peritendinitis, sore muscle, swelling, pain resulting from trauma (eg. contusion, distorsion, sprain). Dosage: Apply 1 plaster to the affected area bd. Contraindications: Avoid in patient with exudative dermatoses, eczema sores & infected skin. Do not apply to the mucous membranes or eyes. Precautions: Avoid in children < 5yrs. Should skin rash occurs after gel application, treatment should be stopped, pregnancy. Interactions: No interaction found Adverse Reactions: Pruritus and localised erythema. Diclofenac 1% Emulgel Voltaren - Trade Name
M02AA15520G3001XX (A)

System: Analgesics Indications: Post-traumatic inflammation of the tendons,ligaments & joints. Localised forms of soft tissue rheumatism and degenerative rheumatism. Dosage: Apply tds - qid and gently rubbed in. Contraindications: Hypersensitivity to diclofenac or other NSAIDs, proctitis. Precautions: Do not apply to diseased skin or open wounds or injuries. Avoid contact with eyes or mucous membranes. Systemic side effects when applied to large areas of skin & over a prolonged period of time. Interactions: Increase plasma concentration of lithium, methotrexate & warfarin. Reduces effects of diuretics & beta blockers. Adverse Reactions: Allergic or non allergic contact dermatitis. Indomethacin 100 mg Suppository I n d o c i d - Trade Name
M02AA23000S2001XX (B) NEDL

System: Analgesics Indications: Pain and inflammation in rheumatic arthritis. Dosage: 100 mg at night.Child not recommended. Contraindications: Hypersensitivity, rhinitis, urticaria, asthma, or allergic 349

reactions to aspirin or other anti-inflammatory agents, use of suppository contraindicated in patients with recent rectal bleeding or proctitis, pregnancy, lactation. Precautions: Suppository may cause tenesmus & irritation of rectal mucosa. Interactions: Salicylates, anticoagulant drugs, probenecid, methotrexate, cyclosporin, lithium, diuretics, digoxin, B-blockers, captopril. Adverse Reactions: Nausea, vomiting, anorexia, epigastric, constipation, fatigue. Methyl Salicylate 25% Ointment
M02AC00260G5001XX (C) NEDL APPL

System: Analgesics Indications: Relief of pain associated with musculoskeletal discomfort. Dosage: To be applied to affected area. Contraindications: Patient with aspirin or salicylate idiosyncrasy. Precautions: Avoid contact with eyes, open wounds Interactions: No interaction found Adverse Reactions: Extreme overdosage results in excessive irritation, tinnitus, nausea, vomiting. Camphor 20% Liniment
M02AX10000L4001XX (C) NEDL

System: Analgesics Indications: As a counter-irritant in fibrositis, neuralgia and similar condition. Dosage: The liniment should be applied to the skin with considerable friction. Contraindications: Not known. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: Ingestion: nausea, vomiting, colic, headache, dizziness, a feeling of warmth, delirium, muscle twitching, epileptiform convulsions, depression of the central nervous system and coma. Suxamethonium Chloride 50 mg/ml lnj S c o l i n e - Trade Name
M03AB01100P3001XX (B) NEDL APPL

System: Anaesthesia Indications: Muscle relaxant as an adjunct to anaesthesia. Dosage: Initial test dose 5 - 10 mg may be given. Usual single dose 0.3 - 1.1 mg/kg IV. Max 100 mg according to the depth and duration of relaxation required. 2.5 - 4 mg/kg IM, max 150 mg. Contraindications: Patients who are burnt, severely hyperkalaemic, with penetrating eye wounds, malignant hyperpyrexia, massively traumatised patients or those with extensive muscle degeneration eg. recent paraplegia. Precautions: Cardiac disease, severe trauma or electrolyte imbalance, preexisting hyperkalaemia. Ocular surgery, glaucoma. Elderly. 350

Interactions: Enhanced effect by aminoglycoside, clindamycin, cyclophosphamide, neostigmine, pyridostigmine, rivastigmine and possibly donepezil. Arrhythmias if given with digoxin. Adverse Reactions: Transient muscle fasciculation before relaxation, increased intraocular and intragastric pressure, post-operative pain, bradycardia, tachycardia, hypertension, hypotension, muscarinic effects. Pancuronium Bromide 4 mg/2 ml lnj P a v u l o n - Trade Name
M03AC01320P3001XX (B) NEDL APPL

System: Anaesthesia Indications: Muscle relaxant as an adjunct to general anaes thesia. Dosage: Adult : Initially 50 - 100 mcg/kg IV, then 10 - 20 mcg/kg as required. Child : Initially 60 - 100 mcg/kg then 10 - 20 mcg/kg. Neonate : 30 - 40 mcg/kg then 10 - 20 mcg/kg. Intensive care, by IV, 60 mcg/kg every 60 - 90 min. Contraindications: Myasthenia gravis or myasthenic syndrome. Precautions: Pre-existing pulmonary and renal disease, pregnancy and neonate acidosis, severe electrolyte disturbances. Interactions: Increased activity with ether, halothane, isoflurane. Adverse Reactions: Local reaction at injection site. Vecuronium Br 10 mg/10 ml Injection N o r c u r o n - Trade Name
M03AC03320P3001XX (A*)

System: Anaesthesia Indications: As an adjunct in anaesthesia to produce skeletal muscle relaxation. Dosage: Adult: 80 - 100 mcg/kg IV. Maintenance 20 - 30 mcg/kg acording to response. Neonate and infant up to 4 months: Initially 10 - 20 mcg/kg, then incremental dose to achive response. Contraindications: Known former anaphylactic reactions to vecuronium or bromide ion. Precautions: Neuromuscular disease, severe obesity, after poliomyelitis. Electrolyte imbalances, dehydration, acidosis. Renal insufficiency and liver disorders. Myasthenia gravis, Eaton-Lambert syndrome. Interactions: Increased effect by anaesthesia, non-depolarising muscle relaxants, prior administration of suxamethonium, aminoglycoside and polypeptide antibiotics, diuretics, beta-adrenergic blockers, thiamine, MAOIs, quinidine, protamine, imidazole, metronidazole, alpha-adrenergic blockers. Decreased effect by neostigmine, corticosteroids, noradrenaline, theophylline, azathioprine, KCl, NaCl, edrophonium. Adverse Reactions: Anaphylactic reactions (rare). Vecuronium Br 4 mg/ml Injection N o r c u r o n - Trade Name System: Anaesthesia Indications: 351
M03AC03320P3002XX (A*) APPL

As an adjunct in anaesthesia to produce skeletal muscle relaxation. Dosage: Adult: 80 - 100 mcg/kg IV. Maintanance dose: 20 - 30 mcg/kg acording to response. Neonate and infant up to 4 months: Initially 10 - 20 mcg/kg, then incremental to achieve response. Contraindications: Known former anaphylactic reactions to vecuronium or bromide ion. Precautions: Neuromuscular disease, severe obesity, after poliomyelitis. Electrolyte imbalances, dehydration, acidosis. Renal insufficiency and liver disorders. Myasthenia gravis, Eaton-Lambert syndrome. Interactions: Increased effect by anaesthesia, non-depolarising muscle relaxants, prior administration of suxamethonium, aminoglycoside and polypeptide antibiotics, diuretics, beta-adrenergic blockers, thiamine, MAOIs, quinidine, protamine, imidazole, metronidazole, alpha-adrenergic blockers. Decreased effect by neostigmine, corticosteroids, noradrenaline, theophylline, azathioprine, KCl, NaCl, edrophonium. Adverse Reactions: Anaphylactic reactions (rare). Atracurium Besylate 25 mg/2.5 ml Injection Atracurium Besylate 50 mg/5 ml Injection T r a c r i u m - Trade Name
M03AC04197P3001XX (A*) APPL M03AC04197P3002XX (A*)

System: Anaesthesia Indications: Muscle relaxation. Dosage: Adult and child > 1 month: Initially 300 - 600 mcg/kg IV injection. Subsequent doses of 80 - 200 mcg/kg may be given as necessary. IV infusion: 5 - 10 mcg/kg/minute (300 - 600 mcg/kg/hr). Contraindications: Not known Precautions: Other neuromuscular disease, severe cardiovascular disease. Interactions: Effect enhanced by inhalation anaesthesia, aminoglycoside, polymyxins, lithium, magnesium salts, procainamide and quinidine. Adverse Reactions: Bronchospasm, tachycardia, flushing, skin reactions and allergic reactions. Rocuronium Bromide 10 mg/ml Injection E s m e r o n - Trade Name System: Anaesthesia
M03AC09320P3001XX (A*)

352

Indications: As an adjunct to general anaesthesia to facilitate endotracheal intubation, to provide skeletal muscle relaxation during surgery and to facilitate mechanical ventilati on in adults, children and infants from 3 mths of age. Dosage: Adult (usual) : Intubation: (rapid sequence intubation) initial, 0.6-1.2 mg/kg IV Intubation: (tracheal intubation) initial, 0.6 mg/kg IV Intubation: maintenance, 0.1-0.2 mg/kg IV repeated as needed Intubation: maintenance, 0.01-0.012 mg/kg/minute continuous IV infusion Skeletal muscle relaxation: initial, 0.6 mg/kg IV Skeletal muscle relaxation: maintenance, 0.1-0.2 mg/kg IV repeated as needed Skeletal muscle relaxation: maintenance, 0.01-0.012 mg/kg/minute continuous IV infusion Dosage, Paediatric, (usual) Intubation: (age 3 months-12 yr) initial, 0.6 mg/kg/dose IV Intubation: (age 3 months-12 yr) maintenance, 0.075-0.125 mg/kg IV as needed Intubation: (age 3 months-12 yr) maintenance, 0.012 mg/kg/min continuous IV infusion Skeletal muscle relaxation: (age 3 months-12 yr) initial, 0.6 mg/kg/dose IV Skeletal muscle relaxation: (age 3 months-12 yr) maintenance, 0.075-0.125 mg/kg IV as needed Skeletal muscle relaxation: (age 3 months-12 yr) maintenance, 0.012 mg/kg/min continuous IV infusion Contraindications: Not known. Precautions: Hepatic, biliary tract and renal diseases, condition associated with prolonged circulation time, neuromuscular disease, hypothermic condition, obesity. hypokalaemia, hypermagnesaemia, hypocalcaemia, hypoproteinaemia, dehydration, acidosis, hypercapnoea. Interactions: Anaesthetics, other non-depolarising neuromuscular blocking agents, neostigmine, edrophonium, pyridostigmine, aminopyridine derivatives, phenytoin or carbamazepine, moradrenaline, azathioprine, theophylline and calcium chloride. Adverse Reactions: Minimal histamine-releasing and cardiovascular effects, high doses produce mild vagolytic activity. Clostridium Botulinum Toxin Type A 100 units Clostridium Botulinum Toxin Type A 500 units Botox, Dysport - Trade Name
M03AX01000P4001XX (A*) M03AX01000P4002XX (A*)

System: Neurology Indications: i) Focal dystonias ii) Hemifacial spasm iii) Spasticity including cerebral palsy Dosage: 20 - 200 units 3 mths once. Contraindications: Generalised disorders of muscle activity eg. Myasthenia gravis, bleeding disorders. Pregnancy and breast feeding. Precautions: Anaphylaxis and corneal exposure. 353

Interactions: Effects enhanced by aminoglycosides and non-depolarizing muscle relaxant. Adverse Reactions: Misplaced injections may paralyse nearby muscle groups and excessive doses may paralyse distant muscle, influenza-like syndrome. Eperisone HCl 50 mg Tablet M y o n a l - Trade Name
M03B000110T1001XX (A)

System: Neurology Indications: Myotonic symptoms associated with cervical syndrome, periarthritis of shoulder and lumbago spastic paralysis. Dosage: 50 mg tds Contraindications: Not known. Precautions: Hepatic disorders, drug hypersensitivity. Interactions: Methocarbamol, Tolperisone HCl Adverse Reactions: Weakness, dizziness, insomnia, drowsiness, numbness or trembling in the extremities, hepatic and renal dysfunction/ haematological changes, rashes, GI disturbances, urinary disorders. Orphenadrine 100 mg Tablet N o r f l e x - Trade Name
M03BC01110T1001XX (A) NEDL

System: Neurology Indications: Painful muscle spasm. Dosage: Initially 150 mg daily in divided doses. Max : 400 mg dly. Contraindications: Glaucoma, prostatic hypertrophy or bladder neck obstruction, myasthenia gravis. Precautions: Tachycardia, cardiac decompensation, coronary insufficiency, pregnancy. Interactions: No interaction found. Adverse Reactions: Nausea, vomiting, blurred vision, rarely rash or drowsiness. Baclofen 10 mg Tablet Lioresal - Trade Name
M03BX01000T1001XX (B) NEDL APPL

System: Neurology Indications: Spasticity of the skeletal muscle Dosage: Adult : 5 mg tds dly. Max : 80 mg dly. Child: 0.75 - 2 mg/kg dly (> 10 yrs, max: 2.5 mg/kg dly.) Contraindications: Epilepsy and other convulsive conditions, corticol or subcorticol brain damage, peptic ulceration Precautions: Pregnancy, abrupt withdrawal, patients suffering not only from spasticity but also from psychotic disorders, schizophrenia or confusional states. 354

Interactions: Tricyclics and lithium enhance muscle relaxant effect. ACE inhibitors, diuretics and antihypertensives enhance hypotensive effect. Sedative effect enhanced with alcohol, anxiolytics and hypnotics. Excretion reduced by ibuprofen and possibly other NSAIDs. Adverse Reactions: Daytime sedation, drowsiness, nausea & other CNS disorder. GI disturbances, dysuria, frequency of micturition, enuresis or retention of urine. Allopurinol 300 mg Tablet Zyloric - Trade Name
M04AA01000T1001XX (B) NEDL APPL

System: Rheumatology Indications: Gout and or uric acid and calcium oxalate renal stones. Dosage: Initial dose : 100-300 mg dly. Maintenance : 300-600 mg dly. Max. 900 mg dly. Contraindications: Hypersensitivity to allopurinol, pregnancy, lactation. Precautions: Renal/hepatic dysfunction, asymptomatic hyperuricaemia. Interactions: Oral anticoagulants, azathioprine, antidiabetics, mercaptopurine. Adverse Reactions: Skin rash, maculopapular, pruritic, Stevens Johnson Syndrome, peripheral neuritis, alopecia ,GI upset, toxic epidermal necrolysis. Colchicine 0.5 mg Tablet
M04AC01000T1001XX (B) NEDL

System: Dermatology Indications: i) Acute gout and prophylaxis of recurrent gout. ii) Leucocytoclastic Vasculitis either cutaneous or systemic involvement, Behcet's syndrome, Urticarial vasculitis, Systemic sclerosis, Sweet's syndrome and severe recalcitrant aphthous stomatitis. Dosage: i)Initial dose, 0.5-1.2 mg, then 0.5-0.6 mg every hr until relief of pain is obtained or vomiting or diarrhoea occurs (MAX 8 mg) The course should not be repeated within 3 days. Prevention of attacks during initial treatment with allopurinol or uricosuric drugs: 0.5 mg 1-3 times dly. ii) 0.5 mg 1-3 times daily depends on disease and severity, up to a maximum of 3 mg/day. Contraindications: Serious GI, renal, hepatic & cardiac disorders and those with blood dyscrasias, hypersensitivity to colchicine, children under 2 years old ,pregnancy. Precautions: Pregnancy, lactation, children and elderly. Interactions: Reversible malabsorption of Vit B12, action inhibited by acidifying agents & enhanced by alkalinizing agents, cyclosporin,erythromycin. Adverse Reactions: Bone marrow depression with aplastic anaemia, peripheral neuritis, myopathy, hair loss, GI disturbances, epigastric pain, diarrhoea, nausea, vomiting, myelosuppression. Clodronate 800 mg Tablet Bonefos - Trade Name System: Endocrine 355
M05BA02011T1011XX (A*)

Indications: Treatment of hypercalcaemia due to malignancy. Dosage: 2 tablets in single or two divided doses. Contraindications: Hypersensitivity to Clodronate, bisphosponate or any component of the formulation, severe GI inflammation, renal impairment, pregnancy, breast feeding. Precautions: History of hypoparathyroidism and hypocalcaemia, food may reduce absorption, renal impairment, pregnancy, lactation. Interactions: Aminoglicoside, aspirin, NSAIDs, loop diuretics, ranitidine. Adverse Reactions: Hypocalcaemia, GIT disturbances, elevated serum creatinine, angioedema, urticaria, proteinuria, bronchospasm. Pamidronate Disodium 30 mg Injection Aredia - Trade Name
M05BA03520P3001XX (A*)

System: Endocrine Indications: Hypercalcaemia of malignancy (tumour -induced hypercalcemia) Dosage: Dose depends on the initial serum calcium levels. Doses range from a single infusion of 30 - 90 mg. Contraindications: Hypersensitivity to biphosphonates. Precautions: Hypocalcaemia especially in patients with Paget's disease, monitor renal function tests as nephropathy may occur, monitor serum calcium, phosphate, magnesium, and potassium, if pre-existing anaemia, leucopenia, or thrombocytopenia are present, follow complete blood count during the first 2 wks of treatment, history of hypoparathyroidism; risk of hypocalcaemia. Interactions: No interaction found. Adverse Reactions: Myelosuppression, hypertension, thrombophlebitis, malaise, nausea, vomiting, fever, anorexia, hypophosphataemia, hypocalcaemia, hypomagnesaemia. Alendronate Sodium 70 mg Tablet Fosamax - Trade Name
M05BA04520T1001XX (A*)

System: Endocrine Indications: Osteoporosis in post menopausal women with a history of vertebral fracture and whom is oestrogen replacement therapy is contraindicated. Dosage: 70 mg once wkly. Swallow the tablet whole with a full glass of water on an empty stomach at least 30 min before breakfast (and any other oral medication); stand or sit upright for at least 30 min and do not lie down until after eating breakfast. Contraindications: Hypersensitivity to alendronate products,hypocalcaemia,esophageal abnormalities,inability to stand or sit upright for 30 minutes. Precautions: Creatinine clearance less than 35 ml/min,vitamin D and mineral deficiencies to be corrected before initiating therapy. 356

Interactions: Concurrent use with aspirin and mesalamine may result in GI distress.Concurrent use with calcium and antacids may result in reduced alendronate absorption. Adverse Reactions: Oesophageal reactions, abdominal pain,musculoskeletal pain,headache,diarrhoea,constipation. Prolase Tablet P a p a s e - Trade Name
M09AB00000T1001XX (B) NEDL APPL

System: Rheumatology Indications: Oedema and inflammation in conjunction with other physical or chemotherapeutic measures. Dosage: 2 tab qid. Contraindications: Blood clotting disease. Precautions: Renal or hepatic dysfunction and pregnancy. Interactions: No interaction known. Adverse Reactions: Skin rash, vertigo and GI upsets. Trypsin & Chymotrypsin 5000units/vial Injection Chymar - Trade Name
M09AB52000P4001XX (A)

System: Rheumatology Indications: As an adjunct in the management of acute inflammation of traumatic or surgical origin, reduction of viscosity of mucous/ sputum in upper respiratory disease. Dosage: 5000 units IM 1-3 times daily. Contraindications: Patient with thromboembolic disease requiring anticoagulant therapy. Precautions: Renal insufficiency. Interactions: Heparin, succinylcholine. Adverse Reactions: Thrombocytopenia, leucocytosis, atrial fibrillation, ventricular tachycardia, hypotension, thromboembolism, fever, nausea, vomiting, nephrotoxicity, anaphylaxis. Mecobalamin 500 mcg Tablet M e t h y l c o b a l - Trade Name
M09AX00000T1001XX (B)

System: Neurology Indications: Peripheral neuropathies Dosage: 1 tab tds. Contraindications: Not known Precautions: Discontinue medication if there is no response after taking orally for several months. Interactions: No Interaction found Adverse Reactions: Anorexia, nausea or diarrhoea, skin rash and hypersensitivity 357

Ether Solvent

N01AA01000L9901XX (C) NEDL APPL

System: Miscellaneous Indications: To remove adhesive plaster from the skin. Dosage: Dose depending on the route and procedure. Contraindications: Hypersensitivity to iohexol/iopromide products,intrathecal corticosteroids, immediate repeat myelography, local/systemic infection. Precautions: Not known. Interactions: Not interaction found. Adverse Reactions: No information available. Halothane Liquid F l u o t h a n e - Trade Name
N01AB01000L5001XX (B) NEDL APPL

System: Anaesthesia Indications: Induction and maintenance for general anaesthesia. Dosage: Induction: 1.5 - 3.0 % v/v. Maintenance : 0.5 - 1.5 % v/v. Contraindications: Unexplained jaundice or pyrexia following exposure to halothane, malignant hyperthermia. Precautions: History of previous exposure and reaction to halothane, avoid repeated exposure within 3 months, ensure adequate room ventilation, pheochromocytoma, myasthenia gravis. Interactions: Adrenaline and other sympathomimetics aminophylline, theophylline. Adverse Reactions: Severe hepatotoxicity, cardiorespiratory depression, post-op nausea and vomiting, shivering during recovery. Isoflurane Liquid F o r a n e - Trade Name
N01AB06000L5001XX (A) APPL

System: Anaesthesia Indications: i) Induction ii) Maintenance. Dosage: i) Induction- Initiate at a concentration of 0.5 % ii) Maintenance- 1 - 2.5 % in oxygen or nitrous oxide mixture. 0.5 - 0.75 % with oxygen and nitrous oxide for Caesarian section. Contraindications: Hypersensitivity to isoflurane, halogenated agents, malignant hyperthermia. Precautions: Uterine curettage, increase intracranial pressure. Interactions: Alfentanil, atracurium, cisatracurium, doxacurium, labetalol, mivacurium, pancuronium, pipecuronium, rapacuronium, tubocurarine,vecuronium, verapamil. Adverse Reactions: Cardio-respiratory depression, hepatotoxicity, malignant hyperthermia, transient rise in CSF pressure, gastrointestinal upset, post358

operation shivering. Sevoflurane Liquid S e v o r a n e - Trade Name

N01AB08000L5001XX (A*)

System: Anaesthesia Indications: To be used only for i) induction and ii) maintenance of anaesthesia. Dosage: (i) Up to 8 % in oxygen or Nitrous oxide-oxygen mixture. (ii) maintenance : 1 - 3 % . Contraindications: Hypersensitivity to sevoflurane/halogenated anaesthetics, malignant hyperthermia. Precautions: Coronary artery disease, pregnancy, lactation. Avoid the use of flow rates of less than 2 litres/minute with soda lime in patients with renal disease. Interactions: Isoniazid nitrous oxide, thiopental, midazolam, phenobarbital, primidone, rocuronium, vecuronium, atracurium, succinylcholine, tubocurarine, verapamil. Adverse Reactions: Excitatory movements, cardiorespiratory depression, vomiting. Alfentanil HCl 0.5 mg/ml Injection R a p i f e n - Trade Name
N01AH02110P3001XX (A*)

System: Analgesics Indications: For use as short acting narcotic analgesic in short procedures and day -care surgical procedures. Dosage: Initial dose: 20 - 40 mcg/kg. Supplemental dose: 15 mcg/kg or infusion 0.5 1.0 mcg/kg/min. Contraindications: Hypersensitivity to alfentanil and other opioids. Precautions: Continuous monitoring of vital signs. Initial dose reduction in the elderly and debilitated. Impaired hepatic or renal function. Concurrent diazepam may produce vasodilation and hypotension; resulting in delayed recovery. Head injury, increased intracranial pressure. Pulmonary disease, decreased respiratory reserve. Interactions: Diltiazem, fluconazole : prolonged alfentanil efficacy. Erythromycin : decreased alfentanil clearance. Itraconazole : increased alfentanil serum concentrations and potential alfentanil toxicity (CNS depression, respiratory depression). Naltrexone : precipitation of opioid withdrawal symptoms. Adverse Reactions: Tacycardia, hypotension, respiratory depression. Dehydrobenzperidol 2.5 mg/ml Injection Dr o p e r i d o l - Trade Name System: Gastro-Intestinal 359
N01AX01000P3001XX (A)

Indications: Chemotherapy Induced Nausea or Vomiting. Dosage: 1-10mg 30mins before chemotherapy followed by continuos 1-3mg/hour or 15mg IM or IV injection every 1-6 hours as necessary. Children 0.1 mg/kg/dose IV slowly 4 - 6 hrly. Contraindications: Hypersensitivity to Droperidol. Precautions: Concomitant administration of other central nervous system depressants; elderly, debilitated, or poor-risk patients require reduced dosages; high doses in patients at risk for cardiac dysrhythmia; impaired hepatic or renal function; hypotension; EEG pattern may slowly return to normal. Interactions: CNS depressants (eg. Antidepressants, barbiturates) have additive or potentiating CNS effects with droperidol. Adverse Reactions: Tachycardia, mild to moderate hypotension, elevated blood pressure, extrapyramidal symptoms, postoperative drowsiness. Ketamine 10 mg/ml Injection Ketamine 50 mg/ml Injection K e t a l a r - Trade Name
N01AX03110P3001XX (B) NEDL APPL N01AX03110P3002XX (B) NEDL APPL

System: Anaesthesia Indications: Sole anaesthetic for short procedures or induction of anaesthesia in certain types of patients (e.g in shock states). Dosage: IV - onset 30 sec : 2 mg/kg body wt. or IM - onset 3 - 4 min : 10 mg/kg body wt. Contraindications: Hypersensitivity to ketamine products, conditions where hypertension is hazardous. Precautions: Those prone to hallucinations, severe coronary heart disease, eclampsia/pre-eclampsia, history of convulsive or psychiatric disorders, raised intracranial or intraocular pressure. Interactions: Atracurium, metrizamide, theophylline, tramadol, tubocurarine, barbiturates, opioid. Adverse Reactions: Cardiovascular stimulation, increased arterial pressure, tachycardia, emergence phenomena ( hallucination and other transient psychotic squelae, vivid dreams ), muscle hyperactivity. Etomidate 20mg/10mg Injection E t o m i d a t e L i p u r o - Trade Name
N01AX07000P3001XX (A*)

System: Anaesthesia Indications: Induction of general anaesthesia for haemodynamically unstable patients. Dosage: Child greater 10yrs and adult: 0.15 - 0.3mg/kg Elderly: 0.15mg/kg - 0.2mg/kg Contraindications: Hypersensitivity to etomidate. Precautions: Not for administra-tion by prolonged infusion due to hazarads of prolonged suppression of endogenous cortisol and aldosterone production, severe asthma, severe cardiovascular disease. Not to use for maintenance of 360

anaesthesia. Interactions: Fentanyl, verapamil, St. John'swort. Adverse Reactions: Hypertension, adrenal suppression, myoclonus, transient skeletal movements, uncontrolled eye movements, hiccups. Propofol 1% Prefilled Syringes D i p r i v a n - Trade Name
N01AX10000P5001XX (A*)

System: Anaesthesia Indications: To be used in controlled infusions(as recommended by manufacturer) for total intravenous anaesthesia. Dosage: As in Total Intravenous Anaesthesia (TIVA : (a) Induction : IV 2 - 2.5 mg/kg body wt. Maintenance: 4 - 12 mg/kg/hour or IV 25 - 50 mg repeat bolus; (b) Target Controlled Infusion ( applicable only with 1% prefilled syringes ), induction : 4 - 8 mcg/ml; maintenance : 3 - 6 mcg/ml. Sedation for intensive care patients : 0.3 - 4 mg/kg/hr up to 3 days. Contraindications: Children < 3 years and obstetric anaesthesia. Precautions: Monitor blood lipid concentration in patients at risk for fat overload, risk of convulsion in epileptic patients, monitor signs of hypotension, airway obstruction and oxygen desaturation. Interactions: Bupivacaine, lidocaine, succinylcholine. Adverse Reactions: Convulsions, anaphylaxis, hypotension, apnoea, injection site pain, cardiac arrest, post-op fever. Propofol 1 % Injection D i p r i v a n - Trade Name
N01AX10000P9901XX (A*) NEDL APPL

System: Anaesthesia Indications: Induction of anaesthesia and maintenance. Dosage: As in Total Intravenous Anaesthesia (TIVA) : Induction : IV 2 - 2.5 mg/kg body wt. Maintenance: 4 -12 mg/kg/hour or IV 25-50 mg repeat bolus. Sedation for intensive care patients : 0.3 - 4 mg/kg/hr up to 3 days. Contraindications: Children < 3 years and obstetric anaesthesia. Precautions: Monitor blood lipid concentration in patients at risk for fat overload, risk of convulsion in epileptic patients, monitor signs of hypotension, airway obstruction and oxygen desaturation. Interactions: Bupivacaine, lidocaine, succinylcholine. Adverse Reactions: Convulsions, anaphylaxis, hypotension, apnoea, injection site pain, cardiac arrest, post- op fever. Bupivacaine 0.25 % Injection M a r c a i n e - Trade Name
N01BB01110P3001XX (B) NEDL

System: Anaesthesia Indications: For infiltration anaesthesia, peripheral sympathetic nerve and epidural 361

(excluding caudal) anaesthesia and obstetric anaesthesia. Dosage: Generally recommended max. single dose is 150mg (60ml). Epidural block during labour, lumbar: max. 12 ml. Not to exceed 2mg/kg in a single dose. Contraindications: Hypovolaemia, complete heart block. intravenous regional anaesthesia (Bier's block). Precautions: Neurological disorder, severe bradycardia, cardiac conduction abnormalities, hypoxaemia, acidosis, hyperkalaemia, predisposition to malignant hypothermia, pregnancy. Interactions: Hyaluronidase, propofol, rapacuronium, verapamil, antiarrhythmias. Adverse Reactions: Confusion, nervousness, dizziness, tinnitus, respiratory depression and convulsion, hypotension and bradycardia, hypersensitivity. Bupivacaine 0.5 % Injection M a r c a i n e - Trade Name
N01BB01110P3002XX (B) NEDL

System: Anaesthesia Indications: For peripheral sympathetic nerve and epidural (excluding caudal) anaesthesia and obstetrics anaesthesia. Dosage: Regional nerve block or epidural block: 15 - 30 ml. Nerve block of finger or toe: 2 - 6 ml. Max: 2 mg/kg body wt. in any 4 hrs period, equivalent to 25 - 30 ml in adults of average weight. Contraindications: Hypovolaemia, complete heart block ,intravenous regional anaesthesia (Bier's block). Precautions: Neurological disorder, severe bradycardia, cardiac conduction abnormalities, hypoxaemia, acidosis, hyperkalaemia, predisposition to malignant hypothermia, pregnancy. Interactions: Hyaluronidase, propofol, rapacuronium, verapamil, antiarrhythmias. Adverse Reactions: Confusion, nervousness, dizziness, tinnitus, respiratory depression and convulsion, hypotension and bradycardia, hypersensitivity. Bupivacaine 0.5 % Heavy Injection M a r c a i n e S p i n a l H e a v y - Trade Name
N01BB01110P3003XX (A) NEDL

System: Anaesthesia Indications: Used for spinal anaesthesia. Dosage: Adult: 2 - 4 ml. Not to exceed 2mg/kg in a single dose. Contraindications: Hypovolaemia, complete heart block,intravenous regional anaesthesia (Bier's block). Precautions: Neurological disorder, severe bradycardia, cardiac conduction abnormalities, hypoxaemia, acidosis, hyperkalaemia, predisposition to malignant hypothermia, pregnancy. Interactions: Hyaluronidase, propofol, rapacuronium, verapamil, antiarrhythmias. 362

Adverse Reactions: Confusion, nervousness, dizziness, tinnitus, respiratory depression and convulsion, hypotension and bradycardia, hypersensitivity. Bupivacaine 0.125% Epidural Injection M a r c a i n e E p i d u r al - Trade Name
N01BB01110P3004XX (A)

System: Anaesthesia Indications: Epidural analgesia for postoperative pain relief. Dosage: Infuse at 6 - 15 ml/hour. Not to exceed 2mg/kg in a single dose. Contraindications: Hypovolaemia, complete heart block, intravenous regional anaes thesia (Bier's block). Precautions: Neurological disorder, severe bradycardia, cardiac conduction abnormalities, hypoxaemia, acidosis, hyperkalaemia, predisposition to malignant hypothermia, pregnancy. Interactions: Hyaluronidase, propofol, rapacuronium, verapamil, antiarrhythmias. Adverse Reactions: Confusion, nervousness, dizziness, tinnitus, respiratory depression and convulsion, hypotension and bradycardia, hypersensitivity. Lignocaine 10 % w/w Spray
N01BB02110A4001XX (B) NEDL

System: Anaesthesia Indications: For surface anaesthesia in dental practice, in otorhinolaryngology and paracentesis. Dosage: Spray to affected part. Contraindications: Hypersensitivity to lidocaine or amide type of local anaesthetics. Precautions: Avoid contact with eyes, wound or traumatised mucosa, cardiovascular disease, advanced liver disease. Interactions: Potentiation of cardiac effects antiarrhythmias. Adverse Reactions: Circumoral paraesthesia, numbness of the tongue, light headedness, tinnitus, severe hypotension, braycardia, arrhytmia, CV collapse. Lignocaine 2 % Cream X y l o c a i n e - Trade Name
N01BB02110G1001XX (B)

System: Anaesthesia Indications: For pain control in mild, non-extensive burns and sunburn, x-ray injuries, sore nipples and herpetic lesions; various anal conditions eg haemorrhoids, proctoscopy and sigmoidoscopy; pruritis and dentistry. Dosage: Apply to affected part as required. Contraindications: Hypersensitivity to lidocaine or amide type of local anaesthetics. Precautions: Traumatised mucosa and sepsis. Interactions: Potentiation of cardiac effects antiarrhythmias. 363

Adverse Reactions: Allergic reactions. Lignocaine 2 % Jelly X y l o c a i n e - Trade Name

N01BB02110G4001XX (B) NEDL APPL

System: Anaesthesia Indications: Use for endotracheal tubes and instruments, painful procedures in the ear, nose and throat, burns, wounds, abrasions, lacerations; catheterisation of the male and female urethra and for symptomatic treatment of cystitis and urethritis. Dosage: Apply to affected area 10 mins before catheterization, etc. Contraindications: Hypersensitivity to lidocaine or amide type of local anaesthetics. Precautions: Traumatised mucosa and sepsis. Interactions: Potentiation of cardiac effects antiarrhythmias. Adverse Reactions: Allergic reactions. Lignocaine 2% Viscous Solution X y l o c a i n e - Trade Name
N01BB02110L5001XX (A) NEDL

System: Anaesthesia Indications: For post- tonsilectomy, sore throat, dumping syndrome, hiccough, reflux vomiting, painful lesions of the mouth, cardiospasm, instrumentation of the respiratory and digestive tract. Dosage: To be taken orally as directed. Contraindications: Hypersensitivity to lidocaine or amide type of local anaesthetics. Precautions: Traumatised mucosa and sepsis, minimum interval between doses: 3 hrs. Interactions: Potentiation of cardiac effects, antiarrhythmias. Adverse Reactions: Intoxication, hypersensitivity, drowsiness, excitement, dizziness, nausea, vomiting, blurred vision. Lignocaine 4 % Solution X y l o c a i n e - Trade Name
N01BB02110L5002XX (B) NEDL

System: Anaesthesia Indications: For anaesthesia of mucous membranes of the oropharyngeal, tracheal and bronchial areas eg. in laryngoscopy and bronchoscopy. Dosage: Bronchoscopy, 2 - 3 ml with suitable spray; biopsy in mouth, 3 - 4 ml with suitable spray or swab (with adrenaline if necessary); max. 7.5 ml. Contraindications: Hypersensitivity to lidocaine or amide type of local anaesthetics. Precautions: Traumatised mucosa and sepsis, minimum interval between doses: 3 hrs. 364

Interactions: Potentiation of cardiac effects, antiarrhythmias. Adverse Reactions: Perioral numbness, tinnitus, hypersensitivity, drowsiness, excitement, dizziness, nausea, vomiting, blurred vision, arrhythmias. Lignocaine (Lidocaine) HCl 2 % Injection X y l o c a i n e - Trade Name
N01BB02110P3001XX (B) NEDL A PPL

System: Anaesthesia Indications: For local anaesthesia including infiltration, nerve and plexus blocks. Dosage: By infiltration: not to exceed 4 mg/kg body weight. Contraindications: Local inflammation and/or sepsis, septicaemia. Precautions: Neurological disorder, severe bradycardia, cardiac conduction abnormalities, pregnancy. Interactions: Potentiation of cardiac effects antiarrhythmias, phenytoin. Adverse Reactions: Nervousness, dizziness, sedation, blurred vision, tinnitus, GI effects, dose-related methaemoglobinaemia and cyanosis. Prilocaine 0.5% Plain Injection (5 mg/ml) C i t a n e s t - Trade Name
N01BB04110P3001XX (A*)

System: Anaesthesia Indications: Only for IV regional anaesthesia or Bier's Block. Dosage: Adjust dose according to the site of operation and response of patient: to a max of 400 mg or 6 mg/kg. Contraindications: Hypovolumia and complete heart block. Precautions: Methaemoglobinaemia may occur in high doses and renal impairment. Interactions: Cisatracurium and hyaluronidase. Adverse Reactions: Confusion, respiratory depression, hypotension and bradycardia, hypersensitivity, methaemoglobinemia, myocardial depression, seizures. Ropivacaine HCl 2 mg/ml Injection N a r o p i n - Trade Name
N01BB09110P3001XX (A*)

System: Anaesthesia Indications: i)Acute pain management. ii)Obstetric labour analgesia. Dosage: i)Lumbar epidural- 12 - 28 mg/hr (6 - 14 mls/hr). ii)Obstetric labour analgesia- 12 - 24 mg/hr (6 -12 mls/hr). Contraindications: Hypovolumia, hypersensitivity to ropivacaine/amide-type anaesthetics, severe hypotension, complete heart block. Precautions: Severe liver disease, acidosis, chronic renal disease. Interactions: Hyaluronidase, propofol, rapacuronium, verapamil, antiarrhythmias, fluvoxamine, imipramine, theophylline. 365

Adverse Reactions: Confusion, respiratory depression and convulsion, hypersensitivity, hypotension, tachycardia, nausea, backache, Horner's syndrome. Ropivacaine HCl 7.5 mg/ml Injection N a r o p i n - Trade Name
N01BB09110P3002XX (A*)

System: Anaesthesia Indications: Surgical epidural anaesthesia including obstetrics. Dosage: i) Surgical lumbar epidural anaesthesia- 113 - 188 mg (15 - 25 ml). Ii) Obstetric lumbar epidural anaesthesia- 113 - 150 mg (15 - 20 ml). Contraindications: Hypovolumia, hypersensitivity to ropivacaine/amide-type anaesthetics, severe hypotension, complete heart block. Precautions: Severe liver disease, acidosis, chronic renal disease. Interactions: Hyaluronidase, propofol, rapacuronium, verapamil, antiarrhythmias, fluvoxamine, imipramine, theophylline. Adverse Reactions: Confusion, respiratory depression and convulsion, hypersensitivity, hypotension, tachycardia, nausea, backache, Horner's syndrome. Bupivacaine 0.25 % with Adrenaline 1:200,000 Injection M a r c a i n e -A d r e n a l i n e
N01BB51974P3001XX (B) NEDL
- Trade Name

System: Anaesthesia Indications: Regional nerve block or epidural block. Dosage: 10 - 40 ml (0.25 %) or 15 - 30 ml (0.5 %). Max : 2 mg/kg body wt. in any 4 hrs period, equivalent to 25 - 30 ml of 0.5 % soln. Contraindications: Obstetrical paracervical block and IV regional anaesthesia local inflammation and/or sepsis, nerve blocks fingers, toes or for circumcisions. Precautions: Neurological disorder, severe bradycardia, cardiac conduction abnormalities, hypoxaemia,acidosis,hyperkalaemia,pregnancy. Interactions: Antiarrhythmias, tricyclic antidepressant. Adverse Reactions: Nervousness, dizziness, sedation, blurred vision, tremor,tinnitus, GI effects Bupivacaine 0.5 % with Adrenaline 1:200,000 Injection M a r c a i n e -A d r e n a l i n e System: Anaesthesia
N01BB51975P3001XX (B) NEDL APPL
- Trade Name

366

Indications: Regional nerve block or epidural block. Dosage: 10 - 40 ml (0.25 %) or maximum : 2 mg/kg body weight in any 4 hrs period, equivalent to 25 - 30 ml of 0.5 % solution. Contraindications: Obstetrical paracervical block and IV regional anaesthesia, local inflammation and/or sepsis , nerve blocks fingers, toes or for circumcisions. Precautions: Neurological disorder, severe bradycardia, cardiac conduction abnormalities, hypoxaemia, acidosis, hyperkalaemia, pregnancy. Interactions: Antiarrhythmias, tricyclic antidepressant. Adverse Reactions: Nervousness, dizziness, sedation, blurred vision, tremor, tinnitus, gastrointestinal effects. Lignocaine and Prilocaine (1:1 ratio) Eutectic Mixture N01BB52974G1001XX (A) E m l a - Trade Name System: Anaesthesia Indications: Used for painless venepunctures, radial artery cannulations before extradural/spinal and other regional blocks in children above 1 year old and adults. Also used in chronic renal failure patients for insertion of A-V fistulas & shunts for haemodialysis. Dosage: Apply a thick layer under occlusive dressing at least 1 hour before the procedure. Contraindications: Methaemoglobinaemia, avoid in infant less than 6 months old. Precautions: Not for use on wounds or mucous membrane, atopic dermatitis. Interactions: Potentiation of cardiac effects, antiarrhythmias; other local anaesthetics. Adverse Reactions: Oedema, itching and exanthema allergic reactions, increase methaemoglobin level. Lignocaine 2% with Chlorhexidine 0.05% Gel X y l o c a i n e w i t h C h l o r h e x i d i n e - Trade Name
N01BB52974G3001XX (B) NEDL

System: Anaesthesia Indications: To provide local anaesthesia and lubrication during catheterization, exploration by sound and other endourethral operations and examinations, cytoscopy and symptomatic treatment of painful cystitis and urethritis. Dosage: 6 -11 ml into urethra Contraindications: Hypersensitivity to lidocaine or amide type of local anaesthetics. Precautions: Severe hypertension, arteriosclerotic heart disease, cerebrovascular insufficiency, heart block. Interactions: Potentiation of cardiac effects, antiarrhythmias. Adverse Reactions: Nervousness, dizziness, sedation, blurred vision, tinnitus, 367

gastrointestinal effects. Lidocaine 25 mg & Prilocaine 25 mg Patch E m l a - Trade Name

N01BB52974M7001XX (A)

System: Anaesthesia Indications: Topical anaesthesia of skin for insertion of arterial / venous catheter, blood sampling or superficial skin procedures. Dosage: Apply 1.5 g / 10 cm2 on skin and occlusive dressing applied for at least half an hour. Contraindications: Methaemoglobinaemia, avoid in infants less than 6 months old. Precautions: Not for use on wounds or mucous membrane, atopic dermatitis. Interactions: Potentiation of cardiac effects antiarrhythmias, other local anaesthetics. Adverse Reactions: Oedema, itching and exanthema allergic reactions, increase methaemoglobin level. Lignocaine 2 % with Adrenaline (1:80,000) Injection N01BB52974P3001XX (B)
NEDL

Xylocaine with Adrenaline

- Trade Name

System: Anaesthesia Indications: For local anaesthesia including infiltration, nerve and plexus blocks. Dosage: By infiltration : 0.5 - 1 ml ; not to exceed 7 mg/kg body weight. Contraindications: Thyrotoxicosis, region with compromised blood supply. Precautions: Severe hypertension, arteriosclerotic heart disease cerebrovascular insufficiency, heart block. Interactions: Potentiation of cardiac effects antiarrhythmias, tricyclic antidepressants. Adverse Reactions: Nervousness, dizziness, sedation, blurred vision, tinnitus, gastrointestinal effects. Lignocaine HCl 5% in Glucose (Heavy) Injection N01BB52974P3002XX (B) NEDL X y l o c a i n e H e a v y - Trade Name System: Anaesthesia Indications: Used for spinal anaesthesia only. Dosage: 2 - 3 mls. Contraindications: Hypovolumia, complete heart block. Precautions: Congestive heart failure, bradycardia, respiratory depression, hepatic insufficiency. Interactions: Potentiation of cardiac effects antiarrhythmias, propranolol, cimetidine. Adverse Reactions: Confusion, respiratory depression, convulsion, 368

hypotension, bradycardia and hypersensitivity. Cocaine 10% Solution

N01BC01110L5001XX (B)

System: Anaesthesia Indications: To produce local anaesthesia or vasoconstriction during endoscopic nasal surgery, turbinectomy septoplasty, polypectomy etc. Dosage: Maximum total dose recommended for application to the nasal mucosa in healthy adult is 1.5 mg/kg. Contraindications: Never given by injection due to its marked sympathomimetic effcts. Precautions: Avoid in porphyria and direct sunlight. Interactions: Interacts with some drugs and can cause arrhythmia. Adverse Reactions: Can cause addiction, arrythmia, palpitation, central nervous system stimulation, syncope. Ethyl Chloride Spray
N01BX01000A4001XX (C) NEDL

System: Anaesthesia Indications: For minor surgical procedures including lancing boils, incision and drainage of small abscesses, pain due to athletic injuries and pain due to injection administration. Dosage: Spray to affected area at a distance of about 30cm until a fine white film is produced. Contraindications: Hypersensitivity to ethyl chloride products and vascular impairment of the extremities. Precautions: Ethyl chloride is highly flammable and mixtures of the gas with 5% to 15% of air are explosive; never use it in the presence of an open flame or near electric cautery equipment. Caution should be taken to avoid frostbite; when used for cryotherapy, protect adjacent skin with petrolatum. Inhalation of ETHYL CHLORIDE can produce narcosis or even fatal coma with respiratory or cardiac arrest. Cover eyes, nose and mouth if spraying near the face. Interactions: Cis atracurium. Adverse Reactions: Transient hypertension, narcosis, vomiting and coma. Morphine HCl 10 mg/5ml Solution
N02AA01110L9901XX (B)

System: Analgesics Indications: For use in management of moderate to severe pain especially that associated with neoplastic disease. Dosage: 5 - 20 mg or more regularly every 4 hrs in terminal pain. Contraindications: Raised intra-cranial pressure, respiratory depression and biliary colic (these conditions are not contra-indicated in patients who are terminally ill). Hypersensitivity to morphine. Precautions: Neonates, children, elderly, obstetric patients, chronic obstructive 369

airway disease, pregnancy, lactation, renal and hepatic impairment, hypothyroidism. Interactions: MAOIs : hypotension and exaggeration of CNS and respiratory depressant effects. Naltrexone : precipitation of opioid withdrawal symptoms. Cimetidine : morphine toxicity (CNS depression, respiratory depression). Adverse Reactions: Constipation, nausea, vomiting, drowsiness, dry mouth, psychomimetic effect (dysphoria, hallucination, nightmare), urinary retention, respiratory depression (rare) Morphine Sulphate 10 mg/ml Injection
N02AA01183P3001XX (B) NEDL APPL

System: Analgesics Indications: For moderate to severe pain especially that associated with neoplastic disease. Dosage: Adult: 10 - 20 mg/kg or more SC or IM every 4 hrs in terminal pain. Child : Up to 1 month : 0.15 mg/kg body wt. ; 1 - 12 mths : 0.2 mg/kg body wt. ; 1 - 5 yrs : 2.5 - 5 mg ; 6 - 12 yrs : 5 - 10 mg. Contraindications: Acute bronchial asthma, respiratory insufficiency, sev ere CNS depression, GI obstruction, biliary colic (these conditions are not contraindications in patients who are terminally ill), hypersensitivity to morphine, MAOIs. Precautions: Children < 1yr, neonates, premature infants, elderly,chronic obstructive airway disease, pregnancy, lactation, renal and hepatic impairment, hypothyroidism. Interactions: MAOIs : hypotension and exaggeration of CNS and respiratory depressant effects. Naltrexone : precipitation of opioid withdrawal symptoms. Cimetidine : morphine toxicity (CNS depression, respiratory depression). Adverse Reactions: Constipation, sedation, dry mouth, psychomimetic effect (dysphoria, hallucination, nightmare), urinary retention, respiratory depression (clinically significant respiratory depression) is a rare occurrence in patients whose opioid doses have been titrated. Morphine Sulphate 10mg Suppository Morphine Sulphate 20mg Suppository Morphine Sulphate 30mg Suppository Stat ex - Trade Name
N02AA01183S2001XX (A*) N02AA01183S2002XX (A*) N02AA01183S2003XX (A*)

System: Analgesics Indications: Relief of severe chronic pain (Cancer patient). Dosage: 15-30mg regularly every 4 hrs. Contraindications: Acute bronchial asthma, respiratory insufficiency, severe CNS depression, GI obstruction, biliary colic (these conditions are not contraindications in patients who are terminally ill), hypersensitivity to morphine, MAOIs. Precautions: Children <1 yr, neonates, premature infants, elderly, chronic obstructive airway disease, pregnancy, lactation, renal and hepatic impairment, hypothyroidism. 370

Interactions: MAOIs: hypotension and exaggeration of CNS and respiratory depressant effects. Naltrexone: precipitation of opioid withdrawal symptoms. Cimetidine: morphine toxicity (CNS depression, respiratory depression). Adverse Reactions: Constipation, sedation, dry mouth, psychomimetic effect (dysphoria, hallucination, nightmare), urinary retention, respiratory depression (clinically respiratory depression) is a rare occurrence in patients whose opioid doses have been titrated. Morphine Sulphate 10 mg Controlled Release Tablet N02AA01183T5001XX (A)
NEDL

MST Continus

- Trade Name

System: Analgesics Indications: Prolonged relief of severe pain associated with neoplastic disease;assists in procuring sleep where sleeplessness is due to pain or shock. Dosage: 10 - 60 mg 12 hourly intervals, depend upon the severity of the pain. Contraindications: MAOIs, raised intra-cranial pressure, respiratory depression and biliary colic(these conditions are not contra-indicated in patients who are terminally ill). Hypersensitivity to morphine. Precautions: Neonates, children, elderly, obstetric patients, chronic obstructive airway disease, pregnancy, lactation, renal and hepatic impairment, hypothyroidism. Interactions: MAOIs : hypotension and exaggeration of CNS and respiratory depressant effects. Naltrexone : precipitation of opioid withdrawal symptoms. Cimetidine : morphine toxicity (CNS depression, respiratory depression). Adverse Reactions: Constipation, nausea, vomiting, drowsiness, dry mouth, psychomimetic effect (dysphoria, hallucination, nightmare), urinary retention, respiratory depression (rare). Morphine Sulphate 30 mg Controlled Release Tablet N02AA01183T5002XX (A)
NEDL

MST Continus

- Trade Name

System: Analgesics Indications: Prolonged relief of severe pain associated with neoplastic disease;assists in procuring sleep where sleeplessness is due to pain or shock. Dosage: 10 - 60 mg bd when necessary. Contraindications: MAOIS, raised intra-cranial pressure, respiratory depression and biliary colic(these conditions are not contra-indicated in patients who are terminally ill). Hypersensitivity to morphine. Precautions: Neonates, children, elderly, obstetric patients, chronic obstructive airway disease, pregnancy, lactation, renal and hepatic impairment, hypothyroidism. Interactions: MAOIs : hypotension and exaggeration of CNS and respiratory depressant effects. Naltrexone : precipitation of opioid withdrawal symptoms. Cimetidine : morphine toxicity (CNS depression, respiratory depression). Adverse Reactions: Constipation, nausea, vomiting, drowsiness, dry mouth, 371

psychomimetic effect (dysphoria, hallucination, nightmare), urinary retention, respiratory depression (rare.) Morphine Sulphate 60 mg Controlled Release Tablet N02AA01183T5003XX (A)
NEDL

MST Continus

- Trade Name

System: Analgesics Indications: Prolonged relief of severe pain associated with neoplastic disease;assists in procuring sleep where sleeplessness is due to pain or shock. Dosage: 10 - 60 mg 12 hourly intervals, depend upon the severity of the pain. Contraindications: MAOIs, raised intra-cranial pressure, respiratory depression and biliary colic(these conditions are not contra-indicated in patients who are terminally ill). Hypersensitivity to morphine. Precautions: Neonates, children, elderly, obstetric patients, chronic obstructive airway disease, pregnancy, lactation, renal and hepatic impairment, hypothyroidism. Interactions: MAOIs : hypotension and exaggeration of CNS and respiratory depressant effects. Naltrexone : precipitation of opioid withdrawal symptoms. Cimetidine : morphine toxicity (CNS depression, respiratory depression). Adverse Reactions: Constipation, nausea, vomiting, drowsiness, dry mouth, psychomimetic effect (dysphoria, hallucination, nightmare), urinary retention, respiratory depression (rare.) Morphine Sulphate Immediate Release 5mg Tablet N02AA01183T6001XX (A*) Statex - Trade Name System: Analgesics Indications: Relief of moderate to severe pain. (Cancer patient) Dosage: 1 tab qid Contraindications: Respiratory depression, obstructive airway desease, known morphine sensitivity or acute hepatic disease. Acute alcoholism, head injuries and conditions in which intracranial pressure is raised. Patients who has or is suspected of having a paralytic ileus. Pre-op administration. Precautions: Neonates, children, elderly, obstetric patients, chronic obstructive airway disease, pregnancy, lactation, renal and hepatic impairment, hypothyroidism. Interactions: Alcohol, general anaesthetics, CNS depressants. Antipsychotic agents, barbiturates, respiratory depressants. Skeletal muscle relaxants, antimuscarinics, naloxone, methadone or opiate agonist analgesics. Neuromuscular blockers, MAOIs. Adverse Reactions: CV reactions, CNS reactions, GI disturbances,urinary retention, hesitance, reduced libido or potency, endocrinal changes, allergic reaction, dependence, respiratory & circulatory depression, respiratory arrest, shock, cardiac arrest, sedation, vomiting, nausea, constipation, sweating. 372

Morphine Sulphate Immediate Release 10mg Tablet N02AA01183T6002XX (A*) Statex - Trade Name System: Analgesics Indications: Relief of moderate to severe pain. (Cancer patient) Dosage: 1 tab qid Contraindications: Respiratory depression, obstructive airway desease, known morphine sensitivity or acute hepatic disease. Acute alcoholism, head injuries and conditions in which intracranial pressure is raised. Patients who has or is suspected of having a paralytic ileus. Pre-op administration. Precautions: Neonates, children, elderly, obstetric patients, chronic obstructive airway disease, pregnancy, lactation, renal and hepatic impairment, hypothyroidism. Interactions: Alcohol, general anaesthetics, CNS depressants. Antipsychotic agents, barbiturates, respiratory depressants. Skeletal muscle relaxants, antimuscarinics, naloxone, methadone or opiate agonist analgesics. Neuromuscular blockers, MAOIs. Adverse Reactions: CV reactions, CNS reactions, GI disturbances,urinary retention, hesitance, reduced libido or potency, endocrinal changes, allergic reaction. Dependence. Resp & circulatory depression. Resp arrest, shock, cardiac arrest. Sedation, vomiting, nausea, constipation, sweating. Dihydrocodeine Tartrate 30 mg Tablet DF 118 - Trade Name
N02AA08123T1001XX (B) NEDL APPL

System: Analgesics Indications: For the control of moderate to severe chronic pain. Dosage: Adult: 30 - 60 mg every 4 - 6 hrs. Paed, over 4 yrs: 0.5 - 1 mg/kg body wt. every 4-6 hrs. Contraindications: Respiratory depression, obstuctive airway disease, acute alcoholism. Precautions: Hypothyroidism, chronic hepatic or adrenocortical disease, renal insufficiency, elderly. Interactions: Naltrexone : precipitation of opioid withdrawal symptoms. Adverse Reactions: GI disturbance, headache, vertigo, respiratory depression. Pethidine HCl 50 mg/ml Injection
N02AB02110P3001XX (B) NEDL APPL

System: Analgesics Indications: For relief of moderate to severe pain (medical and surgical), pre-anaesthetic medication and obstetrical analgesia. Dosage: Adult : 0.5 - 2 mg/kg SC or IM every 2 - 3 hrs if necessary. Child : by IM 0.5 2 mg/kg. Up to 1 yr : 1- 2 mg/kg weight IM, 1 - 5 yrs : 12.5 - 25 mg IM, 6 - 12 373

yrs : 25 - 50 mg IM. Contraindications: Hypersensitivity, concurrent use of MAOIs, intracranial lesions causing increased pressure, atrioventricular flutter , respiratory depression, renal failure and a predisposition to convulsions or seizures. Precautions: Cirrhosis, elderly, neonates, children, obstetric patients, liver/renal dysfunction, convulsive disorders,reduced cardiac output, cardiac infarction, cardiac disease, supraventricular tachycardia, pregnancy, lactation. Interactions: Cimetidine : pethidine toxicity (respiratory depression, Central Nervous System depression, hypotension). Isoniazid : hypotension and central nervous system depression. Moclobemide : cardiovascular instability, hyperpyrexia, coma or possible serotonin syndrome (hypertension, hyperthermia, myoclonus, mental status changes). Naltrexone : precipitation of opioid withdrawal symptoms. Phenothiazines : increase in central nervous system and respiratory depression. Phenytoin : decreased pethidine effectiveness. Procarbazine, selegiline : cardiac instability, hyperpyrexia, coma. Ritonavir : increased risk of Central Nervous System stimulation and excitation. Adverse Reactions: Respiratory depression, dizziness, sweating, disorientation, hallucination,agitation, tremor, multifocal myoclonus, convulsion, Gastrointestinal disturbances, hypotension, hypertension, bradycardia, urine retention. Pethidine HCl 100 mg/2 ml Injection
N02AB02110P3002XX (B) APPL

System: Analgesics Indications: For relief of moderate to severe pain (medical and surgical), pre-anaesthetic medication and obstetrical analgesia. Dosage: Adult : 0.5 - 2 mg/kg SC or IM every 3-4 hrs if necessary. Child : by IM 0.5 - 2 mg/kg. Up to 1 yr : 1- 2 mg/kg weight IM, 1 - 5 yrs : 12.5 - 25 mg IM, 6 - 12 yrs : 25 - 50 mg IM. Contraindications: Hypersensitivity, concurrent use of MAOIs, intracranial lesions causing increased pressure, atrioventricular flutter , respiratory depression, renal failure and a predisposition to convulsions or seizures. Precautions: Cirrhosis, elderly, neonates, children, obstetric patients, liver/renal dysfunction, convulsive disorders,reduced cardiac output, cardiac infarction, cardiac disease, supraventricular tachycardia, pregnancy, lactation. Interactions: Cimetidine : pethidine toxicity (respiratory depression, Central Nervous System depression, hypotension). Isoniazid : hypotension and central nervous system depression. Moclobemide : cardiovascular instability, hyperpyrexia, coma or possible serotonin syndrome (hypertension, hyperthermia, myoclonus, mental status changes). Naltrexone : precipitation of opioid withdrawal symptoms. Phenothiazines : increase in central nervous system and respiratory depression. Phenytoin : decreased pethidine effectiveness. Procarbazine, selegiline : cardiac instability, hyperpyrexia, coma. Ritonavir : increased risk of Central Nervous System stimulation and excitation. Adverse Reactions: Respiratory depression, dizziness, sweating, disorientation, hallucination,agitation, tremor, multifocal myoclonus, convulsion, 374

gastrointestinal disturbances, hypotension, hypertension, bradycardia, urine retention. Fentanyl 25 mcg/h Transdermal Patch Fentanyl 50 mcg/h Transdermal Patch Durogesic - Trade Name
N02AB03136M7001XX (A*) N02AB03136M7002XX (A*)

System: Analgesics Indications: As a second line drug in the management of chronic cancer pain. The use is to be restricted to pain specialists, palliative medicine specialists and oncologists. Dosage: Patients who have not previously received a strong opioid analgesic, initial dose , one 25 mcg/hr patch to be replaced after 72 hrs. Patients who have received a strong opioid analgesic, initial dose based on previous 24 hrs opioid requirement (oral morphine sulphate 90 mg over 24 hrs = one 25 mcg/hr patch). Not recommended in children. Contraindications: Hypersensitivity, acute pain, raised intra-cranial pressure, respiratory depression and biliary colic (these conditions are not contraindicated in patients who are terminally ill). Precautions: Elderly, neonates, children, obstetric patients,hepatic/renal dysfunction, pulmonary disease, increased intracranial pressure, pregnancy, lactation.Avoid exposing patch to direct heat. Interactions: CNS depressant, including opiods, sedatives, hypnotics, general anaesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines and alcohol beverages : additive depressant effects. Adverse Reactions: Local skin reaction, constipation, nausea, vomiting, drowsiness, dry mouth, psychomimetic effect (dysphoria, hallucination, nightmare), urinary retention, respiratory depression (clinically significant respiratory depression is a rare occurance in patients whose opioid doses have been titrated against pain), physical dependence (physical dependence can be prevented by gradual withdrawal of opioids). Fentanyl Citrate 50 mcg/ml Injection Fentanyl - Trade Name
N02AB03136P3001XX (B) NEDL APPL

System: Analgesics Indications: Analgesia during operation, relief of pain in the immediate postoperative period. Adjunct in maintenance of general / regional anaesthesia. Dosage: Dose should be individualized according to age, body weight, physical status, underlying pathological conditions and type of surgery and anaesthesia. With spontaneous respiration, 50 - 200 mcg, then 50 mcg every 20 - 30 mins. as required. With assisted respiration: 0.3 - 3.5 mg, then 100 - 200 mcg as required up to 600 mcg. Child with spontaneous respiration: 3 - 5 mcg/kg, then 1 mcg/kg as required. Child with assisted ventilation : 10 - 15 mcg/kg, then 1 3 mcg/kg as required. Contraindications: Children < 2yrs, asthma, respiratory depression, head 375

injury, patients receiving MAOIs within previous 14 days. Precautions: Pulmonary function impairment, liver/kidney dysfunction, cardiac arrhythmias, myasthenia gravis. Interactions: Amiodarone : cardiac toxicity (low cardiac output). Azole antifungals, macrolide antibiotics : increased or prolonged opioid effects (CNS depression, respiratory depression). Beta-adrenergic blockers, calcium channel blockers : severe hypotension. Carbamazepine : decreased plasma concentrations of fentanyl. Diazepam : significant decreases of mean arterial pressure and systemic vascular resistance. Naltrexone : precipitation of opioid withdrawal symptoms. Phenytoin : decreased plasma concentrations of fentanyl. Protease inhibitors : increased risk of fentanyl toxicity (CNS depression, respiratory depression). Adverse Reactions: Respiratory depression, apnoea, muscle rigidity,bradycardia. Nalbuphine HCl 10 mg/ml Injection N u b a i n - Trade Name
N02AF02110P3001XX (B) NEDL APPL

System: Analgesics Indications: Perioperative analgesia, for relief of moderate to severe pain. Dosage: 10 - 20 mg SC, IM or IV every 3 - 6 hrs. Contraindications: Hypersensitivity to nalbuphine. Precautions: Impaired renal/hepatic function, MI, impaired respiration, biliary tract surgery. Interactions: Phenothiazines, alcohol, CNS depressants Adverse Reactions: Sedation, sweating, GI upsets, vertigo, dry mouth, allergic reactions. Tramadol HCl 50 mg Capsule T r a m a l - Trade Name
N02AX02110C1001XX (A/KK)

System: Analgesics Indications: Post-operative pain, chronic cancer pain, analgesia/pain relief, for patients with impaired renal function. Dosage: 50 - 100 mg every 4 hrs. Max 400 mg dly. Not recommended in children. Contraindications: Narcotic withdrawal treatment, hypersensitivity, acute alcoholism. Precautions: Reduced level of consciousness, resp. disorders, increased intracranial pressure, pregnancy, lactation, history of epilepsy. Interactions: Amitryptiline, chlorpromazine, clozapine, dothiepin, fluoxetine, fluvoxamine, haloperidol, risperidone, sertraline, sulpiride, thioridazine, trifluoperazine : increased risk of seizures. Moclobemide, selegiline : nausea, vomiting, cardiovascular collapse, respiratory depression, seizures. Carbamazepine : decreased tramadol efficacy. Digoxin : increased risk of digoxin toxicity (nausea, vomiting, cardiac arrhythmias). Adverse Reactions: Sweating, dizziness, vomiting, dry mouth, GI 376

disturbances, cerebral convulsions esp on co-medication with neuroleptics, physical dependence. Tramadol HCl 100 mg/ml Drops T r a m a l - Trade Name
N02AX02110D5001XX (A*)

System: Analgesics Indications: Post-operative pain, chronic cancer pain, analgesia/pain relief, for patients with impaired renal function. Dosage: 50 - 100 mg every 4 hrs. Max : 400 mg dly. Not recommended in children. Contraindications: Narcotic withdrawal treatment, hypersensitivity, acute alcoholism. Precautions: Reduced level of consciousness, resp. disorders, increased intracranial pressure, pregnancy, lactation,history of epilepsy. Interactions: Amitryptiline, chlorpromazine, clozapine, dothiepin, fluoxetine, fluvoxamine, haloperidol, risperidone, sertraline, sulpiride, thioridazine, trifluoperazine : increased risk of seizures. Moclobemide, selegiline : nausea, vomiting, cardiovascular collapse, respiratory depression, seizures. Carbamazepine : decreased tramadol efficacy. Digoxin : an increased risk of digoxin toxicity (nausea, vomiting, cardiac arrhythmias). Adverse Reactions: Sweating, dizziness, vomiting, dry mouth, GI disturbances, cerebral convulsions especially on co-medication with neuroleptics, physical dependence (physical dependence can be prevented by gradual withdrawal of opioids). Tramadol HCl 50 mg/ml Injection T r a m a l - Trade Name
N02AX02110P3001XX (A*) NEDL

System: Analgesics Indications: Post-operative pain, chronic cancer pair and analgesia/pain relief for patients with impaired renal function. Dosage: Adult : By IM / IV inj. (over 2-3 mins) or by IV infusion . Initially 100 mg then 50 - 100 mg every 4 - 6 hrs. Max : 600 mg dly. Child not recommended. Contraindications: Narcotic withdrawal treatment, hypersensitivity, acute alcoholism. Precautions: Reduced level of consciousness, respiratory disorders, increased intracranial pressure, pregnancy, lactation, history of epilepsy. Interactions: Amitryptiline, chlorpromazine, clozapine, dothiepin, fluoxetine, fluvoxamine, haloperidol, risperidone, sertraline, sulpiride, thioridazine, trifluoperazine : increased risk of seizures. Moclobemide, selegiline : nausea, vomiting, cardiovascular collapse, respiratory depression, seizures. Carbamazepine : decreased tramadol efficacy. Digoxin : an increased risk of digoxin toxicity (nausea, vomiting, cardiac arrhythmias). Adverse Reactions: Sweating, dizziness, vomiting, dry mouth, GI 377

disturbances, cerebral convulsions especially on co-medication with neuroleptics, physical dependence (physical dependence can be prevented by gradual withdrawal of opioids). Tramadol HCl 100 mg Suppository T r a m a l - Trade Name
N02AX02110S2001XX (A*)

System: Analgesics Indications: Post-operative pain, chronic cancer pain, analgesia/pain relief, for patients with impaired renal function. Dosage: 100 mg rectally. Contraindications: Narcotic withdrawal treatment, hypersensitivity, acute alcoholism. Precautions: Reduced level of consciousness, resp. disorders, increased intracranial pressure, pregnancy, lactation, history of epilepsy. Interactions: Amitryptiline, chlorpromazine, clozapine, dothiepin, fluoxetine, fluvoxamine, haloperidol, risperidone, sertraline, sulpiride, thioridazine, trifluoperazine : increased risk of seizures. Moclobemide, selegiline : nausea, vomiting, cardiovascular collapse, respiratory depression, seizures. Carbamazepine : decreased tramadol efficacy. Digoxin : an increased risk of digoxin toxicity (nausea, vomiting, cardiac arrhythmias). Adverse Reactions: Sweating, dizziness, vomiting, dry mouth, GI disturbances, cerebral convulsions esp on co-medication with neuroleptics, physical dependence (physical dependence can be prevented by gradual withdrawal of opioids). Acetylsalicylic Acid, Soluble 300 mg Tablet N02BA01000T4001XX (C) NEDL APPL A s p i r i n S o l u b l e - Trade Name System: Analgesics Indications: Mild to moderate pain. Dosage: 300 - 900 mg every 4 - 6 hrs as required. Max 4 g dly. Child not recommended. Contraindications: Gastric and duodenal ulcers, haemorrhagic diathesis, hypersensitivity to aspirin or other NSAIDs, children under 12 years old. Precautions: Renal disorders, G6PD deficiency, pregnant women, patients with flu, chicken pox or haemorrhagic fever, history of GI ulceration or asthma Interactions: Acetazolamide, Dipyridamol : salicylate toxicity (vomiting, tachycardia, hyperpnea, mental confusion) or acetazolamide toxicity (fatigue, lethargy, somnolence, confusion, hyperchloremic metabolic acidosis). Alendronate : GI distress. Antacids, calcium. Adverse Reactions: Gastric haemorrhage, hypersensitivity, thrombocytopenia

378

Choline Salicylate 8.7%, Cetylkonium Chloride 0.01% Dental Gel Bonjela

N02BA03900G3001XX (B) NEDL
- Trade Name

System: Ear, Nose and Oropharynx Indications: For relief of the pain and discomfort in mouth ulcers and sores, infant teething and denture irritation. Dosage: Apply to area qid. Contraindications: Infants < 4 months. Precautions: Excessive use can lead to salicylate poisoning. Interactions: No interaction found. Adverse Reactions: No information available. Paracetamol 120 mg/5 ml Syrup Panadol - Trade Name
N02BE01000L9001XX (C) NEDL APPL

System: Analgesics Indications: Mild to moderate pain and pyrexia. Dosage: Child : up to 1 yr : 60 - 120 mg. 1 - 5 yrs: 120 - 240 mg. 6 - 12 yrs: 240 - 480 mg per dose. Repeat every 4-6 hrs when necessary. Max. of 4 doses in 24 hrs. Contraindications: Not known. Precautions: Renal and hepatic failure. Interactions: Anticoagulants, alcohol, liver enzyme inducers, aspirin, chloramphenicol and phenobarbitone. Adverse Reactions: Allergic reactions. Paracetamol 250 mg Suppository
N02BE01000S2001XX (B)

System: Analgesics Indications: Post operative pain relief for paediatric cases. Dosage: 20 mg/kg body wt. Contraindications: Not known. Precautions: Renal and hepatic failure. Interactions: Anticoagulants, alcohol, liver enzyme inducers, aspirin, chloramphenicol and phenobarbitone. Adverse Reactions: Allergic reactions. Paracetamol 500 mg Tablet Panadol - Trade Name System: Analgesics
N02BE01000T1001XX (C) NEDL APPL

379

Indications: Mild to moderate pain and pyrexia. Dosage: Adult: 500 - 1000 mg every 4 - 6 hrs, max. of 4 g dly. Contraindications: Not known. Precautions: Renal and hepatic failure. Interactions: Anticoagulants, alcohol, liver enzymes inducers, aspirin, chloramphenicol and phenobarbitone. Adverse Reactions: Allergic reactions. Sumatriptan 6 mg/0.5 ml S/C Injection I m i g r a n - Trade Name
N02CC01000P5001XX (A)

System: Neurology Indications: Treament of acute migraine attacks and cluster headache Dosage: 6 mg as soon as possible after onset.Dose may be repeated once after not less than 1 hour if migraine recurs; max. 12mg in 24 hours; child not recommended. Contraindications: Ischaemic heart disease, cerebrovascular disease variant angina, uncontrolled hypertension, hypersensitivity to sumatriptan products, combination therapy with ergotamine or MAOI, severe hepatic impairment. Precautions: Patient with risk of atherosclerosis, renal or hepatic insufficiency, coronary artery disease, history of epilepsy. Interactions: Risk of CNS toxicity increased with SSRIs, lithium and MAOIs (including moclobemide). Increases risk of vasospasm with ergotamine. Adverse Reactions: Flushing, palpitations, chest discomfort, dizziness, fatigue, drowsiness, bradycardia or tachycardia. Sumatriptan 50 mg Tablet I m i g r a n - Trade Name
N02CC01000T1001XX (A)

System: Neurology Indications: Treatment of acute migraine attacks. Dosage: 50 mg per attack and not more than 300 mg dly. Contraindications: Ischaemic heart disease, cerebrovascular disease variant angina, uncontrolled hypertension, hypersensitivity to sumatriptan products, combination therapy with ergotamine or MAOI, severe hepatic impairment. Precautions: Patient with risk of atherosclerosis, renal or hepatic insufficiency, coronary artery disease, history of epilepsy. Interactions: Risk of CNS toxicity increased with SSRIs, lithium and MAOIs (including moclobemide). Increases risk of vasospasm with ergotamine. Adverse Reactions: Flushing, palpitations, chest discomfort, dizziness, fatigue, drowsiness, bradycardia or tachycardia.

380

Sumatriptan 100 mg Tablet I m i g r a n - Trade Name

N02CC01000T1002XX (A/KK)

System: Neurology Indications: Treatment of acute migraine attacks. Dosage: 50 mg per attack and not more than 300 mg dly. Contraindications: Ischaemic heart disease, cerebrovascular disease variant angina, uncontrolled hypertension, hypersensitivity to sumatriptan products, combination therapy with ergotamine or MAOI, severe hepatic impairment. Precautions: Patient with risk of atherosclerosis, renal or hepatic insufficiency, coronary artery disease, history of epilepsy. Interactions: Risk of CNS toxicity increased with SSRIs, lithium and MAOIs (including moclobemide). Increases risk of vasospasm with ergotamine. Adverse Reactions: Flushing, palpitations, chest discomfort, dizziness, fatigue, drowsiness, bradycardia or tachycardia. Pizotifen 0.5 mg Tablet S a n d o m i g r a n - Trade Name
N02CX01253T1001XX (B) NEDL

System: Neurology Indications: Prophylactic treatment of vascular headache. Dosage: 0.5 mg in the evening for first 2 days, then 0.5 mg mid-day and evening for next 2 days, then 0.5 mg tds. Contraindications: Hypersensitivity to the drug. Precautions: Narrow-angle glaucoma, obesity, urinary retention. May affect ability to drive and operate machinery. Pregnancy, breast feeding. Interactions: Central effects of sedatives, hypnotics, antihistamines, including certain common cold preparations and alcohol may be enhanced. Antagonised hypotensive effect of adrenergic neuron blockers. Adverse Reactions: Sedation, dizziness, dry mouth and constipation . Appetite-stimulating effect of pizotifen may lead to increase in body weight. Phenobarbitone 15 mg Tablet Phenobarbitone 30 mg Tablet L u m i n a l - Trade Name
N03AA02000T1001XX (B) N03AA02000T1002XX (B) NEDL APPL

System: Neurology Indications: Epilepsy. Dosage: Adult: 60 - 180 mg daily on. Paed: Up to 8 mg/kg dly. Contraindications: Hypersensitivity to phenobarbital products, porphyria. Precautions: Depression, renal impairment, pulmonary insufficiency, elderly, avoid abrupt discontinuation, pregnancy, breast feeding, porphyria, hyperactivity in children. 381

Interactions: Alcohol, antibacterial, warfarin, antidepressants, other antiepileptics, antipsychotics, antiviral, cyclosporin. Adverse Reactions: Hypersensitivity, rash, hypotension, drowsiness, ataxia, respiratory depression, dyskinesias. Phenobarbitone Sodium 200 mg/ml Injection Gardenal - Trade Name
N03AA02520P3001XX (B) NEDL

System: Neurology Indications: Status Epilepticus. Dosage: Adult : 10 mg/kg IV at a rate of not faster than 100 mg/min. Initial maximum dose does not exceeding 1 gm. Daily maintenance of 1-4 mg/kg/day. Paeds : 10-20 mg/kg/dose loading dose, followed by repeated doses at 10 mg/kg/dose (strictly in ICU setting). Maintenance 5-8 mg/kg/day. Contraindications: Hypersensitivity to phenobarbital products, porphyria. Precautions: Depression, renal impairment, pulmonary insufficiency, elderly, avoid abrupt discontinuation, pregnancy, breast feeding, porphyria, hyperactivity in children. Interactions: Alcohol, antibacterial, warfarin, antidepressants, other antiepileptics, antipsychotics, antiviral, cyclosporin. Adverse Reactions: Hypersensitivity, rash, hypotension, drowsiness, ataxia, respiratory depression, dyskinesias. Primidone 250 mg Tablet M y s o l i n e - Trade Name
N03AA03000T1001XX (B)NEDL

System: Neurology Indications: Epilepsy. Dosage: Initially 1 tab dly in the evening, increasing by 1 tab every 4 - 7 days to 3 - 4 tab dly. Paed: 6 - 8 yrs: Up to 1/2 adult dose. Contraindications: Hypersensitivity to primidone products and porphyria. Precautions: Avoid acute withdrawal (may precipitate status epilepticus) and pregnancy. Interactions: Enhances effects of other CNS depressants. Reduces efficacy of other anticonvulsants, oral anticoagulants, oral contraceptives and phenytoin. Adverse Reactions: Dizziness, somnolence, nausea, vomiting, musculoskeletal problems, ataxia, visual disturbances and rashes. Phenytoin Sodium 30 mg Capsule Phenytoin Sodium 100 mg Capsule D i l a n t i n - Trade Name
N03AB02520C1001XX (B) NEDL APPL N03AB02520C1002XX (B) NEDL APPL

System: Neurology Indications: Epilepsy. Dosage: Adult & Paed > 6 yrs: 150 - 300 mg dly as single dose or two divided doses 382

before meals with maximum total dose of 600 mg dly. Paed: 5 - 8 mg/kg dly. Contraindications: Hypersensitivity to phenytoin or hydantoin products. Precautions: Avoid abrupt withdrawal, liver insufficiency, porphyria, discontinue if skin rash occurs, diabetes, elderly, pregnancy, breast feeding. Interactions: Chloramphenicol, coumadin anticoagulants, diazepam, oestrogen, cimetidine, fluconazole, etc may increase serum levels. Methotrexate, folic acid, carbamazepine, theophylline, etc may decrease serum levels. Adverse Reactions: Nystagmus, ataxia, lethargy, blood dyscrasias, cardiovascular toxicity, nausea, vomiting, headache, tremor, insomnia, gingival hypertrophy, acne, lupus erythematosus, Stevens-Johnson syndrome, leucopenia, megaloblastic anaemia, hirsutism, hepatitis. Phenytoin Sodium 125 mg/5ml Suspension D i l a n t i n - Trade Name
N03AB02520L8001XX (B) NEDL

System: Neurology Indications: Epilepsy. Dosage: Paed: < 6 yrs: 31.25 - 62.5 mg bd or qid. Contraindications: Hypersensitivity to phenytoin or hydantoin products. Precautions: Avoid abrupt withdrawal, liver insufficiency, porphyria, discontinue if skin rash occurs, diabetes, elderly, pregnancy, breast feeding. Interactions: Chloramphenicol, coumadin anticoagulants, diazepam, oes trogen, cimetidine, fluconazole, etc may increase serum levels. Methotrexate, folic acid, carbamazepine, theophylline, etc may decrease serum levels. Adverse Reactions: Nystagmus, ataxia, lethargy, blood dyscrasias, cardiovascular toxicity, nausea, vomiting, headache, tremor, insomnia, gingival hypertrophy, acne, lupus erythematosus, Stevens-Johnson syndrome, leucopenia, megaloblastic anaemia, hirsutism, hepatitis. Phenytoin Sodium 250 mg/5ml Injection D i l a n t i n - Trade Name
N03AB02520P3001XX (B) NEDL APPL

System: Neurology Indications: Status epilepticus. Dosage: 15 mg/kg slow IV not exceeding 50 mg per min. Neurosurgery: 100 - 200 mg IM at approximately 4 hr intervals. Contraindications: Hypersensitivity to phenytoin or hydantoin products. Precautions: Avoid abrupt withdrawal, liver insufficiency, porphyria, discontinue if skin rash occurs, diabetes, elderly, pregnancy, breast feeding. Interactions: Chloramphenicol, coumadin anticoagulants, diazepam, oestrogen, cimetidine, fluconazole, etc may increase serum levels. Methotrexate, folic acid, carbamazepine, theophylline, etc may decrease serum levels. Adverse Reactions: Nystagmus, ataxia, lethargy, blood dyscrasias, 383

cardiovascular toxicity, nausea, vomiting, headache, tremor, insomnia, gingival hypertrophy, acne, lupus erythematosus, Stevens-Johnson syndrome, leucopenia, megaloblastic anaemia, hirsutism, hepatitis. Ethosuximide 250 mg/5 ml Syrup Z a r o n t i n - Trade Name
N03AD01000L9001XX (B)

System: Neurology Indications: Absence seizures. Dosage: Child up to 6 yrs: 250 mg dly increasing gradually to a max of 1 g dly. Usual dose: 20 mg/kg dly. Contraindications: Hypersensitivity to succinimides. Precautions: Patients with mixed seizure disorders; ethosuximide therapy when used alone may increase the incidence of grand mal seizures, avoid abrupt withdrawal, liver and renal disease, patients with potentially fatal blood dyscrasias. Interactions: Carbamazepine, phenobarbital, phenytoin, antidepressants, isoniazid, antibiotics and antipsychotics. Adverse Reactions: Blood dyscrasias, ataxia, headache, nausea, vomiting, GI disturbances, weight loss, drowsiness, dyskinesia, headache depression,rashes. Clonazepam 0.5 mg Tablet R i v o t r i l - Trade Name
N03AE01000T1001XX (B)NEDL

System: Neurology Indications: i) Epilepsy ii) Non-epileptic myoclonus. Dosage: Adult : 4 - 8 mg dly in 3 - 4 divided doses. Paed : Up to 1 yr : 0.5 - 1 mg ; 1 - 5 yrs: 1 - 3 mg ; 5 - 12 yrs : 3 - 6 mg. To be given dly in 3 - 4 divided doses. Contraindications: Hypersensitivity to clonazepam products, severe liver disease, narrow angle glaucoma, respiratory depression, acute pulmonary insufficiency. Precautions: Avoid abrupt withdrawal, renal insufficiency, respiratory disease, acute intermittent porphyria, uncontrolled open angle glaucoma, elderly, pregnancy, breast feeding, may exacerbate tonic seizures. Interactions: Alcohol may reduce the efficacy of treatment or produce unexpected side effects. Increases phenytoin or primidone concentrations. Combination with valproate may cause petit mal status epilepticus. Amiodarone, carbamazepine, theophylline. Adverse Reactions: Drowsiness, ataxia, hypotonia, aggravation of seizure, fatigue, dizziness. Clonazepam 2 mg Tablet R i v o t r i l - Trade Name System: Neurology Indications: 384
N03AE01000T1002XX (B) NEDL APPL

i) Epilepsy ii) Non-epileptic myoclonus. Dosage: Adult: 4 - 8 mg dly in 3 - 4 divided doses. Paed up to 1 yr : 0.5 - 1 mg ; 1 - 5 yrs: 1 - 3 mg ; 5 - 12 yrs : 3 - 6 mg. To be given dly in 3 - 4 divided doses. Contraindications: Hypersensitivity to clonazepam products, severe liver disease, narrow angle glaucoma, respiratory depression, acute pulmonary insufficiency. Precautions: Avoid abrupt withdrawal, renal insufficiency, respiratory disease, acute intermittent porphyria, uncontrolled open angle glaucoma, elderly, pregnancy, breast feeding, may exacerbate tonic seizures. Interactions: Alcohol may reduce the efficacy of treatment or produce unexpected side effects. Increases phenytoin or primidone concentrations. Combination with valproate may cause petit mal status epilepticus. Amiodarone, carbamazepine, theophylline. Adverse Reactions: Drowsiness, ataxia, hypotonia, aggravation of seizure, fatigue, dizziness. Carbamazepine 100 mg/5 ml(2 % w/v) Syrup T e g r e t o l - Trade Name
N03AF01000L9001XX (A) NEDL

System: Neurology Indications: Epilepsy. Dosage: Paed: Up to 1 yr : 100 - 200 mg dly; 1 - 5 yrs: 200 - 400 mg dly; 5 - 10 yrs: 400 - 600 mg dly; 10 - 15 yrs: 0.6 - 1 g dly. Contraindications: Hypersensitivity to carbamazepine products, bone marrow suppression, porphyria. Precautions: Breast feeding, pregnancy, liver or kidney dysfunction, increased intraocular pressure, history of cardiac damage, elderly patients, glaucoma, may exacerbate certain types of idiopathic epilepsy. Interactions: Plasma level is increased by erythromycin, diltiazem, isoniazid, verapamil, fluoxetine, cimetidine and decreased by other antiepileptics and theophylline. May reduce alcohol tolerance and antagonise the effects of nondepolarising muscle relaxants. Adverse Reactions: Rash, Stevens-Johnson Syndrome, nausea, drowsiness, dizziness, ataxia, blood dyscrasias, confusion, agitation, visual disturbance, constipation or diarrhoea, anorexia, leucopenia, blood disorders, Syndrome of Inappropriate ADH(SIADH), cardiac conduction abnormalities, gynaecomastia. Carbamazepine 200 mg Tablet T e g r e t o l - Trade Name
N03AF01000T1001XX (B) NEDL APPL

System: Neurology Indications: i) Epilepsy ii) Trigeminal neuralgia Dosage: i) Adult: 100 - 200 mg 1 - 3 times dly increased gradually to usual dose of 0.8 1.2 g dly in divided doses. Paed: Up to 1 yr: 100 - 200 mg dly; 1 - 5 yrs: 200 400 mg dly; 5 - 10 yrs: 400 - 600 mg dly; 10 - 15 yrs: 0.6 - 1 g dly. ii) Initially 385

100 mg 1-2 times daily (but some patients may require higher initial dose), increased gradually according to response; usual dose 200 mg 3-4 times daily, up to 1.6 g daily in some patients. Contraindications: Hypersensitivity to carbamazepine products, bone marrow suppression, porphyria. Precautions: Breast feeding, pregnancy, liver or kidney dysfunction, increased intraocular pressure, history of cardiac damage, elderly patients, glaucoma, may exacerbate certain types of idiopathic epilepsy. Interactions: Plasma level is increased by erythromycin, diltiazem, isoniazid, verapamil, fluoxetine, cimetidine and decreased by other antiepileptics and theophylline. May reduce alcohol tolerance and antagonise the effects of nondepolarising muscle relaxants. Adverse Reactions: Rash, Stevens-Johnson Syndrome, nausea, drowsiness, dizziness, ataxia, blood dyscrasias, confusion, agitation, visual disturbance, constipation or diarrhoea, anorexia, leucopenia, blood disorders, Syndrome of Inappropriate ADH(SIADH), cardiac conduction abnormalities, gynaecomastia. Carbamazepine 200 mg CR Tablet Carbamazepine 400 mg CR Tablet T e g r e t o l C R - Trade Name
N03AF01000T5001XX (A) NEDL N03AF01000T5002XX (A) NEDL

System: Neurology Indications: Epilepsy. Dosage: Initially 100 - 200 mg od/bd increased slowly until optimum response achieved. Usually 400 mg bd - tds. Contraindications: Hypersensitivity to carbamazepine products, bone marrow suppression, porphyria. Precautions: Breast feeding, pregnancy, liver or kidney dysfunction, increased intraocular pressure, history of cardiac damage, elderly patients, glaucoma, may exacerbate certain types of idiopathic epilepsy. Interactions: Plasma level is increased by erythromycin, diltiazem, isoniazid, verapamil, fluoxetine, cimetidine and decreased by other antiepileptics and theophylline. May reduce alcohol tolerance and antagonise the effects of nondepolarising muscle relaxants. Adverse Reactions: Rash, Stevens-Johnson Syndrome, nausea, drowsiness, dizziness, ataxia, blood dyscrasias, confusion, agitation, visual disturbance, constipation or diarrhoea, anorexia, leucopenia, blood disorders, Syndrome of Inappropriate ADH(SIADH), cardiac conduction abnormalities, gynaecomastia. Sodium Valproate 200 mg/5 ml Syrup E p i l i m - Trade Name
N03AG01520L9001XX (B) NEDL

System: Neurology Indications: Epilepsy. Dosage: Child < 20 kg: 20 mg/kg dly. Severe cases : 50 mg/kg dly. Contraindications: Hepatic disease or significant hepatic dysfunction, 386

hypersensitivity to valproate, porphyria. Precautions: Children under 2 years old, breast feeding, monitor liver function, avoid sudden withdrawal, certain metabolic disorders. Interactions: Increases phenobarbital, primidone and phenytoin plasma concentrations. Potentiates toxic effect of carbamazepine. Risk of rash may be increased by coadministration with lamotrigine. May potentiate the effect of neuroleptics, MAOIs, antidepressants and benzodiazepines. Adverse Reactions: Nausea, vomiting, headache, dizziness, ataxia, tremor, weight gain, transient hair loss, oedema, thrombocytopenia, leucopenia. Sodium Valproate 400 mg Injection E p i l i m - Trade Name
N03AG01520P4001XX (B) NEDL

System: Neurology Indications: Status epilepticus. Dosage: Monotherapy: Adult: 400 - 800 mg slow IV depending on body weight (up to 10 mg/kg) over 3 - 5 mins then continuous or repeated infusion up to max of 2500 mg/day. Paed: 20 - 30 mg/kg/day. Contraindications: Hepatic disease or significant hepatic dysfunction, hypersensitivity to valproate, porphyria. Precautions: Children under 2 years old, breast feeding, monitor liver function, avoid sudden withdrawal, certain metabolic disorders. Interactions: Increases phenobarbital, primidone and phenytoin plasma concentrations. Potentiates toxic effect of carbamazepine. Risk of rash may be increased by coadministration with lamotrigine. May potentiate the effect of neuroleptics, MAOIs, antidepressants and benzodiazepines. Adverse Reactions: Nausea, vomiting, headache, dizziness, ataxia, tremor, weight gain, transient hair loss, oedema, thrombocytopenia, leucopenia. Sodium Valproate 200 mg Tablet E p i l i m - Trade Name
N03AG01520T1001XX (B) NEDL APPL

System: Neurology Indications: Epilepsy. Dosage: Initially 600 mg dly in 2 - 3 divided doses, increasing by 200 mg/day at 3-day interval to a maximum of 2.5 g dly. Usual maintenance: 1 - 2 g dly. Child up to 20 kg: Initially 20 mg/kg dly. Contraindications: Hepatic disease or significant hepatic dysfunction, hypersensitivity to valproate, porphyria. Precautions: Children under 2 years old, breast feeding, monitor liver function, avoid suddent withdrawal, certain metabolic disorders. Interactions: Increases phenobarbital, primidone and phenytoin plasma concentrations. Potentiates toxic effect of carbamazepine. Risk of rash may be increased by coadministration with lamotrigine. May potentiate the effect of neuroleptics, MAOIs, antidepressants and benzodiazepines. Adverse Reactions: Nausea, vomiting, headache, dizziness, ataxia, tremor, 387

weight gain, transient hair loss, oedema, thrombocytopenia, leucopenia. Lamotrigine 50 mg Tablet Lamictal - Trade Name
N03AX09000T1001XX (A)NEDL

System: Neurology Indications: i) For the treatment of partial seizures & generalised tonic-clonic seizures not satisfactorily controlled with other antiepileptic drugs. Dosage: i) Up to 200 mg dly in single or divided dosage. Contraindications: Hypersensitivity to lamotrigine products, hepatic impairment. Precautions: Concomitant use of other antiepileptics, discontinue therapy at the first sign of rash, avoid abrupt withdrawal, renal, hepatic or cardiac impairment, pregnancy, breast feeding. Interactions: Metabolism is increased by carbamazepine , phenobarbital, phenytoin and primidone; decreased by valproate. CNS events occur with carbamazepine. Adverse Reactions: Dizziness, fatigue, headache, hypersensitivity reactions, Steven's Johnson Syndrome, rashes, malaise, leucopenia, thrombocytopenia, photosensitivity, blurred vision, conjunctivitis, drowsiness, insomnia, ataxia, nausea. Lamotrigine 100 mg Tablet Lamictal - Trade Name
N03AX09000T1002XX (A)NEDL

System: Neurology Indications: i) For the treatment of partial seizures & generalised tonic-clonic seizures not satisfactorily controlled with other antiepileptic drugs. Dosage: i) Up to 200 mg dly in single or divided dosage. Contraindications: Hypersensitivity to lamotrigine products, hepatic impairment. Precautions: Concomitant use of other antiepileptics, discontinue therapy at the first sign of rash,avoid abrupt withdrawal, renal, hepatic or cardiac impairment, pregnancy, breast feeding. Interactions: Metabolism is increased by carbamazepine , phenobarbital, phenytoin and primidone; decreased by valproate. CNS events occur with carbamazepine. Adverse Reactions: Dizziness, fatigue, headache, hypersensitivity reactions, Steven's Johnson Syndrome, rashes, malaise, leucopenia, thrombocytopenia, photosensitivity, blurred vision, conjunctivitis, drowsiness, insomnia, ataxia, nausea. Lamotrigine 25 mg Dispersible/Chewable Tablet Lamictal Di s p e r s i b l e - Trade Name System: Neurology Indications: 388
N03AX09000T2001XX (A)

Add-on therapy in intractable partial seizures. Dosage: 25 mg dly - 50 mg bd. Contraindications: Hypersensitivity to lamotrigine products, hepatic impairment. Precautions: Concomitant use of other antiepileptics, discontinue therapy at the first sign of rash, avoid abrupt withdrawal, renal, hepatic or cardiac impairment, pregnancy, breast feeding. Interactions: Metabolism is increased by carbamazepine, phenobarbital, phenytoin and primidone; decreas ed by valproate. CNS events occur with carbamazepine. Adverse Reactions: Dizziness, fatigue, headache, hypersensitivity reactions, Steven's Johnson Syndrome, rashes, malaise, leucopenia, thrombocytopenia, photosensitivity, blurred vision, conjunctivitis, drowsiness, insomnia, ataxia, nausea. Lamotrigine 5 mg Dispersible/Chewable Tablet L a m i c t a l D i s p e r s i b l e - Trade Name
N03AX09000T2002XX (A)

System: Neurology Indications: i) Management of seizures in children aged 2 - 12 yrs. Dosage: i) a)Add-on therapy in patients not taking Valproate: Wk 1 & 2: 2 mg/kg/day bd; Wk 3 & 4: 5 mg/kg/day bd. Maintenance: 5 - 15 mg/kg/day bd. b) Add-on therapy in patients taking Valproate or other anti-epileptic drugs Wk 1&2 : 0.2 mg/kg/day as a single dose (children < 25 kg may take 5 mg on alternate days). Wk 3&4 : 0.5 mg/kg/day as a single dose. Maintenance dose: 1 -5 mg/kg/day once daily or bd. Contraindications: Hypersensitivity to lamotrigine products, hepatic impairment. Precautions: Concomitant use of other antiepileptics, discontinue therapy at the first sign of rash, avoid abrupt withdrawal, renal, hepatic or cardiac impairment, pregnancy, breast feeding. Interactions: Metabolism is increased by carbamazepine, phenobarbital, phenytoin and primidone decreased by valproate. CNS events occur with carbamazepine. Adverse Reactions: Dizziness, fatigue, headache, hypersensitivity reactions, Steven's Johnson Syndrome, rashes, malaise, leucopenia, thrombocytopenia, photosensitivity, blurred vision, conjunctivitis, drowsiness, insomnia, ataxia, nausea. Topiramate Capsule Sprinkle 15mg Topamax - Trade Name System: Neurology
N03AX11000C1001XX (A*)

389

Indications: Add-on therapy for intractable partial epilepsy. Dosage: Adult: 200 - 400 mg/day in 2 divided doses. Max 1600 mg/day. Paed: initial 25 mg(1-3 mg/kg/day), then titrated by 1-3 mg/kg/1-2 weeks in 2 divided doses. Maintenance 5-9 mg/kg/day in 2 divided doses. Contraindications: Hypersensitivity to topiramate, breast feeding. Precautions: Avoid abrupt withdrawal, pregnancy, hepatic or renal impairment, behavioral disorders or cognitive deficit, paraesthesia, ensure adequate hydration. Interactions: Plasma concentration decreased by phenytoin and carbamazepine. Metabolism of oral contraceptive (oestrogens and progestogens) accelerated (reduced contraceptive effect). Adverse Reactions: Cognitive dysfuction, sedation, diarrhoea, weight loss, dizziness, abdominal pain, nausea, anorexia, confusion, impaired speech, ataxia, drowsiness, fatigue, asthenia, visual disturbances, nystagmus, taste disorder, leucopenia, renal calculi. Topiramate Capsule Sprinkle 25 mg Topamax - Trade Name
N03AX11000C1002XX (A*)

System: Neurology Indications: Add-on therapy for intractable partial epilepsy. Dosage: Adult: 200 - 400 mg/day in 2 divided doses. Max 1600 mg/day. Paed: initial 25 mg(1-3 mg/kg/day), then titrated by 1-3 mg/kg/1-2 weeks in 2 divided doses. Maintenance 5-9 mg/kg/day in 2 divided doses. Contraindications: Hypersensitivity to topiramate, breast feeding. Precautions: Avoid abrupt withdrawal, pregnancy, hepatic or renal impairment, behavioral disorders or cognitive deficit, paraesthesia, ensure adequate hydration. Interactions: Plasma concentration decreased by phenytoin and carbamazepine. Metabolism of oral contraceptive (oestrogens and progestogens) accelerated (reduced contraceptive effect). Adverse Reactions: Cognitive dysfuction, sedation, diarrhoea, weight loss, dizziness, abdominal pain, nausea, anorexia, confusion, impaired speech, atax ia, drowsiness, fatigue, asthenia, visual disturbances, nystagmus, taste disorder, leucopenia, renal calculi. Topiramate 25 mg Tablet Topamax - Trade Name System: Neurology
N03AX11000T1001XX (A*)

390

Indications: Add-on therapy for intractable partial epilepsy. Dosage: Adult: 200 - 400 mg/day in 2 divided doses. Max 1600 mg/day. Paed: initial 25 mg (1-3 mg/kg/day), then titrated by 1-3 mg/kg/1-2 weeks in 2 divided doses. Maintenance 5-9 mg/kg/day in 2 divided doses. Contraindications: Hypersensitivity to topiramate, breast feeding. Precautions: Avoid abrupt withdrawal, pregnancy, hepatic or renal impairment, behavioral disorders or cognitive deficit, paraesthesia, ensure adequate hydration. Interactions: Plasma concentration decreased by phenytoin and carbamazepine. Metabolism of oral contraceptive (oestrogens and progestogens) accelerated (reduced contraceptive effect). Adverse Reactions: Cognitive dysfuction, sedation, diarrhoea, weight loss, dizziness, abdominal pain, nausea, anorexia, confusion, impaired speech, ataxia, drowsiness, fatigue, asthenia, visual disturbances, nystagmus, taste disorder, leucopenia, renal calculi. Topiramate 50 mg Tablet Topamax - Trade Name
N03AX11000T1002XX (A*)

System: Neurology Indications: Add-on therapy for intractable partial epilepsy. Dosage: Adult: 200 - 400 mg/day in 2 divided doses. Max 1600 mg/day Paed: initial 25 mg(1-3 mg/kg/day), then titrated by 1-3 mg/kg/1-2 weeks in 2 divided doses. Maintenance 5-9 mg/kg/day in 2 divided dos es. Contraindications: Hypersensitivity to topiramate, breast feeding. Precautions: Avoid abrupt withdrawal, pregnancy, hepatic or renal impairment, behavioral disorders or cognitive deficit, paraesthesia, ensure adequate hydration. Interactions: Plasma concentration decreased by phenytoin and carbamazepine. Metabolism of oral contraceptive (oestrogens and progestogens) accelerated (reduced contraceptive effect). Adverse Reactions: Cognitive dysfuction, sedation, diarrhoea, weight loss, dizziness, abdominal pain, nausea, anorexia, confusion, impaired speech, ataxia, drowsiness, fatigue, asthenia, visual disturbances, nystagmus, taste disorder, leucopenia, renal calculi. Topiramate 100 mg Tablet Topamax - Trade Name System: Neurology
N03AX11000T1003XX (A*)

391

Indications: Add-on therapy for intractable partial epilepsy. Dosage: Adult: 200 - 400 mg/day in 2 divided doses. Max 1600 mg/day Paed: initial 25 mg(1-3 mg/kg/day), then titrated by 1-3 mg/kg/1-2 weeks in 2 divided doses. Maintenance 5-9 mg/kg/day in 2 divided doses. Contraindications: Hypersensitivity to topiramate, breast feeding. Precautions: Avoid abrupt withdrawal, pregnancy, hepatic or renal impairment, behavioral disorders or cognitive deficit, paraesthesia, ensure adequate hydration. Interactions: Plasma concentration decreased by phenytoin and carbamazepine. Metabolism of oral contraceptive (oestrogens and progestogens) accelerated (reduced contraceptive effect). Adverse Reactions: Cognitive dysfuction, sedation, diarrhoea, weight loss, dizziness, abdominal pain, nausea, anorexia, confusion, impaired speech, ataxia, drowsiness, fatigue, asthenia, visual disturbances, nystagmus, taste disorder, leucopenia, renal calculi. Gabapentin 300 mg Capsule Neuront i n - Trade Name
N03AX12000C1001XX (A*)

System: Neurology Indications: i) Add-on therapy for intractable partial epilepsy, refractory to standard antiepileptic drugs. ii) Treatment of various types of neuropathic pain, both peripheral (which includes diabetic neuropathy, post-herpetic neuralgia, trigeminal neuralgia). Dosage: i) Adult : 900 - 1800 mg/day in 3 divided doses. Paed: 10-40 mg/kg/day in 3 divided doses. ii) Adult : 900 mg/day in 3 equally divided doses, max: 3600 mg/day. Initiate therapy with 300 mg once on Day 1, 300mg bd on Day 2, 300mg tds on Day 3. Thereafter, the dose may be increased in 3 equally divided doses up to max 3600 mg/day. Contraindications: Hypersensitivity to gabapentin. Precautions: Renal insufficiency, avoid abrupt withdrawal, patients less than 12 years old, elderly, diabetes, pregnancy, breast feeding. Interactions: Antacid like Maalox reduced the bioavailability of gabapentin. Adverse Reactions: Somnolence, dizziness, ataxia, weight gain, fatigue, nystagmus, tremor, diplopia, amnesia, dyspepsia, asthenia, leucopenia, headache, myalgia. Gabapentin 400 mg Capsule N e u r o n t i n - Trade Name
N03AX12000C1002XX (A*)

System: Neurology Indications: i) Add-on therapy for intractable partial epilepsy, refractory to standard antiepileptic drugs. ii) Treatment of various types of neuropathic pain, both peripheral (which includes diabetic neuropathy, post-herpetic neuralgia, 392

trigeminal neuralgia). Dosage: i) Adult : 900 - 1800 mg/day in 3 divided doses. Paed: 10-40 mg/kg/day in 3 divided doses. ii) Adult : 900 mg/day in 3 equally divided doses, max: 3600 mg/day. Initiate therapy 300 mg once on Day 1, 300 mg bd on Day 2, 300 mg tds on Day 3. Thereafter, the dose may be increased in 3 equally divided doses up to max 3600 mg/day. Contraindications: Hypersensitivity to gabapentin. Precautions: Renal insufficiency, avoid abrupt withdrawal, patients less than 12 years old, elderly, diabetes, pregnancy, breast feeding. Interactions: Antacid like Maalox reduced the bioavailability of gabapentin. Adverse Reactions: Somnolence, dizziness, ataxia, weight gain, fatigue, nystagmus, tremor, diplopia, amnesia, dyspepsia, asthenia, leucopenia, headache, myalgia. Levetiracetam 250 mg Tablet K e p p r a - Trade Name
N03AX14000T1001XX (A*)

System: Neurology Indications: Adjunctive therapy in treatment of refractory partial epilepsy. Dosage: Initially: 250 mg bd. gradually increasing to maximum 1.5g bd. Contraindications: Hypersensitivity to levetiracetam products. Precautions: Avoid abrupt discontinuation, renal impairment, severe hepatic impairment, pregnancy lactation, elderly. Interactions: Evening primrose, ginkgo. Adverse Reactions: Asthenia, depression, nervousness, somnolence, infection, ataxia, dizziness, vertigo, seizures, anorexia, diarrhoea, dyspepsia. Levetiracetam 500 mg Tablet K e p p r a - Trade Name
N03AX14000T1002XX (A*)

System: Neurology Indications: Adjunctive therapy in treatment of refractory partial epilepsy. Dosage: Initially: 250 mg bd. gradually increasing to maximum 1.5g bd. Contraindications: Hypersensitivity to levetiracetam products. Precautions: Avoid abrupt discontinuation, renal impairment, severe hepatic impairment, pregnancy,lactation, elderly. Interactions: Evening primrose, ginkgo. Adverse Reactions: Asthenia, depression, nervousness, somnolence, infection, ataxia, dizziness, vertigo, seizures, anorexia, diarrhoea, dyspepsia. Benzhexol 2 mg Tablet A r t a n e - Trade Name System: Neurology Indications: 393
N04AA01110T1001XX (B) NEDL APPL

i) Parkinson's disease ii) Drug induced parkinsonism iii) Dystonias Dosage: Adult: Initially 1 mg dly. Maintenance: 5 - 15 mg dly in 3 - 4 divided doses. Child: 0.02 mg/kg/dose 8 hrly, gradually increasing to 0.1 - 0.3 mg/kg/dose. Contraindications: Children under 3 years, narrow-angle glaucoma, tardive dyskinesias, prostatic enlargement, paralytic ileus. Lactation. Precautions: Autonomic neuropathy, heart disease, hepatic or renal disease, hyperthyroidism, paediatric, elderly, potential for abuse, prostatic hypertrophy, use with caution in patients with ileostomy or colostomy, avoid driving or hazardous activities, monitor intraocular pressure. Interactions: Alcohol and CNS depressants may increase the sedative effect of benzhexol. Adverse Reactions: Severe mental disturbances, excitement, nausea, and vomiting. Procyclidine HCl 10 mg/2 ml Injection K e m a d r i n - Trade Name
N04AA04110P3001XX (B) NEDL

System: Neurology Indications: To control drug-induced Parkinsonism. Dosage: By IM inj 5 - 10 mg repeated if necessary after 20 mins. Max 20 mg dly. By IV inj 5 - 10 mg. Contraindications: Closed-angle glaucoma, hypersensitivity to procyclidine products. Precautions: Hypotension, severe psychoses, prostatic hypertrophy, tachycardia, urinary retention, breast- feeding, pregnancy, children, elderly. Interactions: Anticholinergic-like drugs, chlorpromazine, haloperidol, promethazine, thioridazine, trifluoperazine and prochlorperazine. Adverse Reactions: Xerostomia, blurred vision, disorientation, mydriasis, lightheadedness and confusion. Benztropine Mesylate 2 mg Tablet C o g e n t i n - Trade Name
N04AC01196T1001XX (B) NEDL

System: Neurology Indications: i) Parkinson's disease ii) Drug induced parkinsonism iii) Dystonias Dosage: Adult: 0.5 - 1 mg dly usually at bedtimes. Maintenance: 1 - 4 mg dly in single or divided doses. Max 6 mg dly. Child: 0.02 - 0.06 mg/kg/dose 1 - 2 times a day. Contraindications: Narrow angle glaucoma,tardive dyskinesia,children below 3 yrs old. Precautions: Prostatic hypertropy,mental disorder,pregnancy,older children and tachycardia. Interactions: Phenothiazine,tricyclic antidepresant and anticholinergic. Adverse Reactions: Dry mouth, blurred vision,nausea and vomiting,constipation,allergic reaction. 394

Carbidopa 25 mg & Levodopa 250 mg Tablet N04BA02000T1002XX (B) NEDL APPL Sinemet - Trade Name System: Neurology Indications: Parkinson's disease. Dosage: Patients not receiving Levodopa before, initially 100 - 125 mg 3 - 4 times dly adjusted according to response. Maintenance: 0.75 - 2 g in divided doses. In patients previously treated with Levodopa the dose should be about 20 - 25% of the dose previous being taken. Contraindications: Hypersensitivity to levodopa/carbidopa products, narrow angle glaucoma, undiagnosed skin lesion, melanoma, MAOIs concurently or 2 weeks prior. Precautions: Severe CV disease,pulmonary disease,renal or hepatic disease, history of psycoses or convulsions, history of peptic ulcer, chronic wide-angle glaucoma. Interactions: Tricyclic antidepressants, antihypertensives, phenytoin. Adverse Reactions: Anorexia, nausea, vomiting , orthostatic hypotension, dyskinesia, psychotic symptoms. Levodopa 100 mg, Benserazide 25 mg HBS capsule N04BA02977C1001XX (B)
NEDL

Madopar

- Trade Name

System: Neurology Indications: Parkinson's Disease. Dosage: 1 cap tds. Max initial dose 6 caps dly. Contraindications: Hypersensitivity to this drug. Patient on MAOIs therapy, with decompensated endocrine, renal or hepatic function, cardiac disorders, psychiatric diseases or closed-angle glaucoma. Pregnancy. Precautions: Open-angle glaucoma, depression, diabetes, severe CV disease, bronchial asthma,renal, hepatic or endocrine disease,history of psychoses or convulsion. Lactation. Interactions: Hypertensive crisis with MAOIs, increased hypotensive effect with antihypertensives, antagonism effect of antipsychotic, reduced absorption by iron, plasma concentration increased by metoclopramide. Tricylic antidepressant, phenothiazines, phenytoin. Adverse Reactions: Anorexia, nausea and vomiting, diarrhoea, insomnia, agitation, postural hypotension (rarely labile hypertension), dizziness, tachycardia, arrhythmias, reddish discoloration of urine and other body fluid, rarely hypersensitivity abnormal involuntary movement. Carbidopa 25 mg & Levodopa 100 mg Tablet N04BA02977T1001XX (B) NEDL APPL Sinemet - Trade Name System: Neurology Indications: 395

Parkinson's disease. Dosage: Patients not receiving Levodopa before, initially 100 - 125 mg 3 - 4 times dly adjusted according to response. Maintenance: 0.75 - 2 g in divided doses. In patients previously treated with Levodopa the dose should be about 20 - 25% of the dose previously being taken. Contraindications: Hypersensitivity to this drug. Patient on MAOIs therapy or 2 weeks prior, with decompensated endocrine, renal or hepatic function, cardiac disorders, psychiatric diseases or closed-angle glaucoma. undiagnosed skin lesion, melanoma,Pregnancy. Precautions: Open-angle glaucoma, depression, diabetes,severe CV disease,pulmonary disease,renal, endocrine or hepatic disease, history of psycoses or convulsions, history of peptic ulcer, chronic wide-angle glaucoma.Lactation. Interactions: Hypertensive crisis with MAOIs, increased hypotensive effect with antihypertensives, antagonism effect of antipsychotic, reduced abs orption by iron, plasma concentration increased by metoclopramide. Tricylic antidepressant, phenothiazines, phenytoin. Adverse Reactions: Anorexia, nausea and vomiting, diarrhoea, insomnia, agitation, postural hypotension (rarely labile hypertension), dizziness, tachycardia, arrhythmias, reddish discoloration of urine and other body fluid, rarely hypersensitivity abnormal involuntary movement,dyskinesia, psychotic symptoms. Levodopa 200 mg, Benserazide 50 mg Tablet N04BA02977T1002XX (B) NEDL APPL M a d o p ar - Trade Name System: Neurology Indications: Parkinson's Disease. Dosage: Expressed as Levo-dopa, initially 50 - 100 mg bd, adjusted according to response. Usual maintenance dose 400 - 800 mg in daily divided doses after meals. Contraindications: Hypersensitivity to this drug. Patient on MAOIs therapy or 2 weeks prior, with decompensated endocrine, renal or hepatic function, cardiac disorders, psychiatric diseases or closed-angle glaucoma. undiagnosed skin lesion, melanoma,Pregnancy. Precautions: Open-angle glaucoma, depression, diabetes, severe CV disease, bronchial asthma,renal, hepatic or endocrine disease,history of psychoses or convulsion. history of peptic ulcer, chronic wide-angle glaucoma.Lactation. Interactions: Hypertensive crisis with MAOIs, increased hypotensive effect with antihypertensives, antagonism effect of antipsychotic, reduced absorption by iron, plasma concentration increased by metoclopramide. Tricylic antidepressant, phenothiazines, phenytoin. Adverse Reactions: Anorexia, nausea and vomiting, diarrhoea, insomnia, agitation, postural hypotension (rarely labile hypertension), dizziness, tachycardia, arrhythmias, reddish discoloration of urine and other body fluid, rarely hypersensitivity abnormal involuntary movement,dyskinesia, psychotic symptoms. 396

Levodopa 100 mg, Benserazide 25 mg Dispersible Tablet Madopar Dispersible

N04BA02977T4001XX (A*)
- Trade Name

System: Neurology Indications: Parkinson's Disease. Dosage: Expressed as L-dopa, initially 50 - 100 mg bd, adjust according to response. Usual maintenance dose 400 - 800 mg daily in divided doses after meals. Dispersible formulation for dysphagia or where a more rapid onset of action is required ie patients with early morning/afternoon akinesia. Contraindications: Hypersensitivity to this drug. Patient on MAOIs therapy, with decompensated endocrine, renal or hepatic function, cardiac disorders, psychiatric diseases or closed-angle glaucoma. Pregnancy. Precautions: Open-angle glaucoma, depression, diabetes, severe CV disease, bronchial asthma,renal, hepatic or endocrine disease,history of psychoses or convulsion. Lactation. Interactions: Hypertensive crisis with MAOIs, increased hypotensive effect with antihypertensives, antagonism effect of antipsychotic, reduced absorption by iron, plasma concentration increased by metoclopramide. Tricylic antidepressant, phenothiazines, phenytoin. Adverse Reactions: Anorexia, nausea and vomiting, insomnia, agitation, postural hypotension (rarely labile hypertension), dizziness, tachycardia, arrhythmias, reddish discoloration of urine and other body fluid, rarely hypersensitivity abnormal involuntary movement and psychiatric symptoms which include hypomania and psychosis may be dose-limiting; depression, drowsiness, headache, flushing, sweating, gastrointestinal bleeding, peripheral neuropathy and liver enzyme changes. Amantadine HCl 100 mg Capsule S y m m e t r e l - Trade Name
N04BB01110C1001XX (B)NEDL

System: Neurology Indications: Parkinson's disease Dosage: Initial dose : 100 mg dly and is increased to 100 mg bd (not later than 4 p.m.) after a wk. Elderly over 65 yrs: < 100 mg or 100 mg at intervals of more than 1 day. Contraindications: Hypersensitivity to amantadine products, pregnancy, lactation, epilepsy, history of gastric ulceration, severe renal impairment. Precautions: Seizure disorder, psychiatry disorder,history of heart failure,recurrent eczema,gastric ulceration. Interactions: Alcohol, methyldopa, metoclopramide, domperidone, antipsychotic, antimuscarinics. Adverse Reactions: Oedema of ankles,livedo reticularis,depression, hallucination, nausea, vomiting, dizziness, insomnia, blurred vision, dry mouth. 397

Piribedil 50 mg Tablet T r i v a s t a l R e t a r d - Trade Name

N04BC00000T5001XX (A*)

System: Neurology Indications: Parkinson disease. Dosage: i) As monotherapy: 150 - 250 mg as 3 - 5 divided doses daily. ii) As combination with L-dopa therapy: 50 - 150 mg dly ( 50 mg per 250 mg of L-dopa). Contraindications: Hypersensitivity to piribedil, cardiogenic shock, acute phase of myocardial infaction. Precautions: Hepatic dysfunction , elderly, psychosis, parkinsonism, mania, thyroid disorder. Interactions: Dopaminergic antagonists. Adverse Reactions: Drowsiness, confusion, anxiety, dizziness, delusions, hallucinations, hypotension, tachycardia, extrapyramidal effects, dyskinesias, mania, gastric discomfort, nystagmus, changes in liver function. Dihydroergo-cristine,-cryptine, -conine Mesylates 1 mg Tablet Hydergine
N04BC03196T1001XX (A/KK) APPL
- Trade Name

System: Neurology Indications: Adjunct in elderly with mild to moderate dementia. Dosage: 1 - 2 mg tds before meals. Contraindications: Hypersensitivity to ergoloid mesylate products, acute or chronic psychosis. Precautions: Because target symptoms are of unknown etiology, careful diagnosis should be attempted before prescribing this agent. Severe bradycardia. Interactions: Indinavir, saquinavir ,sodium bicarbonate. Adverse Reactions: Nasal stuffiness; initially gastric upsets (take with food). Ropinirole HCl 0.25mg Tablet Ropinirole HCl 1 mg Tablet
N04BCO4110T1001XX (A*) N04BCO4110T1002XX (A*)

System: Neurology Indications: Parkinson Disease in younger patients and patients with dyskinesias, especially peak dose dyskinesias. Dosage: 0.25 mg tds gradually increasing till adequate response obtained up to a maximum of 24 mg/day. Most patients need 3-9 mg/day. Contraindications: Hypersensitivity to ropinirole, pregnancy. Precautions: Several renal or hepatic failure, concomitant use of alcohol, others CNS depressants and neuroleptics. Interactions: Neuroleptics and other centrally active dopamine antagonist, 398

other dopamine agonists, Ciprofloxacin, high dose oestrogen, HRT, antiarrhythmias. Adverse Reactions: Dizziness, headache, somnolence, nausea, vomiting, dyskinesia, hallucinations (dose related), sleep attacks, postural hypotension, syncope. Selegiline HCl 5 mg Tablet J u m e x - Trade Name
N04BD01110T1001XX (A*) APPL

System: Neurology Indications: Only for treatment of late stage Parkinsonism with on and off phenomenon Dosage: 10 mg at breakfast or 5 mg bd at breakfast and lunch. Contraindications: Extrapyramidal symptoms not related to dopamine deficiency,thyrotoxicosis,narrow angle glaucoma agitated psychosis, hypersensitivity to selegiline products. Pregnancy. Precautions: History of peptic ulcer,pregnancy and lactation, elderly, concurrent use of tricyclic antidepressants, uncontrol hypertension. Interactions: Hyperpyrexia and CNS toxicity with pethidine. Hypertension and CNS excitation with fluoxetine and sertraline. Hypotension with MAOIs. Carbamazepine, amitriptyline, amphetamine. Adverse Reactions: Hypotension,nausea,confusion,agitation,hallucination, dyskinesia, sleep disturbances, psychosis, constipation, dry mouth, headache, tremor, dizziness. Entacapone 200 mg Tablet Comtan - Trade Name
N04BX02000T1001XX (A)

System: Neurology Indications: Parkinson's Disease. An adjunct to standard levodopa/benserazide or levodopa/carbidopa for use in patients with Parkinson's Disease and end of dose motor fluctuations, who cannot be stabilised on those combinations. Dosage: 200 mg to be taken with each daily dose of levodopa/dopa-decarboxylase inhibitor. Contraindications: Pregnancy and breast- feeding, hepatic impairment, phaeochromocytoma, history of neuroleptic malignant syndrome or nontraumatic rhabdomyolysis. Precautions: Levodopa-induced orthostatic hypotension may be aggravated. Abrupt withdrawal. Interactions: Entacapone and ferrous product should be taken at least 2 - 3 hours apart. Dosage of levodopa and other antiparkinson drugs may need to be adjusted when initiating entacapone. Effects of medicinal products metabolised by catechol-O-methyl transferase may be potentiated. Adverse Reactions: Nausea, vomiting, abdominal pain, constipation, diarrhoea, urine may be coloured reddish-brown, dry mouth,dyskinesia, dizziness, anaemia, rarely elevated liver enzymes. 399

Chlorpromazine HCl 25 mg Tablet Chlorpromazine HCl 100 mg Tablet L a r g a c t i l - Trade Name

N05AA01110T1001XX (B) NEDL APPL N05AA01110T1002XX (B) NEDL APPL

System: Psychiatry Indications: Psychosis mania and agitation. Dosage: Adult : initial dose - 25 mg tds according to response up to 1 g dly. Paeds; Up to 5 yrs: 0.5 mg/kg body wt. every 4 - 6 hrs (Max. 40 mg dly). Child 6 - 12 yrs: A third to half adult dose (Max.75 mg dly). Contraindications: Hypersensitivity to chlorpromazine products, phenothiazines, myelosuppression, coma, severe CNS depression. Precautions: Pregnancy and lactation, elderly, impaired kidney and liver function, Parkinson's disease, severe hypotension. Interactions: Alcohol, CNS depressant, anticholinergic. Tramadol, increased risk of seizures. Phenobarbitone, decreased chlorpromazine effectiveness. Metoprolol, atenolol, hypotension and/or phenothiazine toxicity. Captopril, hypotension. Norepinephrine, decreased norepinephrine effectiveness. Procyclidine, decreased phenothiazine serum concentrations, decreased phenothiazine effectiveness, enhanced anticholinergic effects (ileus, hyperpyrexia, sedation, dry mouth). Warfarin, decreased efficacy of warfarin. Epinephrine, hypotension and tachycardia. Cimetidine, decreased chlorpromazine effectiveness. Ethanol, increased sedation. Adverse Reactions: Hypotension, akathisia, tardive dyskinesia, arrhythmias, constipation, haematologic effects, agranulocytosis, aplastic anaemia, thrombocytopenia, neuroleptic malignant syndrome, tardive dyskinesia, jaundice, hypotension, agitation, insomnia, arrhythmias, constipation, parkinsonism symptoms, drowsiness, convulsion and tachycardia. Fluphenazine Decanoate 25 mg/ml Injection N05AB02135P3001XX (B) NEDL APPL M o d e c a t e - Trade Name System: Psychiatry Indications: Long term management of psychotic disorders. Dosage: By deep IM : Test dose 12.5 mg (6.25 mg in elderly), then after 4-7 days 12.5 mg-100 mg repeated at intervals of 14-35 days, adjusted according to response. Child not recommended. Contraindications: Comatose or severely depressed patients, blood dyscrasias, liver damage, hypersensitivity to fluphenazine products, subcortical brain damage, phaeochromocytoma, severe hypotension. Precautions: Patients exposed to extreme heat or phosphorous insecticides, history of convulsive disorder, mitral insufficiency or other cardiovascular diseases and phaeochromocytoma; history of neuroleptic malignant syndrome; history of cholestatic jaundice, hypersensitivity reaction to other phenothiazines, patients undergoing surgery may require lower doses of anaesthetics or depressants, history of dermatoses, impaired liver function, 400

myasthenia gravis, Parkinson's disease, seizure disorder. Interactions: Tramadol, increased risk of seizures. Cisapride, levofloxacin, increased risk of cardiotoxicity (QT prolongation, torsades de pointes, cardiac arrest). Pethidine, increase in central nervous system and respiratory depression. Levodopa, loss of levodopa efficacy. Procyclidine, decreased phenothiazine serum concentrations, decreased phenothiazines effectiveness, enhance anticholinergic effects (ileus, hyperpyrexia, sedation, dry mouth). Sertraline, fluoxetine; increased risk of developing acute parkinsonism. Class Ia and III antiarrhytmics, beta2 agonists, carbamazepine, central alpha2 agonists, systemic corticosteroids, diuretics, lithium tricyclic antidepressants. Adverse Reactions: Weight gain, agranulocytosis, akathisia, extrapyramidal effects, hepatotoxicity, neuroleptic malignant syndrome, hyperprolactinaemia, sedation, orthostatic hypotension, anticholinergic effects, seizures, aplastic anaemia, cholestatic jaundice. Perphenazine 4 mg Tablet
N05AB03000T1001XX (B)NEDL

System: Psychiatry Indications: Schizophrenia and other psychoses. Dosage: Adult dose : initially 4 mg tds adjusted according to response, max 24 mg dly. Elderly: 1/4 to 1/2 adult dose. Child : not recommended. Contraindications: Blood dyscrasias, bone marrow suppression, subcortical brain damage, comatose/obtunded patients, hypersensitivity to perphenazine products, severe liver disease, high doses of CNS depressants. Precautions: Concomitant epinephrine use, seizure disorder, patients undergoing alcohol withdrawal, pregnancy and lactation, respiratory impairment secondary to pulmonary infection or chronic pulmonary disorders, increased risk of tardive dyskinesia development in older patients, sulfite hypersensitivity, history of neuroleptic malignant syndrome. Interactions: Tramadol, increased risk of seizures. Cisapride, levofloxacin, cardiotoxicity. Procyclidine, decreased phenothiazine serum concentrations, decreased phenothiazine effectiveness, enhanced anticholinergic effects (ileus, hyperpyrexia, sedation, dry mouth). Pethidine, increase in central nervous system and respiratory depression. Levodopa, loss of levodopa efficacy. Ethanol, increased central nervous system depression and an increased risk of extrapyramidal reactions. Class Ia and III antiarrhythmics, beta 2 agonists, carbamazepine, central alpha 2 agonists, systemic corticosteroids, diuretics, lithium, MAOIs, tricyclic antidepressants. Adverse Reactions: Extrapyramidal syndrome, drowsiness, insomnia, convulsion, allergic reaction, tachycardia, postural hypotension, dizziness, impaired glucose tolerance, tardive dyskinesia, liver damage, nausea, vomiting, cardiac arrest, agranulocytosis, haemolytic anaemia, hepatotoxicity. Prochlorperazine Mesylate 12.5mg/ml Injection N05AB04253P3001XX (B) NEDL APPL Stemetil - Trade Name System: Gastro-Intestinal Indications: 401

i) Severe nausea & vomitting ii) Vertigo/labyrinthine disorders. Dosage: Deep IM injection,12.5 mg repeated if necessary after 6 hrs and then followed by an oral dose. Not recommended in children. Contraindications: Comatose states, CNS depression, phaeochromocytoma, CV collapse and bone marrow depression. Precautions: Hypotension, epilepsy, acute narrow angle glaucoma, pregnancy and lactation. Interactions: Alcohol (increased central nervous system depression) G.anaesthetics (enhanced hypotensive effect) Tramadol (increased risk of seizures). Metoclopramide (increased risk of extrapyramidal side-effects), Bromocriptine (loss of hypoprolactinaemic and antiparkinsonian effects) Levodopa , (loss of levodopa efficacy) Procyclidine (decreases phenothiazine serum concentrations & effectiveness, enhanced anticholinergic effects (ileus, hyperpyrexia, sedation, dry mouth). Cimetidine (enhances effects of stemetil) Antacids (reduce absorption of phenothiazines) Antimuscarinics (reduce plasma concentration of phenothiazines but increase risk of antimuscarinic side-effects). Adverse Reactions: Extrapyramidal symptoms, drowsiness, postural hypotension, coma, neuroleptic malignant syndrome, cholestatic jaundice, leukopenia and agranulocytosis, constipation, dry mouth, urinary retention, liver damage and insomnia. Prochlorperazine Maleate 5mg Tablet Stemetil - Trade Name
N05AB04253T1002XX (B) NEDL APPL

System: Gastro-Intesti nal Indications: i) Severe nausea & vomitting Anti-emetic ii) Vertigo / labyrinthine disorders. Dosage: i) For severe nausea & vomitting. Inj IM 12.5mg stat and repeated if necessary after 6 hours or orally 20 mg stat followed by 10 mg after 2 hrs. Prevention: 510 mg bd/tds. Paeds: (over 10 kg only) 250 mcg/kg bd/tds ii) For labyrinthine disorders 5mg 3 times daily, gradually increased to 30mg daily in divided doses, then reduced after several weeks to 5-10mg daily. Not recommended in children. Contraindications: CNS depression or coma, bone marrow depression, phaeochromocytoma, hypersensitivity to phenothiazines, comatose states, cardiovascular collapse. Precautions: Hypotension, pregnancy and lactation, glaucoma, prostatic hypertrophy, stenosing peptic ulcer, children with acute illnesses, dehydration or electrolyte imbalance, signs and symptoms suggestive of Reye's syndrome in children and adolescents, patients with tardive dyskinesia or a history of neuroleptic malignant syndrome, epilepsy, acute narrow angle glaucoma, liver damage, insomnia. Interactions: Tramadol, increased risk of seizures. Procyclidine, decreased phenothiazine serum concentrations, decreased phenothiazine effectiveness, enhanced anticholinergic effects (ileus, hyperpyrexia, sedation, dry mouth). 402

Levodopa, loss of levodopa efficacy. Ethanol, increased central nervous system depression and an increased risk of extrapyramidal reactions. Adverse Reactions: Extrapyramidal symptoms, drowsiness, postural hypotension, coma, neuroleptic malignant syndrome, cholestatic jaundice, leucopenia and agranulocytosis, constipation, dry mouth, urinary retention, liver damage and insomnia. Trifluoperazine HCl 5 mg Tablet S t e l a z i n e - Trade Name
N05AB06110T1001XX (B)APPL

System: Psychiatry Indications: Psychotic disorder. Dosage: Adult dose: Initially 5 mg bd, increase by 5 mg after 1 wk, then at 3-day intervals. Maximum 40 mg/day. Child up to 12 yrs : Initially up to 5 mg dly in divided doses adjusted to response, age and body wt. Contraindications: Coma, bone marrow depression, hypersensitivity to trifluoperazine products, hypersensitivity to other phenothiazines, pre-existing liver damage, CNS depression. Precautions: Tardive dyskinesias may develop, concomitant lithium therapy (encephalopathic syndrome), may increase anginal pain, neuroleptic malignant syndrome, cardiovascular disorders, glaucoma or retinopathy. Interactions: Tramadol, increased risk of seizures. Lithium, weakness, dyskinesias, increased extrapyramidal symptoms, encephalopathy, and brain damage. Procyclidine, decreased phenothiazine serum concentrations, decreased phenothiazine effectiveness, enhanced anticholinergic effects (ileus, hyperpyrexia, sedation, dry mouth). Phenytoin, increased or decresed phenytoin levels and possibly reduced phenothiazine levels. Ethanol, increased central nervous system depression and an increased risk of extrapyramidal reactions. Amphotericins, class Ia and III antiarrhythmics, beta2 agonists, acetazolamide, central alpha2 agonists, systemic corticosteroids, diuretics, MAOIs, tricyclic antidepressants. Adverse Reactions: Seizures, extrapyramidal effects, blood dyscrasias, agranulocytosis, neuroleptic malignant syndrome , dry mouth, constipation, orthostatic hypotension, blurred vision, tardive dyskinesia, urinary retention, photosensitivity, rash, nausea, tachycardia, dizziness, fatigue, headache, weight gain and jaundice. Haloperidol 5 mg/ml Injection S e r e n a c e - Trade Name
N05AD01000P3001XX (B)NEDL

System: Psychiatry Indications: Acute psychoses and mania. Dosage: Adult: IM or IV , 2 - 10 mg then every 4 - 8 hrs according to response to total max 18 mg dly. Child not recommended. Contraindications: Parkinson's disease, toxic central nervous system depression, comatose states, hypersensitivity to haloperidol. 403

Precautions: Concomitant anticoagulant use, concomitant CNS depressant use (anaesthetics, opiates, and alcohol), history of convulsive disorders, known allergies or allergic reactions to drugs, manic patients, neuroleptic malignant syndrome, elderly patients, impaired liver function, CV disease, thyrotoxicosis. Interactions: Tramadol, increased risk of seizures. Fluoxetine, fluvoxamine, increased risk of haloperidol toxicity (pseudoparkinsonism, akathisia, tongue stiffness). Carbamazepine, decreased haloperidol effectiveness. Cisapride, worsening of psychotic symptoms. Dicoumarol, decreased anticoagulant effectiveness. Procyclidine, excessive anticholinergic effects (sedation, constipation, dry mouth). Methyldopa, CNS toxicity (dementia) or reversible parkinsonism. Olanzapine, increased risk of parkinsonism (cogwheeling rigidity, unstable gait). Rifampicin, decreased haloperidol effectiveness. Lithium, tricyclic antidepressants. Adverse Reactions: Extrapyramidal symptoms (EPS), tardive dyskinesia, sedation, hypotension, tachycardia, insomnia, anxiety, weight changes, anticholinergic effects, gynaecomastia, galactorrhoea, menstrual irregularities, neuroleptic malignant syndrome, arrhythmias, hypotension, seizure, jaundice, hyperpyrexia. Haloperidol 1.5 mg Tablet S e r e n a c e - Trade Name
N05AD01000T1001XX (B) NEDL APPL

System: Psychiatry Indications: Schizophrenia and other psychoses Dosage: Adult dose : 1.5 - 5 mg 2 - 3 times daily up to 30 mg dly. Paed : 25 - 50 mcg/kg dly in 2 divided doses. Max 10 mg. Contraindications: Parkinson's disease, toxic central nervous system depression, comatose states, hypersensitivity to haloperidol. Precautions: Concomitant anticoagulant use, concomitant CNS depressant use (anaesthetics, opiates, and alcohol), history of convulsive disorders, known allergies or allergic reactions to drugs, manic patients, neuroleptic malignant syndrome, elderly patients, impaired liver function, CV disease, thyrotoxicosis. Interactions: Tramadol, increased risk of seizures. Fluoxetine, fluvoxamine, increased risk of haloperidol toxicity (pseudoparkinsonism, akathisia, tongue stiffness). Carbamazepine, decreased haloperidol effectiveness. Cisapride, worsening of psychotic symptoms. Dicoumarol, decreased anticoagulant effectiveness. Procyclidine, excessive anticholinergic effects (sedation, constipation, dry mouth). Methyldopa, CNS toxicity (dementia) or reversible parkinsonism. Olanzapine, increased risk of parkinsonism (cogwheeling rigidity, unstable gait). Rifampicin, decreased haloperidol effectiveness. Lithium, tricyclic antidepressants. Adverse Reactions: Extrapyramidal symptoms (EPS), tardive dyskinesia, sedation, hypotension, tachycardia, insomnia, anxiety, weight changes, anticholinergic effects, gynaecomastia, galactorrhoea, menstrual irregularities, neuroleptic malignant syndrome, arrhythmias, hypotension, seizure, jaundice, hyperpyrexia.

404

Haloperidol 5 mg Tablet S e r e n a c e - Trade Name

N05AD01000T1002XX (B) NEDL

System: Psychiatry Indications: Schizophrenia and other psychoses. Dosage: Adult dose : 1.5 - 5 mg 2 - 3 times daily up to 30 mg dly. Paed : 25 - 50 mcg/kg dly in 2 divided doses. Max 10 mg. Contraindications: Parkinson's disease, toxic central nervous system depression, comatose states, hypersensitivity to haloperidol. Precautions: Concomitant anticoagulant use, concomitant CNS depressant use (anaesthetics, opiates, and alcohol), history of convulsive disorders, known allergies or allergic reactions to drugs, manic patients, neuroleptic malignant syndrome, elderly patients, impaired liver function, CV disease, thyrotoxicosis. Interactions: Tramadol, increased risk of seizures. Fluoxetine, fluvoxamine, increased risk of haloperidol toxicity (pseudoparkinsonism, akathisia, tongue stiffness). Carbamazepine, decreased haloperidol effectiveness. Cisapride, worsening of psychotic symptoms.Dicoumarol, decreased anticoagulant effectiveness. Procyclidine, excessive anticholinergic effects (sedation, constipation, dry mouth). Methyldopa, CNS toxicity (dementia) or reversible parkinsonism. Olanzapine, increased risk of parkinsonism (cogwheeling rigidity, unstable gait). Rifampicin, decreased haloperidol effectiveness. Lithium, tricyclic antidepressants. Adverse Reactions: Extrapyramidal symptoms (EPS), tardive dyskinesia, sedation, hypotension, tachycardia, insomnia, anxiety, weight changes, anticholinergic effects, gynaecomastia, galactorrhoea, menstrual irregularities, neuroleptic malignant syndrome, arrhythmias, hypotension, seizure, jaundice, hyperpyrexia. Flupenthixol Decanoate Depot 20 mg/ml lnjection N05AF01135P2001XX (B)APPL F l u a n x o l - Trade Name System: Psychiatry Indications: Chronic psychoses. Dosage: By deep IM, test dose 20 mg, then after at least 7 days. 20 - 40 mg repeated at intervals of 2 - 4 wks. M ax. 400 mg wkly. Usual maintenance dose 50 mg every 4 weeks to 300 mg every 2 weeks. Elderly, initially quarter to half adult dose. Child not recommended. Contraindications: Hypersensitivity to flupenthixol. Extremely excitable or overactive patients. Acute alcohol, barbiturate or opiate poisoning. Bone marrow depression, coma. Precautions: Patients known to have a predisposition to movement disorders (may cause extrapyramidal symptoms). Hepatic or renal impairment. CV or respiratory disease, phaeochromocytoma, epilepsy. Interactions: Tramadol, increased risk of seizures. May enhance the response to alcohol, barbiturates and other CNS depressants. May block the 405

antihypertensive effects of guanethidine or similar compounds. May reduce the effect of levodopa and adrenergic drugs. Increase risk of extrapyramidal symptoms with metoclopramide and piperazine. Adverse Reactions: Sedation, restlesness, extrapyramidal symptoms, anticholinergic effects, weight gain. Zuclopenthixol 20 mg/ml Drops C l o p i x o l - Trade Name
N05AF05000D5001XX (A*)

System: Psychiatry Indications: Only for psychoses with poor sight or compliance. Dosage: 20 - 30 mg dly in divided doses. Max.150 mg dly. Usual maintenance dose 2050mg dly. Elderly (or debilitated), initially quarter to half adult dose. Child not recommended. Contraindications: Severe CNS depression, coma, blood dyscrasias, phaeocromocytoma. Previous hypersensitivity to zuclopenthixol or clopenthixol. Precautions: Previous hypersensitivity to other neuroleptic agents, particularly thioxanthenes, fluphenazine, and perphenazine, Hepatic or renal disease, pregnancy, breastfeeding, epileptic or parkinsonian patients. Interactions: Alcohol, barbiturates and CNS depressant, tricyclic antidepressant, metoclopramide - increased effect. Adverse Reactions: Extrapyramidal syndrome, drowsines, anticholinergic effect, tachycardia, postural hypotension, dizziness, tardive dyskinesia. Zuclopenthixol Acetate 50 mg/ml Injection Zuclopenthixol Acetate 100 mg/2 ml Injection C l o p i x o l - A c u p h a s e - Trade Name
N05AF05122P3001XX (A*) NEDL N05AF05122P3002XX (A*)

System: Psychiatry Indications: Only for treatment of agitated and violent schizophrenics not responding to the available standard drugs. Dosage: 50 - 150 mg repeated after 2 - 3 days if necessary. Additional dose may be needed 1 - 2 days after the first injection. Max cumulative dose 400 mg per course and max 4 injections; max duration of treatment 2 weeks. Change to oral dose 2 - 3 days after last injection. Contraindications: Severe CNS depression, coma, blood dyscrasias, phaeocromocytoma. Previous hypersensitivity to zuclopenthixol or clopenthixol. Precautions: Previous hypersensitivity to other neuroleptic agents, particularly thioxanthenes, fluphenazine, and perphenazine, hepatic or renal disease, pregnancy, breastfeeding, epileptic or parkinsonian patients. Interactions: Alcohol, barbiturates and CNS depressant, tricyclic antidepressant, metoclopramide - increased effect. Adverse Reactions: Extrapyramidal syndrome, drowsines, anticholinergic effect, tachycardia, postural hypotension, dizziness, tardive dyskinesia.

406

Zuclopenthixol Decanoate 200 mg/ml Injection C l o p i x o l D e p o t - Trade Name

N05AF05135P2001XX (A*)

System: Psychiatry Indications: Only for treatment of agitated and violent schizophrenics not responding to the available standard drugs. Dosage: By deep IM inj. test dose 100 mg followed after 7 - 28 days by 100 - 200 mg or more followed by 200 - 400 mg at intervals of 2 - 4 weeks adjusted according to response. Max. 600mg weekly. Child not recommended. Contraindications: Severe CNS depression, coma, blood dyscrasias, phaeocromocytoma. Previous hypersensitivity to zuclopenthixol or clopenthixol. Precautions: Previous hypersensitivity to other neuroleptic agents, particularly thioxanthenes, fluphenazine, and perphenazine, hepatic or renal disease, pregnancy, breastfeeding, epileptic or parkinsonian patients. Interactions: Alcohol, barbiturates and CNS depressant, tricyclic antidepressant, metoclopramide - increased effect. Adverse Reactions: Extrapyramidal syndrome, drowsines, anticholinergic effect, tachycardia, postural hypotension, dizziness, tardive dyskinesia. Clozapine 25 mg Tablet Clozaril - Trade Name
N05AH02000T1001XX (A)

System: Psychiatry Indications: Resistant schizophrenia. Dosage: Initial dose : 12.5 mg ( once or twice ) dly, increase slowly in steps of 25 - 50 mg up to 300 mg dly within 2 - 3 wks. Maximum 900 mg/day. Contraindications: Severe cardiac failure, severe hepatic and renal impairment, myeloproliferative disorders, uncontrolled epilepsy, pregnancy, lactation, coma, hypersensitivity to clozapine products, myocarditis with clozapine history, agranulacytosis, with clozapine history, WBC <3500, GI/GU obstruction, narrow angle glaucoma, CNS depression. Precautions: Patients who are elderly, cachectic, or have serious underlying medical illnesses; cardiovascular and or pulmonary disease; discontinue treatment if myocarditis is suspected; history of seizures; failure to demonstrate a clinical response; history of neuroleptic malignant syndrome; rapid escalation of dose, prostatic hypertrophy, hypotension, impaired renal or liver function, seizure disorder. Interactions: Tramadol, carbamazepine, fluoxetine, sertraline, fluvoxamine, erythromycin, phenobarbitone, phenytoin, rifampicin, cimetidine, benzodiazepines, other antipsychotics, tricyclic antidepressants, valproic acid derivatives. Adverse Reactions: Agranulocytosis, sedation, salivation, cardiovascular effects, dizziness / vertigo, seizures, drowsiness, confusion, blurred vision, dry mouth, jaundice, leucopenia, neuroleptic malignant syndrome, hyperglycaemia, anticholinergic toxicity, hepatitis, hypotension, syncope, constipation, tremor, 407

weight gain, confusion. Clozapine 100 mg Tablet Clozaril - Trade Name

N05AH02000T 1002XX (A)

System: Psychiatry Indications: Resistant schizophrenia. Dosage: Initial dose : 12.5 mg ( once or twice ) dly, increase slowly in steps of 25 - 50 mg up to 300 mg dly within 2 - 3 wks. Maximum 900 mg/day. Contraindications: Severe cardiac failure, severe hepatic and renal impairment, myeloproliferative disorders, uncontrolled epilepsy, pregnancy, lactation, coma, hypersensitivity to clozapine products, myocarditis with clozapine history, agranulocytosis with clozapine history, WBC <3500, GI/GU obstruction, narrow angle glaucoma, CNS depression. Precautions: Patients who are elderly, cachectic, or have serious underlying medical illnesses; cardiovascular and or pulmonary disease; discontinue treatment if myocarditis is suspected; history of seizures; failure to demonstrate a clinical response; history of neuroleptic malignant syndrome; rapid escalation of dose, prostatic hypertrophy, hypotension, impaired renal or liver function, seizure disorder. Interactions: Tramadol, carbamazepine, fluoxetine, sertraline, fluvoxamine, erythromycin, phenobarbitone, phenytoin, rifampicin, cimetidine, benzodiazepines, other antipsychotics, tricyclic antidepressants, valproic acid derivatives. Adverse Reactions: Agranulocytosis, sedation, salivation, cardiovascular effects, dizziness / vertigo, seizures, drowsiness, confusion, blurred vision, dry mouth, jaundice, leucopenia, neuroleptic malignant syndrome, hyperglycaemia, anticholinergic toxicity, hepatitis, hypotension, syncope, constipation, tremor, weight gain, confusion. Olanzapine 5 mg Tablet Z y p r e x a - Trade Name
N05AH03000T1001XX (A*)

System: Psychiatry Indications: i) Acute and maintenance treatment of schizophrenia and other psychoses where positive and or negative symptoms are prominent. ii) Short-term use for acute mania episodes associated with Bipolar 1 disorder. Dosage: i) 5-10 mg once daily, increase to 10 mg once dly within 5-7 days, adjust by 510 mg/day at 1 week intervals, max 20 mg/day. ii) 10-15 mg once daily, increase by 5 mg/day at intervals of not less than 24 hrs. Maintenance 5-20 mg/day; max 20 mg/day. Contraindications: Hypersensitivity to olanzapine products, narrow angle glaucoma, lactation. Precautions: History of neuroleptic malignant syndrome, patients with liver disease, seizure disorder, pneumonia, narrow angle glaucoma, pregnancy, cardiovascular disease, history of brease cancer, tardive dyskinesia, GI/GU 408

obstruction, paralytic ileus, cerebrovascular disease, elderly, hypotension, hypovolaemia, dehydration, risk of aspiration pneumonia. Interactions: Carbamazepine, ciprofloxacin, fluvoxamine, levodopa, haloperidol, activated charcoal, ethanol, central alpha2 agonists, cimetidine, epinephrine, muscle relaxants, tricyclic antidepressants. Adverse Reactions: Somnolence, agitation, dizziness, constipation, drowsiness, weight gain, peripheral oedema, dry mouth, postural hypotension, elevated liver transaminases, hyperglycaemia. Olanzapine 10 mg Tablet Z y p r e x a - Trade Name
N05AH03000T1002XX (A*)

System: Psychiatry Indications: i) Acute and maintenance treatment of schizophrenia and other psychoses where positive and or negative symptoms are prominent. ii) Short-term use for acute mania episodes associated with Bipolar 1 disorder. Dosage: i) 5-10 mg once daily, increase to 10 mg once dly within 5-7 days, adjust by 510 mg/day at 1 week intervals, max 20 mg/day. ii) 10-15 mg once daily, increase by 5 mg/day at intervals of not less than 24 hrs. Maintenance 5-20 mg/day; max 20 mg/day. Contraindications: Hypersensitivity to olanzapine products, narrow angle glaucoma, lactation. Precautions: History of neuroleptic malignant syndrome, patients with liver disease, seizure disorder, pneumonia, narrow angle glaucoma, pregnancy, cardiovascular disease, history of breast cancer, tardive dyskinesia, GI/GU obstruction, paralytic ileus, cerebrovascular disease, elderly, hypotension, hypovolaemia, dehydration, risk of aspiration pneumonia. Interactions: Carbamazepine, ciprofloxacin, fluvoxamine, levodopa, haloperidol, activated charcoal, ethanol, central alpha2 agonists, cimetidine, epinephrine, muscle relaxants, tricyclic antidepressants. Adverse Reactions: Somnolence, agitation, dizziness, constipation, drowsiness, weight gain, peripheral oedema, dry mouth, postural hypotension, elevated liver transaminases, hyperglycaemia. Quetiapine Fumarate 25mg Tablet S e r o q u e l - Trade Name
N05AH04138T1001XX (A*)

System: Psychiatry Indications: Schizophrenia. Dosage: Initial 25 mg bd. Increased by 25-50 mg/dose every 1-2 days to a target dose of 300-400 mg/day.Beyond 400 mg/day dose increases should occur not less than 2 days .Maximum 800 mg/day. Contraindications: Hypersensitivity, severe CNS depression, bone marrow suppression, blood dyscrasias, severe hepatic disease, coma. Precautions: Pregnancy, hepatic impairment, renal impairment, cerebrovascular disease. 409

Interactions: Antihypertensives, cimetidine, CNS depressants, alcohol, carbamazepine, barbiturates, valproate, phenytoin, rifampicin, thioridazine, ketoconazole, erythromycin. Adverse Reactions: Headache, somnolence, weight gain, postural hypotension, tachycardia, palpitations, dizziness, rash, abdominal pain, constipation, dyspepsia, anorexia. Quetiapine Fumarate 100mg Tablet S e r o q u e l - Trade Name
N05AH04138T1002XX (A*)

System: Psychiatry Indications: Schizophrenia. Dosage: Initial 25 mg bd. Increased by 25-50 mg/dose every 1-2 days to a target dose of 300-400 mg/day. Beyond 400 mg/day dose increases should occur not less than 2 days .Maximum 800 mg/day. Contraindications: Hypersensitivity, severe CNS depression, bone marrow suppression, blood dyscrasias, severe hepatic disease, coma. Precautions: Pregnancy, hepatic impairment, renal impairment, cerebrovascular disease. Interactions: Antihypertensives, cimetidine, CNS depressants, alcohol, carbamazepine, barbiturates, valproate, phenytoin, rifampicin, thioridazine, ketoconazole, erythromycin. Adverse Reactions: Headache, somnolence, weight gain, postural hypotension, tachycardia, palpitations, dizziness, rash, abdominal pain, constipation, dyspepsia, anorexia. Sulpiride 50 mg Capsule D o g m a t i l - Trade Name
N05AL01000C1001XX (B)

System: Psychiatry Indications: Acute and chronic schizophrenia, chronic delusional psychoses. Dosage: 200-400 mg twice dly; 800 mg dly in predominantly negative symptoms; and 2.4 g dly in mainly positive symptoms. Elderly, lower initial dose; increased gradually according to response. Child under 14 yrs not recommended. Contraindications: Hypersensitivity to sulpiride, phaeochromocytoma, Parkinson's disease. Precautions: Cardiovascular disease, manic or hypomanic patients, renal insufficiency, patients with epilepsy, hyperthyroidism, pulmonary disease, urinary retention, previous hypersensitivity to other benzamide derivatives eg. metoclopramide, elderly patients. Pregnancy, lactation, Parkinson's disease. Interactions: Tramadol, increased risk of seizures. Other CNS depressants, alcohol, levodopa. Adverse Reactions: Extrapyramidal syndrome, drowsiness, dry mouth, urinary retention, tachycardia, postural hypotension, dizziness, galactorrhoea, gynaecomastia, amenorrhoea, sedation, somnolence. 410

Sulpiride 200 mg Tablet D o g m a t i l - Trade Name

N05AL01000T1001XX (B)

System: Psychiatry Indications: Acute and chronic schizophrenia, chronic delusional psychoses Dosage: 200-400 mg twice dly; 800 mg dly in predominantly negative symptoms; and 2.4 g dly in mainly positive symptoms. Elderly, lower initial dose; increased gradually according to response. Child under 14 yrs not recommended. Contraindications: Hypersensitivity to sulpiride, phaeochromocytoma, Parkinson's disease. Precautions: Cardiovascular disease, manic or hypomanic patients, renal insufficiency, patients with epilepsy, hyperthyroidism, pulmonary disease, or urinary retention, previous hypersensitivity to other benzamide derivatives eg. metoclopramide, elderly patients.Pregnancy, lactation, Parkinson's disease. Interactions: Tramadol, increased risk of seizures.Other CNS depressants, alcohol, levodopa. Adverse Reactions: Extrapyramidal syndrome, drowsiness, dry mouth, urinary retention, tachycardia, postural hypotension, dizziness, galactorrhoea, gynaecomastia, amenorrhoea, sedation, somnolence. Lithium Carbonate 300 mg Tablet
N05AN01121T1001XX (A) NEDL

System: Psychiatry Indications: Mental depression and bipolar disorder. Dosage: 1800 mg/day in 2-3 divided doses, desired serum lithium level ranging between 0.4-1 mmol/litre. Maintenance 900-1200 mg/day in 2-3 divided doses. Contraindications: Renal insufficiency, Addison's disease, untreated hypothyrodism, lactation, delibated or dehydrated patient, pregnancy. Precautions: CV insufficiency, elderly, electrolyte imbalance, current infection, impaired renal function, volume depletion, thyroid disorder, CAD. Interactions: Diuretics, steroids, haloperidol, fluphentixol, diazepam, methyldopa, tetracyclines, phenytoin, carbamazepine, ACE inhibitors, caffeine, COX2 inhibitors, metronidazole, non-depolarising neuromuscular blockers, NSAIDs, potassium iodide, SSRIs, tricyclic antidepressants. Adverse Reactions: GI effect, vertigo, muscle weakness, dazed feeling, fine hand tremor, polyuria, drowsiness, muscle weakness, arrhythmia, anorexia, dry mouth, fatigue, seizures, leucocytosis, goitre, coma. Risperidone 1 mg/ml Oral Solution R i s p e r d a l - Trade Name
N05AX08000L5001XX (A)

System: Psychiatry Indications: Psychoses and schizophrenia. Dosage: Adult dose : 2 mg in 1 - 2 divided doses on 1st day then 4 mg in 1 - 2 divided 411

doses on 2nd day then 6 mg in 1 - 2 divided doses on 3rd day (slower titration appropriate in some patients); usual range 4 - 8 mg dly; dose above 10 mg dly only if benefit outweigh risk (max 16 mg dly). Elderly (or in hepatic or renal impairment) : initially 0.5 mg bd increased in steps of 0.5 mg bd to 1-2 mg bd. Not recommended in children under 15 yrs. Contraindications: Hyperprolactinaemia, hypersensitivity to risperidone products, prolonged QT interval. Precautions: Neuroleptic malignant syndrome, tardive dyskinesia, QT prolongation, cardiovascular or cerebrovascular disease or conditions that predispose patients to orthostatic hypotension, hypothermia or hyperthermia, previous diagnosis of breast cancer or prolactin-dependent tumours, renal insufficiency, hepatic insufficiency, Parkinson's disease, seizure history, pathologic changes in blood count, dysphagia, elderly patients, hyppotension, hypovolaemia, dehydration, agents prolonging QT, risk of aspiration pneumonia. Interactions: Tramadol, increased risk of seizures. Carbamazepine, increased risperidone clearance. Lev odopa, loss of levodopa efficacy. Clozapine, decreased risperidone clearance. Amphotericin, Class Ia and III antiarrhythmics, acetalozamide, central alpha2 agonists, systemic corticosteroids, diuretics, tricyclic antidepressants. Adverse Reactions: Somnolence, dizziness, hyperkinesia, nausea, extrapyramidal effects, constipation, anxiety, headache, rhinitis, rash, dyspepsia, tachycardia, dry mouth, weight gain, sexual dysfunction, hyperprolactinaemia, menstrual irregularities, severe hypotension, tardive dy skinesia, neuroleptic malignant syndrome and hyperglycaemia. Risperidone 1 mg Tablet Risperidone 2 mg Tablet R i s p e r d a l - Trade Name
N05AX08000T1001XX (A) N05AX08000T1002XX (A)

System: Psychiatry Indications: Psychoses and schizophrenia. Dosage: Adult dose : 2 mg in 1 - 2 divided doses on 1st day then 4 mg in 1 - 2 divided doses on 2nd day then 6 mg in 1 - 2 divided doses on 3rd day (slower titration appropriate in some patients); usual range 4 - 8 mg dly; dose above 10 mg dly only if benefit outweigh risk (max 16 mg dly). Elderly (or in hepatic or renal impairment) : initially 0.5 mg bd increased in steps of 0.5 mg bd to 1-2 mg bd. Not recommended in children under 15 yrs. Contraindications: Hyperprolactinaemia, hypersensitivity to risperidone products, prolonged QT interval. Precautions: Neuroleptic malignant syndrome, tardive dyskinesia, QT prolongation, cardiovascular or cerebrovascular disease or conditions that predispose patients to orthostatic hypotension, hypothermia or hyperthermia, previous diagnosis of breast cancer or prolactin-dependent tumours, renal insufficiency, hepatic insufficiency, Parkinson's disease, seizure history, pathologic changes in blood count, dysphagia, elderly patients, hypotension, hypovolaemia, dehydration, agents prolonging QT, risk of aspiration pneumonia. 412

Interactions: Tramadol, increased risk of seizures. Carbamazepine, increased risperidone clearance. Levodopa, loss of levodopa efficacy. Clozapine, decreased risperidone clearance. Amphotericin, Class Ia and III antiarrhythmics, acetalozamide, central alpha2 agonists, systemic corticosteroids, diuretics, tricyclic antidepressants. Adverse Reactions: Somnolence, dizziness, hyperkinesia, nausea, extrapyramidal effects, constipation, anxiety, headache, rhinitis, rash, dyspepsia, tachycardia, dry mouth, weight gain, sexual dysfunction, hyperprolactinaemia, menstrual irregularities, severe hypotension, tardive dyskinesia, neuroleptic malignant syndrome and hyperglycaemia. Diazepam 5 mg Rectal Solution S t e s o l i d - Trade Name
N05BA01000G2001XX (C) NEDL

System: Neurology Indications: i) Status epilepticus, skeletal muscle spasm. Dosage: i) Status epilepticus - Adult: 0.5 mg/kg repeated after 12 hours if necessary. Child (febrile convulsions, prolonged or recurrent): 0.5 mk/kg (max 10 mg), repeated if necessary. Not recommended for children below 2 years. Contraindications: Respiratory depression, acute pulmonary insufficiency, severe hepatic impairment, acute narrow angle glaucoma, myasthenia gravis. Precautions: Respiratory disease, history of drug or alcohol abuse, drug dependence, pregnancy, breast feeding, renal and hepatic impairment and avoid operating vehicles or machinery. Interactions: CNS depressants, alcohol, barbiturates, antibacterials, antivirals, omeprazole. Adverse Reactions: Drowsiness, dizziness, vertigo, hallucinations, blurred vision, confusion, muscle weakness, fatigue, incontinence or urinary retention, constipation, rashes, changes in libido, leucopenia and GI disturbances. Diazepam 10 mg/2 ml Injection Valium - Trade Name System: Neurology
N05BA01000P3001XX (B) NEDL APPL

413

Indications: i) Status epilepticus ii) Skeletal muscle spasm iii) Anxiety disorders Dosage: i) Status epilepticus, by slow IV: 5-10 every 10-15 min (rate not more than 5 mg/min), to a total dose of 30 mg; may repeat in 2 hr if needed. Infants 30 days to 5 yrs, 0.05-0.3 mg/kg/dose given over 2-3 mins, every 15-30 mins to a total dose of 5 mg; repeat in 2-4 hrs if necessary. Child > 5 yrs, 1 mg by slow IV, every 2-5 mins, max 10 mg, repeat in 2-4 hours if necessary. ii) Skeletal muscle spasm, by slow IV or IM, 5-10 mg repeated if necessary in 3-4 hours. Paeds (tetanus): 30 days - 5 yrs, 1-2 mg IM or IV slowly every 3-4 hrs as needed. 5 yrs and above, 5-10 mg IM or IV slowly ev ery 3-4 hrs if needed. iii) Anxiety disorders, 2-10 mg by slow IV (not more than 5 mg/min). Repeat if necessary every 3-4 hours. Contraindications: Respiratory depression, acute pulmonary insufficiency, severe hepatic impairment, acute narrow angle glaucoma, myasthenia gravis, hypersensitivity to diazepam products, patients less than 6 months old, alcohol intoxication, CNS depression. Precautions: Respiratory disease, history of drug or alcohol abuse, drug dependence, pregnancy, breast feeding, renal and hepatic impairment and avoid operating vehicles or machinery. Interactions: CNS depressants, barbiturates, alcohol and anaesthetics. Metabolism inhibited by isoniazid and increased with rifampicin. Increases or decreases phenytoin plasma. concentration. Plasma concentration increased by ritonavir (risk of extreme sedation and respiratory depression). Metabolism inhibited by omeprazole (increased plasma concentration). Adverse Reactions: Drowsiness, dizziness, vertigo, hallucinations, blurred vision, confusion, muscle weakness, fatigue, incontinence or urinary retention, constipation, rashes, changes in libido, leucopenia and GI, hypotension, ataxia, respiratory depression, sedation, depression, headache, nausea, tremor, withdrawal syndrome, neutropenia, hepatotoxicity, pancytopenia, thrombocytopenia, blood dyscrasias, bradycardia, dependence/abuse. Diazepam 2 mg Tablet Diazepam 5 mg Tablet Diazepam 10 mg Tablet Valium - Trade Name
N05BA01000T1001XX (B)NEDL N05BA01000T1002XX (B)NEDL N05BA01000T1003XX (B)

System: Neurology Indications: i)Muscle spasm of varied aetiology, including tetanus ii)Anxiety disorders. Dosage: i) Muscle spasm of varied aetiology, including tetanus: Adult, 2-10 mg 3-4 times dly. Paed: 0.12 - 0.8 mg/kg daily in divided doses, ev ery 6-8 hrs. ii)Anxiety disorders: Adult, 2 mg tds, increased in severe anxiety to 15 - 30 mg dly in divided doses. Paeds (night terrors), 1 - 5 mg at bedtime. Contraindications: Respiratory depression, acute pulmonary insufficiency, severe hepatic impairment, acute narrow angle glaucoma, myasthenia gravis, hypersensitivity to diazepam products, patients less than 6 months old, alcohol 414

intoxication and CNS depression. Precautions: Respiratory disease, history of drug or alcohol abuse, drug dependence, pregnancy, breast feeding, renal and hepatic impairment and avoid operating vehicles or machinery. Interactions: Erythromycin, clarithromycin, isoniazid, fentanyl, itraconazole, ketoconazole, digoxin, phenytoin, rifampicin, ethanol. Adverse Reactions: Drowsiness, dizziness, vertigo, hallucinations, blurred vision, confusion, muscle weakness, fatigue, incontinence or urinary retention, constipation, rashes, changes in libido, leucopenia and GI, hypotension, ataxia, respiratory depression, sedation, depression, headache, nausea, tremor, withdrawal syndrome, neutropenia, hepatotoxicity, pancytopenia, thrombocytopenia, blood dyscrasias, bradycardia, dependence/abuse. Lorazepam 1 mg Tablet Ativan - Trade Name
N05BA06000T1001XX (A/KK)

System: Psychiatry Indications: Severe anxiety and insomnia. Dosage: Severe anxiety: 1 - 4 mg increased to 10 mg dly in divided doses. Insomnia: 1 - 2 mg at bedtime. Not recommended in children. Contraindications: Respiratory depression, acute pulmonary insufficiency, sleep apnoea syndrome, severe hepatic impairment, myasthenia gravis, phobic or obsessional states, depression or anxiety with depression. Precautions: Concomitant use of CNS drugs such as phenothiazines, narcotic analgesics, barbiturates, antidepressants, scopolamine, and MAOIs; elderly and debilitated patients, patients with a limited pulmonary reserve; doses exceeding 2 mg/day in geriatric patients or debilitated patients, not recommended in patients with primary depressive disorder or psychosis. Potential for drug abuse, impaired liver/renal function. Interactions: Theophylline, decreased benzodiazepine effectiveness. Valproic acid, increased lorazepam concentrations. Clozapine, CNS depression. Contraceptive, decreased lorazepam effect. Ethanol, opiate agonists/antagonists, phenytoins. Adverse Reactions: Fatigue, hypotension, ataxia, respiratory depression, sedation, confusion, depression, headache, nausea, tremor, urinary retention, vertigo, withdrawal syndrome, neutropenia, hepatotoxicity, pancytopenia, thrombocytopenia, blood dyscrasias, bradycardia, dependence/abuse. Bromazepam 1.5 mg Tablet Lexotan - Trade Name System: Psychiatry
N05BA08000T1001XX (A)

415

Indications: Anxiety disorders Dosage: 3 - 18 mg dly in divided doses. Severe hospital cases up to 60 mg dly. Children not recommended. Contraindications: Shock, severe psychosis, pregnancy and breastfeeding. Precautions: May produce physical and psychological dependence, amnesia, may increase frequency and severity of grand mal seizures. Care in organic brain disease, cardiorespiratory insufficiency, decreased hepatic or renal function. COPD or respiratory failure. Reduce dose in elderly and avoid chronic use. Interactions: Theophylline, decreased benzodiazepine effectiveness. Cimetidine, bromazepam toxicity (CNS depression). Sedative effects increased by other centrally acting drugs. Enhances CNS depressant effect of alcohol. Adverse Reactions: Fatigue, muscle weakness, drowsiness, hypotension, nausea and vomiting. Bromazepam 3 mg Tablet Lexotan - Trade Name
N05BA08000T1002XX (A)

System: Psychiatry Indications: Anxiety disorders Dosage: 3 - 18 mg dly in divided doses. Severe hospital cases up to 60 mg dly. Children not recommended. Contraindications: Shock,severe psychosis, pregnancy and breastfeeding. Precautions: May produce physical and psychological dependence, amnesia, may increase frequency and severity of grand mal seizure. Care in organic brain disease, cardiorespiratory insufficiency, decreased hepatic or renal function. COPD or respiratory failure. Reduce dose in elderly and avoid chronic use. Interactions: Theophylline, decreased benzodiazepine effectiveness. Cimetidine, bromazepam toxicity (CNS depression). Sedative effects increased by other centrally actinf drugs. Enhances CNS depressants effect of alcohol. Adverse Reactions: Fatigue, muscle weakness, drowsiness, hypotension, nausea and vomiting. Alprazolam 0.25 mg Tablet X a n a x - Trade Name
N05BA12000T1001XX (A/KK)

System: Psychiatry Indications: Anxiety disorders. Dosage: 250 - 500 mcg tds, increased if necessary to a total dose of 3 mg/day. Not recommended for children Contraindications: Hypersensitivity to benzodiazepines, acute narrow angle glaucoma, concomitant use of ketoconazole/ itraconazole, CNS depression. Precautions: Avoid operating vehicles or machinery, abuse prone patient, 416

pregnancy and breastfeeding, renal or hepatic dysfunction, elderly patients. Interactions: Ketoconazole, fluconazole, itraconazole, contraceptives; increased alprazolam serum concentrations and potential alprazolam toxicity (sedation, slurred speech, CNS depression). Omeprazole, erythromycin, clarithromycin, cimetidine; benzodiazepine toxicity (CNS depression, ataxia, lethargy). Sertraline, increased risk of psychomotor impairment and sedation. Fluoxetine, increased risk of alprazolam toxicity (somnolence, dizziness, ataxia, slurred speech, hypotension, psychomotor impairment). Fluvoxamine, increased risk of CNS side effects. Ritonavir, increased plasma concentrations of alprazolam and enhanced alprazolam effects. Antihistamine/decongestant combinations, antipsychotic, ethanol, maprotiline, mirtazapine, phenothiazines, venlafaxine (increased risk of CNS depression, psychomotor impairment), sedative/hypnotics, tricyclic antidepressants (CNS depression). Adverse Reactions: Drowsiness, blurred vision, coordination disorder, GI disturbance, agitation, lightheadedness, dry mouth, depression, headache, confusion, hypotension, syncope, tachycardia, seizures, respiratory depression, coma, constipation, diarrhoea, nausea, vomiting, insomnia, nasal congestion, rigidity, increased salivation, dermatitis, sedation. Alprazolam 0.5 mg Tablet X a n a x - Trade Name
N05BA12000T1002XX (A)

System: Psychiatry Indications: Anxiety disorders. Dosage: 250 - 500 mcg tds, increased if necessary to a total dose of 3 mg/day. Not recommended for children. Contraindications: Hypersensitivity to benzodiazepines, acute narrow angle glaucoma, concomitant use of ketoconazole/ itraconazole, CNS depression. Precautions: Avoid operating vehicles or machinery, abuse prone patient, pregnancy and breastfeeding, renal or hepatic dysfunction, elderly patients. Interactions: Ketoconazole, fluconazole, itraconazole, contraceptives; increased alprazolam serum concentrations and potential alpraz olam toxicity (sedation, slurred speech, CNS depression).Omeprazole, erythromycin, clarithromycin, cimetidine; benzodiazepine toxicity (CNS depression, ataxia, lethargy). Sertraline, increased risk of psychomotor impairment and sedation. Fluoxetine, increased risk of alprazolam toxicity (somnolence, dizziness, ataxia, slurred speech, hypotension, psychomotor impairment). Fluvoxamine, increased risk of CNS side effects. Ritonavir, increased plasma concentrations of alprazolam and enhanced alprazolam effects. Antihistamine/decongestant combinations, antipsychotic, ethanol, maprotiline, mirtazapine, phenothiazines, venlafaxine (increased risk of CNS depression, psychomotor impairment), sedative/hypnotics, tricyclic antidepressants (CNS depression). Adverse Reactions: Drowsiness, blurred vision, coordination disorder, GI disturbance, agitation, lightheadedness, dry mouth, depression, headache, confusion, hypotension, syncope, tachycardia, seizures, respiratory depression, coma, constipation, diarrhoea, nausea, vomiting, insomnia, nasal congestion, rigidity, increased salivation, dermatitis, sedation. 417

Alprazolam 1 mg Tablet X a n a x - Trade Name

N05BA12000T1003XX (A)

System: Psychiatry Indications: Anxiety disorders. Dosage: 250 - 500 mcg tds, increased if necessary to a total dose of 3 mg/day. Not recommended for children. Contraindications: Hypersensitivity to benzodiazepines, acute narrow angle glaucoma, concomitant use of ketoconazole/ itraconazole, CNS depression. Precautions: Avoid operating vehicles or machinery, abuse prone patient, pregnancy and breastfeeding, renal or hepatic dysfunction, elderly patients. Interactions: Ketoconazole, fluconazole, itraconazole, contraceptives; increased alprazolam serum concentrations and potential alprazolam toxicity (sedation, slurred speech, CNS depression). Omeprazole, erythromycin, clarithromycin, cimetidine; benzodiazepine toxicity (CNS depression, ataxia, lethargy). Sertraline, increased risk of psychomotor impairment and sedation. Fluoxetine, increased risk of alprazolam toxicity (somnolence, dizziness, ataxia, slurred speech, hypotension, psychomotor impairment). Fluvoxamine, increased risk of CNS side effects. Ritonavir, increased plasma concentrations of alprazolam and enhanced alprazolam effects. Antihistamine/decongestant combinations, antipsychotics, ethanol, maprotiline, mirtazapine, phenothiazines, venlafaxine (increase risk of CNS depression, psychomotor impairment), sedative/hypnotics, tricyclic antidepressants (CNS depression). Adverse Reactions: Drowsiness, blurred vision, coordination disorder, GI disturbance, agitation, lightheadedness, dry mouth, depression, headache, confusion, hypotension, syncope, tachycardia, seizures, respiratory depression, coma, constipation, diarrhoea, nausea, vomiting, insomnia, nasal congestion, rigidity, increased salivation, dermatitis, sedation. Hydroxyzine HCl 25 mg Tablet Atarax - Trade Name
N05BB01110T1001XX (A)

System: Ear, Nose and Oropharynx Indications: Allergic pruritis. Dosage: Initially 25 mg at night, increased if necessary; up to 25 mg tds - qid. Adult & Children > 10 yrs: 50 - 75 mg; 6 - 10 yrs: 25 - 50 mg; 1 - 5 yrs: 12.5 - 25 mg; to be taken daily in divided doses. Contraindications: Pregnancy, breastfeeding and hypersensitivity reaction. Precautions: Concomitant administration with central nervous system depressants, asthma, dose adjustment in liver disease. Avoid driving and operating machinery. Interactions: Sedating antihistamines may enhance the sedative effects of 418

CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics. Have an additive antimuscarinic action with other antimuscarinic drugs. Adverse Reactions: Sleepiness, drowsiness, headache, dizziness, weakness, depression and irritability, dry mouth. Thiopental Sodium 500 mg Injection P e n t o t h a l - Trade Name
N05CA19520P3001XX (B) NEDL APPL

System: Anaesthesia Indications: General anaesthesia, induction, anticonvulsant for cases resistant to conventional anticonvulsants in th e ICU. Dosage: Adults: For induction 200-400 mg. For repeat inj. 3-5 mg/kg over 10-15 sec. until desired depth of anaesthesia is obtained. Contraindications: Porphyria, status asthmaticus, respiratory failure, shock and fixed cardiac output states. Precautions: Reduce dose in severe liver disease, cardiovascular disease, elderly, bronchiol asthma, adrenocorticol insufficiency. Interactions: Alfentanil, hydromorphone, metoclopramide, midazolam, sevoflurane, nalbuphine, pentazocine, propoxyphene, alcohol, succinylcholine. Adverse Reactions: Cardio-respiratory depression, coughing, laryngospasm, bronchoconstriction, haemolytic anaemia with renal failure, vasodilation, intracranial pressure changes, hepatotoxicity and erythema. Chloral Hydrate 200 mg/5 ml Mixture
N05CC01010L2101XX (B) NEDL

System: Psychiatry Indications: Anxiety and preoperative sedation. Dosage: Adult : 0.5 - 1 g (max 2 g) with plenty of water at bedtime. Child : 30 - 50 mg/kg up to a max dose of 1 g. Contraindications: Hypersensitivity to chloral hydrate products, cardiac disease, hepatic or renal impairment, pregnancy, breast feeding, porphyria. Precautions: History of gastritis or duodenal ulcers, mentally depressed patients, severe cardiac disease, respiratory disease. Interactions: Warfarin, increased risk of bleeding. Frusemide, cardiovascular toxicity (diaphoresis, hypertension, tachycardia). Alcohol, increased sedation. Adverse Reactions: Arrhythmias, hallucination, disorientation, nausea, vomiting, diarrhoea, gastric irritation. Vertigo, nightmares, delirium, flatulence. Paraldehyde 10 ml Injection System: Neurology
N05CC05000P3001XX (C) NEDL

419

Indications: Status epilepticus. Dosage: 5 - 10 ml IM as a single dose. Usual max 20 ml dly with not more than 5 ml at any one site. Contraindications: Hypersensitivity to paraldehyde products, lung or hepatic disease, gastric disorders. Precautions: May be irritating to the throat, bronchopulmonary disease, hepatic impairment, pregnancy, breast feeding. Interactions: Disulfiram, alcohol. Adverse Reactions: Hypotension, mental confusion, metabolic acidosis, dyspnoea, delirium, rashes. Nitrazepam 5 mg Tablet Mogadon - Trade Name
N05CD02000T1001XX (B)NEDL

System: Neurology Indications: Epilepsy (Infantile spasms). Dosage: 5 - 10 mg at bedtime. Elderly or debilitated 2.5-5 mg. Child not recommended. increasing slowly according to response. Contraindications: Hypersensitivity to nitrazepam products or benzodiazepines, respiratory depression, acute pulmonary insufficiency, severe hepatic impairment, myasthenia gravis. Precautions: Elderly patients (increased sensitivity to CNS effects), pregnancy, breast feeding, respiratory disease, muscle weakness. Interactions: Enhances sedative effect of centrally acting drugs. Adverse Reactions: Confusion, dependence, dizziness, drowsiness. Temazepam 10 mg Capsule N o r m i s o n - Trade Name
N05CD07000C1001XX (A)

System: Psychiatry Indications: Insomnia. Dosage: 10 - 20 mg at bedtime, exceptional circumstances 30-40 mg; elderly or debilitated: 10 mg at bedtime, exceptional circumstances 20 mg; child not recommended. Contraindications: Hypersensitivity to benzodiazepines, pregnancy, breastfeeding, respiratory depression, severe hepatic impairment, myasthenia gravis. Precautions: Addiction-prone individual, chronic pulmonary insufficiency, concomitant use with alcohol and other CNS depressants, elderly, epilepsy, impaired renal & hepatic function and azole antifungals. Interactions: Theophylline, decreased benzodiazepine effectiveness. Contraceptives, (combination) may result in decreased temazepam effectiveness. Caffeine, reduced sedative and anxiolytic effects of temazepam. Ethanol, impaired psychomotor functions. Sedating antihistamines, central 420

alpha2 agonists, muscle relaxants, opiate agonists/antagonists, phenytoin, tricyclic antidepressants. Adverse Reactions: Drowsiness, headache, confusion, hypotension, hangover, dizziness, dry mouth, euphoria, nightmares, vertigo, respiratory depression, seizures and coma. Midazolam 5 mg/5 ml Injection Midazolam 5 mg/ml Injection D o r m i c u m - Trade Name
N05C D08110P3001XX (A) NEDL N05CD08110P3002XX (A)

System: Anaesthesia Indications: Pre-operative sedation, induction of general anaesthesia, premedication and sedation in ICU and sedation for minor procedures. Dosage: Usual sedative range 2.5 - 7.5 mg (about 70 mcg/kg by IV injection over 30 secs). Premedication by IM injection 70 - 100 mcg/kg 30 -60 mins before surgery. Elderly : 1-1.5 mg/kg Induction: Induction by slow IV infusion 200 - 300 mcg/kg (elderly 100 - 200 mcg/kg. Child over 7 yrs 150-200 mcg/kg). Max:0.35mg/kg. Sedation in ICU 0.03-0.2mg/kg/hr. Contraindications: Acute narrow angle glaucoma, hypersensitivity to midazolam products, acute alcohol intoxication, shock, lactation. Precautions: Elderly, COPD, CHF, respiratory failure, severe electrolyte and fluid disturbances, pregnancy and lactation. Interactions: Neuroleptics, tranquilizer, antidepressant, hypnotics, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepiletics, antihistamines, erythromycin, clarithromycin, carbamazepine, phenytoin, cimetidine, omeprazole, diltiazem, efavirenz, indinavir, nelfinavir, ritonavir, saquinavir, fluvoxamine, halothane, sevoflurane, thiopental, itraconazole, theophylline. Adverse Reactions: Muscle stiffness, induration of veins, pain,redness, headache, apnoea, nausea, coughing, vomitting, drowsiness, respiratory depression, phlebitis. Midazolam 7.5 mg Tablet D o r m i c u m - Trade Name
N05CD08110T1001XX (A/KK)

System: Anaesthesia Indications: Pre and post-operative sedation. Dosage: Adult : Usually 7.5 - 15 mg at bedtime; or for premedication, 30 - 60 mins. before the procedure. For elderly, debilitated or impaired liver/kidney function : 7.5 mg. Contraindications: Acute narrow angle glaucoma, hypersensitivity to midazolam products. Precautions: Elderly,COPD,resp. failure,severe electrolyte and fluid imbalance,pregnancy and lactation Interactions: Neuroleptics, tranquilizer, antidepressant, hypnotics. Adverse Reactions: Muscle stiffness, induration, headache, apnoea, nausea, vomiting, drowsiness. 421

Midazolam 15 mg Tablet D o r m i c u m - Trade Name

N05CD08110T1002XX (A)NEDL

System: Anaesthesia Indications: Pre and post- operative sedation. Dosage: Adult : Usually 7.5 - 15 mg at bedtime; or for premedicati on, 30 - 60 min. before the procedure. For elderly, debilitated or impaired liver or kidney function : 7.5 mg. Contraindications: Acute narrow angle glaucoma, hypersensitivity to midazolam products. Precautions: Elderly, COPD, respiratory failure, severe eletrolyte and fluid imbalance, pregnancy and lactation. Interactions: Neuroleptics, tranquilizer, antidepressant, hypnotics. Adverse Reactions: Muscle stiffness, induration, headache, apnoea, nausea, vomiting, drowsiness. Zolpidem Tartrate 10mg Tablet Stilnox - Trade Name
N05CF02123T1001XX (A)

System: Psychiatry Indications: For treatment of insomnia. Dosage: 10mg initially at bedtime and may increased to 15 or 20 mg according to the patient's response. In elderly, 5mg initially. Contraindications: Obstructive sleep apnoea, acute pulmonary insufficiency, respiratory depression, myasthenia gravis, severe hepatic impairment, psychotic illness, pregnancy, breastfeeding. Precautions: Depression, drug or alcohol abuse, hepatic impairment, avoid prolonged use in elderly. Interactions: Alcohol, analgesics, antidepressants, anticoagulants, antivirals, sedating antihistamines, antipsychotics, benzodiazepines, central alpha2 agonists, ethanol, opiate agonists/antagonists. Adverse Reactions: Nausea, dizziness, dependence, vertigo, headache, drowsiness, myalgias, dyspepsia, dry mouth, lethargy, flu-like symptoms, depression, constipation, ataxia, hallucinations. Dexmedetomidine HCl 100 mcg/ml Injection Precedex - Trade Name
N05CM00110P4001XX (A*)

System: Anaesthesia Indications: For use by specialist anaesthetist in ICU for sedation and analgesia of patient on mechanical ventilation in ICU. Dosage: Not to be infused for > 24hrs. 1 mcg/kg over 20 min as loading dose. Maintenance dose: 0.2 - 0.7 mcg/kg/hr. Contraindications: Hypersensitivity to dexmedetomidine. 422

Precautions: Significant CV dysfunction, advanced heart block, renal & hepatic impairment, elderly > 65 yr, pregnancy, lactation. Interactions: Enhances effects of anaesthesia, sedative, hypnotics & other CNS depressants, opiods. Adverse Reactions: Hypotension, hypertension, bradycardia, nausea, dry mouth, hypoxia, somnolence. Imipramine HCl 25 mg Tablet T o f r a n i l - Trade Name
N06AA02110T1001XX (B) NEDL APPL

System: Psychiatry Indications: Depression. Dosage: Initially up to 75 mg daily in divided doses increased gradually to 150 - 200 mg (up to 300 mg in hospital patients); up to 150 mg may be given as a single dose at bedtime. Elderly initially 10 mg daily; increased gradually to 30 - 50 mg daily ; child is not recommended. Contraindications: MAOIs use within 14 days, first trimester of pregnancy, hypersensitivity to imipramine products, recovery period after MI. Precautions: Patient with thrombosis, angina, CHF disorder, urinary retention, glaucoma and agitated patient, seizure, thyroid disease, impaired liver function. Interactions: Barbiturates, alcohol, tranquilliser, anticholinergics, class Ia and III antiarrhythmics, beta2 agonists, carbamazepine, cimetidine, lithium, quinolones, indirect/mixed sympathomimetics. Adverse Reactions: Anticholinergic, drowsiness, dizziness, tinitus, palpitation and tachycardia, seizure, weight gain, constipation, urinary retention, increased appetite, confusion, agranulocytosis, thrombocytopenia, blood dyscrasias. Clomipramine HCl 25 mg Tablet A n a f r a n i l - Trade Name
N06AA04110T1001XX (A)NEDL

System: Psychiatry Indications: Depressive illness, obsessive-compulsive disorder Dosage: Initially 10 mg daily, increased gradually as necessary to 30 - 150 mg daily in divided doses or as a single dose at bedtime; max 250 mg daily. Elderly initially 10 mg daily increased carefully over approximately 10 days to 30 - 75 mg daily; child not recommended. Contraindications: Hypersensitivity to drug, concomitant/recent use of MAOIs, recent MI, urinary retention, glaucoma, phaeochromocytoma. Precautions: Heart failure, acute MI, disturbance of cardiac conduction, low BP, impaired liver function, impaired renal function, seizure disorder. Interactions: May diminish antihypertensive effect of adrenergic neuron inhibitors, class Ia and III antiarrhythmics, anticholinergics, beta2 agonists, cimetidine, lithium, MAOIs, antipsychotics, phenytoin, SSRIs, indirect/mixed sympathomimetics. Adverse Reactions: Anticholinergic reactions, CV effects, insomnia, increase anxiety, skin rashes, dizziness, somnolence, headache, constipation, fatigue, 423

nausea, sweating, dyspepsia, libido changes, seizures. Amitriptyline HCl 25 mg Tablet Laroxyl - Trade Name
N06AA09110T1001XX (B)NEDL

System: Psychiatry Indications: Depression. Dosage: Initially 75 mg (adolescents & elderly 30 -75 mg)dly in divided doses or as a single dose at bedtime increase gradually as necessary to 150 - 200 mg; child < 16 yrs are not recommended. Contraindications: Hypersensitivity to drug/class. Immediate recovery phase after MI, heart block, mania. MAOI use within the last 14 days. Precautions: CV disease, hyperthyroidism, impaired hepatic function, urinary retention, history of seizures, glaucoma, suicide risk. Interactions: Barbiturate, phenytoin, carbamazepine, cimetidine, amphetamines, antiarrhythmics, class Ia and III, anticholinergics, antihistamines, beta 2 agonists, benzodiazepines, systemic carbonic anhydrase inhibitors, central alpha2 agonists, cholinergic agents, clozapine, intranasal decongestants, flumazenil, halothane, lithium, MAO inhibitors, methylphenidate, metoclopramide, muscle relaxants, nitrates, opiates, antipsychotics, phenytoin, protease inhibitors, sedatives/hypnotics, SSRI's, indirect/mixed sympathomimetics. Adverse Reactions: Dry mouth, constipation, urinary retention, blurred vision, drowsiness, dizziness, tachycardia, increased appetite, confusion, seizures, myocardial infarction, stroke, agranulocytosis, thrombocytopenia. Dothiepin HCl 25 mg Capsule P r o t h i a d e n - Trade Name
N06AA16110C1001XX (A)

System: Psychiatry Indications: Depression of any aetiology. Dosage: Initially 75 mg (elderly and adolescents 30 - 75 mg) daily in divided doses or single dose at bedtime, increased to 150 - 200 mg, up to 225 mg dly in some circumstances. Child is not recommended. Contraindications: Concomitant use of MAOIs, recovery phase of MI, hepatic failure, epilepsy. Precautions: May activate latent schizophrenia, exaggerate paranoid delusions. Renal or hepatic impairment. Pregnancy and lactation. Children < 16 years. Interactions: Alcohol, barbiturate, tranquilliser, MAOIs, anticholinergic, antihistamine, sympathomimetics. Adverse Reactions: Drowsiness, extrapyramidal symptoms, tremor, confusional state, disorientation, dizziness, anticholinergic effects, paraesthesia, hypotension, tachycardia, palpitations, arrhythmias, conduction defects, libido changes, nausea, vomiting, constipation. 424

Dothiepin HCl 75 mg Tablet P r o t h i a d e n - Trade Name

N06AA16110T1001XX (A)NEDL

System: Psychiatry Indications: Depression of any aetiology. Dosage: Initially 75 mg (elderly and adolescents 30 - 75 mg) daily in divided doses or single dose at bedtime, increased to 150 - 200 mg, up to 225 mg dly in some circumstances. Child is not recommended. Contraindications: Concomitant use of MAOIs, recovery phase of MI, hepatic failure, epilepsy. Precautions: May activate latent schizophrenia, exaggerate paranoid delusions. Renal or hepatic impairment. Pregnancy and lactation. Children < 16 years. Interactions: Alcohol, barbiturate, tranquilliser, MAOIs, anticholinergic, antihistamine, sympathomimetics. Adverse Reactions: Drowsiness, extrapyramidal symptoms, tremor, confusional state, disorientation, dizziness, anticholinergic effects, paraesthesia, hypotension, tachycardia, palpitations, arrhythmias, conduction defects, libido changes, nausea, vomiting, constipation. Fluoxetine HCL 20 mg Capsule P r o z a c - Trade Name
N06AB03110C1001XX (A)

System: Psychiatry Indications: i) Depressive illness ii) Obsessive-compulsive disorder. Dosage: i) 20 mg once daily increased after 3 weeks if necessary, usual dose 20 - 60 mg (elderly 20 - 40 mg) once daily max 80 mg once daily (elderly max 60 mg once daily). ii) Initially 20 mg once daily increased after 2 weeks if necessary, usual dose 20 - 60 mg (elderly 20 - 40 mg) once daily, max 80 mg (elderly max 60 mg) once daily, discontinue if no improvement within 10 weeks. Child & adolescent under 18 years are not recommended. Contraindications: Present or recent treatment with MAOIs, hypersensitivity to fluoxetine. Precautions: History of seizure, elderly, volume depletion, diabetes, pregnancy and breastfeeding, impaired renal/liver function. Interactions: Drugs metabolised by cytochrome P450, CNS active drugs, drugs highly bound to protein plasma. Benzodiazepines, caffeine, ergotamine, clozapine, lithium, MAOIs, phenytoin, antipsychotics, propranolol, warfarin. Adverse Reactions: Tremor, asthenia, GI disorder, inappropriate secretion of ADH, nervousness, insomnia, headache, anorexia, anxiety, dry mouth, decreased libido, delayed ejaculation, anorgasmia, sweating and serotonin syndrome. 425

Sertraline HCL 50 mg Tablet Z o l o f t - Trade Name

N06AB06110T1001XX (B)

System: Psychiatry Indications: Major depression, obsessive-compulsive disorder (OCD), panic disorder. Dosage: Depression, OCD: 50mg/day. Panic disorder: Initially 25mg/day. After 1 week, increase dose to 50mg/day. All dose changes should be made at intervals of > 1 week, max: 200mg/day. Contraindications: Concurrent use or recent use of MAOIs, hypersensitivity to sertraline products. Precautions: Concomitant use with tryptophan and fenfluramine, hepatic insufficency, electroconvulsive therapy. Interactions: MAOIs, serotonergic drugs, caffeine/ergotamine, cimetidine, lithium, metoprolol, phenytoin, propranolol, warfarin. Adverse Reactions: Male sexual dysfunction, GI complain, tremor, dizziness, insomnia, headache, dry mouth, somnolence, ejaculatory dysfunction, dyspepsia, decreased libido, sweating, anorexia, agitation, visual disturbances, serotonin syndrome, withdrawal syndrome. Fluvoxamine 50 mg Tablet Fluvoxamine 100 mg Tablet Luvox - Trade Name
N06AB08253T1001XX (B) N06AB08253T1002XX (B)

System: Psychiatry Indications: Depressive disorder. Dosage: For depression, initially 50 - 100 mg dly in the evening, increased if necessary to 300 mg dly (over 150 mg in divided doses); usual maintenance dose 100 mg daily. Children is not recommended. Contraindications: Use of MAOI within 14 days, coadministration of terfenadine, astemizole, or cisapride hypersensitivity to fluvoxamine. Precautions: Concomitant use with MAOIs, hepatic insufficiency, children & epilepticus, pregnancy & lactation. CV disease. Avoid abrupt withdrawal. Interactions: Warfarin, phenytoin, theophyline, propanolol, lithium, benzodiazepines, caffeine, ergotamine, MAOIs, propranolol, sildenafil, statins, warfarin. Adverse Reactions: Blurred vision, dry mouth, tremor, GI disturbance, somnolence, constipation, headache, insomnia, vomiting, dizziness, agitation, extrapyramidal effects, bradycardia, seizures, hepatotoxicity, withdrawal syndrome. Moclobemide 150 mg Tablet A u r o r i x - Trade Name System: Psychiatry
N06AG02000T1001XX (A*)

426

Indications: As a second line treatment of depression. Dosage: Initially 300 mg dly. Gradually to increase up to 600 mg dly in divided doses depending on response. Usual range 150 - 600 mg dly. Not recommended in children. Contraindications: Acute confusional state, hypersensitivity to moclobemide products. Precautions: Avoid in excited and agitated patient, thyorotoxicosis, hepatic impairment, pregnancy and breastfeeding. Interactions: Tricyclic antidepressants, beta-2 agonist, carbamazepine. Adverse Reactions: Sleep disturbance, dizziness, GI disturbance, restlessness, agitation, blurred vision, dry mouth, headache, constipation. Mirtazapine 30 mg Tablet R e m e r o n - Trade Name
N06AX11000T1001XX (A*)

System: Psychiatry Indications: Episodes of major depression. Dosage: Initially 15 mg daily at bedtime increased according to response up to 45 mg daily as a single dose at bedtime or in 2 divided doses; child not recommended. Contraindications: Hypersensitivity to Mirtarzapine or component of formulation, MOAIs. Precautions: Heart disease, hypotension, epilepsy, hepatic disease, renal impairment, pregnancy, mania & hypomania, hypersensitivity to other antidepressants. Interactions: Clonidine, monoamine oxidase inhibitors, ethanol, warfarin, carbamazepine, phenytoin, ketoconazole, cimetidine, methadone, rifampicin, other antivirals such as saquinavir, St. John's wort. Adverse Reactions: Agranulocytopenia, neutropenia, mania, dizziness, increase appetite, constipation, somnolence. Venlafaxine Hydrochloride 75 mg Extended Release Tablet Efexor XR
N06AX16110T5001XX (A*)
- Trade Name

System: Psychiatry Indications: Depression, generalized anxiety disorder. Dosage: 37.5 - 75 mg orally. May increase dosage by 75 mg/day increments every 4 days to a max. dose of 225mg/day. Contraindications: Recent or concomitant use of MAOIs. Precautions: Activation of mania/hypomania, changes in appetite or weight, glaucoma, history of seizure, hyponatraemia, syndrome of inappropriate antidiuretic hormone syndrome, liver disease, patients with recent myocardial infarction or unstable heart disease, renal impairment, sustained hypertension. Careful monitoring required due to risk of suicide in depressed patients. 427

Interactions: Clozapine, dexfenfluramine droperidol, fenfluramine, haloperidol, linezolid, lithium, metoclopramide, moclobemide, NSAIDs, procarbazine, selegiline, thioridazine, tramadol, trifluoperazine. Adverse Reactions: Abnormal ejaculation, anorgasmia, impotence, anorexia, constipation, weight loss, diarrhoea, dyspepsia, anxiety, dizziness, insomnia, nervousness, somnolence, tremor, asthenia, abnormal bleeding, activation of mania, suicide, hepatitis, hypertension, hyponatraemia, seizures. Venlafaxine Hydrochloride 150 mg Extended Release Tablet Efexor XR
N06AX16110T5002XX (A*)
- Trade Name

System: Psychiatry Indications: Depression, generalized anxiety disorder. Dosage: 37.5 - 75 mg orally. May increase dosage by 75 mg/day increments every 4 days to a max. dose of 225mg/day. Contraindications: Recent or concomitant use of MAOI. Precautions: Activati on of mania/hypomania, changes in appetite or weight, glaucoma, history of seizure, hyponatraemia, syndrome of inappropriate antidiuretic hormone syndrome SIADH, liver disease, patients with recent myocardial infarction or unstable heart disease, renal impairment, sustained hypertension. Careful monitoring required due to risk of suicide in depressed patients. Interactions: Clozapine, dexfenfluramine, droperidol, fenfluramine, haloperidol, linezolid, lithium, metoclopramide, moclobemide, NSAIDs, procarbazine, selegiline, thioridazine, tramadol, trifluoperazine. Adverse Reactions: Abnormal ejaculation, anorgasmia, impotence, anorexia, constipation, weight loss, diarrhoea, dyspepsia, anxiety, dizziness, insomnia, nervousness, somnolence, tremor, asthenia, abnormal bleeding, activation of mania, suicide, hepatitis, hypertension, hyponatraemia, seizures. Methylphenidate HCl 10 mg Tablet R i t a l i n - Trade Name
N06BA04110T1001XX (A)

System: Neurology Indications: Hyperkinetic disorder (Attention deficit hyperactivity disorder) Dosage: Child over 6 yrs, initially 5 mg 1 - 2 times daily, increased if necessary at weekly intervals by 5 - 10 mg daily to max. 60 mg daily in divided doses; discontinue if no response after 1 month, also suspend periodically to assess child's condition (usually finally discontinued during or after puberty). Contraindications: Anxiety and tension states, agitation, tics, tics in siblings, familial history or diagnosis of Tourette's syndrome, glaucoma, hyperthyrodism, cardiac arrythmias, severe angina pectoris, hypersensitivity to drug/class, children < 6 years of age, MAOIs use within 14 days. Precautions: May exacerbate behavioral disturbance and thought disorder in psychotic patients. Not for severe depression. Chronic abuse can lead to 428

marked tolerance and psychic dependence. Epilepsy and hypertension. Monitor blood count during long-term treatment. Careful supervision during drug withdrawal. Children less than 6 years. Pregnancy and lactation. Caution in road/machinery users. CV disease, alcohol/drug abuse, hyperthyroidism. Interactions: Pressor agents, MAOIs, anticoagulants, tricyclic antidepressants, phenylbutazone, guanethidine, caffeine, central alpha2 agonists, MAOIs, phenytoin, tricyclic antidepressants, warfarin. Adverse Reactions: Nervousness, insomnia, decreased appetite. Ocassionally headache, drowsiness, dizziness, dry mouth, tachycardia, palpitations, arrhythmias, changes in BP and heart rate. GI disturbances, skin reactions, fever, arthralgia. Rare: blurred vision, moderately reduced weight gain and minor growth retardation in children. Seizures, dependency, leucopenia. Methylphenidate HCl SR 20 mg Tablet R i t a l i n S R - Trade Name
N06BA04110T5001XX (A)

System: Neurology Indications: Attention-deficit hyperactivity disorder (ADHD) children that goes to school. Dosage: >6 years old: 10-20mg od-bd. Initial 10mg in the morning. Increase by 10mg/day every 7 days. Maximum: 2mg/kg/day up to 60mg/day. Contraindications: Anxiety and tension states, agitation, tics, tics in siblings, familial history or diagnosis of Tourette's syndrome, glaucoma, hyperthyrodism, cardiac arrythmias, severe angina pectoris, hypersensitivity to drug/class, children < 6 years of age, MAOIs use within 14 days. Precautions: May exacerbate behavioral disturbance and thought disorder in psycotic patients. Not for severe depression. Chronic abuse can lead to marked tolerance and psychic dependence. Epilepsy and hypertension. Monitor blood count during long-term treatment. Careful supervision during drug withdrawal. Children less than 6 years. Pregnancy and lactation. Caution in road/machinery users. CV disease, alcohol/drug abuse, hyperthyroidism. Interactions: Pressor agents, MAOIs, anticoagulants, tricyclic antidepressants, phenylbutazone, guanethidine, caffeine, central alpha 2 agonists, MAOIs, phenytoin, tricyclic antidepressants, warfarin. Adverse Reactions: Nervousness, insomnia, decreased appetite. Ocassionally headache, drowsiness, dizziness, dry mouth, tachycardia, palpitations, arrhythmias, changes in BP and heart rate. GI disturbances, skin reactions, fever, arthralgia. Rare: blurred vision, moderately reduced weight gain and minor growth retardation in children. Seizures, dependency, leucopenia. Piracetam 20%Solution Noot ropil - Trade Name
N06BX03000L5001XX (A*)

System: Neurology Indications: Children with learning disability, progressive myoclonic epilepsy and hypoxia. Dosage: 429

30 - 160 mg/kg/day orally. To be given bd or tds - qid. Max 24 g/day. Contraindications: Previous hypersensitivity to piracetam. Precautions: Renal insufficiency (possible need for dose adjustments), elderly patients with multiple diseases. Interactions: No interaction found. Adverse Reactions: Nervousness, agitation, irritability, anxiety and sleep disturbances, fatigue or drowsiness, gastrointestinal disturbances. Piracetam 1 g Injection Nootropil - Trade Name
N06BX03000P3001XX (A*)

System: Neurology Indications: Treatment of cerebral functional impairment & ischaemic stroke. Dosage: 30 - 160 mg/kg/day orally or parenterally bd or tds - qid. Max. : 24 g/day. Contraindications: Previous hypersensitivity to piracetam. Precautions: Renal insufficiency (possible need for dose adjustments), elderly patients with multiple diseases. Interactions: No interaction found. Adverse Reactions: Nervousness, agitation, irritability, anxiety and sleep disturbances, fatigue or drowsiness, gastrointestinal disturbances. Piracetam 1.2 g Tablet Nootropil - Trade Name
N06BX03000T1001XX (A*)

System: Neurology Indications: Post concussional head syndrome, head injury disorder, chronic vertigo and myoclonus. Dosage: Initially 7.2 g daily in 2 - 3 divided doses, increased according to response by 4.8 g daily every 3 - 4 days to max. 20 g dly. Child under 16 yrs not recommended. Contraindications: Previous hypersensitivity to piracetam. Precautions: Renal insufficiency (possible need for dose adjustments), elderly patients with multiple diseases. Interactions: No interaction found. Adverse Reactions: Nervousness, agitation, irritability, anxiety and sleep disturbances, fatigue or drowsiness, gastrointestinal disturbances. Donepezil HCl 5 mg Tablet Aricept - Trade Name
N06DA02110T1001XX (A*)

System: Neurology Indications: For psychiatrists and neurologists only. Treatment of mild to moderate dementia in Alzheimer's disease. Dosage: 5 - 10 mg once dly. Max. 10 mg daily. Contraindications: Hypersensitivity to donepezil hydrochloride and piperidine 430

derivatives. Pregnancy and breast feeding. Precautions: History of ulcer disease, asthma or obstructive pulmonary disease or seizures or those receiving concurrent NSAIDs, pregnancy. Interactions: Has the potential for synergistic activity with concurrent succinylcholine, other neuromuscular blocking agents or cholinergic agonist. Has the potential to interfere with drugs having anticholinergic activity. Muscle relaxants drugs, suxamethonium. Adverse Reactions: Diarrhoea, muscle cramps, nausea, vomiting, insomnia, fatigue, dizziness, hallucination, agitation. Donepezil HCL 10 mg Tablet Aricept - Trade Name
N06DA02110T1002XX (A*)

System: Neurology Indications: For psychiatrists and neurologists only. Treatment of mild to moderate dementia in Alzheimer's disease. Dosage: 5-10mg once dly. Max. 10 mg daily. Contraindications: Hypersensitivity to donepezil hydrochloride and piperidine derivatives. Pregnancy and breast feeding. Precautions: History of ulcer disease, asthma or obstructive pulmonary disease or seizures or those receiving concurrent NSAIDs, pregnancy. Interactions: Has the potential for synergistic activity with concurrent succinylcholine, other neuromuscular blocking agents or cholinergic agonist. Has the potential to interfere with drugs having anticholinergic activity. Muscle relaxants drugs, suxamethonium. Adverse Reactions: Diarrhoea, muscle cramps, nausea, vomiting, insomnia, fatigue, dizziness, hallucination, agitation. Rivastigmine 1.5 mg Capsule Rivastigmine 3 mg Capsule Rivastigmine 4.5 mg Capsule E x e l o n - Trade Name
N06DA03123C1001XX (A*) N06DA03123C1002XX (A*) N06DA03123C1003XX (A*)

System: Neurology Indications: For psychiatrists and neurologists only. Treatment of mild to moderate dementia in Alzheimer's Disease. Dosage: 1.5 mg PO bd; may increase by 1.5 mg bd every 2 weeks to max of 6 mg bd. Contraindications: Known hypersensitivity to the drug, other carbamate derivatives, severe liver impairment. Precautions: History of toxicity (especially excessive cholinergic responses)related to other cholinesterase inhibitors (e.g,tacrine), diabetes, cardiovascular/pulmonary disease, gastrointestinal disorders, concurrent use of agents with anticholinergic activity, urogenital tract obstruction, parkinsonism, pregnancy, renal or hepatic insufficiency, high incidence of nausea and vomiting, concurrent NSAIDs. Interactions: Cholinomimetic drugs, anticholinergic medications, 431

succinylcholine-type muscle relaxants during anaesthesia, diazepam, dixogin, fluoxetine and warfarin. Adverse Reactions: Nausea, vomiting, anorexia, dizziness, diarrhoea, abdominal pain, loss of appetite, dyspepsia and headache. Rivastigmine 6 mg Capsule E x e l o n - Trade Name
N06DA03123C1004XX (A*)

System: Neurology Indications: For psychiatrists and neurologists only. Treatment of mild to moderate dementia in Alzheimer's Disease. Dosage: 1.5 mg PO bd; may increase by 1.5 mg bd every 2 weeks to max of 6 mg bd. Contraindications: Known hypersensitivity to the drug, other carbamate derivatives, severe liver impairment. Precautions: History of toxicity (especially excessive cholinergic responses)related to other cholinesterase inhibitors (e.g,tacrine), diabetes, cardiovascular/pulmonary disease, gastrointestinal disorders, concurrent use of agents with anticholinergic activity, urogenital tract obstruction, parkinsonism, pregnancy, renal or hepatic insufficiency, high incidence of nausea and vomiting, concurrent NSAIDs. Interactions: Cholinomimetic drugs, anticholinergic medications, succinylcholine-type muscle relaxants during anaesthesia, diazepam, dixogin, fluoxetine and warfarin. Adverse Reactions: Nausea, vomiting, aneroxia, dizziness, diarrhoea, abdominal pain, loss of appetite, dyspepsia and headache. Rivastigmine Oral 2mg/ml Solution E x e l o n - Trade Name
N06DA03123L9901XX (A*)

System: Neurology Indications: Mild to moderately severe dementia of the Alzheimer type. Dosage: Initial dose 1.5mg bd. May be increased after a minimum of 2 wks of treatment to 3mg bd. Subsequently to 4.5 mg bd, up to max. of 6mg bd. If treatment is interrupted for several days, should be reinitiated at the lowest daily dose. Contraindications: Known hypersensitivity to the drug, other carbamate derivatives. Severe liver impaiment. Precautions: Renal impairment, mild to moderate hepatic impairment, sick sinus syndrome, conduction abnormalities, gastric or duodenal ulcers (and those at risk of developing ulcers), history of asthma or obstructive pulmonary disease, pregnancy, monitor body weight. Interactions: Cholinomimetic drugs, anticholinergic medications, succinylcholine-type muscle relaxants during anaesthesia. Adverse Reactions: GI disturbances, loss of appetite, wt loss, dizziness, headache, somnolence, tremor, agitation, confusion, sweating, malaise, fatigue, asthenia, syncope. Rarely, angina pectoris, gastroduodenal ulcers, seizures & rash. Very rarely, cardiac arrhythmias, hypertension, GI 432

haemorrhage & mild pancreatitis. Edrophonium Cl 10 mg/ml Injection T e n s i l o n - Trade Name

N07AA00100P3001XX (B)

System: Neurology Indications: i) For reversal of neuromuscular block ii) Diagnosis of Myasthenia Gravis Dosage: i) IV inj. On over several minutes, 500 - 700 mcg/kg (after or with Atropine sulphate 600 mcg). ii) IV 2 mg followed if no response occurs within 30 sec, by 8 mg. Children- 20 mcg followed by 80 mcg/kg after 30 sec. Contraindications: GI or urinary obstruction, hypersensitivity to edrophonium products. Precautions: Overdosage may lead to a 'cholinergic crisis'. Patients who have undergone recent intestinal or bladder surgery and in patients with bronchial asthma cardiovascular disorders including arrhythmias, bradycardia, recent myocardial infarction and hypotension. Interactions: Antagonism effect by antimuscarinic. Succinylcholine. Adverse Reactions: Increased GI secretions, hypotension, bradycardia, increased salivation, nausea, vomiting, abdominal cramps, diarrhoea, allergic reactions. Neostigmine Methylsulphate 0.5 mg/ml Injection N07AA01183P3001XX (B) NEDL P r o s t i g m i n e - Trade Name System: Neurology Indications: i) Myasthenia gravis. ii) Reversal of non-depolarising neuromuscular blockade. Dosage: i) Adult: 1 - 2.5 mg at suitable intervals by SC, IM or IV. Usual total daily dose 5 - 20 mg. Paed: 200 - 500 mcg at suitable intervals throughout the day. Neonate: 50 - 250 mcg every 4 hrs. ii) By IV injection over 1 min, 50 - 70 mcg/kg (max 5 mg) after or with Atropine Sulphate 0.6 - 1.2 mg. Contraindications: Mechanical intestinal or urinary obstruction, peritonitis. Precautions: Bronchial asthma, bronchitis, bradycardia, peptic ulcer, epilepsy, Parkinsonism, pregnancy and lactation. Interactions: Antagonism effect by lithium, antimuscarinics, aminoglycoside, clindamycin, procainamide, quinidine, propranolol. Enhanced effect of suxamethonium. Chloroquine have potential to increase symptoms of myasthenia gravis. Cyclopropane or halothane. Adverse Reactions: Allergic reactions, salivation, GI upsets.

433

Neostigmine Methylsulphate 2.5 mg/ml Injection Prostigmine

N07AA01183P3002XX (B) NEDL APPL
- Trade Name

System: Neurology Indications: i) Myasthenia gravis ii) Reversal of non-depolarising neuromuscular blockade Dosage: i) Adult: 1 - 2.5 mg at suitable intervals by SC, IM or IV. Usual total daily dose 5 - 20 mg. Paed: 200 - 500 mcg at suitable intervals throughout the day. Neonate: 50 - 250 mcg every 4 hrs. ii) By IV injection over 1 min, 50 - 70 mcg/kg (max 5 mg) after or with Atropine Sulphate 0.6 - 1.2 mg. Contraindications: Mechanical intestinal or urinary obstruction, peritonitis. Precautions: Bronchial asthma, bronchitis, bradycardia, peptic ulcer, epilepsy, Parkinsonism, pregnancy and lactation. Interactions: Antagonism effect by lithium, antimuscarinics, aminoglycoside, clindamycin, procainamide, quinidine, propranolol. Enhanced effect of suxamethonium. Chloroquine have potential to increase symptoms of myasthenia gravis. Cyclopropane or halothane. Adverse Reactions: Allergic reactions, salivation, GI upsets. Pyridostigmine Bromide 60 mg Tablet M e s t i n o n - Trade Name
N07AA02320T1001XX (B) NEDL APPL

System: Neurology Indications: Myasthenia gravis, intestinal atony, atonic constipation. Dosage: Adult: 0.3 - 1.2 g divided throughout the day and night if required. Child up to 6 yrs initially 30 mg, 6 - 12 years initially 60 mg, usual total daily dose 30 - 360 mg. Contraindications: Intestinal or urinary obstruction. Precautions: Bronchial asthma (extreme caution) or bronchitis, renal disease. Interactions: Potentiates actions of morphine derivatives and barbiturates. Adverse Reactions: Abdominal cramps, excessive sweating, bronchoconstriction, lacrimation, bradycardia, asystole. Distigmine Bromide 0.5 mg/ml Injection U b r e t i d - Trade Name
N07AA03320P3001XX (A)

System: Genitourinary Indications: Prevention and treatment of intestinal atony and neurogenic bladder. Dosage: 500 mcg dly IM about 12 hrs after surgery and may be repeated every 24 hrs. Contraindications: Severe constipation, intestinal or urinary obstruction or where increased muscular activity of urinary or gastrointestinal tract harmful, asthma postoperative shock, serious circulatory insufficiency. 434

Precautions: Cardiac disorder, hyperthyrodism, epilepsy, parkinsonism. Interactions: Antiarrythmics, antimalarials, antibacterials, lithium. Adverse Reactions: Dyspnoea, muscle twitching, urinary frequency. Distigmine Bromide 5 mg Tablet Ubreti d - Trade Name
N07AA03320T1001XX (A)

System: Genitourinary Indications: i) Myasthenia gravis ii) Prevention and treatment of post-operative intestinal atony, urinary retention and neurogenic bladder. Dosage: i) Adult : 5 mg dly 30 mins before breakfast. Max. 20 mg dly. Paed: Up to 10 mg dly according to age. ii) Urinary retention : 5 mg dly 30 mins before breakfast. Neurogenic bladder : 5 mg dly or on alternate days 30 mins before breakfast. Contraindications: Severe constipation, intestinal or urinary obstruction or where increased muscular activity of urinary or gastrointestinal tract harmful, asthma postoperative shock, serious circulatory insufficiency. Precautions: Cardiac disorder, hyperthyrodism, epilepsy, parkinsonism. Interactions: Antiarrythmics, antimalarials, antibacterials, lithium. Adverse Reactions: Dyspnoea, muscle twitching, urinary frequency. Naltrexone HCl 50 mg Tablet T r e x a n - Trade Name
N07BB04110T1001XX (A) NEDL APPL

System: Emergency Indications: Adjunct in relapse prevention treatment in detoxified formerly opioid-dependant patients. Dosage: Initial 25 mg may be increased to 50 mg. Maintenance : 350 mg weekly; administered as 50 mg dly. Dosing interval may be lengthened to improve compliance - 100 mg on alternate days or 150 mg every third day. Contraindications: Concomitant opioid analgesics, opioid dependency or withdrawal, hypersensitivity to naltrexone, acute hepatitis or liver failure . Precautions: Should be discontinued at least 48 hours before elective surgery involving opioid analgesia. When analgesia is required, larger doses than usual of opioids will be needed and there is an increased risk of respiratory depression and other adverse effects. Interactions: Opioids analgesics: precipitation of opioid withdrawal symptoms. Adverse Reactions: Opioid withdrawal-like syndrome, nausea, headache, dizziness, anxiety. Betahistine Dihydrochloride 8 mg Tablet M e r i s l o n - Trade Name System: Ear, Nose and Oropharynx
N07CA01110T1001XX (A/KK)

435

Indications: Vertigo, tinnitus and hearing loss associated with Meniere's disease. Dosage: Initially 16 mg tds, preferably with food, maintenance 24 - 48 mg daily. Child not recommended. Contraindications: Hypersensitivity, phaeochromocytoma. Precautions: Betahistine should not be given to patients with phaeochromocytoma. It should be given with care to patients with asthma, peptic ulcer disease or a history of peptic ulcer disease. Interactions: Selegiline. Adverse Reactions: Nausea, vomiting, skin rash Betahistine Dihydrochloride 16 mg Tablet M e r i s l o n - Trade Name
N07CA01110T1002XX (A/KK)

System: Ear, Nose and Oropharynx Indications: Vertigo, tinnitus and hearing loss associated with Meniere's disease. Dosage: Initially 16 mg tds, preferably with food ; maintenance 24 - 48 mg daily. Child not recommended. Contraindications: Hypersensitivity, phaeochromocytoma. Precautions: Betahistine should not be given to patients with phaeochromocytoma. It should be given with care to patients with asthma, peptic ulcer disease or a history of peptic ulcer disease. Interactions: Selegiline. Adverse Reactions: Nausea, vomiting, skin rash. Cinnarizine 25 mg Tablet S t u g e r o n - Trade Name
N07CA02000T1001XX (B) NEDL APPL

System: Ear, Nose and Oropharynx Indications: Vestibular disorders. Dosage: 30 mg tds. Child 5 - 12 yrs : half adult dose. Contraindications: Avoid in porphyria. Precautions: Pregnancy. Parkinson's disease. May affect ability to drive or operate machinery. Interactions: Alcohol, CNS depressants. Adverse Reactions: Rarely, somnolence & GI disturbances. Flunarizine HCl 5 mg Capsule Sibelium - Trade Name System: Neurology
N07CA03110C1001XX (B) NEDL

436

Indications: i) Migraine prophylaxis. ii) Maintenance treatment of vestibular disturbances and of cerebral and peripheral disorders. Dosage: i) Adult: 5 - 10 mg dly preferably at night. Elderly >65 yrs : 5 mg at night. Maintenance 5-day treatment at the same dly dose. ii) 5 - 10 mg at night. If no improvement after 1 mth, discontinue treatment. Contraindications: Hypersensitivity to flunarizine or cinnarizine, history of depressive illness, pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders. Precautions: Hepatic insufficiency, elderly, depression, pregnancy, breast feeding, may impair ability to drive or operating machinery. Interactions: Excessive sedation can occur with alcohol, hypnotics or tranquilizers. Amiodarone, beta blockers, carbamazepine, NSAIDs, anticoagulants, rifampin, sumatriptan, alcohol, hypnotics or tranquilisers. Adverse Reactions: Drowsiness, fatigue, asthenia, depression, headache, porphyria, dizziness, insomnia, tremor, extrapyramidal effects, nausea, vomiting, dry mouth, gastric pain, weight gain. Chloroquine Phosphate 250 mg Tablet (150 mg Chloroquine base)
P01BA01162T1001XX (C) NEDL

System: Antiinfectives Indications: Treatment of malaria - acute attack. Dosage: 600 mg base stat, 300 mg 6 - 8 hrs later and a further 300 mg on each of 2 following days. Child : 3 - 4 yrs : 150 mg base stat, 75 mg 6 hrs later, then 75 mg dly for 2 days. 5 - 8 yrs: 300 mg stat, 150 mg 6 hrs later, then 150 mg dly for 2 days. Contraindications: G6PD deficiency, diseases of haematopoietic organs or CNS, retinopathy. Precautions: May exacerbate psoriasis or trigger an acute attack of hepatic porphyria (metabolic abnormality). Pre-existing kidney damage, first trimester of pregnancy. Interactions: Simultaneous use of corticosteroids can accentuate possible myopathies & cardiomyopathies. Adverse Reactions: Loss of appetite, nausea, pressure over the stomach, visual disturbances. Hydroxychloroquine Sulphate 200 mg Tablet P l a q u e n i l - Trade Name System: Rheumatology
P01BA02183T1001XX (A)

437

Indications: i) SLE and Mixed Connective Tissue Disease for skin, joint and serosa. ii) Second line therapy for acute Rheumatoid Arthritis Dosage: i) Initially 400 mg dly in divided dose. Maintenance : 200 - 400 mg dly. ii) Adult 400 - 600 mg dly. Maintenance: 200 - 400 mg dly. Child up to 6.5 mg/kg dly (max 400mg dly). Contraindications: Pre-existing maculopathy, pregnancy. Precautions: Liver disease, alcoholism or concurrent administration with known hepatotoxic drugs. G6PD deficiency, renal impairment or metabolic acidosis, patients with psoriasis or porphyria, haematologic disorders. If patient develops pigmentary abnormality or visual field defect, discontinue drug. Interactions: Digoxin - increase level. Adverse Reactions: GI disturbances, headache, skin reactions,bleaching of hair, alopecia,blurred vision, difficulty in focusing, blood dyscrasias. Primaquine 7.5 mg base Tablet
P01BA03162T1001XX (B) NEDL APPL

System: Antiinfectives Indications: i) Treatment of malaria. Ii) Prophylaxis together with a schizonticide such as chloroquine. Dosage: i) Treatment of malaria - Adult: 15 mg daily for 14 days. Child : 0.3 mg/kg body wt dly for 14 days. Ii) Prophylaxis together with a schizonticide such as Chloroquine :- 30 - 60 mg base once wkly together with a schizonticide such as Chloroquine. Contraindications: Concomitant medications which cause bone marrow suppression, rheumatoid arthritis, lupus erythematosus. Precautions: Use with caution in patients with a deficiency in glucose-6phosphate dehydrogenase (may cause acute haemolytic anaemia) and Patients with a nicotinamide-adenine dinucleotide hydroxide (NADH) methaemoglobin-reductase deficiency (at risk of developing methaemoglobinemia and cyanosis). Interactions: Mepacrine: increased plasma concentration of primaquine (risk of toxicity). Adverse Reactions: Anaemia, leucocytosis and abdominal pain. Quinine Dihydrochloride 600 mg/2 ml Injection P01BC01110P3001XX (B) NEDL System: Antiinfectives Indications: Suppression or treatment of chloroquine-resistant P. falciparum malaria in conjunction with other antimalarial agents. Dosage: 600 mg up to 3 times dly by slow IV or by slow IV infusion in 200 ml of normal saline. Rate should not exceed 50 mg/min. Contraindications: Presence of haemoglobinuria during malaria or of optic neuritis. Precautions: Atrial fibrillation or other serious heart disease, myasthenia 438

gravis. Interactions: Amiodarone, terfenadine, thioridazine,digoxin, cimetidine. Adverse Reactions: Headache, fever, vomiting; muscle weakness, excitement, confusion, blindness, deafness, loss of consciousness, fall in blood pressure. Quinine Sulphate 300 mg Tablet
P01BC01183T1001XX (B)NEDL

System: Antiinfectives Indications: Suppression or treatment of chloroquine-resistant P. falciparum malaria in conjunction with other antimalarial agents. Dosage: 300 - 600 mg daily. Treatment: 1.2 - 2 g dly in divided doses. Child: <1 yr: 100 200 mg dly, 1 - 3 yrs: 200 - 300 mg dly, 4 - 6 yrs: up to 500 mg dly, > 7 yrs: up to 1 g dly. All above doses are given for 7 days in 2 - 3 divided doses. Contraindications: Presence of haemoglobinuria during malaria or of optic neuritis. Precautions: Atrial fibrillation or other serious heart disease, myasthenia gravis. Interactions: Amiodarone, terfenadine, thioridazine,digoxin, cimetidine. Adverse Reactions: Headache, fever, vomiting; muscle weakness, excitement, confusion, blindness, deafness, loss of consciousness, fall in blood pressure. Mefloquine HCl 250 mg Tablet Lariam - Trade Name
P01BC02110T1001XX (A*) NEDL

System: Antiinfectives Indications: For multi -drug resistant cases of malaria only. USAGE MUST BE APPROVED BY THE STATE DIRECTORS OF HEALTH / DIRECTOR OF K.L. HOSPITAL. Dosage: Adult: Initial, 15 mg base/kg as single dose, followed by 10 mg base/kg 8-24 hrs after initial dose. Contraindications: Hypersensitivity, history of psychosis or convulsions. Precautions: Impaired liver function, cardiac conduction diseases, pregnancy, lactation, young children. Interactions: Quinine or related compounds, cardioactive agents eg betablockers, oral live typhoid vaccines. Adverse Reactions: Nausea, vomiting, dizziness, vertigo, loss of balance, headache, somnolence, sleep disorders, diarrhoea, abdominal pain. Sulfadoxine 500 mg & Pyrimethamine 25 mg Tablet Fansidar
P01BD51981T1001XX (B) NEDL APPL
- Trade Name

System: Antiinfectives Indications: Treatment of Plasmodium falciparum malaria in patients in whom chloroquine resistance is suspected; malaria prophylaxis for travellers to areas where 439

chloroquine-resistant malaria is endemic. Dosage: Treatment as single dose. Adults : 2 - 3 tab. Child : Up to 4 yrs : 1/2 tab. 4 - 8 yrs : 1 tab. >8 yrs : 2 tab. Contraindications: Hypersensitivity to sulfonamides. Premature or newborn infants, pregnancy, prophylactic (prolonged) use in patients with renal/hepatic failure and with blood dyscrasias. Precautions: Discontinue if skin reactions occur. Avoid excessive exposure to sunlight. Interactions: Folate antagonists Adverse Reactions: Rash, pruritus, GI disturbances (nausea & feeling of fullness); rarely, Steven-Johnson & Lyell's syndromes; blood dyscrasias, liver cell damage. Pentamidine Kethionate 300 mg Injection P e n t a m i d i n e - Trade Name
P01CX01198P3001XX (A*) NEDL

System: Antiinfectives Indications: Only for the treatment of pneumonia due to Pneumocytosis carinii. Dosage: 4 mg/kg body wt once daily by slow IV infusion for at least 14 days. Contraindications: Pregnancy, lactation, hypersensitivity to pentamidine or diamidine compounds. Precautions: Malnutrition, hyperglycaemia or hypoglycaemia, hepatic dysfunction, renal dysfunction, hypertension or hypotension, anaemia, leucopenia or thrombocytopenia. Interactions: Nephrotoxic effects of pentamidine when given concomittantly with other nephrotoxic drugs or sequentially, may be additive. Adverse Reactions: Hypotension, hypoglycaemia, pancreatitis, cardiac arrhythmias, leucopenia, thrombocytopenia, acute renal failure, hypocalcaemia, Stevens-Johnson syndrome. Azotaemia, abnormal liver function tests, albuminuria. Albendazole 200 mg/5 ml Suspension Zentel - Trade Name
P02CA03000L8001XX (C) NEDL APPL

System: Antiinfec tives Indications: i) Single or mixed infestations of intestinal parasites ii) Strongyloides infection Dosage: i) Adults and child over 2 yrs: 400 mg as a single dose. ii) Adult: 400 mg as a single dose for 3 consecutive days. Child, 12 - 24 months: 1/2 adult dose. Contraindications: Patients with hypersensitivity to albendazole or to the benzimidazole drug class. Pregnancy (avoid pregnancy for at least one month following therapy). Precautions: Discontinue therapy if LFT elevations are significant, retinal lesions. Interactions: Concurrent use with dexamethasone may result in an increased 440

risk of albendazole adverse effects. Adverse Reactions: GI discomfort, dizziness, headache. Albendazole 200 mg Tablet Zentel - Trade Name
P02CA03000T2001XX (C) NEDL APPL

System: Antiinfectives Indications: i)Single or mixed infestations of intestinal parasites ii) Strongyloides infection Dosage: i) Adults and child over 2 yrs: 400 mg as a single dose. ii) 400 mg as a single dose for 3 consecutive days. Child: 12 - 24 months: 1/2 adult dose. Contraindications: Patients with hypersensitivity to albendazole or to the benzimidazole drug class, pregnancy (avoid pregnancy for at least one month following therapy). Precautions: Discontinue therapy if LFT elevations are significant, retinal lesions. Interactions: Concurrent use with dexamethasone may result in an increased risk of albendazole adverse effects. Adverse Reactions: GI discomfort, dizziness, headache. Diethylcarbamazine Citrate 50 mg Tablet H e t r a z a n - Trade Name
P02CB02136T1001XX (B)NEDL

System: Antiinfectives Indications: i) Bancrofti Filariasis, Onchocerciasis, Loasis, Creeping eruption ii) Ascariasis iii)Tropical Eosinophilia. Dosage: i) Bancrofti Filariasis, Onchocerciasis, Loasis, Creeping eruption - 1 mg/kg tds on the first day and gradually over 3 days to 6 mg/kg dly in divided doses. This dosage is maintained for 21 days. ii) Ascariasis - 13 mg/kg once dly for 7 days. Child: 6 - 10 mg/kg tds for 7 days. iii)Tropical Eosinophilia - 13 mg/kg once dly for 4 - 7 days. Contraindications: Hypersensitivity to Diethylcarbamazine. Precautions: Patients with onchocerciasis or Loa loa infestation, renal insufficiency. The toxicity of Diethylcarbamazine may be increased in patients with highly alkaline urine (eg, pH 7.5 to 8). Interactions: No interactions found. Adverse Reactions: Headache, lassitude, weakness or general malaise, GI upset, skin rash, allergic reactions, facial oedema, pruritis. Pyrantel Pamoate 125 mg Tablet C o m b a n t r i n - Trade Name System: Antiinfectives
P02CC01127T1001XX (C) NEDL

441

Indications: Intestinal nematodes. Dosage: Adult & Child: 2 years and older - single dose 10mg/kg body wt once. Max 1 g. Contraindications: Known hypersensitivity to pyrantel pamoate. Precautions: Impaired liver function, anaemia, malnutrition or pregnancy. Interactions: Piperazine. Adverse Reactions: Nausea, vomiting, anorexia, abdominal pain & discomfort, diarrhoea, headache, dizziness, drownsiness. Pyrantel Pamoate 250 mg Tablet C o m b a n t r i n - Trade Name
P02CC01127T1002XX (C) NEDL

System: Antiinfectives Indications: Intestinal nematodes. Dosage: Adult & Child: 2 years and older - single dose 10mg/kg body wt once. Max 1 g. Contraindications: Known hypersensitivity to pyrantel pamoate. Precautions: Impaired liver function, anaemia, malnutrition or pregnancy. Interactions: Piperazine. Adverse Reactions: Nausea, vomiting, anorexia, abdominal pain & discomfort, diarrhoea, headache, dizziness, drownsiness. Levamisole 40 mg Tablet E r g a m i s o l - Trade Name
P02CE01110T1001XX (A)

System: Haematology/Oncology Indications: Adjuvant treatment of Dukes' Stage B and C Colorectal Cancer Dosage: 50 mg by mouth 8 hrly for 3 days starting 7 - 30 days after surgery and repeated every 14 days. Contraindications: Hypersensitivity to levamisole products. Precautions: Liver and kidney disease. Rheumatoid arthritis and HLA B27 positivity (may be increased risk of agranulocytosis). Monitor leukocyte and platelet counts during levamisole therapy; discontinue therapy if persistent leucopenia or dermatitis develop. Monitor Interactions: Fluorouracil, hepatotoxicity. Warfarin, increased risk of bleeding. Adverse Reactions: Nausea, vomiting, diarrhoea, myelosuppression, confusion, impaired concentration, skin rash, hallucination, flu-like illness. Crotamiton 10 % Cream Eurax - Trade Name System: Dermatology
P03A000000G1001XX (A)NEDL

442

Indications: i) Pruritus ii) Scabies iii) Insect bite reactions Dosage: i) & iii) Massage into area affected unti l the medication is completely absorbed. Repeat as needed. Apply bd - tds. ii) Apply topically (do not rinse off), apply a second time and leave on skin for 24-48 hrs. for resistant scabies, treatment (2 applications at 24 hr interval) may be repeated after 1 week. Contraindications: Do not apply on nipples when breastfeeding Precautions: Avoid contact with eyes & mucous membranes. Pregnancy. Do not apply on acutely inflammed or weeping skin. Interactions: No interaction found Adverse Reactions: Local skin irritation or contact allergy. Gamma Benzene Hexachloride 0.5 % Cream Lindane - Trade Name
P03AB02100G1001XX (A/KK)

System: Dermatology Indications: Only for scabies in children. Dosage: Apply on dry and cool skin and leave for 6 - 8 hrs before washing off. Only 1 application is necessary. In children under 2 yrs, use GBH cream 0.5%, with caution. Contraindications: Pregnancy and premature babies. Breast feeding, avoid in patients with a history of epilepsy or who have a low body -weight. Precautions: Not for oral ingestion and avoid eye contact. Dermatological disorders, excoriated skin, elderly. Simultaneous use of lindane lotion and other creams, ointments or oils. Interactions: No interaction found. Adverse Reactions: Seizures, dermatitis, dizziness, atypical leukaemia. Gamma Benzene Hexachloride 1% Cream Lindane - Trade Name
P03AB02100G1002XX (A/KK) NEDL

System: Dermatology Indications: Only for scabies in adult. Dosage: Apply on dry and cool skin and leave for 6 - 8 hrs before washing off. Only 1 application is necessary. In children under 2 yrs, use GBH cream 0.5%, with caution. Contraindications: Pregnancy and premature babies. Breastfeeding, avoid in patients with a history of epilepsy or who have a low body -weight. Precautions: Not for oral ingestion and avoid eye contact. Dermatological disorders, excoriated skin, elderly. Simultaneous use of lindane lotion and other creams, ointments or oils. Interactions: No interaction found. 443

Adverse Reactions: Seizures, dermatitis, dizziness, atypical leukaemia. Gamma Benzene Hexachloride 0.1 % Lotion Lindane - Trade Name
P03AB02100L6001XX (C) NEDL

System: Dermatology Indications: Scabies Dosage: Apply lotion to entire body from neck down for 8 to 24 hours, then rinse. Contraindications: Pregnancy and premature babies. Breast feeding, avoid in patients with a history of epilepsy or who have a low body -weight. Precautions: Not for oral ingestion and avoid eye contact. Dermatological disorders, excoriated skin. Elderly. Simultaneous use of lindane lotion and other creams, ointments or oils. Interactions: No interaction found. Adverse Reactions: Seizures, dermatitis, dizziness, atypical leukaemia. Gamma Benzene Hexachloride 0.1% in Oil Solution P03AB02100L9901XX (C) Lindane - Trade Name System: Dermatology Indications: Head lice. Dosage: Apply to the root of hair & on scalp in the evening and wash off in morning. Contraindications: Pregnancy and premature babies. Breast feeding, avoid in patients with a history of epilepsy or who have a low body -weight. Precautions: Not for oral ingestion and avoid eye contact. Dermatologic disorders, excoriated skin. Elderly. Simultaneous use of lindane lotion and other creams, ointments or oils. Interactions: No interaction found. Adverse Reactions: Seizures, dermatitis, dizziness, atypical leukaemia. Benzyl Benzoate 25 % Emulsion(Adult)
P03AX01000L2002XX (C) NEDL APPL

System: Dermatology Indications: Scabies and pediculosis. Dosage: After bath, apply over the whole body, omitting the head and neck; leave on for 24 hours then wash off ; reapply for another 24 hours; a third application may be required in some cases. Contraindications: Hypersensitivity to benzyl benzoate. Precautions: Contact with mucous membranes, head, face, broken or inflammed skin. Interactions: No interaction found Adverse Reactions: May be irritant to the skin of some patients, burning, stinging and contact dermatitis. 444

Benzyl Benzoate 12.5 % Emulsion(child)

P03AX01252L2001XX (C)

System: Dermatology Indications: Scabies and pediculosis, for child under 2 years. Dosage: After bath, apply over the whole body, omitting the head and neck; leave on for 24 hours then wash off ; reapply for another 24 hours; a third application may be required in some cases. Contraindications: Hypersensitivity to benzyl benzoate Precautions: Contact with mucous membranes, head, face, broken or inflammed skin. Interactions: No interaction found. Adverse Reactions: May be irritant to the skin of some patients, burning, stinging and contact dermatitis. Malathion 1 % Shampoo
P03AX03000L5201XX (A) NEDL

System: Dermatology Indications: Lice infestation. Dosage: Wet hair, apply shampoo and work up lather. Leave for 15 minutes and rinse, comb. Repeat if necessary after 7 - 9 days. Contraindications: Neonates and infants. Known sensitivity to malathion or any of the vehicle ingredients. Precautions: May cause eye irritation and systemic absorption. Keep preparation and medicated hair away from heat or flame. Interactions: No interaction found. Adverse Reactions: Acute renal insufficiency has been described in one patient associated with excessive exposure to a malathion spray. Alkaline Nasal Douche
R01A000999L5001XX (A)

System: Ear, Nose and Oropharynx Indications: To remove nasal plug due to radiation. Dosage: To be diluted with an equal volume of warm water before use. Contraindications: Not known. Precautions: Epistaxis, not to be used in cranial surgery or trans nasal neuro surgical procedure. Interactions: No interaction found. Adverse Reactions: Excessive use can be toxic due to its absorption. Ephedrine 0.5% w/v Nasal Drops System: Ear, Nose and Oropharynx
R01AA03110D6001XX (A/KK)

445

Indications: Decongestion of the upper respiratory tract. Dosage: 2 drops tds. Max. use for 1 wk. Contraindications: Patients treated with MAOIs or within 10 days of ceasing such treatment. Precautions: Topical administration of ephedrine in hypertension, in infant below 3 months if irritant occurs might narrow nasal passage. Interactions: Interact with anaesthetics, antidepressants, antihypertensives,etc. Adverse Reactions: Local irritation, rebound congestion, headache. Oxymetazoline HCl 0.025% (Paed) Nasal Spray A f r i n , I l i a d i n - Trade Name
R01AA05110A4101XX (A)

System: Ear, Nose and Oropharynx Indications: Acute colds, paranasal sinusitis and otitis media. Dosage: 1 spray into each nostril bd for child > 1 yr. Contraindications: Skin & mucosal inflammation of the nasal vestibules with incrustation. Precautions: Cardiovascular disease, diabetes mellitus, hypertension, prostatic enlargement, prolonged use over 3 to 5 days, thyroid disease. Interactions: Since oxymetazoline is absorbed through the mucosa, interactions may follow topical application. Sympathomimetic nasal decongestants are liable to cause a hypertensive crisis if used during treatment with MAOI. Adverse Reactions: After local use of oxymetazoline transient irritation may occur. Rebound congestion may occur after frequent or prolonged nasal use. Systemic effects have occurred after local administration. Oxymetazoline HCl 0.05% (Adult) Nasal Spray A f r i n , I l i a d i n - Trade Name
R01AA05110A4102XX (A)

System: Ear, Nose and Oropharynx Indications: Acute colds, paranasal sinusitis and otitis media. Dosage: 1 spray into each nostril bd. Contraindications: Skin & mucosal inflammation of the nasal vestibules with incrustation. Precautions: Cardiovascular disease, diabetes mellitus, hypertension, prostatic enlargement, prolonged use over 3 to 5 days, thyroid disease. Interactions: Since ox ymetazoline is absorbed through the mucosa, interactions may follow topical application. Sympathomimetic nasal decongestants are liable to cause a hypertensive crisis if used during treatment with MAOI. Adverse Reactions: After local use of oxymetazoline transient irritation may occur. Rebound congestion may occur after frequent or prolonged nasal use. 446

Systemic effects have occurred after local administration. Oxymetazoline HCl 0.025% (Paed) Nasal Drops R01AA05110D6001XX (A/KK) A f r i n , I l i a d i n - Trade Name System: Ear, Nose and Oropharynx Indications: Acute colds, paranasal sinusitis and otitis media. Dosage: 1 - 2 drops bd in each nostril for child > 1 year. Contraindications: Skin & mucosal inflammation of the nasal vestibules with incrustation. Precautions: Cardiovascular disease, diabetes mellitus, hypertension, prostatic enlargement, prolonged use over 3 to 5 days, thyroid disease. Interactions: Since oxymetazoline is absorbed through the mucosa, interactions may follow topical application. Sympathomimetic nasal decongestants are liable to cause a hypertensive crisis if used during treatment with MAOI. Adverse Reactions: After local use of oxymetazoline transient irritation may occur. Rebound congestion may occur after frequent or prolonged nasal use. Systemic effects have occurred after local administration. Oxymetazoline HCl 0.05% (Adult) Nasal Drops R01AA05110D6002XX (A/KK) A f r i n , I l i a d i n - Trade Name System: Ear, Nose and Oropharynx Indications: Acute colds, paranasal sinusitis and otitis media. Dosage: 1 - 2 drops bd in each nostril. Contraindications: Skin & mucosal inflammation of the nasal vestibules with incrustation. Precautions: Cardiovascular disease, diabetes mellitus, hypertension, prostatic enlargement, prolonged use over 3 to 5 days, thyroid disease. Interactions: Since oxymetazoline is absorbed through the mucosa, interactions may follow topical application. Sympathomimetic nasal decongestants are liable to cause a hypertensive crisis if used during treatment with MAOI. Adverse Reactions: After local use of oxymetazoline transient irritation may occur. Rebound congestion may occur after frequent or prolonged nasal use. Systemic effects have occurred after local administration. Beclomethasone Dipropionate 50 mcg/dose Nasal Spray Beconase
R01AD01133A4101XX (A/KK) NEDL
- Trade Name

System: Ear, Nose and Oropharynx Indications: Prophylaxis and treatment of perennial and seasonal allergic rhinitis and vasomotor rhinitis. Dosage: 447

Adult and child > 6 yrs: Apply 100 mcg (2 sprays) into each nostril bd or 50 mcg (1 spray) into each nostril tds - qid. Max : 400 mcg dly (8 sprays). When symptoms controlled reduce dose to 50 mcg (1 spray)into each nostril twice daily. Contraindications: After nasal surgery or if having untreated nasal infection. Precautions: TB, first trimester of pregnancy. Interactions: Effects enhanced by nasal vasoconstrictors. Adverse Reactions: Nasal irritation, sneezing, epistaxis nasopharyngeal candidiasis, nasal septal perforation, dryness and irritation of the nose and throat. Occassionally, hoarseness. Unpleasant taste and smell, glaucoma, rashes, urticaria, pruritis, erythema . Budesonide 50 mcg/dose Nasal Spray Rhinocort - Trade Name
R01AD05000A4101XX (A)NEDL

System: Ear, Nose and Oropharynx Indications: i) Symptomatic controlled of allergic rhinitis ii) Nasal polyps. Dosage: i) Adult & child over 12 years: 2 sprays into each nostril bd. May be reduced to 1 spray bd when control achieved. ii) Adult & child over 12 years: 100 mcg (1 spray)into each nostril bd for up to 3 months. Contraindications: Severe nasal infection, recurrent nasal bleeding. Precautions: Fungal and viral nasal infection, chronic use, liver cirrhosis, reduce liver function, pulmonary tuberculosis. Interactions: No interaction found. Adverse Reactions: Nasal irritation, nose bleeding, dryness of throat. Mometasone Furoate 50 mcg Aqueous Nasal Spray R01AD09139A4101XX (A*) Nasonex - Trade Name System: Ear, Nose and Oropharynx Indications: Allergic rhinitis. Dosage: Adult & child over 12 years: 100 mcg/day (2 sprays) to each nostril daily. Max 200 mcg (4 sprays) daily. Reduce to 50 mcg (1 spray) once daily when control achieved. Children : 6-12 yrs old : 50 mcg (1 spray) to each nostril once daily. Contraindications: Severe nasal infections esp candidiasis, patients with haemorrhagic diathesis or a history of recurrent nasal bleeding, fungal, viral or tubercular skin lesions, herpes simplex or zoster. Precautions: Presence of untreated localized infection involving the nasal mucosa, recent nasal surgery or trauma, pregnancy. Interactions: CYP3A4. Adverse Reactions: Headache, pharyngitis, cough epistaxis, viral infection, chest pain, dysmenorrhoea, vomiting, diarrhoea, dyspepsia, nausea. Menthol 1.6% in Ind. Methylated Spirit Inhalation System: Ear, Nose and Oropharynx 448
R01AX30000A9901XX (C)

Indications: Decongestion of the upper respiratory tract. Dosage: As directed for local use. Contraindications: Not known. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: Hypersentivity reactions including contact dermatitis. Bismuth Subnitrate, Iodoform & Liquid Paraffin Paste R01AX30984G6001XX (B) BIPP - Trade Name System: Ear, Nose and Oropharynx Indications: As a mild antiseptic for wounds and abscesses. Sterile gauze impregnated with paste for packing cavities after otohinological surgery. Dosage: As directed for local application. Contraindications: Allergy to iodine or other components in the preparations. Precautions: Hyperthyroidism, nasal packing use not more than 3 days. Ear packing use not more than 2 weeks. Interactions: No interaction found Adverse Reactions: Erythematous rash, encephalopathy reported only with large packs or when placed directly on neural tissue, nasal mucosal fi brosis. Balsam Tolu, Storax, Iodoform, Tinct. Benzoin Compound & Ether Solution W h i t e h e a d V a r n i s h - Trade Name
R01AX30984L7001XX (B)

System: Ear, Nose and Oropharynx Indications: Used as a protective covering following surgical procedure, where the application of a surgical dressing is undesireable or impracticable, used to hold gauze dressing and radium needles in position. Dosage: As directed for local application as a mild antiseptic. Contraindications: Allergy to the compound, hyperthyroidism. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: No information available. Triprolidine HCl, Pseudoephedrine HCl & Dextromethorphan Linctus Actifed Comp
R01BA52988L1101XX (B)
- Trade Name

System: Ear, Nose and Oropharynx Indications: Unproductive cough accompanied by congestion of the upper respiratory tract including congestion with an allergic component. Dosage: Adult & Child >12 yrs: 10 ml. Child 6 - 12 yrs: 5 ml ; 2 - 5 yrs : 2.5 ml. 2 mths 449

2 yrs : 1.25 ml. Doses to be taken tds. Contraindications: Neonates and narrow angle glaucoma. Precautions: Diabetes, hypertension, heart disease, hyperthyroidism, elevated intraocular pressure, prostatic enlargement, avoid operating vehicles and machinery. Interactions: Antihypertensives, tricyclic antidepressants, decongestants, appetite suppressants, other sympathomimetics. Adverse Reactions: Drowsiness, sleep disturbances, skin rashes, dryness of nose, mouth and throat. Triprolidine HCl 1.25 mg & Pseudoephedrine HCl 30 mg per 5 ml Syrup Actifed
- Trade Name

R01BA52988L9001XX (B) NEDL

System: Ear, Nose and Oropharynx Indications: Decongestion of the upper respiratory tract in common cold, hay fever, allergic and vasomotor rhinitis and sinusitis. Dosage: Adult & Child >12 yr: 10 ml Child : 6 - 12 yrs : 5 ml 2 - 5 yrs : 2.5 ml 6 mths - < 2yrs : 1.25 ml Doses to be taken bd or tds. Contraindications: Neonates, narrow angle glaucoma, severe hypertension, severe coronary disease. Precautions: Diabetes, hypertension, heart disease, hyperthyroidism, elevated intraocular pressure, prostatic enlargement, avoid operating vehicles and machinery. Interactions: Antihypertensives, tricyclic antidepressants, decongestants, appetite suppressants, amphetamine-like psychostimulant, other sympathomimetics. Adverse Reactions: Drowsiness, sleep disturbances, skin rashes, dryness of nose, mouth and throat. Loratadine 5 mg & Pseudoephedrine Sulphate 120 mg Tablet C l a r i n a s e - Trade Name
R01BA52988T1001XX (A/KK)

System: Ear, Nose and Oropharynx Indications: For treatment of allergic rhinitis and allergic dermatoses. Dosage: Adult and child > 12 yrs: 1 tab bd. Contraindications: Narrow-angle glaucoma, urinary retention, severe coronary artery disease, severe hypertension, concomitant therapy with MAO inhibitor therapy or within 10 days of continuing such treatment, hyperthyroidism. Precautions: Avoid in hepatic insufficiency, renal insufficiency (use lower initial dose). Pregnancy, hypertension, diabetes mellitus, ischaemic heart disease, 450

increased intraocular pressure, hyperthyroidism, prostatic hypertrophy, stenosing peptic ulcer. Interactions: Loratadine is metabolised by cytochrome P450 isoenzymes CYP3A4 and CYP2D6. Therefore concomitant administration of other drugs that inhibit or are metabolised by these hepatic enzymes may result in changes in plasma concentrations of either drug. Adverse Reactions: Headache, nervousness, dizziness, tachycardia, rhinitis, pruritis, acne. Triprolidine HCl 2.5 mg & Pseudoephedrine HCl 60 mg Tablet Actifed
R01BA52988T1002XX (B)NEDL
- Trade Name

System: Ear, Nose and Oropharynx Indications: Decongestion of the upper respiratory tract in common cold, hay fever, allergic and vasomotor rhinitis and aerotitis. Dosage: Adult and child > 12 yrs: 1 tab tds. Contraindications: MAOIs, severe hypertension, narrow angle glaucoma. Precautions: Diabetes, hypertension, heart disease, hyperthyroidism, elevated intraocular pressure, prostatic enlargement. May impair ability to drive or operate machinery. Interactions: Antihypertensives, tricyclic antidepressants, decongestants, appetite suppresants, amphetamine-like psychostimulant, other sympatomimetics. Adverse Reactions: Drowsiness, sleep disturbances, skin rashes, dryness of nose, mouth & throat. Occassionally urinary retention. Chlorhexidine Acetate 0.2% Mouthwash H i b i t a n e - Trade Name
R02AA05122M2001XX (C)

System: Ear, Nose and Oropharynx Indications: For use as a gargle, rinse the mouth with 10 ml for about 1 min bd. Dosage: Rinse the mouth with 10 ml for about 1 min bd. Contraindications: Hypersensitivity to chlorhexidine acetate or any component of the formulation. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: Discolour the tounge or teeth. Chlorhexidine Gluconate 0. 2 % Mouthwash H i b i t a n e - Trade Name System: Ear, Nose and Oropharynx
R02AA05137M2001XX (C)

451

Indications: As a gargle. Dosage: Rinse the mouth with 10 ml for about 1 min bd. Contraindications: Patients who have previously shown a hypersensitivity reaction to chlorhexidine. However, such reaction are extremely rare. Precautions: Avoid prolonged skin contact with alcoholic solution. Avoid contact with eyes, brain, meninges, middle ear & body cavities. For external use only. Interactions: No interaction found. Adverse Reactions: Occasionally, irritative skin reactions, extremely rare, generalised allergic reactions. Fusafungine 1% Nasal Spray L o c a b i o t a l - Trade Name
R02AB03000A4101XX (A)

System: Ear, Nose and Oropharynx Indications: Local antibiotic, anti-inflammatory treatment of infectious and inflammatory syndromes of the respiratory mucosa. Dosage: Adult : 1 oral or 1 nasal inhalation 4 hrly, withdraw if no improvement after 7 days. Child : 1 oral or 1 nasal inhalation 6 hrly, withdraw if no improv ement after 7 days. Contraindications: Hypersensitivity to fusafungine. Children less than 30 months of age (risk of laryngospasm). Precautions: Treatment should be less than 10 days. Reevaluate after this. Interactions: Systematically report any other ongoing treatment to the doctor or pharmacist so as to avoid any interaction between several drugs. Adverse Reactions: Rare cases of buccopharyngeal irritation and sneezing. Salbutamol 100 mcg/dose Inhalation V e n t o l i n , B u v e n t o l - Trade Name
R03AC02183A1001XX (B)NEDL

System: Respiratory Indications: Asthma and other conditions associated with reversible airways obstruction. Dosage: Adult : 100 - 200 mcg up to tds - qid. Child : 100 mcg increased to 200 mcg if necessary. Contraindications: Hypersensitivity to any of their components. Precautions: Thyrotoxicosis. Not appropriate for managing premature labour. Pregnancy and lactation. Interactions: MAOIs : increased risk of tachycardia, agitation, or hypomania. Adverse Reactions: Fine tremor(particularly in the hands), nervous tension, headache, peripheral dilatation and palpitations, tachycardia, arrhythmias, disturbances of sleep and behaviour in children, muscle cramps, hypersensitivity reactions including paradoxical bronchospasm, urticaria, and angioedema. 452

Salbutamol 0.5 % Inhalation Solution V e n t o l i n - Trade Name

R03AC02183A3001XX (B) NEDL APPL

System: Respiratory Indications: Asthma and other conditions associated with reversible airways obstruction. Dosage: 2 ml may be inhaled up to 4 times dly over a period of 3 min. per inhalation. Contraindications: Hypersensitivity to any of their components. Precautions: Thyrotoxicosis. Interactions: MAOIs : increased risk of tachycardia, agitation, or hypomania. Adverse Reactions: Fine tremor(particularly in the hands), nervous tension, headache, peripheral dilatation and palpitations, tachycardia, arrhythmias, disturbances of sleep and behaviour in children, muscle cramps and hypersensitivity reactions including paradoxical bronchospasm, urticaria, and angioedema. Terbutaline Sulphate 250 mcg/dose Inhalation R03AC03183A2101XX (B) NEDL APPL B r i c a n y l - Trade Name System: Respiratory Indications: Asthma and other conditions associated with reversible airways obstruction. Dosage: Adult & child : 1 - 2 inhalations repeated up to 3-4 times daily. Contraindications: Hypersensitivity to terbutaline and other sympathomimetic amines. Precautions: Hypertension, cardiovascular disease, unstable diabetes, hypersensitivity to sympathomimetic amines, hypertrophic cardiomyopathia, hypokalaemia. Interactions: Beta-blockers : inhibit bronchodilating effect. Monoamine oxidase inhibitors : increased risk of tachycardia, agitation, or hypomania. Theophylline : decreased theophylline concentrations. Adverse Reactions: Increases in heart rate and cardiac output. Terbutaline Sulphate 10 mg/ml Inhalation Solution Bricanyl
- Trade Name

R03AC03183A3001XX (B) NEDL APPL

System: Respiratory Indications: Asthma and other conditions associated with reversible airways obstruction. Dosage: Adult : 5 - 10 mg bd - qid, additional doses may be necessary in severe acute asthma. Child : up to 3 yrs: 2 mg, 3 - 6 yrs: 3 mg, 6 - 8 yrs : 4 mg, over 8 yrs: 5 mg bd qid. Contraindications: Hypersensitivity to terbutaline and other sympathomimetic amines. Precautions: Hypertension, cardiovascular disease, unstable diabetes, 453

hypersensitivity to sympathomimetic amines, hypertrophic cardiomyopathy, hypokalaemia. Interactions: Beta-blockers: inhibit bronchodilating effect. Monoamine oxidase inhibitors: increased risk of tachycardia, agitation, or hypomania. Theophylline: decreased theophylline concentrations. Adverse Reactions: Tremor, tonic cramp, and palpitations(reversible within 1st 1-2 week of treatment). Terbutaline Sulphate 0.5 mg/ml Injection B r i c a n y l - Trade Name
R03AC03183P3001XX (B)

System: Respiratory Indications: Bronchial asthma, chronic bronchitis, emphysema & other lung diseases where broncoconstriction is a complicating factor. Dosage: SC, IM or slow IV, 250-500 mcg up to 4 times daily. Paeds, 2-15 yrs 10mcg/kg to a max of 300mcg. Continuous IV infusion, as a solution containing 3-5 mcg/ml, 1.5-5 mcg/min for 8-10 hrs; reduce dose for children. Contraindications: Thyrotoxicosis. Precautions: Hypertension, CV diseases, unstable diabetes, hypersensitivity to sympathomimetic amines, hypertrophic cardiomyopathy, hypokalaemia. Interactions: Beta-blockers: inhibit bronchodilating effect. Monoamine oxidase inhibitors: increased risk of tachycardia, agitation, or hypomania. Theophylline: decreased theophylline concentrations. Adverse Reactions: Tremor, tonic cramp & palpitations (reversible within 1st 1-2 wk of treatment). Salmeterol Xinafoate 25mcg/dose Inhalation Serevent - Trade Name
R03AC12235A1002XX (A*) NEDL

System: Respiratory Indications: For asthmatics not responding after optimal dose of steroid 1000 mcg/day Dosage: Adult & Child >6 yrs : 2 inhalations bd. Severe cases : 4 inhalations bd. Child over 4 years : 50 mcg (2 puffs or 1 blister) twice daily. Contraindications: Hypersensitivity to salmeterol or any of its components. Precautions: Not for relief in acute severe asthma. Thyrotoxicosis. Interactions: Monoamine oxidase inhibitors : increased risk of tachycardia, agitation, or hypomania. Tricyclic antidepressants : increased risk of cardiovascular excitation. Adverse Reactions: Tachycardia, dizziness, headache, tremor. Formoterol Fumarate Dihydrate 4.5 mcg /dose Inhalation Formoterol Fumarate Dihydrate 9 mcg/dose Inhalation Oxis
- Trade Name

R03AC13138A2101XX (A*) R03AC13138A2102XX (A*)

System: Respiratory 454

Indications: Moderate persistent asthma, severe persistent and COPD patients. Dosage: Adult and elderly : 6-12 mcg once or twice dly. In more severe cases increase to 24 mcg twice daily. Some patients may need 18 mcg once or twice dly. Max. 36 mcg dly (as single dose); 72 mcg dly (total max). Contraindications: Hypersensitivity to formoterol or to inhaled lactose. Pregnancy and lactation. Precautions: Thyrotoxicosis, severe cardivascular disorder eg. ischaemic heart disease, tachyarrhythmias or severe heart failure, diabetes, acute severe asthma, severe liver chirrhosis. Interactions: MAOIs : increased risk of tachycardia, agitation or hypomania. Adverse Reactions: Headache, palpitations, tremor. Ipratropium Bromide 20 mcg & Salbutamol base 100 mcg/dose Inhalation Combivent
R03AK04320A1001XX (B)
- Trade Name

System: Respiratory Indications: Management of reversible bronchospasm associated with obstructive airway diseases. Dosage: Adult : 2 inhalations qid. Max : 12 inhalations in 24 hr. Child under 12 years not recommended. Contraindications: Hypersensitivity to atropine or its derivatives or to any other component. Hypertrophic obstructive cardiomyopathy or tachyarrhythmia. Precautions: Patients predisposed to glaucoma, insufficiently controlled diabetes mellitus, recent MI, severe organic heart or vascular disorders, hyperthyroidism, phaechromocytoma, risk of narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction, hypoxia, cystic fibrosis, pregnancy and lactation. Interactions: Xanthines derivatives, other anticholinergics, beta2-agonists, beta-blockers, tricyclic anti depressants, MAOIs, glucocorticoids : increased risk of tachycardia, agitation, hypomania, hypokalaemia. Adverse Reactions: Headache, dizziness, nervousness, tachycardia, fine tremor, palpitations. Potentially serious hypokalaemia may result from beta2agonist therapy, dryness of mouth, dysphonia, ocular complications, allergic type reactions. Ipratropium Bromide 0.5 mg & Salbutamol 2.5 mg per UDV Combivent
R03AK04320A3001XX (B)
- Trade Name

System: Respiratory Indications: Management of reversible bronchospasm associated with obstructive airway diseases. Dosage: Acute attacks: 1 unit dose vial. In severe cases not relieved by 1 unit dose vial ; 455

2 unit dose vials, patient should consult a doctor immediately. Maintenance: 1 unit dose vial tds -qds. Contraindications: Hypersensitivity to atropine or its derivatives or to any other component. Hypertrophic obstructive cardiomyopathy or tachyarrythmia. Precautions: Patients predisposed to glaucoma, insufficiently controlled diabetes mellitus, recent MI, severe organic heart or vascular disorders, hyperthyroidism, phaechromocytoma, risk of narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction, hypoxia, cystic fibrosis. Pregnancy and lactation. Interactions: Xanthine derivatives, other anticholinergics, beta2-agonists, beta-blockers, tricyclic anti depressants, MAOIs, glucocorticoids : increased risk of tachycardia, agitation, hypomania, hypokalaemia. Adverse Reactions: Headache, dizziness, nervousness, tachycardia, fine tremor, palpitations. Potentially serious hypokalaemia may result from beta2agonist therapy, dryness of mouth, dysphonia, ocular complications, allergic type reactions. Salmeterol 50 mcg & Fluticasone Propionate 250 mcg Inhalation Seretide
R03AK06989A2101XX (A*)
- Trade Name

System: Respiratory Indications: Regular treatment of reversible obstructive airways diseases including asthma. Dosage: Adult and child >12 yrs : 1 - 2 inhalations bd. Contraindications: Not known. Precautions: Not for acute unstable or acutely deteriorating asthma. Active or quiescent pulmonary TB, thyrotoxicosis. When transfering from systemic to inhaled steroid therapy, monitor adrenocortical function regularly and withdraw systemic corticosteroid therapy gradually. Pregnancy and lactation. Interactions: Beta-blockers, strong CYP3A4 inhibitors eg. ketoconazole, ritonavir. Adverse Reactions: Hoarseness and dystonia, throat irritation, headache, oropharyngeal candidiasis and palpitations. Salmeterol 25mcg and Fluticasone Propionate 125mcg Inhalation Seretide
- Trade Name

R03AK06989A2102XX (A*)

System: Respiratory Indications: Regular treatment of reversible obstructive airways diseases including asthma. Dosage: Adult & child > 12yr: 1-2 inhalations bd. Contraindications: Not known. Precautions: Not for acute unstable or acutely deteriorating asthma. Active or quiescent pulmonary TB, thyrotoxicosis. When transfering from systemic to inhaled steroid therapy, monitor adrenocortical function regularly and withdraw systemic corticosteroid therapy gradually. Pregnancy and lactation. 456

Interactions: Beta-blockers, strong CYP3A4 inhibitors eg. ketoconazole, ritonavir. Adverse Reactions: Hoarseness and dystonia, throat irritation, headache, oropharyngeal candidiasis and palpitations. Budesonide 160mcg & Formoterol 4.5mcg Inhalation Symbicort
R03AKO7989A2101XX (A*)
- Trade Name

System: Respiratory Indications: Mild, moderate and severe persistent asthma. Dosage: Mild: 1 dose daily. Moderate: 1 dose bd. Severe : 2 doses bd. Contraindications: Hypersensitivity to budesonide or formoterol Precautions: Not for acute attack. Taper dose when discontinuing treatment. Thyrotoxicosis, diabetes mellitus, heart disease, hypokalaemia, severe CV disorders, tuberculosis, phaeocromocytoma. Interactions: Itraconazole, ketoconazole, MAOI. Adverse Reactions: Headache, insomnia, tremor, restlessness, oral candidiasis, cough, hoarseness. Beclomethasone Dipropionate 100 mcg/dose Inhalation Becotide
R03BA01133A2101XX (A) NEDL APPL
- Trade Name

System: Respiratory Indications: Prophylaxis of asthma especially if not fully controlled by bronchodilators. Dosage: Adult : 100 mcg tds - qid or 200 mcg bd. Child > 6 yrs: 50 - 100 mcg bd - qid. Contraindications: Hypersensitivity to beclomethasone dipropionate. Special care is necessary in patients with active or quiescent pulmonary tuberculosis. Precautions: Pulmonary TB, pregnancy. Interactions: No interaction found. Adverse Reactions: Candidiasis of the mouth and throat, hoarseness or throat irritation. Paradoxical bronchospasm (discontinue immediately). Patients are advised to gargle after using the medication. Beclomethasone Dipropionate 200 mcg/dose Inhalation Beclomet
R03BA01133A2102XX (A/KK) NEDL APPL
- Trade Name

System: Respiratory Indications: Prophylaxis of asthma especially if not fully controlled by bronchodilators. Dosage: Adult : 1 - 2 inhalations bd. May increase to 2 inhalations bd - qid. Contraindications: Hypersensitivity to beclomethasone dipropionate. Special 457

care is necessary in patients with active or quiescent pulmonary tuberculosis. Precautions: Pulmonary TB, pregnancy. Interactions: No interaction found. Adverse Reactions: Candidiasis of the mouth and throat, hoarseness or throat irritation. Patients are advised to gargle after using the medication. Paradoxical bronchospasm (discontinue immediately). Budesonide 100 mcg/dose Inhalation P u l m i c o r t , I n f l a m m i d e - Trade Name
R03BA02000A2101XX (B)

System: Respiratory Indications: Prophylaxis of asthma especially if not fully controlled by bronchodilators. Dosage: Adult : 200 - 1600 mcg dly in 2 - 4 divided doses. Child < 12 yrs : 200 - 800 mcg dly in 2 divided doses. Contraindications: Hypersensitivity to budesonide. Moderate to severe bronchiectasis. Precautions: Acute exacerbations, accompanied by increased mucous viscosity and mucous plugging. Caution in viral infections such as varicella, in untreated fungal and bacterial infections of the respiratory system. Pregnancy and lactation. Reduction in growth velocity in paediatrics. Interactions: Oral or parenteral corticosteroids : Effects enhanced by the concomitant use. Amiodarone : increased risk of developing Cushing's syndrome. Ketoconazole : increased budesonide plasma concentrations. Adverse Reactions: Mild irritation of the throat, coughing, and generally reversible hoarseness of the voice. Bad taste, dryness of the throat. Candidiasis of the mouth and throat, paradoxical bronchoconstriction, headache, nausea, tiredness, thirst, diarrhoea, skin reaction. Budesonide 200 mcg/dose Inhalation P u l m i c o r t , I n f l a m m i d e - Trade Name
R03BA02000A2102XX (B) NEDL APPL

System: Respiratory Indications: Prophylaxis of asthma especially if not fully controlled by bronchodilators. Dosage: Adult : 200 - 1600 mcg dly in 2 - 4 divided doses. Child < 12 yrs : 200 - 800 mcg dly in 2 divided doses. Contraindications: Hypersensitivity to budesonide. Moderate to severe bronchiectasis. Precautions: Acute exacerbations, accompanied by increased mucous viscosity and mucous plugging. Caution in viral infections such as varicella, in untreated fungal and bacterial infections of the respiratory system. Pregnancy and lactation. Reduction in growth velocity in paediatrics. Interactions: Oral or parenteral corticosteroids : Effects enhanced by the concomitant use. Amiodarone : increased risk of developing Cushing's syndrome. Ketoconazole : increased budesonide plasma concentrations. Adverse Reactions: Mild irriation of the throat, coughing and generally reversible hoarseness of the voice. Patients are advised to gargle after using 458

the medication. Bad taste, dryness of the throat. Candidiasis of the mouth and throat, paradoxical bronchoconstriction, headache, nausea, tiredness, thirst, diarrhoea, skin reaction. Budesonide 500 mcg/2 ml Nebulising Solution Pulmicort - Trade Name
R03BA02000A3001XX (B)

System: Respiratory Indications: Prophy laxis of asthma especially if not fully controlled by bronchodilators or cromoglycate. Dosage: Adult : initially 1 - 2 mg bd. Child, 3 mths - 12 yrs of age : 500 mcg-1 mg. Maintenance dose: half of the above doses. Contraindications: Hypersensitivity to budesonide. Moderate to severe bronchiectasis. Precautions: Acute exacerbations, accompanied by increased mucous viscosity and mucous plugging. Caution in viral infections such as varicella, in untreated fungal and bacterial infections of the respiratory system. Pregnancy and lactation. Reduction in growth velocity in paediatrics. Interactions: Oral or parenteral corticosteroids : Effects enhanced by the concomitant use. Amiodarone : increased risk of developing Cushing's syndrome. Ketoconazole : increased budesonide plasma concentrations. Adverse Reactions: Mild irritation of the throat, coughing and generally reversible hoarseness of the voice. Bad taste, dryness of the throat. Candidiasis of the mouth & throat, paradoxical bronchoconstriction, headache, nausea, tiredness, thirst, diarrhoea, skin reactions. Budesonide 1 mg/ 2 ml Nebulising Solution Pulmicort - Trade Name
R03BA02000A3002XX (B)

System: Respiratory Indications: Prophylaxis of asthma especially if not fully controlled by bronchodilators or cromoglycate. Dosage: Adult : initially 1 - 2 mg bd. Child, 3 mths - 12 yrs of age : 500 mcg-1 mg. Maintenance dose: half of the above doses. Contraindications: Hypersensitivity to budesonide. Moderate to severe bronchiectasis. Precautions: Acute exacerbations, accompanied by increased mucous viscosity and mucous plugging. Caution in viral infections such as varicella, in untreated fungal and bacterial infections of the respiratory system. Pregnancy and lactation. Reduction in growth velocity in paediatrics. Interactions: Oral or parenteral corticosteroids : Effects enhanced by the concomitant use. Amiodarone : increased risk of developing Cushing's syndrome. Ketoconazole : increased budesonide plasma concentrations. Adverse Reactions: Mild irritation of the throat, coughing and generally reversible hoarseness of the voice. Bad taste, dryness of the throat. 459

Candidiasis of the mouth & throat, paradoxical bronchoconstriction, headache, nausea, tiredness, thirst, diarrhoea, skin reaction. Fluticasone Propionate 125 mcg/dose Inhalation R03BA05133A2101XX (A) F l i x o t i d e - Trade Name System: Respiratory Indications: Prophylactic treatment for asthma. Dosage: Adult & children >16 yr i) Mild asthma: 100 mcg - 250 mcg twice dly. ii) Moderate asthma : 250 - 500 mcg twice dly. iii) Severe asthma : 500 mcg - 1000 mcg twice dly. Alternatively, the starting dose of Fluticasone dipropionate may be gauged at half the total daily dose of beclomethasone dipropionate or equivalent administered by inhalation. Contraindications: Hypersensitivity to any of the components. Precautions: Not for acute attacks but for routine long-term management. Caution when transfering patients from systemic steroid treatment, pregnancy, rarely, inhaled therapy may mask underlying eosinophilic conditions eg Churg Strauss Syndrome, active or quiescent pulmonary tuberculosis. Interactions: No interaction found. Adverse Reactions: Mouth and throat candidiasis, hoarseness (Patients are advised to gargle after using the medication), paradoxical bronchospasm, cutaneous hypersensitivity reactions. Ipratropium Bromide 20 mcg/dose Inhalation R03BB01320A1001XX (B) NEDL Atrovent - Trade Name System: Respiratory Indications: Only for treatment of : i) Patients with chronic bronchitis who have airway obstruction and who do not respond to Salbutamol or Terbutaline. ii)Patients with ischaemic heart disease who develop extrasystole with Salbutamol or Terbutaline. Dosage: 20 - 40 mcg tds - qid. In the early treatment, up to 80 mcg 3-4 times daily. Child up to 6 yrs: 20 mcg tds, 6-12 yrs: 20-40 mcg tds. Contraindications: Hypersensitivity to atropine and its derivatives. Precautions: Narrow-angle glaucoma, prostatic hypertrophy, cystic fibrosis. Interactions: Bronchodilatory effect intensified by beta-adrenergic & xanthine preparation. Anticholinergic effects of other drugs may be enhanced. Cisapride : loss of cisapride efficacy. Adverse Reactions: Headache, nausea, dry mouth; rare and reversible anticholinergic side effects ; ocular side effects if substances enters eyes ; cough.

460

Ipratropium Bromide 0.0125 % Inhalation Soln in unit dose vial (125 mcg/ml) Atrovent
R03BB01320A3001XX (B) NEDL APPL
- Trade Name

System: Respiratory Indications: Only for treatment of: i) Patients with ischaemic heart disease who develop extrasystole with Salbutamol or Terbutaline, ii) Patients with chronic bronchitis who have airway obstruction and who do not respond to Salbutamol or Terbutaline. Reversible airways obstruction, particularly in chronic obstructive pulmonary disease. Dosage: Adult : 100-500 mcg up to 4 times dly. Child 3-14 yrs : 100 - 500 mcg up to 3 times dly. Contraindications: Hypersensitivity to atropine and its derivatives. Precautions: Narrow-angle glaucoma, prostatic hypertrophy, cystic fibrosis. Interactions: Bronchodilatory effect intensified by beta-adrenergic & xanthine preparation. Anticholinergic effects of other drugs may be enhanced. Cisapride : loss of cisapride efficacy. Adverse Reactions: Headache, nausea, dry mouth; rare and reversible anticholinergic side effects ; ocular side effects if substances enters eyes ; cough. Ipratropium Bromide 0.025 % Inhalation Soln (250 mcg/ml) Atrovent
R03BB01320A3002XX (B) NEDL APPL
- Trade Name

System: Respiratory Indications: Only for treatment of: i) Patients with ischaemic heart disease who develop extrasystole with Salbutamol or Terbutaline, ii) Patients with chronic bronchitis who have airway obstruction and who do not respond to Salbutamol or Terbutaline. Reversible airways obstruction, particularly in chronic obstructive pulmonary disease. Dosage: Adult : 100 - 500 mcg up to 4 times dly. Child 3-14 yr : 100-500 mcg up to 3 times dly. Contraindications: Hypersensitivity to atropine and its derivatives. Precautions: Narrow-angle glaucoma, prostatic hypertrophy, cystic fibrosis. Interactions: Bronchodilatory effect intensified by beta-adrenergic & xanthine preparation. Anticholinergic effects of other drugs may be enhanced. Cisapride : loss of cisapride efficacy. Adverse Reactions: Headache, nausea, dry mouth; rare and reversible anticholinergic side effects ; ocular side effects if substances enters eyes ; cough.

461

Tiotropium bromide Inhalation 18 mcg Capsules & Handihaler Spiriva

R03BB04320C9901XX (A*)
- Trade Name

System: Respiratory Indications: Long term maintenance treatment of bronchospasm and dypsnea associated with COPD. Dosage: Inhale the contents of one capsule once daily with the handihaler device at the same time of day. Contraindications: Hypersensitivity to Tiotropium, its derivatives/ any component of the formulation (contains lactose), not for use as an acute ("Rescue") bronchodilator. Precautions: Myasthenia gravis, narrow angle glaucoma, prostatic hyperplasia, renal impairment, pregnancy. Interactions: B-agonists and other anticholinergics. Adverse Reactions: Xerostomia, URTI, sinusitis, rash, cataract, angioedema, tachycardia, urinary retention. Disodium Cromoglycate 5 mg Inhalation Intal - Trade Name
R03BC01520A2101XX (B)

System: Respiratory Indications: Prophylaxis of asthma in children. Dosage: 2 puffs qid daily, increase in severe cases or during period of risk to 6-8 times daily. Maintenance 1 puff qid. Contraindications: Not known. Precautions: Abrupt withdrawal. Interactions: No interaction found. Adverse Reactions: Mild throat irritation, coughing and transient bronchospasm. Very rarely, severe bronchospasm necessitating withdrawal of treatment may occur. Benzoin, Storax, Menthol & Eucalyptus Inhalation R03BX00000A9901XX (C) B e n z o i n C o m p . - Trade Name System: Ear, Nose and Oropharynx Indications: Bronchitis, relief of nasal congestion in acute rhinitis or sinusitis. Dosage: 1 teaspoonful to a pint ( 568 ml) of hot boiling water and inhale the vapour. Contraindications: Not known. Precautions: Not recommended for infants under the age of 3 months. Interactions: No interaction found. Adverse Reactions: No information available. 462

Ephedrine HCl 30 mg/ml Injection

R03CA02110P3001XX (B)APPL

System: Cardiovascular Indications: Hypotension in epidural and spinal anaesthesia. Dosage: By a slow IV bolus of a solution containing Ephedrine HCl 3 mg/ml, 3 - 6 mg (max.: 9 mg) repeated every 3 - 4 mins. to a max.30 mg. Contraindications: Anaesthesia with cyclopropane or halothane, diabetes (for ephedrine injection). Hypersensitivity to ephedrine or other sympathomimetic amines . Hypertension or other cardiovascular disorders, obstetrical procedures with maternal blood pressure, breast feeding. Precautions: Angina pectoris, chronic heart disease. Chronic use may cause an anxiety state . Prostatic hypertrophy, pregnancy. Interactions: Should not be administered concomitantly with other sympathomimetic agents. Alpha & beta-adrenergic blocking agents. Cyclopropane or halogenated hydrocarbons general anaesthetics. MAOIs. Adverse Reactions: Nervousness, anxiety, apprehension, fear, tension, agitation, excitation, restlessness, weakness, irritability, insomnia, dizziness, lightheadness, vertigo, confusion, delirium, hallucinations or euphoria. Throbbing headache, resp difficulty, fever or a feeling of warmth, pallor, dryness of the nose and throat, precordial pain, sweating, mild epigastric distress, anorexia, nausea or vomiting. Acute urinary retention or difficulty in urination. May initially decrease urine formation. Palpitation and tachycardia. Extrasystoles and potentially fatal arrhythmias including ventricular fibrillation especially in patients with organic heart disease. Salbutamol 2 mg/5 ml Syrup V e n t o l i n - Trade Name
R03CC02183L9001XX (B) NEDL

System: Respiratory Indications: Asthma and other conditions associated with reversible airways obstruction. Dosage: Child 2 - 6 yrs : 1 - 2 mg tds - qid. 6 - 12 yrs: 2 mg tds - qid. Contraindications: Hypersensitivity to any of their components. Precautions: Thyrotoxicosis. Interactions: Monoamine oxidase inhibitors : increased risk of tachycardia, agitation, or hypomania. Adverse Reactions: Fine tremor(particularly in the hands), nervous tension, headache, peripheral dilatation and palpitations, tachycardia, arrhythmias, disturbances of sleep and behaviour in children. Salbutamol 0.5 mg/ml Injection V e n t o l i n - Trade Name
R03CC02183P3001XX (A) NEDL

System: Respiratory Indications: Asthma and other conditions associated with reversible airways obstruction. Dosage: 463

500 mcg by SC/IM inj. 4 hrly or 250 mcg by slow IV. If required, by IV infusion , initially 5 mcg/min adjusted according to response and heart rate, usually in the range 3 - 20 mcg/min. Contraindications: Hypersensitivity, hyperthyroidism or thyrotoxicosis, tachycardia or tachycardiac arrthymias, subvalvular aortic stenosis. Precautions: Thyrotoxicosis, pregnancy and lactation. Potential for paradoxical bronchospasm, pts with CV disorders, hyperthyroidism, diabetes mellitus, phaeochromocytoma, patients with history of aneursym and pts who are usually responsive to sympathomimetics amines. Labour and delivery may be complicated. Interactions: Monoamine oxidase inhibitors : increased risk of tachycardia, agitation, or hypomania. Adverse Reactions: Haemorrhage, thrombocytopenia, tachycardia and palpitations, erythema, ventricular ectopic beats, myocardial ischaemia and infarction have been reported following IV administration. Fine tremor (particularly in the hands), nervous tension, headache, peripheral dilatation and palpitations, tachycardia, arrhythmias, disturbances of sleep and behaviour in children. Muscle cramps and hypersensitivity reactions including paradoxical bronchospasm, urticaria, and angioedema. Salbutamol 5 mg/5 ml Injection V e n t o l i n - Trade Name
R03CC02183P3002XX (A*) NEDL

System: Obstetrics, Gynaecology Indications: Prevention of uncomplicated premature labour only. Dosage: Infusions containing 5 mg in 500ml (10 mcg/ml) at the rate of 10 - 45 mcg/min increased at intervals of 10 min. until evidence of patient response as shown by reduction of strength, frequency or duration of contractions; maintain rate for 1 hr after contractions have stopped, then gradually reduce by 50% every 6 hrs. Contraindications: Hypersensitivity, hyperthyroidism or thyrotoxicosis, tachycardia or tachycardic arrthymias, subvalvular aortic stenosis. Precautions: Potential for paradoxical bronchospasm, patients with CV disorders, hyperthyroidism, diabetes mellitus, phaeochromocytoma, patients with history of aneurysm and patients who are usually responsive to sympathomimetic amines. Labour and delivery may be complicated. Thyrotoxicosis, pregnancy and lactation. Interactions: Hypertensive crisis and other adverse effects occur frenquently with the concurrent use of indirect-acting sympathomimetics. Concomitant administration of salbutamol and other beta2 agonists with corticosteroids, diuretics or xanthines increases the risk of toxicity. Adverse Reactions: Haemorrhage, thrombocytopaenia, tachycardia and palpitations, erythema, ventricular ectopic beats, myocardial ischaemia and infarction have been reported following IV administration. Fine tremors (particularly in the hands), nervous tension, headache, peripheral dilatation and palpitations, tachycardia, arrhythmias. Muscle cramps and hypersensitivity reactions including paradoxical bronchospasm, urticaria, and angioedema. 464

Salbutamol 2 mg Tablet V e n t o l i n - Trade Name

R03CC02183T1001XX (B) NEDL APPL

System: Respiratory Indications: Asthma and other conditions associated with reversible airways obstruction. Dosage: Child : 2 - 6 yrs: 1 - 2 mg tds - qid. 6 - 12 yrs : 2 mg tds - qid. Over 12 yrs and adult : 2 - 4 mg tds - qid. Contraindications: Hypersensitivity to any of their components. Premature labour, eg placenta praevia, associated with toxaemia of pregnancy or antepartum haemorrhage from whatever cause. Precautions: Thyrotoxicosis. Interactions: Monoamine oxidase inhibitors : increased risk of tachycardia, agitation, or hypomania. Adverse Reactions: Fine tremor(particularly in the hands), nervous tension, headache, peripheral dilatation and palpitations, tachycardia, arrhythmias, disturbances of sleep and behaviour in children. Terbutaline Sulphate 0.3 mg/ml Syrup B r i c a n y l - Trade Name
R03CC03183L9001XX (B) NEDL

System: Respiratory Indications: Asthma and other conditions associated with reversible airways obstruction. Dosage: Child: <3 yrs : 2.5 ml bd - tds; 3 - 6 yrs : 2.5 - 5 ml bd - tds. Above 7 yrs : 5 10 ml bd - tds. Contraindications: Hypersensitivity to terbutaline and other sympathomimetic amines. Precautions: Hypertension, cardiovascular disease, unstable diabetes, hypersensitivity to sympathomimetic amines, hypertrophic cardiomyopathia and hypokalaemia. Interactions: Beta-blockers: inhibit bronchodilating effect. Monoamine oxidase inhibitors: increased risk of tachycardia, agitation, or hypomania. Theophylline: decreased theophylline concentrations. Adverse Reactions: Palpitations, tachycardia, increases in ejection fraction, increases in cardiac output have been reported following subcutaneous terbutaline, tremor and tonic cramp. Terbutaline Sulphate 2.5 mg Tablet B r i c a n y l - Trade Name
R03CC03183T1001XX (B) NEDL APPL

System: Respiratory Indications: Asthma and other conditions associated with reversible airways obstruction. Dosage: Adult : Initially 2.5 mg tds for 1 - 2 wks, then up to 5 mg tds. Child : 75 mcg/kg tds ; 7-15 yrs : 2.5 mg bd-tds. Contraindications: Hypersensitivity to terbutaline and other sympathomimetic 465

amines. Precautions: Hypertension, cardiovascular disease, unstable diabetes, hypersensitivity to sympathomimetic amines, hypertrophic cardiomyopathia, hypokalaemia. Interactions: Beta-blockers : inhibit bronchodilating effect. Monoamine oxidase inhibitors : increased risk of tachycardia, agitation, or hypomania. Theophylline : decreased theophylline concentrations. Adverse Reactions: Palpitations, tachycardia, increases in ejection fraction, increases in cardiac output have been reported following subcutaneous terbutaline, tremor and tonic cramp. Theophylline 80 mg/15 ml Syrup N u e l i n - Trade Name
R03DA04000L9001XX (B)NEDL

System: Respiratory Indications: Reversible airways obstruction and acute severe asthma. Dosage: Adult: 25 ml qid. Child: over 2 yrs : 1 ml/kg body wt qid. Contraindications: Hypersensitivity to theophylline. Precautions: Active peptic ulcer disease, seizure disorders, cardiac arrhythmias (not including bradyarrhythmias). Patients with migraine headaches may experience an increased frequency of headaches. Patients with congestive heart failure, cor pulmonale, prolonged fever, hypothyroidism, liver disease, sepsis with multi-organ failure, and shock may require reduced theophylline dosage. Concommitant medication use which results in reduced theophylline clearance. Interactions: Adenosine : decreased adenosine effectiveness. Albendazole, allopurinol, cimetidine, ciprofloxacin, clarithromycin, diltiazem, Fluvoxamine, ranitidine, ticlopidine : increased risk of theophylline toxicity (nausea, vomiting, palpitations, seizures). Salbutamol (IV), terbutaline : decreased theophylline concentrations. Azithromycin : increase serum theophylline concentrations. Benzodiazepines : decreased benzodiazepine effectiveness. Cetrizine : elevated cetirizine concentrations, somnolence, fatigue, and dry mouth. Erythromycin : theophylline toxicity or decreased erythromycin effectiveness. Frusemide, nifedipine : altered theophylline concentrations phenytoin, carbamazepine : decreased theophylline effectiveness. Propranolol : decreased theophylline clearance and pharmacological antagonism. Adverse Reactions: Tachycardia, palpitations, nausea and other gastrointestinal disturbances, headache, CNS stimulation, insomnia, arrythmias. Theophylline 125 mg Tablet N u e l i n - Trade Name System: Respiratory
R03DA04000T1001XX (B) NEDL APPL

466

Indications: Reversible airways obstruction, acute severe asthma. Dosage: Adult : 125 mg tds - qid after food, increased to 250 mg if required. Child: 7 12 yrs : 62.5 - 125 mg tds - qid. Contraindications: Hypersensitivity to theophylline. Precautions: Active peptic ulcer disease, seizure disorders, cardiac arrhythmias (not including bradyarrhythmias). Patients with migraine headaches may experience an increased frequency of headaches. Patients with congestive heart failure, cor pulmonale, prolonged fever, hypothyroidism, liver disease, sepsis with multi-organ failure and shock may require reduced theophylline dosage. Concommitant medication use which results in reduced theophylline clearance. Interactions: Adenosine, albendazole, allopurinol, cimetidine, ciprofloxacin, clarithromycin, diltiazem, fluvoxamine, ranitidine, ticlopidine salbutamol (IV), terbutaline, azithromycin, benzodiazepines, cetrizine, erythromycin, frusemide, nifedipine, carbamazepine, propranolol. Adverse Reactions: Tachycardia, palpitations, nausea and other gastrointestinal disturbances, headache, CNS stimulation, insomnia, arrythmias. Theophylline 250 mg Long Acting Tablet N u e l i n S R - Trade Name
R03DA04000T5001XX (B) NEDL

System: Respiratory Indications: Reversible airways obstruction and acute severe asthma. Dosage: Adult : 250 mg bd. Child under 12 yrs: Up to 10 mg/kg body wt bd. Contraindications: Hypersensitivity to theophylline. Precautions: Active peptic ulcer disease, seizure disorders, cardiac arrhythmias (not including bradyarrhythmias). Patients with migraine headaches may experience an increased frequency of headaches. Patients with congestive heart failure, cor pulmonale, prolonged fever, hypothyroidism, liver disease, sepsis with multi-organ failure, and shock may require reduced theophylline dosage. Concommitant medication use which results in reduced theophylline clearance. Interactions: Adenosine : decreased adenosine effectiveness. Albendazole, allopurinol, cimetidine, ciprofloxacin, clarithromycin, diltiazem, Fluvoxamine, ranitidine, ticlopidine : increased risk of theophylline toxicity (nausea, vomiting, palpitations, seizures). Salbutamol (IV), terbutaline : decreased theophylline concentrations. Azithromycin : increase serum theophylline concentrations. Benzodiazepines : decreased benzodiazepine effectiveness. Cetrizine : elevated cetirizine concentrations, somnolence, fatigue, and dry mouth. Erythromycin : theophylline toxicity or decreased erythromycin effectiveness. Frusemide, nifedipine : altered theophylline concentrations phenytoin, carbamazepine : decreased theophylline effectiveness. Propranolol : decreased theophylline clearance and pharmacological antagonism. Adverse Reactions: Tachycardia, palpitations, nausea and other gastrointestinal disturbances, headache, CNS stimulation, insomnia, arrythmias. 467

Aminophylline 25 mg / ml Injection

R03DA05000P3001XX (B) NEDL APPL

System: Respiratory Indications: Reversible airways obstruction, acute severe asthma. Dosage: Deteriorating acute asthma not previously treated with theophylline, by slow IV inj. over 20 mins, 250-500 mg (5 mg/kg), then as for acute severe asthma; Acute severe asthma - by IV infusion, 500 mcg/kg/hr, adjusted according to plasma-theophylline concentration; Child : 6 mth - 9 yrs : 1 mg/kg/hr, 10 - 16 yrs : 800 mcg/kg/hr Contraindications: Allergy to theophyllines, caffeine, theobromine, hypersensitivity to ethylenediamine. Peptic ulcer, active gastritis, severe renal or liver impairment. Precautions: Hyperthyroidism, glaucoma, diabetes mellitus, angina pectoris. Pulmonary, cardiovascular, renal or hepatic diseases. Pregnancy, children and elderly. Interactions: Adenosine : decreased adenosine effectiveness. Albendazole, allopurinol, cimetidine, ciprofloxacin, clarithromycin, diltiazem, Fluvoxamine, ranitidine, ticlopidine : increased risk of theophylline toxicity (nausea, vomiting, palpitations, seizures). Salbutamol (IV), terbutaline : decreased theophylline concentrations. Azithromycin : increase serum theophylline concentrations. Benzodiazepines : decreased benzodiazepine effectiveness. Cetrizine : elevated cetirizine concentrations, somnolence, fatigue, and dry mouth. Erythromycin : theophylline toxicity or decreased erythromycin effectiveness. Frusemide, nifedipine : altered theophylline concentrations phenytoin, carbamazepine : decreased theophylline effectiveness. Propranolol : decreased theophylline clearance and pharmacological antagonism. Adverse Reactions: GI upset, nervousness, urinary frequency, also allergy to ethylenediamine can cause urticaria, erythema, and exfoliative dermatitis. Montelukast Sodium 10 mg Tablet Singulair - Trade Name
R03DC03520T1001XX (A*)

System: Respiratory Indications: Asthmatics, not controlled on high dose inhaled corticosteroids > 1600 mcg/day and with co-morbid allergic disorders. Dosage: 10 mg daily at bedtime; 6-14 yrs 5 mg daily at bedtime. Contraindications: Hypersensitivity to montelukast or its components. Precautions: Should not be used for treatment of acute asthma attacks. Should not be abruptly substituted for inhaled or oral corticosteroids. Pregnancy and lactation. Churg-Strauss syndrome. Child < 2 yrs. Patients with known aspirin sensitivity should continue avoidance of aspirin or NSAIDs. Interactions: Prednisone: severe peripheral oedema. Phenobarbital: decreased bioavailability of montelukast. Adverse Reactions: Abdominal pain, headache. 468

Montelukast Sodium 5 mg Chewable Tablet Singulair - Trade Name

R03DC03520T2001XX (A*)

System: Respiratory Indications: Asthmatics, not controlled on high dose inhaled corticosteroids > 1600 mcg/day and with co-morbid allergic disorders. Dosage: 10 mg at bedtime; 6 - 14 yrs: one 5 mg chewable tablet dly. Contraindications: Hypersensitivity to montelukast or its components. Precautions: Should not be used for treatment of acute asthma attacks. Should not be abruptly substituted for inhaled or oral corticosteroids. Pregnancy and lactation. Churg-Strauss syndrome. Child < 2 yrs. Patients with known aspirin sensitivity should continue avoidance of aspirin or NSAIDs. Interactions: Prednisone: severe peripheral oedema. Phenobarbital: decreased bioavailability of montelukast. Adverse Reactions: Abdominal pain, headache. Ipecacuanha Pro Infant Mixture Ipecac - Trade Name
R05CA04000L2101XX (B)NEDL

System: Ear, Nose and Oropharynx Indications: As paediatric expectorant. Dosage: Child up to 1 yr ; 5 ml; 1 - 5 yrs : 10 ml. Contraindications: Avoid in shock, convulsion and cardiovascular disease. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: Large doses is irritant to whole GI and can lead to vomiting and diarrhoea. Ammonium Bicarb, Tinct Ipecac, etc Mixture Expect Stimulant - Trade Name
R05CA04900L2101XX (C)

System: Ear, Nose and Oropharynx Indications: Cough. Dosage: 10 - 20 ml tds. Contraindications: Not known Precautions: Can be irritant to mucous membrane. Interactions: No interaction found Adverse Reactions: If consumed in very large dose can cause nausea and vomiting. Bromhexine HCl 4 mg/5 ml Elixir B i s o l v o n - Trade Name System: Ear, Nose and Oropharynx 469
R05CB02110L1001XX (B)

Indications: Secretolytic therapy in acute & chronic bronchopulmonary diseases associated with abnormal mucous secretion & impaired mucous transport. Dosage: Adult & child > 12 yrs : 10 ml tds; 6 - 12 yrs : 5 ml tds; 2 - 6 yrs : 2.5 ml tds; < 2 yrs : 1.25 ml tds Contraindications: Hypersensitivity to bromhexine. Precautions: GI ulceration, pregnancy and lactation Interactions: May lead to higher antibiotic concentration in lung tissue. Oral anticoagulants. Adverse Reactions: Nausea,anorexia, abdominal discomfort & pain, headache, allergic reactions. Bromhexine HCl 4 mg/2 ml Injection B i s o l v o n - Trade Name
R05CB02110P3001XX (A)

System: Ear, Nose and Oropharynx Indications: Secretolytic therapy in acute & chronic bronchopulmonary diseases associated with abnormal mucous secretion & impaired mucous transport. Dosage: 4 mg SC, IM or IV bd - tds. Contraindications: Hypersensitivity to bromhexine. Precautions: GI ulceration, pregnancy and lactation. Interactions: May lead to higher antibiotic concentration in lung tissue. Oral anticoagulants. Adverse Reactions: Occasionally GI effects, skin rashes very rarely. Bromhexine HCl 8 mg Tablet B i s o l v o n - Trade Name
R05CB02110T1001XX (B)

System: Ear, Nose and Oropharynx Indications: Secretolytic therapy in acute & chronic bronchopulmonary diseases associated with abnormal mucous secretion & impaired mucous transport. Dosage: Adult and child > 12 yrs : 8 mg tds; 6 - 12 yrs : 4 mg tds; 2 - 6 yrs : 4 mg bd. Contraindications: Hypersensitivity to Bromhexine. Precautions: Same as in elixir Interactions: May lead to higher antibiotic concentration in lung tissue. Oral anticoagulants. Adverse Reactions: Same as in elixir Codeine Phosphate 15 mg/5 ml Linctus
R05DA04162L1101XX (B)NEDL

System: Ear, Nose and Oropharynx Indications: Cough. Dosage: Adult: 5 ml tds. Child: Dilute 1 part to 4 parts of syrup; Up to 1 yr : 5 ml tds; 1 470

- 5 yrs : 10 ml tds. Contraindications: Respiratory depression. Precautions: Seizures, asthma, COPD, head injuries or increased cranial pressure. Concomittant CNS depressants, acute abdominal conditions.Elderly or debilitated. Severe hepatic or renal impairment. Hypothyroidism, Addison's disease. Interactions: Enhanced sedative & hypotensive effects with alcohol, interacts with antibacterials, antidepressants, anxiolytics etc. Adverse Reactions: Drowsiness, constipation may be troublesome with longterm use. Following large doses of codeine, excitement and convulsions may occur. Diphenhydramine HCl 10mg/5ml Elixir B e n a d r y l - Trade Name
R06AA02110L1001XX (B) NEDL

System: Ear, Nose and Oropharynx Indications: Cough and allergic rhinitis. Dosage: Child : Up to 1 yr : 6.25 - 12.5 mg tds or qid; 1 - 5 yrs : 12.5 - 25 mg tds or qid; 6 - 12 yrs : 25 - 50 mg tds. Contraindications: MAOIs therapy. Precautions: May impair ability to drive & operate machine. Pregnancy , lactation. Interactions: Additive effects if use with hypnotics, sedatives, tranquilizers. Adverse Reactions: Drowsiness. Diphenhydramine HCl 14mg/5ml & Ammonium Chloride 135mg/5ml Expectorant R06AA52110L2101XX (B) NEDL APPL B e n a d r y l - Trade Name System: Ear, Nose and Oropharynx Indications: Cough Dosage: Adult: 5 - 10 ml bd or tds. Child : 2.5 - 5 ml bd or tds. Contraindications: Hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure , nursing mothers, newborns or infants. Precautions: Renal or hepatic disease, glaucoma or in patients on MAOIs. May cause drowsiness, may impair ability to drive and operate machine. Interactions: May potentiate other CNS depressants. Actions prolonged by MAOIs. Adverse Reactions: CNS depression, with effects varying from slight drowsiness to deep sleep, and including lassitude, dizziness, and incoordination (although paradoxical stimulation may occasionally occur, especially at high doses and in chidren or the elderly), nausea, vomiting, diarrhoea or epigastric pain.

471

Dexchlorpheniramine Maleate 2 mg/5 ml Syrup R06AB02253L9001XX (B) NEDL P o l a r a m i n e - Trade Name System: Ear, Nose and Oropharynx Indications: Symptomatic treatment of allergic rhinitis. Dosage: Child : Up to 1 yr : 0.5 mg tds or qid; 1 - 5 yrs : 12.5 - 25 mg tds or qid ; 6 - 12 yrs : 25 -50 mg tds. Contraindications: Newborn and premature infants. MAOIs therapy. Precautions: Narrow-angle glaucoma, stenosing peptic ulcers, cardiovascular diseases,hyperthyrodism, avoid driving & operating machinery. Interactions: Actions prolonged by MAOIs, alcohol, tricyclic antidepressant, barbiturates. Other CNS depressants can potentiate effects. Adverse Reactions: Drowsiness, urticaria, drug rashes, anaphylactic shock, dry mouth, chills. Dexchlorpheniramine Maleate 2 mg Tablet P o l a r a m i n e - Trade Name
R06AB02253T1001XX (B)NEDL

System: Ear, Nose and Oropharynx Indications: Symptomatic treatment of allergic rhinitis and allergic dermatoses. Dosage: Adult : 2 mg tds. Child; 1 - 12 yrs : 2 mg tds. Contraindications: Newborn and premature infants. MAOIs therapy. Precautions: Narrow-angle glaucoma, stenosing peptic ulcers, cardiovascular diseases, hyperthyroidism, prostatic hypertrophy, avoid driving & operating machinery. Interactions: Actions prolonged by MAOIs, alcohol, tricyclic antidepressants, barbiturates. Other CNS depressants can potentiate effects. Adverse Reactions: Drowsiness, urticaria, drug rashes, anaphylactic shock, dry mouth, chills. Dexchlorpheniramine Maleate 6 mg Tablet P o l a r a m i n e - Trade Name
R06AB02253T5002XX (B)NEDL

System: Ear, Nose and Oropharynx Indications: Symptomatic treatment of allergic rhinitis. Dosage: Adult : 1 repetab bd. Contraindications: Newborn and premature infants. MAOIs therapy. Precautions: Narrow-angle glaucoma, stenosing peptic ulcers, cardiovascular diseases, hyperthyroidism, avoid driving & operating machinery. Interactions: Actions prolonged by MAOIs, alcohol, tricyclic antidepressant, barbiturates. Other CNS depressants can potentiate effects. Adverse Reactions: Drowsiness, urticaria, drug rashes, anaphylactic shock, dry mouth, chills, etc. 472

Chlorpheniramine Maleate 2 mg/5ml Syrup P i r i t o n - Trade Name

R06AB04253L9001XX (C) NEDL APPL

System: Ear, Nose and Oropharynx Indications: Symptomatic treatment of allergic conditions responsive to antihistamine. Dosage: Adult: 5 - 10 ml. Child: Up to 1 yr: 2.5 ml bd; 1 - 5 yrs: 2.5 - 5 ml tds; 6 - 12 yrs: 10 ml tds - qid. Contraindications: Hypersensitivity to chlorpheniramine. Precautions: Porphyria, pregnancy, asthma. Avoid operating vehicles or machinery. Interactions: Alcohol pontentiate CNS depressants,actions prolonged by MAOIs, anticholigernic drugs. Increase in phenytoin plasma level. Adverse Reactions: Drowiness, dizziness, stinging, hypotension due to arrhythmia, CNS stimulation (hallucination and seizure). Chlorpheniramine Maleate 10 mg/ml Injection R06AB04253P3001XX (B) NEDL APPL P i r i t o n - Trade Name System: Ear, Nose and Oropharynx Indications: Allergic conditions. Dosage: 10 - 20 mg IM or SC as a single dose. Not to exceed 40 mg in 24 hrs. 10 - 20 mg over 1 min by slow IV. Contraindications: Acute asthma attack, premature infants, epileptic. Precautions: Glaucoma, avoid operating vehicles or machinery, pregnancy. Parenteral injection have to be protected from light to prevent discolouration. Interactions: Alcohol pontentiate CNS depressants, actions prolonged by MOAIs, anticholigernic drugs. Increase in phenytoin plasma level. Adverse Reactions: Drowsiness, dizziness, stinging, burning sensation at injection site, hypotension, CNS stimulation, tinnitus, blurred vision, irritability, lassitude. Chlorpheniramine Maleate 4 mg Tablet P i r i t o n - Trade Name
R06AB04253T1001XX (C) NEDL APPL

System: Ear, Nose and Oropharynx Indications: Symptomatic treatment of allergic conditions responsive to antihistamines. Dosage: Adult: 4 mg every 4 - 6 hrs. Max: 24 mg dly. Child: 0.1 mg/kg/dose tds - qid. Contraindications: Hypersensitivity to chlorpheniramine. Precautions: Prophyria, pregnancy, asthma. Avoid operating vehicles or machinery. Interactions: Alcohol pontentiate CNS depressants, actions prolonged by MAOIs, anticholigernic drugs. Increase in phenytoin plasma level. Adverse Reactions: Drowiness, dizziness, stinging, hypotension due to arrythmia,CNS stimulation (hallucination and seizure). 473

Promethazine HCl 5 mg/5 ml Syrup P h e n e r g a n - Trade Name

R06AD02110L9001XX (C) NEDL APPL

System: Ear, Nose and Oropharynx Indications: Allergic conditions. Dosage: Child : 2 - 5 yrs: 5 - 15 mg dly; 5 - 10 yrs: 10 - 25 mg dly. Contraindications: Comatose patients, acute attack of asthma, children under 2 years. Precautions: Pregnancy, lactation, cardiovascular or hepatic diseases, narrow angle glaucoma, cross sensitivity to related drugs. Interactions: Antihypertensives, phenothiazines, alcohol, anticholinergics, tricyclic antidepressants, MAOIs, evening primrose oil. Adverse Reactions: Sedation, GI disturbances, antimuscarinic effects, muscular weakness, tinnitus, allergic reactions, blood disorders. Promethazine HCl 25 mg/ml Injection P h e n e r g a n - Trade Name
R06AD02110P3001XX (B) NEDL APPL

System: Ear, Nose and Oropharynx Indications: Allergic conditions. Dosage: By deep IM: Adult: 25 - 50 mg, max : 100 mg. Child : 5 - 10 yrs : 6.25 - 12.5 mg. By slow IV : 25 - 50 mg in a solution of 2.5 mg/ml in Water for Injection. Max : 100 mg. Contraindications: Comatose patients, acute attack of asthma, children under 2 years, SC & intra-arterial injection. Precautions: Pregnancy, lactation, cardiovascular or hepatic diseases, narrow angle glaucoma, peptic ulcer, pyloduodenal obstruction, prostatic hypertrophy, cross sensitivity to related drugs. Interactions: Antihypertensives, phenothiazines, alcohol, anticholinergics, tricyclic antidepressants, MAOIs, evening primrose oil. Adverse Reactions: Sedation, GI disturbances, antimuscarinic effects, muscular weakness, tinnitus, allergic reactions, blood disorders. Meclozine HCl 25 mg Tablet A n c o l a n - Trade Name
R06AE05110T1001XX (B)NEDL

System: Neurology Indications: Nausea, vomiting and motion sickness. Dosage: 25 - 50 mg bd - tds. Contraindications: Hypersensitivity to Meclozine. Precautions: Use with caution in prostatic hyperthrophy, urinary retention, glaucoma and pyloroduodenal obstruction, hepatic disease, severe heart failure, asthma and operating vehicles or machinery. Interactions: May enhance the sedative effects of CNS depressants including 474

alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, and tranquilizers. Have an additive antimuscarinic action with other antimuscarinic drugs. Adverse Reactions: Drowsiness, occasional dry mouth and blurred vision. Cetirizine HCl 10 mg Tablet Zyrtec - Trade Name
R06AE07110T1001XX (A/KK)

System: Ear, Nose and Oropharynx Indications: Urticaria, allergic dermatoses (adverse drug reactions, insect bites, atopic eczema), perennial rhinitis, allergic rhinitis. Dosage: 10 mg dly or 5 mg bd. Contraindications: Hypersensitivity to cetirizine or hydroxyzine. Precautions: Activities requiring mental alertness. Concurrent use of central nervous system depressants. Renal insufficiency or hepatic dysfunction, elderly. Interactions: Decreased cetirizine clearance resulting in elevated cetirizine serum concentrations and possibly cetirizine toxicity with theophylline. Adverse Reactions: Somnolence, fatigue, headache and dry mouth. Meclozine HCl 25mg & Pyridoxine 50mg Tablet R06AE55919T1001XX (B)NEDL N a v i d o x i n e - Trade Name System: Gastro-Intestinal Indications: Nausea & vomiting of pregnancy. Dosage: 1 - 2 tab bd or tds in severe cases. Contraindications: Hypersensitivity to meclozine. Precautions: Use with caution in prostatic hyperthrophy, urinary retention, glaucoma and pyloroduodenal obstruction, hepatic disease, severe heart failure, asthma. Avoid operating vehicles and machinery. Interactions: May enhanced sedative effect of central depressants including alcohol. Adverse Reactions: Drowsiness, dry mouth, blurred vision, headache, GI disturbance Loratadine 1 mg/ml Syrup C l a r i t y n e - Trade Name
R06AX13000L9001XX (A)

System: Ear, Nose and Oropharynx Indications: Allergic rhinitis, chronic urticaria and other allergic dermatologic disorders. Dosage: Adult and child 2-12 yrs & > 30 kg : 10 ml ; < 30 kg : 5 ml. Contraindications: Avoid in porphyria, pregnancy, breast feeding. Precautions: Use with caution in prostatic hypertrophy, urinary retention, glaucoma. Avoid operating vehicle and machinery. Interactions: Cimetidine, erythromycin, ketoconazole & other hepatic enzyme 475

inhibitors. Adverse Reactions: Headache, nervousness, sedation. Loratadine 10 mg Tablet C l a r i t y n e - Trade Name
R06AX13000T1001XX (A/KK) APPL

System: Ear, Nose and Oropharynx Indications: Allergic rhinitis and allergic dermatoses. Dosage: Adult and child 2-12 years & > 30 kg : 10 mg dly. Child : 2 - 12 yrs and < 30 kg : 5 mg dly. Contraindications: Avoid in porphyria,pregnancy, breast feeding. Precautions: Impaired liver and renal function (use lower dose). Should not take with alcohol and avoid operating vehicle and machinery. Interactions: Cimetidine, erythromycin, ketoconazole & other hepatic enzyme inhibitors. Adverse Reactions: Headache, sedation, nervousness. Colfosceril palmitate 108 mg Powder Intratracheal Suspension Exosurf
R07AA01126P4001XX (A*)
- Trade Name

System: Respiratory Indications: Treatment of newborn baby with birth weight of 700 g or greater undergoing mechanical ventilation for respiratory distress syndrome, whose heart rate and arterial oxygenation are continuously monitored. Dosage: 5 ml of reconstituted suspension/kg birth weight via endotracheal tube. A 2nd dose 12 hr later if baby is intubated. Contraindications: Not known. Precautions: Neonates weighing less than 700 g. Interactions: No interaction found. Adverse Reactions: Pulmonary haemorrhage, mucous plugging, gagging. Beractant Intratracheal Suspension (200 mg phospholipids in 8 ml. vial) Survan t a
R07AA02000L8001XX (A*)
- Trade Name

System: Respiratory Indications: Treatment of newborn baby with birth weight of 700 g or greater undergoing mechanical ventilation for respiratory distress syndrome, whose heart rate and arterial oxygenation are continuously monitored. Dosage: 4 ml/kg body weight via endotracheal tube within 8 hrs of birth. May be repeated within 48 hrs at interval of at least 6 hrs for up to 4 doses. Contraindications: Not known. Precautions: Continuous monitoring are required to avoid hyperoxaemia. Interactions: No interaction found. 476

Adverse Reactions: Transient bradycardia, endotracheal tube reflux, decreased oxygen saturation. Amphotericin-B 0.1% Eye Drops
S01A000801D2002XX (A)

System: Ophthalmology Indications: Fungal infection of the cornea. Dosage: 1 drop hourly or 2 hourly. Contraindications: Hypersensitivity to Amphotericin B Precautions: Renal impairment. Interactions: Cyclosporin, digitalis glycosides, nondepolarizing neuromuscular blockers. Adverse Reactions: nausea & vomiting, anaemia, thrombocytopenia Amphotericin-B 0.25% Eye Drops
S01A000801D2003XX (A)

System: Ophthalmology Indications: Fungal infection of the cornea. Dosage: 1 drop hourly or 2 hourly. Contraindications: Hypersensitivity to Amphotericin B Precautions: Renal impairment. Interactions: Cyclosporin, digitalis glycosides, nondepolarizing neuromuscular blockers. Adverse Reactions: nausea & vomiting, anaemia, thrombocytopenia Chloramphenicol 0.5% Eye Drops C h l o r o m y c e t i n - Trade Name
S01AA01000D2001XX (C) NEDL APPL

System: Ophthalmology Indications: Broad spectrum antibiotic in superficial eye infections. Dosage: 1 - 2 drops every 3 - 4 hours. Contraindications: Hypersensitivity to chloramphenicol products. Precautions: Overgrowth of non-susceptible organisms ; prolonged use. Interactions: No interaction found. Adverse Reactions: Allergic reactions, superinfection, bone marrow hypoplasia including aplastic anaemia. Chloramphenicol 1% Eye Ointment C h l o r o m y c e t i n - Trade Name System: Ophthalmology
S01AA01000G5101XX (C) NEDL APPL

477

Indications: Conjunctivitis and other superficial eye infection. Dosage: Apply 1/2 inch of ointment every 3 - 4 times into the conjunctival sac. Contraindications: Hypersensitivity to chloramphenicol products. Precautions: Overgrowth of non-susceptible organisms ; prolonged use. Interactions: No interaction found. Adverse Reactions: Allergic reactions, superinfection, bone marrow hypoplasia including aplastic anaemia. Chlortetracycline 1% Eye Ointment
S01AA02000G5101XX (B)NEDL

System: Ophthalmology Indications: Eye infections require a broad spectrum antibiotic. Dosage: Instill 1/2 inch 2 - 3 times /day. Contraindications: Hypersensitivity to chlortetracycline or to any agents in the tetracycline class. Precautions: Overgrowth of non-susceptible organisms. Interactions: Cyclosporin. Adverse Reactions: Allergic reaction (occasional). Gentamicin 0.3% Eye Drops G a r a m y c i n - Trade Name
S01AA11183D2001XX (A/KK) NEDL

System: Ophthalmology Indications: Broad spectrum antibiotic in superficial eye infections and also for Pseudomonas aeruginosa. Dosage: 1 - 2 drops tds-qid. Contraindications: Hypersensitivity to Gentamicin products. Precautions: Contact lens users. Overgrowth of non-susceptible organisms on prolonged use. Discontinue if irritation or sensitization occurs. Interactions: No interaction found. Adverse Reactions: Non-specific conjunctivitis, conjunctival epithelial defect & hyperemia, temporary burning sensation(rare), irritation, stinging, itching & dermatitis. Gentamicin 3% Fortified Eye Drops
S01AA11183D2002XX (A)

System: Ophthalmology Indications: Broad spectrum antibiotic in superficial eye infections and also for Pseudomonas aeruginosa Dosage: Dose according to the needs of the patient. Contraindications: Hypersensitivity to gentamicin products. Precautions: Contact lens users. Overgrowth of non-susceptible organisms on 478

prolonged use. Discontinue if irritation or sensitization occurs. Interactions: No interaction found. Adverse Reactions: Non-specific conjunctivitis, conjunctival epithelial defect & hyperemia, temporary burning sensation(rare), irritation, stinging, itching & dermatitis. Gentamicin 0.3% Eye Ointment G a r a m y c i n - Trade Name
S01AA11183G5101XX (A/KK) NEDL

System: Ophthalmology Indications: Conjunctivitis, blepharitis, blepharo-conjunctivitis, keratitis, keratoconjunctivitis, episcleritis, dacrocystitis, corneal ulcers, styes & infected eye socket. Dosage: Apply into the conjunctival sac tds - qid. Contraindications: Hypersensitivity to gentamicin products. Precautions: Contact lens users. Overgrowth of non-susceptible organisms on prolonged use. Discontinue if irritation or sensitization occurs. Interactions: No interaction found Adverse Reactions: Non-specific conjunctivitis, conjunctival epithelial defect & hyperemia, temporary burning sensation(rare), irritation, stinging, itching & dermatitis. Fusidic Acid 1% Eye Drops F u c i t h a l m i c - Trade Name
S01AA13000D2001XX (A)

System: Ophthalmology Indications: For staphylococcal infections Dosage: 1 drop in conjunctival sac 12 hrly. To be continued for 2 days after the eye appears normal. On the 1st day of treatment, may be applied more frequently: 1 drop 4 hourly. Contraindications: Allergy to any of the constituents. Precautions: Do not apply to eyes with contact lenses. Interactions: Cross allergy between fusidic acid and other antibiotics has not been reported. Adverse Reactions: Transient stinging. Benzylpenicillin 2,500 units/ml (1.5 mg/ml) Eye Drops S01AA14702D2001XX (B) System: Ophthalmology Indications: Eye infection Dosage: 1-2 drops every 15 minutes or accordingly to needs of the patient. Contraindications: History of anaphylaxis, accelerated (e.g., hives) or serum sickness reaction to previous penicillin administration. Precautions: Patients with a history of penicillin or cephalosporin hypersensitivity reactions, atopic predispostion (e.g., asthma), impaired renal function, or pre-existing seizure disorder. 479

Interactions: No interaction found. Adverse Reactions: Skin rashes, anaphylaxis, urticaria. Benzylpenicillin 10,000 units/ml Eye Drops
S01AA14702D2002XX (B)

System: Ophthalmology Indications: Eye infection Dosage: 1-2 drops every 15 minutes or accordingly to needs of the patient. Contraindications: History of anaphylaxis, accelerated (e.g., hives) or serum sickness reaction to previous penicillin administration. Precautions: Patients with a history of penicillin or cephalosporin hypersensitivity reactions, atopic predisposition (e.g., asthma), impaired renal function, or pre-existing seizure disorder. Interactions: No interaction found. Adverse Reactions: Skin rashes, anaphylaxis, urticaria. Oxytetracycline with Polymyxin B Sulphate Eye Ointment Terramycin
S01AA30947G5101XX (B) NEDL APPL
- Trade Name

System: Ophthalmology Indications: Conjunctivitis, dacryocystitis, blepharoconjunctivitis, keratitis, trachoma, blepharitis; pre-op prophylaxis against infection. Dosage: Apply into the conjunctival sac qid. Contraindications: Hypersensitivity to any of the components. Precautions: Prolonged use may enable overgrowth of non-susceptible organisms, including fungi. Interactions: No interaction found Adverse Reactions: Allergic reaction. Neomycin with Polymyxin B Sulphate and Gramicidin Eye Drops Neosporin
S01AA30990D2001XX (A) APPL
- Trade Name

System: Ophthalmology Indications: Eye infections that require a broad spectrum antibiotic. Dosage: 1 - 2 drops in the affected eye 2 - 4 times daily. In severe infections: 1 - 2 drops every 15 - 30 minutes. Contraindications: Hypersensitivity to any of the components or to other aminoglycosides. Precautions: Cross-sensitivity may occur with kanamycin, streptomycin, tobramycin, and gentamicin. Prolonged use may enable overgrowth of nonsusceptible organisms, including fungi. Interactions: No interaction found Adverse Reactions: Burning and stinging or local irritation may occur. The 480

preparation may also be associated with localized hypersensitivity (due to neomycin content). Symptoms consist of ocular itching, reddening, conjunctival oedema, rash, or persistent irritation, and may be mistakenly confused as a worsening of the condition being treated. Sensitization to neomycin is more likely when the drug is given topically for longer than 5 or 6 days. These reactions are reversible. The product should be discontinued if signs of sensitization occur, and such patients should avoid neomycin-containing products in the future. Bilateral periorbital oedema has been reported. Sulphacetamide 10% Eye Drops Sulphacetamide 30% Eye Drops
S01AB04000D2001XX (C) NEDL S01AB04000D2002XX (C)

System: Ophthalmology Indications: Non-purulent blepharitis, blepharo-conjunctivitis, non-purulent conjunctivitis. Dosage: 1 - 2 drops qid. Contraindications: Hypersensitivity to Sulfacetamide or other sulfonamides Precautions: Patients with dry-eye syndrome. Some ophthalmic Sulfacetamide preparations contains sulfites, which may induced hypersensitivity reactions in susceptible individuals. Interactions: Pilocarpine Adverse Reactions: Tearing, stinging, burning, headache, bitter taste, and hypersensitivity reactions; Stevens-Johnson syndrome. Corneal plaques (Sulfacetamide crystallization) in patients with dry-eye syndrome. Idoxuridine 0.1% Eye Drops H e r p i d u - Trade Name
S01AD01000D2001XX (A)NEDL

System: Ophthalmology Indications: Herpes simplex keratitis. Dosage: Instill 1 drop hourly during the 1st day. Night dose may be reduced to 1 drop every other hour. Contraindications: Hypersensitivity to idoxuridine products Precautions: Recurrence of herpes keratitis may occur if idoxuridine is not continued for 5 to 7 days after healing of lesions. B. Concomitant administration of corticosteroids. Interactions: Boric acid Adverse Reactions: Ocular burning, ocular stinging and photophobia Idoxuridine 0.1% Eye Ointment H e r p i d u - Trade Name
S01AD01000G5101XX (A)

System: Ophthalmology Indications: Herpes simplex keratitis Dosage: Use at night. Contraindications: Hypersensitivity to idoxuridine products. 481

Precautions: Recurrence of herpes keratitis may occur if idoxuridine is not continued for 5 to 7 days after healing of lesions. Concomitant administration of corticosteroids. Interactions: Boric acid Adverse Reactions: Ocular burning, ocular stinging, photophobia Acyclovir 3 % Eye Ointment Z o v i r a x - Trade Name
S01AD03000G5101XX (A*) NEDL

System: Ophthalmology Indications: Only for the treatment of herpes simplex keratitis. Dosage: Apply 1 cm 5 times daily. Continue for at least 3 days after healing. Contraindications: Not known Precautions: Not known Interactions: No interaction found Adverse Reactions: Local irritation and inflammation reported. Mitomycin-C 0.025% Eye Drops
S01AX00000D2001XX (A)

System: Ophthalmology Indications: Pterygium, conjunctival tumour, glaucoma surgery. Dosage: 1 - 2 drops several times a day. Contraindications: Hypersensitivity to any component of this products Precautions: Elderly patients,previous cytotoxic or radiation therapy,hepatic and renal disorders. Interactions: No interaction found Adverse Reactions: Chronic hypotony, sometimes associated with maculopathy and irreversible visual loss. Norfloxacin 0.3% Eye Drops C h i b r o x i n - Trade Name
S01AX12000D2001XX (A*)

System: Ophthalmology Indications: Superficial infections of the eye (Pseudomonas aeruginosa & MRSA) and its adnexae. Dosage: Adults & children > 1 year : 1-2 drops qds. First day : 1 - 2 drops two-hourly during waking hours (depending on severity). Contraindications: Hypersensitivity to norfloxacin or other quinolones. Precautions: Pregnancy, lactation. Children < 1 yr. Interactions: No interaction found. Adverse Reactions: Local burning or smarting. Rarely, conjunctival hyperemia, chemosis, photophobia & a bitter taste following instillation.

482

Ciprofloxacin HCl 0.3% Ophthalmic Solution. C i l o x a n - Trade Name

S01AX13000D2001XX (A*)

System: Ophthalmology Indications: i) For corneal ulcer ii) For bacterial conjunctivitis: Dosage: i)First day : 2 drops every 15 mins for first 6 hours, then 2 drops every 30 mins for the rest of the day. Second day: 2 drops every hour. Subsequent days(3rd - 14th day) : 2 drops every 4 hours. ii) 1-2 drops 2 hrly into the conjunctival sac while awake for 2 days and 1-2 drops 4 hrly while awake for the next 5 days. Contraindications: History of hypersensitivity to ciprofloxacin or other quinolones. Precautions: Prolonged use may result in overgrowth of nonsusceptible organisms. Discontinue use at 1st appearance of skin rash or other sign of hypersensitivity reactions. Children < 1 yr. Interactions: No interaction found. Adverse Reactions: Local burning or discomfort, itching, lid oedema, tearing, white crystalline precipitates which resolve. Dexamethasone Sodium Phosphate 0.1% Eye Drops S01BA01162D2001XX (A) Maxidex - Trade Name System: Ophthalmology Indications: Acute steroid responsive inflammatory & allergic conditions. Dosage: 1 - 2 drops several times a day. Contraindications: Viral, fungal, TB & other infections of the eye. Precautions: Prolonged use may lead to posterior subcapsular cataract formation & glaucoma with raised optic-ocular pressure. Perforation, thinning of cornea. Pregnancy. Extensive use may lead to systemic effects. Interactions: No interaction found Adverse Reactions: Red eye, steroid glaucoma, steroid cataract, thinning of the cornea and sclera. Betamethasone Disod Phos 0.1% Eye Drops B e t n e s o l - Trade Name
S01BA06162D2001XX (A)

System: Ophthalmology Indications: Non-infected inflammatory conditions of the eyes Dosage: 1 - 2 drops several times a day. Contraindications: bacterial, fungal, viral, tuberculous or purulent conditions of the eye. Glaucoma, herpetic keratitis(eg. dendritic ulcer). Hypersensitivity to any component of the preparation. Precautions: Prolonged use in infants. May impair ability to drive or operate machinery. Pregnancy. Withdrawal if there is spread of infection. Interactions: No interaction found. 483

Adverse Reactions: Rise in intraocular pressure, corneal ulcers. Rarely, acute sensitization to neomycin, optic nerve damage, visual acuity & field defects. Betamethasone Disod Phos 0.1% Eye Ointment Celestone - Trade Name
S01BA06162G5101XX (A)

System: Ophthalmology Indications: Non-infected inflammatory conditions of the eyes Dosage: To be applied bd - qid and once or twice at night. Contraindications: Bacterial, fungal, viral, tuberculous or purulent conditions of the eye. Glaucoma, herpetic keratitis ( eg. dendritic ulcer). Hypersensitivity to any component of the preparation. Precautions: Prolonged use in infants. May impair ability to drive or operate machinery. Pregnancy. Withdrawal if there is spread of infection. Interactions: No interaction found. Adverse Reactions: Rise in intraocular pressure, corneal ulcers. Rarely, acute sensitization to neomycin, optic nerve damage, visual acuity & field defects. Fluorometholone 0.1% Ophthalmic Suspension S01BA07000D2001XX (A*) F M L l i q u i f i l m , F l a r e x o p h t h S u s p - Trade Name System: Ophthalmology Indications: Treatment of steroid responsive ocular inflammation. Dosage: 1-2 drops bd - qid. Contraindications: Hypersensitivity, viral disease of cornea and conjunctiva, mycobacterial of fungal infection, TB, purulent eye infection. Precautions: Glaucoma, pregnancy and lactation. Interactions: No interaction found. Adverse Reactions: Glaucoma with optic nerve damage, visual acuity and visual field defects, cataract formation, secondary ocular infection, thinning of cornea and sclera. Ketorolac Tromethamine 0.5% Eye drop A c u l a r - Trade Name
S01BC05239D2001XX (A)

System: Ophthalmology Indications: i) Ocular itching due to allergic conjunctivitis. ii) Prophylaxis and reduction of inflammation and associated symptoms following ocular surgery. Dosage: 1 drops 4 times dly. Contraindications: Asthma, hypovolaemia, dehydration, history of peptic ulcer or coagulation disorders, hypersensitivity or other NSAIDs and aspirin or other prostaglandin synthesis inhibitors. GI bleeding, cerebrovascular bleeding, 484

diathesis. Precautions: May increase bleeding time associated with ocular surgery. Use with caution in patients with known bleeding tendencies or those receiving anti coagulants. Interactions: ACEIs: decreased antihypertensive and natriuretic effects. Aspirin, NSAIDs : enhanced gastrointestinal adverse effects (peptic ulcers, gastrointestinal bleeding and or perforation) and possible increase in serum ketorolac levels. Beta-adrenergic block. Adverse Reactions: Transient burning/stinging, headache, corneal erosion, Corneal perforation, corneal thinning, epithelial breakdown. Dexamethasone & Neomycin Sulph & Polymyxin B Sulph Ophthalmic Suspension S01CA01990D2001XX (A) Maxitrol - Trade Name System: Ophthalmology Indications: Treatment of ocular inflammation when concurrent use of an antimicrobial is judged necessary. Dosage: 1 - 2 drops, hrly for severe cases and 4 - 6 hrly for mild infection. Contraindications: Viral, fungal, TB & other infections of the eye. Precautions: Cross-sensitivity may occur with kanamycin, streptomycin, tobramycin, and gentamicin. Prolonged use may enable overgrowth of nonsusceptible organisms, including fungi. Interactions: No interaction found Adverse Reactions: Burning and stinging or local irritation may occur. Hypersensitivity (due to neomycin content). Ocular itching, reddening, conjunctival oedema, rash or persistent irritation, periorbital oedema has been reported. Gentamicin Sulphate & Betamethasone Disod Phosphate Eye Drops Garasone
S01CA05990D2001XX (A/KK)
- Trade Name

System: Ophthalmology Indications: Inflammatory & allergic conditions involving superficial eye structures & when bacterial infection is present: conjunctivitis, blepharitis, keratitis, episcleritis, dacryocystitis, hordeolum, meibomianitis, injuries involving anterior segment of the eye. Dosage: 2 drops tds - qid. Contraindications: Hypersensitivity to any of the components or to other aminoglycosides. Precautions: Prolonged use in infants. May impair ability to drive or operate machinery. Pregnancy. Withdraw if there is spread of infection. Interactions: No interaction found. Adverse Reactions: Rise in intraocular pressure, corneal ulcers. Rarely, acute sensitization to neomycin, optic nerve damage, visual acuity & field 485

defects. Gentamicin Sulphate & Betamethasone Disod Phos Eye Ointment Garasone
- Trade Name

S01CA05990G5101XX (A)

System: Ophthalmology Indications: Inflammatory & allergic conditions involving superficial eye structures & when bacterial infection is present: conjunctivitis, blepharitis, keratitis, episcleritis, dacryocystitis, hordeolum, meibomianitis, injuries involving anterior segment of the eye. Dosage: Thin coating of ointment tds or qid. Contraindications: Hypersensitivity to any of the components or to other aminoglycosides. Precautions: Prolonged use in infants. May impair ability to drive or operate machinery. Pregnancy. Withdraw if there is spread of infection. Interactions: No interaction found. Adverse Reactions: Rise in intraocular pressure, corneal ulcers. Rarely, acute sensitization to neomycin, optic nerve damage, visual acuity & field defects. Betamethasone Disod Phos & Neomycin Sulp. Eye Drops B e t n e s o l -N
- Trade Name

S01CA05991D2001XX (A)APPL

System: Ophthalmology Indications: Infected inflammatory conditions of the eyes. Dosage: 2 - 3 drops every 2 - 3 hrs. Contraindications: bacterial, fungal, viral, tuberculous or purulent conditions of the eye. Glaucoma, herpetic keratitis(eg. dendritic ulcer). Hypersensitivity to any component of the preparation. Precautions: Prolonged use in infants. May impair ability to drive or operate machinery. Pregnancy. Withdrawal if there is spread of infection. Interactions: No interaction found. Adverse Reactions: Rise in intraocular pressure, corneal ulcers. Rarely, acute sensitization to neomycin, optic nerve damage, visual acuity & field defects. Adrenaline (Epinephrine) 1:100 Eye Drops System: Ophthalmology
S01EA01000D2003XX (B)

486

Indications: Reduce production rate of aqueous humour and increase outflow through the trabecular meshwork. Contraindicated in angle-closure glaucoma unless an iridectomy has been carried out. Dosage: 1 - 2 drops several times a day. Contraindications: Angle-closure glaucoma Precautions: Hypertension and heart disease. Interactions: Antipsychotic agents (Phenothiazines) ,beta-blockers , MAOIs , tricyclic antidepressants Adverse Reactions: Severe smarting and redness of the eye. Adrenaline (Epinephrine) 1:100,000 Eye-Drop Adrenaline (Epinephrine) 1:200,000 Eye-Drop Adrenaline (Epinephrine) 1:200 Eye Drop
S01EA01110D2001XX (B) S01EA01110D2002XX (B) S01EA01110D2004XX (B)

System: Ophthalmology Indications: Reduce production rate of aqueous humour and increase outflow through the trabecular meshwork. Contraindicated in angle-closure glaucoma unless an iridectomy has been carried out. Dosage: 1 - 2 drops several times a day. Contraindications: Angle-closure glaucoma. Precautions: Hypertension and heart disease. Interactions: No interaction found. Adverse Reactions: Severe smarting and redness of the eye. Pilocarpine 1% Eye Drops Pilocarpine 2% Eye Drops Pilocarpine 4% Eye Drops
S01EB01110D2001XX (B) NEDL S01EB01110D2002XX (B) NEDL S01EB01110D2003XX (B NEDL)

System: Ophthalmology Indications: Miotics in chronic open-angle glaucoma. Dosage: 1 drop 1 - 4 times a day. Contraindications: Contraindicated in conditions where pupillary constriction is undesirable such as acute iritis, anterior uveitis and some forms of secondary glaucoma. Acute inflammatory disease of the anterior segment. Precautions: Retinal disease, conjunctival or corneal damage. Intraocular pressure and visual fields should be monitored in those with simple chronic glaucoma and those receiving long-term treatment with a miotic. Caution in cardiac disease, hypertension, asthma, peptic ulceration, urinary-tract obstruction and parkinson's disease. Interactions: No interaction found. Adverse Reactions: Ciliary spasm leads to headache and browache which may be more severe in the initial 2-4 weeks of treatment. Ocular side effects include burning, itching, smarting, blurred vision, conjunctival vascular congestion, myopia, lens changes with chronic use, vitreous haemorrhage, and 487

pupillary block. Carbachol 0.01% Intraocular Solution Miostat - Trade Name

S01EB02100D2001XX (A)

System: Ophthalmology Indications: For intraocular use for miosis during surgery. Dosage: Instill no more than 1/2 ml gently into the anterior chamber. Contraindications: Contraindicated in conditions where pupillary constriction is undesirable such as acute iritis, anterior uveitis and some forms of secondary glaucoma. Acute inflammatory disease of the anterior segment. Precautions: Retinal disease; conjunctival or corneal damage. Intraocular pressure and visual fields should be monitored in those with simple chronic glaucoma and those rec eiving long-term treatment with a miotic. Caution in cardiac disease, hypertension, asthma, peptic ulceration, urinary-tract obstruction and parkinson's disease. Interactions: No interaction found. Adverse Reactions: Ciliary spasm leads to headache and browache which may be more severe in the initial 2-4 weeks of treatment. Ocular side effects include burning, itching, smarting, blurred vision, conjunctival vascular congestion, myopia, lens changes with chronic use, vitreous haemorrhage, and pupillary block. Physostigmine (Eserine) 0.5% Eye Drops Physostigmine (Eserine) 1% Eye Drops
S01EB05183D2001XX (B) S01EB05183D2002XX (B)

System: Ophthalmology Indications: To decrease intraocular pressure in glaucoma. Dosage: 1 - 2 drops several times a day. Contraindications: Hypersensitivity to physostigmine, active eye inflammation. Precautions: Ophthalmic physostigmine should be used cautiously in patients with retinal detachment. Physostigmine should be discontinued three weeks before surgery to avoid the possible development of hyphema during ophthalmic surgery. Interactions: Succinylcholine. Adverse Reactions: Stinging, miosis, lacrimation. Acetazolamide 500 mg SR Capsule Diamox - Trade Name
S01EC01000C2001XX (A)

System: Ophthalmology Indications: Reduction of intra-ocular pressure in open-angle glaucoma, secondary glaucoma and peri-operatively in angle-closure glaucoma. Dosage: 500 mg twice daily Contraindications: Hypokalaemia, hyponatraemia, hyperchloraemic acidosis, 488

severe hepatic impairment, renal impairment, sulphonamide hypersensitivity. Precautions: Not generally recommended for prolonged use but if given monitor blood count and plasma electrolyte concentration, pulmonary obstruction(risk of acidosis), elderly, pregnancy and breastfeeding. Interactions: Aspirin, cyclosporin, digitalis, digoxin, lithium, phenytoin, quinidine, topiramate Adverse Reactions: Nausea, vomiting, diarrhoea, taste disturbances, loss of appetite, paraesthesia, flushing, headache, dizziness, fatigue, irritability, depression, thirst, polyuria, reduced libido, metabolic acidosis and electrolyte disturbances on long-term therapy. Acetazolamide 500 mg Injection Diamox - Trade Name
S01EC01000P4001XX (B) NEDL

System: Ophthalmology Indications: Reduction of intra-ocular pressure in open-angle glaucoma, secondary glaucoma and peri-operatively in angle-closure glaucoma. Dosage: 250 - 500 mg IM or IV. Contraindications: Hypokalaemia, hyponatraemia, hyperchloraemic acidosis, severe hepatic impairment, renal impairment, sulphonamide hypersensitivity. Precautions: Not generally recommended for prolonged use but if given monitor blood count and plasma electrolyte concentration, pulmonary obstruction (risk of acidosis), elderly, pregnancy and breastfeeding. Interactions: Aspirin, cyclosporin, digitalis, digoxin, lithium, phenytoin, quinidine, topiramate. Adverse Reactions: Nausea, vomiting, diarrhoea, taste disturbances, loss of appetite, paraesthesia, flushing, headache, dizziness, fatigue, irritability, depression, thirst, polyuria, reduced libido, metabolic acidosis and electrolyte disturbances on long-term therapy Acetazolamide 250 mg Tablet Diamox - Trade Name
S01EC01000T1001XX (B) NEDL APPL

System: Ophthalmology Indications: Reduction of intraocular pressure in open-angle glaucoma, secondary glaucoma and peri-operatively in angle-closure glaucoma. Dosage: 250 - 500 mg daily. Contraindications: Hypokalaemia, hyponatraemia, hyperchloraemic acidosis, severe hepatic impairment, renal impairment, sulphonamide hypersensitivit y. Precautions: Not generally recommended for prolonged use but if given monitor blood count and plasma electrolyte concentration, pulmonary obstruction (risk of acidosis), elderly, pregnancy and breastfeeding. Interactions: Aspirin, cyclosporin, digitalis , digoxin, lithium, phenytoin, quinidine, topiramate Adverse Reactions: Nausea, vomiting, diarrhoea, taste disturbances, loss of appetite, paraesthesia, flushing, headache, dizziness, fatigue, irritability, 489

depression, thirst, polyuria, reduced libido, metabolic acidosis and electrolyte disturbances on long-term therapy Dorzolamide HCl 2% ophthalmic solution Trusopt - Trade Name
S01EC03110D2001XX (A*)

System: Ophthalmology Indications: All glaucoma patients where beta-blockers are contraindicated and when intraocular pressure is not well controlled by other drugs. Dosage: Monotherapy: 1 drop tds. Adjunctive therapy with an ophthalmic beta-blocker: 1 drop bd.When substituting for another ophthalmic antiglaucoma agent with this product, discontinue the other agent after proper dosing on one day & start Trusopt on the next day. If more than 1 topical ophthalmic drug is used, the drugs should be administered at least 10 mins apart. Contraindications: Patients who are hypersensitive to any component of this product. Precautions: Patients with severe renal or hepatic impairment. Pregnancy & lactation. Children. Remove contact lens prior to administration & do not reinsert < 15 mins after use. Acute angle glaucoma, sensitivity to sulfonamide. Interactions: High dose of salicylate therapy. Potential additive effect with oral carbonic anhydrase inhibitors. Adverse Reactions: Burning, stinging, conjunctivitis, eyelid inflammation, eye itching, eyelid irritations, headache, bitter taste, nausea, itching, fatigue/asthenia, blurred vision, tearing. Rarely, iridocyclitis & rash. Angioedema, bronchospasm, urticaria, pruritis, dizziness, paraesthesia, transient myopia(resolve upon discontinuation) & superficial punctate keratitis. Timolol maleate 0.5% Ophthalmic Drops T i m o p t o l , T i m o p t o l X E - Trade Name
S01ED01253D2001XX (A) NEDL APPL

System: Ophthalmology Indications: For better intraocular pressure control. Dosage: 1) Gel: Once a day dosage 2) Solution: Initial, 1 drop in the affected eye bd: Should be used with a miotic when treating closed-angle glaucoma Contraindications: Bronchial asthma or a history of bronchial asthma, severe COPD, sinus bradycardia, 2nd or 3rd degree AV block, overt cardiac failure and cardiogenic shock. Precautions: History of atopy or a history of severe anaphylactic reaction to a variety of allergens, pregnancy & lactation. May impair ability to drive or operate machinery. Interactions: Cathecolamine-depleting drugs. Concurrent administration of oral or systemic beta-adrenergic blockers. Concurrent use of beta-blockers & digitalis with diltiazem or verapamil may have additive effects in prolonging AV conduction time. Quinidine. Adverse Reactions: Bradycardia, hypotension, confusion, depression, 490

dizziness, fatigue, abdominal pain, diarrhoea, nausea, vomiting, dyspepsia, dry eye, ocular burning, corneal anaesthesia. Betaxolol 0.25% Eye Suspension Betoptic - Trade Name
S01ED02110D2001XX (A)

System: Ophthalmology Indications: Chronic open-angle glaucoma, ocular hypertension Dosage: One drop in the affected eye(s) twice daily Contraindications: Patients with bradycardia, heart block, or uncontrolled heart failure. Precautions: Diabetes, thyrotoxicosis, patients with excessive restriction of pulmonary function, severe reactive airway disease, asthma, pregnancy. Interactions: Epinephrine, catecholamine-depleting drugs, adrenergic psychotropic drugs, oral beta-blockers. Adverse Reactions: Ocular stinging, pain, itching, erythema, dry eyes and allergic blepharoconjunctivitis, corneal disorders. Latanoprost 0.005% Eye Drops X a l a t a n - Trade Name
S01EX03000D2001XX (A*)

System: Ophthalmology Indications: Reduction of elevated intraocular pressure in patients with open-angle glaucoma: Dosage: 1 drop once daily in the evening. Contraindications: Known hypersensitivity to any component of the products. Precautions: Inflammatory, neovascular, angle closure or congenital glaucoma, open angle glaucoma of pseudophakic patients, pigmentary glaucoma, acute attacks of closed angle glaucoma, pregnancy & lactation. Contact lens users. Interactions: Effects additive to beta-adrenergic antagonist, adrenergic agonists, carbonic anhydrase inhibitors & cholinergic agonists. Other eye preparation containing thiomersal. Adverse Reactions: Slight discomfort, mild to moderate conjunctival hyperaemia, transient punctate ephitelial erosions, increased pigmentation of iris, rash. Atropine Sulp. 0.3%, Cocaine HCl 1.7%, Adrenaline Acid Tartrate 0.03% Injection Mydriatic (Mydriacaine) S01F000183P3001XX (A) System: Ophthalmology Indications: Subconjunctival Inj. to dilate pupils resistant to topical mydriatics. Dosage: 1-2 drops. Contraindications: Glaucoma or suspected glaucoma. Hypersensitivity. Precautions: Elderly, infant, children. 491

Interactions: No interaction found Adverse Reactions: Prolonged use may produce local irritation, dry throat & eczema of eyelids. Atropine Sulphate 1% Eye Drops Atropine Sulphate 2% Eye Drops
S01FA01183D2001XX (B)NEDL S01FA01183D2002XX (B)

System: Ophthalmology Indications: Determination of refraction, strabismus, iritis & iridocyclitis, after extra or intracapsular extraction of lens. Dosage: 1 - 4 drops daily. Contraindications: Glaucoma or suspected glaucoma. Hypersensitivity. Precautions: Risk of systemic effects with the eye drops in infants under 3 months -eye ointment preferred. Interactions: No interaction found Adverse Reactions: Transient stinging and raised intra-ocular pressure ; local irritation, hyperaemia, oedema and conjunctivitis. Atropine Sulphate 1% Eye Ointment
S01FA01183G5101XX (B)

System: Ophthalmology Indications: Determination of refraction, strabismus, iritis & iridocyclitis, after extra or intracapsular extraction of lens. Dosage: 10 mm to be applied 1 - 3 times a day. Contraindications: Glaucoma or suspected glaucoma. Hypersensitivity. Precautions: Elderly, infant, children. Interactions: No interaction found Adverse Reactions: Transient stinging and raised intraocular pressure ; local irritation, hyperaemia, oedema and conjunctivitis. Cyclopentolate 0.5% Eye Drops Cyclopentolate 1% Eye Drops C y c l o g y l - Trade Name
S01FA04000D2001XX (A)NEDL S01FA04000D2002XX (A)

System: Ophthalmology Indications: Mydriasis & cycloplegia Dosage: 1 - 2 drops several times a day. Refractory Procedures: Adult: 1 drop of 0.5% solution. Paed: 6-12 yrs: 1 drop of 1% solution. Under 6 yrs: 1 -2 drops of 1% solution. Contraindications: Narrow-angle glaucoma Precautions: May impair ability to drive or operate machinery. Interactions: Cyclopentolate may interfere with antiglaucoma action of carbachol or pilocarpine. Adverse Reactions: Mild tachycardia, secretion decrease & action on the CNS, blurred vision, increased intraocular pressure, allergic reactions. 492

Homatropine 0.5% Eye Drops Homatropine 1% Eye Drops Homatropine 2% Eye Drops

S01FA05330D2001XX (B) S01FA05330D2002XX (B) S01FA05330D2003XX (B NEDL)

System: Ophthalmology Indications: Treatment of anterior segment inflammation. Producing cycloplegia and mydriasis for refraction. Dosage: 1 drop 1 - 4 times daily. Contraindications: Glaucoma or tendency towards glaucoma, narrow anterior chamber angle. Precautions: Systemic toxicity especially in infants & small children. Interactions: Cisapride, procainamide Adverse Reactions: Transient stinging, local irritation. Tropicamide 0.5% Eye Drops Tropicamide 1% Eye Drops M y d r i a c y l - Trade Name
S01FA06000D2001XX (A/KK) S01FA06000D2002XX (A/KK) NEDL

System: Ophthalmology Indications: Topical use to produce cycloplegic refraction for diagnostic purposes. Dosage: 1 - 2 drops several times a day. Contraindications: Narrow-angle glaucoma. Precautions: Individuals susceptible to belladona alkaloids, inflammed eyes, pregnancy, children, elderly. Interactions: Antimuscarinic effects potentiated by concomitant use of amantadine, tricyclic antidepressants, phenothiazine & butyrophenones & antihistamines. Adverse Reactions: Increased intraocular pressure, dryness of mouth, transient stinging, allergic reactions, tachycardia, headache, parasympathetics stimulation, blurred vision, photosensitivity. Phenylephrine HCl 2.5% Eye Drops M y d f r i n - Trade Name
S01FB01110D2001XX (B)

System: Ophthalmology Indications: For pupillary dilation in uveitis, for refraction w/o cyclopegic. For fundascopy & other diagnostic procedures. Dosage: For use in children 1 - 2 drops according to purpose of application. Contraindications: Narrow-angle glaucoma, infant, elderly with severe arteriosclerotic, cardiovascular or cerebrovascular disease. During intraocular operative procedures when corneal epithelial barrier is disturbed. Precautions: Caution if administered with or up to 3 weeks after MAOI therapy. Infant with cardiac anomalies. Interactions: Tricyclic antidepressants, propranolol. 493

Adverse Reactions: Marked increase in blood pressure in low-weight neonates, infant & adult with idiopathic hypotension. Cardiovascular reactions in the elderly. Phenylephrine HCl 10% Eye Drops
S01FB01110D2002XX (B)NEDL

System: Ophthalmology Indications: For pupillary dilation in uveitis, for refraction w/o cyclopegic. For fundoscopy & other diagnostic procedures. Dosage: 1 - 2 drops several times a day. Contraindications: Narrow-angle glaucoma, infant, elderly with severe arteriosclerotic, cardiovascular or cerebrovascular disease. During intraocular operative procedures when corneal epithelial barrier is disturbed. Precautions: Caution if administered with or up to 3 weeks after MAOI therapy. Infant with cardiac anomalies. Interactions: Tricyclic antidepressants, propranolol. Adverse Reactions: Marked increase in blood pressure in low-weight neonates, infant & adult with idiopathic hypotension. Cardiovascular reactions in the elderly. Antazoline HCL, Tetrahydrozoline HCL & Benzalkonium Cl Eye Drops Spers allerg
S01GA52110D2001XX (A/KK)
- Trade Name

System: Ophthalmology Indications: Hay fever, conjunctivitis, allergic conjunctivitis, vernal keratoconjunctivitis and eczematosa. Dosage: 1 drop 3 - 4 times daily. Contraindications: Hypersensitivity to any of the components of product. Precautions: Infants. Interactions: No interaction found. Adverse Reactions: Mild burning sensation, headache, and sleepiness. Cyclopentolate HCl 0.2% with Phenylephrine HCl 1% Eye Drops Cyclomydril
S01GA55990D2001XX (A)
- Trade Name

System: Ophthalmology Indications: Dilating agent for premature babies Dosage: 1 drop every 5 - 10 minutes; not exceeding three times to produce rapid mydriasis Contraindications: Narrow-angle glaucoma Precautions: May impair ability to drive or operate machinery. Interactions: Cyclopentolate may interfere with antiglaucoma action of carbachol or pilocarpine. 494

Adverse Reactions: Increased intraocular pressure, psychotic reactions & behavioural disturbances in children. Sodium Cromoglycate 2% Eye Drops O p t i c r o m - Trade Name
S01GX01520D2001XX (A/KK) NEDL

System: Ophthalmology Indications: Prevention & treatment of allergic conjunctivitis including seasonal & perennial allergic conjunctivitis & vernal keratoconjunctivitis. Dosage: 1 or 2 drops qid. Contraindications: Patients with known hypersensitivity to sodium cromoglycate or any other ingredient of the products. Precautions: Pregnancy Interactions: No interaction found Adverse Reactions: Transient stinging and burning may occur after instillation and other symptoms of local irritation. Sodium Cromoglycate 4% Eye Ointment
S01GX01520G5101XX (A)

System: Ophthalmology Indications: Prevention & treatment of allergic conjunctivitis including seasonal & perennial allergic conjunctivitis & vernal keratoconjunctivitis. Dosage: A ribbon bd-tds Contraindications: Patients with known hypersensitivity to sodium cromoglycate or any other ingredient of the products. Precautions: Pregnancy Interactions: No interaction found Adverse Reactions: Transient stinging and burning may occur after instillation and other symptoms of local irritation. Oxybuprocaine HCl 0.4 % Eye- Drops N o v e s i n - Trade Name
S01HA02110D2001XX (B)NEDL

System: Ophthalmology Indications: Local anaesthesia for diagnostic eye procedures, eye surgery, removal of foreign bodies & contact-lens fitting. Dosage: 2, 3 or 5 instillations as may be required. Contraindications: Hypersensitivity to oxybuprocaine or any ingredients of the product. Precautions: Cornea may be damaged by prolonged application. Interactions: No interaction found. Adverse Reactions: Severe contact keratitis(prolonged use). Known to inhibit the rate of movement of corneal epithelial cells migrating to cover wounds. 495

Amethocaine HCl 1 % Eye-Drops

S01HA03110D2001XX (B)

System: Ophthalmology Indications: Local anaesthetic. Dosage: 1 - 2 drops Contraindications: Hypersensitivity to amethocaine or any ingredients of the product Precautions: Cornea may be damaged by prolonged application. Interactions: No interaction found Adverse Reactions: Severe keratitis and corneal adverse effects may occur(prolonged use). Fluorescein 1 mg Ophthalmic Strip Fluorets - Trade Name
S01JA01520M9901XX (B)NEDL

System: Diagnostic Indications: Diagnostic fluorescein angiography or angioscopy of the fundus & of the iris vasculature. Dosage: Moisten tip with tear fluid from lower fornix, sterile water or ophthalmic solution and gently stroke across the conjunctiva. Contraindications: Hypersensitivity to any of the components of product. Precautions: History of allergy or bronchial asthma. Pregnancy esp. in the 1st trimester. Interactions: No interaction known Adverse Reactions: Nausea & headache, other symptoms & signs of hypersensitivity. Fluorescein Sodium 10% in 5 ml Injection F l u o r e s c i t e - Trade Name
S01JA01520P3001XX (A) NEDL

System: Diagnostic Indications: Diagnostic fluorescein angiography or angioscopy of the fundus & of the iris vasculature. Dosage: 500 mg IV. Contraindications: Hypersensitivity to any of the components of product. Precautions: History of allergy or bronchial asthma. Pregnancy esp. in the 1st trimester. Interactions: No interaction known Adverse Reactions: Nausea & headache, GI distress, syncope, vomiting, hypotension, other symptoms & signs of hypersensitivity. Cardiac arrest, basilar artery ischaemia, severe shock, convulsions & thrombophlebitis at injection site. 496

Glycerin 15% Eye Drops

S01XA00000D2002XX (B)

System: Ophthalmology Indications: As an adjunct in the management of acute glaucoma. Dosage: 1 - 2 drops Contraindications: Hypersensitivity to any component in the preparation, severe dehydration, severe cardiac decompensation Precautions: Administer with caution to patients with cardiac, renal, or hepatic disease, diabetes, haemolytic anaemia Interactions: No interaction found Adverse Reactions: May damage endothelial cells of the cornea. Methylcellulose 1% with 50 mg Vitamin C Eye Drops S01XA00990D2001XX (B) System: Ophthalmology Indications: To be used only for i) post- operative cases with dry eye ii) Unconscious patients in CCU with exposure keratitis. Dosage: Dosage qid or hourly depending on severity of cases. Contraindications: Not known Precautions: Not known Interactions: No interaction available Adverse Reactions: No information available Vitamin C 10% Eye-Drops
S01XA15000D2001XX (B)

System: Ophthalmology Indications: For all types of severe chemical corneal burns especially acid and alkali burns. Dosage: Q.i.d. or hourly depending on severity of case. Contraindications: Hypersensitivity to vitamin C products. Precautions: Not known Interactions: No interaction found Adverse Reactions: No information available. Hydroxyethyl Cellulose 3% Eye Drops G o n i o s c o p i c P r i s m - Trade Name
S01XA20000D2001XX (B) NEDL

System: Ophthalmology Indications: For use with laser photocoagulation and for gonioscopic examination of the eyes. Dosage: Use as required Contraindications: Hypersensitivity to hydroxyethyl cellulose 497

Precautions: Not known Interactions: No interaction found Adverse Reactions: No information available Hypromellose 0.3% Eye Drops D a c r o l u x - Trade Name
S01XA20000D2002XX (B)

System: Ophthalmology Indications: Tear deficiency, ophthalmic lubricant; for relief of dry eyes and eye irritation Dosage: 1 - 2 drops several times a day. Contraindications: Hypersensitivity to hydroxypropyl methylcellulose Precautions: Self-prescribed use as an ocular lubricant should not exceed 3 days. Interactions: No interaction found Adverse Reactions: Increases in intraocular pressure, blurred vision Protein Free Haemodialysate 20 % Eye Gel S o l c o s e r y l - Trade Name
S01XA20000G3001XX (A)NEDL

System: Ophthalmology Indications: Eyes disorders eg burns, scalds, ulcers, prevention & treatment of radiation dermatitis, traumatic & ischaemic wound. Dosage: Instill 1 drop tds - qid. Contraindications: Not known. Precautions: Burning sensation after application. Interactions: No interaction found. Adverse Reactions: Burning sensation. Sodium Carboxy Methylcellulose 2% Eye Drops S01XA20520D2002XX (B) NEDL System: Ophthalmology Indications: Management of dry eyes. Dosage: 1-2 drops several times a day. Contraindications: Not known Precautions: Not Known Interactions: No interaction found. Adverse Reactions: No information available Ofloxacin 0.3% Otic Solution T a r i v i d - Trade Name System: Ear, Nose and Oropharynx
S02AA00000D1001XX (A)

498

Indications: Acute otitis media with tympanostomy tubes, chronic suppurative otitis media with perforated tympanic membranes and otitis externa. Dosage: Child: 1 - 12 yrs: 5 drops bd for 10 days; > 12 yrs: 10 drops bd for 10 days Contraindications: Pregnancy ,breast feeding. Precautions: If otic therapy does not resolve otorrhea after a full course of therapy, further evaluation is suggested for other underlying causes. Prolonged use may result in overgrowth of fungal. Interactions: Reduce absorption of antacids. Enhanced anticoagulant effects. Adverse Reactions: Ear ache, secondary fungal infection. Chloramphenicol 5% w/v Ear Drops C h l o r o m y c e t i n - Trade Name
S02AA01000D1001XX (C) NEDL APPL

System: Ear, Nose and Oropharynx Indications: Acute otitis media, otitis externa with perforation. Dosage: Apply 2 - 3 drops into the ear bd - tds. Not to be used for long term. Contraindications: Hypersensitivity, perforated tympanic membrane, chronic otitis media with perforation. Precautions: Use with caution in the presence of perforated tymphanic membrane. Overgrowth of non-susceptible infection over prolonged use. Interactions: With other antibacterials, antiepileptics, anticoagulants, cyclosporin. Adverse Reactions: Sensitivity to the vehicle propylene glycol, local irritation with symptoms of burning, itching, urticaria. Boric Acid with Spirit 2% w/v Ear Drops
S02AA03000D1001XX (C)

System: Ear, Nose and Oropharynx Indications: Perforated eardrum. Dosage: 3 drops instilled into affected ear tds - qid. Contraindications: Not known. Precautions: Cumulative effect, if ingest can cause GI iritation, loss of appetite. Not recommended for children below 3 years except with paediatrician consultation. Interactions: No interaction found. Adverse Reactions: Poisoning if absorb too much, headache, dermatitis. Hydrogen Peroxide 1.5% Ear Drops System: Ear, Nose and Oropharynx
S02AA06241D1001XX (C) NEDL

499

Indications: To soften impacted ear wax. Dosage: Instill 1 - 2 drops into the ear ( leave for a few mins) as required. Contraindications: Perforated eardrum, suppurative otitis media, history of ear discharge. Precautions: Not known Interactions: No interaction found Adverse Reactions: No information available Acetic Acid & Spirit 2% v/v Ear Drops
S02AA10134D1001XX (C)

System: Ear, Nose and Oropharynx Indications: Otitis externa and otitis media. Dosage: 3 drops instilled into affected ear tds - qid. Contraindications: Allergy to acetic acid and any of the compounds. Precautions: Not known Interactions: No interaction found Adverse Reactions: No information available Ichthammol Glycerin 10% Ear Drops
S02AA30000D1001XX (C) NEDL

System: Ear, Nose and Oropharynx Indications: Ear wick for otitis externa with oedema. Dosage: 2 - 3 drops tds - qid and in ear wick for otitis externa. Contraindications: Allergy to Ichthammol glycerin. Precautions: Not known Interactions: No interaction found Adverse Reactions: Slightly irritant to skin, if excessive can impair hearing ability. Polymyxin B Sulph 10,000 U, Neomycin Sulp 5 mg & Hydrocortisone 10 mg Ear Drops S02CA03991D1001XX (B) NEDL APPL O t o s p o r i n - Trade Name System: Ear, Nose and Oropharynx Indications: Treatment of bacterial infection and inflammation of the external auditory meatus. Dosage: 3 drops tds - qid. External auditory meatus and canal to be thoroughly cleansed and dried before each application but soap should not be used as the antibiotics may be inactivated by it. Contraindications: Untreated infection, perforated eardrum. Precautions: Avoid prolong use. Interactions: Antibacterials eg. Amphotericin; anticoagulants, antifungals, 500

antivirals etc. Adverse Reactions: Local sensitivity reactions. Triamcinolone Acetonide, Neomycin, Gramicidin & Nystatin Ear Drops Kenacomb
S02CA04991D1001XX (A/KK)
- Trade Name

System: Ear, Nose and Oropharynx Indications: For otitis externa (acute and chronic) when a topical steroid is required and active infections with susceptible organisms are either present or likely to supervene. Dosage: 2 - 3 drops tds - qid. Contraindications: Viral, tuberculosis infections. Precautions: Perforated eardrums. Interactions: Antibacterials eg. amphotericin, anticoagulants, anti fungals, antivirals etc. Adverse Reactions: Occassionally sensitivity reactions. Paradichlorobenzene, Turpentine Oil & Chlorbutol Ear Drops Cerumol
S02DA30900D1001XX (B)NEDL
- Trade Name

System: Ear, Nose and Oropharynx Indications: Occlusion or partial occlusion of the external auditory meatus by soft wax or wax plug. Dosage: Instill 5 drops into the ears. Contraindications: Otitis externa, seborrhoeic dermatitis, eczema affecting the external ear, perforated eardrums. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: No information available. Glycerin with Spirit 33% w/w Ear Drops.
S02DA30991D1001XX (C)

System: Ear, Nose and Oropharynx Indications: To relieve oedematosus otitis externa. Dosage: 2 - 3 drops tds - qid. Contraindications: Hypersensitivity to any component in the preparation, severe dehydration, severe cardiac decompensation. Precautions: Administer with caution to patients with cardiac, renal, or hepatic disease, diabetes, haemolytic anaemia. Interactions: No interaction found. Adverse Reactions: No information available.

501

Olive Oil Ear Drops System: Ear, Nose and Oropharynx Indications: Impacted wax softener. Dosage: 3 - 4 drops tds - qid or as directed. Contraindications: Not known. Precautions: Perforated ear drum. Interactions: No interaction found. Adverse Reactions: No information available. Sodium Bicarbonate 5% w/v Ear Drops

S02DC00000D1001XX (C) NEDL

S02DC00131D1001XX (C)

System: Ear, Nose and Oropharynx Indications: To soften the impacted ear wax. Dosage: 2 - 3 drops tds - qid. Contraindications: Not known. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: Contact dermatitis to sodium bicarbonate. Betamethasone Disod Phos 0.1% Ear Drops Betamethasone Disod Phos 0.5% Ear Drops B e t n e s o l - Trade Name
S03BA03162D1001XX (B) NEDL S03BA03162D1002XX (B)

System: Ear, Nose and Oropharynx Indications: Non-infected inflammatory conditions. Dosage: Apply 2 - 3 drops every 2 - 3 hrs, reduce frequency when relief obtained. Contraindications: Viral, fungal, TB, purulent eye infection, glaucoma, herpetic keratitis, otitis media, history of perforation of the ear drum. Precautions: Prolonged use in infants, pregnancy, may result in secondary fungal infections. Interactions: As general with other corticosteroids. Adverse Reactions: Local sensitivity reactions. Dexamethasone & Neomycin Sulph & Polymyxin B Eye Ointment Maxitrol
S03CA01990G5101XX (A)
- Trade Name

System: Ophthalmology

502

Indications: Treatment of ocular inflammation when concurrent use of an antimicrobial is judged necessary. Dosage: Apply 1-1.5 cm tds - qid, may be used adjunctively with drops at bedtime. Contraindications: Viral, fungal, TB & other infections of the eye. Precautions: Cross-sensitivity may occur with kanamycin, streptomycin, tobramycin, and gentamicin. Prolonged use may enable overgrowth of nonsusceptible organisms, including fungi. Interactions: No interaction found. Adverse Reactions: Burning and stinging or local irritation may occur. Hypersensitivity (due to neomycin content). Ocular itching, reddening, conjunctival oedema, rash or persistent irritation, periorbital oedema has been reported. Framycetin Sulp 0.5%, Dexamethasone 0.05% & Gramicidin 0.005% Ear Drops S03CA01991D1001XX (A/KK) APPL Sofradex - Trade Name System: Ear, Nose and Oropharynx Indications: Otitis externa. Dosage: Apply 2 - 3 drops tds - qid. Contraindications: Herpes simplex infection, viral diseases of cornea and conjuctiva, TB and fungal diseases of ey es, herpetic keratitis. Precautions: Glaucoma, pregnancy, prolonged use in infants. Interactions: Can increase nephrotocixity with amphotericin, cyclosporin. Adverse Reactions: Sensitivity reactions. Betamethasone Disod Phos & Neomycin Sulp 0.5% Ear Drops B e t n e s o l -N
S03CA06991D1001XX (B)
- Trade Name

System: Ear, Nose and Oropharynx Indications: Allergic dermatosis in the ear. Dosage: Apply 2 - 3 drops 3 - 4 times daily, reduce frequency when relief obtained. Contraindications: Viral, fungal infection, TB, purulent eye infection, glaucoma, otitis media, history of perforation of the ear drum, allergy to neomycin. Precautions: Prolonged use in infants, may impair ability to drive & operate machinery, pregnancy, withdraw if there is spread of infection. Interactions: As general with other corticosteroids. Adverse Reactions: Rise in intraocular pressure, epistaxis, ulceration of throat.

503

Fuller's Earth 30 % Suspension F u l l e r ' s E a r t h - Trade Name

V03AB00000F2101XX (C)

System: Emergency Indications: Adsorbent in pesticide poisoning. Dosage: 200 - 500 ml of Fuller's Earth together with magnesium sulphate or mannitol every 2 hrs for several days. Contraindications: Not known. Precautions: Not known Interactions: No interaction found Adverse Reactions: Irritation of the skin, inflammation, blistering, cracking, shedding of the nails, delayed healing of cuts and wounds. Calcium Disodium Edetate 200 mg Injection C a D i s o d . V e r s e n a t e - Trade Name
V03AB03999P3001XX (A)

System: Emergency Indications: Lead Poisoning. Dosage: 60 - 70 mg/kg body weight daily given IV infusion in 2 daily doses for up to 5 days; repeated if necessary after an interval of 2 days. Any further treatment with Calcium Edetate should not be recommended for 7 days. Contraindications: Hypersensitivity to edetate products, anuria or active renal disease, hepatitis. Precautions: Renal impairment, haematuria, proteinuria, cerebral oedema. Interactions: No interaction found. Adverse Reactions: Nephrotoxicity, malaise, chills, thirst, nausea, vomiting, diarrhoea, abdominal pain. Pralidoxime Chloride 0.5g/20 ml Injection Protopam - Trade Name
V03AB04100P3002XX (B) NEDL APPL

System: Emergency Indications: Antidote in the treatment of organophosphorus insecticide poisoning and in the control of overdosage by anticholinergic drugs used in the treatment of myaesthenia gravis. Dosage: 1 - 2 g by IV infusion in 100 ml saline over 15 - 30 mins. Or slow IV inj. Over 10 min as 5 % soln. In water, followed after 1 hr by a second dose of 1 - 2 g. Child: 20 - 40 mg /kg body wt, may be given depending on the severity and response to treatment. Contraindications: Hypersensitivity to pralidoxime, phosphorus/inorganic phosphate poisoning, organophosphates without anticholinesterase activity. Precautions: Myasthenia gravis, renal dysfunction, slow iv infusion may prevent : tachycardia, laryngospasm and muscle rigidity. Interactions: No interaction found. 504

Adverse Reactions: Nausea, vomiting, dizziness, headache, blurred vision, bitter after taste. Sodium Thiosulphate 500 mg/ml Injection
V03AB06181P3001XX (B)NEDL

System: Emergency Indications: For cyanide poisoning. Dosage: For cyanide poisoning : 300 mg Sodium Nitrite IV over 3 min followed after 5 min with 50 ml Sodium Thiosulphate 50 % Inj administered over 10 min. Child : 4.5 - 10 mg/kg Sodium Nitrite IV followed by 1.65 ml/kg of 25 % Sodium Thiosulphate Inj. Contraindications: Not known. Precautions: Too rapid intravenous administration has caused hypotension. Interactions: No Interaction found. Adverse Reactions: Diarrhoea, allergic contact dermatitis. Sodium Nitrite 30 mg/ml Injection
V03AB08220P3001XX (B)NEDL

System: Emergency Indications: For cyanide poisoning. Dosage: 300 mg IV over 3 min followed after 5 min with 50 ml Sodium Thiosulphate 50 % Inj administered over 10 min. Child : 4.5 - 10 mg/kg followed by 1.65 ml/kg of 25 % Sodium Thiosulphate Inj. Contraindications: Not Known Precautions: Not Known Interactions: No interaction found Adverse Reactions: Nausea, vomiting, abdominal pain, dizziness, headache, flushing, cyanosis, tachypnoea, dyspnoea; vasodilatation resulting in syncope, hypotension and tachycardia. Overdosage may result in cardiovascular collapse, coma, convulsions and death. Dimercaprol 50 mg/ml Injection B A L - Trade Name
V03AB09000P3001XX (B)NEDL

System: Emergency Indications: Poisoning by antimony, arsenic, bismuth, gold, mercury, possibly thallium; adjunct (with calcium disodium edetate) in lead poisoning. Dosage: IM: 2.5 - 3 mg/kg every 4 hours for 2 days, 2 - 4 times on the third day, then 1 2 times daily for 10 days or until recovery. For ophthalmic use: instillation of 50 mg/ml oily solution in conjunctival sac, within 5 min. of contamination. Contraindications: G6PD, alkyl mercury poisoning, hepatic insufficiency. Precautions: Pregnancy, hypertension, acute renal insufficiency. Interactions: No interaction found. Adverse Reactions: Nausea, vomiting, headache, tremor, rhinorrhoea, lacrimation, elevated blood pressure & pulse. 505

Protamine Sulphate 50 mg/5 ml Injection

V03AB14183P3001XX (B)

System: Emergency Indications: Heparin overdose and following cardiac or arterial surgery or dialysis procedures when required to neutralize the effects of heparin administered during extracorporeal circulation. Dosage: 5 ml slow IV injected over 10 mins. If administered within 15 mins of heparin dose, 1 mg will neutralise approx. 100 units of heparin. If longer time has elapsed, less protamine is required. Not more than 50 mg should be injected at any one time. Contraindications: Hypersensitivity to protamine products. Precautions: The rapid administration of PROTAMINE is associated with a higher incidence of adverse haemodynamic effects and anaphylactoid-like reactions. A solution of 10 mg/mL should be injected slowly over 1 to 3 minutes to prevent haemodynamic effects and anaphylactic-like reaction, patients with a history of fish allergy may also develop sensitivity reaction. Interactions: No interaction found. Adverse Reactions: Hypotension, bradycardia, hypersensitivity reactions. Naloxone HCl 0.02 mg/ml Injection N a r c a n - Trade Name
V03AB15110P3001XX (B) NEDL APPL

System: Emergency Indications: For the complete/partial reversal of narcotic depression including respiratory depression induced by opioids such as natural & synthetic narcotics. Diagnosis of suspected acute opioids overdosage. Dosage: 0.005 - 0.01 mg/kg body wt repeated at intervals of 2 - 3 mins. according to the patient's needs by IM, IV or SC. Contraindications: Hypersensitivity to naloxone. Precautions: Dependence may precipitate withdrawal symptoms, concurrent cardiotoxic drugs, pre-existing cardiac disease, narcotic dependency, pregnancy, breast feeding. Interactions: Clonidine : hypertension. Adverse Reactions: Opiate withdrawal symptoms, nausea, vomiting, tachycardia, tremor, sweating, pulmonary oedema, hyperventilation. Naloxone HCl 0.4 mg/ml (Adult) Injection N a r c a n - Trade Name
V03AB15110P3002XX (B) NEDL APPL

System: Emergency Indications: For the complete/partial reversal of narcotic depression including respiratory depression induced by opioids such as natural & synthetic narcotics. Diagnosis of suspected acute opioids overdosage. Dosage: Initially 0.4 - 2 mg IV repeated at intervals of 2 - 3 mins. according to patient's 506

needs. Contraindications: Hypersensitivity to naloxone. Precautions: Dependence may precipitate withdrawal symptoms, concurrent cardiotoxic drugs, pre-existing cardiac disease, narcotic dependency, pregnancy, breast feeding. Interactions: Clonidine : hypertension. Adverse Reactions: Opiate withdrawal symptoms, nausea, vomiting, tachycardia, tremor, sweating, pulmonary oedema, hyperventilation. Methylene Blue 1% Injection
V03AB17100P3001XX (B)NEDL

System: Emergency Indications: For treatment of idiopathic and drug-induced methaemoglobinemia. Dosage: IV 1% solution in dose of 1 - 2 mg/kg body wt. A repeat dose may be given after 1 hour if required. Contraindications: Hypersensitivity to methylene blue, severe renal impairment,methaemoglobinemia in cyanide poisoning, intraspinal injection,G6PD. Precautions: Haemolytic anaemia (Heinz-body anaemia) and hyperbilirubinaemia in neonates who had been exposed to methylene blue in the amniotic cavity. Interactions: No interaction found. Adverse Reactions: Headache, dizziness, nausea, vomiting. Acetylcysteine 200 mg/ml Injection Parvolex - Trade Name
V03AB23520P3001XX (A*)

System: Emergency Indications: To be used only in the treatment of paracetamol poisoning. Dosage: Diluted with Dextrose 5% and infused IV. Initially, 150 mg/kg in 200 ml over 15 min. Then 50 mg/kg in 500 ml over 4 hrs; followed by 100 mg/kg in 1000 ml over 16 hrs. Contraindications: Hypersensitivity to acetylcysteine products. Precautions: Asthma, history of bronchospasm and history of peptic ulceration. Interactions: Carbamazepine : increased risk of subtherapeutic carbamazepine levels. Nitroglycerin : enhanced hypotension and nitroglycerin-induced headache. Penicillin G, tetracycline : loss of antibiotic efficacy. Adverse Reactions: Bronchoconstriction, nausea, vomiting, anaphylactic reactions, rash. Flumazenil 0.5 mg/5 ml Injection A n e x a t e - Trade Name System: Emergency Indications: 507
V03AB25000P3001XX (B)NEDL

i) Diagnosis and/or management of benzodiazepine overdose due to selfpoisoning or accidental overdose. ii) Reversal of sedation following anaesthesia with benzodiazepine. Dosage: i) Diagnosis and/or management of benzodiazepine overdose- Initial dose is 0.2 mg IV within 15 secs. Followed at intervals of 60 secs by a further dose of 100 - 200 mcg to a max. of 1 mg. ii) Reversal of sedation following anaesthesia with benzodiazepine- 200 mcg IV given over 30 secs. A further 300 mcg can be given after another 30 secs and can be followed by doses of 500 mcg at 1-minute intervals to a total dose of 3 mg. Contraindications: Hypersensitivity to flumazenil/benzodiazepines, cyclic antidepressant overdose. Precautions: Patients with a history of long-term benzodiazepine abuse, head injuries, history of panic disorder, liver disease, drug and alcohol dependent patients. Interactions: Thiopental : decreased duration of thiopental anaesthetic effects. Adverse Reactions: Cardiac arrhythmias, bradycardia, dizziness, nausea, vomiting, seizure. Desferrioxamine B Methanesulphonate 0.5 g Injection Desferal
V03AC01196P3001XX (A) NEDL APPL
- Trade Name

System: Nutrition and Blood Disorder Indications: i) Acute iron poisoning in children ii) Investigation & treatment of haemochromatosis, iii) Diagnosis and treatment of Aluminium toxicity in patients with renal failure and dialysis iv) chronic iron toxicity/overload. Dosage: i) 2 g by IM immediately and 5 g by mouth after gastric lavage ii) 0.5 - 1.5g by IM inj dly. iii) Diagnosis: 5mg per kg by slow intravenous infusion during the last hour of haemodialysis. Treatment: 5mg per kg once a week by slow intravenous infusion during the last hour of dialysis. iv) 30-50mg/kg. Contraindications: Anuria or severe renal disease. Precautions: Safety and effectiveness have not been established in children under the age of 3 years, vision or auditory problem. Interactions: Ascorbic acid, prochlorperazine. Adverse Reactions: Thrombocytopenia, hypotension, tachycardia, flushing, rash, anaphylactic reaction, disturbance of vision and hearing, vomiting, diarrhoea. Deferiprone 500mg Tablet Ferriprox - Trade Name System: Nutrition and Blood Disorder 508
V03AC02000T1001XX (A*)

Indications: Treatment of iron overload in patients with Thalasemia Major for whom desferrioxamine therapy is contra-indicated or who present serious toxicity with desferrioxamine therapy. Dosage: 25mg/kg three times a day for total daily dose of 75mg/kg. Doses greater 100mg/kg are not recommended. Contraindications: Severe liver dysfunction, existing neutropenia, agranulocytosis, pregnancy and lactation. Precautions: In case of persistent arthropathy, deferiprone therapy should be discontinued.Monitor neutrophil counts weekly. Interrupt therapy if patient develops an infection. Interactions: Aluminium containing antacids. Adverse Reactions: Genotoxicity, neutropenia, agranulocytosis, tachycardia. vasculitis, weight gain, zinc defficiency, abdominal pain, urine discoloration, hepatotoxicity, visual Impairment, joint problems, ototoxicity and skin rash. Sodium Polystyrene Sulphonate Powder R e s o n i u m -A - Trade Name
V03AE01520F2101XX (A) APPL

System: Emergency Indications: For hyperkalaemia associated with anuria or severe oliguria, in dialysis patients or those on prolonged peritoneal dialysis. Dosage: Adult : Oral : 15 g 1- 4 times/day. Rectal : 30 - 50 g in 100 ml 2 % methylcellulose and 100 ml water as a dly retention enema. Retain for 9 hrs followed by non-sodium cleansing enema. Child : 1 g/kg in 1- 4 doses in acute hyperkalemia. Maintenance : 0.5 g/kg/daily. Contraindications: Neonates with reduced gut motility or in any patient with obstructive bowel disease. Precautions: Renal failure and with conditions requiring a restricted sodium intake, such as heart failure and severe hypertension; calcium polystyrene sulphonate may be preferred in these patients. Interactions: Magnesium-containing laxatives, aluminum carbonate, aluminum hydroxide, aluminum phosphate, calcium : increased risk of metabolic alkalosis. Levothyroxine : hypothyroidism. Adverse Reactions: Anorexia, nausea, vomiting, constipation, and occasionally diarrhoea. Constipation may be severe. Calcium Polystyrene Sulphonate Powder K a l i m a t e - Trade Name
V03AE01999F2101XX (A)

System: Emergency Indications: Hyperkalemia resulting from acute or chronic renal failure. Dosage: 15-30g daily in 2-3 divided doses. Each dose should be suspended in 30-50ml of water and administered orally. Contraindications: Should be avoided in patients with conditions such as 509

hyperparathyroidism, multiple myeloma, sarcoidosis, or metastatic carcinoma who may present with renal failure together with hypercalcaemia. Precautions: Patients should be monitored for electrolytes disturbances, especially hypokalaemia and hypercalcaemia. May cause perforation in intestine, necrosis in mucous membrane of intestine, large intestine ulcer,colon necrosis. Interactions: Digitalis preparation, antacid and laxatives containing aluminium, magnesium or calcium, Dried aluminium hydroxide gel, magnesium hydroxide, precipitate calcium carbonate. Adverse Reactions: Bronchopneumonia associated with inhalation of calcium polystyrene sulphonate. Anorexia, nausea, vomiting, constipation, diarrhea, colon perforation, hypopotassaemia. Mesna 400 mg/4 ml Injection U r o m i t e x a n - Trade Name
V03AF01520P3001XX (A)

System: Emergency Indications: For prevention of urotoxic effects of oxazaphosphorines eg. Ifosfamide and cyclophosphamide. Dosage: IV inj. at a dosage of 20 % of the corresponding oxazaphosphorine dose over 30 mins. at the times 0 hrs (concurrently with the oxazaphosphorine), 4 hrs and 8 hrs thereafter. Child : Dose given at greater frequency (eg. 6 times) and a shorter intervals (eg. 3 hrs). Contraindications: Hypersensitivity to mesna/other thiol compounds. Precautions: Do not use multi-dose vial in infants and neonates due to benzyl alcohol content, patients treated with mesna may have false positive test for urinary ketones. Interactions: Warfarin : increased risk of bleeding. Adverse Reactions: Hypotension, nausea, vomiting, headache, limb pain, headache, GI effects, skin rash. Leucovorin Calcium (Calcium Folinate) 3 mg Injection V03AF03237P3001XX (A)
NEDL

Leucovorin Calcium

- Trade Name

System: Haematology/Oncology Indications: i) Biochemical modulator for 5-Fluorouracil in the treatment of colorectal cancer. ii) As rescue for high dose methotrexate. iii) Megaloblastic anaemias due to deficiency of folic acid. Megaloblastic anaemias due to deficiency of folic acid. Dosage: i) 20 mg/m2 daily for 5 days before 5-Fluorouracil; OR 200 mg/m2 IV infusion over 2 hours prior to 5-Fluorouracil on Day1 and Day2 (refer specific protocol) ii) Starting 24 - 42 hours of methotrexate administration, doses usually 15-30 mg/m2 every 6 hrs for 3 to 6 doses depending on protocol . iii) 1mg orally qid. Contraindications: Pernicious anaemia, other vit. B12 deficency 510

megaloblastic anaemia. Precautions: Pregnancy. Interactions: Phenobarbitone, phenytoin. Adverse Reactions: Anaphylatoid reactions, urticaria, rash, erythema. Leucovorin Calcium (Calcium Folinate) 50 mg Injection Leucovorin Calcium
V03AF03237P3002XX (A) NEDL APPL
- Trade Name

System: Haematology/Oncology Indications: i) Biochemical modulator for 5-Fluorouracil in the treatment of colorectal cancer. ii) As rescue for high dose methotrexate. iii) Gestational trophoblastic disease. Dosage: i) 20 mg/m2 daily for 5 days before 5-Fluorouracil; OR 200 mg/m2 IV infusion over 2 hours prior to 5-Fluorouracil on Day1 and Day2 or 500mg/m2 IV Day 1 weekly (refer to specific protocol). ii) Starting 24 - 42 hours of methotrexate administration, doses usually 15-30 mg/m2 every 6 hrs for 8 to 12 doses depending on protocol and serum methotrexate levels. iii) 6-12mg exactly 30 hrs after each dose of methotrexate.In EMA-CO regime for high risk gestational trophoblastic disease, use 30mg IM Contraindications: Pernicious anaemia, other vit. B12 deficient megaloblastic anaemia. Precautions: Pregnancy, lactation, elderly. Interactions: Phenobarbitone, phenytoin, primidone. Adverse Reactions: Anaphylatoid reactions and urticaria. Sodium Bicarbonate and Tartaric Acid Tablet G a s t r o l u f t , B a r i t o p - Trade Name
V04C000000T1001XX (B) NEDL

System: Diagnostic Indications: Gas producing agents for double contrast examinations Dosage: No information available Contraindications: Respiratory alkalosis, Hypocalcaemia, Hypochloraemia Precautions: History of congestive heart failure, History of renal impairment, Cirrhosis, Hypertension, Concurrent corticosteroids Interactions: No interaction found Adverse Reactions: Strong solutions of tartaric acid are mildly irritant and if ingested undiluted may cause violent vomiting and diarrhoea, abdominal pain, and thirst. Cardiovascular collapse or acute renal failure may follow especially in patients with renal disease may result in hypernatraemia and hyperosmolality. Dextrose Powder System: Nutrition and Blood Disorder 511
V04CA02000F2101XX (B)NEDL

Indications: Use as a diagnostic agent for diabetes. Dosage: According to the needs of the patient. Contraindications: Do not use concentrated solutions of dextrose in patients with: anuria, diabetic coma and hyperglycaemia, intracranial or intraspinal haemorrhage, delirium tremens in dehydrated patients and glucose-galactose malabsorption syndrome. Precautions: Diabetes mellitus or carbohydrate intolerance and hyperglycaemia may accentuate neurologic damage for an ischemic insult, patients at risk for cerebral ischemia, acute stroke, impending cardiac arrest, or severe hypotension unless hypoglycaemia is suggested or until glucose is determined. Interactions: No interaction found Adverse Reactions: thrombophlebitis, rebound hypoglycaemia, hypokalaemia. Sulphobromophthalein Sodium 500 mg/ml Injection V04CE02520P3001XX (A) B r o m s u l p h a l e i n - Trade Name System: Diagnostic Indications: For testing the functional capacity of the liver Dosage: Dose: 5 mg/kg bodywt given as a 5% solution IV over a period of about 3 minutes. Contraindications: Hypersensitivity Precautions: A 5% soln of sulphobromophthalein, on standing, may yield a deposit which is not readily visible, therefore recommended that ampoules should, immediately before use, be immersed for 20min in boiling water, well shaken and cooled to body temp. Interactions: Clearance reduced by drugs that impair hepatic function, cholagogues, cholecystographic agents, opioid analgesics, probenecid, sex hormone and drugs extensively excreted in bile. Adverse Reactions: severe hypersensitivity reactions, subcutaneous infiltration may cause irritation and necrosis Tuberculine PPD Injection T u b e r c u l i n e - Trade Name
V04CF01000P3001XX (B) NEDL APPL

System: Immunological Products and Vaccines Indications: For routine Mantoux (tuberculin sensitivity) test Dosage: 10 units is injected intradermally. Contraindications: Subcutaneous injection Precautions: Sensitivity to tuberculin may be diminished in the following conditions: viral or severe bacterial infection including HIV infection and severe tuberculosis; neoplastic disease particularly lymphoma; sarcoidosis; corticosteroid or immunosuppressive therapy; recent administration of live virus vaccines; ultraviolet light treatment; chronic renal failure; and malnutrition. 512

Tuberculins may be adsorbed onto the surface of syringes and should therefore be administered immediately. TUBERCULIN skin tests should not generally be administered to known TUBERCULIN reactors because of the risk of a severe reaction at the test site. Interactions: Corticosteroid, immunosuppressive therapy, live virus vaccines Adverse Reactions: Pain and pruritus may occur at the injection site, occasionally with vesiculation, ulceration, or necrosis in highly sensitive persons. If given to patients with tuberculosis a severe reaction may occur. Granuloma has been reported. Hypersensitivity reactions, including anaphylaxis, to tuberculins have been reported rarely. Methylene Blue 2.5% Injection
V04CG05100P3002XX (B)

System: Diagnostic Indications: Renal Function Test Dosage: Dose: 2 ml of 2.5% solution IM may be given. Contraindications: Hypersensitivity to methylene blue,severe renal impairment, methaemoglobinemia in cyanide poisoning, intraspinal injection, G6PD Precautions: Haemolytic anaemia (Heinz-body anaemia) and hyperbilirubinaemia in neonates who had been exposed to methylene blue in the amniotic cavity Interactions: No interaction found Adverse Reactions: Headache, dizziness, nausea, vomiting Water for Injection
V07AB00000P3001XX (C) NEDL APPL

System: Nutrition and Blood Disorder Indications: As diluent and vehicle for the administration of medications. Dosage: According to the needs of the patient. Contraindications: Not known. Precautions: The stability of any medicament prepared should be checked. Interactions: No Interaction found Adverse Reactions: No information available. Magnesium, Aluminium Hydroxide & Simethicone Suspension Maalox Plus
V07AB00900L8001XX (C)
- Trade Name

System: Gastro-Intestinal Indications: As a buffering agent for reconstituting Didanosine powder for oral administration so as to prevent acid degradation of Didanosine which is used for the treatment of paediatric patients (> 6 months old) with symptomatic HIV infection. Dosage: DDI should be mixed with water and diluted with the appropriate dose of 513

antacids to a final concentration of 10mg per ml Contraindications: Severe debilitation, kidney failure. Precautions: Aluminium hydroxide may react with phosphate to form insoluble aluminium phosphate. This can be overcome by regular intake of milk or phosphorus supplements. Elevated serum magnesium ion concentration may cause CNS depression. Interactions: Inhibits absorption of tetracyclines, vitamin. Adverse Reactions: GI disturbances (constipation or diarrhoea). Chlorinated Lime Powder
V07AV00000F9901XX (C) NEDL

System: Miscellaneous Indications: Antiseptic and disinfectants. Dosage: Not applicable. Contraindications: Not known. Precautions: Bleaches fabric, irritant, do not use on open wounds. Interactions: No interaction found. Adverse Reactions: Dermatologic: Irritating to skin Hematologic: Dissolves blood clots, delay clotting. Glutaral (Glutaraldehyde) 3 % Crystals
V07AV00000F9902XX (A)

System: Miscellaneous Indications: Cleansing of electron microscope. Dosage: Not known Contraindications: Hypersensitivity to any of its component. Precautions: Protect surrounding skin, not for application to face, mucosa or anogenital areas Interactions: No interaction found. Adverse Reactions: Nausea, headache, airway obstruction, asthma, rhinitis, eye irritation, and dermatitis, occurring among medical personnel exposed to glutaraldehyde, generally at concentrations below the recommended limits. Skin reactions were due to hypersensitivity or a direct irritant effect. Cresol and Soap 50% Solution L y s o l - Trade Name
V07AV00000L9901XX (C) APPL

System: Miscellaneous Indications: Antiseptic and disinfectants Dosage: Use as general disinfectant. Contraindications: Not known. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: Tachycardia, cerebral oedema, dermal burns, fatty degeneration, lacrimation, haematuria, renal failure. 514

O-phenyl phenol,P-tertiary amylphenol Solution V07AV00000L9902XX (B) NEDL A m p h y l - Trade Name System: Miscellaneous Indications: As disinfectant. Dosage: 1 in 200 dilution (0.5%) for disinfecting medical equipment, eg. anaesthetic machine. Contraindications: Not known. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: No information available. Sodium Hypochlorite 5% Solution Sodium Hypochlorite 10% Solution Milton , Clorox - Trade Name
V07AV00000L9903XX (C) NEDL V07AV00000L9904XX (C)

System: Miscellaneous Indications: Surface disinfection. Dosage: Soaking 1:10 dilution. Contraindications: Hypersensitivity to any component of the formulation. Precautions: For external use only, avoid eye or mucous membrane contact, do not use on open wounds. Interactions: No interaction found. Adverse Reactions: Dermatologic: Irritating to skin. Hematologic: Dissolves blood clots, delays clotting. Glutaraldehyde Solution C i d ex - Trade Name
V07AV00000L9905XX (A) NEDL APPL

System: Miscellaneous Indications: Disinfection of endoscopes. Dosage: 20 minutes' immersion is recommended for endoscopes before the session and between patients after thorough cleaning. Contraindications: Hypersensitivity to any of its component. Precautions: Protect surrounding skin,not for application to face ,mucosa or anogenital areas Interactions: No interaction found Adverse Reactions: Nausea, headache, airway obstruction, asthma, rhinitis, eye irritation, and dermatitis, occurring among medical personnel exposed to glutaraldehyde, generally at concentrations below the recommended limits. Skin reactions were due to hypersensitivity or a direct irritant effect.

515

Hydroxyethyl Cellulose Jelly KY Jelly - Trade Name System: Diagnostic Indications: For lubricating purpose Dosage: Apply sufficiently for lubricating purpose. Contraindications: Not known Precautions: Not known. Interactions: No interaction found. Adverse Reactions: No information available Meglumine Diatrizoate 65% Injection A n g i o g r a f i n - Trade Name

V07AY00250G4001XX (B)NEDL

V08AA01254P3001XX (B)NEDL

System: Diagnostic Indications: For peripheral angiography. Dosage: Depend on the type of procedure and the degree and extent of contrast required. Contraindications: Anuria, coagulation defects, hypersensitivity to diatrizoate, joint/disc infection (arthrography/discography) Precautions: Asthma or a history of allergy, hypersensitivity to contrast media or to iodine, severe hepatic or renal impairment or others who may be at increased risk of renal failure, dehydrated patients should have their fluid and electrolyte balance corrected before contrast medium administration. Interactions: Diltiazem, metformin, propranolol Adverse Reactions: Nausea, vomiting, angioneurotic, oedema, hyperthyroidism, when given by injection,may cause nausea,metallic taste, vomiting, flushing and sensations of heat, weakness, dizziness, headache, coughing, rhinitis, sweating, sneezing, lachrymation, visual disturbances, pruritus, salivary gland enlargement, pallor, tachycardia, bradycardia, transient ECG abnormalities, haemodynamic disturbances, and hypotension, convulsions, paralysis, coma, rigors, ventricular fibrillation, pulmonary oedema, circulatory failure,cardiac arrest and anaphylactoid or hypersensitivity reactions. Injection of diatrizoates into the CNS produces severe neurotoxicity.Acute renal failure may follow intravenous administration, particularly in dehydrated patients and patients with other predisposing factors. Sodium & Meglumine Diatrizoate 58-60% Injection V08AA01993P3002XX (B)NEDL U r o v i s o n - Trade Name System: Diagnostic

516

Indications: For IV pyelography Dosage: Depend on the type of procedure and the degree and extent of contrast required. Contraindications: Anuria, coagulation defects, hypersensitivity to diatrizoate, joint/disc infection (arthrography/discography) Precautions: Asthma or a history of allergy, hypersensitivity to contrast media or to iodine severe hepatic or renal impairment or others who may be at increased risk of renal failure, dehydrated patients should have their fluid and electrolyte balance corrected before contrast medium administration. Interactions: Diltiazem, metformin, propranolol. Adverse Reactions: Nausea, vomiting, angioneurotic, oedema and hyperthyroidism. When given by injection may cause nausea,metallic taste, vomiting, flushing and sensations of heat, weakness, dizziness, headache, coughing, rhinitis, sweating, sneezing, lachrymation, visual disturbances, pruritus, salivary gland enlargement, pallor, tachycardia, bradycardia, transient ECG abnormalities, haemodynamic disturbances, and hypotension, convulsions, paralysis, coma, rigors, ventricular fibrillation, pulmonary oedema, circulatory failure , cardiac arrest and anaphyloctoid or hypersensitivity reactions. Injection of diatrizoates into the CNS produces severe neurotoxicity. Acute renal failure may follow intravenous administration, particularly in dehydrated patients and patients with other predisposing factors. Pain at the injection site, extravasation may be followed by tissue damage, thrombophlebitis, thrombosis, venospasm and embolism. Fibrinolysis and possible depressant effect on blood coagulation factors. The accidental aspiration of solutions of these salts has caused fatal pulmonary oedema. Iodamide Injection I s t e r o p a c - Trade Name
V08AA03000P3001XX (A)

System: Diagnostic Indications: For hysterosalpingography Dosage: According to the procedure and route of administration. Contraindications: Hypersensitivity to iodamide products Precautions: Multiple myeloma, known or suspected pheochromocytoma should use the lowest possible dose; blood pressure should be monitored throughout the procedure, severely debilitated and marked hypertension, severe concomitant hepatic and renal disease or anuria, dehydration. Interactions: Metformin Adverse Reactions: Warm sensation, hypertension, hypotension, nausea, vomiting,taste changes. Sodium Iothalamate 26% & Meglumine Iothalamate 52% Injection Ca r d i o -C o n r a y I n j System: Diagnostic 517
- Trade Name

V08AA04995P3001XX (A)

Indications: For cardiac catheterization. Dosage: According to the procedure and route of administration. Contraindications: Cerebral angiography -direct inject to carotid/vertebral arteries, arthrography -infection in/near joint, cholangio-pancreatography (pancreatitis), myelography. Percutaneous transhepatic cholangiography in patients with coagulation defects and prolonged prothrombin time. Precautions: Avoid prolonged contact of blood with syringes containing ionic contrast media, known or suspected pheochromocytoma, blood pressure should be monitored throughout the procedure. Interactions: Metformin Adverse Reactions: Nausea, vomiting, vasodilation, aphasia, syncope, intestinal necrosis, nephropathy, arthralgias. Iohexol Injection O m n i p a q u e - Trade Name
V08AB02000P3001XX (A)

System: Diagnostic Indications: X-ray contrast medium for use in adults and children for cardioangiography, arteriography, urography, phlebography and CT-enhancement. Lumbar, thoracic, cervical myelography and computed tomography of the basal cisterns, following subarachnoid injection. Arthrography, endoscopic retrograde pancreatography (ERCP), herniography, hysterosalpingography, sialography and studies of the gastrointestinal tract. Dosage: Dose depending on the route and procedure. Contraindications: Manifest thyrotoxicosis. History of serious reaction to iohexol. Precautions: Patients should be well hydrated prior to and following iohexol administration,previous reaction to a contrast medium,sensitivity to iodine,asthma,hay fever,food allergy. Meticulous angiographic techniques are recommended, including close attention to guidewire and catheter manipulation, use of manifold systems and/or 3-way stopcocks, frequent catheter flushing with heparinized solutions, and minimizing the length of the procedure. Interactions: Locetamic acid, iopanoic acid, ipodate, metformin, tyropanoate sodium, interleukin-2. Adverse Reactions: Nausea, vomiting, arrhythmias, thromboembolism, injection site pain, headache, altered taste, general feeling of warmth. Iopamidol Injection I o p a m i r o - Trade Name
V08AB04000P3001XX (A)

System: Diagnostic Indications: i) Neuroradiology: myeloradiculography, cisternography and ventriculography. ii) Angiograph: cerebral arteriography, thoracic aortography, abdominal aortography, angiocardiography, selective visceral arteriography, peripheral 518

arteriography, venography, digital subtraction angiography (DSA), DSA of cerebral arteries, DSA of peripheral arteries, DSA of abdominal arteries. iii)Urography: intravenous urography. iv)Contrast enhancement in CT Scanning, Arthrography, Fistulography. Dosage: For angiography and cardiac cases- dose depending on the route and procedure. For selected vascular examination- bottles of 30 ml & 100 ml; dose depending on the route and procedure. Contraindications: There are no definite or absolute contraindications, with the possible exception of Waldenstrom's macroglobulinaemia, multiple myeloma and severe liver and kidney diseases. Precautions: Asthma, history of allergy, severe hepatic and renal impairment, dehydrated patient, severe hypertension, advanced cardiac disease, phaeochromocytoma,sickle-cell disease, hyperthyroidism, very old and very young patient. Interactions: Metformin. Adverse Reactions: Pulmonary hypertension, cerebral venous thrombosis, coagulation abnormalities, hypotension, nausea, vomiting, neurological sequelae to lumbar myelography. Iopromide 300mg/50ml Injection U l t r a v i s t - Trade Name
V08AB05000P3001XX (A)

System: Diagnostic Indications: i) For angiography, urography, aortography and the visualization of body cavities. ii) Contrast enhancement during computerized tomography. iii) To check functioning of a dialysis shunt. Dosage: Dose depending on the route and procedure. Contraindications: Hypersensitivity to iopromide, iodine, or any component of the formulation; intrathecal use. In paediatrics: additional contraindication of prolonged fasting and laxative use prior to administration of iopromide. Precautions: Patients should be well hydrated prior to and following iopromide administration,previous reaction to a contrast medium,sensitivity to iodine,asthma,hay fever,food allergy. Caution in patients with renal dysfunction, combined renal and hepatic disease, combined renal and cardiac disease, dehydration, diabetes mellitus, sickle-cell disease, severe thyrotoxicosis, myelomatosis or anuria. Interactions: Interleukins, metformin. Adverse Reactions: Vasodilation, chest pain, hypertension, injection site pain, headache, nausea, vomiting, urinary urgency, back pain. Meglumine Iotroxinate Injection B i l i s c o p i n - Trade Name System: Diagnostic
V08AC02254P3001XX (A)

519

Indications: For visualization of the gall bladder and biliary tract. Dosage: A dose containing the equivalent of 5.4 g of iodine may be given by IV injection of 30ml of a 38% solution over at least 5 minutes. Contraindications: Anuria, coagulation defects, hypersensitivity to iotroxinate, joint/disc infection (arthrography/discography). Precautions: Asthma or a history of allergy, hypersensitivity to contrast media or to iodine severe hepatic or renal impairment or others who may be at increased risk of renal failure.Dehydrated patients should have their fluid and electrolyte balance corrected before contrast medium administration. Interactions: Diltiazem, metformin, propranolol Adverse Reactions: Hyperthyroidism. When given by injection,may cause nausea, metallic taste, vomiting, flushing and sensations of heat, weakness, dizziness, headache, coughing, rhinitis, sweating, sneezing, lachrymation, visual disturbances, pruritus, salivary gland enlargement, pallor, tachycardia, bradycardia, transient ECG abnormalities, haemodynamic disturbances, and hypotension, convulsions, paralysis, coma, rigors, ventricular fibrillation, pulmonary oedema, circulatory failure, cardiac arrest ,anaphylactoid or hypersensitivity reactions. Injection of diatrizoates into the CNS produces severe neurotoxicity. Acute renal failure may follow intravenous administration, particularly in dehydrated patients and patients with other predisposing factor. Pain at the injection site; extravasation may be followed by tissue damage, thrombophlebitis, thrombosis, venospasm, and embolism, fibrinolysis and possible depressant effect on blood coagulation factors. The accidental aspiration of solutions of these salts has caused fatal pulmonary oedema. Sodium Ipodate 500 mg Capsule B i l o p t i n - Trade Name
V08AC08520C1001XX (B)NEDL

System: Diagnostic Indications: For routine cholecystography Dosage: 3 g in the evening, 10-12 hours before examination. In fractionated oral cholecystography this may be followed by a second similar dose the second day, 3 hours before examination. Contraindications: Severe hepatic or renal disease; acute gastrointestinal disorders. Precautions: Doses higher than 3 g should not be given to patients with renal impairment, history of hypersensitivity to iodine or to other contrast media, severe hyperthyroidism, hyperuricaemia, or cholangitis. Interactions: No interaction found. Adverse Reactions: Nausea, vomiting, abdominal cramp, and diarrhoea, mild stinging or burning on micturition,skin rashes and flushing, acute renal failure, thrombocytopenia, and hypersensitivity reactions,potent uricosuric and anticholinesterase effects.

520

Barium Sulphate Suspension B a r i t o p , B a r y t g e n - Trade Name

V08BA01183L8001XX (B) NEDL

System: Diagnostic Indications: For x-ray examination of the alimentary tract: i)Oesophagus ii) Stomach & duodenum iii) Colon. Dosage: i)Oesophagus: Up to 150 ml of a 50% to 200% suspension orally. ii)Stomach & duodenum : Up to 300 ml of a 30% to 200% suspension orally. iii)Colon : Up to 2 litre of a 30% - 200% suspension orally. Contraindications: Gastrointestinal perforation, acute bleeding from GI tract. Precautions: Intestinal obstruction, pyloric stenosis or lesions which may predispose to obstruction, conditions which may predispose to perforation such as acute ulcerative colitis and acute diverticulitis. Adequate hydration should be ensured after the procedure to prevent severe constipation. Interactions: No interaction found. Adverse Reactions: Hypersensitivity reactions, constipation, aspiration pneumonia if aspirated. Gadopentetate Dimeglumine 469 mg/ml M a g n e v i s t - Trade Name
V08CA01000P3001XX (A)

System: Diagnostic Indications: i) Cranial and spinal magnetic resonance imaging ii) Whole body MRI Dosage: i)Cranial and spinal MRI: Adult and child > 2 years, usual dose: 0.2 mg/kg IV.Max. 20ml ii) Whole body MRI:0.4 ml/kg may be needed. Contraindications: Hypersensitivity to gadopentetate products. Precautions: History of asthma ,allergic conditions,severe renal insufficiency,sickle cell anaemia,chronic haemolytic anaemia,history of seizure disorder, gastrointestinal disorders, particularly with diarrhoea (for oral gadopentetate dimeglumine/mannitol only) Interactions: No interaction found. Adverse Reactions: Thrombophlebitis, hypotension, headache, naus ea, vomiting, cold/warm sensation. Gadodiamide 287mg (0.5mmol/ml) O m n i s c a n - Trade Name
V08CA03000P3001XX (A)

System: Diagnostic Indications: Contrast medium for cranial and spinal magnetic resonance imaging (MRI) after intravenous administration. Th e product provides contrast enhancement and facilitates visualisation of abnormal structure or lesions in the CNS. Dosage: 521

0.1 mmol/kg body weight (equivalent to 0.2 ml/kg body weight) up to 100 kg. Above 100 kg body weight 20 ml is usually sufficient to provide diagnostically adequate contrast. Contraindications: Hypersensitive to Omniscan or its constituent. Precautions: Severe renal impairment, epilepsy, hypotension, history of hypersensitivity, asthma or allergic respiratory disorders. Care should taken to avoid extravasation. Interactions: No interaction found Adverse Reactions: Headache, nausea, vomiting, transient sensations of heat, taste disturbance, anaphylaxis, shock, paraesthesias, dizziness, localized pain. Technetium-99m Sterile Generator
V09CA01000P3001XX (A*)

System: Miscellaneous Indications: Sodium pertechnitate is used for scintigraphy particularly of the brain and thyroid. It is used to prepare various technitium-99m labelled injections for selective organ imaging, especially liver, lung, bone and kidney, heart and spleen. Dosage: Technetium-99m as pertechnetate is obtained by elution with a sterile soln of NaCl 0.9%; can be administered in relatively large dose. Contraindications: Pregnancy and lactation. Precautions: Not known. Interactions: No Interaction found. Adverse Reactions: Hypersensitivity reactions. Sodium Iothalamate 60% (w/v) & Iodine 360 mg/ml Solution G a s t r o- Conray
V09CX03995L9901XX (A)
- Trade Name

System: Diagnostic Indications: For investigation of alimentary tract. Dosage: According to the procedure and route of administration. Contraindications: Cerebral angiography -direct inject to carotid/vertebral arteries, arthrography -infection in/near joint, cholangio-pancreatography (pancreatitis),myelography. Percutaneous transhepatic cholangiography in patients with coagulation defects and prolonged prothrombin time. Precautions: Avoid prolonged contact of blood with syringes containing ionic contrast media, known or suspected pheochromocytoma blood pressure should be monitored throughout the procedure, hyperthyroidism or autonomously functioning thyroid nodule. Interactions: Metformin Adverse Reactions: Vasodilatation, nausea, vomiting, aphasia, syncope, nephropathy, arthralgias.

522

Sodium Iothalamate 70% Injection C o n r a y 4 2 0 - Trade Name

V09CX03995P3001XX (B) NEDL

System: Diagnostic Indications: For intravenous pyelography and aortography Dosage: Usual dose: 0.5 ml/kg body wt. IV or intra-arterially. Contraindications: Cerebral angiography -direct into carotid/vertebral arteries, arthrography -infection in/near joint,cholangio-pancreatography (pancreatitis), myelography, percutaneous transhepatic cholangiography in patients with coagulation defects and prolonged prothrombin time. Precautions: Avoid prolonged contact of blood with syringes containing ionic contrast media known or suspected pheochromocytoma; blood pressure should be monitored throughout the procedure. Interactions: Metformin Adverse Reactions: Vasodilatation, nausea, vomiting, aphasia, syncope, nephropathy, arthralgias. Chromium EDTA (Chromium-51) Injection System: Miscellaneous Indications: Determination of glomerular filtration rate. Dosage: 10 - 200 microcuries IV. Contraindications: Pregnancy and lactation. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: No information available. Sodium Iodide (Iodine-131) Capsule (Diagnostic)
V09FX03200C1001XX (A*) V09CX04000P3001XX (A*)

System: Miscellaneous Indications: Determination of various thyroid functions. Dosage: 5-10 milicuries. Contraindications: Pregnancy, lactation, large toxic nodular goitres, severe thyrotoxic heart disease. Precautions: There may be severe and potentially dangerous swelling of thyroid in patient with large goitres and has produced asphyxiation. Interactions: Antihistamines. Adverse Reactions: Hypothyroid, hypoparathyroid, thyroiditis, leukaemia, thyroid CA. Sodium Iodide (Iodide-131) Injection System: Miscellaneous Indications: 523
V09FX03200P3001XX (A*)

Used in the determination of various thyroid functions Dosage: 5-50 millicuries. Contraindications: Pregnancy, lactation, large toxic nodular goitres, severe thyrotoxic heart disease. Precautions: There may be severe and potentially dangerous swelling of thyroid in patienttn with large goitres and has produced asphyxiation. Interactions: No interaction found. Adverse Reactions: Hypothyroid, hypoparathyroid, thyroiditis, leukaemia, thyroid CA. Sodium Chromate (Chromium-51) Solution
V09GX00143L9901XX (A*)

System: Miscellaneous Indications: Labelling of erythrocytes for the investigation of haemotological disorders. Dosage: Usual dose range: 10 - 200 microcuries IV. Contraindications: Not known Precautions: Not known Interactions: No interaction found Adverse Reactions: No information available Thallous Chloride (Thallium-201) Injection
V09GX01100P3001XX (A*)

System: Miscellaneous Indications: Used in myocardial perfusion scintigraphy, acute myocardial infarction and post-surgical assessment of coronary artery bypass graft patency, muscle perfusion scintigraphy, visualisation of brain and thyroid tumours and metastases. Dosage: As IV infusion. Contraindications: Pregnancy and lactation. Precautions: Not known. Interactions: No interaction found. Adverse Reactions: No information available. Sodium Iodide (Iodine-131) Capsule (Therapeutic) V10XA01200C1001XX (A*) System: Miscellaneous Indications: i) Thyrotoxicosis. ii) Thyroid carcinoma. Dosage: i) 2 - 30 millicuries ii) 100 - 300 millicuries Contraindications: Pregnancy, lactation, large toxic nodular goitres, severe thyrotoxic heart disease. Precautions: There may be severe and potentially dangerous swelling of 524

thyroid in patient with large goitres and has produced asphyxiation. Interactions: Antihistamines Adverse Reactions: Hypothyroid, hypoparathyroid, thyroiditis, leukaemia, thyroid CA. Sodium Iodide (Iodine-131) Solution
V10XA01200L9901XX (A*)

System: Miscellaneous Indications: i) Thyrotoxicosis ii) Thyroid carcinoma. Dosage: i) 5-15 millicuries ii) 60-150 millicuries Contraindications: Pregnancy, lactation, large toxic nodular goitres, severe thyrotoxic heart disease. Precautions: There may be severe and potentially dangerous swelling of thyroid in patient with large goitres and has produced asphyxiation. Interactions: Antihistamines Adverse Reactions: Gastritis, nausea, vomiting, bone marrow suppresion. Sodium Phosphate (Phosphorus-32) Injection
V10XX01162P3001XX (A*)

System: Miscellaneous Indications: Polycythemia vera, chronic myeloid and chronic lymphocytic leukemia and palliative treatment of bone metastases Dosage: Initially 5 millicuries,follow if necessary by a dose of not more than 3 or 4 millicurie at intervals of not less than 2 months. Contraindications: Pregnancy and lactation Precautions: Not Known Interactions: No interaction found Adverse Reactions: No information available

525

Index

526

Index by Generic Name

Acarbose 50 mg Tablet, 35 Acetazolamide 250 mg Tablet, 489 Acetazolamide 500 mg SR Capsule, 488 Acetic Acid & Spirit 2% v/v Ear Drops , 500 Acetylcysteine 200 mg/ml Injection, 507 Acetylsalicylic Acid 100 mg, Glycine 45 mg Tablet, 57 Acetylsalicylic Acid 150 mg Tablet, 57 Acetylsalicylic Acid, Soluble 300 mg Tablet, 378 Acitretin 25 mg Capsule, 151 Actinomycin D (Dactinomycin) 500 mcg/ml Injection, 311 Acyclovir 200 mg Tablet, 271 Acyclovir 200 mg/5 ml Suspension, 269 Acyclovir 800 mg Tablet, 271 Adenosine 3 mg/ml Injection, 101 Adrenaline (Epinephrine) 1 100 Eye Drops , 486 200 Eye Drop, 487 Adrenaline Ac id (Epinephrine) Tartrate 1 mg/ml Injection, 97 Albendazole 200 mg Tablet, 441 Alcohol 70% Solution, 167 Alendronate Sodium 70 mg Tablet, 356 Alfacalcidol 0.25 mcg Capsule, 40 Alfacalcidol 2 mcg/ml Injection, 41 Alfentanil HCl 0.5 mg/ml Injection, 359 Alfuzosine HCl 10mg Tablet, 201 Alkaline Nasal Douche, 445 Allopurinol 300 mg Tablet, 355 All-Trans Retinoic Acid 10 mg Capsule, 320 Alprazolam 0.25 mg Tablet, 416 Alprazolam 0.5 mg Tablet, 417 Alprazolam 1 mg Tablet, 418 Aluminium Hydroxide 300 mg/5 ml Liquid, 2 Aluminium Hydroxide Dried Gel 600 mg Tablet, 2 Amantadine HCl 100 mg Capsule, 397 Amikacin 100 mg/2 ml Injection, 252 Amiloride HCl 5 mg & Hydrochlorothiazide 50 mg Tablet, 109 Amino Acids Injection, 70 Amino Acids with Electrolytes Injection, 73 Amino Acids with Fat Emulsion Injection, 74 Amino Acids with Glucose with Electrolytes Injection, 74 Amino Acids with Glucose without Electrolytes Injection, 74 Amino Acids, Glucose, Electrolytes & Lipid Injection, 73 Aminoglutethimide 250 mg Tablet, 325 Aminophylline 25 mg / ml Injection, 468 Amiodarone 150 mg/3 ml Injection, 93 Amiodarone 200 mg Tablet, 94 Amitriptyline HCl 25 mg Tablet, 424 Amlodipine Besylate 5 mg Tablet, 119 Ammonium Bicarb, Tinct Ipecac, etc Mixture, 469 Amorolfine 5 % Nail Lacquer, 138 Amoxycillin & Clavulanic Acid 1.2 g Injection, 229 Amoxycillin & Clavulanic Acid 600 mg Injection, 229 Amoxycillin 250 mg Capsule, 221 Amoxycillin Trihydrate 125mg/5ml syrup, 221 Amoxycillin/Clavulanate 228 mg/5 ml Syrup, 229 Amphotericin B 50 mg for Injection, 260 Amphotericin-B 0.1% Eye Drops , 477 Amphotericin-B 0.25% Eye Drops , 477 Ampicillin & Sulbactam 1.5 g Injection, 228 Ampicillin & Sulbactam 250 mg/5 ml Suspension, 227 Ampicillin & Sulbactam 375 mg Tablet, 228 Ampicillin & Sulbactam 750 mg Injection, 228 Ampicillin Trihydrate 125 mg/5 ml Suspension. , 220 Anastrozole 1 mg Tablet, 325 Antazoline HCL, Tetrahydrozoline HCL & Benzalkonium Cl Eye Drops , 494 Anti RhD Gamma Globulin 250 mcg/2 ml Injection (500 units=100 mcg), 285 Antilymphocyte/Antithymocyte Immunoglobulin (from Horse) Injection, 334 Antirabies Immunoglobulin (Human) 300 iu/2ml, 286 Antitetanus Human Immunoglobulin 250 Units/Vial, 285 Antithymocyte Immunoglobulin (from Rabbit) Injection, 335

527

Antivenene Malaysian Pit Viper Injection, 283 Antivenene Serum (Cobra) Injection, 283 Antivenene Serum (Sea snake) 1000 units/26.3ml Injection, 284 Aprotinin 10,000 KIU/ml Injection, 60 Aqueous Cream , 142 Ascorbic Acid 1,000 mg Effervescent Tablet, 46 Ascorbic Acid 50 mg Tablet, 45 Ascorbic Acid 500 mg/2 ml Injection, 45 Atorvastatin 20 mg Tablet, 131 Atracurium Besylate 25 mg/2.5 ml Injection, 352 Atracurium Besylate 50 mg/5 ml Injection, 352 Atropine Sulp. 0.3%, Cocaine HCl 1.7%, Adrenaline Acid Tartrate 0.03% Injection Mydriatic (Mydriacaine), 491 Atropine Sulphate 1% Eye Ointment, 492 Atropine Sulphate 1mg/ml Injection, 13 Azathioprine 50 mg Injection, 339 Azathioprine 50 mg Tablet, 339 Azithromycin 200 mg/5 ml Granules, 247 Azithromycin 250 mg Tablet, 248 Azithromycin 500mg Injection, 248 Bacampicillin 400 mg Tablet, 221 Baclofen 10 mg Tablet, 354 Balanced Salt Solution PLUS (fortified with sodium bicarbonate, glucose & glutathione), 78 Balsam Tolu, Storax, Iodoform, Tinct. Benzoin Compound & Ether Solution, 449 Barium Sulphate Suspension, 521 Basiliximab 20 mg Injection, 338 BCG 81 mg/3 ml, 331 BCG.Freeze-dried Vaccine Injection, 290 Beclomethasone Dipropionate 100 mcg/dose Inhalation, 457 Beclomethasone Dipropionate 200 mcg/dose Inhalation, 457 Beclomethasone Dipropionate 50 mcg/dose Nasal Spray , 447 Benzathine Penicillin 2.4 mega units Injection (1.8 g), 224 Benzhexol 2 mg Tablet, 393 Benzoic Acid Compound Ointment, 137 Benzoin Compound Tincture, 166 Benzoin, Storax, Menthol & Eucalyptus Inhalation, 462

Benztropine Mesylate 2 mg Tablet, 394 Benzylpenicillin 1 mega unit (600 mg) Injection, 222 Benzylpenicillin 10,000 units/ml Eye Drops, 480 Benzylpenicillin 2,500 units/ml (1.5 mg/ml) Eye Drops , 479 Benzylpenicillin 5 mega units (3 g) Injection, 223 Beractant Intratracheal Suspension (200 mg phospholipids in 8 ml. vial), 476 Betamethasone 0.5 mg Tablet, 207 Betamethasone Disod Phos & Neomycin Sulp 0.5% Ear Drops , 503 Betamethasone Disod Phos & Neomycin Sulp. Eye Drops, 486 Betamethasone Disod Phos 0.1% Eye Drops, 483 Betamethasone Disod Phos 0.1% Eye Ointment, 484 Betamethasone Sodium Phosphate 4mg/ml Injection, 208 Betaxolol 0.25% Eye Suspension, 491 Bicalutamide 50 mg Tablet, 325 Bisacodyl 10 mg Suppository , 22 Bismuth Subgallate & Benzyl Benzoate Ointment, 111 Bismuth Subgallate & Benzyl Benzoate Suppository, 111 Bismuth Subnitrate, Iodoform & Liquid Paraffin Paste, 449 Bisoprolol Fumarate 2.5 mg Tablet, 117 Bisoprolol Fumarate 5 mg Tablet, 117 Bleomycin HCl 15 mg Injection, 315 Boric Acid with Spirit 2% w/v Ear Drops , 499 Bromazepam 1.5 mg Tablet, 415 Bromazepam 3 mg Tablet, 416 Bromhexine HCl 4 mg/2 ml Injection, 470 Bromhexine HCl 4 mg/5 ml Elixir, 469 Bromhexine HCl 8 mg Tablet, 470 Bromocriptine Mesylate 2.5 mg Tablet, 181 Budesonide 100 mcg/dose Inhalation, 458 Bumetanide 1 mg Tablet, 108 Bupivacaine 0.125% Epidural Injection, 363 Bupivacaine 0.25 % with Adrenaline 1 200,000 Injection, 366 Bupivacaine 0.5 % with Adrenaline 1 200,000 Injection, 366 Busulphan 2 mg Tablet, 297

528

Calamine Cream, 144 Calamine Lotion, 144 Calamine Oily Lotion, 144 Calamine with 2 - 6 % Precipitated Sulphur Lotion, 145 Calcipotriol 50 mcg/g Cream , 149 Calcipotriol 50 mcg/ml Scalp Solution, 149 Calcitriol 0.25 mcg Capsule, 41 Calcitriol 1 mcg/ml. Injection, 42 Calcitriol 2 mcg/ml Injection, 42 Calcium Carbonate 500 mg Capsule, 48 Calcium Chloride 1 g/10 ml Injection, 49 Calcium Disodium Edetate 200 mg Injection, 504 Calcium Lactate 0.3 g Tablet, 48 Calcium Polystyrene Sulphonate Powder, 509 Camphor 20% Liniment, 350 Capecitabine 500 mg Tablet, 306 Captopril 12.5 mg Tablet, 124 Carbachol 0.01% Intraocular Solution, 488 Carbamazepine 100 mg/5 ml(2 % w/v) Syrup, 385 Carbamazepine 200 mg Tablet, 385 Carbamide (Urea) 10 % Cream , 141 Carbimazole 5 mg Tablet, 213 Carboplatin 150 mg Injection, 317 Carboplatin 450 mg Injection, 317 Carboprost Tromethamine 250 mcg. Injection, 177 Cardioplegia solution containing KCl, MgCl2 & Procaine HCl Injection, 87 Cefaclor 125 mg/5 ml Suspension, 234 Cefaclor 375 mg Tablet, 234 Cefepime 500 mg Injection, 237 Cefoperazone 500mg & Sulbactam 500mg Injection, 238 Cefotaxime 1 g Injection, 234 Cefotaxime 500 mg Injection, 234 Ceftazidime 1 g Injection, 235 Ceftazidime 500 mg Injection, 235 Ceftriaxone 0.25 g Injection, 236 Ceftriaxone 0.5 g Injection, 236 Ceftriaxone 1g Injection, 237 Cefuroxime Axetil 125 mg Tablet, 232 Celecoxib 200 mg Capsule, 346 Cephalexin Monohydrate 250 mg Capsule, 230 Cephalexin Monohydrate 250 mg Tablet, 231 Cetirizine HCl 10 mg Tablet, 475

Chloral Hydrate 200 mg/5 ml Mixture, 419 Chlorambucil 5 mg Tablet, 296 Chloramphenicol 0.5% Eye Drops , 477 Chloramphenicol 1% Eye Ointment, 477 Chloramphenicol 5% w/v Ear Drops , 499 Chloramphenicol Sodium Succinate 1 g Injection, 219 Chlorhexidine Acetate 0.02 % Sterile Solution For Bladder Washout, 77 Chlorhexidine Acetate 0.2% Mouthwash, 451 Chlorhex idine Gluconate 0. 2 % Mouthwash, 451 Chlorhexidine Gluconate 4% Scrub, 162 Chlorhexidine Gluconate 5% Soln 1 10 in 70%alcohol with lanolin as emollient, 162 Chlorinated Lime Powder, 514 Chlorinated Lime Solution & Buffered Acetate Solution, 161 Chlorothiazide 500 mg Tablet, 105 Chlorpheniramine Maleate 10 mg/ml Injection, 473 Chlorpheniramine Maleate 2 mg/5ml Syrup, 473 Chlorpheniramine Maleate 4 mg Tablet, 473 Chlorpromazine HCl 25 mg Tablet, 400 Chlorpropamide 250 mg Tablet, 33 Chlortetracycline 1% Eye Ointment, 478 Cholera Vaccine, 287 Cholestyramine resin 4 mg, 132 Choline Salicylate 8.7%, Cetylkonium Chloride 0.01% Dental Gel, 379 Chorionic Gonadotrophin Human (HCG) 10,000 IU Injection, 194 Chorionic Gonadotrophin Human (HCG) 5000 IU Injection, 193 Chromium EDTA (Chromium -51) Injection, 523 Cimetidine 400 mg Tablet, 4 Cimetidine 800 mg Tablet, 4 Cimetidine HCl 200 mg/10 ml Suspension, 4 Cimetidine HCl 200 mg/2 ml Injection, 4 Ciprofloxacin 100 mg / 50 ml Injection, 253 Ciprofloxacin 250 mg Tablet, 254 Ciprofloxacin HCl 0.3% Ophthalmic Solution., 483

529

Cisplatin (Cis-Platinum) 10 mg Injection, 316 Cisplatin (Cis-Platinum) 50 mg Injection, 316 Clarithromycin 250 mg Tablet, 247 Clarithromycin 500 mg Injection, 246 Clarithromycin Granules 125 mg/5 ml, 246 Clindamycin HCl 300 mg Capsule, 248 Clindamycin Phosphate 150 mg/ml Injection, 249 Clobetasol Propionate 0.05 % Ointment, 158 Clobetasone Butyrate 0.05 % Cream, 156 Clodronate 800 mg Tablet, 355 Clomiphene Citrate 50 mg Tablet, 196 Clomipramine HCl 25 mg Tablet, 423 Clonazepam 0.5 mg Tablet, 384 Clonazepam 2 mg Tablet, 384 Clonidine HCl 0.025 mg Tablet, 102 Clopidogrel 75mg Tablet, 56 Clotrimazole 100mg Pessary , 172 Cloxacillin Sodium 125 mg/5 ml Suspension, 226 Clozapine 100 mg Tablet, 408 Clozapine 25 mg Tablet, 407 Coal Tar and Salicylic Acid (various concentrations) Ointment, 146 Cocaine 10% Solution, 369 Cocois Co. Ointment, 146 Codeine Phosphate 15 mg/5 ml Linctus, 470 Colchicine 0.5 mg Tablet, 355 Colfosceril palmitate 108 mg Powder Intratracheal Suspension, 476 Colloidal Bismuth Subcitrate 120 mg Tablet, 11 Compound Sodium Chloride (Ringers Solution) Injection, 75 Conjugated Oestrogen & Medrogestone Tablets (calendar pack of 31 Tablets), 192 Conjugated Oestrogen 0.625mg (28 Tablet) & Medroxyprogesterone 5 mg (14 Tablet), 191 Conjugated Oestrogens 0.3 mg Tablet, 187 Conjugated Oestrogens 0.625 mg Tablet, 186 Conjugated Oestrogens 0.625mg (28 Tablets) & Medroxyprogesterone Acetate 5 mg (28 Tablets), 192 Conjugated Oestrogens 0.625mg/g cream , 186

Conjugated Oestrogens 1.25 mg Tablet, 187 Continuous Ambulatory Peritoneal Dialysis Soln containing 1.5% Dextrose, 78 Continuous Ambulatory Peritoneal Dialysis Soln containing 2.5% Dextrose, 79 Continuous Ambulatory Peritoneal Dialysis Soln containing 4.25% Dextrose, 78 Copper 250 mm2 Intrauterine Device, 178 Copper 375 mm2 Intrauterine Device, 178 Copper Sulphate Crystal, 161 Cresol and Soap 50% Solution, 514 Cyanocobalamin 0.1 mg Injection, 65 Cyanocobalamin 10 mcg Tablet, 66 Cyclopentolate 1% Eye Drops , 492 Cyclopentolate HCl 0.2% with Phenylephrine HCl 1% Eye Drops , 494 Cyclophosphamide 200 mg Injection, 294 Cyclophosphamide 50 mg Tablet, 295 Cyclosporin 100 mg/ml Drink Solution, 332 Cyclosporin 50 mg/ml Injection, 333 Cyproterone Acetate 2.0 mg & Ethinyloestradiol 0.035 mg Tablet, 197 Cyproterone Acetate 50 mg Tablet, 196 Cytarabine (Cytosine Arabinoside) 1g Injection, 304 Cytarabine (Cytosine Arabinoside) 40 mg Injection, 302 Cytarabine (Cytosine Arabinoside) 500 mg Injection, 303 Dacarbazine 100 mg Injection, 297 Dapsone 100 mg Tablet, 269 Deferiprone 500mg Tablet, 508 Dehydrobenzperidol 2.5 mg/ml Injection, 359 Desferrioxamine B Methanesulphonate 0.5 g Injection, 508 Desmopressin 0.1mg Tablet, 204 Desmopressin 0.2mg Tablet, 205 Desmopressin Acetate 4 mcg/ml Injection, 204 Desogestrol 150 mcg & Ethinyloestradiol 30 mcg Tablet, 183 Dexamethasone & Neomycin Sulph & Polymyxin B Eye Ointment, 502

530

Dexamethasone & Neomycin Sulph & Polymyxin B Sulph Ophthalmic Suspension, 485 Dexamethasone 0.5 mg Tablet, 208 Dexamethasone Sodium Phosphate 0.1% Eye Drops , 483 Dexchlorpheniramine Maleate 2 mg Tablet, 472 Dexchlorpheniramine Maleate 2 mg/5 ml Syrup, 472 Dexchlorpheniramine Maleate 6 mg Tablet, 472 Dexmedetomidine HCl 100 mcg/ml Injection, 422 Dextrose 20 % Injection, 72 Dextrose 37.5 % & Electrolytes Injection, 75 Dextrose 50 % Injection, 72 Dextrose Powder, 511 Diazepam 10 mg Tablet, 414 Diazepam 10 mg/2 ml Injection, 413 Diazepam 2 mg Tablet, 414 Diazepam 5 mg Rectal Solution, 413 Diazepam 5 mg Tablet, 414 Diclofenac 1% Emulgel, 349 Diclofenac Sodium 12.5 mg Suppository, 341 Diclofenac Sodium 25 mg Suppository, 341 Diclofenac Sodium 50 mg Tablet, 341 Diclofenac Sodium 75mg/3ml Injection, 340 Diethylcarbamazine Citrate 50 mg Tablet, 441 Digoxin 50 mcg/ml Elixir, 90 Digoxin 500 mcg/2 ml Injection, 90 Digoxin 62.5 mcg Tablet, 91 Dihydralazine Methanesulphonate 25 mg Injection, 103 Dihydrocodeine Tartrate 30 mg Tablet, 373 Dihydroergo-cristine,-cryptine, -conine Mesylates 1 mg Tablet, 398 Diltiazem HCl 30 mg Tablet, 123 Dimethyl Polysiloxane 20 mg/ml Liquid, 11 Dinoprost (Prostaglandin F2) 5 mg/ml Injection, 175 Dinoprostone (Prostagladin E2) 0.5mg Tablet, 176 Dinoprostone (Prostagladine E2) 3mg Vaginal Tablet, 176 Diosmin 450 mg & Hesperidin 50 mg Tablet, 113 Diphenhydramine HCl 10mg/5ml Elixir, 471

Diphenhydramine HCl 14mg/5ml & Ammonium Chloride 135mg/5ml Expectorant, 471 Diphtheria Antitoxin 20,000 units/10 ml Injection, 287 Diphtheria-Pertussis-Tetanus Vaccine Injection, 289 Diphtheria-Tetanus Vaccine Injection, 290 Dipyridamole 75 mg Tablet, 58 Disodium Cromoglycate 5 mg Inhalation, 462 Distigmine Bromide 0.5 mg/ml Injection, 434 Distigmine Bromide 5 mg Tablet, 435 Dobutamine HCl 250 mg/20 ml Injection, 95 Docetaxel 20mg/0.5ml Injection concentrate, 311 Docetaxel 80mg/2ml Injection concentrate, 311 Domperidone 1mg/ml Suspension, 17 Donepezil HCL 10 mg Tablet, 431 Donepezil HCl 5 mg Tablet, 430 Dopamine HCl 40 mg/ml Injection, 95 Dorzolamide HCl 2% ophthalmic solution, 490 Dothiepin HCl 25 mg Capsule, 424 Doxorubicin HCl 10 mg Injection, 312 Doxorubicin HCl 50 mg Injection, 313 Doxycycline 100 mg Capsule, 216 Doxycycline 100 mg Injection, 217 Doxycycline 100 mg Tablet, 217 Doxycycline 5 mg/ml Syrup, 216 Dydrogesterone HCI 10 mg Tablet, 189 Edrophonium Cl 10 mg/ml Injection, 433 Efavirenz 600 mg Tablet, 282 Electrolyte Solution Injection, 80 Emulsificants Ointment, 141 Enalapril 10 mg Tablet, 125 Enoxaparin Sodium 20 mg Injection, 54 Enoxaparin Sodium 60 mg Injection, 54 Entacapone 200 mg Tablet, 399 Eperisone HCl 50 mg Tablet, 354 Ephedrine 0.5% w/v Nasal Drops , 445 Ephedrine HCl 30 mg/ml Injection, 463 Epirubicin 10 mg Injection, 314 Epirubicin 50 mg Injection, 314 Ergometrine Maleate 0.5 mg/ml Injection, 174 Ergometrine Maleate 0.5mg Tablet, 174 Erythromycin Ethylsuccinate 200 mg/5 ml Suspension, 244

531

Erythromycin Ethylsuccinate 400 mg/5 ml Suspension, 245 Erythromycin Lactobionate 500 mg Injection, 244 Erythromycin Stearate 250 mg Tablet, 245 Erythropoietin Human Recombinant 2000 units Prefilled Syringes , 67 Erythropoietin Human Recombinant 3000 units Prefilled Syringes , 67 Erythropoietin Human Recombinant 4000 units Prefilled Syringes , 67 Esmolol HCl 10 mg/ml Injection, 117 Esmolol HCl 250 mg/ml Injection, 117 Essential Phospholipids 250 mg/5 ml Injection, 20 Essential Phospholipids Capsule, 20 Ethambutol HCl 200 mg Tablet, 267 Ethambutol HCl 400 mg Tablet, 267 Ether Solvent, 358 Ethosuximide 250 mg/5 ml Syrup, 384 Ethyl Chloride Spray , 369 Etomidate 20mg/10mg Injection, 360 Etoposide 100 mg Capsule, 309 Etoposide 100 mg/5 mg Injection, 309 Etoposide 25 mg Capsule, 309 Etoricoxib 120 mg Tablet, 347 Etoricoxib 90 mg Tablet, 347 Ezetimibe 10mg tablet, 133 Factor IX concentrate 540-570 units Injection, 62 Factor IX concentrate with Factor VIII Inhibitor Bypassing activity Injection, 62 Factor VIIa (Recombinant)eptacog alfa (activated) 120 KIU (2.4 mg) Injection, 63 Factor VIIa (Recombinant)eptacog alfa (activated) 240 KIU (4.8 mg) Injection, 63 Factor VIIa (Recombinant)eptacog alfa (activated) 60 KIU (1.2 mg) Injection, 63 Factor VIII concentrate 270-300 units Injection, 62 Fat Emulsion 10% for IV Infusion, 70 Fat Emulsion 20% for IV Infusion, 71 Fat Emulsion, High Calorie, 70 Felodipine 5 mg Tablet, 120 Fentanyl 25 mcg/h Transdermal Patch, 375 Fentanyl 50 mcg/h Transdermal Patch, 375 Fentanyl Citrate 50 mcg/ml Injection, 375

Ferric Ammonium Citrate 800 mg/10ml Paed Mixture, 64 Ferrous Fumarate 200 mg Tablet, 64 Filgrastim (G-CSF) 30 MU/ml Injection, 326 Finasteride 5 mg Tablet, 202 Flecainide Acetate 100 mg Tablet, 92 Fluconazole 2 mg/ml Injection, 262 Fluconazole 50 mg Capsule, 261 Flucytosine 2.5 g/250 ml Injection, 264 Flucytosine 500 mg Tablet, 264 Fludarabine phosphate 50 mg Injection, 301 Fludrocortisone Acetate 0.1 mg Tablet, 207 Flumazenil 0.5 mg/5 ml Injection, 507 Flunarizine HCl 5 mg Capsule, 436 Fluorescein 1 mg Ophthalmic Strip, 496 Fluorescein Sodium 10% in 5 ml Injection, 496 Fluorometholone 0.1% Ophthalmic Suspension, 484 Fluorouracil 100 mg Tablet, 305 Fluorouracil 250 mg/5 ml Injection, 304 Fluoxetine HCL 20 mg Capsule, 425 Flupenthixol Decanoate Depot 20 mg/ml lnjection, 405 Fluphenazine Decanoate 25 mg/ml Injection, 400 Flutamide 250 mg Tablet, 324 Fluvoxamine 50 mg Tablet, 426 Folic Acid 5 mg Tablet, 67 Follicle-Stimulating Hormone (FSH) Human Urinary 150 IU & Luteinizing Hormone (LH) Human 150IU, 194 Follitropin Alpha (FSH Recombinant) 75IU Injection, 195 Follitropin Beta (Recombinant Human FSH) 50IU Injection, 195 Formoterol Fumarate Dihydrate 4.5 mcg /dose Inhalation, 454 Framycetin Sulp 0.5%, Dexamethasone 0.05% & Gram icidin 0.005% Ear Drops, 503 Frusemide 20 mg/2 ml Injection, 106 Frusemide 40 mg Tablet, 107 Frusemide 500 mg Tablet, 107 Fusafungine 1% Nasal Spray , 452 Fusidic Acid 1% Eye Drops, 479 Fusidic Acid 250 mg Tablet, 257 Fusidic Acid 50 mg/ml Suspension, 256 Fusidic Acid 500 mg Injection, 256 Gabapentin 300 mg Capsule, 392 Gabapentin 400 mg Capsule, 392 Gadodiamide 287mg (0.5mmol/ml), 521

532

Gadopentetate Dimeglumine 469 mg/ml, 521 Gamma Benzene Hexachloride 0.1% in Oil Solution, 444 Gemcitabine HCl 1g Injection, 306 Gemcitabine HCl 200 mg Injection, 305 Gemeprost (Prostagladin E1 Synthetic Analogue) 1 mg Pessary , 177 Gemfibrozil 300 mg Capsule, 131 Gentamicin 0.3% Eye Drops , 478 Gentamicin 0.3% Eye Ointment, 479 Gentamicin 3% Fortified Eye Drops, 478 Gentamicin Sulphate & Betamethasone Disod Phos Eye Ointment, 486 Gentamicin Sulphate & Betamethasone Disod Phosphate Eye Drops , 485 Gentamicin Sulphate 20 mg/2 ml Injection, 250 Gentamicin Sulphate 5 mg/ml Injection, 250 Gentamicin Sulphate 80 mg/2 ml Injection, 251 Gestrinone 2.5 mg Capsule, 198 Glibenclamide 5 mg Tablet, 33 Gliclazide 30mg Modified Release Tablet, 34 Gliclazide 80 mg Tablet, 34 Glucagon (Lyophilised) 1 mg/ml Injection, 215 Glucometamine 150 mg Injection, 21 Glucometamine Capsule, 20 Glutaral (Glutaraldehyde) 3 % Crystals, 514 Glycerin, 25, 497, 501 Glycerin 15% Eye Drops , 497 Glycerin 25 % & Sodium Chloride 15 % Disposable Enema, 25 Glycerin with Spirit 33% w/w Ear Drops., 501 Glyceryl Trinitrate 0.5 mg Tablet, 98 Glyceryl Trinitrate 25 mg/5 ml Injection, 98 Glyceryl Trinitrate 5 mg Transdermal Patch, 97 Glycine 1.5% Irrigating Solution, 80 Glycopyrrolate 200 mcg/ml Injection, 12 Goserelin 3.6 mg Depot Injection, 323 Granisetron HCl 1 mg Tablet, 19 Granisetron HCl 3 mg/3 ml Injection, 18 Griseofulvin (Ultramicrosize 125 mg =250 mg Microsize) Tablet, 139 Griseofulvin Syrup, 138 Haemodialysis Concentrate Solution, 89

Haemodialysis Concentrate with Acetate, 89 Haemodialysis Concentrate with Bicarbonate, 89 Haemophilus Influenzae Type B Conjugate 10 mcg Vaccine, 288 Haloperidol 1.5 mg Tablet, 404 Haloperidol 5 mg/ml Injection, 403 Halothane Liquid, 358 Hepatitis A, Inactivated vaccine 160 antigen units Injection, 291 Hepatitis B Immunoglobulin (Human) Injection, 286 Hepatitis B Vaccine Injection, 290 Homatropine 0.5% Eye Drops, 493 Homatropine 1% Eye Drops , 493 Homatropine 2% Eye Drops , 493 Human Albumin Injection, 68 Hydralazine HCl 25 mg Tablet, 104 Hydrocortisone 10 mg Tablet, 212 Hydrocortisone Enema 0.17 %, 28 Hydrogen Peroxide 1.5% Ear Drops , 499 Hydrogen Peroxide 20 vol Solution, 166 Hydroxychloroquine Sulphate 200 mg Tablet, 437 Hydroxyethyl Cellulose 3% Eye Drops , 497 Hydroxyethyl Cellulose Jelly, 516 Hydroxyethyl Starch 6% Injection, 69 Hydroxynorephedrine (Metaraminol) 10mg/ml lnj, 96 Hydroxyprogesterone Caproate 250mg/ml Injection, 188 Hydroxyurea 500 mg Capsule, 320 Hydroxyzine HCl 25 mg Tablet, 418 Hyoscine HBr 600 mcg/ml Injection, 15 Hyoscine N-Butylbromide 1 mg/ml Liquid, 14 Hyoscine N-Butylbromide 10 mg Tablet, 15 Hyoscine N-Butylbromide 20 mg/ml Injection, 14 Hyperimmune Gamma Globulin Injection, 284 Hypoallergenic Ambiphilic Base Cream , 140 Hypromellose 0.3% Eye Drops , 498 Ibuprofen 200 mg Tablet, 343 Ichthammol Glycerin 10% Ear Drops, 500 Idarubicin 10 mg Injection, 314 Idarubicin 5 mg Injection, 314 Idoxuridine 0.1% Eye Drops , 481 Idoxuridine 0.1% Eye Ointment, 481

533

Ifosfamide 1 g Injection, 296 Imipenem 250 mg & Cilastatin 250 mg Injection, 240 Imipenem 500 mg & Cilastatin 500 mg Injection, 240 Imipramine HCl 25 mg Tablet, 423 Indinavir Sulphate 400 mg Capsule, 273 Indomethacin 100 mg Suppository, 349 Indomethacin 25 mg Capsule, 340 Insulin Recombinant Neutral Human short-acting 100IU/ml Injection in 10ml vial, 31 Insulin Recombinant Synthetic human, intermediate-acting 100 IU/ml Injection in10ml vial, 31 Insulin Recombinant Synthetic Human, Intermediate-acting 100 IU/ml Penfill and Refill, 32 Insulin Recombinant Synthetic human, pre-mixed 100 IU/ml Injection in10ml vial, 32 Insulin Recombinant Synthetic Human, pre-mixed 100 IU/ml Penfill and Refill, 32 Insulin Recombinant Synthetic Human, short-acting 100 IU/ml Penfill and Refill, 31 Interferon Alfa-2b 18 MIU Multidose Injection Pen, 328 Interferon Alfa-2b 30 MIU Multidose Injection Pen, 328 Interferon Alpha-2a 4.5MIU Injection, 328 Interferon Beta-1a 22 mcg, 329 Interferon Beta-1a 44 mcg, 329 Iodamide Injection, 517 Iodine & Potassium Iodide Solution, 214 Iodine 2.5 % Solution, 164 Iohexol Injection, 518 Iopamidol Injection, 518 Iopromide 300mg/50ml Injection, 519 Ipecacuanha Pro Infant Mixture, 469 Irbesartan 150mg Tablet, 127 Irbesartan 300mg Tablet, 127 Irinotecan HCl Trihydrate 100mg/5ml Injection, 321 Irinotecan HCl Trihydrate 40 mg/2 ml Injection, 321 Isoflurane Liquid, 358 Isoniazid 100 mg Tablet, 266 Isoprenaline HCl 0.2 mg/ ml Injection, 94 Isosorbide Dinitrate 1 mg/ml Injection, 99

Isosorbide Dinitrate 10 mg Tablet, 99 Isotretinoin 10 mg Capsule, 170 Itraconazole 10 mg/ml Oral Solution, 263 Itraconazole 100 mg Capsule, 263 Ketamine 10 mg/ml Injection, 360 Ketamine 50 mg/ml Injection, 360 Ketoconazole 200 mg Tablet, 260 Ketoprofen 100 mg/2ml Injection, 345 Ketoprofen 100mg Slow Release Capsule, 345 Ketoprofen 2.5% Gel, 348 Ketoprofen 30mg Transdermal Plaster, 349 Ketorolac Tromethamine 0.5% Eye drop, 484 Ketorolac Tromethamine 30 mg/ml Injection, 342 Labetalol HCl 100 mg/20 ml Injection, 118 Lactated Ringer's Solution 500ml Injection, 75 Lactulose 3.35 g/5 ml Liquid, 23 Lamivudine 100 mg Tablet, 280 Lamotrigine 25 mg Dispersible/Chewable Tablet, 388 Lamotrigine 5 mg Dispersible/Chewable Tablet, 389 Lanolin, 142 Lansoprazole 30 mg Tablet, 10 Latanoprost 0.005% Eye Drops, 491 Leflunomide 10 mg Tablet, 338 Leflunomide 100 mg Tablet, 338 Leflunomide 20 mg Tablet, 338 Letrozole 2.5 mg Tablet, 326 Leucovorin Calcium (Calcium Folinate) 3 mg Injection, 510 Leuprolide Acetate 3.75 mg Injection, 323 Levamisole 40 mg Tablet, 442 Levetiracetam 250 mg Tablet, 393 Levetiracetam 500 mg Tablet, 393 Levodopa 100 mg, Benserazide 25 mg Dispersible Tablet, 397 Levodopa 100 mg, Benserazide 25 mg HBS capsule, 395 Levonorgestrel 150 mcg & Ethinyloestradiol 30 mcg Tablet, 193 Levonorgestrel releasing intrauterine system, 179 Lidocaine 25 mg & Prilocaine 25 mg Patch, 368 Lignocaine (Lidocaine) HCl 2 % Injection, 365 Lignocaine 10 % w/w Spray , 363

534

Lignocaine 100 mg/ml Injection, 92 Lignocaine 2 % Cream, 363 Lignocaine 2 % Jelly, 364 Lignocaine 2 % with Adrenaline (1 80,000) Injection, 368 Lignocaine 2% Viscous Solution, 364 Lignocaine 2% with Chlorhexidine 0.05% Gel, 367 Lignocaine 4 % Solution, 364 Lignocaine 500 mg/ml Injection, 92 Lignocaine and Prilocaine (1 1 ratio) Eutectic Mixture, 367 Lignocaine HCl 5% in Glucose (Heavy) Injection, 368 Linezolid 2mg/ml Injection, 259 Liquid Paraffin, 21 Lithium Carbonate 300 mg Tablet, 411 Loperamide 2 mg Capsule, 27 Lopinavir 133.3mg & Ritonavir 33.3 mg Capsule, 274 Lopinavir/Ritonavir Oral Solution, 274 Loratadine 1 mg/ml Syrup, 475 Loratadine 10 mg Tablet, 476 Loratadine 5 mg & Pseudoephedrine Sulphate 120 mg Tablet, 450 Lorazepam 1 mg Tablet, 415 Losartan 50 mg Tablet, 126 Losartan Potassium 100 mg & Hydrochlorothiazide 25 mg, 128 Losartan Potassium 50 mg & Hydrochlorothiazide 12.5 mg Tablet, 128 Lovastatin 20 mg Tablet, 130 Magnesium Sulphate 45 % Paste, 171 Magnesium Trisilicate Mixture, 1 Magnesium Trisilicate Tablet, 2 Magnesium, Aluminium Hydroxide & Simethicone Suspension, 513 Mannitol 10 % Injection (10 g/100 ml), 76 Measles, Mumps & Rubella Vaccine Live, 292 Mebeverine HCl 100 mg Tablet, 12 Meclozine HCl 25 mg Tablet, 474 Mecobalamin 500 mcg Tablet, 357 Medroxyprogesterone Acetate 100 mg Tablet, 322 Medroxyprogesterone Acetate 10mg Tablet, 188 Medroxyprogesterone Acetate 150 mg/3ml Injection, 184 Medroxyprogesterone Acetate 500 mg/2.5 ml Injection, 321 Medroxyprogesterone Acetate 5mg Tablet, 188 Mefenamic Acid 250 mg Capsule, 345

Mefenamic Acid 250 mg Tablet, 346 Mefloquine HCl 250 mg Tablet, 439 Meglumine Diatrizoate 65% Injection, 516 Meglumine Iotroxinate Injection, 519 Meloxicam 7.5mg Tablet, 343 Melphalan 2 mg Tablet, 296 Meningococcal A, C, Y, W135 Vaccine Injection, 288 Menthol 1.6% in Ind. Methylated Spirit Inhalation, 448 Mercaptopurine 50 mg Tablet, 301 Mesalazine 250 mg Suppository, 29 Mesalazine 250 mg Tablet, 30 Mesna 400 mg/4 ml Injection, 510 Methotrexate 50 mg Injection, 298 Methotrexate 500 mg/20 ml Injection, 299 Methotrexate Sod 2.5 mg Tablet, 300 Methoxamine HCl 20 mg/ml Injection, 96 Methyl Salicylate 25% Ointment, 350 Methylcellulose 1% with 50 mg Vitamin C Eye Drops, 497 Methyldopa 250 mg Tablet, 102 Methylene Blue 1% Injection, 507 Methylene Blue 2.5% Injection, 513 Methylphenidate HCl 10 mg Tablet, 428 Methylphenidate HCl SR 20 mg Tablet, 429 Methylprednisolone Sodium Succinate 0.5 g Injection, 209 Metoclopramide HCl 10 mg Tablet, 16 Metoclopramide HCl 10 mg/2 ml Injection, 16 Metoclopramide HCl 5 mg/5 ml Syrup, 16 Metolazone 5 mg Tablet, 106 Metoprolol Tartrate 50 mg Tablet, 116 Metronidazole 0.5 g Suppository, 258 Metronidazole 200 mg Tablet, 258 Metronidazole 200 mg/5 ml Suspension, 257 Metronidazole 500 mg/100 ml Injection, 257 Miconazole 10 mg/ml Injection, 260 Midazolam 5 mg/ml Injection, 421 Midazolam 7.5 mg Tablet, 421 Minocycline 100 mg Capsule, 218 Minocycline 50 mg Capsule, 218 Minoxidil 5 mg Tablet, 104 Mirtazapine 30 mg Tablet, 427 Mitomycin-C 0.025% Eye Drops , 482 Mitomycin-C 10 mg Injection, 316

535

Mitoxantrone 20mg / 10ml Injection, 315 Mixed Gas-Gangrene Antitoxin 25,000 units/5 ml Injection, 284 Moclobemide 150 mg Tablet, 426 Modified Fluid Gelatin 4% Injection, 69 Modified Polypeptides (Polygeline) 3.5% Injection, 70 Molgramostim 150 mcg Injection, 327 Molgramostim 300 mcg Injection, 327 Molgramostim 400 mcg Injection, 327 Mometasone Furoate 0.1% Cream , 160 Montelukast Sodium 5 mg Chewable Tablet, 469 Morphine Sulphate 10 mg Controlled Release Tablet, 371 Morphine Sulphate 10 mg/ml Injection, 370 Morphine Sulphate 10mg Suppository, 370 Morphine Sulphate 20mg Suppository, 370 Morphine Sulphate 30mg Suppository, 370 Morphine Sulphate 60 mg Controlled Release Tablet, 372 Morphine Sulphate Immediate Release 10mg Tablet, 373 Multivitamin Drops , 36 Multivitamin Injection, 37 Multivitamin Syrup, 37 Multivitamin Tablet, 37 Mupirocin 2% Cream, 154 Muromonab-CD3 5 mg Injection, 334 Mycophenolate Mofetil 250 mg tablet, 337 Mycophenolate Mofetil 500 mg tablet, 337 Nadroparin Calcium 0.2 ml Injection, 54 Nadroparin Calcium 0.3 ml Injection, 54 Nadroparin Calcium 0.4 ml Injection, 54 Nadroparin Calcium 0.6 ml Injection, 54 Nalbuphine HCl 10 mg/ml Injection, 376 Naloxone HCl 0.4 mg/ml (Adult) Injection, 506 Nandrolone Decanoate 25 mg/ml Injection, 51 Naproxen 25 mg/ml Suspension, 344 Naproxen 250 mg Tablet, 344 Naproxen Sodium 275 mg Tablet, 344 Neomycin 0.5 % Ointment, 153 Neomycin with Polymyxin B Sulphate and Gramicidin Eye Drops , 480 Neostigmine Methylsulphate 0.5 mg/ml Injection, 433

Neostigmine Methylsulphate 2.5 mg/ml Injection, 434 Netilmicin Sulph 100 mg/2ml Injection, 252 Netilmicin Sulph 150 mg/2 ml Injection, 252 Netilmicin Sulph 50 mg/2 ml Injection, 252 Nevirapine 200 mg Tablet, 281 Nicotinic Acid 50 mg Tablet, 46 Nicotinic Acid 500 mg Tablet, 132 Nifedipine 10 mg Capsule, 120 Nifedipine 10 mg Tablet, 121 Nimodipine 10 mg/50 ml Infusion Solution, 121 Nitrazepam 5 mg Tablet, 420 Nitrofurantoin 100mg Tablet, 259 Norepinephrine Bitartrate 4 mg/4 ml Injection (Noradrenaline acid tartrate), 95 Norethisterone 0.35 mg Tablet, 183 Norethisterone Enanthate 200 mg/ml Injection, 184 Norfloxacin 0.3% Eye Drops , 482 Nystatin 100,000 units pessary, 171 Nystatin 100,000 units/g Cream, 133 Nystatin 100,000 units/g Ointment, 133 Nystatin 100,000 units/ml Suspension, 25 Nystatin 500,000 units Tablet, 26 Octreotide 0.05mg/ml Injection, 206 Oestradiol 1 mg & Norethisterone Acetate 0.5 mg Tablet, 190 Oestradiol Valerate 1 mg Tablet, 185 Oestradiol Valerate 2mg & Norgestrel 0.5mg Tablet (calender pack x 21 Tablets), 190 Ofloxacin 0.3% Otic Solution, 498 Ofloxacin 100 mg Tablet, 253 Ofloxacin 200 mg Injection, 252 Olanzapine 5 mg Tablet, 408 Olive Oil Ear Drops , 502 Omeprazole 10 mg Capsule, 7 Omeprazole 20 mg Capsule, 8 Omeprazole 40 mg Injection, 8 Ondansetron 4 mg Tablet, 18 Ondansetron 4 mg/2ml Injection, 17 Ondansetron 8 mg Tablet, 18 Ondansetron 8 mg/4ml Injection, 17 O-phenyl phenol,P-tertiary amylphenol Solution, 515 Oral Rehydration Salt, 26 Oxaliplatin 50mg Injection, 318 Oxybuprocaine HCl 0.4 % Eye- Drops , 495

536

Oxymetazoline HCl 0.025% (Paed) Nasal Drops , 447 Oxymetazoline HCl 0.025% (Paed) Nasal Spray , 446 Oxymetazoline HCl 0.05% (Adult) Nasal Drops, 447 Oxymetazoline HCl 0.05% (Adult) Nasal Spray , 446 Oxytetracycline with Polymyxin B Sulphate Eye Ointment, 480 Oxytocin 10 units/ml Injection, 206 Oxytocin 5 units & Ergometrine Maleate 0.5mg/ml Injection, 175 Paclitaxel 100 mg Injection, 310 Paclitaxel 30 mg/5 ml Injection, 310 Palivizumab 100mg Injection, 286 Pamidronate Disodium 30 mg Injection, 356 Pancreatic Enzymes & Vitamins Tablet, 30 Pancreatic Enzymes Tablet, 30 Pancuronium Bromide 4 mg/2 ml lnj, 351 Pantoprazole 40 mg Tablet, 9 Papaverine HCl 30 mg/ml Injection, 200 Paracetamol 250 mg Suppository, 379 Paracetamol 500 mg Tablet, 379 Paradichlorobenzene, Turpentine Oil & Chlorbutol Ear Drops, 501 Paraffin, White Soft, 141 Paraffin, Yellow Soft, 141 Paraldehyde 10 ml Injection, 419 Pefloxacin 400 mg Injection, 255 Peginterferon Alpha-2a 135 mcg Prefilled Syringe, 330 Peginterferon Alpha-2a 180 mcg Prefilled Syringe, 330 Pegyinterferon Alpha-2b 100mcg Injection, 329 Pegyinterferon Alpha-2b 120mcg Injection, 329 Pegyinterferon Alpha-2b 150mcg Injection, 329 Pegyinterferon Alpha-2b 50mcg Injection, 329 Pegyinterferon Alpha-2b 80mcg Injection, 329 Pentamidine Kethionate 300 mg Injection, 440 Pentoxifylline 400 mg Tablet, 110 Perindopril 4 mg Tablet, 125 Peritoneal Dialysis with 1.5% Glucose Solution, 80 Peritoneal Dialysis with 4.25% Glucose Solution, 80

Perphenazine 4 mg Tablet, 401 Pethidine HCl 100 mg/2 ml Injec tion, 374 Pethidine HCl 50 mg/ml Injection, 373 Phenobarbitone 30 mg Tablet, 381 Phenoxybenzamine 100 mg/2 ml Injection, 110 Phenoxybenzamine 5 mg Capsule, 110 Phenoxymethyl Penicillin 125 mg Tablet, 223 Phenoxymethyl Penicillin 125 mg/5 ml Syrup, 223 Phenylephrine HCl 10% Eye Drops , 494 Phenylephrine HCl 2.5% Eye Drops, 493 Phenytoin Sodium 100 mg Capsule, 382 Phenytoin Sodium 30 mg Capsule, 382 Phosphate Solution containing Sod Acid Phosphate 1.936 g / 15 ml, 87 Physostigmine (Eserine) 0.5% Eye Drops, 488 Physostigmine (Eserine) 1% Eye Drops, 488 Pilocarpine 4% Eye Drops, 487 Piperacillin 4g & Tazobactam 500mg Injection, 230 Piperacillin Sodium 2 g Injection, 221 Piracetam 1 g Injection, 430 Piracetam 1.2 g Tablet, 430 Piracetam 20%Solution, 429 Piribedil 50 mg Tablet, 398 Piroxicam 10 mg Tablet, 342 Pizotifen 0.5 mg Tablet, 381 Pneumococcal Vaccine (Polyvalent), 289 Policresulen 360mg/g Concentrate, 173 Policresulen 90 mg Vaginal pessary, 173 Polio Oral Vaccine, 292 Polycitra Syrup, 50 Potassium Chloride (Slow Release) 600 mg. Tablet, 50 Potassium Chloride 1 g/10 ml Injection, 81 Potassium Chloride 1 g/15 ml Mixture, 49 Potassium Citrate 3g/10 ml & Citric Acid Mixture, 50 Potassium Hydrogen Phosphate 1.83 g/10 ml Injection, 86 Potassium Iodide Mixture, 214 Potassium Permanganate 1 10,000 Solution, 166

537

Povidone Iodine 10% (eqvt. to 1% iodine) Solution, 164 Povidone Iodine 7.5% (eqvt. to 0.75% iodine) Scrub, 163 Pralidoxime Chloride 0.5g/20 ml Injection, 504 Pravastatin Sodium 20 mg Tablet, 130 Pre/Post-Natal Vitamin & Mineral Capsule, 36 Pre/Post-Natal Vitamin & Mineral Tablet, 36 Prednisolone 3 mg/5 ml Syrup, 210 Prednisolone 5 mg Tablet, 210 Prilocaine 0.5% Plain Injection (5 mg/ml), 365 Primaquine 7.5 mg base Tablet, 438 Primidone 250 mg Tablet, 382 Procaine Benzylpenicillin Aqueous 3 mega units (3 g) Injection, 225 Procaine Benzylpenicillin Aqueous 4 mega units (4 g) Injection, 225 Procarbazine HCl 50 mg Capsule, 318 Prochlorperazine Mesylate 12.5mg/ml Injection, 401 Procyclidine HCl 10 mg/2 ml Injection, 394 Prolase Tablet, 357 Promethazine HCl 25 mg/ml Injection, 474 Promethazine HCl 5 mg/5 ml Syrup, 474 Propantheline Bromide 15 mg Tablet, 12 Propranolol HCl 1 mg/ml Injection, 114 Propranolol HCL 40 mg Tablet, 115 Protamine Sulphate 50 mg/5 ml Injection, 506 Protein Free Haemodialysate 10 % Jelly, 143 Protein Free Haemodialysate Dental Adhesive Paste, 143 Protein Free Haemodialysate Injection, 144 Pyrantel Pamoate 125 mg Tablet, 441 Pyrazinamide 500 mg Tablet, 267 Pyridostigmine Bromide 60 mg Tablet, 434 Py ridoxine HCl 10 mg (Vitamin B6)Tablet, 47 Pyridoxine HCl 50 mg/2 ml Injection, 47 Quetiapine Fumarate 100mg Tablet, 410 Quetiapine Fumarate 25mg Tablet, 409 Quinine Dihydrochloride 600 mg/2 ml Injection, 438 Quinine Sulphate 300 mg Tablet, 439

Rabies Human Diploid Cell Vaccine (Lyophilised) Injection, 292 Raloxifene HCl 60mg Tablet, 198 Ranitidine 150 mg Tablet, 6 Ranitidine 150 mg/10 ml Syrup, 5 Ranitidine 300 mg Tablet, 7 Ranitidine 50 mg/2 ml Injection, 5 Red Petroleum, Zinc Oxide & 2Ethoxyethyl P-Methoxy Cinnamate Ointment, 142 Repaglinide 2mg Tablet, 35 Riboflavine 3 mg Tablet, 48 Rifampicin 100 mg/5 ml Syrup, 266 Rifampicin 150 mg Capsule, 265 Rifampicin, Dapsone & Clofazimine, 268 Risperidone 1 mg Tablet, 412 Risperidone 1 mg/ml Oral Solution, 411 Risperidone 2 mg Tablet, 412 Ritodrine HCI 10 mg Tablet, 180 Ritodrine HCI 50 mg/5ml Injection, 180 Ritonavir 100 mg Capsule, 273 Rituximab 500 mg/50 ml Injection, 319 Rivastigmine 1.5 mg Capsule, 431 Rivastigmine 3 mg Capsule, 431 Rivastigmine 4.5 mg Capsule, 431 Rivastigmine 6 mg Capsule, 432 Rocuronium Bromide 10 mg/ml Injection, 352 Ropinirole HCl 0.25mg Tablet, 398 Ropinirole HCl 1 mg Tablet, 398 Ropivacaine HCl 2 mg/ml Injection, 365 Ropivacaine HCl 7.5 mg/ml Injection, 366 Rosiglitazone 8 mg Tablet, 35 Rubella Virus Vaccine (Live Attenuated) Injection, 292 Salbutamol 0.5 % Inhalation Solution, 453 Salbutamol 0.5 mg/ml Injection, 463 Salbutamol 100 mcg/dose Inhalation, 452 Salbutamol 5 mg/5 ml Injection, 464 Salicylazosulphapyridine (Sulphasalazine) 500 mg Tablet, 28 Salicylic Acid 2% Lotion, 137 Salicylic Acid, Lactic Acid and Oxypolyethoxydodicane Solution, 171 Salicylic Acid, Starch, Zinc Oxide Paste, 138 Salmeterol 25mcg and Fluticasone Propionate 125mcg Inhalation, 456 Selected Plasma Protein 5 g/100 ml Injection, 68 Selegiline HCl 5 mg Tablet, 399

538

Selenium Sulphide 2.5 % Shampoo, 170 Sertraline HCL 50 mg Tablet, 426 Sevoflurane Liquid, 359 Simvastatin 10 mg Tablet, 129 Sod Bicarb, Mag Carb, Co Card Tinct, etc Mixture, 3 Sodium & Meglumine Diatrizoate 5860% Injection, 516 Sodium Bicarbonate 1 g/15 ml Mixture, 3 Sodium Bicarbonate 4.2% (0.5 mmol/ml) Injection, 81 Sodium Bicarbonate 5% w/v Ear Drops , 502 Sodium Bicarbonate 8.4% (1 mmol/ml) Injection, 82 Sodium Bicarbonate and Tartaric Acid Tablet, 511 Sodium Bicarbonate Mixture (Paediatric), 3 Sodium Biphosphate 16% & Sodium Phosphate 6% Enema, 23 Sodium Carboxy Methylcellulose 2% Eye Drops, 498 Sodium Chloride (Half Strength) 0.45% Injection, 82 Sodium Chloride 0.18% with Dextrose 4.23% Injection, 85 Sodium Chloride 0.45% with Dextrose 10% Injection, 84 Sodium Chloride 0.45% with Dextrose 5% Injection, 86 Sodium Chloride 0.9% Injection, 83 Sodium Chloride 0.9% with Dextrose 5% Injection, 85 Sodium Chloride 20% Injection, 83 Sodium Chromate (Chromium -51) Solution, 524 Sodium Citrate 0.3 M Solution, 78 Sodium Citrate 3.8% Solution, 77 Sodium Citrate, Citric Acid Mixture 3 g/10 ml, 77 Sodium Citrate, Sodium Lauryl Sulphoacetate, Glycerin, Sorbitol, Sorbic Acid Enema, 25 Sodium Cromoglycate 2% Eye Drops , 495 Sodium Cromoglycate 4% Eye Ointment, 495 Sodium Hypochlorite 10% Solution, 515 Sodium Hypochlorite 5% Solution, 515 Sodium Iodide (Iodide-131) Injection, 523

Sodium Iodide (Iodine-131) Capsule (Diagnostic), 523 Sodium Iodide (Iodine-131) Capsule (Therapeutic), 524 Sodium Iodide (Iodine-131) Solution, 525 Sodium Iothalamate 26% & Meglumine Iothalamate 52% Injection, 517 Sodium Iothalamate 60% (w/v) & Iodine 360 mg/ml Solution, 522 Sodium Iothalamate 70% Injection, 523 Sodium Ipodate 500 mg Capsule, 520 Sodium Lactate Compound (Hartmanns Solution), 88 Sodium Lauryl Sulphate Shampoo, 171 Sodium Nitrite 30 mg/ml Injection, 505 Sodium Phosphate (Phosphorus -32) Injection, 525 Sodium Polystyrene Sulphonate Powder, 509 Sodium Tetradecyl Sulphate 1 % Injection, 113 Sodium Thiosulphate 10-20% Solution, 136 Sodium Thiosulphate 500 mg/ml Injection, 505 Sodium Valproate 200 mg/5 ml Syrup, 386 Sodium Valproate 400 mg Injection, 387 Sotalol HCl 160 mg Tablet, 116 Spironolactone 25 mg Tablet, 109 Stavudine 1 mg/ml Solution, 280 Streptokinase 1,500,000 IU Injection, 58 Sucralfate 1 g Tablet, 10 Sulfadoxine 500 mg & Pyrimethamine 25 mg Tablet, 439 Sulphacetamide 10% Eye Drops , 481 Sulphacetamide 30% Eye Drops , 481 Sulphamethoxazole 200 mg & Trimethoprim 40 mg/5ml Suspension, 242 Sulphamethoxazole 400 mg & Trimethoprim 80 mg Injection, 242 Sulphamethoxazole 400 mg & Trimethoprim 80 mg Tablet, 243 Sulphobromophthalein Sodium 500 mg/ml Injection, 512 Sulphur 2 % & Salicylic Acid 2 % Cream , 168 Sulpiride 200 mg Tablet, 411 Sulpiride 50 mg Capsule, 410 Sumatriptan 100 mg Tablet, 381 Sumatriptan 50 mg Tablet, 380

539

Sumatriptan 6 mg/0.5 ml S/C Injection, 380 Synthetic ACTH (Tetracosactrin Acetate) 250 mcg/ml Injection, 202 Synthetic Salmon Calcitonin 100 IU Injection, 216 Synthetic Salmon Calcitonin 50 IU Injection, 215 Synthetic Salmon Calcitonin 50IU Nasal Spray , 215 Synthetic Vitamin K1 1 mg/ml Injection, 60 Synthetic Vitamin K1 10 mg/ml Injection, 61 Synthetic Vitamin K1 Mixed Micelle 2 mg/0.2 ml Injection, 61 Tacrolimus 1 mg Capsule, 335 Tacrolimus 5 mg Capsule, 336 Tacrolimus 5mg/ml Injection, 336 Tamoxifen Citrate 20 mg Tablet, 324 Tar, Coal Tar & Oleyl Alcohol Liquid, 147 Technetium-99m Sterile Generator, 522 Tegaserod 6 mg Tablet, 13 Telmisartan 40 mg Tablet, 127 Telmisartan 80 mg Tablet, 127 Temazepam 10 mg Capsule, 420 Terbinafine HCl 250 mg Tablet, 140 Terbutaline Sulphate 0.3 mg/ml Syrup, 465 Terbutaline Sulphate 0.5 mg/ml Injection, 454 Terbutaline Sulphate 10 mg/ml Inhalation Solution, 453 Terbutaline Sulphate 2.5 mg Tablet, 465 Terbutaline Sulphate 250 mcg/dose Inhalation, 453 Terlipressin 1 mg Injection, 205 Testosterone Enanthate 250 mg/ml Injection, 185 Tetanus Antitoxin, 1500 units/ml in Injection, 283 Tetracycline HCI 100 mg & Amphotericin B 50 mg Pessary, 172 Tetracycline HCl 250 mg Capsule, 217 Tetracycline HCl 250 mg Tablet, 218 Thallous Chloride (Thallium-201) Injection, 524 Theophylline 125 mg Tablet, 466 Theophylline 80 mg/15 ml Syrup, 466 Thiamine HCl 100 mg/ml Injection, 42 Thiamine Mononitrate 3 mg Tablet, 43 Thioguanine 40 mg Tablet, 301

Thiopental Sodium 500 mg Injection, 419 Thymol Compound Gargle, 1 Tibolone 2.5mg Tablet, 189 Ticlopidine HCl 250 mg Tablet, 56 Timolol maleate 0.5% Ophthalmic Drops, 490 Tinidazole 500 mg Tablet, 259 Tioconazole 100mg Vaginal Tablet, 173 Tioconazole 6.5% Vaginal Ointment, 172 Tiotropium bromide Inhalation 18 mcg Capsules & Handihaler, 462 Tolterodine L-Tartrate 1 mg Tablet, 199 Tolterodine L-Tartrate 2 mg Tablet, 199 Topiramate 100 mg Tablet, 391 Topiramate Capsule Sprinkle 15mg, 389 Topiramate Capsule Sprinkle 25 mg, 390 Trace Elements and Electrolytes (Adult) Solution, 88 Trace Elements and Electrolytes (Paed) Solution, 88 Tramadol HCl 100 mg Suppository, 378 Tramadol HCl 100 mg/ml Drops , 377 Tramadol HCl 50 mg Capsule, 376 Tranex amic Acid 100 mg/ml Injection, 60 Tranexamic Acid 250 mg Capsule, 59 Triamcinolone Acetonide 10 mg/ml Injection, 211 Triamcinolone Acetonide 40 mg/ml Injection, 211 Triamcinolone Acetonide, Neomycin, Gramicidin & Nystatin Ear Drops , 501 Tribenoside & Lignocaine Cream , 112 Tribenoside & Lignocaine Suppository, 113 Tribenoside 400 mg Capsule, 114 Trifluoperazine HCl 5 mg Tablet, 403 Trimethoprim 100 mg Tablet, 241 Trioxsalen 5 mg Tablet, 150 Triprolidine HCl 1.25 mg & Pseudoephedrine HCl 30 mg per 5 ml Syrup, 450 Triprolidine HCl 2.5 mg & Pseudoephedrine HCl 60 mg Tablet, 451 Triprolidine HCl, Pseudoephedrine HCl & Dextromethorphan Linctus, 449 Triptorelin 3.75 mg. Injection, 323 Tropicamide 0.5% Eye Drops, 493 Tropicamide 1% Eye Drops, 493

540

Trypsin & Chymotryp 5000units/vial sin Injection, 357 Tuberculine PPD Injection, 512 Turpentine & Oleic Acid Liniment, 348 Typhoid Vaccine Injection, 290 Urokinase 6000 iu Injection, 59 Ursodeoxycholic Acid 250 mg Capsule, 19 Valsartan 80 mg Tablet, 127 Vancomycin HCl 500 mg Injection, 256 Varicella Virus Vaccine Live 1350 PFU/0.5 ml Injection, 293 Varicella Virus Vaccine Live Attenuated Injection, 293 Vasopressin 20 units/ml Injection, 203 Vecuronium Br 10 mg/10 ml Injection, 351 Vecuronium Br 4 mg/ml Injection, 351 Venlafaxine Hydrochloride 150 mg Extended Release Tablet, 428 Venlafaxine Hydrochloride 75 mg Extended Release Tablet, 427 Verapamil HCl 40 mg Tablet, 123 Verapamil HCl 5 mg/2 ml Injection, 122 Vinblastine Sulphate 10 mg Injection, 306 Vincristine Sulphate 1 mg Injection, 307 Vinorelbine 10 mg Injection, 308

Vinorelbine 50 mg Injection, 308 Vitamin A & D (Cod Liver Oil), 39 Vitamin A & D Concentrate 25,000units/0.6ml Liquid, 39 Vitamin A 100,000 IU Capsule, 38 Vitamin A 200,000 IU Capsule, 38 Vitamin A 50,000 IU Capsule, 37 Vitamin B Complex 10 ml Injection, 45 Vitamin B Complex Tablet, 45 Vitamin B1, B6, B12 Injection, 44 Vitamin B1, B6, B12 Tablet, 44 Vitamin C 10% Eye-Drops, 497 Vitamin E 50 mg Tablet, 48 Vitamin E, B12, B6, Nicotinamide Tablet, 44 Water for Injection, 474, 513 Zalcitabine 0.75 mg Tablet, 278 Zidovudine 1% Injection, 275 Zidovudine 300 mg Tablet, 276, 281 Zidovudine 300 mg Tablet & Lamivudine 150 mg Tablet, 281 Zinc Oxide Cream, 140 Zinc Oxide Ointment, 140 Zuclopenthixol 20 mg/ml Drops, 406 Zuclopenthixol Acetate 100 mg/2 ml Injection, 406 Zuclopenthixol Decanoate 200 mg/ml Injection, 407

541

Index by Trade Name

3TC, 280, 281 5-FU, 304, 305 Abdec, 36 Achromycin, 217, 218 Aciclovir, 269 Act-Hib, 288 Actifed, 449, 450, 451 Actifed Comp, 449 Activelle, 190 Acyclovir, 155, 269, 270, 271, 337, 338, 482 Adalat, 120, 121 Addamel Solution, 88 Adenocor, 101 Adriamycin, 312, 313 Afrin, Iliadin, 446 Aggrastat, 58 Albothyl, 173 Aldactone, 109 Aldomet, 102 Alkeran, 296 Alprim, 241 Alutab, 2 Amikin, 252 Amoxil, 221 Amphyl, 515 Anafranil, 423 Anapolon, 51 Ancolan, 474 Ancotil, 264 Androcur, 196 Anexate, 507 Angiografin, 516 Angised, 98 Anusol, 111 Aprovel, 127 Aramine, 96 Arava, 338 Arcoxia, 347 Aredia, 356 Aricept, 430, 431 Arimidex , 325 Artane, 393 Aspirin, 46, 57, 59, 109, 124, 133, 342, 378, 485, 489 Aspirin Soluble, 378 Atarax , 418 Atgam, 334 Ativan, 415 Atrovent, 460, 461 ATT, 289 Augmentin, 229 Aurorix, 426 Avandia, 35 Avaxim, 291 B.S.S., 78 Babcon, 11 Bactrim, 242, 243 Bactroban, 154 BAL, 505 Baritop, Barytgen, 521 Beconase, 447 Becotide, 457 Benadryl, 471 Benzoin Comp., 462 Betaloc, 116 Betnesol, 483, 486, 502, 503 Betnesol-N, 486, 503 Betnovate, 157, 158, 159, 160 Betnovate-N, 159, 160 Betoptic, 491 B-Hepavac , 290 Biliscopin, 519 Biloptin, 520 BIPP, 449 Bisolvon, 469, 470 Bleocin, 315 Bonefos, 355 Bonjela, 379 Botox, Dysport, 353 Brevibloc , 117 Bricanyl, 453, 454, 465 Bromsulphalein, 512 Brufen, 343 Burinex , 108 Buscopan, 14, 15 Ca Disod. Versenate, 504 Calcijex , 42 Calmurid, 141 Campto, 321 Canesten, 134, 172 Capoten, 124 Cardio-Conray Inj, 517 Cardiprin, 57 Cardura, 200, 201 Carminative 3 , Casodex , 325 Catapres, 102 Ceclor, Distaclor, 233, 234 Cefobid, 238, 239 Celebrex , 346 Celestone, 207, 208, 484 Cellcept, 337 Ceporex , 230, 231 Cerubidin, 313 Cerumol, 501

542

Cervagem , 177 Cetavlon, 165 Chibroxin, 482 Chloromycetin, 219, 477, 499 Chlotride, 105 Chymar, 357 Cidex , 515 Ciloxan, 483 Ciprobay , 253, 254 Citanest, 365 Claforan, 234 Clarinase, 450 Clarityne, 475, 476 Clexane, 54 Clomid, 196 Clopixol, 406, 407 Clopixol - Acuphase, 406 Clopixol Depot, 407 Clozaril, 407, 408 Co-Diovan, 129 Cogentin, 394 Collomack, 171 Colonic Lavage, 22 Combantrin, 441, 442 Combivent, 455 Combivir, 281 Comtan, 399 Concor, 117 Conray 420, 523 Controloc , 9 Cordarone, 93, 94 Cortef, 212 Cosmegen, 311 Coumadin, 52 Coversyl, 125 Cozaar, 126 Crixivan, 273 Cuprimine, 348 Cyclogyl, 492 Cyclomydril, 494 Cymevene, 272 Cytosar, 302, 303, 304 Dacrolux , 498 Daflon, 113 Daivonex , 149 Daktarin, 134, 135, 260 Daonil, 33 Decadron, 208 Deca-Durabolin, 51 Decapeptyl, 323 De-Nol, 11 Dermovate, 158 Desferal, 508 Detrusitol, 199 DF 118, 373 Diabenese, 33

Diamicron, 34 Diamox , 488, 489 Diane 35, 197 Diavonex , 149 Dibenyline, 110 Difflam, 1 Diflucan, 261, 262 Dilantin, 382, 383 Dilatrend, 119 Dimetriose, 198 Diovan, 127 Diprivan, 361 Ditropan, 199 Diulo, 106 Dobutrex, 95 Dogmatil, 410, 411 Dormicum , 421, 422 Double antigen, 290 Drapolene, 164 Droperidol, 359, 360 Dulcolax , 21, 22 Duphalac, 23 Duphaston, 189 Durogesic, 375 Duspatalin, 12 EES, 245 Efexor XR , 427, 428 Elantan, 100 Elomet, 160 Emla, 367, 368 Endoxan, 294, 295 Enzyplex , 30 Epilim, 386, 387 Eprex , 67 Ergamisol, 442 Eryped, 245 Erythrocin, 244, 245 Esmeron, 352 Essentiale, 20 Eumovate, 156 Eurax , 442 Eusol-T, 161 Evista, 198 Exelon, 431, 432 Exosurf, 476 Expect Stimulant, 469 Fansidar, 439 Fasigyn 259 , Feiba, 62 Feldene, 342 Femara, 326 Fentanyl, 361, 375 Flagyl, 257, 258 Flamazine, 154 Fleet enema, 23 Fleet Phospho-soda, 23

543

Fleet solution, 24 Flixotide, 460 Florinef, 207 Fluanxol, 405 Fludara, 301 Fluorescite, 496 Fluorets, 496 Fluothane, 358 Forane, 358 Fortum, 235, 236 Fortzaar, 128 Fosamax , 356 Fraxiparine, 54 Fucicort, 152 Fucidin, 152, 256, 257 Fucithalmic, 479 Fugerel, 324 Fulcin, 138, 139 Fundamin-E, 44 Fungizone, 260 Furadantin, 259 Gamma-16, 284 Garamycin, 153, 250, 251, 478, 479 Garasone, 485, 486 Gardenal, 382 Gastro-Conray , 522 Gastroluft , Baritop, 511 Gelafusine, 69 Gemzar, 305, 306 Glucagon, 215 Glucobay , 35 Glucophage, 33 Glypressin, 205 Glyvenol, 114 Gonal F, 195 Gonioscopic Prism, 497 Gyno-Trosyd 172, 173 , Haemacel, 70 Haes-Steril, 69 Hemabate, 177 Hepsal, 55 Herbesser, 123 Herpidu, 481 Hetrazan, 441 Hibiscrub, 162 Hibisol, 162 Hibitane, 77, 162, 451 Hivid, 278 Holoxan, 296 Hydergine, 398 Hydrea, 320 Hyperhep, 286 Hyper-Tet, 285 Hytrin, 201 Hyzaar, 128 Imdur, 100

Imferon, 65 Imigran, 380, 381 Immucyst, 331 Imodium, 27 Imogam Rabies , 286 Imorab, 292 Imuran, 339 Inderal, 114, 115 Indocid, 340, 349 Intal, 462 Intralipid, 70, 71 Intron-A, 327, 328 Intropin, 95 Iopamiro, 518 Ipecac, 469 Isoket, 99 Isoptin, 122, 123 Isordil, 99 Isteropac, 517 Isuprel, 94 Jetepar, 20, 21 Jumex , 399 Kaletra, 274 Kalimate, 509 Kemadrin, 394 Kenacomb, 501 Kenacort, 211 Kenacort-A, 211 Kenalog, 1 Keppra, 393 Ketalar, 360 Ketotop, 349 Klacid, 246, 247 Koate, 62 Konakion, 60, 61 Konyne, 62 KY Jelly, 516 Kytril, 18, 19 Ladogal, 197 Lamictal, 388, 389 Lamictal Dispersible, 388 Lamisil, 140 Lamprene, 268 Lanoxin, 90, 91 Lanvis, 301 Largactil, 400 Lariam, 439 Laroxyl, 424 Lasix, 106, 107 Leucomax , 327 Leucovorin Calcium , 510, 511 Leukeran, 296 Leunase, 319 Levophed, 95 Lexinor, 255 Lexotan, 415, 416

544

Lincocin, 248, 249 Lindane, 443, 444 Liniment Alba, 348 Lioresal, 354 Lipitor, 131 Livial, 189 Locabiotal, 452 Loceryl, 138 Lomotil, 27 Loniten, 104 Lopid, 131 Losec , 7, 8 Lucrin Depot, 323 Luminal, 381 Luvox , 426 Lysol, 514 Maalox Plus, 513 Mabthera, 319 Madopar, 395, 396, 397 Madopar Dispersible, 397 Magnevist, 521 Marcaine, 361, 362, 363, 366 Marcaine Epidural, 363 Marcaine Spinal Heavy, 362 Marcaine-Adrenaline, 366 Marvelon, 183 Maxidex , 483 Maxipime, 237 Maxitrol, 485, 502 Maxolon, 16 MB Combi, 268 Meladinine, 148, 150 Merislon, 435, 436 Meronem , 239 Mestinon, 434 Methylcobal, 357 Metrina, 174 Metrogyl, 257 Mevacor, 130 Miacalcic, 215, 216 Micardis, 127 Microlax , 25 Minipress, 103 Minirin, 203, 204, 205 Minocin, 218 Miostat, 488 Mirena, 179 Mist Carminative Paed, 3 Mist Sod Citrate, 77 Mitomycin-C, 316, 482 M-M-R, 292 Mobic, 343 Modecate, 400 Moduretic, 109 Mogadon, 420 Motilium, 17

MST Continus , 371, 372 Multiload MLCu, 178 Myambutol, 267 Mycostatin, 25, 26, 133, 171 Mydfrin, 493 Mydriacyl, 493 Myleran, 297 Myonal, 354 Mysoline, 382 Naprosyn, 344 Narcan, 506 Naropin, 365, 366 Nasonex , 448 Natopherol, 48 Natulan, 318 Navelbine, 308 Navidoxine, 475 Neo-mercazole, 213 Neosporin, 480 Neotigason, 151 Nepresol, 103 Netromycin, 252 Neupogen, 326 Neurobion, 44 Neurontin, 392 Niacin, 46, 132 Nimotop, 121, 122 Nipride, 104 Nitro-bid, 98 Nitroderm TTS , Nitrodisc, 97 Nizoral, 135, 260 Nolvadex , 324 Nootropil, 429, 430 Norcuron, 351 Norflex , 354 Noriday , 183 Noristerat, 184 Normison, 420 Norvasc, 119 Norvir, 273, 274 Novantrone, 315 Novesin, 495 Novonorm, 35 Novoseven, 63 Nubain, 376 Nuelin, 466, 467 Nuelin SR , 467 Okavax , 293, 294 Omniscan, 521, 522 Oncovin, 307 One-Alpha, 40, 41 Opticrom, 495 Orbenin, 226, 227 Orimetene, 325 Oroxine, 213 Orthoclone OKT3, 334

545

Orudis, 345, 348 Oruvail, 345 Otosporin, 500 Oxis, 454 Panadol, 379 Panoxyl, 169 Papase, 357 Paraplatin, 317 Parentrovite, 37 Parlodel, 181, 182 Parvolex , 507 Pavulon, 351 Ped-el, 88 Peflacine, 255 Pegasys, 330 Peg-Intron, 329 Penadur L.A. , 224 Penbritin, 220 Penglobe, 221 Penicillin V, 223, 224 Pentamidine, 440 Pentothal, 419 Pergonal, 194 Persantin, 58 Pharmorubicin, Adriamycin, 314 Phenergan, 474 Phisohex , 163 Pipracil, 221, 222 Piriton, 473 Pitocin, 206 Pitressin, 203 Plaquenil, 437 Plasmanate, 68 Platinul, 316 Plavix, 56 Plendil, 120 Plentiva 5, 192 Plentiva Cycle 5, 191 Pneumo 23, 289 Polaramine, 472 Polioral, 292 Polytar, 147 Ponstan, 345, 346 Pravachol, 130 Precedex , 422 Prednisone, 210, 468, 469 Premarin, 185, 186, 187 Prempak , 192 Prevacid, 10 Probanthine, 12 Procto-glyvenol, 112, 113 Prograf, 335, 336 Progyluton, 190 Progynova, 185 Proluton-Depot, 188 Proscar, 202

Prostigmine, 433, 434 Prostin E2, 176 Prostin F2, 175 Prostin VR, 100 Prothiaden, 424, 425 Protopam, 504 Provera/Farlutal, 184, 188, 321, 322 Prozac , 425 Pulmicort, 458, 459 Puregon, 195 Puri-Nethol, 301 Questran light, 132 Rapifen, 359 Ravin, 25 Rebetol, 272 Rebif, 329 Redoxon, 46 Remeron, 427 Renitec, 125 Resonium -A, 509 Retin-A, 168, 169 Retrovir, 275, 276 Rhinocort, 448 Rhogam , 285 Rifadin, 265, 266 Rifocin, 252 Rigevidon, 193 Risperdal, 411, 412 Ritalin, 428, 429 Ritalin SR , 429 Rivotril, 384 Roaccutane, 170 Rocaltrol, 40, 41 Rocephin, 236, 237 Roferon-A, 328 RV Paque, 142 Salazopyrin, 28 Salofalk, 29, 30 Sandimmum , 332, 333 Sandimmum Neoral, 332 Sandimmun Neoral, 331 Sandomigran, 381 Sandostatin, 206 Scoline, 350 Selsun, 170 Septopal, 250 Serenace, 403, 404, 405 Seretide, 456 Serevent, 454 Seroquel, 409, 410 Sevorane, 359 Sibelium, 436 Simulect, 338 Sinemet, 395 Singulair, 468, 469 Skinoren, 169

546

Slow -K, 50 Sofradex , 503 Sofra-tulle, 167 Solcoseryl, 143, 144, 498 Solu-Cortef, 212 Solu-Medrol, 209 Sotacor, 116 Spersallerg, 494 Spiriva 462 , Sporanox , 263 Statex, 370, 372, 373 Stelazine, 403 Stemetil, 401, 402 Stesolid, 413 Stilnox , 422 Stocrin, 282 Streptase, 58 Stugeron, 436 Sulferazon, 238 Supracream, 140 Survanta, 476 Symbicort, 457 Symmetrel, 397 Synacthen, 202 Synagis, 286 Syntometrine, 175 Tagamet, 4 Talsutin, 172 Tarivid, 253, 498 Taxol / Anzatax , 310 Taxotere, 311 Tazocin 4.5 g, 230 Teepol, 171 Tegretol, 385, 386 Tegretol CR, 386 Tenormin, 117 Tensilon, 433 Terramycin, 480 Testoviron-Depot, 185 Tetramune/ TETRAct-Hib, 288 Ticlid, 56 Tienam, 240 Timoptol, Timoptol XE, 490 Tofranil, 423 Topamax , 389, 390, 391 Toradol, 342 Tracrium, 352 Tramal, 376, 377, 378 Trambocor, 92 Trandate, 118 Transamin, 59, 60 Transamin, Cyklokapron, 60 Trasylol, 60 Trental, 110 Trexan, 435 Triple antigen, 289

Trisoralen, 150 Tritace, 126 Trivastal Retard, 398 Trombovar, 113 Trosyd, 135 Trusopt, 490 Tuberculine, 512 Ubretid, 434, 435 Unasyn 227, 228 , Unasyn Susp. , 227 Ural, 79 Urispas, 199 Urokinase, 59 Uromitexan, 510 Urovison, 516 Ursofalk, 19 Valium, 413, 414 Vamin, 70, 73, 74 Vamin 14,Vamin 18, 74 Vamin Glucose, 74 Vancocin, 256 Varivax , 293 Vaseline, 141, 147 Vasoxine, 96 Vastarel, 101 Velbe, 306 Ventolin, 452, 453, 463, 464, 465 Vepesid, 309 Vesanoid, 320 Vibramycin, 216, 217 Videx , 277, 278 Vitrimix, 73, 74 Voltaren, 340, 341, 349 Whitehead Varnish, 449 Whitfields, 137 Xalatan, 491 Xanax , 416, 417, 418 Xatral XL, 201 Xeloda, 306 Xylocaine, 363, 364, 365, 367, 368 Xylocaine Heavy, 368 Xylocaine with Adrenaline, 368 Xylocaine with Chlorhexidine, 367 Xylocard, 92 Xyloproct, 112 Yutopar, 180 Zantac, 5, 6, 7 Zarontin, 384 Zavedos, 314 Zeffix , 280 Zelmac, 13 Zentel, 440, 441 Zerit, 279, 280 Zinacef, 233 Zinnat, 232 Zithromax , 247, 248

547

Zocor, 129 Zofran, 17, 18 Zoladex , 323 Zoloft, 426 Zovirax , 155, 270, 271, 482 Zyloric, 355 Zyprexa 408, 409 , Zyrtec , 475

548

Forms

549

A/0400

PROFORMA A PROPOSAL TO DELETE ANY DRUG/ DOSAGE FORMS/ STRENGTH IN THE MINISTRY OF HEALTH DRUGLIST 1. I propose deletion of the following: 1.1. 1.2. Drug (Generic Name): .. . Code No. (as in current MOH Drug List): ...........

(a) All dosage forms(s)/ strength(s) (b) Specific Dosage form (c) Specific strength (please specify) 2. Rationale for deletion are: 3. Reference Papers/Documents (please list, if any)
(A copy of each paper/document quoted may be attached, if needed) 550

4.

Other remarks (if any):

Date: Proposed by:

(Clinical Specialist/Consultant/Pharmacist)@

Comments by Head of Dept./Health Office/Hosp Director:

. . . .
Date: . .
Head of Department/Chairman of Hosp drug Committee @

Chairman, Ministry of Health Drug List Review Panel (Attn: Director of Pharmaceutical Services) This is to confirm that after studying the above proposal, the State/HKL# Drug Committee has agreed to support the proposal. Date:. .
Chairman of State/HKL Drug Committee@

551

NOTE: 1. The completed form (original) along with 5 photocopies of the proforma are to be forwarded to:Chairman Ministry of Health Drug List Review Panel. (Attn: Director of Pharmaceutical Services) Ministry of Health Malaysia Locked Bag No. 924 Jalan Sultan Post Office 46790 Petaling Jaya. Only 2 sets of Reference Papers/Documents if any is to be enclosed. 2. 3. 4. Use additional sheets of paper if the space provided above is inadequate.
#

Tick where applicable

The name and designation of the signatory should be stamped.

552

B/0400

PROFORMA B PROPOSAL TO ADD/ ALTER FORMULATION/ DOSAGE FORM/ CATEGORY/ DOSAGE/ INDICATIONS IN THE MINISTRY OF HEALTH DRUGLIST

1.

Proposal for the following addition/ alteration: 1.1 Drug (Generic Name):

[Please specify dosage forms & strength(s)].

1.2 Proprietary Names:

.

1.3 Manufacturer: ..
.

1.4 Distributor/Registration holder: ..

1.5 WHO ATC: ..

1.6 DCA registration No: . . 1.7

Addition/Alteration* of : Dosage form and strength Dosage Formulation Indication (please attach approval from DCA) Category of prescriber
553

1.7.1 1.7.2 1.7.3

Add or Change from To .. DCA approved Indications & treatment details (dosage, frequency,
duration etc. please attach approved Product Information)

2.

Financial Implications of addition new formulation/ dosage form/ change category/ add indications# Cost per dosage unit = RM Daily cost = RM Treatment Cost per patient = RM Estimated number of patients on the drug annually in hosp = Estimated Annual Cost in hospital RM (item 2.3 x 2.4) = Rationale for the proposal

[Please give in form of an executive summary and this should not exceed more than one page. Please also do a comparative summary]

554

Comparative summary why the proposed drug is preferred or superior to drugs already in MOH Formulary for similar indications

1. 2. 3. 4. 5. 6.

Clinical Performance/ Efficacy CostEffectiveness Tolerability and safety Drugs/Food interaction Convenience/ compliance Others

4.

Existing drug(s) with same indications in MOH Drug Formulary 4.1 4.2 4.3 4.4

555

5. List of drug(s) to be DELETED from the MOH Drug Formulary with the introduction of the proposed formulation/strength/dosage form.
[Not applicable for change of category]

Drugs to be deleted
[Strength & dosage form]

Annual usage in the hospital (RM)

5.1 .... 5.2 .... 5.3 Total Savings: RM...

Date: . Proposed by: .

(Clinical Specialist/Consultant/Pharmacist & chop)

6. Comments by Head of Department:

. . .
Date:

Head of Department & chop

556

7. Comments by Director of hospital/Health Office . . .

Date:

Director of Hospital/Health Office & chop

8. Chairman, Ministry of Health Drug List Review Panel (Attn: Director of Pharmaceutical Services) This is to confirm that after studying the above proposal, the State/HKL# Drug Committee has agreed to support the proposal. The estimated annual purchase value for this drug in the state/HKL is:

. . .
Date:

.
Chairman of State /HKL# Drug Committee & chop

557

NOTE:
1. The completed form (original) along with 5 photocopies of the proforma are to be forwarded to:Chairman Ministry of Health Drug List Review Panel. (Attn: Director of Pharmaceutical Services) Ministry of Health Malaysia Locked Bag No. 924 Jalan Sultan Post Office 46790 Petaling Jaya. Only 2 sets of Reference Papers/Documents if any is to be enclosed 2. Use additional sheets of paper if the space provided above is inadequate.
#

3. 4. 5.

Cancel where applicable

* Tick where applicable. The secretariat will not be able to process incomplete forms

558

D/0400

PROFORMA D PROPOSAL TO INTRODUCE A NEW DRUG INTO THE MINISTRY OF HEALTH DRUG LIST/FORMULARY 1. DETAILS OF DRUG REQUIRED: 1.1 Approved Generic Name: ...
[Please specify dosage form(s) & strength(s)]

1.2 Trade names: ... 1.3 Manufacturer: ... 1.4 Distributor/Registration holder: ... 1.5 WHO Anatomical Therapeutic Classification: ... 1.6 DCA Registration No. & Date Registered: ... 1.7 DCA approved indications & treatment details such as dose, frequency, duration, details of monitoring required etc. (Please attach approved Product
Information)

... ... ... ...

559

2.

FINANCIAL IMPLICATIONS OF INTRODUCTION OF THIS DRUG: 2.1 Cost per dosage unit: 2.2 Daily Cost: 2.3 Treatment Cost per patient: 2.4 Estimated number of patients annually on the treatment in hosp/Institution: 2.5 Estimated Annual cost in your hospital/Institution (item 2.3 x 2.4):

3.

RATIONALE FOR LISTING

[Please give in form of an executive summary and this should not exceed more than one page. Please submit also informations required in appendix A] :

... ... ... ... ... ...

560

4.

EXISTING DRUG(S) IN MOH DRUG FORMULARY FOR SAME INDICATIONS: 4.1 . 4.2 . 4.3 . 4.4 .

5.

REASONS WHY PROPOSED DRUG NEED TO BE INCLUDED IN THE MOH FORMULARY IF THERE ARE ALREADY ALTERNATIVE DRUGS FOR THE SAME INDICATIONS: Comparative summary why the proposed drug is preferred or superior to drugs already in MOH Formulary 1. 2. Clinical Performance/ Efficacy Cost-Effectiveness

3. 4. 5. 6.

Tolerability and safety Drugs/Food interaction Convenience/ compliance Others

561

6.

List of drug(s) to be DELETED from the MOH Drug Formulary to enable savings for purchase of this new introduction: Drugs to be deleted
[Strength & dosage form]

Annual savings in the hospital with this deletion (RM)

6.1 .......... 6.2 .......... 6.3 Total SavingsRM.......... 7. Date: Request is Proposed by: ..
(Clinical Specialist/Consultant/Pharmacist & chop)

8. Comments by Head of Dept: ... ... Date: ....

Head of Department & chop

9.

Comments by Director of hospital/Health Office: .. .. .. .. .....

Director of Hospital/Health Office & chop

Date:

562

10.

Chairman, Ministry of Health Drug List Review Panel (Attn: Director of Pharmaceutical Services)

This is to confirm that after studying the above proposal, the State/HKL# Drug Committee has agreed to support the proposal. The estimated annual purchase value for this drug for the state/HKL is: ... ... Date: ....
Chairman of State/HKL Drug Committee & chop

563

NOTE:
1. The completed form (original) along with 5 photocopies of the proforma are to be forwarded to:Chairman Ministry of Health Drug List Review Panel. (Attn: Director of Pharmaceutical Services) Ministry of Health Malaysia Locked Bag No. 924 Jalan Sultan Post Office 46790 Petaling Jaya. Only 2 sets of Reference Papers/Documents if any is to be enclosed. 2. 3. 4. Use additional sheets of paper if the space provided above is inadequate.
#

Cancel where applicable.

The secretariat will not be able to process incomplete forms.

* Efficacy and level of evidence supporting the proposed therapy Grade A Supported by at least one, and preferably more large randomised trials with clear-cut results and low risk of error, (statistically significant results P<0.05), and the results of such studies published in peer-reviewed journals. It would be expected that the results would demonstrate substantial clinical benefit Supported by at least one small randomised trial with uncertain results and moderate to high risk of error (statistically not significant P>0.05), ie randomised trials with positive trends but of low power due to small sample size to reach statistically significant results. It would be expected that the results would demonstrate substantial clinical benefit. Supported by only non-randomised concurrent cohort comparisons between contemporaneous patients, or non-randomised historical cohort comparisons between current patients and former patients, or case studies with no controls. It would be expected that the results would demonstrate substantial clinical benefit.

Grade B

Grade C

564

1. Efficacy and Level of Evidence Please give not more than 5 Pivotal studies/trials supporting the proposed therapy and also synopsis and grade the studies Reference 1. Title: Author(s): .. Journal: . Date/Year:
Randomised trial Yes No Non-Randomised trial Yes No Case study with no controls Yes No Absolute Risk Reduction c.f. control __________ Statistically significant P<0.05 Yes No 95% Confidence Interval Yes No Number Needed to Treat __________ Evidence of clinical improvement __________ _____% Active vs _____% Control Grading A B C
* See notes for details

Reference 2. Title: Author(s): .. Journal: . Date/Year:

Randomised trial Yes No Non-Randomised trial Yes No Case study with no controls Yes No Absolute Risk Reduction c.f. control __________ Statistically significant P<0.05 Yes No 95% Confidence Interval Yes No Number Needed to Treat __________ Evidence of clinical improvement __________ _____% Active vs _____% Control Grading A B C
* See notes for details

565

Reference 3. Title: Author(s): .. Journal: . Date/Year:

Randomised trial Yes No Non-Randomised trial Yes No Case study with no controls Yes No Absolute Risk Reduction c.f. control __________ Statistically significant P<0.05 Yes No 95% Confidence Interval Yes No Number Needed to Treat __________ Evidence of clinical improvement __________ _____% Active vs _____% Control Grading A B C
* See notes for details

Reference 4. Title: Author(s): .. Journal: . Date/Year:

Randomised trial Yes No Non-Randomised trial Yes No Case study with no controls Yes No Absolute Risk Reduction c.f. control __________ Statistically significant P<0.05 Yes No 95% Confidence Interval Yes No Number Needed to Treat __________ Evidence of clinical improvement __________ _____% Active vs _____% Control Grading A B C
* See notes for details

566

Reference 5. Title: Author(s): .. Journal: . Date/Year:

Randomised trial Yes No Non-Randomised trial Yes No Case study with no controls Yes No Absolute Risk Reduction c.f. control __________ Statistically significant P<0.05 Yes No 95% Confidence Interval Yes No Number Needed to Treat __________ Evidence of clinical improvement __________ _____% Active vs _____% Control Grading A B C
* See notes for details

2. State briefly the results of clinical trial(s) conducted in Malaysia, quoting the approval given by the Ministry of Health to use samples. If no official trial(s) have been done state personal experiences and/or submit documentary proof. ... ... ... ...

567

KPK02

MEMOHON KEBENARAN MEMPEROLEHI DAN MENGGUNAKAN UBAT-UBAT BERDAFTAR DI DALAM / DI LUAR SENARAI UBAT-UBATAN KKM YANG MEMERLUKAN KELULUSAN KETUA PENGARAH KESIHATAN
Hospital Yang Memohon: ... . a) Nama Pesakit: b) No. Pendaftaran/No. Kad Pengenalan: ....................................................... c) Wad: ...................................... d) Tujuan Rawatan/Diagnosis: ..................................... .................................................................................. .................................................................................. .................................................................................. e) Penggunaan ubat adalah seperti indikasi yang diluluskan oleh PBKD Ya Tidak f) Nama, tandatangan & Cop Pakar yang memohon: .................................................................................. .................................................................................. ..................................................................................

g) Ulasan Ketua Jabatan: ............................................ .................................................................................. ..................................................................................

Nama, Tandatangan & Cop

568

h) Ketua Pegawai Farmasi: 8.1 Ulasan: ............................................................... ............................................................................ ............................................................................ 8.2 Maklumat Kegunaan: ......................................... ............................................................................ Jumlah kegunaan ubat ini tahun lepas: RM .................. Jumlah kegunaan ubat ini tahun semasa termasuk permohonan ini: RM ...............

1. Nama ubat yang dipohon (Nama Generik): .................................................................................. 2. Pendaftaran Dengan Pihak Berkuasa Kawalan Dadah: No. Pendaftaran: .................................... Syarikat /Agen: ....................................... 3. Dosis/ Regime Rawatan: .. 4. Jangkamasa Rawatan: . 5. Kuantiti Ubat yang dipohon: . 6. Kos Anggaran Ubat Yang dipohon: 7. i) Ubat sedia ada bagi indikasi yang sama: ii) Kenapa ubat di atas tidak boleh digunakan:

569

8. Bahan Rujukan/ Penyelidikan mengenai ubat di atas yang berkaitan dengan rawatan: .................................................................................. .................................................................................. .................................................................................. .................................................................................. 9. Saya mengesahkan peruntukan adalah mencukupi untuk pembelian ini:
Nama, tandatangan & cop Pengarah Hospital

Ulasan Ketua Pengarah Kesihatan LULUS / TIDAK LULUS . Tandatangan

Nota:

Permohonan tidak dapat diproses jika: i. tidak lengkap, termasuk seksyen 7(i) dan (ii) ii. indikasi yang dipohon bukan satu indikasi yang diluluskan oleh Pihak Berkuasa Kawalan Dadah iii. untuk permohonan ubat tidak berdaftar, sila gunakan borang yang berkaitan

570

PENGHARGAAN Bahagian Perkhidmatan Farmasi, KKM merakamkan ribuan terima kasih kepada semua yang terlibat secara langsung atau tidak dalam penyediaan formulari ini. Formulari ini telah disemak. Bagaimanapun jika terdapat kesalahan, sila maklumkan ke Bahagian ini atau hubungi talian: 03-79682219 / 03-79682263. ACKNOWLEDGEMENT Pharmaceutical Services Division, MOH is grateful to all those who are involved either directly or indirectly in preparation of this formulary. This formulary had been edited. However if any further error is found, kindly inform this Division or contact: 03-79682219 / 0379682263.