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MEDICINE MONOGRAPH KEY

The medicine monograph key summarizes and describes the types of information
contained in this formulary that the physicians and dentists can utilize in prescribing medicines for
their patients. Also, this key shows the format of how the prescribing information is arranged.

BRAND NAME

GENERIC NAME

DOSAGE FORM/STRENGTH

INDICATION/S: This section only includes Philippine FDA-approved indications.

CONTRAINDICATION/S: This section details diseases states where and patient populations for
whom the medicine should not be used.

DOSE: This section lists dosages of the medicines for adult, child and elderly patients, if specified,
as indicated in the official FDA-approved labeling and/or other main references.

DOSE ADJUSTMENT/S: This section gives dosage adjustment recommendations for the elderly
patients or for patients with renal and hepatic impairment.

PRECAUTIONS: This section details (1) harmful conditions related to the use of the medicine
(e.g., exacerbations, increased risk of adverse effects), and (2) disease states or patient
populations where caution is advised. This may also include precautions for breastfeeding
mothers and nursing infants. Black Box Warnings are included.

ADVERSE DRUG REACTIONS: This section denotes side effects and adverse drug reactions
(ADRs) listed in the official FDA-approved labeling. Only Common ADRs are listed in this
Formulary.

DRUG INTERACTION/S: This section includes the effects and implications of the concomitant
administration of different medicines, or their use together with food.

ADMINISTRATION: This section lists recommendations on the proper intake or administration of


the medicines.

PREGNANCY CATEGORY: This section is based on the US FDA Pregnancy Risk Categories.

ATC CODE: This section is based on the WHO ATC/DDD Index 2016. (WHO Collaborating
Centre for Drug Statistics Methodology).

STORAGE

COST
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US FDA PREGNANCY RISK CATEGORIES

The FDA-assigned pregnancy categories as used in the Drug Formulary are as follows:

Category Interpretation

A CONTROLLED STUDIES SHOW NO RISK.

Adequate and well-controlled studies in pregnant women have


failed to demonstrate a risk to the fetus in the first trimester of
pregnancy (and there is no evidence of risk in later trimesters).

B NO EVIDENCE OF RISK IN HUMANS.

Animal reproduction studies have failed to demonstrate a risk to


the fetus and there are no adequate and well-controlled studies
in pregnant women.

C RISK CANNOT BE RULED OUT.

Animal reproduction studies have shown an adverse effect on the


fetus and there are no adequate and well-controlled studies in
humans, but potential benefits may warrant use of the drug in
pregnant women despite potential risks.

D POTENTIAL EVIDENCE OF RISK.

There is positive evidence of human fetal risk based on adverse


reaction data from investigational or marketing experience or
studies in humans, but potential benefits may warrant use of the
drug in pregnant women despite potential risks.

X CONTRAINDICATED IN PREGNANCY.

Studies in animals or humans have demonstrated fetal


abnormalities and/or there is positive evidence of human fetal risks based on
adverse reaction data from investigational or marketing experience, and the
risks involved in the use of the drug in pregnant women clearly outweigh
potential benefits.
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SYMBOLS AND ABBREVIATIONS

ACE - Angiotensin-converting L - Liter


Enzyme LA - Long-Acting
ADR - Adverse drug reaction lin. - Liniment
AIDS - Acquired lot. - Lotion
Immunodeficiency MAOI - Monoamine Oxidase Inhibitor
Syndrome MDI - Metered Dose Inhaler
a.m. - Morning; before noon MDR-TB - Multidrug-resistant Tuberculosis
Amp - Ampule mEq - Milliequivalent
AV - Atrioventricular Mg - Milligram
BCG - Bacille Calmette-Guérin mL - Milliliter
BP - Blood pressure Mmol - Millimole
BSA - Body surface area MR - Modified Release [includes CR,
cap., caps - Capsule(s) ER, SR, LA]
CNS - Central Nervous System nebul. - Spray
comp. - Compound NSAID - Non-steroidal Anti- Inflammatory
cr., crm. - Cream Drugs
CR - Controlled-release p.m. - Afternoon / Evening
CSF - Cerebrospinal fluid RE - Retinol Equivalent
D5NS - Glucose (dextrose) 5% Resp. Soln. - Respiratory Solution
in normal saline (0.9%) Rx - Prescription
D5W - Glucose (dextrose) 5% (SC) - Subcutaneous
solution (SL) - Sublingual; under the tongue
DOTS - Directly observed sig. - Signa / write on label
treatment, short-course Soln. - Solution
DMARD - Disease modifying agents spp. - Species
in rheumatoid disorders SR - Sustained Release
DPI - Dry powder inhaler SSRI - Selective Serotonin Reuptake
EC - Enteric-coated Inhibitor
ECG - Electrocardiogram supp. - Suppository
emuls. - Emulsion susp. - Suspension
EPS - Extrapyramidal syndrome syr. - Syrup
ER - Extended Release tab., tabs. - Tablet(s)
FC - Film-coated TB - Tuberculosis
G - Gram top. - Topical
GFR - Glomerular Filtration Rate XDR-TB - Extensively Drug-resistant
GI - Gastrointestinal Tuberculosis
gtt(s) - Drop(s)
h, hr. - Hour
HAI - Hospital-Acquired
Infections
HIV - Human
Immunodeficiency Virus
HRT - Hormone Replacement
Therapy
(ID) - Intradermal
(IM) - Intramuscular
Inj. - Injection
INR - International Normalized Ratio
IU - International Unit
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(IV) - Intravenous

MEDICINE AND
THERAPEUTIC
INFORMATION
Page |5

Analgesics (non-opioid) & Antipyretics

TEMPRA
OTC
Paracetamol

Dosage Forms/ Strength:


 Tablet: 325 mg
 Forte: 500mg
 Syrup: Each 5ml contains 120mg Paracetamol
 Forte Syrup: Each 5ml contains 250mg Paracetamol
 Oral Drops: Each ml contains 100mg Paracetamol

Indication: Fever, headache, muscular aches & pain, toothache, colds, ear ache, fever due to
tonsillectomy, inoculations & vaccinations.

Contraindications: Hypersensitivity, patients with anemia, cardiac, pulmonary, renal and/or liver diseases

Dosage:

 Tablet: Indicated doses as follows may be given 3 to 4 times daily or as needed but not more than
5 times daily. (Adult 1-2 tab. Childn 6-12 yr ½-1 tab)

 Forte Tablet: Indicated doses as follows may be given 3 to 4 times daily or as needed but not more
than 5 times daily. (Adult 1-2 tab.)

 Syrup: Dosing is based on single doses in the range of 10-15 mg/kg/dose repeated 3 to 4 times a
day. Those indicated as follows may be given every 4 hours as needed but more than 5 times daily.
(Childn 6-12 yr 2-4 tsp, 1-5 yr 1-2 tsp, 3 mth-1 yr ½-1 tsp.)

 Forte Syrup: Dosing is based on single dose in the range of 10-15 mg/kg/dose repeated 3 to 4
times a day or as needed but not more than 5 times daily. (Childn ≥13 yr 2-3 tsp, 6-12 yr 1-2 tsp,
1-5 yr ½-1 tsp.)

 Oral Drops: Dosing is based on single dose in the range of 10 mg/kg/dose repeated 3 to 4 times a
day. In very young infants, those doses given as follows may be given every 4 hours but should not
exceed more than 4 times in 24 hours. (3 mth-1 yr 0.6-1.2 mL, <3 mth 10 mg/kg body wt.)

 Missed Dose: Since acetaminophen (paracetamol) is taken as needed, the patient may not be on a
dosing schedule. Take the missed dose as soon as the patient remembers. Skip the missed dose if
it is almost time for the next scheduled dose. Do not take extra medicine to make up to the missed
dose.

 Overdosage

 S/Sx: may manifest with nonspecific abdominal signs and symptoms such as loss of
appetite, nausea and vomiting, pallor, excessive sweating, right upper abdominal discomfort
or pain and a feeling of fullness, decreased urine output, nausea, vomiting, loss of appetite,
jaundice, decreased blood glucose and bleeding tendencies, acute renal failure may also set
in as well as disturbances of cardiac rhythm.

 Tx: A doctor or a Poison Control Center should be consulted immediately if a patient has
been given more than the recommended dose or if there is any suspicion that this may have
been given or ingested. Prompt medical attention is of prime importance to prevent liver
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toxicity. Delay in seeking medical attention may lead to serious liver failure and other
problems.

Dosage Adjustments: Not stated

Precautions

WARNINGS: If fever persists for more than 3 days (72 hours) or if pain continues for more than 5 days, consult
the physician. As with any drug, if the patient is pregnant or nursing a baby, seek the advice of a health
professional before using this product.

 Hepatic toxicity: adult who takes > 4 in 24 hours; children if given > 5 doses in 24 hours.

 For patients with liver or kidney problems, a doctor must first be consulted before giving this drug.

 Care should also be taken in giving acetaminophen (paracetamol) to those who are malnourished or
in those with eating disorders.

 Consult a Doctor: If fever persists more than 3 days (72 hours) or if pain continues for more than 5
days in children and 10 days in adults, consult the doctor.

Adverse Drug Reactions: Skin rashes, other allergic reactions.

Drug Interactions: alcoholic drinks, anticonvulsant drugs, diflunisal, isoniazid, aspirin, warfarin,
cholestyramine, product containing acetaminophen (paracetamol) and drugs that affect liver enzyme should
be avoided.

Administration: May be taken with or without food.

Storage: Temperatures not exceeding 30°C. Protect from light.

Pregnancy Category: B

ATC Code: N02BE01

Cost:

BIOGESIC
OTC Paracetamol

Dosage Forms/ Strength: 500 mg tablet

Indication: Relief of minor aches & pains (eg, headache, backache, menstrual cramps, muscular aches,
minor arthritis pain, toothache & pain associated w/ common cold & flu).

Contraindications: Hypersensitivity. Anemia, cardiac & pulmonary disease. Hepatic or severe renal
disease.

Dosage: Adults and Children >12 years: 1-2 tabs every 4-6 hrs, or as needed. Do not take >8 tabs in 24
hrs.

 Overdosage:
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 S/Sx: Nausea, vomiting, diaphoresis and general malaise.

 Tx: In case of accidental overdose, contact a physician or poison control center immediately.
Prompt medical attention is critical for adults as well as for children even if signs or
symptoms are not noticed; Plasma paracetamol level drawn and be treated with N-
acetylcysteine.

Dosage Adjustments: Not stated

Precautions:

 Taking more than the recommended dose can cause serious health problems, including liver
damage. Discontinue use and consult a doctor if: Symptoms do not improve, new symptoms occur,
pain or fever persists or gets worse, or redness or swelling is present. Do not exceed recommended
dose. Keep out of reach of children.

 Use in Pregnancy & Lactation: Paracetamol crosses the placenta but the drug has been widely
used as an analgesic in pregnancy and no adverse fetal effects have been recorded. However, as
with any drug, a doctor is to be consulted before using Biogesic if pregnant or breastfeeding.

 Hepatic toxicity: adults and children >12 years, may occur following ingestion of >7.5-10 g over a
period of ≤8 hrs.

Adverse Drug Reactions: Allergic skin reactions, GI disturbances & changes in the number of WBC &
platelets.

Drug Interactions: Anticonvulsants, aspirin, INH, phenothiazines, alcohol.

Administration: May be taken with or without food.

Storage: Temperatures not exceeding 30°C. Protect from light.

Pregnancy Category: B

ATC Code: N02BE01

Cost:
Page |8

Analgesics (opioid)

ALGESIA
Rx
Tramadol + Paracetamol

Dosage Forms/ Strength: Tramadol HCl 37.5 mg, Paracetamol 325 mg tablet

Indication: Short-term (≤5 days) management of moderate to severe pain.

Contraindications: Hypersensitivity, Acute intoxication w/ alcohol, hypnotics, narcotics, centrally-acting


analgesics, opioids or psychotropic drugs, Patients on MAOI therapy, Severe hepatic or renal impairment,
Impaired kidney function (CrCl <10 mL/min), Respiratory impairment, Acute alcoholism, delirium tremens &
convulsive disorders, Suspected or known mechanical GI obstruction, Significant acute respiratory
depression, elevated CO2 levels in the blood & cor pulmonale, Uncontrolled epilepsy, Severe CNS
depression, increased cerebrospinal or intracranial pressure & head injury and Tonsillectomy &/or
adenoidectomy in children <12-18 yr.

Dosage: Adults and children >16 years old: Orally, one to two tablets every four to six hours, as needed for
pain relief, or, as prescribed by a physician. Maximum: Eight (8) tablets per day.

 Overdosage:

a. Tramadol

 S/Sx: respiratory depression, somnolence progressing to stupor or coma, skeletal


muscle flaccidity, cold and clammy skin, constricted pupils, pulmonary edema (in some
cases), bradycardia, hypotension, partial or complete airway obstruction, atypical
snoring, seizures, cardiac arrest, and death.

 Tx: Gastrointestinal decontamination with activated charcoal or by gastric lavage may


also be performed within one to two hours of oral tramadol intoxication to remove any
unabsorbed drug.

b. Paracetamol

 S/Sx: Anorexia, nausea, vomiting, malaise, and diaphoresis; Right upper abdominal pain
or tenderness, liver enlargement which may be characterized by abdominal discomfort of
"feeling full", elevated bilirubin and liver enzyme concentrations, prolongation of
prothrombin time, and occasionally oliguria; Anorexia, nausea, vomiting, and malaise
recur and signs of liver (e.g., jaundice) and possibly kidney failure and cardiomyopathy
may develop; Recovery or progression to fatal complete liver failure.

 Tx: Emergency measures include: Immediate hospitalization; A serum paracetamol


assay to be obtained as soon as possible, but no sooner than four hours following oral
ingestion; Administer the antidote N-acetylcysteine (NAC) as early as possible by
intravenous (IV) or oral route.

Dose Adjustments:

 Elderly patients: In patients over 75 years old, it is recommended that the minimum interval
between doses should not be less than six hours.
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 Renal impairment (creatinine clearance < 30 mL/min): It is recommended that the dosing interval
of tramadol + paracetamol should be prolonged, and the dose should not exceed 75 mg of tramadol
and 650 mg of paracetamol (two tablets) every 12 hours. As tramadol is removed only very slowly
by hemodialysis or by hemofiltration, post-dialysis administration to maintain analgesia is not usually
required.

 Hepatic impairment: In patients with moderate hepatic impairment, prolongation of the dosage
interval should be carefully considered.

Precautions:

 Risk of hepatotoxicity, suicidal ideation, resp & CNS depression.

 Increased intracranial pressure or head trauma.

 May precipitate seizure & serotonin syndrome w/ MAOIs & SSRIs.

 Not to be used in opioid-dependent patients.

 May complicate clinical assessment of patients w/ acute abdominal conditions.

 Hepatic & renal impairment.

 Increased risk of misuse, abuse or diversion & overdosage.

 Avoid abrupt discontinuation. Tramadol: May impair ability to drive or operate machinery.

 Pregnancy & lactation, Children (< 12 years old) and Elderly.

Adverse Drug Reactions: abdominal pain, anorexia, constipation, diarrhea, dizziness, dry mouth,
dyspepsia, fatigue, flatulence, headache, hot flushes, HTN, hypoesthesia, increased sweating, flu-like
symptoms, insomnia, nausea, nervousness, prostatic disorder, pruritus, rash, somnolence, trembling &
vomiting.

Drug Interactions:

 May alter effect of warfarin.

 Tramadol: Additive effects w/ other opioids (eg, fentanyl, pethidine) or illicit drugs causing CNS
depression (eg, γ-hydroxybutyrate, flunitrazepam).

 Decreased analgesic effect & risk of tramadol-associated seizures w/ carbamazepine.

 Decreased plasma conc w/ CYP3A4 inducers eg, rifampicin, St. John's wort.

 Reduced metabolic clearance w/ CYP2D6 inhibitors (eg, amitriptyline, fluoxetine, paroxetine)


&/or CYP3A4 inhibitors (eg, ketoconazole, erythromycin).

 Increased plasma conc w/ quinidine.

 Increased risk of serious adverse events including seizures & serotonin syndrome w/ serotonergic
drugs (MAOIs, SSRIs, SNRIs, triptans, lithium).

 Paracetamol: Increased risk of hepatotoxicity w/ anticonvulsants eg, phenytoin, barbiturates,


carbamazepine.

 Possible increased risk of hepatotoxicity w/ INH & severe hypothermia w/ phenothiazines.


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 Additive effects w/ ethanol.

Administration: May be taken with or without food.

Storage: Temperatures not exceeding 30°C

Pregnancy Category: C

ATC Code: N02AJ13

Cost:

SIVEROL
Rx Tramadol Hydrochloride

Dosage Forms/ Strength: 50mg capsule

Indication: Relief of moderate to severe pain.

Contraindications:

 Hypersensitivity to tramadol, opioids or to any component in the product

 Acute intoxication with alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or
psychotropic drug.

 Patients on monoamine oxidase inhibitor (MAOI) therapy or if patients have taken such medications
within the last 14 days before treatment with tramadol

 Severe hepatic or renal impairment

 Severely impaired kidney function (creatinine clearance < 10 mL/min)

 Severe respiratory impairment (e.g., acute or severe bronchial asthma) in an unmonitored setting or
in the absence of resuscitative equipment

 Suspected or known mechanical gastrointestinal (GI) obstruction, (e.g., bowel obstruction or


strictures); any conditions affecting bowel transit (e.g., ileus of any type); or in patients with
suspected surgical abdomen (e.g., acute appendicitis or pancreatitis)

 Children who are younger than 12 years old and to patients younger than 18 years old who have
tonsillectomy and/or adenoidectomy

 Significant respiratory depression

 Patients suffering from uncontrolled epilepsy, or epilepsy not adequately controlled by treatment

 Tramadol must not be used for narcotic withdrawal treatment.

Dosage: Children ≥ 12 yrs and Adults


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 Moderate pain: Initial Dose: Orally, 50 mg (1 capsule) administered two to three times daily. May
be increased to 100 mg (2 capsules) two to three times daily.

 Moderate to Severe pain: Orally, 50 mg to 100 mg (1 to 2 capsules) as needed, every four to six
hours. The 100 mg dose is usually more effective as the initial dose for more severe pain.
Maximum Dose: 400 mg/day.

 Overdosage

 S/Sx: S/Sx: respiratory depression, somnolence progressing to stupor or coma, skeletal


muscle flaccidity, cold and clammy skin, constricted pupils, pulmonary edema (in some
cases), bradycardia, hypotension, partial or complete airway obstruction, atypical
snoring, seizures, cardiac arrest, and death.

 Tx: Gastrointestinal decontamination with activated charcoal or by gastric lavage may


also be performed within one to two hours of oral tramadol intoxication to remove any
unabsorbed drug.

Dose Adjustments:

 Patients with Renal Impairment/Renal Dialysis

 Impaired renal function results in a decreased rate and extent of excretion of tramadol and M1.
The usual initial adult doses should be employed, but the dosage interval should be adjusted.

 Creatinine clearance <30 mL/min: Dose interval should be increased to 12 hours.

 Patients on hemodialysis can receive their regular dose on the day of dialysis since only seven
percent of an administered dose is removed by hemodialysis.

 Tramadol is removed very slowly by hemodialysis or hemofiltration and therefore post-dialysis


dosing to maintain analgesia is usually unnecessary.

 Patients with Hepatic Impairment

 The elimination of tramadol may be prolonged. Depending on the severity of the impairment and
individual clinical response, the usual dosage should be divided in two or the dosage interval
should be extended to 12 hours.

 Elderly patients

 Changes in renal and/or hepatic function in the elderly may require dose adjustment. Daily
doses of 300 mg are not recommended in patients over 75 years old.

Precautions:

 Addiction, Abuse, and Misuse


The use of tramadol HCl exposes patients and other users to the risks of opioid addiction, abuse,
and misuse, which can lead to overdose and death. The patient's risk should be assessed prior to
prescribing tramadol, and the development of related behaviors and conditions should be monitored
regularly.

 Life-Threatening Respiratory Depression


Serious, life-threatening, or fatal respiratory depression may occur with the use of tramadol. Close
monitoring for respiratory depression should be performed, especially during initiation of tramadol
and following a dose increase.
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Adverse Drug Reactions: Sleep-related breathing disorders (e.g. sleep-related hypoxaemia, central sleep
apnoea), withdrawal symptoms, convulsions, reversible adrenal insufficiency, severe hypotension
(including syncope and orthostatic hypotension), hyponatraemia (including severe cases), CNS depression,
spasm of the sphincter of Oddi. Rarely, drug dependence (prolonged use) and abuse; hypoglycaemia
(including severe cases).

Drug Interactions: Carbamazepine, Cimetidine, alcohol, general anesthetics, anxiolytics, phenothiazines,


sedatives and hypnotics, other centrally acting analgesics, opiate agonists, tranquilizers, muscle relaxants,
other illicit CNS depressant drugs, fluoxetine, paroxetine, amitriptyline, bupropion, rifampicin, St. John's
Wort, phenytoin, erythromycin, ketoconazole, protease inhibitors, Digoxin, SSRIs, TCAs, antipsychotics,
buproprion, mirtazapine, tetrahydrocannabinol, General anesthetic agents, selegiline, phenelzine,
butorphanol, buprenorphine, nalbuphine, pentazocine, Ondansetron, warfarin, Serotonin-Norepinephrine
Reuptake Inhibitors (SNRIs), triptans, linezolid, lithium

Administration: May be taken with or without food.

Storage: Temperatures not exceeding 30°C. Keep the product out of sight and reach of children

Pregnancy Category: C

ATC Code: N02AX02

Cost:
P a g e | 13

Antacids, Antireflux Agents & Antiulcerants

GAVISCON
OTC Sodium alginate, Sodium bicarbonate, Calcium carbonate

Dosage Forms/ Strength:

 Chewable Tablet: Na alginate 250mg; NaHCO₃ 133.5mg; CaCO₃ 80mg

 Oral Suspension (10ml): Na alginate 500 mg, Na bicarbonate 267 mg, Ca carbonate 160 mg

Indication: Symptoms of GERD eg, acid regurgitation, heartburn due to reflux of stomach content.

Contraindications: Hypersensitivity to any of the ingredients of Gaviscon as very rare difficulty in


breathing and skin rashes have occurred.

Dosage:

 Adults and Children >12 years: 2-4 tablets. The tablet must be chewed thoroughly before
swallowing.

 Adults and Children >12 years: Take 10-20 mL (two to four 5 mL spoonfuls). Administered after
meals and at bedtime.

Dosage Adjustments: Not stated

Precautions: Not stated


Adverse Drug Reactions: Not stated
Drug Interactions: Not stated
Administration: Should be taken with food: Take after meals & at bedtime. Chew tab thoroughly before
swallowing.

Storage: Chewable Tablet: Store below 30°C. Oral Suspension: Store at room temperature not exceeding
30°C. Shelf-Life: 2 years.

Pregnancy Category: Not classified

ATC Code: A02A

Cost:

KREMIL-S
OTC Aluminum Hydroxide, Magnesium Hydroxide, Simeticone

Dosage Forms/ Strength: Al hydroxide 178 mg, Mg hydroxide 233 mg, Simeticone 30 mg
P a g e | 14

Indication: Symptomatic relief of hyperacidity associated w/ peptic ulcer, gastritis, esophagitis &
dyspepsia. Antiflatulent to alleviate the symptoms of gassiness including post-op gas pain associated w/
hyperacidity. Adjunct to H2-blockers or proton pump inhibitors for rapid relief of ulcer symptoms.
Contraindications: Hypersensitivity. Kidney disease, intestinal obstruction, appendicitis, fecal impaction,
gastric outlet obstruction, constipation, phosphate depletion, & low serum phosphate, osteomalacia.

Dosage: Recommended Adult Dose: 1 to 2 tablets to be taken one hour after each meal and at bedtime.
Or, as prescribed by a doctor.

 Missed Dose: If the patient misses a dose, just give the next dose and the subsequent doses at the
recommended time or schedule. Do not double the dose unless recommended by a doctor.

Dosage Adjustments: Not stated

Precautions: Patients with advanced kidney disease are at risk of Aluminum and Magnesium
accumulation and toxicity. Do not use these products in such patients. Phenylketonurics: This product
contains Phenylalanine as one of the metabolites of Aspartame. Consult the doctor: Ask a doctor before
use if the patient is: Pregnant or breastfeeding. Taking other medicines; antacids may interact with certain
medicines. Stop use and ask a doctor if the patient needs to take this product for more than 14 days.

Adverse Drug Reactions: Diarrhea or constipation.

Drug Interactions:

 May decrease absorption of tetracycline & Fe; take tetracycline 1 hr before or 2 hr after antacids & 2
hr before or 3 hr after Fe-containing prep.

 May decrease absorption of oral digoxin or indomethacin, INH, quinolones (eg, ciprofloxacin,
ofloxacin), ketoconazole.

 May increase urinary excretion due to changes in urine pH & decrease blood conc of salicylates eg,
aspirin.

 Increase in urine pH may decrease excretion of weakly basic drugs (eg, quinidine, chlorpromazine,
propranolol, diazepam)

 Increase excretion of weakly acidic drugs (eg, phenytoin, pentobarbital, warfarin).

 May increase absorption of dicumarol, diazepam & pseudoephedrine.

 May decrease the rate of chlordiazepoxide absorption.

 May reduce the bioavailability of biphosphonates (eg, alendronate, etidronate, risedronate).

Administration: Should be taken on an empty stomach: Take 1 hr after each meal & at bedtime. Swallow
whole w/ water. May be chewed then swallow w/o water.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: Not classified

ATC Code: A02AF02

Cost:
P a g e | 15

RHEA SODIUM BICARBONATE


OTC Sodium bicarbonate

Dosage Forms/ Strength: 325mg; 650mg tablets

Indication: Relief of symptoms of hyperacidity (eg, belching, heartburn, acid indigestion, gas pains,
gastritis & peptic ulcer). Urine alkalinizer.

Dosage:

 325 mg: Adults: 3 to 6 tablets 4 times a day or as prescribed by thy physician.

 650 mg: Adults: 2 to 4 tablets 3 times a day or as prescribed by the physician.

Dosage Adjustments: Not stated

Precautions: Patients w/ HTN, kidney & heart diseases.

Adverse Drug Reactions: Not stated


Drug Interactions: Not stated

Administration: Should be taken with food

Storage: Store at temperatures not exceeding 30°C. Keep container tightly closed and protected from light.

Pregnancy Category: C

ATC Code: B05CB04

Cost:
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Antiasthmatic & COPD Preparations

BREZU
Rx Procaterol Hydrochloride

Dosage Forms/ Strength: 5mcg/ml (60ml) syrup

Indication: Bronchodilator in the management of reversible airway obstruction as in asthma or in patients


w/ COPD.

Contraindications: Hypersensitivity.

Dosage:

 Adult 10 mL once before bed or bid (morning & before bed).

 Childn ≥6 yr 5 mL once before bed or bid (morning & before bed), <6 yr 0.25 mL/kg bid (morning &
before bed) or tid (morning, early afternoon & before bed).

 Overdosage:

 S/Sx: has not been associated with tachycardia, tachycardiac arrhythmia, hypotension,
nervousness, tremor, hypokalemia and hyperglycemia. In the event, any overdosage-related
abnormalities are observed.

 Tx: discontinued and if required, gastric lavage should be performed; Emergency treatment
and general maintenance therapy; Serious tachycardiac arrhythmia: β-blockers (eg,
propranolol) may be effective, but administration of these drugs to asthma patients should be
performed with care.

Dosage Adjustments: Not stated

Precautions:

 Patients w/ hyperthyroidism, HTN, heart disease, DM.

 Continuous administration in excessive amounts may cause cardiac arrhythmia/arrest.

 Not a substitute for inhaled corticosteroids & other anti-inflammatory agents.

 Patients may develop acute asthma episodes during long-term management of bronchial asthma.

 Pregnancy & lactation. Low birth wt infants & neonates.

 Elderly.

Adverse Drug Reactions: Shock or anaphylactoid reaction; significant decrease in serum K levels.
Palpitations, tachycardia; tremor & headache; nausea, vomiting; skin rash.

Drug Interactions:

 Potential induction of arrhythmias w/ catecholamines (eg, adrenaline & isoproterenol).


P a g e | 17

 Possible decrease in serum K levels & aggravating CV adverse effects w/ xanthine derivatives (eg,
theophylline, aminophylline & diprophylline).
 Risk of excessive decrease in serum K levels w/ corticosteroids (eg, betamethasone, prednisolone
& hydrocortisone Na succinate)
 Diuretics (eg, furosemide).

Administration: Should be taken with food

Storage: Store at temperatures not exceeding 25°C. Protect from light.

Pregnancy Category: Not classified

ATC Code: R03CC08

Cost:

SERETIDE
Rx Salmeterol + Fluticasone

Dosage Forms/ Strength:

 250 Diskus Salmeterol xinafoate 50 mcg, fluticasone propionate 250 mcg.

 500 Diskus Salmeterol xinafoate 50 mcg, fluticasone propionate 500 mcg.

 25/250 MDI Salmeterol xinafoate 25 mcg, fluticasone propionate 250 mcg

Indication: Regular treatment of reversible obstructive airways disease (ROAD) including asthma where
use of combination therapy (bronchodilator & inhaled corticosteroid) is appropriate; COPD including chronic
bronchitis & emphysema.

Contraindications: Hypersensitivity.

Dosage:

 Diskus ROAD Adult & adolescent ≥12 yr 1 inhalation of Seretide 100 or 250 or 500 bid. Childn ≥4
yr 1 inhalation of Seretide 100 bid. COPD Adult 1 inhalation of Seretide 250-500 bid.

 MDI ROAD Adult & adolescent ≥12 yr 2 inhalations of Seretide 25/50 or 25/125 or 25/250 bid.
Childn ≥4 yr 2 inhalations of Seretide 25/50 bid. COPD Adult 2 inhalations of Seretide 25/125 or
25/250 bid.

 Overdosage:

 S/Sx: tremor, headache, tachycardia, increases in systolic blood pressure and hypokalaemia

 Tx: The patient should be treated supportively with appropriate monitoring as necessary. It is
important to review therapy regularly and titrate down to the lowest approved dose at which
effective control of disease is maintained.

Dosage Adjustments: Not stated


P a g e | 18

Precautions: Not for relief of acute asthma symptoms. Consider increasing corticosteroid therapy in
sudden & progressive deterioration of asthma control. Avoid abrupt w/drawal. Possible development of
pneumonia in patients w/ COPD. Active or quiescent pulmonary TB, thyrotoxicosis, preexisting CV disease.
Patients predisposed to low serum K levels. Systemic effects (including Cushing's syndrome, Cushingoid
features, adrenal suppression, growth retardation in childn & adolescents, decrease in bone mineral
density, cataract, glaucoma & central serous chorioretinopathy) may occur at high doses for prolonged
periods. Monitor height of children receiving prolonged treatment. Possibility of impaired adrenal response
in patients transferring from oral steroid therapy. History of DM. Concomitant use w/ ritonavir, ketoconazole
& other strong CYP3A4 inhibitors. Discontinue use if paradoxical bronchospasm occurs. Pregnancy &
lactation. Children <4 yr.

Adverse Drug Reactions: Headache. Mouth & throat candidiasis, pneumonia (in COPD patients);
hoarseness/dysphonia; muscle cramps, arthralgia.

Drug Interactions: Avoid use w/ non-selective & selective β-blockers. Increased plasma conc w/ ritonavir.
Increased systemic exposure w/ ketoconazole.

Administration: Inhalation

Storage: Stored at temperatures not exceeding 30°C and in a dry place. Protect it from frost and direct
sunlight. As with most inhaled medications in pressurized canisters, the therapeutic effect of this medication
may decrease when the canister is cold.

 Diskus: Sealed in a foil overwrap which should only be opened when it is to be used for the first
time. Once opened, the foil overwrap should be discarded.

 MDI: Replace the mouthpiece cover firmly and snap it into position.

Pregnancy Category: C

ATC Code: R03AK06

Cost:

SALMEFLO
Rx Salmeterol + Fluticasone

Dosage Forms/ Strength: MDI Salmeterol xinafoate 25 mcg, fluticasone propionate 250 mcg.

Indication: Reversible obstructive airways disease including asthma where use of combination therapy is
appropriate. Maintenance treatment of COPD including chronic bronchitis & emphysema.

Contraindications: Hypersensitivity

Dosage: Adult & adolescent ≥12 yr 2 inhalations bid. Childn ≥4 yr 2 inhalations bid.
Dosage Adjustments: Not stated

Precautions: Risk of exacerbation when therapy in patients w/ asthma is stopped abruptly. Cessation of
therapy in patients w/ COPD may be associated w/ symptomatic decompensation. Patients w/ active or
quiescent pulmonary TB, thyrotoxicosis, systemic effects including adrenal suppression, growth retardation
(childn & adolescents) decrease in bone mineral density, cataract, glaucoma. Regularly monitor height in
childn w/ prolonged treatment.

Adverse Drug Reactions: Tachycardia, palpitations, cardiac arrhythmias, precipitation of angina pectoris,
CNS stimulation, dry mouth, sweating, headache, dizziness, nausea, vomiting, nervousness, anxiety &
P a g e | 19

tremor, hypersensitivity reactions. DPI: Salmeterol: Peripheral vasodilatation; muscle cramps; potentially
serious hypokalemia w/ large doses; paradoxical bronchospasm, angioedema, urticaria, hypotension,
collapse. Fluticasone: Churg-Strauss syndrome.

Drug Interactions: Nonselective & selective β-blockers. Fluticasone: Potential increased systemic
exposure when co-administered w/ strong CYP3A4 inhibitors eg, ketoconazole, ritonavir.

Administration: Inhalation

Storage: Store at temperatures not exceeding 25°C.

Pregnancy Category: C

ATC Code: R03AK06

Cost:

VENTAR
Rx Salbutamol

Dosage Forms/ Strength: Neb. Soln - Each mL solution contains Salbutamol (as sulfate), 1 mg.

Indication: Relief of bronchospasm in bronchial asthma, chronic bronchitis, bronchiectasis, emphysema &
other reversible obstructive pulmonary diseases.

Contraindications: Hypersensitivity.

Dosage: Nebulizing soln: Adult & adolescent Initially 2.5-5 mg by wet inhalation, up to qid.

Dosage Adjustments: Not stated

Precautions:

Warnings
Salbutamol administered intravenously or orally during labor or delivery inhibits uterine contraction.
Patients taking this medication should consult their physician if they do not respond to the usual dose of
this medication for reassessment of therapy.

 Thyrotoxicosis. Cardiac arrhythmias, coronary insufficiency, HTN, ischemic heart disease, DM,
hyperthyroidism, ketoacidosis, pheochromocytoma, sensitivity to sympathomimetics.

 Concomitant use w/ anesth cyclopropane or halothane; cardiac glycosides, quinidine or TCAs.


Pregnancy (1st trimester).

Adverse Drug Reactions: Fine tremor of skeletal muscle particularly the hands, nausea, pounding
heartbeat, nervousness or restlessness. In large doses, slight tachycardia, peripheral vasodilation &
headache, tensed feeling.

Drug Interactions: Increased risk of hypokalemia w/ corticosteroids, diuretics or xanthines.

Administration: Should be taken on an empty stomach: Take 1 hr before or 2 hr after meals.

Storage: Store at temperatures not exceeding 30°C. Protect from light.


P a g e | 20

Pregnancy Category: C

ATC Code: R03CC02 / R03AC02

Cost:

ASMALIN
Rx Salbutamol

Dosage Forms/ Strength: Syrup - Each 5 mL (1 teaspoonful) contains: Salbutamol (as sulfate) 2 mg

Indication: Prevention &/or relief of bronchospasm associated w/ reversible obstructive airway diseases
eg, bronchial asthma & COPD. Pulmoneb: Treatment of acute exacerbations of asthma.

Contraindications: Hypersensitivity.

Dosage: Adult & childn >12 yr 5-10 mL. Childn 7-12 yr 5 mL, 2-6 yr 2.5-5 mL. To be taken tid or qid.

 Overdosage:

 S/Sx: angina, arrhythmias, palpitation, tachycardia, nervousness, dizziness, tremor,


seizures, insomnia/sleeplessness, headache, fatigue, malaise, dry mouth, and nausea.
Hypokalemia has also been reported; thus, plasma potassium concentrations should be
monitored.

 Tx: Discontinue Salbutamol and institute appropriate symptomatic therapy.

Dosage Adjustments: Not stated

Precautions:

Warnings
The bronchodilator effect of each administration of Salbutamol syrup lasts for at least 6 hours. If a
previously effective dose fails to provide the usual relief or the usual duration of action is reduced, consult a
physician for medical advice as this is a sign of worsening of asthma that would require reassessment of
therapy.

 Worsening asthma.

 CV disorders including coronary insufficiency, cardiac arrhythmias or HTN; convulsive disorders;


hyperthyroidism; DM; patients unusually responsive to sympathomimetic amines.

 Acute severe asthma. Monitor plasma K conc in severe asthma.

 Pregnancy & lactation.

Adverse Drug Reactions: Hand tremors, nervousness, headache, tachycardia, palpitations, cough,
wheezing, hoarseness, vomiting, urticaria, angioedema, rash, anaphylaxis, paradoxical bronchospasm,
oropharyngeal edema, HTN, peripheral edema, arrhythmias, collapse, angina, vertigo, CNS stimulation, dry
mouth, hypokalemia. Young childn: Hyperkinesia, emotional lability, fatigue, pallor, GI symptoms,
conjunctivitis

Drug Interactions: Other oral or aerosol sympathomimetic bronchodilators, epinephrine; MAOIs, TCAs; β-
blockers.

Administration: Should be taken on an empty stomach: Take 1 hr before or 2 hrs after meals.
P a g e | 21

Storage: Store at temperatures not exceeding 30°C. Always keep the container tightly closed.

Pregnancy Category: C

ATC Code: R03CC02 / R03AC02

Cost:

ASMALIN MDI
Rx Salbutamol

Dosage Forms/ Strength: Each actuation of metered-dose inhaler delivers: Salbutamol sulfate 100 mcg.

Indication: Relief of bronchospasm associated w/ reversible obstructive airway disease eg, bronchial
asthma & COPD. Prevention of exercise-induced bronchospasm.

Contraindications: Hypersensitivity. Tocolytic therapy (eg, eclampsia or severe preeclampsia, intrauterine


infection/fetal death, antepartum hemorrhage, placenta previa, cord compression or toxemia of pregnancy).
Not to be used for threatened abortion.

Dosage:

 Relief of bronchospasm Adult & childn ≥4 yr 1 or 2 inhalations every 4-6 hr as needed.

 Prevention of exercised-induced bronchospasm Adult 2 inhalations 15-30 min before exercise.


Childn ≥4 yr 1 or 2 inhalations 15-30 min before exercise.

 Overdosage:
 S/Sx: tachycardia, central nervous system stimulation, tremor, hypokalemia, and
hypoglycemia, nausea, vomiting and hyperglycemia have been reported, predominantly in
children and when salbutamol overdose has been taken via the oral route. Lactic acidosis
has been reported in association with high therapeutic doses as well as overdoses of short-
acting beta-agonist therapy. Cardiac arrest and even death may occur following excessive
use of salbutamol.

 Tx: Discontinue Salbutamol and institute appropriate symptomatic therapy. Administration of


a beta-adrenergic blocking agent may be appropriate, but use with caution in patients with a
history of bronchospasm. There is no adequate evidence to support the use of dialysis in the
treatment of salbutamol overdose.

Dosage Adjustments: Not stated

Precautions: Paradoxical bronchospasm. Deterioration of asthma. Hypokalemia. Metabolic effects. Co-


existing conditions eg, CV disorders including coronary insufficiency, cardiac arrhythmias or HTN;
convulsive disorders; hyperthyroidism; DM, Pregnancy & lactation, Childn <4 yr.& Elderly ≥65 yr.

Adverse Drug Reactions: UTI; hypersensitivity; DM, edema, hypokalemia, metabolic acidosis; aggressive
behavior, anxiety, depression, dysphonia/voice alteration, hyperactivity, insomnia, nervousness, nightmare,
somnolence; agitation, altered taste, central nervous stimulation, dizziness, headache, hyperkinesia,
inhalation site/taste sensation, lightheadedness, tremor, vertigo; ear disorder, ear pain, tinnitus; angina,
cardiac arrhythmias, dyspnea, myocardial ischemia, palpitations, tachycardia; epistaxis, HTN, peripheral
vasodilatation; asthma exacerbation, cough, flu syndrome, paradoxical bronchospasm, pharyngitis, rhinitis,
upper resp tract infection; constipation, diarrhea, dry mouth, eructation, flatulence, gagging, gastroenteritis,
glossitis, heartburn, mouth & throat irritation, nausea, tongue ulceration, vomiting; back pain, muscle
cramps; ataxia, increased sweating; accidental injury.
P a g e | 22

Drug Interactions: erious adverse CV effects w/ other sympathomimetic agents or epinephrine. May inhibit
effect w/ β-adrenergic blocking agents (eg, propranolol). ECG changes &/or hypokalemia w/ non-K-sparing
diuretics (eg, loop or thiazide diuretics). Decreased serum digoxin conc. May potentiate effect on the
vascular system w/ MAOIs or TCAs.

Administration: Inhalation

Storage: Store at temperatures not exceeding 30°C. Protect from direct sunlight or heat. Do not freeze or
refrigerate. The efficacy of this medicine may decrease when the metal aerosol canister is cold. Do not
break, puncture or burn the canister even when apparently empty.

Pregnancy Category: C

ATC Code: R03AC02

Cost:

VENTOLIN INHALER
Rx Salbutamol

Dosage Forms/ Strength: Each Salbutamol (Ventolin) Inhaler is a pressurised metered-dose inhaler which
delivers 100 micrograms salbutamol (as sulphate) per actuation, into the mouthpiece of a specially
designed actuator. The inhaler also contains the CFC-free propellant HFA 134a. Each canister contains at
least 200 actuations.

Indication: Hypersensitivity. Threatened abortion. Rotacap: Patients w/ severe milk-protein allergy or have
a history of salbutamol hypersensitivity.

Contraindications: Hypersensitivity. Tocolytic therapy (eg, eclampsia or severe preeclampsia, intrauterine


infection/fetal death, antepartum hemorrhage, placenta previa, cord compression or toxemia of pregnancy).
Not to be used for threatened abortion.

Dosage:

 Relief of bronchospasm Adult 100 or 200 mcg. Childn 100 mcg. May be increased to 200 mcg if
required.

 Prevention of exercised-induced bronchospasm Adult 200 mcg before exertion. Childn 100
mcg before exertion. May be increased to 200 mcg if required.

 Chronic therapy Adult & childn Up to 200 mcg qid.

 Overdosage:

 S/Sx: tachycardia, central nervous system stimulation, tremor, hypokalemia, and


hypoglycemia, nausea, vomiting and hyperglycemia have been reported, predominantly in
children and when salbutamol overdose has been taken via the oral route. Lactic acidosis
has been reported in association with high therapeutic doses as well as overdoses of short-
acting beta-agonist therapy. therefore monitoring for elevated serum lactate and consequent
metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite
resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting
of overdose.

 Tx: Further management should be as clinically indicated or as recommended by the


national poisons centre, where available.
P a g e | 23

Dosage Adjustments: Not stated

Precautions: Inhaled salbutamol prep is not appropriate for managing premature labour. Sudden &
progressive deterioration in asthma control. Severe/underlying heart disease, assess CV status. Hypoxic
patient on infusion, supplemental oxygen is required. May induce reversible metabolic changes in diabetic
patient. Pregnancy & lactation. Infant <18 mth. Must be used by inhalation, w/ a nebulizer & should breath
through the mouth. Must not be inj or swallowed. Patients known to receive large doses of other
sympathomimetic drugs; thyrotoxicosis. Transient hypoxemia. Avoid contact w/ eyes. Increased blood
sugar levels & ketoacidosis may develop in diabetic patients. Monitor for the development of elevated
serum lactate & consequent metabolic acidosis.

Adverse Drug Reactions: Tremor, headache; tachycardia, palpitations; muscle cramps.

Drug Interactions: Hypersensitivity. Nonselective β-blockers eg, propranolol.

Administration: Should be taken on an empty stomach: Take 1 hr before or 2 hr after meals.

Storage: Replace the mouthpiece cover firmly and snap it into position. Store below 30°C. Protect from
frost and direct sunlight. As with most inhaled medications in aerosol canisters, the therapeutic effect of this
medication may decrease when the canister is cold. The canister should not be broken, punctured or burnt,
even when apparently empty.

Pregnancy Category: C

ATC Code: R03AC02

Cost:

SPIRIVA
Rx Salbutamol

Dosage Forms/ Strength: Each capsule for inhalation contains tiotropium as bromide monohydrate 18
mcg.

Indication: Maintenance treatment of patients w/ COPD (including chronic bronchitis & emphysema).
Maintenance treatment of associated dyspnoea, the improvement of COPD compromised quality of life &
reduction of exacerbations.

Contraindications: History of hypersensitivity to atropine or its derivatives eg, ipratropium or oxitropium.

Dosage: 1 cap (18 mcg) inhaled once daily via Handihaler (1 puff once daily at the same time of day)

 Overdosage: there were no systemic anticholinergic adverse effects following a single inhaled dose
of up to 282 mcg tiotropium in healthy volunteers. Bilateral conjunctivitis in addition to dry mouth
was seen in healthy volunteers following repeated once-daily inhalation of 141 mcg in healthy
volunteers, which resolved while still under treatment. In a multiple-dose study in COPD patients
with a maximum daily dose of 36 mcg tiotropium over 4 weeks, dry mouth was the only observed
adverse event attributable to tiotropium. Acute intoxication by oral ingestion of tiotropium capsules is
unlikely due to low oral bioavailability.

Dosage Adjustments: Not stated


P a g e | 24

Precautions: Not for initial treatment of acute episodes of bronchospasm or for relief of acute symptoms.
Not to be used as a 1st-line treatment of asthma; use more frequently than once daily. Immediate
hypersensitivity reactions may occur. Patients w/ narrow-angle glaucoma, prostatic hyperplasia or bladder-
neck obstruction. May cause inhalation-induced bronchospasm. Avoid the soln or mist from entering the
eyes. Contains benzalkonium Cl which may cause wheezing & breathing difficulties especially in patients
w/ asthma. Occurrence of dizziness or blurred vision may influence the ability to drive & use machinery.
Moderate to severe renal impairment (CrCl ≤50 mL/min). Avoid use during pregnancy & lactation. Childn <1
yr w/ asthma.

Adverse Drug Reactions: Handihaler: Dry mouth, constipation, cough & local irritation, tachycardia,
difficulty in micturition & urinary retention, hypersensitivity reactions. Respimat inhaler: Dehydration;
dizziness, insomnia; glaucoma, increased IOP, blurred vision; atrial fibrillation, palpitations, supraventricular
tachycardia; cough, epistaxis, pharyngitis, dysphonia, bronchospasm, laryngitis, sinusitis; dry mouth
(usually mild), constipation, oropharyngeal candidiasis, dysphagia, GERD, gingivitis, glossitis, stomatitis,
intestinal obstruction including paralytic ileus; rash, pruritus, angioneurotic edema, urticaria, skin infection &
skin ulcer, dry skin, hypersensitivity (including immediate reactions); joint swelling; urinary retention (usually
in men w/ predisposing factors), dysuria, UTI.

Drug Interactions: Not recommended w/ chronic administration w/ other anticholinergic drugs.

Administration: Should be taken on an empty stomach: Take 1 hr before or 2 hr after meals.

Storage: Store at temperatures not exceeding 25°C. Do not freeze.

Pregnancy Category: C

ATC Code: R03BB04

Cost:

STELIX
Rx Montelukast sodium + Levocetirizine dihydrochloride

Dosage Forms/ Strength: Each film-coated tablet contains: Montelukast (as sodium) 10 mg,
Levocetirizine (as dihydrochloride) 5 mg.

Indication: Chronic allergic conditions eg, seasonal allergic rhinitis, perennial allergic rhinitis, rhinitis
associated w/ asthma.

Contraindications: Hypersensitivity to montelukast Na, levocetirizine or cetirizine. Severe renal impairment


(CrCl <10 mL/min). Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Dosage: Adults (>15 years): 1 tablet once daily.

 Overdosage:

 S/Sx: (montelukast) abdominal pain, somnolence, thirst, headache, vomiting and


psychomotor hyperactivity; (levocetirizine) drowsiness in adults, and in children, initially
agitation and restlessness, followed by drowsiness.

 Tx: (montelukast) peritoneal dialysis or hemodialysis; (levocetirizine) gastric lavage should


be considered following short-term ingestion.

Dosage Adjustments: Not stated


P a g e | 25

Precautions: May impair ability to drive or operate machinery. Renal & hepatic impairment. Pregnancy &
lactation. Childn <15 yr. Elderly. Montelukast: Not for the reversal of bronchospasm in acute asthma
attacks, including status asthmaticus. Not to be used as monotherapy for the treatment & management of
exercise-induced bronchospasm. Avoid concurrent treatment w/ aspirin & NSAIDs. Levocetirizine diHCl:
Avoid alcohol intake. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption.

Adverse Drug Reactions: Montelukast: Dyspepsia, abdominal pain, rash, dizziness, headache, fatigue,
fever, trauma, cough, nasal congestion, flu. Levocetirizine: Somnolence, fatigue, nasopharyngitis, dry
mouth & pharyngitis.

Drug Interactions: Montelukast: Decrease AUC w/ phenobarb or rifampin.

Administration: May be taken with or without food: Take in the morning or evening.

Storage: Store below 30ºC. Shelf-life: 24 months.

Pregnancy Category: not classified

ATC Code: R03DC53

Cost:

GLYCOAIR BREEZHALER
Rx Indacaterol maleate + Glycopyrronium bromide

Dosage Forms/ Strength: Indacaterol/glycopyrronium 110/50 microgram, inhalation powder in hard


capsules.

Indication: Relieve symptoms & reduce exacerbations of COPD in adult patients.

Contraindications: Hypersensitivity to indacaterol or glycopyrronium.

Dosage: 1 cap once-daily inhalation at the same time each day (recommended dose)

 Overdosage:

 S/Sx: tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular


arrhythmias, metabolic acidosis, hypokalemia, and hyperglycemia or could induce
anticholinergic effects, i.e. increased intraocular pressure (causing pain, vision disturbances
or reddening of the eye), obstipation or difficulties in voiding

 Tx: Supportive and symptomatic treatment is indicated. In serious cases, patients should be
hospitalized. Use of cardio-selective beta blockers may be considered for treating beta2-
adrenergic effects, but only under the supervision of a physician and with extreme caution
since the use of beta-adrenergic blockers may provoke bronchospasm.

Dosage Adjustments: Renal impairment, Hepatic impairment, Geriatric patients (75 years or above) can
be used at the recommended dose.

Precautions: Not to be used for the treatment of asthma & acute episodes of bronchospasm. Discontinue
immediately if paradoxical bronchospasm & allergic reactions occur. Patients w/ narrow-angle glaucoma or
urinary retention; CV & convulsive disorders or thyrotoxicosis; those unusually responsive to β2-adrenergic
P a g e | 26

agonists; severe COPD, hypokalemia & hyperglycemia. QTc interval prolongation may occur. Do not co-
administer w/ products containing other long-acting β-adrenergic agonists or muscarinic antagonists.
Severe renal (GFR <30 mL/min/1.73 m2) or hepatic impairment, or end-stage renal disease requiring
dialysis. Pregnancy & lactation. Not to be used in childn <18 yr.

Adverse Drug Reactions: Upper resp tract infection. Nasopharyngitis, UTI, sinusitis, rhinitis;
hypersensitivity; hyperglycemia & DM; dizziness, headache; cough, oropharyngeal pain including throat
irritation; dyspepsia, dental caries; bladder obstruction & urinary retention; pyrexia, chest pain.
Drug Interactions: Indacaterol: May weaken or antagonize effects w/ β-adrenergic blockers (including eye
drops). May potentiate effects w/ MAOIs, TCAs or drugs known to prolong QT interval. May potentiate
adverse reactions w/ sympathomimetic agents. May potentiate possible hypokalemic effect w/
methylxanthine derivatives, steroids, or non-K-sparing diuretics. Glycopyrronium: Increased total exposure
(AUC) & decreased renal clearance w/ cimetidine or other inhibitors or organic cation transport.
Anticholinergics.

Administration: administered only by the oral inhalation route and only using the Breezhaler inhaler.
Capsules must not be swallowed

Storage: Do not store above 30°C. Protect from moisture.

Pregnancy Category: not classified

ATC Code: R03AL04

Cost:

ULTIBRO BREEZHALER
Rx Indacaterol maleate + Glycopyrronium bromide

Dosage Forms/ Strength: Per cap Indacaterol maleate 85 mcg, glycopyrronium bromide 43 mcg

Indication: Once-daily maintenance bronchodilator treatment to relieve symptoms & reduce exacerbations
in adults w/ COPD.

Contraindications: Hypersensitivity

Dosage: 1 cap once daily w/ inhaler.

 Overdosage:

 S/Sx: tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular


arrhythmias, metabolic acidosis, hypokalemia, and hyperglycemia or could induce
anticholinergic effects, i.e. increased intraocular pressure (causing pain, vision disturbances
or reddening of the eye), obstipation or difficulties in voiding

 Tx: Supportive and symptomatic treatment is indicated. In serious cases, patients should be
hospitalized. Use of cardio-selective beta blockers may be considered for treating beta2-
adrenergic effects, but only under the supervision of a physician and with extreme caution
since the use of beta-adrenergic blockers may provoke bronchospasm.

Dosage Adjustments: Renal impairment, Hepatic impairment, Geriatric patients (75 years or above) can
be used at the recommended dose.
P a g e | 27

Precautions: Not to be administered concomitantly w/ other long-acting β-adrenergic agonists or long-


acting muscarinic antagonists. Not to be used in treatment of asthma & in acute episodes of
bronchospasm. Discontinue immediately & institute alternative therapy if hypersensitivity & paradoxical
bronchospasm occurs. Narrow-angle glaucoma or urinary retention. CV disorders (CAD, acute MI, cardiac
arrhythmias, HTN); convulsive disorders or thyrotoxicosis; in patients who are unusually responsive to β2-
adrenergic agonists. May need to be discontinued if a clinically significant CV effect as measured by
increases in pulse rate, BP, &/or symptoms occur. Known or suspected QT prolongation interval or patients
w/ medicinal products affecting QT interval. Hypokalemia may be potentiated by hypoxia & concomitant
treatment which may increase susceptibility to cardiac arrhythmias in patients w/ severe COPD. May
increase plasma glucose w/ high dose. Closely monitor plasma glucose in diabetic patients upon initiation.
Severe hepatic & renal impairment (EGFR <30 mL/min/1.73 m2) including those w/ end-stage renal
disease requiring dialysis. May inhibit labor due to relaxant effect on uterine smooth muscle. Pregnancy &
lactation. Not to be used in childn <18 yr.

Adverse Drug Reactions: Upper resp tract infection. Nasopharyngitis, UTI, sinusitis, rhinitis;
hypersensitivity; hyperglycaemia & DM; dizziness, headache; cough, oropharyngeal pain including throat
irritation; dyspepsia, dental caries; bladder obstruction & urinary retention; pyrexia, chest pain.

Drug Interactions: Indacaterol: May weaken or antagonize the effect w/ β-adrenergic blockers. May
potentiate QT interval w/ MAOIs, TCAs or drugs known to prolong QT interval. May potentiate undesirable
effects w/ other sympathomimetic agents (alone or as part of combination therapy). May potentiate possible
hypokalaemic effect w/ methylxanthine derivatives, steroids, or non-K-sparing diuretics. Glycopyrronium:
Not recommended w/ co-administration of inhaled anticholinergic-containing drugs.

Administration: administered only by the oral inhalation route and only using the inhaler. Capsules must
not be swallowed

Storage: Do not store above 30°C. Protect from moisture.

Pregnancy Category: not classified

ATC Code: R03AL04

Cost:

COMBIVENT UDV
Rx Ipatropium bromide + Salbutamol

Dosage Forms/ Strength: Soln for inhalation Ipratropium Br 500 mcg, salbutamol 2.5 mg

Indication: Management of reversible bronchospasm associated w/ obstructive airway diseases in patients


who require more than a single bronchodilator.

Contraindications: Hypertrophic obstructive cardiomyopathy or tachyarrhythmia.

Dosage: Adult & childn >12 yr 1 vial 6-8 hrly. Childn 2-12 yr 3 drops/kg/dose (max: 2,500 mcg of
salbutamol) 6-8 hrly.

 Overdosage:

 S/Sx: tachycardia, palpitation, tremor, hypertension, hypotension, widening of the pulse


pressure, anginal pain, arrhythmias and flushing.
P a g e | 28

 Tx: Administration of sedatives, tranquillizers, in severe cases intensive therapy. Beta-


receptor blockers, preferably β1-selective, are suitable as specific antidotes; however, a
possible increase in bronchial obstruction must be taken into account and the dose should
be adjusted carefully in patients suffering from bronchial asthma.

Dosage Adjustments: not stated


Precautions: Insufficiently controlled DM, recent MI, severe organic heart or vascular disorders,
hyperthyroidism, pheochromocytoma, risk of narrow-angle glaucoma, prostatic hypertrophy or bladder-neck
obstruction; cystic fibrosis. Pregnancy & lactation.

Adverse Drug Reactions: Fine tremor of skeletal muscle; palpitations; headache, dizziness, nervousness;
dryness of mouth, throat irritation; urinary retention.

Drug Interactions: Other β-adrenergics, anticholinergics, xanthine derivatives, glucocorticosteroids,


diuretics; digoxin, β-blockers; MAOIs, TCAs, halogenated hydrocarbon anesth.

Administration: administered only by the oral inhalation route and only using the inhaler.

Storage: Do not store above 30°C.

Pregnancy Category: C

ATC Code: R03AL02

Cost:

DUAVENT
Rx Ipatropium bromide + Salbutamol

Dosage Forms/ Strength: Per 2.5 mL pulmoneb Ipratropium Br 500 mcg, salbutamol sulfate 2.5 mg.

Indication: Management of reversible bronchospasm associated w/ obstructive airway diseases (eg,


bronchial asthma). Patients w/ COPD on a regular inhaled bronchodilator who continue to have evidence of
bronchospasm & who require a 2nd bronchodilator.

Contraindications: Hypersensitivity to salbutamol, ipratropium bromide or to atropine & its derivatives.


Hypertrophic obstructive cardiomyopathy or tachyarrhythmia.

Dosage: Adult, adolescent >12 yr & elderly Treatment of acute attacks 1-2 pulmoneb. Maintenance: 1
pulmoneb every 6-8 hr daily. Childn 2-12 yr 3 drops/kg/dose. Max: 2.5 mg every 6-8 hr.

 Overdosage:

 S/Sx: Seizure, angina, hypertension or hypotension, arrhythmias, palpitation, tachycardia,


nervousness, dizziness, tremor, headache, sleeplessness or insomnia, dry mouth, fatigue,
malaise, and nausea, Hypokalemia

 Tx: Discontinue use of the product and institute appropriate symptomatic therapy in cases of
overdosage. Administration of a beta-adrenergic blocking agent may be appropriate, but use
with caution if the patient is asthmatic. There is no adequate evidence to support the use of
dialysis in the treatment of Salbutamol overdose.

Dosage Adjustments: not stated


P a g e | 29

Precautions: Cardiac arrest following severe, acute asthmatic crisis & hypoxia. Discontinue immediately if
paradoxical bronchospasm occurs. Increased IOP & precipitate angle-closure glaucoma. Patients w/ cystic
fibrosis may be more prone to GI motility disturbances. Narrow-angle glaucoma; CV disorders including
coronary insufficiency, cardiac arrhythmias or HTN; convulsive disorders; hyperthyroidism; DM; patients
who are unusually responsive to sympathomimetic amines; prostatic hypertrophy or bladder-neck
obstruction. Hepatic or renal disease. Severe airway obstruction where concomitant therapy w/ steroid,
xanthine derivatives or diuretics may result in hypokalemia. Monitor plasma K conc. Pregnancy & lactation.
Salbutamol: Decreased plasma K conc through intracellular shunting resulting in CV adverse reactions.
Ipratropium bromide: Increased risk of mortality &/or CV events (eg, MI, stroke, transient ischemic attacks).

Adverse Drug Reactions: Bronchitis, dyspnea, cough, lower/upper resp tract disorders, pneumonia,
bronchospasm, sinusitis, pharyngitis/sore throat, rhinitis, flu-like symptoms, nasal congestion, wheezing,
lung disease, dysphonia/voice alterations, increased sputum, exacerbation of resp symptoms, hemoptysis,
oropharyngeal edema, laryngospasm, bronchospasm, anaphylactic reactions, paradoxical bronchospasm;
tachycardia, palpitation, angina, chest pain, hypotension, HTN, arrhythmias, vasodilation, heartburn;
tremor, nervousness, dizziness, headache, drowsiness, coordination difficulty, paresthesia, hypertonia,
flushing, reduced appetite, insomnia, migraine, anxiety, vertigo, CNS stimulation; dry mouth, throat &
tongue; mucosal ulcers, thirst, diarrhea, dyspepsia, GI distress, constipation, paralytic ileus, nausea,
vomiting; slight elevation of serum alanine aminotransferase, increased sweating, hypokalemia; arthralgia,
pain, back pain, leg cramps, asthenia/muscle weakness, myalgia, muscle cramps; skin rash; angioedema
of the tongue, lips & face; urticaria, pruritus, contact dermatitis; precipitation or worsening of narrow-angle
glaucoma, temporary pupillary dilation, blurred vision, acute eye pain; UTI/dysuria, urinary
retention/difficulty; otitis media, tinnitus; viral infection, local irritation, unusual taste/taste perversion,
fatigue.

Drug Interactions: May increase risk of adverse CV events w/ other sympathomimetic agents. ECG
changes &/or hypokalemia w/ non-K sparing diuretics (eg, loop or thiazide diuretics). Salbutamol: Inhibit
effect w/ β-receptor blocking agent. May potentiate effect w/ MAOIs & TCAs. Ipratropium bromide: Potential
for additive interaction w/ anticholinergic medications.

Administration: administered only by the oral inhalation route and only using the inhaler.

Storage: Store at temperatures not exceeding 30°C. Protect from direct sunlight or heat. Do not freeze or
refrigerate. Do not use if the solution is discolored.

Pregnancy Category: C

ATC Code: R03AL02

Cost:
P a g e | 30

GIT Regulators, Antiflatulents & Anti-Inflammatories

RESTIME
OTC Simeticone

Dosage Forms/ Strength: 40 mg/mL Oral drops (susp)

Indication: Relief of discomfort due to gas accumulation in the stomach & intestines including sensations
of bloating, pressure, fullness or stuffed feeling which can be caused by certain food, air swallowing &
dyspepsia. Relief of symptoms of excess gas associated w/ colic.

Contraindications: Hypersensitivity.

Dosage: Children 2-12 yr 1 mL qid; <2 yr 0.5 mL qid.

 Missed Dose: If the patient misses a dose, just take the next dose if still needed for the condition
being treated and the subsequent doses at the recommended time or schedule
.
 Overdosage: There have been no cases of overdosage reported with simeticone use. If
overdosage is suspected and if patient has taken more than the recommended dosage, consult a
doctor immediately.

Dosage Adjustments: Not stated

Precautions: Avoid fizzy, carbonated drinks & food that may increase stomach gas.

Adverse Drug Reactions: There have been no reports of undesirable effects after ingestion of simeticone.
A very severe allergic reaction is rare. However, if the patient notices any undesirable effects, consult the
doctor immediately.

Drug Interactions: Reduce air swallowing by avoiding fizzy, carbonated drinks, and food that may
increase gas in the stomach.

Administration: Should be taken with food: Take after meals & at bedtime. Chew tab thoroughly before
swallowing.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: C

ATC Code: A03AX13

Cost:
P a g e | 31

Vitamins & Minerals (Pre & Post Natal) / Antianemics

RHEA FERROUS SULFATE


OTC Ferrous Sulfate

Dosage Forms/ Strength: 325mg tablet

Indication: Prophylaxis & treatment of simple Fe-deficiency disorders & Fe-deficiency anemia.

Contraindications: Anemia not due to Fe-deficiency, intolerance to Fe, inability to absorb Fe, regional
enteritis, colostomy, ileostomy or hemochromatosis.

Dosage: Adult 1-2 tab tid.

Dosage Adjustments: Not stated

Precautions: Not stated

Adverse Drug Reactions: GI irritation

Drug Interactions: Decreased absorption of Fe with tetracyclines & some antacids

Administration: Take on empty stomach; May be taken with meals to reduce GI discomfort

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: Not Classified

ATC Code: B03AA07

Cost:
P a g e | 32

Anti-Anginal Drugs

MONTRA
Rx Isosorbide-5-mononitrate

Dosage Forms/ Strength: 325mg tablet

Indication: Management & prophylaxis of angina pectoris; adjunct in CHF.

Contraindications: Hypersensitivity to other nitrates/nitrites. Acute circulatory failure associated w/ marked


hypotension (shock & states of collapse), angle-closure glaucoma, functional or organic GI hypermotility or
malabsorption syndrome; increased intracranial pressure eg, head trauma or cerebral hemorrhage;
myocardial insufficiency due to obstruction eg, presence of aortic or mitral stenosis or of constrictive
pericarditis. Obstructive hypertrophic cardiomyopathy, pericarditis, cardiogenic shock, postural or
orthostatic hypotension, severe anemia. Concomitant use w/ PDE-5 inhibitors (eg, sildenafil, tadalafil,
vardenafil).

Dosage: Adult Initially 30 mg once daily in the morning for 1st 2-4 days, may be increased to 60 or 120 mg
once daily in the morning.

 Overdosage:

 S/Sx: severe hypotension, tachycardia, bradycardia, heart block, palpitation, death


secondary to circulatory collapse, vertigo, confusion, fever, syncope (particularly in the
upright posture), persistent throbbing headache, visual disturbances, increased intracranial
pressure, paralysis and coma followed by seizures, flushing and diaphoresis, cold and
clammy skin, nausea and vomiting, colic and bloody diarrhea, dyspnea, and
methemoglobinemia.

 Tx: Manage nitrate overdose by inducing emesis, then administer activated charcoal. In the
occurrence of marked hypotension, place the patient in supine position with legs elevated.
Give further symptomatic treatment, including IV fluids, if necessary. If bradycardia is
present, atropine may be useful. When methemoglobinemia is diagnosed, IV administration
of methylene blue 1-2 mg/kg may be required. Management of ISMN overdosage in patients
with renal disease or congestive heart failure may be difficult and may require invasive
monitoring. Dialysis is ineffective in removing ISMN from the body.

Dosage Adjustments: Not stated

Precautions:

 Anginal patients w/ acute MI or CHF.

 Vol-depleted or hypotensive patients.


P a g e | 33

 Tolerance to hemodynamic & antianginal effects may develop at higher doses (>120 mg/day) &/or
more frequent doses eg, bid.

 Avoid abrupt w/drawal. Severe cerebral arteriosclerosis; arterial hypoxia due to anemia, hypoxemia,
ventilation or perfusion imbalance.

 May impair ability to drive or operate machinery.

 Pregnancy & lactation.

 Children

Adverse Drug Reactions: Headache, postural hypotension, transient flushing.

Drug Interactions: PDE-5 inhibitors eg, sildenafil, tadalafil, vardenafil. Dihydroergotamine, propranolol,
vasodilators, Ca channel blockers, ACE inhibitors, β-blockers, diuretics, antihypertensives, TCA, major
tranquilizers, phenothiazines & nitrates/nitrites. Alcohol.

Administration: Swallow capsule whole with a glass of water with or without food.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: C

ATC Code: C01DA14

Cost:

TMZ-MR
Rx Trimetazidine Hydrochloride

Dosage Forms/ Strength: 35mg tablet

Indication: Prophylactic treatment of angina pectoris episodes. Adjuvant symptomatic treatment of vertigo
& tinnitus. Adjuvant treatment of decline in visual acuity & field disturbances presumably of vascular origin.

Contraindications: Hypersensitivity. Not recommended during lactation.

Dosage: One tablet of mealtime in the morning and evening.

Dosage Adjustments: Not stated

Precautions: Do not take during pregnancy and lactation

Adverse Drug Reactions: Gastric discomfort, nausea, headache, vertigo.

Drug Interactions: No drug interactions have been reported. In particular, no interactions have been
reported with beta-blockers, calcium antagonists, nitrates, heparin, hypolidaemic agents or digitalis
preparation.

Administration: Should be taken with food: Swallow whole, do not break/chew/crush.

Storage: Store at temperatures not exceeding 30°C. Shelf Life: 36 months from the date of manufacturing.
P a g e | 34

Pregnancy Category: C

ATC Code: C01EB15

Cost:

Quinolones

INOFLOX
Rx Ofloxacin

Dosage Forms/ Strength: 400mg Tablet

Indication: Listed in Dosage

Contraindications: Hypersensitivity. Not recommended during lactation.

Dosage:

 Lower respiratory tract skin & skin structure 400mg 12 hourly for 10 days.

 Prostatitis 300mg 12 hourly for 6 weeks

 UTI 200mg 12 hourly for 3-10 days

 STD 300mg 12 hourly for 2-7 days

 Acute uncomplicated gonorrhea 400mg as a single dose for 1 day

 Typhoid fever 300-400mg 12 hourly for 2 weeks

 Shigella enteritis 400mg as a single dose or 200 mg 8 hourly for 1 day

 Overdosage:

 S/Sx: Dizziness, confusion, impaired consciousness, increased QT interval, convulsive


seizures, nausea, mucosal erosions

 Mgt: Symptomatic treatment. May employ gastric lavage or administer adsorbents and Na
sulfate during the 1st 30 minutes to remove any unabsorbed drug. Antacids may be given for
protection of gastric mucosa. Elimination may be increased by forced diuresis. Monitor ECG.
Dosage Adjustments:

 Renal Impairment

 Oral: Patient on haemodialysis or peritoneal dialysis: 100-200 mg 24 hourly following usual


initial dose.
P a g e | 35

 Hepatic Impairment

 Oral/Intravenous: (Severe) Reduce dose. Max: 400 mg daily.

Precautions: CNS disorders. Reduced renal function

Adverse Drug Reactions: GI effects, neurological reactions, super-infection, tendinitis. Rarely,


pseudomembranous colitis

Drug Interactions: Antacids, theophylline, cimetidine

Administration: May be taken with or without food. Avoid antacids or supplements containing Fe or Zn
w/in 2 hr before or after ofloxacin. Ensure adequate hydration.

Storage: Store between 20-25°C

Pregnancy Category: C (Caution esp. in 1st trimester)

ATC Code: J01MA01

Cost:

LEVOX
Rx Levofloxacin

Dosage Forms/ Strength: 500mg Tablet

Indication: Mild, moderate or severe infections: Acute bacterial sinusitis, acute bacterial exacerbation of
chronic bronchitis, community-acquired pneumonia, health-care associated pneumonia; complicated skin &
skin structure infections (SSSI), uncomplicated SSSI including abscesses, cellulitis, furuncles, impetigo,
pyoderma, wound infections; complicated/uncomplicated UTI, acute pyelonephritis, chronic bacterial
prostatitis for adults ≥18 yr. Reduce the incidence or progression of inhalational anthrax in adults & childn
≥6 mth. Treatment of plague including pneumonic & septicemic plague. Prophylaxis for plague in adults &
childn ≥6 mth.

Contraindications: Hypersensitivity to levofloxacin or other quinolones. Patients w/ a history of tendon


disorders related to quinolone therapy; epilepsy.

Dosage:

 Adult Tab 250-500 mg once daily

 Acute bacterial exacerbation of chronic bronchitis 500 mg once daily for 7 days or 750 mg once
daily for 5 days.

 Community-acquired pneumonia 500 mg once daily for 7-14 days or 750 mg once daily for 5
days.

 Healthcare-associated pneumonia 750 mg once daily for 7-14 days.

 Complicated SSSI 750 mg once daily for 7-14 days.

 Uncomplicated SSSI 500 mg for 7-10 days.


P a g e | 36

 Complicated UTI 250 mg once daily for 10 days or 750 mg once daily 5 days.

 Acute pyelonephritis 250 mg for 10 days or 750 mg once daily for 5 days.

 Chronic bacterial prostatitis 500 mg once daily for 28 days.

 Uncomplicated UTI 250 mg once daily for 3 days.

 Overdosage:

 S/Sx: CNS symptoms such as confusion, dizziness, impairment of consciousness, and


convulsive seizures, as well as GI reactions such as nausea and mucosal erosions.

 Mgt: Symptomatic treatment should be implemented. The patient should be observed and
proper hydration maintained. ECG monitoring should be undertaken, because of the
possibility of QT interval prolongation. The administration of activated charcoal as soon as
possible after oral overdose may prevent excessive increase of systemic levofloxacin
exposure. Antacids may be used for protection of the gastric mucosa. Hemodialysis,
including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the
body. No specific antidote exists.
Dosage Adjustments:

 Renal Impairment

 CrCl 20-49 mL/min 750 mg 750 mg every 48 hr. 500 mg Initially 500 mg, then 250 mg every
24 hr, 10-29 mL min 750 mg Initially 750 mg then 500 mg every 48 hr. 500 mg Initially 500
mg then 250 mg every 48 hr. 250 mg 250 mg every 48 hr.

 Hemodialysis or chronic ambulatory peritoneal dialysis

 50 mg Initially 750 mg then 500 mg every 48 hr. 500 mg Initially 500 mg then 250 mg every
48 hr.

Precautions:
Warnings: 750 mg Infusion: Fluoroquinolones, including levofloxacin, are associated with an
increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older
patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with
kidney, heart or lung transplants.

 Hypersensitivity in levofloxacin & fluoroquinolones.

 Risk of tendinitis & tendon rupture in all ages especially patients taking corticosteroids, patients w/
kidney, heart or lung transplants.

 Discontinue treatment if pain, swelling, inflammation, or rupture of a tendon occurs & 1st
appearance of skin rash or any other sign of hypersensitivity; patient experiences symptoms of
neuropathy; hypoglycemia. Myasthenia gravis.

 Severe hepatotoxicity. May cause CNS stimulation which may lead to tremors, restlessness,
anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia,
anxiety & rarely, suicidal thoughts or acts. Patients w/ unstable known or suspected CNS disorders,
other risk factors that may predispose to seizures or lower the seizure threshold or unstable
psychiatric illness; known prolongation of the QT interval, uncorrected hypokalemia, significant
P a g e | 37

bradycardia, cardiomyopathy, or MI; latent or actual defects in G6PD activity. C. difficile-associated


diarrhea.

 Musculoskeletal disorders in childn. Blood glucose disturbances usually in diabetic patients


receiving concomitant treatment w/ an oral hypoglycemic agent (eg, glibenclamide) or w/ insulin.

 Overgrowth of non-susceptible organisms (long-term or repeated use).

 Monitor blood glucose in patients receiving concomitant treatment w/ oral hypoglycemic agent or w/
insulin.

 Avoid direct exposure to excessive sunlight or UV radiation during treatment. Periodic assessment
of organ system functions, including renal, hepatic & hematopoietic. False +ve urine screening
results for opiates. False -ve results in bacteriological diagnosis of TB. Adequate hydration during
therapy to prevent the formation of a highly conc urine.

 Discontinue treatment if phototoxicity occurs. Rapid or bolus IV infusion may result in hypotension;
administer over a period of not less than 60 min. Avoid performing tasks which require complete
mental alertness eg, driving & operating machinery.

 Pregnancy & lactation. Childn <6 mth. Elderly.

Adverse Drug Reactions: Nausea, vomiting, diarrhea, constipation, headache, insomnia, & dizziness.

Drug Interactions: May interfere w/ the absorption w/ antacids containing Ca, Mg, or Al; sucralfate,
didanosine, metal cations (eg, Fe), multivit prep w/ Zn. Potential pharmacologic interaction w/ class IA (eg,
quinidine, procainamide) or class III (eg, amiodarone, sotalol); fluoxetine or imipramine. May cause
disturbances of blood glucose w/ antidiabetic agents. Increased AUC of ciclosporin or tacrolimus. Increased
risk of tendon rupture w/ corticosteroids. Prolonged QT interval w/ fluconazole. Increased risk of CNS
stimulation & convulsive seizures w/ NSAIDs. Prolonged elimination t½, elevated serum theophylline levels
& increased risk of theophylline-related adverse reactions w/ theophylline. Enhanced effect of warfarin.
False -ve results in bacteriological diagnosis of TB. Tab: May interfere w/ the GI absorption w/ antacids,
sucralfate, metal cations & Zn-containing multivit prep. Infusion: Do not co-administer w/ any soln
containing multivalent cations eg, Mg through the same IV line.

Administration: May be taken with or without food: Ensure adequate fluid intake.

Storage: Store between 20-25°C

Pregnancy Category: C

ATC Code: J01MA12

Cost:

MOXIFLOX
Rx Moxifloxacin

Dosage Forms/ Strength: 400mg Tablet

Indication: Acute bacterial sinusitis, exacerbation of chronic bronchitis; community-acquired pneumonia,


uncomplicated & complicated skin & skin structure & complicated intra-abdominal susceptible infections.

Contraindications: Hypersensitivity to quinolones.


P a g e | 38

Dosage: Adult Tab 400 mg once daily

 Overdosage:

 S/Sx: QT prolongation.

 Mgt: Administer activated charcoal immediately after absorption. Perform ECG monitoring.
 500 mg every 48 hr. 500 mg Initially 500 mg then 250 mg every 48 hr.

Dosage Adjustments: Not stated

Precautions: Epilepsy or history of CNS disorders, impaired hepatic or renal function, G6PD deficiency or
myasthenia gravis. Discontinue if patients experience tendon pain, inflammation or rupture. Risk of
crystalluria; maintain adequate fluid intake & avoid excessive urine alkalinity. Avoid exposure to excessive
sunlight or sunlamps. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn &
adolescents.

Adverse Drug Reactions: GI disturbances eg, nausea, vomiting, diarrhea, abdominal pain, dyspepsia;
headache, dizziness, restlessness; tremor, drowsiness, insomnia, nightmares, visual & sensory
disturbances. Rash, pruritus. Potentially vasculitis, erythema multiforme, Stevens-Johnson syndrome &
toxic epidermal necrolysis.

Drug Interactions:

 Increased risk of bradycardia with potassium-reducing agents (e.g. loop diuretics). Increased risk of
tendon disorder with corticosteroids. Decreased absorption by forming chelates with antacids
containing Al, Mg, Fe, sucralfate and multivalent cations. May enhance anticoagulant effects of
warfarin.

 Potentially Fatal: Increased risk of QT prolongation with class IA (e.g. quinidine) and class III (e.g.
amiodarone) antiarryhthmics, terfenadine, cisapride, erythromycin, antipsychotics (e.g. haloperidol),
and TCA (e.g. amitriptyline).

Administration: May be taken with or without food

Storage: Store between 30°C

Pregnancy Category: C

ATC Code: J01MA14

Cost:
P a g e | 39

Penicillins

AMOCLAV
Rx Amoxicillin + Clavulanic acid

Dosage Forms/ Strength:

 Per 5 mL of 200 mg/28.5 mg susp Amoxicillin 200 mg, clavulanic acid 28.5 mg.

 Per 5 mL of 400 mg/57 mg susp Amoxicillin 400 mg, clavulanic acid 57 mg

Indication: Treatment of infections due to β-lactamase producing strains eg, resp tract infections, GUT &
abdominal infections, cellulitis, animal bites & severe dental infection w/ spreading cellulitis.

Contraindications: Hypersensitivity to penicillins. History of penicillin-associated jaundice/hepatic


dysfunction.

Dosage:

 200 mg/28.5 mg/5 mL

 Childn >6 yr w/ body wt 18-40 kg Mild to moderate infections 5-10 mL ; Severe infections 10-
20 mL.

 Childn 1-6 yr w/ body wt 10-18 kg ; Mild to moderate infections 2.5-5 mL. ; Severe infections
5-10 mL.

 Childn <1 yr w/ body wt <10 kg Mild, moderate, severe infections 2.5 mL.

 400 mg/57 mg/5 mL

 Childn >6 yr w/ body wt 18-40 kg Mild to moderate infections 2.5-5 mL. ; Severe infections 5-
10 mL.

 Childn 1-6 yr w/ body wt 10-18 kg Mild to moderate infections 2.5 mL. ; Severe infections
2.5-5 mL. To be given 12 hrly.

 Overdosage:

 S/Sx: gastrointestinal symptoms, fluid and electrolyte imbalance. Amoxicillin crystalluria,


leading to renal failure

 Tx: Symptomatic treatment is recommended. Co-amoxiclav can be removed by


hemodialysis.
P a g e | 40

Dosage Adjustments:

 Children up to 12 years old on Hemodialysis: 15 mg/kg body weight once daily. Patients should
receive an additional dose of 15 mg/kg body weight both during and at the end of dialysis.

 Children up to 12 years old with Hepatic Impairment: Dose with caution and monitor hepatic
function regularly.

Precautions: Cross-sensitivity w/ other β-lactam antibiotics eg, cephalosporins. Periodically evaluate renal,
hepatic & hematologic functions during prolonged therapy.

Adverse Drug Reactions: Diarrhea, enterocolitis, hemorrhagic/pseudomembranous colitis, gastritis,


indigestion, mucocutaneous candidiasis, nausea, vomiting & black hairy tongue. Skin rashes, pruritus,
urticaria, angioedema, serum sickness-like reactions, erythema multiforme, exfoliative dermatitis.
Dizziness, headache, anxiety, agitation, insomnia, reversible hyperactivity, confusion, behavioral changes.
Increased serum conc of AST, ALT, alkaline phosphatase & bilirubin. Interstitial nephritis, hematuria.
Anemia eg, hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, leukopenia, eosinophilia,
agranulocytosis, thrombocytosis.

Drug Interactions: Probenecid, allopurinol, disulfiram.

Administration: May be taken with or without food: Preferably taken at the start of meals for better
absorption & to reduce GI discomfort.

Storage: Store in a dry place at temperatures not exceeding 25°C.

Pregnancy Category: B

ATC Code: J01CR02

Cost:

SOCLAV
Rx Amoxicillin + Clavulanic acid

Dosage Forms/ Strength: Per 500 mg/125 mg FC tab Amoxicillin 500 mg, clavulanic acid 125 mg.

Indication: Infections due to β-lactamase-producing strains (where amoxicillin alone is not appropriate)
including respiratory tract infections, genitourinary & abdominal infections, cellulitis, animal bites, severe
dental infection w/ spreading cellulitis.

Contraindications: Hypersensitivity to penicillins. History of penicillin-associated jaundice/hepatic


dysfunction.

Dosage: Adult Usual dose: 250mg/125mg 8 hourly. Severe infection 500mg/125mg 8 hourly.

Dosage Adjustments:

 Renal Impairment

a. (Upper respiratory tract infections; Ear, nose and/or throat infections; Acute bacterial sinusitis;
Genitourinary infections; Cystitis; Pyelonephritis; Skin and soft tissue infections; Infected animal
bites; Intra-abdominal infections)
P a g e | 41

 Haemodialysis: Adults and children ≥40 kg: As 250 mg/125 mg conventional tab: 500
mg/250 mg 24 hourly, then 500 mg/250 mg dose during and repeated at the end of dialysis;
As 500 mg/125 mg conventional tab, 125 mg/31.25 mg and 250 mg/62.5 mg per 5 mL oral
susp: 500 mg/125 mg 24 hourly, then 500 mg/125 mg dose during and repeated at the end
of dialysis; Children <40 kg: As 500 mg/125 mg conventional tab, 125 mg/31.25 mg and
250 mg/62.5 mg per 5 mL oral susp: 15 mg/3.75 mg/kg once daily. Give 15 mg/3.75 mg/kg
dose prior to and after dialysis. As extended-release tab: Contraindicated.

b. (Acute otitis media; Lower respiratory tract infections; Acute exacerbations of chronic bronchitis;
Community-acquired pneumonia; Bone and joint infections; Osteomyelitis)

 Haemodialysis: Adults and children ≥40 kg: As 500 mg/125 mg conventional tab, 125
mg/31.25 mg and 250 mg/62.5 mg per 5 mL oral susp: 500 mg/125 mg 24 hourly, then 500
mg/125 mg dose during and repeated at the end of dialysis; Children <40 kg: As 500
mg/125 mg conventional tab, 125 mg/31.25 mg and 250 mg/62.5 mg per 5 mL oral susp: 15
mg/3.75 mg/kg once daily. Give 15 mg/3.75 mg/kg dose prior to and after dialysis. As
extended-release tab: Contraindicated.

Precautions: Monitor liver function. Severe renal impairment, hepatic dysfunction, glandular fever. Avoid
prolonged use.

Adverse Drug Reactions: Nausea, vomiting, diarrhea, rashes

Drug Interactions: Reduced pre-dose concentrations of mycophenolate mofetil active metabolite. May
reduce the efficacy of combined oral oestrogen/progesterone contraceptives. Allopurinol, acenocoumarol,
warfarin.

Administration: Extended-Release: Should be taken with food. Must be taken at the start of meals.
May be taken with or without food. May be given w/o regard to meals. Best taken at the start of meals for
better absorption & to reduce GI discomfort.

Storage: Store below 25°C. Protect from moisture.

Pregnancy Category: B

ATC Code: J01CR02

Cost:

AUGMENTIN
Rx Amoxicillin + Clavulanic acid

Dosage Forms/ Strength: Per Augmentin 625 mg tab Amoxicillin 500 mg, clavulanic acid 125 mg

Indication: Infections of upper & lower resp tract, GUT, skin & soft tissue, bone & joint, septic abortion,
puerperal sepsis, intra-abdominal sepsis, dental infection.

Contraindications: Hypersensitivity to β-lactams eg, penicillins & cephalosporins. History of co-amoxiclav-


associated jaundice/hepatic dysfunction.

Dosage: Adult Mild to moderate infections 625 mg bid-tid. Severe infections 625 mg tid.

 Overdosage:
P a g e | 42

 S/Sx: Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may
be evident. Amoxicillin crystalluria, in some cases leading to renal failure, has been
observed.

 Tx: Gastrointestinal symptoms may be treated symptomatically, with attention to the


water/electrolyte balance. Co-amoxiclav can be removed from the circulation by
haemodialysis.

Dosage Adjustments:

 Haemodialysis

 Adults: 1 times 500/125 mg or 2 times 250/125 mg every 24 hours, plus 1 dose during
dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxicillin
and clavulanic acid are decreased)(+).

 (+)The 875/125 mg and 1000/125 mg presentations should only be used in patients with a
creatinine clearance of more than 30 mL/min.

Precautions:

 Careful enquiry should be made concerning previous hypersensitivity reactions to penicillins,


cephalosporins or other allergens prior to initiation of therapy.

 History of penicillin hypersensitivity. Discontinue & initiate alternative therapy if an allergic reaction
occurs.

 Suspected infectious mononucleosis. Overgrowth of non-susceptible organisms in prolonged use.


Pseudomembranous colitis. Discontinue treatment if prolonged or significant diarrhea occurs or the
patient experiences abdominal cramps.
 Concomitant use w/ anticoagulants. Ensure adequate hydration & urinary output especially w/
parenteral therapy or high doses.

 Hepatic dysfunction & Renal impairment.

 Pregnancy & lactation.

 Tab/susp: Perform periodic assessment of organ system functions including renal, hepatic,
hematopoietic function during prolonged therapy.

Adverse Drug Reactions: Diarrhoea, nausea, vomiting, mucocutaneous candidiasis.

Drug Interactions: Decreased renal tubular secretion w/ probenecid. Increased allergic skin reactions w/
allopurinol. May affect the gut flora leading to lower estrogen reabsorption & reduced efficacy of combined
OCs. Increased INR w/ acenocoumarol or warfarin, mycophenolate mofetil, methotrexate.

Administration: May be taken with or without food: Best taken at the start of meals for better absorption &
to reduce GI discomfort.

Storage: Temperatures not exceeding 30°C. Protect from moisture. Tablets should be used within 14 days
after opening of foil pouch.

Pregnancy Category: B

ATC Code: J01DD08

Cost:
P a g e | 43

RITEMED CLOXACILLIN
Rx Cloxacillin

Dosage Forms/ Strength: 250mg/5ml powder for oral solution

Indication: Treatment of infections due to penicillinase-producing Staph eg, skin & soft tissue, resp & GUT
infections.

Contraindications: Hypersensitivity to cloxacillin & penicillins. Pregnancy (1st trimester)

Dosage: Adult 500mg (2 tsp). Chldn 3-10 yr 250mg (1 tsp). Up to 2 yr 125mg (1/2 tsp). All doses to be
taken qid.

Dosage Adjustments: Not stated

Precautions:
Warnings: Serious and occasionally fatal hypersensitivity (anaphylactic shock with collapse) reactions
have occurred in patients receiving penicillin. The incidence of anaphylactic shock in all penicillin-
treated patients is between 0.015 and 0.04%. Anaphylactic shock resulting in death has occurred in
approximately 0.002% of patients treated. Although anaphylaxis is more frequent following parenteral
administration, it has occurred in patients receiving oral penicillins. When penicillin therapy is indicated,
it should be initiated only after a comprehensive patient drug and allergy history has been obtained.
Discontinue cloxacillin and give supportive treatment (ie, artificial maintenance of ventilation, pressor
amines, antihistamines and corticosteroids) if an allergic reaction occurs.

 Overgrowth of non-susceptible organism from prolonged use. Poor renal function.

Adverse Drug Reactions: Hypersensitivity reactions. Occasionally anaphylaxis; hepatitis & cholestatic
jaundice

Drug Interactions: Aminoglycosides. May decrease efficacy of estrogen-containing OCs.

Administration: Should be taken on an empty stomach: Take 1 hr before or 2 hr after meals.

Storage: Temperatures not exceeding 30°C.

Pregnancy Category: B

ATC Code: J01CF02

Cost:

UNASYN
Rx Sultamicillin tosylate

Dosage Forms/ Strength: 750 mg Film-Coated Tablet: Each tablet contains 750 mg sultamicillin (as
tosylate) yielding the equivalent of 294 mg sulbactam and 440 mg ampicillin.
P a g e | 44

Indication: Upper resp tract infections including sinusitis, otitis media & tonsillitis; lower resp tract infections
including bacterial pneumonia & bronchitis; UTI & pyelonephritis; skin & soft tissue, intra-abdominal &
gonococcal infections.

Contraindications: History of allergic reaction to any of the penicillins.

Dosage: Adult including elderly 375-750 mg bid. Treatment is continued until 48 hr after pyrexia & other
abnormal signs have resolved. Duration of treatment: 5-14 days. Uncomplicated gonorrhea 2.25 g as a
single dose w/ concomitant probenecid 1 g to prolong plasma conc of sulbactam/ampicillin. Infections
caused by hemolytic strep Administer for at least 10 days to prevent occurrence of acute rheumatic fever
or glomerulonephritis. Childn ≥30 kg Usual adult dose, <30 kg 25-50 mg/kg/day in 2 divided doses.
Treatment is continued until 48 hr after pyrexia & other abnormal signs have resolved. Duration of
treatment: 5-14 days.
 Overdosage:

 S/Sx: produce manifestations that are principally extensions of the adverse reactions
reported with the drug. The fact that high cerebrospinal fluid (CSF) concentrations of beta-
lactam antibiotics may cause neurologic effects, including seizures, should be considered..

 Tx: Haemodialysis.

Dosage Adjustments: Not stated

Precautions:

 Previous hypersensitivity reactions to penicillins, cephalosporins, & other allergens.

 Severe skin reactions eg, toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative
dermatitis, & erythema multiforme may occur. Observe for signs of overgrowth of non-susceptible
organisms including fungi; discontinue if superinfection occurs.

 Clostridium difficile-associated diarrhea.

 Drug induced liver injury eg, cholestatic hepatitis & jaundice.

 Not to be used in patients w/ infectious mononucleosis. Periodically check for organ system
dysfunction during prolonged therapy including renal, hepatic & hematopoietic systems. Galactose
intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

 Pregnancy. Not recommended during lactation.

 Neonates.

Adverse Drug Reactions: Pseudomembranous colitis, candida infection; thrombocytopenia; anaphylactic


shock/reaction, Kounis syndrome, hypersensitivity; dizziness, somnolence, sedation, headache; dyspnea;
enterocolitis, melena, diarrhea, vomiting, abdominal pain, dyspepsia, nausea, stomatitis, dysgeusia, tongue
discoloration; jaundice, abnormal hepatic function; toxic epidermal necrolysis, Stevens-Johnson syndrome,
erythema multiforme, angioedema, urticaria, dermatitis, rash, pruritus; arthralgia; fatigue, malaise;
increased ALT/AST.

Drug Interactions: Increased incidence of rashes w/ allopurinol. Additive effects w/ anticoagulants. May
interfere bactericidal effect w/ bacteriostatic drugs (chloramphenicol, erythromycin, sulfonamides &
tetracyclines). Reduced effectiveness of estrogen-containing OCs. Decreased clearance of methotrexate.
Decreased renal tubular secretion w/ probenecid. False +ve glycosuria in urinalysis using
Benedict's/Fehling's reagent & Clinitest.

Administration: May be taken with or without food


P a g e | 45

Storage: Temperatures not exceeding 30°C.

Pregnancy Category: B

ATC Code: J01CR04

Cost:

Macrolides

CLARITHRO-NATRAPHARM
Rx Clarithromycin

Dosage Forms/ Strength: Each 5 mL of the prepared suspension contains: Clarithromycin 125 mg.

Indication: Upper resp tract eg, tonsillitis/pharyngitis, lower resp tract eg, community acquired pneumonia
& skin & soft tissue infections of mild to moderate severity. Acute otitis media in childn. Sinusitis & acute
exacerbation of chronic bronchitis in adult & adolescents >12 yr. Eradication of H. pylori in adult w/ H. pylori
associated ulcers.

Contraindications: Hypersensitivity to clarithromycin or macrolides. Concomitant use w/ astemizole,


cisapride, domperidone, pimozide, terfenadine, ticagrelor or ranolazine, ergot alkaloids (eg, ergotamine or
dihydroergotamine), HMG-CoA reductase inhibitors (lovastatin or simvastatin), colchicine, oral midazolam.
Patients w/ history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular
cardiac arrhythmia including torsade de pointes. Hypokalemia. Severe hepatic failure in combination w/
renal impairment.

Dosage: Adult & adolescent 250 mg bid, may be increased to 500 mg bid in severe infections. Duration of
treatment: 6-14 days. Adult Elimination of H. pylori Clarithromycin 500 mg bid + amoxicillin 1,000 mg bid +
omeprazole 20 mg bid for 7 days. Strep pyogenes infections Duration of therapy: At least 10 days.

 Overdosage:

 S/Sx: gastrointestinal symptoms, altered mental status, paranoid behaviour, hypokalemia,


and hypoxemia.

 Tx: prompt elimination of unabsorbed active substance and supportive measures. As with
other macrolides, clarithromycin serum levels are not expected to be appreciably affected by
haemodialysis or peritoneal dialysis.

Dosage Adjustments:

 Renal Impairment

 CrCl <30 mL/min 250 mg daily or 250 mg bid in most severe infections. Duration of
treatment: Do not exceed 14 days. Childn 6 mth- 12 yr 7.5 mg/kg bid. Childn 8-12 yr 10
mL bid for up to 5-10 days, 4-8 yr 7.5 mL bid, 2-4 yr, 5 mL bid, 1-2 yr 2.5 mL bid.

 CrCl <30 mL/min 7.5 mg/kg once daily. Duration of treatment: Do not exceed 14 days.
P a g e | 46

Precautions: Hepatic dysfunction including increased liver enzymes & hepatocellular &/or cholestatic
jaundice w/ or w/o jaundice. Patients w/ preexisting hepatic disease or those taking other hepatotoxic
medicinal products. Clostridium difficile-associated diarrhea. Avoid use of medicinal products that inhibits
peristalsis. Patients w/ CAD, severe cardiac insufficiency, conduction disturbances or clinically relevant
bradycardia; electrolyte disturbances eg, hypomagnesemia. Should not be given to patient w/ hypokalemia.
Short term risk of arrhythmia, MI & CV mortality. Perform sensitivity testing when prescribing for
community-acquired pneumonia & skin & soft tissue infections of mild to moderate severity. Discontinue
immediately in the event of severe acute hypersensitivity reactions eg, anaphylaxis, severe cutaneous
adverse reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis & drug rash w/ eosinophilia &
systemic symptoms.
Monitor for signs & symptoms of myopathy. Monitor glucose when in concomitant use w/ sulphonylureas.
Frequently monitor INR & prothrombin time when in concurrent use w/ oral anticoagulants. Colonisation w/
increased numbers of non-susceptible bacteria & fungi on long-term use. Concomitant use w/
triazolobenzodiazepenes eg, triazolam & IV or oromucosal midazolam; other medicinal products associated
w/ QT prolongation; cytochrome CYP3A4 inducers. Visual impairment & vision blurred may affect ability to
drive or operate machinery. Moderate to severe renal impairment & impaired hepatic function. Pregnancy.

Adverse Drug Reactions: Insomnia; dysgeusia, headache, taste perversion, vasodilation; diarrhea,
vomiting, dyspepsia, nausea, abdominal pain; abnormal liver function test; rash, hyperhidrosis.

Drug Interactions: Acute ergot toxicity w/ ergotamine or dihydroergotamine. Increased AUC of midazolam,
triazolam & alprazolam. Increased risk of myopathy including rhabdomyolysis w/ HMG-CoA Reductase
inhibitors (statins). Induced metabolism w/ CYP3A inducers (eg, rifampicin, phenytoin, carbamazepine,
phenobarb, St. John's wort) & strong cytochrome P450 inducers (eg, efavirenz, nevirapine, rifampicin,
rifabutin & rifapentine). Decreased serum levels w/ rifabutin. Decreased exposure w/ etravirine. Increased
mean steady-state Cmin & AUC w/ fluconazole. Marked inhibition of metabolism w/ ritonavir. Risk of QT
prolongation & cardiac arrhythmias including ventricular tachycardia/fibrillation & torsades de pointes w/
CYPA3A substrates astemizole, cisapride, domperidone, pimozide & terfenadine. Risk of torsades de
pointes w/ quinidine or disopyramide. Hypoglycemia w/ disopyramide; nateglinide & repaglinide. Increased
steady-state plasma conc of omeprazole. Increased exposure of phosphodiesterase inhibitors exposure w/
sildenafil, tadalafil, vardenafil, atazanavir. Increased circulating levels of theophylline or carbamazepine.
Higher serum conc of tolterodine. Increased exposure to colchicine & digoxin. Decreased steady-state of
zidovudine conc. Increased serum levels of phenytoin & valproate. Risk of hypotension w/ Ca channel
blockers (eg, verapamil, amlodipine, diltiazem). Increased plasma levels w/ itraconazole. Higher steady-
state AUC & Cmax values of saquinavir.

Administration: May be taken with or without food and w/ milk.

Storage: Store below 30°C.

Pregnancy Category: C

ATC Code: J01FA09

Cost:

ZENITH SUSPENSION
Rx Azithromycin monohydrate

Dosage Forms/ Strength: 200mg/5ml Powder for Oral Suspension

Indication: Treatment of mild to moderate infections caused by susceptible microorganisms including


upper & lower resp tract infections (eg. acute bacterial bronchitis & sinusitis, community-acquired
P a g e | 47

pneumonia, acute otitis media, acute streptococcal pharyngitis or tonsillitis; uncomplicated skin & skin
structure infections; Chlamydia trachomatis conjunctivitis & trachoma).

Contraindications: Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic.


History of cholestatic jaundice or hepatic dysfunction. Co-administration w/ pimozide.

Dosage: Childn Total dose: 30 mg/kg in a 3-day or 5-day regimen. 3-day regimen: 10 mg/kg once daily for
3 days. 5-day regimen: 10 mg/kg on Day 1 followed by 5 mg/kg once daily for Days 2-5. 3-day (Days 1-3) &
5-day (Day 1) therapy (10 mg/kg/day): >45 kg 12.5 mL, 36-45 kg 10 mL, 26-35 kg 7.5 mL, 17-25 kg 5 mL,
16 kg 4 mL, 14 kg 3.5 mL, 12 kg 3 mL, 10 kg 2.5 mL. 5-day therapy (Days 2-5) therapy (5 mg/kg/day): >45
kg 6.25 mL, 36-45 kg 5 mL, 26-35 kg 3.75 mL, 17-25 kg 2.5 mL, 16 kg 2 mL, 14 kg 1.75 mL, 12 kg 1.5
mL, 10 kg 1.25 mL. Streptococcal pharyngitis 10 or 20 mg/kg once daily for 3 days. Max: 500 mg/day.
Conjunctivitis & trachoma Childn ≥12 mth 20 mg/kg as a single dose or once a wk for up to 3 wk.

 Overdosage:

 S/Sx: reversible hearing loss, severe nausea, vomiting and diarrhea

 Tx: lavage and general supporting measures are indicated.

Dosage Adjustments: Not stated

Precautions: Hypersensitivity reactions; hepatotoxicity; pneumonia inappropriate for oral treatment due to
moderate to severe illness or risk factors; myasthenia gravis; ventricular arrhythmias associated w/
prolonged QT interval including ventricular tachycardia & Torsades de pointes. Severe renal impairment
&/or significant liver disease. Consider diagnosis of pseudomembranous colitis in patients who develop
diarrhea. Avoid long-term or repeated use. Neurological or psychiatric disorders. Not for infected burn
wounds & systemic severe infections. Perform serologic test for syphilis & appropriate cultures for
gonorrhea. Co-administration w/ ergot derivatives. Lysosomal lipid storage diseases eg, Tay-Sachs
disease, Niemann-Pick disease. Fructose intolerance, glucose-galactose malabsorption syndrome or
sucrase-isomaltase insufficiency. May impair ability to drive or operate machinery. Pregnancy & lactation.
Childn <6 mth (community-acquired pneumonia, acute otitis media or bacterial sinusitis) or <2 yr
(pharyngitis & tonsillitis).

Adverse Drug Reactions: Nausea, vomiting, diarrhea or loose stools, abdominal discomfort (pain,
cramps), headache & rash.

Drug Interactions: decreased rate of absorption w/ Al & Mg hydroxide containing antacids. Additive
synergistic effects w/ antimalarial agents in vitro. Enhances risk of cardiotoxicity of astemizole & significant
inhibition of alfentanil clearance. Potentiates the anticoagulant effect of coumarin-type anticoagulants eg,
warfarin. Increased Cmax & AUC of ciclosporin. Elevated digoxin levels. Increases pharmacological effects
of disopyramide. Ergotism w/ ergot derivatives. Increased conc w/ nelfinavir. Increased serum conc of
phenytoin, hexobarbital & theophylline. Inhibit pimozide metabolism. Cardiac repolarization (QTc) interval
w/ terfenadine.

Administration: May be taken with or without food: Drink fruit juice immediately after swallowing to avoid
bitter after-taste.

Storage: Store at temperatures not exceeding 30°C. Reconstituted suspension: Do not store above 25°C.
Do not refrigerate or freeze. The ready-to-use suspension is stable for 5 days.

Pregnancy Category: B

ATC Code: J01FA10

Cost:
P a g e | 48

ZENITH
Rx Azithromycin monohydrate

Dosage Forms/ Strength: Each film-coated tablet contains: Azithromycin (as monohydrate) 500 mg.

Indication: Mild to moderate community-acquired pneumonia caused by Mycoplasma pneumoniae,


Chlamydophila psittaci (ornithosis) or Chlamydophila pneumoniae (TWAR). Acute exacerbation of chronic
bronchitis. Acute bacterial sinusitis. Tonsillitis, pharyngitis, acute otitis media, & skin & soft tissue infections
(eg, furunculosis, pyoderma, impetigo & erysipelas) in patients w/ hypersensitivity to β-lactam antibiotics or
when such treatment is not suitable. Uncomplicated genital infections caused by Chlamydia trachomatis or
Neisseria gonorrhoeae.

Contraindications: Hypersensitivity to azithromycin monohydrate, erythromycin, & to any macrolide or


ketolide antibiotics.

Dosage: Adult Uncomplicated genital infections due to Chlamydia trachomatis or sensitive Neisseria
gonorrhoeae 1,000 mg as single dose. Other indications 500 mg daily for 3 consecutive days. Alternatively,
500 mg on the 1st day then 250 mg on the 2nd-5th day. Childn >45 kg Normal adult dose.

 Overdosage:

 S/Sx: reversible hearing loss, severe nausea, vomiting and diarrhea

 Tx: the administration of medicinal charcoal and general symptomatic treatment and
supportive measures are indicated as required

Dosage Adjustments: Not stated

Precautions:

 Discontinue if an allergic reaction occurs.

 Fulminant hepatitis potentially leading to life-threatening liver failure in patients w/ preexisting


hepatic disease or taking other hepatotoxic medicinal products.

 Perform liver function tests in case of signs & symptoms of liver dysfunction eg, rapid developing
asthenia associated w/ jaundice, dark urine, bleeding tendency or hepatic encephalopathy.

 Discontinue immediately if signs & symptoms of hepatitis occur. Infantile hypertrophic pyloric
stenosis in neonates (treatment up to 42 days of life).

 Pseudomembranous colitis. Observe for signs of superinfection w/ non-susceptible organisms,


including fungi.
 Cross-resistance w/ erythromycin-resistant gm +ve strains & methicillin-resistant staphylococci
strains. Not intended for severe infections where fast high blood conc of antibiotic have to be
achieved. Clostridium difficile-associated diarrhoea.

 Patients w/ ongoing proarrhythmic conditions (especially women & elderly) eg, w/ congenital or
documented QT prolongation; current treatment w/ other active substances that prolong QT interval
eg, antiarrhythmics class IA (quinidine & procainamide) & class III (dofetilide, amiodarone, &
sotalol), cisapride, terfenadine, antipsychotics (eg, pimozide), antidepressants (eg, citalopram), &
fluoroquinolones (eg, moxifloxacin & levofloxacin); electrolyte disturbance, particularly hypokalaemia
& hypomagnesaemia; clinically relevant bradycardia, cardiac arrhythmia or severe cardiac
insufficiency.
P a g e | 49

 Exacerbations of the symptoms of myasthenia gravis & new onset of myasthenia syndrome. Long-
term use.

 Neurological & psychiatric disorders.

 Should not be co-administered w/ ergot derivatives.

 Visual impairment & blurred vision may have an effect on ability to drive or operate machinery.
Significant hepatic disease & severe renal impairment (GFR <10 mL/min).

 Pregnancy & lactation. Childn <45 kg.

Adverse Drug Reactions: Diarrhoea. Headache; vomiting, abdominal pain, nausea; decreased
lymphocyte count & blood bicarbonate; increased eosinophil count, basophils, monocytes, & neutrophils.

Drug Interactions: Reduced peak serum conc w/ antacids. Increased serum levels of P-glycoprotein
substrates (eg, digoxin & colchicine). Ergotism w/ ergot alkaloids. Increased conc of phosphorylated
zidovudine. Rhabdomyolysis w/ statins. Potentiated anticoagulation w/ coumarin-type oral anticoagulants
eg, warfarin. Elevated Cmax & AUC0-5 of cyclosporine. Increased conc w/ nelfinavir. Neutropenia may
occur w/ rifabutin. Co-resistance w/ other macrolides. Medicinal products known to prolong QT interval.

Administration: May be taken with or without food: Swallow whole, do not chew/crush.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: B

ATC Code: J01FA10

Cost:

AZI-500
Rx Azithromycin monohydrate

Dosage Forms/ Strength: Each film-coated tablet contains: Azithromycin (as monohydrate) 500 mg.

Indication: Bronchitis, severe campylobacter enteritis, chancroid diphtheria, Legionnaire's disease & other
Legionella infections, neonatal conjunctivitis, pertussis, pneumonia (mycoplasma & other atypical
pneumonias, streptococcal), sinusitis; STI. Surgical prophylaxis for bowel surgery in combination w/
neomycin. Component in the treatment & prophylaxis of Mycobacterium avium complex (MAC) infections.

Contraindications: Patients with hepatic impairment.

Dosage: Adult 500 mg once daily for 3 days or initially, 500mg followed by 250mg daily for a further 4-7
days.

Dosage Adjustments: Not stated

Precautions: Azithromycin should not be used in patients with hepatic impairment.

Adverse Drug Reactions: GI disturbances. Transient liver enzyme values elevation. Rashes, headache,
dizziness. Rare but may be prolonged, severe hypersensitivity. Transient alterations in neutrophil counts.
P a g e | 50

Drug Interactions: Not stated

Administration: May be taken with or without food: May be taken w/ meals to reduce GI discomfort.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: B

ATC Code: J01FA10

Cost:

Other Antibiotics

DALACIN C
Rx Clindamycin

Dosage Forms/ Strength: Each capsule contains Clindamycin hydrochloride hydrate equivalent to 300 mg
of Clindamycin respectively.

Indication: Upper resp infections including tonsillitis, pharyngitis, sinusitis, otitis media, & scarlet fever.
Lower resp infections including bronchitis, pneumonia, empyema, & lung abscess. Skin & soft tissue
infections including acne, furuncles, cellulitis, impetigo, abscess, & wound infections; erysipelas &
paronychia (panaritium). Bone & joint infections including osteomyelitis & septic arthritis. Gynecological
infections including endometritis, cellulitis, vag cuff infection & tubo-ovarian abscess, salpingitis, & pelvic
inflammatory disease when given in conjunction w/ an antibiotic of appropriate gm -ve aerobic spectrum;
cervicitis due to Chlamydia trachomatis. Intra-abdominal infections including peritonitis & abdominal
abscess when given in conjunction w/ an antibiotic of appropriate gm -ve aerobic spectrum. Septicemia &
endocarditis. Dental infections eg, periodontal abscess & periodontitis. In combination w/ pyrimethamine for
toxoplasmic encephalitis in AIDS patients if intolerant to conventional treatment. In combination w/
primaquine for Pneumocystis jiroveci pneumonia in AIDS patients if intolerant or do not respond adequately
to conventional treatment. In combination w/ quinine for malaria including multi-resistant Plasmodium
falciparium. Prophylaxis of endocarditis in patients sensitive/allergic to penicillin(s); infection in neck & head
surgery. Inj: Intraoperative irrigant of the surgical field. In concomitant use w/ aminoglycosides (eg,
gentamicin or tobramycin) in prevention of peritonitis or intra-abdominal abscess after bowel perforation &
bacterial contamination secondary to trauma.

Contraindications: Hypersensitivity to clindamycin or lincomycin.

Dosage: Adult 600-1800 mg/day divided in 2, 3 or 4 equal doses. To avoid the possibility of esophageal
irritation, clindamycin HCl capsules should be taken with a full glass of water. For children who are able to
swallow capsules): To avoid the possibility of esophageal irritation, clindamycin HCl capsules should be
taken with a full glass of water. Doses of 8-25 mg/kg/day in 3 or 4 equal doses.

 Overdosage: Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from
the serum.

Dosage Adjustments: Not stated

Precautions: Discontinue if hypersensitivity or severe skin reactions eg, drug reaction w/ eosinophilia &
systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), &
P a g e | 51

acute generalized exanthematous pustulosis (AGEP) occurs. Pseudomembranous colitis. Clostridium


difficile-associated diarrhea. Not to be used in the treatment of meningitis. Perform liver & kidney function
tests for prolonged therapy. Pregnancy & lactation. Inj: Overgrowth of non-susceptible organisms,
particularly yeasts. Do not inj IV undiluted as a bolus. Gasping syndrome in premature & low birth wt infants
due to benzyl alcohol content.

Adverse Drug Reactions: Pseudomembranous colitis, Clostridium difficile colitis, vag infection;
agranulocytosis, neutropenia, thrombocytopenia, leukopenia, eosinophilia; anaphylactic shock & reaction,
anaphylactoid reaction, hypersensitivity; dysgeusia; cardio-resp arrest; hypotension; diarrhea, abdominal
pain, vomiting, nausea; jaundice; toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction
with eosinophilia & systemic symptoms, acute generalized exanthematous pustulosis, angioedema,
exfoliative dermatitis, bullous dermatitis, maculopapular rash, urticaria, erythema multiforme, pruritus,
morbilliform rash; abnormal liver function test. Cap/granules for oral soln: Esophageal ulcer, esophagitis.
Inj: Thrombophlebitis; pain, inj site abscess/irritation.

Drug Interactions: May enhance the action of other neuromuscular blocking agents. May reduce
clearance w/ CYP3A4 & CYP3A5 inhibitors. May increase clearance w/ CYP3A4 & CYP3A5 inducers. Loss
of effectiveness w/ strong CYP3A4 inducers eg, rifampicin.

Administration: May be taken with or without food: Swallow whole w/ a full glass of water & in an upright
position

Storage: Store below 30°C.

Pregnancy Category: B

ATC Code: J01FF01

Cost:
P a g e | 52

Cephalosporins

TRIOCEF
Rx Cefixime

Dosage Forms/ Strength: 400 mg FC tablet

Indication: Treatment of susceptible infections including gonorrhea, otitis media, pharyngitis, lower resp
tract infections eg, bronchitis & UTI.

Contraindications: Hypersensitivity to cefixime or other cephalosporins. Renal impairment (CrCl <60


mL/min).

Dosage: FC tab Adult 400 mg once daily or 200 mg 12 hrly. Uncomplicated cervical/urethral
gonococcal infections 400 mg as single dose. Childn 8 mg/kg/day as single dose or 4 mg/kg 12 hrly.
Typhoid 20 mg/kg/day in 2 divided doses for 10 days. S. pyogenes infections 20 mg/kg/day as single
dose for 10 days.

Dosage Adjustments:

 Renal Impairment

 CrCl <20 mL/min Patient on CAPD or haemodialysis: Max: 200 mg once daily.

Precautions:

 Hypersensitivity to penicillins. History of allergy.

 Renal impairment.

 Avoid prolonged use. Discontinue use if diarrhea occurs.

 May interfere w/ Jaffe's method of measuring creatinine conc & may produce falsely high values.
False +ve direct Coombs' test. False +ve reaction for glucose in urine w/ Benedict's or Fehling's
soln or copper sulfate test.

 Pregnancy & lactation.


P a g e | 53

Adverse Drug Reactions: GI disturbances eg, diarrhea & stool changes; headache, dizziness; skin
rashes, pruritus, urticaria, fever, serum sickness-like reactions, arthralgia, anaphylaxis; thrombocytopenia,
leukopenia, eosinophilia.

Drug Interactions: Enhances anticoagulant effect of coumarin drugs (eg, warfarin).

Administration: May be taken with or without food: May be taken w/ food or milk to reduce GI discomfort.

Storage: Store below 30°C.

Pregnancy Category: B

ATC Code: J01DD08

Cost:

TERGECEF
Rx Cefixime

Dosage Forms/ Strength: Each 5 mL suspension contains: Cefixime 100 mg. Each mL suspension (oral
drops) contains: Cefixime 20 mg.

Indication: Acute bronchitis, acute exacerbations of chronic bronchitis, bronchiectasis w/ infection,


secondary infections in chronic resp tract diseases, pneumonia; UTI including pyelonephritis & cystitis;
gonococcal urethritis; cholecystitis, cholangitis; scarlet fever; sinusitis, tonsillitis, pharyngitis, otitis media;
typhoid fever (enteric fever) including multi-drug resistant typhoid fever.

Contraindications: Hypersensitivity to cefixime, other cephalosporins or penicillins.

Dosage: Childn 8 mg/kg as single dose or in 2 divided doses every 12 hr. Typhoid fever 15-20 mg/kg
once daily or divided into 2 doses every 12 hr for 7-14 days. Max: 400 mg/day. Granules for oral susp
Adult & childn >12 yr 20 mL once daily or 10 mL every 12 hr. Childn 7-12 yr 10-15 mL once daily or 5-7.5
mL every 12 hr, 3-6 yr 5-10 mL once daily or 2.5-5 mL every 12 hr, 1-2 yr 2.5-5 mL once daily or 1.25-2.5
mL every 12 hr. Usual treatment duration: 7-14 days. Oral drops Childn 1-2 yr 2.5-5 mL once daily or 1.25-
2.5 mL every 12 hr, 6-11 mth 2.5-5 mL once daily or 1.25-2.5 mL every 12 hr. Usual treatment duration: 7-
14 days.

 Overdosage: Gastric lavage may be indicated; otherwise, no specific antidote exists. Cefixime is
not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis.
Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of
cefixime did not differ from the profile seen in patients treated at the recommended doses.

Dosage Adjustments: Not stated

Precautions:

 Serious acute hypersensitivity reactions.

 Clostridium difficile-associated diarrhea & colitis. Fall in prothrombin activity. Overgrowth of non-
susceptible organisms including fungi on long-term or repeated use.

 Patients w/ history of colitis; kidney or liver impairment or poor nutritional state; receiving a
protracted course of antimicrobial therapy or previously stabilized on anticoagulant therapy.
P a g e | 54

 False +ve direct Coombs' test; ketones in the urine using nitroprusside test; & glucose in the urine
using Clinitest, Benedict's soln or Fehling's soln.

 Pregnancy & lactation. Childn <6 mth.

Adverse Drug Reactions: Anaphylactic/anaphylactoid reactions, skin rashes, urticaria, fever, pruritus,
arthralgia, angioedema, facial edema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal
necrolysis, serum sickness-like reactions; diarrhea, loose or frequent stools, abdominal pain, anorexia,
flatulence, dry mouth, dyspepsia, nausea, vomiting, pseudomembranous colitis; transient elevation of ALT,
AST, alkaline phosphatase, hepatitis, jaundice; transient elevations in BUN or creatinine levels; headache,
dizziness, nervousness, insomnia, somnolence, malaise, fatigue, seizures; transient thrombocytopenia,
leukopenia, neutropenia, eosinophilia; hyperbilirubinemia.

Drug Interactions: Elevated carbamazepine levels. Increased prothrombin time w/ or w/o clinical bleeding
w/ warfarin & other anticoagulants. Increased peak serum conc & AUC w/ probenecid & decreased renal
clearance & vol distribution. Decreased peak serum conc & AUC w/ aspirin.

Administration: May be taken with or without food: May be taken w/ food or milk to reduce GI discomfort.

Storage: Store below 30°C.


Pregnancy Category: B

ATC Code: J01DD08

Cost:

CEFALIN
Rx Cefalexin

Dosage Forms/ Strength: Oral susp 250mg/5ml; 125mg/5ml. Oral drops 100mg/ml

Indication: Infections of the resp tract, GUT, ear & bone, skin & soft tissues including penicillinase-
producing S. aureus infections. Dental infections.

Contraindications: Hypersensitivity to cephalosporins

Dosage: Childn 25-50 mg/kg/day in 4 divided doses. Severe infection Double dose. β-hemolytic strep
infection Take for 10 days. Otitis media 75-100 mg/kg/day divided qid.

 Overdosage:

 S/Sx: nausea, vomiting, epigastric distress, diarrhea and hematuria

 Tx: the administration of medicinal charcoal and general symptomatic treatment and
supportive measures are indicated as required

Dosage Adjustments:

 Renal Impairment – decreases in doses and/or frequency of administration of cefalexin may be


required and should be based on the degree of renal impairment, severity of infection, susceptibility
of the causative organism, and serum concentrations of cefalexin.

Precautions: Penicillin-sensitive patients. Impaired renal function.

Adverse Drug Reactions: GI disturbances; diarrhea, hypersensitivity reactions.


P a g e | 55

Drug Interactions: Alcohol, Probenecid, Estrogens/Progestins, Metformin, Nephrotoxic drugs, diuretics


and other anti-infective agents.

Administration: May be taken with food to reduce GI discomfort.

Storage: Store in a dry place below 30°C. Protect from light. Keep the products out of sight and reach of
children.

Pregnancy Category: B

ATC Code: J01DB01

Cost:

ZEGEN
Rx Cefuroxime axetil

Dosage Forms/ Strength: Each tablet contains: Cefuroxime (as axetil) 500 mg.

Indication: Treatment of infections caused by susceptible microorganisms including upper & lower resp
tract, uncomplicated skin & skin structure infections, uncomplicated UTI & gonorrhea; early Lyme disease.

Contraindications: Hypersensitivity to cefuroxime, other cephalosporins or penicillins.

Dosage:

 Adult & adolescent ≥13 yr Acute sinusitis, acute tonsillopharyngitis, acute bacterial
exacerbations of chronic bronchitis, uncomplicated skin & skin structure infections 250 or
500 mg every 12 hr for 10 days. Acute otitis media 500 mg every 12 hr for 10 days.
Uncomplicated gonorrhea 1,000 mg once as single dose. Secondary bacterial infections of
acute bronchitis 250 or 500 mg every 12 hr for 5-10 days. Uncomplicated UTI 250 or 500 mg
every 12 hr for 7-10 days. Early Lyme disease 500 mg every 12 hr for 20 days.

 Childn 7-12 yr Acute sinusitis, acute otitis media, acute tonsillopharyngitis, acute bacterial
exacerbations of chronic bronchitis, uncomplicated skin & skin structure infections 250 mg
every 12 hr for 10 days. Secondary bacterial infections of acute bronchitis 250 mg every 12 hr
for 5-10 days. Uncomplicated UTI 250 mg every 12 hr for 7-10 days. Early Lyme disease 250 mg
every 12 hr for 20 days.

 Overdosage:

 S/Sx: cerebral irritation leading to convulsions

 Tx: removed by hemodialysis or peritoneal dialysis.

Dosage Adjustments: Not stated

Precautions:

 Clostridium difficile-associated diarrhea. History of colitis.


P a g e | 56

 Patients w/ kidney or liver impairment, poor nutritional state, receiving protracted course of
antimicrobial therapy & previously stabilized on anticoagulant therapy.

 Monitor prothrombin time.

 Pregnancy & lactation. Childn <3 mth. Elderly

 Tab: History of cephalosporin-associated hemolytic anemia. Periodic monitoring for signs &
symptoms of hemolytic anemia including measurement of hematological parameters of drug-
induced antibody testing.

 Discontinue if seizures develop. Monitor renal function when given concurrently w/ aminoglycosides
&/or diuretics.

 Jarisch-Herxheimer reaction following treatment of Lyme disease. Overgrowth of non-susceptible


organisms including fungi on long-term or repeated use. May impair ability to drive or operate
machinery.

 Renal impairment..

Adverse Drug Reactions: Rash, hives, erythema, pruritus, urticaria, drug fever, angioedema, serum
sickness-like reaction, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
(exanthemic necrolysis), shortness of breath & severe bronchospasm; diarrhea, nausea, vomiting,
abdominal pain/cramps, gagging, epigastric burning, epigastric pain/dyspepsia, flatulence, indigestion, GI
bleeding, mouth ulcers, swollen tongue, dislike of taste, stomach cramps, anorexia, thirst, GI infection,
ptyalism, pseudomembranous colitis; urethral pain or bleeding, kidney pain, UTI, dysuria, acute renal
failure/dysfunction, interstitial nephritis, transient increases in BUN & serum creatinine conc, decreased
CrCl, bilateral renal cortical necrosis, vaginitis, vag candidiasis, vulvovag pruritus, vag discharge or
irritation, menstrual irregularities; eosinophilia, neutropenia, hemolytic anemia, leukopenia, pancytopenia,
thrombocytopenia, thrombocytosis, lymphocytosis, increased prothrombin time, increased erythrocyte
sedimentation rate, decreased Hb &/or hematocrit, +ve Coombs' test; transient elevations in AST, ALT, γ-
glutamyl transferase, alkaline phosphatase, lactate dehydrogenase, & bilirubin, jaundice, hepatic
impairment; muscle spasm of the neck, muscle cramps or stiffness, arthralgia/joint pain or swelling;
headache, dizziness, somnolence/sleepiness, irritable behavior, seizures, myoclonic jerks, generalized
hyperexcitability/hyperactivity; pleural effusion, pulmonary infiltrate, dyspnea or resp distress, upper resp
infection, rhinitis, sinusitis, cough; chest pain or tightness, tachycardia; Jarisch-Herxheimer reaction in
patients treated for Lyme disease, candidiasis/candida overgrowth, mild to severe hearing loss, increased
or decreased serum glucose conc, lockjaw-type reaction, viral illness.

Drug Interactions: Increased risk of nephrotoxicity w/ aminoglycosides. Increased risk of renal toxicity w/
potent diuretics including furosemide & ethacrynic acid. Slows down tubular secretion w/ probenecid. Tab:
Lower bioavailability w/ oral antacids. Reduced efficacy of combined OCs.

Administration: Should be taken with food: Take immediately after meals.

Storage: Store in a cool, dry and dark place at temperatures not exceeding 30°C.

Pregnancy Category: B

ATC Code: J01DC02

Cost:

ZINNAT
Rx
P a g e | 57

Cefuroxime axetil

Dosage Forms/ Strength: Granules of cefuroxime axetil for oral suspension containing 125mg or 250mg
of cefuroxime in each 5ml.

Indication: Upper & lower resp tract infections, GUT, skin & soft tissue infections, gonorrhoea, acute
uncomplicated gonococcal urethritis & cervicitis.

Contraindications: Hypersensitivity to cephalosporins and other β-lactams.

Dosage:

 Recommended dose: 10 mg/kg bid. Max: 250mg daily. Childn 2-12 yr 125 mg, 6mth-2yr 60-
120mg, 3-6mth 40-60mg all doses be taken bid.

 Otitis media/severe infections Recommended dose: 15mg/kg bid. Max: 500mg daily. Childn 2-
12yr 180-250mg, 16mth-2 yr 90-180mg, 3-6mth 60-90mg all doses be taken bid.

 Overdosage:

 S/Sx: cerebral irritation leading to convulsions

 Tx: removed by hemodialysis or peritoneal dialysis.

Dosage Adjustments: Not stated

Precautions: Diabetic patients; phenylketonuria. Allergic reaction to penicillins or other β-lactams.


Overgrowth of non-susceptible organisms eg, enterococci & Clostridium difficile. Pseudomembranous
colitis. May affect ability to drive & use machines. Pregnancy & lactation.

Adverse Drug Reactions: Overgrowth of Candida; eosinophilia; headache, dizziness; GI disturbances eg,
diarrhoea, nausea, abdominal pain; transient increase in ALT (SGPT), AST (SGOT), LDH.

Drug Interactions: Lowered bioavailability w/ drugs reducing gastric acidity. Lowered oestrogen
reabsorption & reduced efficacy of combined OCs. False -ve result in ferricyanide test.

Administration: Should be taken with food: Take immediately after meals for optimum absorption

Storage: The reconstituted suspension must be refrigerated immediately at between 2 and 8°C. Shelf-Life:
The unreconstituted suspension should be stored below 30°C. The reconstituted suspension when
refrigerated between 2 and 8°C can be kept for up to 10 days.

Pregnancy Category: B

ATC Code: J01DC02

Cost:
P a g e | 58

Dyslipidaemic Agents

AVAMAX
Rx Atorvastatin Calcium

Dosage Forms/ Strength: Each tablet contains 10mg, 20mg, 40 mg and 80mg of Atorvastatin Ca.

Indication: Reduces LDL-cholesterol, apolipoprotein B & triglycerides; increases HDL-cholesterol in the


treatment of hyperlipidemias. Adjunct therapy in patients w/ homozygous familial hypercholesterolemia who
have some LDL-receptor function. Primary prophylaxis of CV events in patients w/ multiple risk factors.

Contraindications: Active liver disease or unexplained persistent elevations of serum transaminases.


Pregnancy, women of childbearing potential, lactation.

Dosage: Dose range: 10-80 mg once daily. Doses may be given any time of the day. Dosage should be
individualized according to baseline LDL-cholesterol levels, goal of therapy & patient response. Primary
hypercholesterolemia & combined hyperlipidemia 10 mg once daily. Homozygous familial
hypercholesterolemia 10-80 mg daily.

 Overdosage: There is no specific treatment for atorvastatin overdosage. In the event of an


overdosage, the patient should be treated symptomatically and supportive measures instituted as
required to ensure the functioning of vital organs. Due to extensive drug-binding to plasma proteins,
hemodialysis is not expected to significantly enhance atorvastatin elimination from the body.

Dosage Adjustments: Not stated

Precautions: Perform liver function tests & monitor for creatine phosphokinase & transaminase elevations.
Avoid alcohol consumption. Temporarily discontinue therapy in patients w/ an acute, serious condition
suggestive of a myopathy or renal failure secondary to rhabdomyolysis.

Adverse Drug Reactions: Chest pain, face edema, fever, neck rigidity, malaise, photosensitivity reaction,
generalized edema. Nausea & vomiting, gastroenteritis, colitis, gastritis, dry mouth. Arthritis, leg cramps,
bursitis, tenosynovitis, myasthenia, tendinous contracture, myositis. Anaphylaxis, angioneurotic edema,
bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
rhabdomyolysis & fatigue.
P a g e | 59

Drug Interactions: Cyclosporin, fibric acid derivatives, erythromycin, azole antifungals or niacin. Oral
antacid susp containing Mg & Al hydroxide, colestipol, digoxin. PIs, diltiazem HCl & grapefruit juice.
Norethisterone & ethinylestradiol.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: X

ATC Code: C10AA05

Cost:

ITORVAZ
Rx Atorvastatin Calcium

Dosage Forms/ Strength: Each film-coated tablet contains Atorvastatin (as Calcium) 20 mg, 40 mg or 80
mg.

Indication: Adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B &
triglycerides in adults & childn ≥10 yr w/ primary hypercholesterolemia, heterozygous familial
hypercholesterolemia or combined (mixed) hyperlipidemia. Raises HDL-cholesterol & lowers LDL/HDL &
total cholesterol/HDL ratios. Adjunct to diet & non-dietary measures in reducing elevated total cholesterol,
LDL-cholesterol, & apolipoprotein B in patients w/ homozygous familial hypercholesterolemia. Primary
prevention in Type II DM.

Contraindications: Hypersensitivity. Active liver disease or unexplained persistent elevations of serum


transaminase. Pregnancy & lactation.

Dosage: Adult Primary hypercholesterolemia & combined hyperlipidemia 10 mg once daily. Familial
hypercholesterolemia Initially 10 mg daily, increased at intervals of 4 wk to 40 mg once daily. Max: 80 mg
once daily. Childn & adolescent 10-17 yr Heterozygous familial hypercholesterolemia Initially 10 mg
once daily. Max: 20 mg daily.

 Overdosage: There is no specific treatment in the event of overdose. In case of overdosage,


discontinue rosuvastatin, and institute appropriate symptomatic and supportive therapy. Liver
function and creatinine levels should be monitored. Hemodialysis is unlikely to be of benefit.

Dosage Adjustments: Not stated

Precautions: Monitor skeletal muscle (eg, myopathy, rhabdomyolysis), renal (eg, proteinuria, hematuria) &
endocrine (eg, increased HbA1c & fasting serum glucose levels) effects. Perform liver function tests before
initiation of therapy & if signs & symptoms of liver injury occur. Increased risk of interstitial lung disease
(particularly w/ long-term therapy), DM (in patients w/ fasting glucose 5.6-6.9 mmol/L). Childn <10 yr.
Elderly.

Adverse Drug Reactions: Not stated

Drug Interactions: Risk of myopathy w/ cyclosporin, fibric acid derivatives, niacin, erythromycin & azole
antifungals. Decreased plasma conc w/ antacids containing Mg & Al hydroxide, colestipol. Increased
P a g e | 60

steady-state plasma digoxin conc. Higher plasma conc w/ erythromycin & clarithromycin. Increased AUC
values of norethisterone & ethinyl estradiol.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C. Protect from light.

Pregnancy Category: X

ATC Code: C10AA05

Cost:

ROSWIN
Rx Rosuvastatin Calcium

Dosage Forms/ Strength: Each tablet contains Rosuvastatin (as Calcium) 5 mg.

Indication: Decrease elevated total cholesterol (total-C), LDL-cholesterol (LDL-C) & triglycerides (TG);
increase high density lipoprotein cholesterol (HDL-C) in adult patients w/ primary hypercholesterolemia
(heterozygous familial & nonfamilial) or mixed dyslipidemia (Fredrickson types IIa & IIb). Decrease Apo B,
non-HDL-C, VLDL-C, VLDL-TG, LDL-C/HDL-C, total-C/HDL-C, non-HDL-C/HDL-C & Apo B/Apo A-I ratios
& increase Apo A-I. Decrease total-C, LDL-C & Apo B levels in adolescent boys & girls (who are at least 1
yr post-menarche), 10-17 yr w/ heterozygous familial hypercholesterolemia if after an adequate trial of diet
therapy, the following are present: LDL-C >190 mg/dL or LDL-C >160 mg/dL & there is +ve family history of
premature CV disease or ≥2 other CV risk factors are present. Treatment of isolated hypertriglyceridemia
(Fredrickson type IV hyperlipidemia) & primary dysbetalipoproteinemia (Fredrickson type III
hyperlipoproteinemia). Decrease total-C & LDL-C in patients w/ homozygous familial hypercholesterolemia
as adjunct to other lipid-lowering treatments (eg, LDL apheresis) or alone if such treatments are
unavailable. Slow progression of CV disease. Primary prevention of CV disease.

Contraindications: Hypersensitivity. Active liver disease including unexplained, persistent elevations in


serum transaminases & any serum transaminase elevation >3 times the upper limit of normal. Moderate &
severe renal impairment, myopathy, hypothyroidism. History of hereditary muscular disorders; muscular
toxicity w/ another HMG-CoA reductase inhibitor or fibrate. Alcohol abuse. Situations where an increase in
plasma rosuvastatin levels may occur. Asian patients. Concomitant use of fibrates. Pregnancy & lactation.

Dosage: 5-40 mg/day as single dose. Hyperlipidemia (including heterozygous familial


hypercholesterolemia), mixed dyslipidemia, isolated hypertriglyceridemia, slowing of
atherosclerosis progression Initially 10 mg once daily. Patient w/ severe hypercholesterolemia
(including heterozygous familial hypercholesterolemia) 20 mg once daily. Childn (10-17 yr) w/
heterozygous familial hypercholesterolemia Initially 5 mg once daily. Max: 20 mg once daily.
Adjustments should be made at intervals of ≥4 wk. Homozygous familial hypercholesterolemia Initially
20 mg once daily. Response to therapy should be estimated from pre-apheresis LDL-C levels. Primary
prevention of CV disease 20 mg once daily. Patient w/ predisposing factors to myopathy, moderate
renal impairment & elderly >70 yr 5 mg once daily. Severe hepatic impairment 10 mg once daily.

 Overdosage: There is no specific treatment in the event of overdose. In case of overdosage,


discontinue rosuvastatin, and institute appropriate symptomatic and supportive therapy. Liver
function and creatinine levels should be monitored. Hemodialysis is unlikely to be of benefit.

Dosage Adjustments: Not stated


P a g e | 61

Precautions: Control hypercholesterolemia w/ appropriate diet, exercise & wt reduction in obese patients &
treat other underlying medical problems. Unexplained muscle pain, tenderness or weakness, particularly if
accompanied by malaise or fever should be reported.

Adverse Drug Reactions: Asthenia, edema, flu syndrome; GI, hepatic, metabolic, nutritional, lab,
musculoskeletal, nervous, resp, skin & urogenital effects.

Drug Interactions: Increased exposure w/ ciclosporin, gemfibrozil; AUC w/ PIs & itraconazole. Increased
INR w/ coumarin anticoagulants; risk of skeletal muscle effects w/ niacin (≥1 g/day), myopathy w/
fenofibrates. Decreased plasma conc w/ antacid containing Al & Mg hydroxide; AUC & Cmax w/
erythromycin. Increased plasma conc of OCs/hormone replacement therapy.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: X

ATC Code: C10AA07

Cost:

LUSTATIN-10 / LUSTATIN 20
Rx Rosuvastatin Calcium

Dosage Forms/ Strength: Each film coated tablet contains: Rosuvastatin Calcium Eq. to Rosuvastatin 10
mg or 20mg.

Indication: Reduce LDL cholesterol, apolipoprotein B & triglycerides & to increase HDL-cholesterol in the
management of hyperlipidemias including primary hypercholesterolemia (type IIa), mixed dyslipidemia (type
IIb) & hypertriglyceridemia (type IV), as well as in patients w/ homozygous familial hypercholesterolemia.
Reduce the progression of atherosclerosis.

Contraindications: Hypersensitivity. Active liver disease or unexplained persistent elevated liver function
tests. Pregnancy & lactation.

Dosage: Adult Primary hypercholesterolemia (heterozygous familial & nonfamilial) & mixed
dyslipidemia Initially 10 mg once daily. Patient w/ marked hypercholesterolemia (LDL-cholesterol
>190 mg/dL) & aggressive lipid targets Initially 20 mg once daily. May be increased as necessary to a
max of 40 mg daily & should be reserved for patients who have not achieved LDL-cholesterol goal w/ the
20-mg daily dosage. Homozygous familial hypercholesterolemia Initially 10 mg once daily. Max: 40 mg
once daily. Hypertriglyceridemia Initially 10 mg once daily; usual dosage range: 5-40 mg daily. Max: 40
mg once daily & should be reserved for patients responding inadequately to the 20-mg daily dosage.

 Overdosage: In case of over dosage treatment should be symptomatic.

Dosage Adjustments: Not stated

Precautions:
Warnings

Hepatic Effects: Therapy with Rosuvastatin and other statins has been associated with increases in
serum aminotransferase (transaminase) concentrations. Therefore, the manufacturer recommends that
liver function tests be performed before and at 12 weeks after initiation of Rosuvastatin therapy or any
increase in dosage and periodically (e.g., semiannually) thereafter. Patients who develop increased
serum transaminase concentrations or manifestations of liver disease should have frequent liver
function tests performed thereafter until the abnormalities return to normal.
Jaundice has been reported rarely with Rosuvastatin therapy.
P a g e | 62

 Perform liver function tests before & at 12 wk after initiation of rosuvastatin therapy or any increase
in dosage & periodically thereafter. Myopathy, rhabdomyolysis. Institute appropriate dietary
regimens, wt reduction, exercise & treatment of any underlying disorder that may cause lipid
abnormality prior to initiation of therapy.

Adverse Drug Reactions: Myalgia, constipation, asthenia, abdominal pain & nausea.

Drug Interactions: Decreased plasma conc w/ Al-Mg hydroxide containing antacids. Enhanced effect w/
bile acid sequestrants. Increased peak plasma conc & AUC w/ cyclosporine.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C. Protect from light.


Pregnancy Category: Not Classified

ATC Code: C10AA07

Cost:
P a g e | 63

Anticonvulsants / Drugs for Neuropathic Pain

LYRICA
Rx Pregabalin

Dosage Forms/ Strength: Each capsule contains 50mg, 75mg, or 150mg pregabalin.

Indication: Neuropathic pain in adults, including neuropathic pain associated w/ spinal cord injury.
Adjunctive therapy in adults w/ partial seizures w/ or w/o secondary generalization. Generalized anxiety
disorder (GAD) in adults. Management of fibromyalgia.

Contraindications: Hypersensitivity.

Dosage: 150-600 mg/day in 2 or 3 divided doses. Neuropathic pain Initially 150 mg/day, may be
increased to 300 mg/day after an interval of 3-7 days. Max: 600 mg/day after an additional 7-day interval.
Fibromyalgia 300-450 mg/day in 2 divided doses. Begin at 75 mg bid & may be increased to 150 mg bid
w/in 1 wk based on efficacy & tolerability. May be further increased to 225 mg bid. Max: 600 mg/day after
an additional wk. Epilepsy Initially 150 mg/day, may be increased to 300 mg/day after 1 wk. Max: 600
mg/day after an additional wk. GAD 150-600 mg/day as 2 or 3 divided doses. Initially 150 mg/day, may be
increased to 300 mg/day after 1 wk. Following an additional wk, may be increased to 450 mg/day. Max: 600
mg/day after an additional wk. Discontinuation: Gradually w/draw over a min of 1 wk.

 Overdosage:

 S/Sx: affective disorder, somnolence, confusional state, depression, agitation, and


restlessness. Seizures were also reported.

 Tx: general supportive measures and may include hemodialysis if necessary

Dosage Adjustments:

 Renal impairment CrCl ≥60 mL/min 150 mg/day bid or tid. Max: 600 mg/day bid or tid, ≥30 to <60
mL/min 75 mg/day bid or tid. Max: 300 mg/day bid or tid, ≥15 to <30 mL/min 25-50 mg/day once
P a g e | 64

daily or bid. Max: 150 mg/day once daily or bid, <15 mL/min 25 mg once daily. Max: 75 mg once
daily.

 Supplementary dose following hemodialysis 25 mg as single dose. Max: 100 mg as single dose.

Precautions: Discontinue immediately if symptoms of angioedema eg, facial, perioral or upper airway
swelling occur. Do not take in patients w/ galactose intolerance, Lapp lactase deficiency or glucose-
galactose malabsorption. Diabetic patients. Loss of consciousness, confusion, mental impairment; transient
visual blurring & other changes in visual acuity; CHF. W/drawal symptoms upon discontinuation (eg,
insomnia, headache, nausea, anxiety, hyperhidrosis & diarrhea). Evaluate patients for history of drug abuse
& observe for signs of pregabalin misuse or abuse. Concomitant use w/ opioids. May cause dizziness &
somnolence influencing the ability to drive or operate machinery. Pregnancy & lactation. Childn <12 yr &
adolescents. Elderly >65 yr.

Adverse Drug Reactions: Dizziness, somnolence; headache. Nasopharyngitis; increased appetite;


euphoric mood, confusion, irritability, depression, disorientation, insomnia, decreased libido; ataxia,
abnormal coordination, tremor, dysarthria, amnesia, memory impairment, disturbance in attention,
paresthesia, hypoesthesia, sedation, balance disorder, lethargy; blurred vision, diplopia; vertigo; vomiting,
constipation, flatulence, abdominal distension, dry mouth; muscle cramp, arthralgia, back pain, limb pain,
cervical spasm; peripheral edema, edema, abnormal gait, fall, feeling drunk, feeling abnormal, fatigue;
increased wt; nausea, diarrhea.

Drug Interactions: May potentiate effects of ethanol & lorazepam. Additive in impairment of cognitive &
gross motor function w/ oxycodone. Resp failure, coma & death w/ other CNS depressants. Reduced lower
GIT function (eg, intestinal obstruction, paralytic ileus, constipation) w/ medications that have potential to
produce constipation eg, opioid analgesics.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: C

ATC Code: N03AX16

Cost:

GABIX
Rx Gabapentin

Dosage Forms/ Strength: Each capsule contains 100mg or 300mg gabapentin.

Indication: Adjunctive treatment of seizures & neuropathic pain..

Contraindications: Not stated

Dosage: Epilepsy Adult & childn >12 yr 900-3600 mg/day. Start w/ 300 mg tid or by dose titration: Day 1:
300 mg once daily; Day 2: 300 mg bid; Day 3: 300 mg tid. Thereafter, increase dose in increments of 300
mg/day for 2-3 days up to max dose of 3600 mg/day. Childn ≥6 yr Starting dose: 10-15 mg/kg/day.
Effective dose: 25-35 mg/kg/day up to 50 mg/kg/day in 3 divided doses. Max time interval between doses is
not >12 hr. Neuropathic pain Titrate dose similar to treatment of epilepsy or start w/ 900 mg/day in 3 divided
doses up to a max of 3600 mg/day.

 Overdosage:
P a g e | 65

 S/Sx: dizziness, double vision, slurred speech, drowsiness, lethargy and mild diarrhea.
Overdose of gabapentin, particularly in combination with other CNS depressant medications
may result in coma

 Tx: Reduced absorption of gabapentin at higher doses may limit drug absorption at the time
of overdosing and, hence, minimize toxicity overdose. In patients with severe renal
impairment, hemodialysis may be indicated.

Dosage Adjustments:

 Patient w/ impaired renal function CrCl ≥80 mL/min 900-3600 mg/day; 50-79 mL/min 600-1800
mg/day; 30-49 mL/min 300-900 mg/day; 15-29 mL/min 150-600 mg/day (150 mg to be
administered as 300 mg every other day); <15 mL/min 150-300 mg/day (150 mg to be administered
as 300 mg every other day).

 Undergoing hemodialysis 300-400 mg then 200-300 mg following each 4 hr of hemodialysis.

Precautions: Discontinue treatment if patient develops acute pancreatitis. Abrupt w/drawal of


anticonvulsant agent in epileptic patients may precipitate status epilepticus. Mixed seizure including
absence seizure. Patients w/ compromised renal function & on hemodialysis. May impair ability to drive or
operate machinery. Pregnancy & lactation. Elderly.

Adverse Drug Reactions: Somnolence, dizziness, ataxia, abnormal thinking & coordination, amnesia,
depression, dysarthria, nervousness, twitching, tremor, hyperkinesias, emotional lability in childn 3-12 yr;
pruritus; wt gain; nausea, vomiting, appetite stimulation, constipation, xerostomia; increased or decreased
WBC count; nystagmus, diplopia, blurred vision; back pain, myalgia; dry throat, fatigue, viral infection,
fever, peripheral edema, dental abnormalities, impotence.
Drug Interactions: Morphine, antacids, cimetidine, hydrocodone.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C. Protect from sunlight and moisture. Shelf-Life: 24
months.

Pregnancy Category: C

ATC Code: N03AX12

Cost:
P a g e | 66

Antidiabetic Agents

DIAMICRON MR
OTC Gliclazide

Dosage Forms/ Strength: One modified release tablet contains gliclazide 60 mg.

Indication: Type 2 diabetes (NIDDM) in adults, in association w/ dietary measures & w/ exercise when
these measures alone are not sufficient.

Contraindications: Hypersensitivity to gliclazide, other sulfonylureas, or sulfonamides. Type 1 diabetes;


diabetic pre-coma & coma, diabetic ketoacidosis. Concomitant use w/ miconazole. Severe renal or hepatic
insufficiency. Lactation.

Dosage: Initially 30 mg daily (½ tab), may be increased to 60, 90 or 120 mg daily, in successive steps.
Interval between each dose increment should be at least 1 mth except in patients whose blood glucose has
not been reduced after 2 wk of treatment. Dose may be increased at the end of the 2nd wk of treatment in
such cases. Max: 120 mg/day. Switching from Gliclazide 80 mg tab to Gliclazide 60 mg MR tab: 1 tab
Gliclazide (Diamicron) 80 mg tab is comparable to 30 mg MR formulation (eg, ½ tab of Diamicron MR 60
mg). Consequently, the switch can be performed w/ careful blood monitoring. Switching from another oral
antidiabetic agent to Gliclazide 60 mg MR tab: Initially 30 mg/day, followed by a stepwise increase in dose,
depending on the metabolic response.

 Overdosage:

 S/Sx: hypoglycemia

 Tx: Moderate symptoms of hypoglycemia, without any loss of consciousness or


neurological signs, must be corrected by carbohydrate intake, dose adjustment and/or
change of diet. Strict monitoring should be continued until the doctor is sure that the patient
is out of danger. Severe hypoglycemic reactions, with coma, convulsions or other
neurological disorders are possible and must be treated as a medical emergency,
requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the
patient should be given a rapid I.V. injection of 50 mL of concentrated glucose solution (20 to
P a g e | 67

30%). This should be followed by continuous infusion of a more dilute glucose solution
(10%) at a rate that will maintain blood glucose levels above 1 g/L. Patients should be
monitored closely and, depending on the patient's condition after this time, the doctor will
decide if further monitoring is necessary. Dialysis is of no benefit to patients due to the
strong binding of gliclazide to proteins.

 Missed Dose: It is important to take the medicine everyday as regular treatment works better.
However, if the patient forgets to take a dose of GLICLAZIDE (DIAMICRON MR) 60 mg, take the
next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Dosage Adjustments: It is recommended that the minimum daily starting dose of 30 mg is used.

 Elderly: GLICLAZIDE (DIAMICRON MR) 60 mg should be prescribed using the same dosing
regimen recommended for patients under 65 years of age.

 Renal impairment: In patients with mild to moderate renal insufficiency, the same dosing regimen
can be used as in patients with normal renal function with careful patient monitoring. These data
have been confirmed in clinical trials.

 Patients at risk of hypoglycemia: Undernourished or malnourished; Severe or poorly


compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotrophic
insufficiency); Withdrawal of prolonged and/or high dose corticosteroid therapy; Severe vascular
disease (severe coronary heart disease, severe carotid impairment, diffuse vascular disease).

 Pediatric population: The safety and efficacy of GLICLAZIDE (DIAMICRON MR) 60 mg in children
and adolescents have not been established. No data are available.

Precautions: Increased risk of hypoglycemia due to low-calorie diet, following major or prolonged
exercises, following ingestion of alcohol or in combination w/ other hypoglycemic agents; patient refuses or
is unable to cooperate (particularly in elderly); malnutrition, irregular mealtimes, skipping meals, periods of
fasting or dietary changes; imbalance between physical exercise & carbohydrate intake; overdosage;
thyroid disorders, hypopituitarism & adrenal insufficiency. St. John's wort prep, fever, injury, infection, or
surgery may affect blood glucose control. Dysglycemia (concomitant use w/ fluoroquinolones, especially in
elderly). Monitor blood glucose levels regularly. G6PD-deficiency. Galactose intolerance, Lapp lactase
deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Avoid use
during pregnancy. Childn & adolescents. Elderly.

Adverse Drug Reactions: Hypoglycemia, headache, intense hunger, nausea, vomiting, lassitude, sleep
disorders, agitation, aggression, poor conc, reduced awareness & slowed reactions, depression, confusion,
visual & speech disorders, aphasia, tremor, paresis, sensory disorders, dizziness, feeling of
powerlessness, loss of self-control, delirium, convulsions, shallow respiration, bradycardia, drowsiness &
loss of consciousness; sweating, clammy skin, anxiety, tachycardia, HTN, palpitations, angina pectoris &
cardiac arrhythmia. Abdominal pain, dyspepsia, diarrhea, constipation.

Drug Interactions: Increased hypoglycemia w/ miconazole (systemic route, oromucosal gel);


phenylbutazone (systemic route); alcoholic drinks & any medicinal products containing alcohol (antabuse
effect). Potentiated blood glucose lowering effect w/ other antidiabetic agents (insulin, acarbose, metformin,
thiazolidinediones, dipeptidylpeptidase-4 inhibitors, GLP-1 receptor agonists), β-blockers, fluconazole, ACE
inhibitors (captopril, enalapril), H2-receptor antagonists, MAOIs, sulfonamides, clarithromycin & NSAIDs.
Diabetogenic effect of danazol. Increased blood glucose levels (reduced insulin release) w/ chlorpromazine
(>100 mg/day); w/ possible ketosis (reduced carbohydrates tolerance) w/ glucocorticoids (systemic & local
route: IA, cutaneous & rectal prep) & tetracosactide; due to β2-agonist effects w/ ritodrine, salbutamol,
terbutaline (IV route). Decreased exposure w/ St. John's wort (Hypericum perforatum). Dysglycemia w/
fluoroquinolones. Potentiation of anticoagulant therapy (warfarin).

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C.


P a g e | 68

Pregnancy Category: Not classified

ATC Code: A10BB09

Cost:

Electrolytes / Vitamins & Minerals (Paedratics)

E-ZINC
OTC Zinc Sulfate

Dosage Forms/ Strength: Each 5 mL (1 teaspoonful) syrup contains: Zinc Sulfate Monohydrate 55 mg
(equivalent to 20 mg elemental Zinc). Each mL syrup (oral drops) contains: Zinc Sulfate Monohydrate 27.5
mg (equivalent to 10 mg elemental Zinc).

Indication: Adjunct in the management of acute diarrhea; helps boost immune function; helps support
optimum physical growth & development.

Contraindications: Hypersensitivity.

Dosage: Syr Adjunct in the management of acute diarrhea together w/ reduced osmolarity ORS
Childn ≥6 mth 5 mL, <6 mth 2.5 mL, to be taken once daily during an acute diarrhea episode for 10-14
days even when diarrhea has already stopped. Nutritional supplement Adult 2.5-5 mL. Childn 9-13 yr
2.5-5 mL, 4-8 yr 2.5 mL, 1-3 yr 1.25 mL, to be taken once daily. Drops Adjunct in the management of
acute diarrhea together w/ reduced osmolarity ORS Childn ≥6 mth 2 mL, <6 mth 1 mL, to be taken
once daily during an acute diarrhea episode for 10-14 days even when diarrhea has already stopped.
Nutritional supplement Childn 1-3 yr 0.5 mL, 6-11 mth 0.5 mL, to be taken once daily.

 Overdosage: rare occurrences of acute zinc poisoning have been reported. The toxicity signs
observed after ingestion of high zinc doses (4-8 grams) include nausea, vomiting, diarrhea, fever,
metallic taste and lethargy (sleepiness). If the patient has taken more than the recommended
dosage, consult a doctor.

 Missed Dose: If the patient missed the dose for the day just take the next dose and the subsequent
doses at the usual recommended schedule, i.e., once a day. Do not double the dose unless
recommended by a doctor.

Dosage Adjustments: Not stated


P a g e | 69

Precautions: Do not take more than the recommended dose. Consult the doctor if any undesirable effect
occurs.

Adverse Drug Reactions: Gastrointestinal side effects such as nausea and vomiting are seen with doses
of elemental zinc greater than 30 mg.

Drug Interactions: The amount of zinc in the products is not expected to interact with food or medicines.

Administration: Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals. May
be taken w/ meals to reduce GI discomfort.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: Not classified

ATC Code: A12CB01

Cost:

Supplements & Adjuvant Therapy

FLOTERA
OTC Lactobacillus reuteri Protectis

Dosage Forms/ Strength: 100 million Colony Forming Units (CFU) in each chewable tablet.

Indication: Enhances intestinal ecology. Improves digestion. Helps enhance natural resistance to intestinal
infections.

Contraindications: Hypersensitivity. Badly damaged intestines (eg, perforated or obstructed intestines).

Dosage: Childn ≥4 yr 1-2 chewable tab/day

Dosage Adjustments: Not stated

Precautions: Patient w/ short bowel syndrome. Weak immune system eg, HIV/AIDS, lymphoma, patients
under long-term corticosteroid treatment, patients undergoing cancer treatment, patients taking medications
that weaken the immune system.

Adverse Drug Reactions: Not stated

Drug Interactions: May reduce the effect of probiotics in the body w/ antibiotic medicines (take probiotics
at least 2 hr before or after antibiotics). May increase chances of getting sick w/ bacteria & yeast w/ drugs
that weaken the immune system (eg, medicines used to prevent transplant rejection eg, azathioprine,
basiliximab, ciclosporin, daclizumab, muromonab-CD-3, mycophenolate, tacrolimus, sirolimus &
prednisone).

Administration: Chew the tablet and take it at night time before bed.

Storage: Store in a dry place at temperatures not exceeding 25°C.

Pregnancy Category: Not classified


P a g e | 70

ATC Code: A07FA01

Cost:

Haemostatics

HEMOSTAN
OTC Tranexamic acid

Dosage Forms/ Strength: Each capsule contains 500mg tranexamic acid.

Indication: Listed in dosage.

Contraindications:

 Hypersensitivity to tranexamic acid or any component of the product

 Active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, cerebral
thrombosis)

 History of thrombosis or thromboembolism (e.g., retinal vein or artery occlusion) or intrinsic risk of
thrombosis or thromboembolism (e.g., thrombogenic valvular disease, thrombogenic cardiac rhythm
disease, hypercoagulopathy), unless at the same time it is possible to give treatments with
anticoagulants

 Patients receiving thrombin because of increased risk of thrombosis

 Patients with acquired disturbances of color vision. If disturbances of color vision arise during the
course of treatment, discontinue the drug

 Patients with subarachnoid hemorrhage since cerebral edema and cerebral infarction may be
caused by tranexamic acid in such cases

Dosage:
P a g e | 71

 General Surgical Cases - 0.5 to 1 g (10 to 15 mg/kg body weight) IV every 8 to 12 hours for the
first few days immediately after surgery, then, orally 1 to 1.5g every 6 to 8 hrs.

 Prostatectomy - 0.5 to 1 g IV every 8 hours (the first injection given during the operation) for the
first three days after surgery, then orally, 1 to 1.5 g every 6 to 8 hours until macroscopic hematuria
is no longer present

 Menorrhagia / Metrorrhagia - Orally, 1 to 1.5 g every 6 to 8 hours for 3 to 4 days

 Postpartum hemorrhage - 1 g IV (taking 1 minute to administer); if bleeding continues, repeat 1 g


after 30 minutes, then orally, 1 to 1.5 g (25 mg/kg body weight) every 6 to 8 hours

 Conisation of the Cervix - After surgery: Orally, 1.5 g every 8 hours for 12 to 14 days

 Epistaxis - Orally, 1.5 g every 8 hours f or 4 t o10 days.

 Gastrointestinal hemorrhage - 1 g IV every 4 hours for a maximum of 3 days, then orally, 1.5 g
every 6 hours for a maximum of 4 days

 Hematuria - Orally, 1 to 1.5 g every 8 to 12 hours until macroscopic hematuria is no longer present

 Hereditary angioneurotic edema - Orally, 1 to 1.5 g every 8 to 12 hours as intermittent or


continuous treatment depending on the prodromal symptoms of the patient

 Dental surgery in patients with coagulopathies - Immediately before surgery: 10 mg/kg body
weight IV After surgery: Orally, 1 to 1.5 g (25 mg/kg body weight) every 6 to 8 hours f or 6 to 8 days.

 Overdosage:

 S/Sx: dizziness, headache, nausea, vomiting, diarrhea, orthostatic symptoms, hypotension,


and convulsions

 Tx: discontinue treatment and institute symptomatic and supportive measures as required.
Activated charcoal may decrease absorption if given within 1 or 2 hours after ingestion.
Administer activated charcoal via a nasogastric tube once the airway is protected in patients
who are not fully conscious or have impaired gag reflex. In patients with severe vomiting or
diarrhea, monitor fluid and electrolyte levels and administer intravenous fluids and replace
electrolytes as necessary. In symptomatic patients, support cardiac and respiratory function.

Dosage Adjustments:

 Children 25 mg/kg body weight per dose, two o r three times a day, depending on the indication

 Renal Impairment

 SeCr 1.36 to 2.83 mg/dL 15 mg/kg body weight twice a day

 SeCr 2.83 to 5.66 mg/dL 15 mg/kg body weight once a day

 SeCr > 5.66 mg/dL 15 mg/kg body weight every 48 hours or 7.5 mg/kg body weight every 24
hours

Precautions: Not advisable to use for prolonged periods in patients predisposed to thrombosis. Not
recommended for prophylaxis during pregnancy & before delivery.

Adverse Drug Reactions: GI disorders, nausea, vomiting, anorexia, headache may appear, impaired
renal insufficiency, hypotension when IV inj is to rapid.
P a g e | 72

Drug Interactions: Thrombin, Batroxobin, Coagulation Factor Agents (Eptacog-Alfa), Hemocoagulase,


Hormonal Contraceptives, Clotting Factor Complexes (Factor IX complex concentrates or anti-inhibitor
coagulant concentrates), Oral tretinoin, Tissue Plasminogen Activators

Administration: Take with or without food.

Storage: Store at temperatures not exceeding 30°C. Keep the product out of sight and reach of children.
Protect from light.

Pregnancy Category: B

ATC Code: B02AA02

Cost:

Topical Anti-infectives with Corticosteroid

CANDIBEC
Rx Clotrimazole beclomethasone dipropionate

Dosage Forms/ Strength: Per g cream/mL soln Beclomethasone dipropionate 250 mcg, clotrimazole 10
mg

Indication: Dermatomycoses complicated by inflammation, pruritus, erythema or other eczematous


features. Tinea capitis, tinea corporis, tinea barbae, tinea cruris, tinea manum, tinea unguium, tinea pedis,
tinea versicolor, vulvovag candidiasis, candidal nappy rash & paronychia.

Contraindications: Hypersensitivity. Skin TB, herpes simplex, chickenpox, measles, vaccinia, syphilitic
skin lesions.

Dosage: Rub onto affected areas bid-tid. In hairy sites, part hair before application to allow direct contact of
cream or soln w/ lesions.

Dosage Adjustments: Not stated

Precautions: Use over large skin areas w/ or w/o occlusive dressing. Not to be used on the eyes or on the
ears if the eardrum is perforated. Pregnancy.

Adverse Drug Reactions: Miliaria, folliculitis or pyoderma may sometimes develop under occlusive
dressing. Localized atrophy & striae.

Drug Interactions: Not stated

Administration: Topical cream

Storage: Store at temperatures not exceeding 30°C. Keep the product out of sight and reach of children.
P a g e | 73

Pregnancy Category: Not classified

ATC Code: D07CC04

Cost:

Hyperuricemia & Gout Preparations

RHEA COLCHICINE
Rx Clotrimazole beclomethasone dipropionate

Dosage Forms/ Strength: Per g cream/mL soln Beclomethasone dipropionate 250 mcg, clotrimazole 10
mg

Indication: Dermatomycoses complicated by inflammation, pruritus, erythema or other eczematous


features. Tinea capitis, tinea corporis, tinea barbae, tinea cruris, tinea manum, tinea unguium, tinea pedis,
tinea versicolor, vulvovag candidiasis, candidal nappy rash & paronychia.

Contraindications: Hypersensitivity. Skin TB, herpes simplex, chickenpox, measles, vaccinia, syphilitic
skin lesions.

Dosage: Rub onto affected areas bid-tid. In hairy sites, part hair before application to allow direct contact of
cream or soln w/ lesions.

Dosage Adjustments: Not stated

Precautions: Use over large skin areas w/ or w/o occlusive dressing. Not to be used on the eyes or on the
ears if the eardrum is perforated. Pregnancy.

Adverse Drug Reactions: Miliaria, folliculitis or pyoderma may sometimes develop under occlusive
dressing. Localized atrophy & striae.

Drug Interactions: Not stated

Administration: Topical cream

Storage: Store at temperatures not exceeding 30°C. Keep the product out of sight and reach of children.
P a g e | 74

Pregnancy Category: Not classified

ATC Code: M04AC01

Cost:

Anorectal Preparations / Phlebitis & Varicose Preparations

DAFLON
OTC Diosmin + Hesperidine

Dosage Forms/ Strength: Each tablet contains Micronized purified flavonoid fraction 1000 mg,
corresponding to Diosmin (90%) 900 mg, Flavonoids expressed as hesperidin (10%) 100 mg.

Indication: Venous circulation disorders (swollen legs, pain, nocturnal cramps, heavy legs, pain, restless
legs) & symptoms due to acute hemorrhoidal attack.

Contraindications: Hypersensitivity

Dosage: Venous insufficiency 1 tab daily. Hemorrhoidal attack 3 tab daily for 4 days then 2 tab daily for
3 days.

 Overdosage:

 S/Sx: astrointestinal events (such as diarrhea, nausea, abdominal pain) and skin events
(such as pruritus, rash).

 Tx: treatment of clinical symptoms. If the patient taken more Daflon than he/she should,
contact the doctor or pharmacist immediately.

Dosage Adjustments: Not stated

Precautions: Hemorrhoid disorder persists for >2 wks. Administration does not preclude treatment for
other anal conditions. Perform proctological exam if symptoms do not subside promptly. Pregnancy &
lactation.
P a g e | 75

Adverse Drug Reactions: Diarrhea, dyspepsia, nausea, vomiting.

Drug Interactions: Not stated

Administration: Should be taken with food: Take at mealtimes.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: Not classified

ATC Code: C05CA53

Cost:

Antihistamines & Antiallergics

DESLOGEN
Rx Desloratadine

Dosage Forms/ Strength: Each Film-Coated Tablet contains: Desloratadine 5 mg.

Indication: Symptomatic relief of allergic conditions eg, rhinitis & urticaria.

Contraindications: Hypersensitivity

Dosage: Adult & childn ≥12 yr 5 mg once daily. Childn 6-11 yr 2.5 mg once daily.

 Overdosage: consider standard measures to remove non adsorbed active substance. Symptomatic
and supportive treatment is recommended. Based on a multiple dose clinical trial in adults and
adolescents, in which up to 45 mg of Desloratadine was administered (9 times the clinical dose), no
clinically relevant effects were observed. Desloratadine is not eliminated by hemodialysis; it is not
known if it is eliminated by peritoneal dialysis.

Dosage Adjustments: Not stated

Precautions: Avoid excessive alcohol intake. May affect performance of skills (eg, driving). Pregnancy &
lactation.

Adverse Drug Reactions: Rashes & hypersensitivity reactions (eg, bronchospasm, angioedema &
anaphylaxis) & cross-sensitivity to related drugs; blood disorders (eg, agranulocytosis, leucopenia,
hemolytic anaemia & thrombocytopenia). Convulsions, sweating, myalgia, paraesthesias, extrapyramidal
effects, tremor, sleep disturbances, depression, confusion, tinnitus, hypotension, hair loss.
P a g e | 76

Drug Interactions: May enhance sedative effects of CNS depressants including alcohol (avoid in excess),
barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives & antipsychotics.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: C

ATC Code: R06AX27

Cost:

ALNIX PLUS
OTC Cetirizine + Phenylephrine HCL

Dosage Forms/ Strength: Each Tablet contains: Cetirizine diHCl 5 mg, phenylephrine HCl 10 mg

Indication: Relief of clogged nose; sneezing; runny, itchy nose; itchy watery eyes associated w/ allergic
rhinitis.

Contraindications: Hypersensitivity. Patients w/ high BP or severe heart disease. Concomitant use w/


medicines for depression.

Dosage: Adult & childn >12 yr 1 tab every 12 hr.

 Overdosage: Symptoms of Cetirizine overdose include sleepiness, drowsiness, restlessness, and


irritability. Phenylephrine HCl overdose is usually associated with tiredness, sweating, dizziness,
slow heart beat, and coma. If the patient has taken more than the recommended dosage, consult a
doctor.

Dosage Adjustments: Not stated

Precautions: High BP or any type of heart problems; glaucoma; thyroid problems; diabetes; bladder
problems or difficulty urinating. Patients w/ kidney or liver disease including those taking drugs that affect
the liver.

Adverse Drug Reactions: Cetirizine diHCl: Headache, drowsiness/sleepiness, dry mouth, sore throat,
coughing, bronchospasm, epistaxis, stomach pain, diarrhea, nausea & vomiting. Phenylephrine HCl:
Tremor, restlessness, anxiety, nervousness, dizziness, high BP, rapid & irregular pulse, weakness, nausea,
vomiting & sweating.

Drug Interactions: Increased toxicity w/ sympathomimetic agents (eg, epinephrine) & general anesth (eg,
halothane). Hypertensive crisis w/ medicines for depression (eg, amitriptyline, imipramine, sertraline,
moclobemide). Phenylephrine HCl: Decreased effect w/ adrenergic-blocking agent (eg, phenothiazine
drugs, phentolamine, propranolol).

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: B

ATC Code: R06AX27


P a g e | 77

Cost:

ALLERKID
OTC Cetirizine Dihydrochloride

Dosage Forms/ Strength: Each mL Syrup (Oral Drops) contains: Cetirizine dihydrochloride 2.5 mg.
Each 5 mL (1 teaspoonful) Syrup contains: Cetirizine dihydrochloride 5 mg.

Indication: Symptomatic relief of allergic conditions including rhinitis & chronic urticaria.

Contraindications: Do not give the medicine if child is allergic to Cetirizine or other ingredients in the
product.

Dosage: Syr Childn 6-12 yr 2 tsp once daily or 1 tsp bid 12 hrly, 2-5 yr 1 tsp once daily or ½ tsp bid 12
hrly. Drops 2-5 yr 2 mL once daily or 1 mL bid 12 hrly, 12 mth to <2 yr 1 mL once or bid 12 hrly, 6 to <12
mth 1 mL once daily.

 Overdosage: Signs and symptoms of Cetirizine overdose include sleepiness, drowsiness,


restlessness, and irritability. If the child has taken more than the recommended dosage, consult a
doctor.

Dosage Adjustments: Not stated

Precautions: May cause drowsiness. Exercise caution when engaging in activities requiring mental
alertness. Consult a Doctor: Before giving this medication, tell the doctor if the child has kidney or liver
disease. There might be a need for dosage adjustment or special monitoring during treatment.

Adverse Drug Reactions: Headache, pharyngitis, abdominal pain, coughing, somnolence, diarrhea,
epistaxis, bronchospasm, nausea & vomiting.

Drug Interactions: Alcohol, other CNS depressants.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: B

ATC Code: R06AE07

Cost:

ALLERZET
Rx Levocetirizine Dihydrochloride

Dosage Forms/ Strength: Each 5 mL (1 teaspoonful) syrup contains: Levocetirizine dihydrochloride 2.5
mg.
P a g e | 78

Indication: Treatment of signs & symptoms associated w/ allergic conditions eg, rhinitis & chronic
idiopathic urticaria.

Contraindications: Hypersensitivity to levocetirizine, cetirizine or other piperazine derivatives. Patients w/


end-stage renal disease (CrCl <10 mL/min) or undergoing hemodialysis. Childn 6 mth-11 yr w/ renal
impairment. Pregnancy & lactation.

Dosage: Adult & childn ≥12 yr 10 mL (2 tsp). Childn 6-11 yr 5 mL (1 tsp), 6 mth-5 yr 2.5 mL (½ tsp). All
doses to be taken once daily at bedtime.

 Overdosage:

 S/Sx: adults may include drowsiness; children, symptoms are initially agitation and
restlessness, followed by drowsiness.

 Tx: If the patient taken more than the recommended dosage, consult a doctor. Gastric
lavage may be considered following short-term ingestion.

Dosage Adjustments:

 Renal Impairment
 Mild (CrCl 50-79 mL/min): 2.5 mg(5ml) once a day
 Moderate (CrCl 30-49 mL/min): 2.5 mg(5ml) once every 2 days
 Severe (CrCl <30 mL/min): 2.5 mg(5ml) once every 3 days
 Dialysis: Contraindicated

 Hepatic Impairment: No dosage adjustment is necessary for patients with hepatic impairment.

Precautions: May impair ability to drive or operate machinery. Renal impairment. Elderly.

Adverse Drug Reactions: Somnolence, fatigue, dry mouth, nasopharyngitis, pharyngitis, pyrexia, cough,
epistaxis, diarrhea, constipation, vomiting, otitis media.

Drug Interactions: Possible additive effect w/ alcohol or other CNS depressants. Increased plasma AUC &
t½ w/ ritonavir. Decreased clearance w/ theophylline & ritonavir.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: B

ATC Code: R06AE09

Cost:

XYZAL
Rx Levocetirizine Dihydrochloride

Dosage Forms/ Strength: Each film-coated tablet contains: Levocetirizine dihydrochloride 5 mg.

Indication: Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) & urticaria.
P a g e | 79

Contraindications: Hypersensitivity to levocetirizine, cetirizine, hydroxyzine, or to any piperazine


derivatives. Severe renal impairment (CrCl <10 mL/min).

Dosage: Adults and Adolescents ≥12 years: 5 mg once daily (1 film-coated tablet or 10 mL of solution or
20 drops). Children 6-12 years: 5 mg once daily (1 film-coated tablet or 10 mL of solution or 20 drops). No
adjusted dosage is possible with the film-coated tablet. It is recommended to use a pediatric formulation of
levocetirizine. Children 2-6 years: 2.5 mg to be administered in 2 intakes of 1.25 mg (2.5 mL of solution or
5 drops twice daily).

 Overdosage:

 S/Sx: drowsiness in adults and initially, agitation and restlessness, followed by drowsiness in
children.

 Tx: There is no known specific antidote to levocetirizine. Should overdose occur,


symptomatic or supportive treatment is recommended. Levocetirizine is not effectively
removed by hemodialysis.

Dosage Adjustments:

 Renal Impairment: dose is recommended in elderly patients with moderate to severe renal
impairment (see Renal Impairment as follows).
 Mild (CrCl 50-79 mL/min): 5mg once daily
 Moderate (CrCl 30-49 mL/min): 5mg once every 2 days
 Severe (CrCl <30 mL/min): 5mg once every 3 days
 Dialysis: Contraindicated

 Hepatic Impairment: No dosage adjustment is necessary for patients with hepatic impairment.

Precautions: Alcohol intake. Predisposing factors of urinary retention (eg, spinal cord lesion, prostatic
hyperplasia). Renal & hepatic impairment. May affect ability to drive or operate machinery. Pregnancy &
lactation. Infant & childn <2 yr. Tab: Galactose intolerance, Lapp lactase deficiency or glucose-galactose
malabsorption. Childn <6 yr. Soln: Contains maltitol which is not recommended for patients w/ fructose
intolerance. Soln/drops: Contains methyl & propyl parahydroxybenzoate which may cause allergic
reactions.

Adverse Drug Reactions: Headache, somnolence; dry mouth; fatigue. Soln/drops: Sleep disorders;
diarrhea, constipation.

Drug Interactions: Small decrease in clearance w/ theophylline. Increased exposure w/ ritonavir. CNS
effects w/ alcohol & other CNS depressants.

Administration: May be taken with or without food

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: B

ATC Code: R06AE09

Cost:

CO-ALEVA
Rx Ebastine + Betamethasone
P a g e | 80

Dosage Forms/ Strength: Each tablet contains: Ebastine 10 mg, betamethasone 500 mcg

Indication: Treatment of seasonal/perennial allergic rhinitis & chronic urticaria

Contraindications: Severe liver insufficiency. Lactation

Dosage: Adults 1 tab bid

Dosage Adjustments: not stated

Precautions: Caution use in patients w/ known cardiac risk eg. long QT syndrome, hypokalemia. Heart
failure, recent MI or HTN, DM, epilepsy, glaucoma, hypothyroidism, hepatic failure, osteoporosis, peptic
ulceration, psychoses or severe affective disorders & renal impairment. Pregnancy

Adverse Drug Reactions: Headache, dry mouth, drowsiness, less common are pharyngitis, abdominal
pain, dyspepsia, asthenia, epistaxis, rhinitis, sinusitis, nausea & insomnia.

Drug Interactions: CYP3A4 enzyme inhibitors eg. azole, antifungals & macrolides. Ketoconazole,
erythromycin. Barbiturates, carbamazepine, phenytoin, primidone, rifampicin. OC, ritonavir. K-depleting
diuretics eg thiazides & furosemide. Amphotericin B, xanthines, β2-antagonists. NSAIDs, anticoagulants,
antidiabetic drugs & antihypertensives, salicylates & antimuscarinics.

Administration: To be taken with food

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: not classified

ATC Code: R06AX

Cost:

CLARICORT
Rx Loratadine + Betamethasone

Dosage Forms/ Strength: Each tablet contains betamethasone 250 mcg and loratadine 5 mg.

Indication: Relief of symptoms of atopic dermatitis, angioedema, urticaria, seasonal & perennial allergic
rhinitis, food & drug allergic reaction, allergic contact dermatitis, severe seborrheic dermatitis,
neurodermatitis, allergic asthma, ocular allergic manifestations (eg, conjunctivitis, iridociclitis & allergic
reactions to insect stings).

Contraindications: Hypersensitivity to loratadine or betamethasone. Betamethasone: Systemic fungal


infections.

Dosage: Adults and children ≥12 years: 1 tablet twice daily.

 Overdosage

 S/Sx: Somnolence, tachycardia and headache

 Tx: The patient should be induced to vomit, even if emesis has occurred spontaneously.
Pharmacologically-induced vomiting by the administration of ipecac solution is a preferred
method
P a g e | 81

Dosage Adjustments: not stated

Precautions: Severe liver impairment. Immunosuppressed patients should avoid exposure to measles or
chickenpox especially in childn. Vaccination. Latent TB. Hypothyroidism, cirrhosis. Ocular herpes simplex.
Psychotic disorders. GI ulceration. Pregnancy & lactation.

Adverse Drug Reactions: Fatigue, headache, somnolence, nervousness, dry mouth, GI disorders (eg,
nausea, gastritis), allergic symptoms eg, rash. Fluid & electrolyte disturbances: Na retention, K loss,
hypokalemic alkalosis; fluid retention; CHF in susceptible patients; HTN, posterior subcapsular cataracts.
Rarely, alopecia, anaphylaxis, abnormal hepatic function, dizziness & convulsion.

Drug Interactions: Increase plasma conc of loratadine w/ ketoconazole, erythromycin or cimetidine.


Enhance metabolism of betamethasone w/ phenobarb, phenytoin, rifampin or ephedrine. Enhance
hypokalemia w/ K-depleting diuretics & effect w/ estrogen. Concurrent use of corticosteroids w/ cardiac
glycosides may enhance possibility of arrhythmias or digitalis toxicity associated w/ hypokalemia; enhance
K-depletion caused by amphotericin B; may increase or decrease anticoagulant effects w/ coumarin.
Increased occurrence or severity of GI ulceration w/ NSAIDs or alcohol. Corticosteroid may decrease blood
salicylate conc. Concomitant glucocorticosteroid therapy may inhibit response to somatotropin. Antidiabetic
drugs.

Administration: To be taken with food

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: not classified

ATC Code: R06AX

Cost:
Calcium Antagonists / Anti-anginal Drugs

AMVASC BE
Rx Amlodipine besilate

Dosage Forms/ Strength: Each tablet contains amlodipine 5mg or 10mg

Indication: Treatment of HTN & prophylaxis of angina.

Contraindications: Advanced aortic stenosis, severe liver failure, history of shock. Pregnancy, women of
childbearing potential, lactation.

Dosage: Adult HTN, stable & Prinzmetal's angina Usual dose: 5 mg once daily. Max: 10 mg once daily.
Chronic stable or vasospastic angina 5-10 mg once daily. Patients w/ CAD 5-10 mg once daily. Childn
6-17 yr HTN 2.5-5 mg once daily.

 Overdosage

 S/Sx: Excessive peripheral vasodilation and possibly a reflex tachycardia.

 Tx: If massive overdose should occur, institute active cardiac and respiratory monitoring.
Frequent blood measurements are essential. Initiate cardiovascular support including
elevation of the extremities and judicious fluid administration should hypotension occur. If
hypotension remains unresponsive to these conservative measures, administration of
vasopressors should be considered with attention to circulating volume and urine output.
P a g e | 82

Calcium gluconate IV may help to reverse the effects of calcium entry blockade. As
amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.

Dosage Adjustments: Elderly and Patients with Hepatic Insufficiency: 5 mg.

Precautions:
Warnings. Rarely, patients particularly those with severe obstructive coronary disease, have developed
documented increased frequency, duration and/or severity of angina or acute myocardial infarction on
starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this
effect has not been elucidated.

 Severe bradycardia, heart failure, cardiogenic shock, left ventricular dysfunction, systolic BP <90
mmHg. Hepatic disease. May impair ability to drive or operate machinery. Childn <6 yr. Elderly.

Adverse Drug Reactions: Flushing; fatigue; edema, palpitation; vertigo, headache, drowsiness; abdominal
pain, nausea.

Drug Interactions: Grapefruit juice.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: C

ATC Code: C08CA01

Cost:

PROVASC
Rx Amlodipine besilate

Dosage Forms/ Strength: Each tablet contains amlodipine 5mg or 10mg

Indication: HTN. Prophylaxis of angina.

Contraindications: not stated

Dosage: Initially 5 mg once daily. Max: 10 mg once daily.

Dosage Adjustments: Small, fragile, elderly or patient w/ hepatic insufficiency Initial dose: 2.5 mg
once daily.

Precautions: Allergies. History of heart & liver disease. Limit intake of alcohol.

Adverse Drug Reactions: Fatigue or tiredness; headache; insomnia; vivid or abnormal dreams; flushing;
abdominal pain; nausea, diarrhea or constipation; increased or difficulty in urination.

Drug Interactions: not stated

Administration: May be taken with or without food.

Storage: Store at a temperature not exceeding 30ºC. Protect from light.

Pregnancy Category: C
P a g e | 83

ATC Code: C08CA01

Cost:

Angiotensin II Antagonists

KENZAR
Rx Losartan potassium

Dosage Forms/ Strength: Each film-coated tablet contains 50 mg and 100 mg.

Indication: Management of HTN particularly in patients who develop cough w/ ACE inhibitors & to reduce
the risk of stroke in patients w/ left ventricular hypertrophy & in the treatment of diabetic nephropathy. 50
mg tab: Management of heart failure.

Contraindications: Hypersensitivity. Renal artery stenosis & hyperkalemia. Concomitant use w/ K-sparing
diuretics. Pregnancy & lactation.

Dosage: HTN 50 mg once daily, may be increased to 100 mg daily based on BP response in 1 or 2 divided
doses. Patient w/ intravascular vol depletion (those treated w/ high-dose diuretics) Initially 25 mg
daily.

Dosage Adjustments: Elderly >75 yr Initially 25 mg once daily. Diabetic nephropathy Initially 50 mg
once daily, increased to 100 mg once daily depending on BP.

Precautions: not stated

Adverse Drug Reactions: Dizziness, asthenia/fatigue & vertigo.


P a g e | 84

Drug Interactions: Reduced levels of active metabolite w/ rifampin & fluconazole. Increased serum K w/ K-
sparing diuretics (eg, spironolactone, triamterene, amiloride), K supplements or salt containing K.
Attenuated antihypertensive effect w/ NSAID indomethacin.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C. Protect from light.

Pregnancy Category: D

ATC Code: C09CA01

Cost:

LIFEZAR
Rx Losartan potassium

Dosage Forms/ Strength: Each film-coated tablet contains 50 mg and 100 mg.

Indication: Essential HTN in adults, childn & adolescents 6-18 yr. Renal disease in adult patients w/ HTN &
type 2 DM w/ proteinuria ≥0.5 g/day as part of antihypertensive treatment. CHF in adult patients to whom
ACE inhibitor is not suitable due to incompatibility, cough & contraindication. Reduction in risk of stroke in
hypertensive adults w/ left ventricular hypertrophy documented by ECG.

Contraindications: Hypersensitivity. Concomitant use w/ aliskiren in type 2 diabetes patients. Severe


hepatic impairment. Pregnancy.
Dosage: HTN & hypertensive type II diabetes w/ proteinuria ≥0.5 g/day Usual starting & maintenance
dose: 50 mg once daily. Max: Antihypertensive effect is attained 3-6 wk after therapy initiation. May be
increased to 100 mg once daily. Heart failure Initially 12.5 mg once daily titrated at wkly intervals as
tolerated by patient. Max: 150 mg once daily. Reduction in the risk of stroke in hypertensive patient w/
left ventricular hypertrophy documented by ECG Initially 50 mg once daily. Add low dose
hydrochlorothiazide &/or increase Lifezar dose to 100 mg daily based on BP response. Patient w/
intravascular vol depletion 25 mg once daily. Childn 6-18 yr >20-50 kg Initially 25 mg once daily. Adjust
dose according to BP response. Max: 50 mg once daily, >50 kg 50 mg once daily. Max: 100 mg once daily.

 Overdosage

 S/Sx: most likely manifestation of overdose would be hypotension and tachycardia.


Bradycardia could occur from parasympathetic (vagal) stimulation.

 Tx: supportive treatment should be instituted; stabilization of the cardiovascular system


should be given priority. After oral intake the administration of a sufficient dose of activated
charcoal is indicated. Afterwards, close monitoring of the vital parameters should be
performed. Vital parameters should be corrected if necessary.

Dosage Adjustments: not stated

Precautions: Hypersensitivity. History of angioedema. Patients who are vol- & Na-depleted by vigorous
diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Monitor plasma conc of K & CrCl; renal
function. Concomitant use w/ K-sparing diuretics, K supplements & K-containing salt substitutes; ACE
inhibitors; β-blocker. Severe hepatic impairment. Bilateral renal artery stenosis or stenosis of the artery to a
solitary kidney. Avoid in severe renal impairment (GFR <30 mL/min). Kidney transplantation. Primary
hyperaldosteronism. CHD & cerebrovascular disease. Heart failure. Aortic & mitral valve stenosis,
P a g e | 85

obstructive hypertrophic cardiomyopathy. Dual blockade of the renin-angiotensin system. May affect ability
to drive & use machines. Pregnancy & lactation. Black people. Childn w/ hepatic impairment, GFR <30
mL/min/1.73 m2.

Adverse Drug Reactions: Dizziness; vertigo; hyperkalaemia, hypoglycaemia, increased blood urea,
serum creatinine & serum K; asthenia, fatigue; anaemia; orthostatic hypotension (including dose-related
orthostatic effects); renal impairment & failure.

Drug Interactions: Increased incidence of hypotension, hyperkalaemia & changes in renal function w/
angiotensin receptor blocker. May have increased hypotensive action w/ other antihypertensives. May
increase risk of hypotension w/ hypotension-inducing products (eg, TCAs, antipsychotics, baclofene &
amifostine). Decreased exposure w/ CYP2C9 inhibitor eg, fluconazole. Reduced plasma conc w/
rifampicine. May increase serum K w/ drugs which retain K (eg, K-sparing diuretics, amiloride, triamterene,
spironolactone, K supplements or salt substitutes containing K) or K levels w/ heparin. May reversibly
increase serum lithium conc & toxicity. May attenuate antihypertensive effect w/ NSAIDs (ie, selective
COX-2 inhibitors, ASA & non-selective NSAIDs). May increase risk of renal function worsening w/ diuretics
& NSAIDs.

Administration: May be taken with or without food: Swallow w/ glass of water.

Storage: Store at temperatures not exceeding 25°C. Store in the original package.

Pregnancy Category: D

ATC Code: C09CA01

Cost:

ACE Inhibitors / Direct Renin Inhibitors

CAPTOBES
Rx Captopril

Dosage Forms/ Strength: Each tablet contains 25 mg.

Indication: Monotherapy or in combination w/ thiazides for mild to moderate essential HTN & severe HTN
resistant to other treatment; CHF, following MI, diabetic nephropathy in insulin-dependent diabetes.

Contraindications: Porphyria; aortic or outflow tract obstruction

Dosage: HTN Initially 12.5mg bid-tid, increased if necessary to 25mg bid-tid after 1-2 wk.

Dosage Adjustments: not stated

Precautions: Patients w/ existing or suspected renovascular disease; peripheral vascular disease or


generalized atherosclerosis; existing renal disease; collagen vascular disorder eg SLE & scleroma or those
receiving immunosuppressive therapy especially if w/ impaired renal function. Asses renal function prior or
during therapy. History of idiopathic hereditary angioedema. Elderly.

Adverse Drug Reactions: Taste disturbances & skin reactions. Vascular effects including hypotension,
dizziness, fatigue, headache, nausea & other GI disturbances.

Drug Interactions: Excessive hypotension w/ diuretics, other antihypertensives or other agents that lower
BP including alcohol. Additive hyperkalemic effects w/ K-sparring diuretics, K supplements including K-
P a g e | 86

containing salt substitutes or other drugs causing hyperkalemia eg ciclosporin or indomethacin. Potentiated
renal effects w/ NSAIDs.

Administration: Take on an empty stomach. Take 1 hr before or 2 hrs after meals.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: D

ATC Code: C09AA01

Cost:

Angiotensin II Antagonists / Calcium Antagonists

TOZAM
Rx Losartan potassium + Amlodipine besilate

Dosage Forms/ Strength: Each film-coated tab contains losartan potassium 50 mg and amlodipine
besilate 5 mg.

Indication: Mild to moderate HTN in case of inadequate control of monotherapy.

Contraindications: Patients allergic to angiotensin receptor blocker or dihydropyridine Ca-channel


antagonist.

Dosage: 1 tab once daily.

 Overdosage

 S/Sx: Losartan K most likely manifestation of overdose would be hypotension and


tachycardia. Bradycardia could occur from parasympathetic (vagal) stimulation; Amlodipine
besilate excessive peripheral vasodilation with marked and probably prolonged hypotension
and possibly a reflex tachycardia.

 Tx: Losartan K If symptomatic hypotension occurs, supportive treatment should be


instituted. Amlodipine besilate gastric lavage should be performed. Active cardiovascular
support including monitoring of cardiac and respiratory function, elevation of extremities, and
attention of circulating fluid volume and urine output should be given. Intravenous calcium
P a g e | 87

gluconate may help to reverse the effects of calcium entry blockade. A vasoconstrictor agent
may be helpful in restoring vascular and blood pressure provided that there is no
contraindication to its use. Since amlodipine is highly protein bound, dialysis is unlikely to be
of benefit.

Dosage Adjustments: not stated

Precautions: Hypotension & Hepatic failure; Symptomatic hypotension in patients w/ vol- &/or salt
depletion. Discontinue therapy if patient developed jaundice or marked elevations of hepatic enzymes.
Impaired liver & renal function. Pregnancy & lactation. Childn & adolescent <18 yr.

Adverse Drug Reactions: Losartan K: Diarrhea, dyspepsia; muscle cramp, myalgia, back & leg pain;
dizziness, insomnia; nasal congestion, cough, upper resp tract infection, sinus disorder, sinusitis.
Amlodipine besilate: Edema, flushing, palpitation, fatigue, headache, somnolence, abdominal pain,
dizziness.

Drug Interactions: Losartan K: Increase AUC w/ cimetidine. Potent inducers of CYP3A4. Increase in
serum K w/ K-sparing diuretics (eg, spironolactone, triamterene, amiloride), K supplements or salt
substitutes containing K.

Administration: May be taken with or without food: Swallow whole, do not chew/crush.

Storage: Store at temperatures not exceeding 30°C..

Pregnancy Category: not classified

ATC Code: C09DB06

Cost:

Angiotensin II Antagonists / Diuretics

GETZAR PLUS
Rx Losartan potassium + Hydrochlorothiazide

Dosage Forms/ Strength: Per 50 mg/12.5 mg FC tab Losartan K 50 mg, hydrochlorothiazide 12.5 mg.
Per 100 mg/25 mg FC tab Losartan K 100 mg, hydrochlorothiazide 25 mg

Indication: HTN including patients w/ left ventricular hypertrophy; diabetic nephropathy in type 2 DM.

Contraindications: Severe renal impairment (CrCl <30 mL/min) or anuria, Addison's disease, preexisting
hypercalcemia. Pregnancy.

Dosage: Usual Dose: Losartan potassium 50 mg/hydrochlorothiazide 12.5 mg once daily. The dose may
be increase, if necessary, to 100 mg/25 mg daily as a single dose or in 2 divided doses.

 Overdosage

 S/Sx: Losartan K: most likely manifestation of overdose would be hypotension and


tachycardia. Bradycardia could occur from parasympathetic (vagal) stimulation;
Hydrochlorothiazide: electrolyte depletion (hypokalemia, hypochloremia, hyponatremia),
dehydration resulting from excessive diuresis
P a g e | 88

 Tx: Losartan K: If symptomatic hypotension occurs, supportive treatment should be


instituted. Hydrochlorothiazide: If digitalis has also been administered, hypokalemia may
accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by
hemodialysis has not been established.

Dosage Adjustments: Elderly >75 yr, patient w/ moderate to severe renal impairment (CrCl <20
mL/min) or intravascular fluid depletion Initially 25 mg once daily.

Precautions: Renal artery stenosis/impairment. Monitor fluid & electrolyte imbalance especially in the
presence of vomiting or during parenteral fluid therapy.

Adverse Drug Reactions: Losartan K: Dizziness & dose-related orthostatic hypotension; hyperkalemia.
Hydrochlorothiazide: Metabolic disturbances at high dose; hyperglycemia & glycosuria; hyperuricemia &
gout-precipitated attacks; electrolyte imbalances including hypochloremic alkalosis, hyponatremia &
hypokalemia.

Drug Interactions: Losartan K: Rifampicin & fluconazole; K-sparing diuretics, K supplements or K-


containing salt substitutes. Hydrochlorothiazide: Alcohol, barbiturates or narcotics; antidiabetic drugs (oral
agents & insulin); other antihypertensive drugs; cholestyramine & colestipol resins; corticosteroids, ACTH;
pressor amines (eg, adrenaline).

Administration: May be taken with or without food

Storage: Store at temperatures not exceeding 30°C..

Pregnancy Category: D

ATC Code: C09DA01

Cost:

Other Anti-hypertensives

CATAPRES
Rx Clonidine HCL

Dosage Forms/ Strength: Each tab contains 75 mcg or 150 mcg of Clonidine HCL

Indication: HTN of any etiology except the pheochromocytoma form.

Contraindications: Sick sinus syndrome

Dosage: Mild to moderate HTN 75-150mcg bid. Severe HTN increase single dose to 300mcg. Could be
repeated up to tid (900mcg).

Dosage Adjustments: not stated

Precautions: Diseases affecting rhythmic & AV conduction system of the heart; renal failure. Sudden
discontinuance. May impair ability to drive or operate machinery.

Adverse Drug Reactions: Dizziness, headache, paresthesia, sedation, gynecomastia, confusion state,
delusional perception, depression, hallucination, decreased libido, nightmare, sleep disorder,
accommodation disorder, decreased lacrimation, AV block, bradyarrhythmia, sinus bradycardia, orthostatic
hypotension. Raynaud’s phenomenon, nasal dryness, alopecia, pruritus, rash, urticaria, erectile
P a g e | 89

dysfunction, fatigue, malaise, colonic pseudo-obstruction, constipation, dry mouth, nausea, salivary gland
pain, vomiting.

Drug Interactions: Enhanced antihypertensive effects by diuretics, vasodilators & β-blockers. Lower heart
rate & dysrhythmia w/ β-blockers &/or cardiac glycosides. Reduction in BP-lowering effects w/ TCAs.

Administration: May be taken with or without food

Storage: Store at temperatures not exceeding 30°C..

Pregnancy Category: C

ATC Code: C02AC01

Cost:

Antiamoebics / Other Antibiotics

DAZOMET
Rx Metronidazole

Dosage Forms/ Strength: Each tab contains 500mg Metronidazole.

Indication: Infections caused by susceptible anaerobic microorganisms; peri-op prophylaxis to reduce


incidence of post-op bacterial infections in patients at high risk for such infections. Intestinal &
extraintestinal or invasive amoebiasis including amoebic liver abscess. Pelvic inflammatory disease (PID) in
combination w/ fluoroquinolones.

Contraindications: Hypersensitivity to metronidazole or nitroimidazole derivatives. Pregnancy (1 st


trimester).

Dosage: Adult Trichomoniasis 2 g as a single dose or 500 mg bid for 7 days. Giardiasis 250 mg tid for
5-7 days. Amoebiasis 500-750 mg tid for 7-10 days. Vag infections including bacterial vaginosis 2 g as
single dose or 500 mg bid for 7 days. Partner should be treated simultaneously. Anaerobic infections as
1st-line or substitute treatment 1-2 g/day every 6-12 hr or 500 mg every 6 hr in 2-4 divided doses.

Dosage Adjustments: not stated


P a g e | 90

Precautions: Patients w/ history of blood dyscrasias; receiving corticosteroids & those predisposed to
edema. Candida overgrowth in GI or genital tract may occur. Perform total & differential leukocyte counts
before & after treatment. Severe hepatic disease. Avoid alcoholic intake during therapy & for at least 3 days
afterward.

Adverse Drug Reactions: Convulsive seizures & peripheral neuropathy; numbness or paresthesia of an
extremity; dizziness, vertigo, incoordination, ataxia, confusion, irritability, depression, weakness, headache,
tinnitus, hearing loss, insomnia; nervousness, malaise or syncope; nausea, headache, anorexia, dry mouth
& sharp, unpleasant metallic taste, vomiting, abdominal discomfort, diarrhea, epigastric distress &
constipation; reversible neutropenia (leukopenia); flattening of T-wave; urticaria, pruritus, maculopapular
rash, erythematous rash, flushing, nasal congestion, dryness of mouth (or vag or vulva), fever & fleeting
joint pains; dysuria, cystitis, polyuria, incontinence, sense of pelvic pressure; urethral burning or discomfort,
dryness of the vag, proliferation of vag candida, dyspareunia, decreased libido, proctitis; genital pruritus,
dysmenorrhea, UTI; darkened urine; upper resp tract infections, rhinitis, sinusitis & pharyngitis;
thrombophlebitis.

Drug Interactions: Oral anticoagulants, alcohol, disulfiram, phenobarb or phenytoin, lithium, azathioprine,
fluorouracil, cimetidine, cyclosporin, corticosteroids.

Administration: Should be taken with food.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: B

ATC Code: J01XD01

Cost:

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

PLOGREL
Rx Clopidogrel

Dosage Forms/ Strength: Each tab contains 75mg Clopidogrel bisulfate.

Indication: Prevention of atherosclerotic events in patients w/ history of recent MI, recent ischemic stroke
or established peripheral arterial disease or non-ST segment elevation acute coronary syndrome including
patients w/ percutaneous coronary intervention & CABG. Given prophylactically as an alternative to aspirin
in patients at risk of thromboembolic disorders..

Contraindications: Peptic ulcer, intracranial hemorrhage or coagulation disorders. Childn.

Dosage: MI, stroke, peripheral arterial disease & prophylaxis of thromboembolic events 75 mg once
daily. Unstable angina/non-Q wave MI Loading dose: 300 mg as a single dose. Continue 75 mg once
daily in combination w/ aspirin.

 Overdosage

 S/Sx: acute toxicity include vomiting, prostration, difficulty in breathing and GI hemorrhage
P a g e | 91

 Tx: Platelet transfusions may be an appropriate treatment when attempting to reverse the
effects of clopidogrel. After decontamination, treatment is symptomatic and supportive.

Dosage Adjustments: not stated

Precautions: Higher bleeding risk in combination therapy w/ aspirin. Thrombocytopenia purpura. Patients
w/ platelet disorder or increased bleeding eg, peptic ulcer, trauma, surgery except in patients w/ cardiac
stents & no complete antiplatelet therapy. Hepatic & renal impairment. Discontinue use 5 days prior to
elective surgery. Pregnancy & lactation.

Adverse Drug Reactions: Bleeding, hemorrhage.

Drug Interactions: Aspirin, NSAIDs, anticoagulants. Phenytoin, tamoxifen, tolbutamide, warfarin,


torsemide & fluvastatin. Bupropion, statins & ciclosporin. Clarithromycin, erythromycin, troleandomycin.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: B

ATC Code: B01AC04

Cost:

CLOVIX
Rx Clopidogrel

Dosage Forms/ Strength: Each tab contains 75mg Clopidogrel bisulfate.

Indication: Prevention of atherosclerotic events in patients w/ history of symptomatic atherosclerotic


disease.

Contraindications: Hypersensitivity. Severe renal impairment. Active pathological bleeding eg, peptic
ulcer or intracranial hemorrhage. Lactation.

Dosage: 1 tab daily.

Dosage Adjustments: not stated

Precautions: Patients who may be at risk of increased bleeding from trauma, surgery or other pathological
conditions. Discontinue use 7 days prior to surgery. Hepatic & renal impairment. Pregnancy.

Adverse Drug Reactions: Hemorrhage, abdominal discomfort, nausea, vomiting, diarrhea, headache,
dizziness, vertigo, paresthesia, rash, pruritus, hepatic & biliary disorder, neutropenia.

Drug Interactions: Increased risk of bleeding w/ warfarin. GI blood loss w/ naproxen; NSAIDs.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C. Protect from light.

Pregnancy Category: B
P a g e | 92

ATC Code: B01AC04

Cost:

Cough & Colds Preparations

TUSSILEV
Rx Levodropropizine

Dosage Forms/ Strength: Each 5 mL (1 teaspoonful) contains: Levodropropizine 30 mg.

Indication: Symptomatic relief of cough.

Contraindications: not stated

Dosage: Adult & childn over 12 yr 10 mL tid at intervals of at least 6 hr. Childn over 2 yr 1 mg/kg tid (3
mg/kg/day) at intervals of at least 6 hr. Childn 20-30 kg 5 mL tid, 10-20 kg 3 mL tid.

Dosage Adjustments: not stated

Precautions: Patients w/ serious renal insufficiency. Diabetics (10 mL contains 3.5 g sucrose). May impair
ability to drive or operate machinery. Childn <24 mth.
P a g e | 93

Adverse Drug Reactions: Nausea, vomiting, heartburn, abdominal discomfort, diarrhea; exhaustion,
faintness, somnolence, clouding of consciousness (stupor), numbness, dizziness, headache; palpitations;
hypersensitivity reactions (contains parabens).

Drug Interactions: No interactions with benzodiazepines were observed during clinical trials, however,
care should be taken when sedative drugs are simultaneously administered to particularly sensitive
individuals.

Administration: Should be taken on an empty stomach.

Storage: Store at temperatures not exceeding 30°C. Discard the product after one (1) month of opening.

Pregnancy Category: not classified

ATC Code: R05DB27

Cost:

LEVOPRONT
Rx Levodropropizine

Dosage Forms/ Strength: Each 5 mL contains 30 mg Levodropropizine.

Indication: Symptomatic relief of cough.

Contraindications: Patients w/ excessive discharge of mucus, w/ limited mucociliary function, severe liver
dysfunction. Pregnancy & lactation. Childn <24 months

Dosage: Adult & childn >12 yr 10 mL, >2 yr 1 mg/kg, 20-30 kg 5 mL, 10-20 kg 3 mL. All doses to be
taken tid.

Dosage Adjustments: not stated

Precautions: Patients w/ serious renal insufficiency; diabetes. May impair ability to drive or operate
machinery. Childn <24 mth.

Adverse Drug Reactions: Hypersensitivity. Nausea, vomiting, heartburn, abdominal discomfort, diarrhea;
exhaustion, faintness, somnolence, clouding of consciousness (stupor), numbness, dizziness, headache;
palpitations.

Drug Interactions: Care should be taken when sedative drugs are simultaneously administered to
particularly sensitive individuals.

Administration: Should be taken on an empty stomach: Take between meals.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: not classified

ATC Code: R05DB27

Cost:
P a g e | 94

SINECOD FORTE
OTC Butamirate citrate

Dosage Forms/ Strength:


Syrup: Each teaspoonful (5 ml) contains 7.5 mg of butamirate citrate. Tablet: Each sustained-release film-
coated tablet contains 50 mg of butamirate citrate.

Indication: Symptomatic treatment of cough of various origins.

Contraindications: Hypersensitivity.

Dosage: SR tab Adult 1 tab tid (at least 8 hr-interval). Max: 150 mg/day. Adolescents >12 yr 1 tab bid.
Max: 100 mg/day. Syr Adult 15 mL qid. Max: 60 mL/day. Adolescents >12 yr 15 mL tid. Max: 45 mL/day.
Childn 6-12 yr 10 mL tid. Max: 30 mL/day, 3-6 yr 5 mL tid. Max: 15 mL/day.

 Overdosage

 S/Sx: somnolence, nausea, vomiting, diarrhea, dizziness and low blood pressure.

 Tx: Further management should be as clinically indicated or as recommended by the


national poison centers, where available. There is no specific treatment for an overdose of
butamirate. If overdose occurs, the patient should be treated supportively with appropriate
monitoring as necessary. If the patient takes more Butamirate Citrate (Sinecod Forte) than
they should have, seek medical advise immediately.

Dosage Adjustments: not stated

Precautions: Avoid simultaneous administration of expectorants. Hereditary fructose intolerance. Minor


influence on the ability to drive & use machines. Pregnancy & lactation. Syr: Contains ethanol.

Adverse Drug Reactions: Rarely, somnolence, itchy skin rashes, nausea, diarrhea.

Drug Interactions: Avoid taking simultaneously w/ other cough medicines.

Administration: May be taken with or without food. SR tab: Swallow whole.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: not classified

ATC Code: R05DB13

Cost:

NEOZEP FORTE / NEOZEP NON-DROWSY


OTC Phenylephrine HCL + Chlorphenamine Maleate + Paracetamol /
Phenylephrine HCL + Paracetamol

Dosage Forms/ Strength: Per Neozep Forte tab Phenylephrine HCl 10 mg, chlorphenamine maleate 2
mg, paracetamol 500 mg. Per Neozep Non-Drowsy tab Phenylephrine HCl 10 mg, paracetamol 500 mg
P a g e | 95

Indication: Neozep Non-Drowsy Relief of clogged nose, post nasal drip, headache, body aches & fever
associated w/ common cold, sinusitis, flu & other minor resp tract infections; decongest sinus openings &
passages. Neozep Forte Itchy & watery eyes, sneezing, allergic rhinitis.

Contraindications: Hypersensitivity. High BP, severe heart disease. Anemia, kidney or liver disease.
Pregnancy & lactation.

Dosage: Neozep Forte tab 1 tab. Neozep Non-Drowsy tab 1 tab every 6 hr.

 Overdosage

 S/Sx: Phenylephrine HCl: Increased blood pressure; Palpitation; Vomiting; Headache;


Paresthesia (sensation of tingling, pricking or numbness of the skin); Cerebral hemorrhage
(bleeding from a ruptured blood vessel in the brain); Seizures; Paracetamol: Overdosage of
Paracetamol usually involves 4 phases with the following signs and symptoms: I. Eating
disorder, nausea, vomiting, malaise, and excessive sweating. II. Right upper abdominal pain
or tenderness, liver enlargement which may be characterized by abdominal discomfort of
"feeling full", elevated bilirubin and liver enzyme concentrations, prolongation of prothrombin
time, and occasionally decreased urine output. III. Eating disorder, nausea, vomiting, and
malaise recur and signs of liver (e.g., jaundice) and possibly kidney failure and
cardiomyopathy (disorder of the heart muscle) may develop. IV. Recovery or progression to
fatal complete liver failure. Phenylpropanolamine HCl: Fast heart rate (tachycardia); Irregular
heart beat (arrhythmia); High blood pressure; Excitation; Seizures; Enlargement of the
pupils; Cases of heart attack, stroke, intracranial bleeding/cerebral hemorrhage (bleeding
from ruptured blood vessel in the brain), and death have also been reported;
Chlorphenamine Maleate: Extreme sleepiness or prolonged drowsiness; Agitation;
Weakness; Irritability; Hallucination; Tachycardia; Convulsion; Coma.

 Tx: If the patient has taken more than the recommended dosage, consult a doctor or contact
a poison control center right away, even if the patient seems well, because of the risk of
delayed, serious liver damage. Quick medical attention is important for adults as well as for
children even if they do not notice any signs or symptoms.

Dosage Adjustments: not stated

Precautions: Severe liver damage may occur. Neozep Forte May impair ability to drive or operate
machinery.

Adverse Drug Reactions: Neozep Forte GI upsets, drowsiness, dizziness; dry mouth, difficulty in
micturition, sweating, reduced appetite; epileptiform seizures (large doses). Neozep Non-Drowsy
Nervousness, insomnia, dizziness, muscular weakness, headache, HTN. Rapid heart rate, tightness of
chest, excitement & dilatation of pupils; skin rashes, itching, swelling of throat & rarely allergic reactions
(large doses of paracetamol).

Drug Interactions: Increased toxicity w/ epinephrine & halothane. Risk of hypertensive crisis w/
amitryptyline, imipramine, sertraline, moclobemide. Decreased effect w/ phenothiazine, phentolamine,
propranolol. Paracetamol. May increase harmful effects to the liver w/ phenobarb. Increase anticoagulation
effect of warfarin.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: not classified

ATC Code: N02BE51

Cost:
P a g e | 96

DECOLGEN FORTE / NON-DROWSE DECOLGEN


OTC Paracetamol + Phenylpropanolamine HCL + Chlorphenamine maleate /
Phenylpropanolamine HCL + Paracetamol

Dosage Forms/ Strength: Decolgen Forte Paracetamol 500 mg, phenylpropanolamine HCl 25 mg,
chlorphenamine maleate 2 mg. No-Drowse Decolgen Phenylpropanolamine HCl 25 mg, paracetamol 500
mg

Indication: Decolgen Forte Relief of watery eyes, sneezing, allergic rhinitis. No-Drowse Decolgen Relief
of clogged nose, postnasal drip, headache, body aches & fever associated w/ common cold, sinusitis, flu &
other minor resp tract infections; decongest sinus openings & passages.

Contraindications: Hypersensitivity. High BP or severe heart disease, anemia. Kidney or liver disease.
Pregnancy & lactation.

Dosage: Adult & childn ≥12 yr 1 tab every 6 hr.

 Missed Dose: If the patient missed a dose, just take the next dose if still needed for the condition
being treated, and the subsequent doses at the recommended time or schedule (i.e., every 6
hours). Do not double the dose.

 Overdosage

 S/Sx: Paracetamol: Overdosage of Paracetamol usually involves 4 phases with the following
signs and symptoms: I. Eating disorder, nausea, vomiting, malaise, and excessive sweating.
II. Right upper abdominal pain or tenderness, liver enlargement which may be characterized
by abdominal discomfort of "feeling full", elevated bilirubin and liver enzyme concentrations,
prolongation of prothrombin time, and occasionally decreased urine output. III. Eating
disorder, nausea, vomiting, and malaise recur and signs of liver (e.g., jaundice) and possibly
kidney failure and cardiomyopathy (disorder of the heart muscle) may develop. IV. Recovery
or progression to fatal complete liver failure.; Phenylpropanolamine HCl: Fast heart rate
(tachycardia); Irregular heart beat (arrhythmia); High blood pressure; Excitation; Seizures;
Enlargement of the pupils; Cases of heart attack, stroke, intracranial bleeding/cerebral
hemorrhage (bleeding from ruptured blood vessel in the brain), and death have also been
reported; Chlorphenamine Maleate: Extreme sleepiness or prolonged drowsiness;
Weakness; Hallucination; Convulsion; Agitation; Irritability; Tachycardia; Coma.

 Tx: If the patient has taken more than the recommended dosage, consult a doctor or contact
a poison control center right away, even if the patient seems well, because of the risk of
delayed, serious liver damage. Quick medical attention is important for adults as well as for
children even if they do not notice any signs or symptoms.

Dosage Adjustments: not stated

Precautions: Patients w/ high BP, toxic goiter, benign prostatic hypertrophy, heart rate irregularity,
glaucoma, & in patients taking antidepressants. Paracetamol: Risk of severe liver damage. Decolgen Forte
May impair ability to drive & operate machines.

Adverse Drug Reactions: Phenylpropanolamine: Aggressiveness, anxiety, confusion, insomnia/sleep


disturbance, nervousness; agitation, dizziness, restlessness, sudden persistent severe headache, tremor;
blurred vision; chest tightness, palpitation; high BP; nausea; irritability. Paracetamol: Changes in WBC &
platelets eg, agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia; allergic reactions
which may cause difficulty in breathing, skin rash, angioedema; minor stomach & intestinal disturbances.
P a g e | 97

Rare cases of serious skin reactions which may include symptoms eg, skin reddening, blisters or rash.
Decolgen Forte Chlorpheniramine maleate: Sleepiness & drowsiness.

Drug Interactions: Increased toxicity w/ sympathomimetics (eg, epinephrine) & general anesth (eg,
halothane). Risk of hypertensive crisis w/ MAOIs (eg, selegiline, moclobemide) & TCAs (amitriptyline,
imipramine). Paracetamol: May increase susceptibility to anticoagulation effect w/ warfarin. May increase
harmful effects to the liver w/ medicines for convulsion (eg, phenobarb, phenytoin). Accelerated absorption
w/ metoclopramide or domperidone. Reduced absorption w/ cholestyramine. Phenylpropanolamine:
Additive increase in BP w/ caffeine.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: not classified

ATC Code: N02BE51

Cost:

NAFARIN-A (REFORMULATED)
OTC Phenylpropanolamine HCL + Chlorphenamine maleate + Paracetamol

Dosage Forms/ Strength: Per tab Phenylpropanolamine HCl 20 mg, chlorphenamine maleate 1 mg,
paracetamol 325 mg.

Indication: Relief of clogged nose, runny nose, postnasal drip, itchy & watery eyes, sneezing, headache,
body aches, & fever associated w/ the common cold, allergic rhinitis, sinusitis, flu, & other minor resp tract
infections. Helps decongest sinus openings & passages.

Contraindications: Hypersensitivity. High BP or severe heart disease; anemia, kidney or liver disease.
Pregnancy & lactation.

Dosage: Adult & childn ≥12 yr 1 tab every 6 hr.

 Missed Dose: If the patient missed a dose, just take the next dose if still needed for the condition
being treated, and the subsequent doses at the recommended time or schedule (i.e., every 6
hours). Do not double the dose.

 Overdosage

 S/Sx: Paracetamol: Overdosage of Paracetamol usually involves 4 phases with the following
signs and symptoms: I. Eating disorder, nausea, vomiting, malaise, and excessive sweating.
II. Right upper abdominal pain or tenderness, liver enlargement which may be characterized
by abdominal discomfort of "feeling full", elevated bilirubin and liver enzyme concentrations,
prolongation of prothrombin time, and occasionally decreased urine output. III. Eating
disorder, nausea, vomiting, and malaise recur and signs of liver (e.g., jaundice) and possibly
kidney failure and cardiomyopathy (disorder of the heart muscle) may develop. IV. Recovery
or progression to fatal complete liver failure.; Phenylpropanolamine HCl: Fast heart rate
(tachycardia); Irregular heart beat (arrhythmia); High blood pressure; Excitation; Seizures;
Enlargement of the pupils; Cases of heart attack, stroke, intracranial bleeding/cerebral
hemorrhage (bleeding from ruptured blood vessel in the brain), and death have also been
reported
P a g e | 98

 Tx: If the patient has taken more than the recommended dosage, consult a doctor or contact
a poison control center right away, even if the patient seems well, because of the risk of
delayed, serious liver damage. Quick medical attention is important for adults as well as for
children even if they do not notice any signs or symptoms.

Dosage Adjustments: not stated

Precautions: Patients w/ high BP, toxic goiter, benign prostatic hypertrophy, heart rate irregularity,
glaucoma, diabetes & those taking antidepressants. Patients taking more than max daily amount (4 g in 24
hr), taking other medicines containing paracetamol, adult w/ ≥3 alcoholic drinks everyday. Kidney or liver
disease. Concomitant use w/ warfarin. Observe caution while driving or performing other tasks requiring
alertness. Discontinue if fever gets worse or lasts >3 days.

Adverse Drug Reactions: Phenylpropanolamine HCl: Aggressiveness (particularly in young childn),


anxiety, confusion, insomnia/sleep disturbance, nervousness; agitation, dizziness, restlessness; sudden
persistent severe headache, tremor; blurred vision; chest tightness, palpitation; high BP; nausea; irritability.
Chlorpheniramine maleate: Insomnia/sleeplessness, nervousness; headache, tremor; blurred vision;
visual disturbance; tinnitus; chest tightness; increased or decreased BP; constipation, diarrhea, GI
discomfort, nausea, vomiting; muscle weakness; difficulty urinating; mouth, nose & throat dryness;
irritability. Paracetamol: Agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia;
allergic reactions; minor stomach & intestinal disturbances; Stevens-Johnson syndrome, toxic epidermal
necrolysis & acute generalized exanthematous pustulosis.

Drug Interactions: Increased toxicity w/ sympathomimetic agents (eg, epinephrine) & general anesth (eg,
halothane). Hypertensive crisis w/ medicines for depression eg, MAOIs (eg, selegiline, moclobemide) &
TCAs (eg, amitriptyline, imipramine). May potentiate drowsiness w/ anxiolytics (eg, alprazolam, diazepam)
& hypnotics (eg, zolpidem). Phenylpropanolamine HCl: Additive increase in BP w/ caffeine. Paracetamol:
Increased anticoagulation effect of warfarin. Increase susceptibility to the harmful effects to the liver w/
anticonvulsants (eg, phenobarb, phenytoin). May accelerate absorption w/ metoclopramide or
domperidone. May reduce absorption w/ cholestyramine.

Administration: May be taken with or without food.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: not classified

ATC Code: N02BE51

Cost:
P a g e | 99

Corticosteroid Hormones

METCORT
Rx Methylprednisolone

Dosage Forms/ Strength: Each tab contains 4mg or 16 mg

Indication: Primary or secondary adrenocortical insufficiency. Rheumatic & nervous system disorders.
Collagen, dermatologic, ophth, GI, resp, hematologic, & neoplastic diseases. Allergic & edematous states.

Contraindications: Hypersensitivity. Systemic infections, unless specific anti-infective therapy is given;


systemic fungal infections. Administration of live or live attenuated vaccines in patients receiving
immunosuppressive doses of corticosteroids..

Dosage: Adult Initially 4-48 mg daily in 4 divided doses; acute severe disease Initially ≥100 mg [suggested
initial daily dose: Severe RA 12-16 mg, moderately severe RA 8-12 mg, moderate RA & childn 4-8 mg.
Systemic dermatomyositis 48 mg. SLE 20-100 mg. Acute rheumatic fever 48 mg until ESR normal for 1
wk. Allergic & ophth diseases 12-40 mg. Bronchial asthma Up to 64 mg single dose/alternate day up to
max of 100 mg. Hematological disorders & leukemias; malignant lymphoma 16-100 mg. Ulcerative
P a g e | 100

colitis 16-60 mg. Crohn's disease Up to 48 mg/day in acute episodes. Organ transplantation Up to 3.6
mg/kg/day. Pulmonary sarcoid 32-42 mg on alternate days. Giant cell arteritis/polymyalgia rheumatica
64 mg. Pemphigus vulgaris 80-360 mg. Multiple sclerosis 200 mg/day. Cerebral edema 200-1,000
mg/day]. Treatment of acute exacerbations of multiple sclerosis 200 mg daily for 1 wk, followed by 80
mg every other day for 1 mth. Childn Initially 0.117-1.66 mg/kg/day (3.3-50 mg/m2/day) in 3 or 4 divided
doses.

 Overdosage

 S/Sx: ulceration of the gastrointestinal tract, electrolyte disturbances, infections, diabetes


and edema

 Tx: There is no known specific antidote available. Treatment of acute overdose is


symptomatic and supportive (including respiratory and cardiovascular function). In case of
chronic toxicity, closely monitor fluids and electrolytes levels. Serum levels are not clinically
useful. Methylprednisolone is dialyzable.

Dosage Adjustments: not stated

Precautions: Risk of immunosuppressive effects/increased susceptibility to infections; endocrine, CV-


renal, GI, hepatobiliary, musculoskeletal, ophth & neuropsychiatric effects; hypersensitivity reactions.
Metabolism & nutrition disorders. Not for the treatment of traumatic brain injury. Pregnancy & lactation.
Childn & infants (prolonged therapy).

Adverse Drug Reactions: GI, musculoskeletal, endocrine-metabolic, psychiatric, nervous system, ophth,
CV & immune system effects; skin & SC tissue, reproductive system & breast disorders; fluid & electrolyte
disturbances; elevated serum liver enzyme levels, hypokalemia, increased Ca excretion/urine Ca; vertigo,
impaired hearing; hiccups, leukocytosis, malaise, w/drawal symptoms & moon face.

Drug Interactions: Enhanced metabolism w/ CYP3A4 inducers eg, barbiturates, phenytoin, primidone,
rifampicin, rifabutin, aminoglutethimide, carbamazepine & other drugs that stimulate hepatic metabolism.
Decreased metabolism w/ CYP3A4 inhibitors eg, antifungals (itraconazole, ketoconazole), antiemetics
(aprepitant, fosaprepitant), immunosuppressants (ciclosporin, cyclophosphamide, tacrolimus), macrolides
(clarithromycin, erythromycin, troleandomycin), HIV-PIs, diltiazem, grapefruit juice. Inhibition or induction of
hepatic clearance w/ CYP3A4 substrates eg, Ca antagonists (mibefradil), H2-receptor antagonists
(cimetidine), contraceptives (ethinylestradiol/norethindrone) & Ca channel blockers (nifedipine, felodipine).
Increased risk of hypokalemia w/ sympathomimetics eg, salbutamol, salmeterol, terbutaline, formoterol (at
high doses of corticosteroids). Increased plasma conc w/ PIs (ie, indinavir & ritonavir). Decreased
absorption w/ antacids. Alterations in plasma protein-binding & metabolism w/ OCs & estrogen. Increased
risk of GI effects eg, GI bleeding & ulceration w/ aspirin or other NSAIDs. Enhanced or diminished effects of
anticoagulants. Hypokalemia w/ K-depleting diuretics (eg, furosemide & thiazide) or carbonic anhydrase
inhibitors (eg, acetazolamide); amphotericin B. Reduced effect w/ mifepristone. Acute myopathy w/
anticholinergics eg, neuromuscular blockers (at high doses of corticosteroids). Increased blood glucose
conc & impaired glucose tolerance w/ insulin & oral antidiabetics. Increased risk of arrhythmias due to
hypokalemia w/ digitalis glycosides. Diminished response to toxoids & live or inactivated vaccines
(prolonged use of corticosteroids).

Administration: Should be taken with food.

Storage: Store at temperatures not exceeding 25°C.

Pregnancy Category: C

ATC Code: H02AB04

Cost:
P a g e | 101

Medsone
Rx Prednisolone

Dosage Forms/ Strength: Each 5 mL contains: Prednisolone (as sodium phosphate) 20 mg.

Indication: Suppression of inflammatory & allergic disorders, inflammatory bowel disease, asthma,
immunosuppression & rheumatic disease.

Contraindications: Hypersensitivity.

Dosage: Adult 10-20 mg daily. Childn 1-2 mg/kg given once or in divided doses.

Dosage Adjustments: not stated

Precautions: Blood dyscrasias or active CNS disease. Pregnancy.

Adverse Drug Reactions: Hypertrophic cardiomyopathy in premature infants. Facial erythema, increased
sweating, impaired wound healing, urticaria, edema. Decreased carbohydrate tolerance, cushingoid state,
hirsutism, increased insulin requirements for diabetic patients, menstrual irregularities, growth suppression
in childn. CHF, HTN, hypokalemic alkalosis. Abdominal distension, elevation in serum liver enzyme levels,
pancreatitis, peptic ulcer, ulcerative esophagitis. Muscle weakness, osteoporosis, tendon rupture, vertebral
compression fractures. Convulsions, headache, increased intracranial pressure, psychic disorders, vertigo.
Exophthalmos, glaucoma, increased IOP. Increased appetite, malaise, nausea & wt gain.

Drug Interactions: Possible of renal damage w/ lithium. Disulfiram-like (antabuse effect) reaction w/
alcohol. Caution in concomitant w/ anticoagulants, phenobarb, cimetidine & disulfiram.

Administration: Should be taken with food: Best taken after breakfast.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: C, D (in 1st trimester)

ATC Code: H02AB04


Cost:

PRED 20 / PRED 30
Rx Prednisone

Dosage Forms/ Strength: Each film coated tablet contains: 20 mg or 30 mg

Indication: Suppression of inflammatory & allergic disorders, inflammatory bowel disease, asthma,
immunosuppression & rheumatic disease.

Contraindications: Hypersensitivity.

Dosage: Adult 10-20 mg daily. Childn 1-2 mg/kg given once or in divided doses.

Dosage Adjustments: not stated

Precautions: Blood dyscrasias or active CNS disease. Pregnancy.


P a g e | 102

Adverse Drug Reactions: Hypertrophic cardiomyopathy in premature infants. Facial erythema, increased
sweating, impaired wound healing, urticaria, edema. Decreased carbohydrate tolerance, cushingoid state,
hirsutism, increased insulin requirements for diabetic patients, menstrual irregularities, growth suppression
in childn. CHF, HTN, hypokalemic alkalosis. Abdominal distension, elevation in serum liver enzyme levels,
pancreatitis, peptic ulcer, ulcerative esophagitis. Muscle weakness, osteoporosis, tendon rupture, vertebral
compression fractures. Convulsions, headache, increased intracranial pressure, psychic disorders, vertigo.
Exophthalmos, glaucoma, increased IOP. Increased appetite, malaise, nausea & wt gain.

Drug Interactions: Possible of renal damage w/ lithium. Disulfiram-like (antabuse effect) reaction w/
alcohol. Caution in concomitant w/ anticoagulants, phenobarb, cimetidine & disulfiram.

Administration: Should be taken with food: Best taken after breakfast.

Storage: Store at temperatures not exceeding 30°C.

Pregnancy Category: C, D (in 1st trimester)

ATC Code: H02AB04


Cost:

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