Pharmacist Counseling Guide (2020)

1 APRIL 2020 Pharmacist Counseling Guide
This pharmacist counseling guide is solely created out of my passion of information sharing and
the pursuit of personal growth as a pharmacist in Malaysia. It does not negate the need for any
pharmacist to look into product leaflets, but functions as a quick reference. Efforts were made to
verify the completeness and accuracy of the information contained. However, always refer to the
relevant sources of information when in doubt.
For more guides and updates, visit https://mypharmacistnote.blogspot.com.
Contents
Acne ................................................................................................................................................ 8
Acne .......................................................................................................................................................... 8
Adapalene 0.1% gel ................................................................................................................................. 10
Azelaic acid 20% cream/lotion ................................................................................................................ 12
Benzoyl peroxide 5% gel ......................................................................................................................... 13
Tretinoin 0.05% cream ............................................................................................................................ 14
Oral doxycycline ...................................................................................................................................... 16
Oral isotretinoin ...................................................................................................................................... 18
Alfacalcidol 2 mcg/ml (One-alpha® drops 20 ml) ......................................................................... 20
Anaphylactic reactions .................................................................................................................. 22
Anaphylaxis ............................................................................................................................................. 22
Epinephrine auto-injector ....................................................................................................................... 24
Apixaban (Eliquis).......................................................................................................................... 28
Benzydamine hydrochloride 3mg/ml throat spray (Difflam forte) .............................................. 30
Bowel cleansing procedure ........................................................................................................... 33
Bowel preparation before colonoscopy in adults ................................................................................... 33
Fleet enema ............................................................................................................................................ 38
Oral fleet solutions .................................................................................................................................. 41
Fortrans ................................................................................................................................................... 52
Pico-salax ................................................................................................................................................ 58
Additional counseling points................................................................................................................... 61
Cholestyramine 4 g powder sachets ............................................................................................. 63
Contraception ............................................................................................................................... 67
Emergency contraception ....................................................................................................................... 67
Contraception ......................................................................................................................................... 70
1|Page Prepared by Rx Note

Combined oral contraceptives ................................................................................................................ 74
Progestogens........................................................................................................................................... 84
Dabigatran (Pradaxa) .................................................................................................................... 87
Dandruff (Pityriasis capitis) ........................................................................................................... 90
Dandruff .................................................................................................................................................. 90
Selsun selenium sulfide 25 mg/ml (2.5%) suspension ............................................................................ 91
Sebitar shampoo ..................................................................................................................................... 92
Ketoconazole 2% w/w shampoo ............................................................................................................. 93
Deferasirox dispersible tablet (Exjade) ......................................................................................... 95
Diabetes mellitus .......................................................................................................................... 98
Diabetes mellitus .................................................................................................................................... 98
Oral anti-diabetic agents....................................................................................................................... 107
Insulin .................................................................................................................................................... 109
Pen needles ........................................................................................................................................... 114
Injection sites ........................................................................................................................................ 120
Insulin storage and disposal .................................................................................................................. 122
Special considerations in injectable therapy ........................................................................................ 124
Foot care for people with diabetes ....................................................................................................... 127
Gestational diabetes mellitus ............................................................................................................... 129
Normal syringe ...................................................................................................................................... 131
Novopen 4 ............................................................................................................................................. 135
Differences between Novopen 3 and Novopen 4................................................................................. 138
Novopen 5 ............................................................................................................................................. 142
Allstar pen ............................................................................................................................................. 145
INSUPen EZ............................................................................................................................................ 157
INSUPen Pro .......................................................................................................................................... 168
Differences between INSUPen EZ and INSUPen PRO ........................................................................... 179
Differences between Novopen 4, Allstar pen and INSUPen EZ ............................................................ 181
FlexPen .................................................................................................................................................. 184
InnoLet .................................................................................................................................................. 189
HumaPen............................................................................................................................................... 191
Glucagon-like peptide-1 (GLP-1) receptor agonists .............................................................................. 193

Accu-Chek Instant S .............................................................................................................................. 198
Accu-Chek Guide ................................................................................................................................... 200
OneTouch Delice Plus lancing device.................................................................................................... 202
OneTouch Verio Flex ............................................................................................................................. 203
Ear drops ..................................................................................................................................... 204
Enoxaparin (Clexane) pre-filled syringes .................................................................................... 206
Eye ............................................................................................................................................... 212
General principles of topical eye drugs ................................................................................................ 212
Eye drops............................................................................................................................................... 216
Eye ointments and gels ......................................................................................................................... 218
Multiple eye drops and/or ointment .................................................................................................... 220
Glaucoma .............................................................................................................................................. 222
Allergic conjunctivitis ............................................................................................................................ 225
Fondaparinux sodium solution for injection 2.5 mg/0.5 ml (Arixtra) ......................................... 227
Glyceryl trinitrate sublingual spray, 400 mcg ............................................................................. 233
Glyceryl trinitrate sublingual tablet, 500 mcg ............................................................................ 235
Head lice...................................................................................................................................... 237
Head lice................................................................................................................................................ 237
Gamma Benzene Hexachloride 1% lotion............................................................................................. 241
Malathion 0.5% lotion........................................................................................................................... 243
Permethrin 1% lotion. ........................................................................................................................... 245
Hemophilia .................................................................................................................................. 247
Hemophilia and related conditions....................................................................................................... 247
Hemophilia ............................................................................................................................................ 248
HIV/AIDS...................................................................................................................................... 255
HIV/AIDS................................................................................................................................................ 255
Symptoms of HIV infection ................................................................................................................... 257
Testing for HIV ...................................................................................................................................... 259
Initial treatment of HIV ......................................................................................................................... 261
Adherence to ART ................................................................................................................................. 268
Assessment of adults with HIV infection .............................................................................................. 270
Adverse events of ARVs ........................................................................................................................ 276

Management of treatment failure: after first line therapy .................................................................. 285
Liquid medications ...................................................................................................................... 288
Nose ............................................................................................................................................ 294
Rhinitis .................................................................................................................................................. 294
Rhinosinusitis ........................................................................................................................................ 299
Nasal sprays .......................................................................................................................................... 301
Nasal pump sprays ................................................................................................................................ 303
Avamys nasal spray (Fluticasone furoate, 27.5 mcg)............................................................................ 306
Desmospray (Desmopressin, 10 mcg)................................................................................................... 311
Nasonex nasal spray (Mometasone furoate, 50 mcg) .......................................................................... 313
Oxynase nasal spray (Oxymetazoline hydrochloride) ........................................................................... 317
Rhinocort® aqua nasal spray (Budesonide, 64 mcg) ............................................................................. 323
Nasal drops ........................................................................................................................................... 326
Alkaline nasal douche ........................................................................................................................... 328
Steam inhalations ................................................................................................................................. 329
Nicotine dependence .................................................................................................................. 330
Nicotine dependence ............................................................................................................................ 330
Modified Fagerstrom Test for Cigarette Dependence .......................................................................... 334
Bupropion ............................................................................................................................................. 335
Nicotine replacement therapy .............................................................................................................. 337
Varenicline ............................................................................................................................................ 341
Additional counseling points................................................................................................................. 343
Nystatin oral suspension 100,000 units/ml ................................................................................ 346
Opioid dependence..................................................................................................................... 348
Opioid dependence ............................................................................................................................... 348
Methadone ........................................................................................................................................... 354
Naltrexone ............................................................................................................................................ 356
Osteoporosis ............................................................................................................................... 359
Osteoporosis ......................................................................................................................................... 359
Fosamax (Alendronate) 70 mg .............................................................................................................. 363
Bonviva (Ibandronic acid) 150 mg......................................................................................................... 365
Protaxos (Strontium ranelate) 2 g......................................................................................................... 367

Miacalcic (Synthetic salmon calcitonin) nasal spray ............................................................................. 369
Pessaries and vaginal creams...................................................................................................... 373
Vaginal tablets, suppositories and creams ........................................................................................... 373
Ramadan ..................................................................................................................................... 377
Ramadan ............................................................................................................................................... 377
Diabetes management in Ramadan ...................................................................................................... 379
Panduan berpuasa bagi pesakit [2013]................................................................................................. 387
Puasa & ubat [2012].............................................................................................................................. 390
Penjagaan pesakit diabetes pada bulan Ramadan [2015] .................................................................... 395
Respiratory .................................................................................................................................. 399
Asthma .................................................................................................................................................. 399
Chronic obstructive pulmonary disease ............................................................................................... 409
Effective pulmonary drug delivery ........................................................................................................ 419
Inhaler technique for people with asthma or COPD ............................................................................. 422
Peak flow meter .................................................................................................................................... 425
In-Check DIAL G16................................................................................................................................. 429
Metered dose inhaler ........................................................................................................................... 436
BI tube ................................................................................................................................................... 442
Spacer.................................................................................................................................................... 444
AeroTrach Plus antistatic valved holding chamber (aVHC) .................................................................. 452
Turbuhaler............................................................................................................................................. 454
Accuhaler (Diskus)................................................................................................................................. 459
Easyhaler ............................................................................................................................................... 462
Handihaler............................................................................................................................................. 466
Soft-mist inhaler (Respimat®) ............................................................................................................... 472
Breezhaler ............................................................................................................................................. 477
Ellipta .................................................................................................................................................... 482
Nexthaler............................................................................................................................................... 487
Diskhaler ............................................................................................................................................... 490
Rectum ........................................................................................................................................ 495
Suppositories ........................................................................................................................................ 495
Enema ................................................................................................................................................... 498

Pentasa enema (Mesalazine 1 g/100 ml enema).................................................................................. 499
Rivaroxaban (Xarelto) ................................................................................................................. 502
Scabies ........................................................................................................................................ 505
Scabies .................................................................................................................................................. 505
Crotamiton 10% cream ......................................................................................................................... 508
Emulsion Benzyl Benzoate 25% ............................................................................................................ 510
Gamma Benzene Hexachloride (Lindane) 1% lotion............................................................................. 512
Permethrin 5% cream/lotion ................................................................................................................ 514
Skin – bacterial skin infections .................................................................................................... 516
Antibacterial preparations .................................................................................................................... 516
Fusidic acid 2% cream/ointment .......................................................................................................... 518
Metronidazole 0.75% gel ...................................................................................................................... 519
Mupirocin 2% cream/ointment ............................................................................................................ 520
Neomycin sulfate 0.5% w/w cream ...................................................................................................... 521
Silver sulfadiazine 1% cream ................................................................................................................. 522
Skin – fungal skin infections ........................................................................................................ 524
Antifungal preparations ........................................................................................................................ 524
Azoles (skin) .......................................................................................................................................... 526
Amorolfine 5% nail lacquer (Loceryl) .................................................................................................... 527
Nystatin 100,000units/g Cream ............................................................................................................ 530
Skin – inflammatory skin conditions ........................................................................................... 531
Eczema .................................................................................................................................................. 531
Eczema and psoriasis, drugs affecting the immune response .............................................................. 535
Psoriasis ................................................................................................................................................ 537
Emollients (moisturizers) ...................................................................................................................... 541
Topical corticosteroids .......................................................................................................................... 543
Calcipotriol ............................................................................................................................................ 548
Coal tar .................................................................................................................................................. 550
Pimecrolimus 1% cream (Elidel)............................................................................................................ 552
Tacrolimus 0.03% and 0.1% ointment (Protopic) ................................................................................. 554
Potassium permanganate ..................................................................................................................... 556
Sodium valproate (Epilim)........................................................................................................... 558

Sunscreens .................................................................................................................................. 561
Tinzaparin (Innohep) ................................................................................................................... 563
Transdermal patches .................................................................................................................. 567
Transdermal patches............................................................................................................................. 567
Buprenorphine patch (Sevonor® patch) ............................................................................................... 571
Fentanyl transdermal system (Duragesic® patch) ................................................................................ 575
Rivastigmine patch (Exelon patch) ........................................................................................................ 581
Rotigotine patch (Neupro) .................................................................................................................... 587
Tuberculosis ................................................................................................................................ 594
Tuberculosis .......................................................................................................................................... 594
Treatment ............................................................................................................................................. 597
TB in pregnancy, lactation & use of oral contraceptives ...................................................................... 601
Liver & renal impairment ...................................................................................................................... 603
Tuberculosis and public health ............................................................................................................. 605
Warfarin ...................................................................................................................................... 606
What is warfarin and why do I need it? ................................................................................................ 606
Warfarin monitoring ............................................................................................................................. 607
Taking warfarin safely ........................................................................................................................... 609
Warfarin side effects ............................................................................................................................. 610
Pregnancy and warfarin ........................................................................................................................ 613
Warfarin interactions ............................................................................................................................ 614
Other recommendations ...................................................................................................................... 618
Warts ........................................................................................................................................... 622
Warts ..................................................................................................................................................... 622
Podophyllum resin 5-25% paint ............................................................................................................ 625
Salicylic acid .......................................................................................................................................... 627
Imiquimod 5% cream ............................................................................................................................ 629
References .................................................................................................................................. 631

Acne
Acne
Acne
Acne is primarily an inherited disorder that involves the pilosebaceous follicles. It is caused by
increased sebum production, abnormal keratinization within the pilosebaceous canal,
Propionibacterium acnes colonization, and an immune-mediated inflammatory reaction.
Inflammatory reactions are typically erythematous and can include:(1)
- Papules: raised, solid lesions up to several millimeters in diameter
- Pustules: raised, superficial, pus-filled lesions
- Nodules: like papules, but larger and deeper in the skin.
Comedones (plugged follicle openings) can be closed (whiteheads) or open (black heads).(1)
Acne Severity
Mild Comedones with or without a few or several pustules or papules
Moderate Comedones, several pustules or papules, with or without a few or several

nodules
Severe Numerous or extensive pustules or papules and many nodules; can include
cases with persistent nodules, extensive scarring, drainage, or formation of
sinus tracts
Very severe Acne variants such as acne conglobate or acne formation
Treatment:
- The goals of therapy are to relieve discomfort, improve skin appearance, prevent scarring,
and minimize the psychosocial impact of the condition.(1)
- No known cure exists. Treatment is preventive and can reduce severity. After a drug
regimen achieves control, treatment must continue with a maintenance regimen for
months to years. Early, aggressive therapy prevents scarring and psychosocial sequelae.(1)
- Drug therapies work by reducing sebum production (e.g. isotretinoin, hormonal therapy),
normalizing follicular keratinization (e.g. retinoids, benzoyl peroxide, azelaic acid),
reducing P. acnes (e.g. antibiotics, benzyl peroxide, azelaic acid, isotretinoin), and
reducing inflammation (e.g. antibiotics, retinoids).(1)
- Topical retinoids and benzoyl peroxide are used as first-line treatments in mild or
moderate acne.(2)
- The topical retinoids are applied once daily and traditionally at night due to photolability
reported with tretinoin. Adapalene and trifarotene are more light-stable. In addition,

newer formulations of tretinoin, tretinoin gel microsphere, and micronized tretinoin 0.05%
in a hydrogel vehicle, are less affected by light exposure than their precursors.(3)
- Topical tretinoin should not be applied at the same time as benzoyl peroxide. Tretinoin is
less stable when exposed to benzoyl peroxide due to oxidation, an effect magnified during
light exposure. Adapalene, tretinoin gel microsphere, micronized tretinoin gel, tazarotene
and trifarotene remain more stable than tretinoin in the presence of benzoyl peroxide. A
combination product, containing adapalene and benzoyl peroxide, is available.(3)
- If topical retinoids or benzoyl peroxide are poorly tolerated, azelaic acid may be used.(2)
- When inflammation is present, topical clindamycin or topical dapsone may be added for
mild acne; oral antibacterials may be added for moderate-to-severe acne.(2)
- Oral isotretinoin is used for severe acne and for moderate acne unresponsive to the above
treatments.(2)
- Hormonal treatments may be added in females with moderate or severe acne.(2)
- Pharmacotherapy works best to prevent new lesions, not to resolve current ones. Topical
therapies should be applied regularly to the entire acne-prone area(s), not just to lesions.
It may take weeks to months to see the full treatment effect.(1)
- Other drug treatments including abrasive agents, e.g. aluminium oxide; degreasing agents
e.g. triclosan, and preparations containing sulfur, salicylic acid, resorcinol and allantoin.
Although widely used, effectiveness is questionable. Exfoliants may limit tolerance to
other more effective agents and have no effect on sebaceous gland activity.(2)
- Nondrug therapy plays a minimal role in the management of acne. Twice-daily face
washing with warm water and a mild facial cleanser remove excess sebum. Aggressive
scrubbing and squeezing of lesions should be avoided.(1)
- Acne scarring is treated with microsurgical techniques, dermabrasion, laser therapy,
chemical peel, and tissue augmentation.(1)
Counselling(2)
- Apply topical treatments to the entire affected area and not just to individual lesions.
- Wash affected areas gently; avoid vigorous scrubbing and abrasive cleansers, which may
cause more inflammation and make acne worse.
- Avoid using toners and oil-based moisturizers.
- Do not squeeze or pick the acne lesions (pimples) as this increases the risk of scarring.
- Eat a healthy balanced diet; there is no relationship between particular foods and acne.
Practice points(2)
- Do not switch or rotate antibacterials in patients who are responding to therapy
(response indicates efficacy and changing antibacterials may promote resistance).

Adapalene 0.1% gel
Indication and dosage(2)
Indication Dosage
Acne vulgaris (includes Apply once at night

fixed combination with
- Before applying, wash with mild soap and warm water; rinse
benzoyl peroxide)
and gently pat dry.
- Apply enough to cover the affected areas (not just the
pimples). Do not apply to eyes, lips, irritated areas (e.g.
sunburnt or broken skin) or in nostrils.
Counseling Points(2, 4)
- Advise patient that symptomatic improvement may not be seen for a few months.
- This medication may cause irritation (e.g. redness, peeling, stinging), especially during the
first few weeks of treatment. To reduce irritation:
o Wait until skin is completely dry (usually 20-30 minutes) before applying
o Apply a thin layer (using too much increases irritation and won’t make it work
faster); a pea-sized amount is usually enough to cover the whole face
o Avoid using other acne medications on the skin unless advised to you by your
doctor
o Using a moisturizer in the morning
o Avoid waxing treated areas
o Your doctor may tell you to apply the medication every other night to wash if off
after a period of time for the first couple of weeks.
- If irritation is troublesome, apply the medication less often or have a break from
treatment for a few days. If it persists or is severe, stop treatment and tell your doctor.
- Protect treated areas from sunlight with protective clothing or broad-spectrum sunscreen,
preferably SPF30 or SPF 50+, containing a physical barrier (e.g. titanium dioxide). Avoid
sunlamps and tanning beds.
- Instruct patient that cold temperatures or wind may also increase skin irritation during
drug therapy.
- Tell patients to avoid concurrent use of topical products which may dry or irritate the skin.
Practice points(2)
- Contraindicated in pregnancy. Although absorption via skin is minimal, in view of
teratogenicity of systemic retinoids, topical retinoids should not be used in pregnancy.
10 | P a g e Prepared by Rx Note
- The fixed combination with benzoyl peroxide is more effective than either agent alone;
trials comparing the efficacy of the fixed combination strengths (0.1% versus 0.3%) are
needed.
- Dryness, stinging and burning are slightly worse with the fixed combination with benzoyl
peroxide than either agent alone (particularly initially), and are more common with the
fixed combination 0.3% strength, but are generally still mild-to-moderate
Azelaic acid 20% cream/lotion
Indications and dosage(2)
Indication Dosage
Acne vulgaris, mild-to- Apply morning and night

moderate
- Before applying, wash affected area with mild soap or soap
Rosacea substitute and warm water; gently pat dry. Apply product
(papulopustular) and massage gently into affected areas (not just the pimples).
- Wash hands after application.
- Avoid contact with eyes and mouth.
- Do not use occlusive dressings or wrappings.
Counseling points(4)
- Side effects may include burning, stinging or tingling of the skin, pruritus, scaling or dry
skin, erythema, contact dermatitis, edema or acne.
- Instruct patient to report excessive or persistent skin irritation or hypopigmentation.
Practice points(2)
- Improvement in acne is generally apparent after 4 weeks; use regularly for periods up to
6 months to obtain optimum results.
- Irritation may occur at the start of treatment and usually subsides, consider applying once
daily, but if irritation persists, is severe, or is thought to be due to allergy, stop treatment.
- Azelaic acid appears to be at least as effective as topical metronidazole for the short-term
treatment of papulopustular rosacea (up to 15 weeks in trials).
Benzoyl peroxide 5% gel
Indication Dosage
Acne vulgaris (includes Begin treatment with lower strength product. Apply 2.5% to 10%
fixed combination with concentration topically once or twice daily.
adapalene or
- Before applying, wash affected area with mild soap or soap
clindamycin)
substitute and warm water; gently pat dry. Apply product
and massage gently into affected areas (not just the pimples)
and rub in gently.
- Wash hands after application.
- Avoid contact with eyes, lips and other sensitive areas
- Avoid contact with hair and colored fabric as bleaching or
discoloration may occur.
- Side effects may include allergic contact dermatitis or skin erythema, peeling or dryness.
- Tell patient to avoid sun exposure and use a sunscreen.
- Warn patient that drug has bleaching effects and to avoid contact with hair, carpet or
fabric.
Practice points(2)
- 2.5% or 5% benzoyl peroxide is less irritant than 10% but appears as effective.
- Use with other topical anti-acne preparations may add to irritant or drying effects.
- If irritation occurs, apply less frequently or use a lower strength product; if it persists, is
severe or is thought to be due to allergy, stop treatment.
- Continue treatment for at least 6 weeks before assessing efficacy.
- Maximum duration of treatment with the clindamycin fixed combination is 11 weeks.
Tretinoin 0.05% cream
Indication Dosage
Acne vulgaris Apply once a day at bedtime, starting with the lowest strength
Mottled - Before applying, wash affected area with mild soap and
hyperpigmentation, warm water; rinse and gently pat dry. Apply enough to cover
roughness and fine affected areas (not just the pimples).
wrinkling due to - Do not apply to eyes, lips, irritated areas (e.g. sunburnt or
photoaging broken skin) or in nostrils.
- Avoid contact with eyes and mucous membranes.
Counseling points(2, 4)
- Some improvement in acne may be noticed within a few weeks, but full benefit may not
be seen for a few months.
- This medication may cause irritation (e.g. redness, peeling, stinging), especially during the
first few weeks of treatment. To reduce irritation:
o Wait until skin is completely dry (usually 20-30 minutes) before applying
o Apply a thin layer (using too much increases irritation and won’t make it work
faster); a pea-sized amount is usually enough to cover the whole face
o Avoid using other acne medications on the skin unless advised to you by your
doctor
o Using a moisturizer in the morning
o Avoid waxing treated areas
o Your doctor may tell you to apply the medication every other night to wash if off
after a period of time for the first couple of weeks.
- If irritation is troublesome, apply the medication less often or have a break from
treatment for a few days. If it persists or is severe, stop treatment and tell your doctor.
- May cause blistering eruptions, burning, stinging, erythema, pruritus, dry or scaly skin,
peeling and pigmentation changes.
- Protect treated areas from sunlight with protective clothing or broad-spectrum sunscreen,
preferably SPF30 or SPF 50+, containing a physical barrier (e.g. titanium dioxide). Avoid
sunlamps and tanning beds.
Practice points(2)
- Contraindicated in pregnancy. Although absorption via skin is minimal, in view of
teratogenicity of systemic retinoids, topical retinoids should not be used in pregnancy.
- After achieving satisfactory response, it may be possible to maintain efficacy with less
frequent application.
- Topical tretinoin may increase the systemic absorption of topical minoxidil; avoid applying
to same area of skin.
Oral doxycycline
Indication Dosage
Adult 200 mg on day 1 (as a single dose or 100 mg twice daily), then 100
mg once daily. In severe infection, e.g. acute Q fever, 100 mg twice
daily can be used (maximum 200 mg daily).
Child > 8 years Initially 2 mg/kg twice daily on day 1 (maximum 200 mg daily); then
2 mg/kg once daily (maximum 100 mg daily). Round the dose to the
nearest 25 mg. In serious infection, e.g. Q fever, the dose can be
increased to 4 mg/kg daily (maximum 200 mg daily) in 1 or 2 doses.
Acne Child >8 years, 50 mg once daily for at least 6 weeks; then if
necessary, increase to 100 mg once daily.
Rosacea 50 mg once daily.
Chlamydial infection, 100 mg twice daily for 1-3 weeks depending on the site and severity
non-gonococcal genital of the infection.
infection
Prophylaxis of malaria Start 2 days before entering and continue taking doxycycline until 4
weeks after leaving an endemic area.
Adult, 100 mg once daily.
Child >8 years, 2 mg/kg (maximum 100 mg) once daily.
Treatment of Adult, 100 mg every 12 hours for 7 days with quinine.

uncomplicated P.
Child >8 years, 2 mg/kg (maximum 100 mg) every 12 hours for 7 days
falciparum malaria
with quinine.
Method of administration(2)
- Take a single daily dose in the morning rather than at night.
- Take with food or milk to reduce stomach upset.
- Take with a large glass of water and remain upright (do not lie down) for an hour after
taking a tetracycline. This is to stop tablets or capsules sticking on the way to your
stomach and causing painful damage to the lining of your throat.
- Do not take antacids, iron, calcium or zinc supplements within 2 hours of a tetracycline as
they may interfere with its absorption.
- Avoid sun exposure, wear protective clothing and use sunscreen while taking this
medicine.
- Side effects may include anorexia, nausea, vomiting, glossitis, dysphagia and enterocolitis.
- Instruct patient to report symptoms of drug rash with eosinophilia and systemic
symptoms (DRESS).
- Advise patient to report symptoms of severe skin reactions such as Stevens-Johnson
syndrome or toxic epidermal necrolysis.
- Instruct patient to report severe diarrhea, onset may occur up to 2 months after drug
administration.
Practice points(2)
- Are useful in treatment of moderate-to-severe inflammatory acne; doxycycline is the
drug of choice. Avoid minocycline as it has more adverse effects. Erythromycin may be
used if tetracyclines are not tolerated or are contraindicated.
- Combine oral antibacterials with a topical retinoid and either benzoyl peroxide or azelaic
acid:
o Change antibacterial or consider an alternative treatment if there is no response
after 6-8 weeks.
o Limit treatment to 3-6 months when possible.
o Consider other treatment options if longer-term treatment is necessary.
- Safe if used during the first 18 weeks of pregnancy (16 weeks post-conception). After this
period, they are contraindicated as tetracyclines can inhibit bone growth in the fetus
(reversible after stopping treatment; permanent bone defects do not appear to occur)
and discolor deciduous teeth.
Oral isotretinoin
Indication Dosage
Cystic acne, severe Adult, child > 12 years, Initially up to 0.5 mg/kg each day as a single
dose or in 2 doses. Dosage may be increased to 1 mg/kg after 4
weeks according to response and tolerance.
To reduce risk of relapse, treatment should be continued until total
cumulative dose is 120-150 mg/kg. A treatment course is usually 4-6
months.
- This medicine is absorbed best if taken with food.
- Females: it is important that you use adequate contraception before, during and for 1
month after treatment, because birth defects can occur during this time.
- Report promptly any nausea, headaches or visual changes (including poor night vision or
blurring) to your doctor.
- This medicine often causes dry lips, mouth and eyes. Use white soft paraffin, e.g. Vaseline,
to treat dry lips; use lubricating eye drops to treat eye irritation. Tell your doctor if you
are unable to manage dry skin, dry lips or dry eyes, of if your contact lenses become
uncomfortable.
- Tell your doctor if you notice a change in your moods (e.g. depression, suicidal ideation
or unusual change in behavior).
- Instruct patient to avoid additional vitamin A supplementation during drug therapy, as
this may increase the risk of toxicity.
- Protect skin from sunlight with protective clothing or a broad-spectrum sunscreen
(preferably SPF 30 or SPF 50+, containing a physical barrier, e.g. titanium dioxide or zinc
oxide). Avoid sunlamps and tanning beds.
- Avoid waxing and dermabrasion during, and for 6 months after stopping, treatment as
they could scar or irritate your skin.
- Do not share medication with others.
- Do not donate blood during treatment and for 8 weeks after stopping treatment.
- Instruct patient to avoid driving or other activities requiring clear vision until drug effects
are realized as drug may cause decreased visual acuity, especially at night.
- Side effects may cause cheilitis, dry skin, pruritus, arthralgia, back pain, epistaxis,
headache, dizziness or hearing loss.
- Advise patient to report signs/symptoms of pseudotumor cerebri (nausea, vomiting,
headache, pulsating intracranial sounds), hepatic dysfunction, pancreatitis, tinnitus,
inflammatory bowel disease, or serious dermatologic reactions (such as Stevens-Johnson
syndrome or toxic epidermal necrolysis).
Practice points(2)
- Avoid combination with tetracyclines as it may increase risk of benign intracranial
hypertension.
- Contraindicated in pregnancy; teratogenic. About 30% of exposed infants have a pattern
of severe birth defects (e.g. face, eyes, ear, skull, limb, cardiovascular and CNS
abnormalities) which may be fatal.
- Avoid using topical anti-acne preparations as local irritation may increase.
- Most patients remain disease-free after a single course or have long remissions;
approximately 10-20% of patients relapse; repeat courses of isotretinoin are
recommended if recurrence is severe.
- Allow at least 2 months after completing a course to see whether further treatment is
necessary, as improvement may continue for several months after stopping.
Alfacalcidol 2 mcg/ml (One-alpha® drops 20 ml)
- One drop of alfacalcidol 2 mcg/ml oral drops contains approximately 100 nanograms
alfacalcidol.(5)
Indication Dosage
Hypophosphataemic Child 1 month-11 year, 25-50 nanograms/kg once daily, dose to

rickets; persistent be adjusted as necessary; maximum 1 microgram per day.
hypocalcemia due to
Child 12-17 years, 1 microgram once daily, dose to be adjusted
hypoparathyroidism or
as necessary.
pseudohypoparathyroidism
Persistent neonatal Neonate, 50-100 nanograms/kg once daily, dose to be adjusted

hypocalcemia as necessary, in resistant cases higher doses may be needed;
increased if necessary up to 2 micrograms/kg daily.
Prevention of vitamin D Neonate, 20 nanograms/kg once daily, dose to be adjusted as

deficiency in renal or necessary.
cholestatic liver disease
Child 1 month-11 years (body-weight up to 20 kg), 15-30
nanograms/kg once daily (max. per dose 500 nanograms).
Child 1 month-11 years (body-weight 20 kg and above), 250-500
nanograms once daily, dose to be adjusted as necessary.
Child 12-17 years, 250-500 nanograms once daily, dose to be
adjusted as necessary.
- Half-drop doses should be rounded up to the next whole number of drops.(6)
Directions for using One-Alpha® drops:(7)

- Remove the bottle cap. (Do not shake the bottle before using.) You will see a dropper
which is ready for you to use.
- Hold the bottle upside down so that a drop appears at the end of the dropper. If a drop
does not form, tap the bottle gently with a finger so that it does.
- Let the drop fall into your (or your child’s) mouth or catch it on a spoon if this is easier.
- Your doctor will tell you how many drops to take – count these out carefully to make sure
that you (or your child) take the correct number.
Adverse effects
- The most frequently reported undesirable effects are various skin reactions such as
pruritus and rash, hypercalcemia, gastrointestinal pain/discomfort and
hyperphosphatemia. Renal failure has been reported post-marketing.(6)
- Symptoms of overdosage include anorexia, lassitude, nausea and vomiting, diarrhea,
constipation, weight loss, polyuria, sweating, headache, thirst, vertigo, and raised
concentrations of calcium and phosphate in plasma and urine.(5)
Storage(6)
- Store at 2 to 8°C (in a refrigerator). Keep the container in the outer carton.
- After opening, the shelf-life is 4 months when stored at 2 to 8°C (in a refrigerator).
Anaphylactic reactions
Anaphylaxis
Anaphylaxis is a severe, life-threatening, generalized or systemic hypersensitivity reaction. An
anaphylactic reaction is likely if the patient develops sudden symptoms of airway and/or
breathing difficulty with or without circulatory problems rapidly following exposure to an
allergen (parenteral antigen - usually within 5-30min; oral antigen – usually occur within 2 hours).
Skin changes (e.g. flushing, angioedema, urticarial) are usually also present but the absence of
skin changes does not rule out anaphylaxis. Gastrointestinal symptoms such as vomiting and
abdominal pain may also be present.(8)
A late-phase reaction may also occur with recrudescence of symptoms after apparent resolution.
Hence, patients should be warned of the possibility of symptom recurrence, and if necessary kept
under observation for up to 24h.(8)
Management of anaphylaxis(2)
First
give IM adrenaline (epinephrine) 1:1 000 into mid-anterolateral thigh, dose 10 micrograms/kg
(0.01 mL/kg) up to maximum 500 micrograms (0.5 mL):
- adult, child >50 kg, 500 micrograms (0.5 mL adrenaline 1:1 000)
- 40 kg, 400 micrograms (0.4 mL adrenaline 1:1 000)
Then
- remove cause if practical, e.g. insect sting, stop an IV infusion

- give high flow oxygen (>6 L/minute via face mask)
- ensure supine position, with elevated legs if tolerated (if breathing is difficult, allow to
sit but not to stand)
- establish IV access
- maintain airway, breathing and circulation (do not delay intubation in progressive
airway obstruction)
If hypotensive
- give IV sodium chloride 0.9% by rapid infusion:
o adult, 1–2 L
o child, 20 mL/kg
o repeat if inadequate response
If inadequate response
- continue to give IM adrenaline every 3–5 minutes

- if unresponsive to IM adrenaline and ECG monitoring is available, consider IV
adrenaline infusion (safer than IV bolus), see local protocols
If response still inadequate, consider
- nebulized adrenaline for upper airway tract obstruction (stridor)

- inhaled (via MDI and spacer) or nebulized salbutamol for lower airway tract obstruction
(wheeze)
- IV glucagon for persistent hypotension in people taking beta-blockers
- additional vasopressors for persistent hypotension
Monitor
- pulse rate, BP, respiratory rate (ECG, pulse oximetry, arterial blood gases if possible)
- for 4–6 hours after recovery; extend period if:
o symptoms were severe or refractory
o continuing absorption of trigger is possible
o there is a history of severe asthma or life-threatening or biphasic reactions
o comorbidities are present
Note:
- Corticosteroids have a delayed effect (4–6 hours). Although they are generally used to
reduce duration of reaction and prevent relapse, there is no evidence of effectiveness;
they may be helpful for asthmatics. They are adjuncts in the management of anaphylaxis
and should not be used instead of adrenaline.(2)
- There is no evidence that H1 antagonists (e.g. promethazine) and H2 antagonists (e.g.
ranitidine) are effective in acute anaphylaxis (parenteral promethazine may worsen
condition). They are adjuncts helpful for associated urticaria, angioedema and itch.(2)
Epinephrine auto-injector
- EpiPen® injection, 0.3 mg/0.3 ml epinephrine(9)
- EpiPen Jr®injection, 0.15 mg/0.3 ml epinephrine(9)
Indication Dosage
Emergency treatment of allergic reactions Selection of the appropriate dosage strength

(Type I) including anaphylaxis to stinging (EpiPen® 0.3 mg or EpiPen Jr® 0.15 mg) is
insects (e.g., order Hymenoptera, which determined according to patient body weight.
include bees, wasps, hornets, yellow jackets
- Patients greater than or equal to 30 kg
and fire ants) and biting insects (e.g., triatoma,
(approximately 66 pounds or more):
mosquitoes), allergen immunotherapy, foods,
EpiPen® 0.3 mg
drugs, diagnostic testing substances (e.g.,
- Patients 15 to 30 kg (33 pounds to 66
radiocontrast media) and other allergens, as
pounds): EpiPen Jr® 0.15 mg
well as idiopathic anaphylaxis or exercise-
induced anaphylaxis.
Method of administration
Inject EpiPen® or EpiPen Jr® intramuscularly or subcutaneously into the anterolateral aspect of
the thigh, through clothing if necessary. Do not inject into veins, buttocks, fingers, toes, hands or
feet. Instruct caregivers of young children who are prescribed an EpiPen® or EpiPen Jr® and who
may be uncooperative and kick or move during an injection to hold the leg firmly in place and
limit movement prior to and during an injection. If you accidentally inject EpiPen® or EpiPen Jr®
into any other part of your body, go to the nearest emergency room right away. Tell the
healthcare provider where on your body you received the accidental injection.(9)
Adverse effects(9)
Common side effects of EpiPen® and EpiPen Jr® include:
- fast, irregular or “pounding” heartbeat
- sweating
- headache
- weakness
- shakiness
- paleness
- feelings of over excitement, nervousness or anxiety
- dizziness
- nausea or vomiting
- breathing problems
These side effects may go away with rest. Tell your healthcare provider if you have any side effect
that bothers you or that does not go away.
Rarely, patients who have used EpiPen® or EpiPen Jr® may develop infections at the injection site
within a few days of an injection. Some of these infections can be serious. Call your healthcare
provider right away if you have any of the following at an injection site:
- redness that does not go away
- swelling
- tenderness
- the area feels warm to the touch
Storage(9)
- Store EpiPen® and EpiPen Jr® at room temperature between 68° to 77° F (20° to 25° C).
- Protect from light.
- Do not expose to extreme cold or heat. For example, do not store in your vehicle’s glove
box and do not store in the refrigerator or freezer.
- Examine the contents in the clear window of your auto-injector periodically. The solution
should be clear. If the solution is discolored (pinkish or brown color) or contains solid
particles, replace the unit.
- Always keep your EpiPen® or EpiPen Jr® Auto-Injector in the carrier tube to protect it
from damage; however, the carrier tube is not waterproof.
- The blue safety release helps to prevent accidental injection. Keep the blue safety release
on until you need to use EpiPen® or EpiPen Jr®.
- Your EpiPen® or EpiPen Jr® has an expiration date. Replace it before the expiration date.
Apixaban (Eliquis)
- 2.5 mg, 5 mg tablet
Indication Dosage
Prevention of VTE Adult, 2.5 mg twice daily, starting 12-24 hours after surgery. Continue for
after hip/knee 10-14 days after knee replacement or 32-38 days after hip replacement.
replacement
Treatment of VTE Adult, 10 mg twice daily for 7 days, then 5 mg twice daily. Reduce dose
after 6 months to that for prevention of subsequent VTE if long-term
treatment is needed.
Prevention of Adult, 2.5 mg twice daily.

subsequent VTE
Prevention of Adult, 5 mg twice daily.

emboli in AF
If at least 2 of: Weight <60 kg, age >80 years, serum creatinine >133
micromol/L, 2.5 mg twice daily.
Switching From apixaban to parenteral anticoagulant (and vice versa), start at the
anticoagulants time of next scheduled dose.
From apixaban to warfarin, give warfarin with apixaban for 2 days, then
check INR before the next apixaban dose. Continue both drugs until INR
>2.
From warfarin to apixaban, stop warfarin and start apixaban when INR <2.
- Renal impairment: Contraindicated when CrCl <25 ml/minute.

- No human data in pregnancy and breastfeeding. Manufacturer contraindicates
combination with strong inhibitors of both CYP3A4 and P-gp, e.g. ritonavir. For treatment
of VTE, the manufacturer does not recommend combination with strong inducers of both
CYP3A4 and P‑gp, e.g. St John’s wort, rifampicin, and advises use with caution for other
indications.
- Contraindicated in severe active bleeding or disease states with an increased risk of
severe bleeding, e.g. severe uncontrolled hypertension, severe thrombocytopenia,
bleeding disorders and severe renal impairment.
- Take with or without food.(4)
- You can crush the tablets and mix them with water, apple juice or apple sauce; take them
within 4 hours.(2)
- Take at about the same time every day; use a calendar to keep a record and to mark off
the date after taking a dose.(2)
- Missed dose: Administer dose as soon as possible on the same day and resume twice-
daily administration. Do not double a dose to make up for a missed dose.(4)
Adverse effects
- You need to see your doctor for regular checks, but tell your doctor immediately if you
have any unexplained bruising, bleeding, pink, red or dark brown urine, or red or black
feces.(2)
- Side effects may include nausea, confusion, anemia, syncope, and hemorrhage.(4)
- Tell patient to immediately report signs of spinal or epidural hematomas (i.e., numbness
or weakness of legs or bowel or bladder dysfunction).(4)
- Tell your doctor and pharmacist that you are taking this medicine before starting or
stopping any other medication, herbal or over-the-counter products.
- Tell your dentist, podiatrist, physiotherapist or chiropractor that you are taking this
medicine.
- Advise patients of the intended duration of anticoagulation, and the potential risks of
stopping treatment without medical advice.
- Consider use of a warning bracelet or necklace.
Benzydamine hydrochloride 3mg/ml throat spray
(Difflam forte)
Difflam forte throat spray(9)
- Each ml of Difflam Forte contains 3.0 mg of benzydamine
hydrochloride in mL.
- Each spray delivers approximately 0.5 mg of benzydamine
hydrochloride.
- It also contains ethanol, saccharin sodium, methyl
hydroxybenzoate, glycerol, PEG-40 hydrogenated castor
oil, purified water and mint flavoring.
- It does not contain gluten, lactose, sugar or color.

Benzydamine is an anti-inflammatory analgesic agent structurally unrelated to the steroid group.
It differs chemically from other NSAIDs in that it is a base rather than an acid. It is indicated for
the temporary relief of painful conditions of the mouth and throat including tonsillitis, sore
throat, radiation mucositis, aphthous ulcers, pharyngitis, swelling, redness, inflammatory
conditions, post orosurgical and periodontal procedures.
Adults and children 2-4 sprays (1-2 mg) directly onto the sore/inflamed area and swallow
over 12 years gently. Repeat every 1.5 to 3 hours as necessary.
Children 6-12 years 2 sprays (1 mg) directly onto sore/inflamed area and swallow gently.
Repeat every 1.5 to 3 hours as necessary.
Children under 6 Not recommended.

years
Cleaning After use, wipe the nozzle with a clean tissue to prevent blockage.
instructions
- Uninterrupted treatment should not exceed seven days, unless under medical supervision.
- If a sore throat is either caused by or complicated by a bacterial infection, appropriate
antibacterial therapy should be considered in addition to the use of Difflam Forte Anti-
inflammatory Throat Spray.
- If you use more Difflam Spray than you should, it should not cause any problems if you
accidentally take too much or you swallow some of your medicine. If you have any
concerns, contact your doctor or pharmacist.
- If you forget to use Difflam Spray, do not take a double dose to make up for a missed dose.
Simply take the next dose as planned.
How to use the spray(9)
To use the spray, hold the bottle in an upright position.
Lift the spray-tube through 90° until it is horizontal. Do not raise the spray-
tube more than shown in the diagram.
The first time you use the spray, you need to prime it. Point the spray-tube
away from your faces. Press down firmly on the green plunger until a fine
spray appears from the end of the spray-tube. The spray is now ready to use.
Aim the spray-tube at the sore part of your mouth or throat and press down
on the green plunger again. One press releases one puff.
After spraying the desired number of puffs, wipe the end of the spray-tube
with a tissue. This helps to stop it becoming blocked.
Push the spray-tube back down as shown in the diagram. This stops any puffs
being accidentally released.
Do not push anything into the end of spray-tube if it becomes blocked. Return
the spray to your pharmacist.
Adverse effects(9)
It is generally well tolerated and side effects are minor. The most commonly reported local
adverse reaction is oral numbness (2.6% of treated case). Occasional burning or stinging
sensation may occur (1.4%). Other local adverse effects were less common and included dryness
or thirst (0.2%), tingling (0.2%) warm feeling in mouth and altered sense of taste (0.1%).
Systemically adverse reactions were uncommon and consisted mainly of nausea, vomiting,
retching, gastrointestinal disorders (0.4%), dizziness (0.1%), headache and drowsiness (0.1%).
Storage(9)
- Store in an upright position.
- Protect from light and store below 25°C.
- Do not store in the refrigerator or freezer.
Bowel cleansing procedure
Bowel preparation before colonoscopy in adults
A successful colonoscopy requires an adequate preparation of the large bowel that facilitates
clear visualization of the mucosal surface. The effectiveness of the bowel preparation is a critical
factor related to the safety, diagnostic accuracy, quality, difficulty, and speed of the
examination.(3)
Patient preparation
Patients need to consume a low-residue diet or clear liquids for at least one day prior to elective
colonoscopy. A low-residue diet is low in fiber, and patients should be instructed to avoid foods
that are high in fiber such as fruits, vegetables, and whole grains. Clear liquids include water,
clear broth, coffee or tea (without milk), ices, gelatin, and fruit juices such as apple, grapefruit,
and lemonade. Liquids that are red can be mistaken for blood in the colon or can obscure mucosal
details and should be avoided.(3)
Patients typically take no food by mouth for four to eight hours prior to the procedure
(sometimes longer if there is known or suspected delayed gastric emptying) and no liquids (other
than sips with medications) for two hours. Recommendations differ with regard to preprocedure
fasting for elective procedures. The American Society for Anesthesiology (ASA) guidelines state
that prior to a procedure, patients should fast a minimum of two hours following clear liquid
ingestion or six hours for a light meal. By contrast, the American College of Emergency Physicians
states "recent food intake is not a contraindication for administering procedural sedation and
analgesia, but should be considered in choosing the timing and target level of sedation".(3)
Most medications may be continued up to the time of colonoscopy and are taken with a small
sip of water the day of the colonoscopy. Some medications may need to be adjusted prior to
colonoscopy, such as medications for diabetes, due to decreased oral intake prior to the
procedure. Oral iron should also be stopped at least five days before the colonoscopy since it
makes the residual feces black, viscous, and difficult to purge.(3)
Decisions regarding the management of antiplatelet agents or anticoagulants must weigh the
risks of bleeding from the procedure with the probability of a thromboembolic event occurring
while the antithrombotic medication is interrupted. Furthermore, the urgency of the procedure
and the availability of alternative tests must be evaluated. Management decisions about
antithrombotic agents should be made following discussion with the patient and the clinician
prescribing the medication. Aspirin and nonsteroidal antiinflammatory drugs in standard doses
may be continued safely in patients having colonoscopy.(3)
Because the risk of infection related to routine diagnostic or therapeutic colonoscopy is low,
antibiotic prophylaxis is not recommended for colonoscopy.(3)
Timing of preparation
The timing and dosing schedule affect the efficacy, patient acceptance, and patient tolerance of
the preparation.(3)
Morning colonoscopy(3)
- For patients undergoing colonoscopy before 12 o’clock noon, the split dose is more
effective and better tolerated.
- Split-dose preparation refers to administration of half of the colon cleansing agent the
evening prior to the colonoscopy and the second half the morning of the colonoscopy.
- Advantages to split-dose preparation include improved efficacy, patient tolerance, and
polyp detection.
- Single dosing of the full preparation on the evening before the colonoscopy is an
alternative to split-dosing; however, evidence favors the efficacy and tolerability of split
dosing. Despite this, some patients prefer to take the entire dose the evening before for
convenience.
Afternoon colonoscopy(3)
- For patients undergoing colonoscopy after 12 o’clock noon, either single dose or split dose
are acceptable options.
- For patients undergoing afternoon procedures, single-dose, same-day preparations
appear to be more effective compared with split-dose preparations.
Choosing a preparation
The ideal bowel preparation must be safe, efficacious, well tolerated, and reasonably priced. All
of the available preparations can produce adequate cleansing results with acceptable tolerance,
though results for individual patients are variable. As a result, none of the regimens has been
universally adopted.(3)
The choice of preparation for an individual patient will depend on the presence of risk factors for
prep-related complications, the patient's preferences regarding the volume of the preparation,
prior experience and results with a given preparation, and cost.(3)
Options of bowel preparation

Available bowel preparations can be divided into 3 categories:
MOA Osmotic Osmotic & stimulant
Osmolarity PEG iso-osmotic Hyper-osmotic solution
solution
Examples PEG-E Sodium phosphate Sodium picosulphate/
magnesium citrate
- KleanPrep® - Fleet
- Fortrans® phosphosoda® - Citrafleet®
- Colokit® - Picoprep®/Picolax®
PEG-E + Vit C
- Moviprep®
Improving tolerability
Many patients find that the bowel preparation is unpalatable and difficult to drink. For some
patients, the volume of the preparation requiring consumption is a major concern. In these cases,
lower-volume preparations and split-dose preparations are better tolerated. Lower-volume
preparations include magnesium citrate, PEG combined with an additional agent to promote
bowel cleansing (e.g., bisacodyl or ascorbic acid), sodium sulfate preparations, and sodium
picosulfate preparations. High-volume (4 liter) preparations are PEG-ELS-based.(3)
Up-to-date recommend that patients use either the flavor packets (if provided with the
preparations) or use a sugar-free powdered flavor enhancer. While sports drinks, sugar-free
powdered flavor enhancers, and carbohydrate-electrolyte solutions may improve the taste of
PEG solutions, improved flavor does not necessarily mean improved tolerance. Furthermore,
some additives can alter the osmolarity of the preparation, be metabolized into explosive gases,
or alter the amount of water and salts absorbed. (3)
Additional measures that may make preparations easier to consume include:(3)
- Chilling the solution
- Drinking the solution through a straw
- Sucking on lemon slices
- Sucking on sugar-free menthol candy drops
Some of these measures can also be used for patients who develop nausea, vomiting, or
excessive bloating after starting the preparation.(3)
Patients who are having difficulty with the preparation can be instructed to temporarily interrupt
the regimen (for one to two hours) or slow the rate of consumption.(3)
Fleet enema
- Fleet enema: Each 118 ml delivers 19 g monobasic sodium phosphate and 7 g dibasic
sodium phosphate. Sodium content 4.4 g.(9)
- Fleet enema for children: Each 59 ml delivers 9.5 g monobasic sodium phosphate and 3.5
g dibasic sodium phosphate. Sodium content 2.2 g.(9)
Indication Dosage
For relief of Single daily dosage.

occasional
Adults and children over 12 years old, one bottle of Fleet enema.
constipation or
bowel cleansing Children 5 to 11 years, one bottle of Fleet enema for children or as directed
before rectal by a doctor.
examinations
Children 2 to under 5 years, one-half bottle of Fleet enema for children (see
below).
Children under 2 years, do not use.
* One-half bottle preparation: unscrew cap and remove 2 tablespoons of
liquid with a measuring spoon. Replace cap and follow directions.
Directions(9)
Positions for using this enema:

- Left-side position
- Knee-chest position
Remove protective shield from enema Comfortip before
inserting.
With steady pressure, gently insert enema tip into the

rectum with a slight side-to-side movement, with tip
pointing toward navel.
Do not force the enema tip into rectum as this can cause
injury.
Squeeze bottle until nearly all liquid is gone. It is not

necessary to empty the bottle completely, as it contains
more liquid than needed.
Remove Comfortip from rectum and maintain position until

urge to evacuate is strong (usually 2 to 5 minutes).
Important
- Onset of action is 30 minutes-3 hours (up to 6 hours with Phospho-Soda) after oral
administration and 2-30 minutes after rectal administration.(2)
- Other oral drugs should not be taken 1 hour before, or after, administration of bowel
cleansing preparations because absorption may be impaired. Consider withholding ACE
inhibitors, angiotensin-II receptor antagonists, and NSAIDs on the day that bowel
cleansing preparations are given and for up to 72 hours after the procedure. Also consider
withholding diuretics on the day that bowel cleansing preparations are given.(10)
- Ensure adequate hydration to reduce the risk of dehydration and electrolyte
disturbance.(2)
- Do not use in patients with congenital megacolon, bowel obstruction, imperforate anus,
or congestive heart failure. Use with caution in patients with impaired renal function, pre-
existing electrolyte disturbances or a colostomy, or in patients on diuretics or other
medications that may affect electrolyte levels. Hypocalcemia, hyperphosphatemia,
hypernatremia, or acidosis may occur.(9)
Warnings(9)
- Using more than one enema in 24 hours can be harmful.
- Ask a doctor before using this product if you:
o Are on a sodium restricted diet.
o Have a kidney disease.
o Are pregnant or nursing a baby.
- Ask a doctor before using any laxative if you:
o Have nausea, vomiting, or abdominal pain.
o Have a sudden change in bowel habits lasting more than 2 weeks.
o Have already used a laxative for more than 1 week.
- Stop using this product and consult a doctor if you have rectal bleeding or have no bowel
movement after the enema is given. These symptoms may indicate a serious condition.
Storage(9)
- Keep out of reach of children.
- Store below 30°C.
Oral fleet solutions
Fleet Phospho-soda(9)
- Phospho-soda buffered oral saline laxative
- Per 15 ml, 7.2 g (48%) monobasic sodium phosphate (monohydrate) and 2.7 g (18%)
dibasic sodium phosphate (heptahydrate)
Indication Dosage
Used for the relief of

occasional constipation
Age (years) Step 1 Step 2 24 Hour
Maximum
Dose
12 years & Mix 1 tablespoon in a Drink at least 1 3

older full glass of cold liquid extra full glass of tablespoons
(8 fl. oz.). Drink. liquid (8 fl. oz.).
10 to 11 years Mix 1 tablespoon in a Drink at least 1 1

full glass of cold liquid extra full glass of tablespoon
(8 fl. oz.). Drink. liquid (8 fl. oz.).
5 to 9 years Mix 1/2 tablespoon in Drink at least 1 ½

a full glass of cold extra full glass of tablespoon
liquid (8 fl. oz.). Drink. liquid (8 fl. oz.).
Under 5 years Do not use. Do not use. Do not use.
- Do not take more unless directed by a doctor.

- Drink as much extra liquids as you can to help replace the fluids you
are losing during bowel movements.
As a purgative for the use Adult only (≥18 years): The taking of Fleet Phospho-soda should be started the
of bowel cleansing day before the appointment.
regimen in preparing the
patient for colon surgery,
or for preparing the colon
for x-ray or endoscopic
examination.
Method of administration for bowel cleansing(9)
- Before your first start taking Fleet Phospho-soda up until after your examination, it is
important that you drink only “clear liquid”. Do not eat any solid food.
- “Clear liquid” means water, clear soup, or soup that has been strained to remove any
solids; fruit juices without pulp (but no red or purple juices); black tea or black coffee and
clear fizzy/non-fizzy drinks e.g. lemonade.
- Dilute the contents of one bottle (45ml) of Fleet Phospho-soda in half a glass (120ml) of
cold water. Drink this and follow it with at least one full glass (240ml) of cold water. Drink
as much clear liquid as possible to replace the fluids lost during bowel movements.
- Fleet Phospho-soda may cause a number of diarrhea-like bowel movements. It often
starts to work within 30 minutes and may go on working up for up to 6 hours. Please stay
within easy reach of a toilet until your bowel have stopped.
- If you have no bowel movement within 6 hours of taking either the first dose or second
dose, you must contact a doctor immediately, because you could become dehydrated.
Morning Appointments 8.00am – 12 Afternoon Appointments 12 noon – 5.00pm

noon
THE DAY BEFORE YOUR APPOINTMENT THE DAY BEFORE YOUR APPOINTMENT
At 7 a.m. drink at least one full glass At 1 p.m., eat a light snack, e.g. soup and a sandwich
(240ml) of clear liquid for breakfast. You for lunch. Do not eat any more solid food until after
may drink more if you wish. Straight your hospital appointment. During the afternoon,
afterwards, take your first dose. you may drink clear liquid to satisfy your thirst.
At 1 p.m., drink at least three more full At 7 p.m., drink at least one full glass (240ml) of
glasses (720ml) of clear liquid for lunch. clear liquid for supper. You may drink more if you
During the afternoon, you may continue wish. Straight afterwards take your first dose.
to drink clear liquid to satisfy your thirst.
During the evening, make sure you drink at least
At 7 p.m. drink at least one full glass three more full glasses (720ml) of water or clear
(240ml) of clear liquid for supper. You liquid before going to bed.
may drink more if you wish. Straight
THE DAY OF YOUR APPOINTMENT
afterwards, take your second dose.
At 7 a.m. drink at least one full glass of clear liquid
You may continue to drink clear liquid
for breakfast. You may drink more if you wish.
until midnight to satisfy your thirst. Clear
Straight afterwards take your second dose.
liquid taken after midnight may cause
further visits to the toilet resulting in You may continue to drink clear liquid until 8 a.m.
sleep loss. to satisfy your thirst. Clear liquid taken after 8 a.m.
may cause further visits to the toilet resulting in
difficulties in getting to your hospital appointment.
After your hospital appointment, make sure you
drink plenty of fluid to replace fluid lost when you
were taking Fleet Phospho-soda.
Alternative administration regimen(9)

- Split the 45 ml Fleet Phospho-soda solution into 3 parts (15 ml each).
- Mix 1 part (15 ml) with 240 ml of clear liquid and drink.
- Make sure that you drink enough water to keep hydrated.
- Try to finish the solution in approximately 20 minutes.
- Continue to drink fluid after you have completed your medication.
- Drinks recommended for dilution solution:
o Soft drinks (coke, sprite & etc.)
o Gatorade
o Strained fruit juices without pulp
o Teh “O”
o Other preferred clear liquid (nothing red or purple)
Important information(9)
- Contraindicated in patients with clinically significant impairment of renal function or
congestive heart failure and when nausea, vomiting or abdominal pain are present.
- Fleet® Phospho-soda® has been rarely associated with severe and potentially fatal cases
of electrolyte disorder in elderly patients. The benefit/risk ratio of Fleet® Phospho-soda®
needs to be carefully considered before initiating treatment in this at-risk population.
Adverse effects(9)
- Like all medicines, this medicine can cause side effects, although not everybody gets them.
- Very rarely, Fleet Phospho-soda can cause serious allergic reactions with or without a rash.
Tell your doctor immediately or contact the emergency department of your nearest
hospital if your hands, face, lips, throat of tongue start to swell, or if you have difficulty in
breathing or swallowing.
Very common Feeling sick, abdominal pain, bloating and diarrhea, chills, weakness and
dizziness
Common Vomiting, chest pain and headache
Uncommon Dehydration
Rare A buildup of calcium in the kidneys
Very rare Heart attack, palpitations, low blood pressure, changes in the amounts of
salts (electrolytes) in the blood (which may lead to twitches and spasms),
muscle cramps, pins and needles, loss of consciousness and kidney failure
Storage(9)
- Do not use this medicine after the expiry date which is stated on the pack after ‘EXP”. The
expiry date refers to the last day of the month.
- Do not store above 25°C.
- Once opened, use immediately. Discard any unused solution.
Cochlear solution(9)
- 100 ml contains 48 g monobasic sodium phosphate and 18 g dibasic sodium phosphate.

- Can be used for the relief of occasional constipation or as purgative for the use of the
bowel cleansing regimen in preparing the patient for the surgery or for the colon for x-
ray or endoscopic examination.
- Dilute recommended dose with at least one-half glass (4 fl. oz.) of cold water or other
clear liquid. Drink, then follow at least two additional glasses (8 fl. oz. each) of water or
other clear liquid.
- Dosage: do not exceed recommended dosage, as serious side effects may occur.
- Single daily dosage: do not take more unless directed by a doctor.
Adults and children 12 years and older 20 to 45 ml (4 to 9 teaspoons)
Children 10 and 11 years 10 to 20 ml (2 to 4 teaspoons)
Children 5 and 9 years 5 to 10 ml (1 to 2 teaspoons)
Children under 5 years DO NOT USE
- Use OSPs with caution in patients over 55 years of age. Use OSPs with caution in patients
with dehydration, kidney disease, delayed bowel emptying, or acute colitis.
- In patients who may be at increased risk for acute phosphate nephropathy, including
those with vomiting and/or signs of dehydration, obtain baseline and post-procedure labs
(electrolytes, calcium, phosphate, BUN and creatinine). For smaller, frail individuals, also
monitor glomerular filtration rate.
Adverse effects(9)
- Diarrhea is an expected effect of this medication.
- However, nausea, vomiting, stomach/abdominal, plain/bloating, dizziness, or headache
may also occur. If any of these effects persist or worsen, notify your doctor promptly.
- Tell your doctor immediately if any of these serious side effects occur: blood in the stool,
dark (black) stool, muscle cramps.
- Tell your doctor immediately if any of these highly unlikely but serious side effects occur:
dizziness, fainting, irregular heartbeat, hyperphosphatemia, hypokalemia.
Storage condition(9)
- Store at or below 25°C
Casen Phospho-Soda(9)
- Disodium phosphate dodecahydrate 10.8 g – Sodium dihydrogen phosphate dihydrate
24.4 g per 45 ml bottle.
- Oral colorless solution with ginger and lime flavor without precipitation or impurities.
- Casen Phospho-soda is a saline laxative that works by osmotic processes to increase fluid
retention in small bowel lumen. The resultant fluid accumulation in the ileum causes
distention and induces in turn bowel movement and evacuation. The start of these
peristaltic movements depends on the patient and occurs 1 to 2 hours after
administration.
Indications Dosage
Laxative for It is recommended to drink one glass of water before taking. Always dilute
cases of severe the amount indicated in a glass of cold water (±120 ml).
constipation
- Adult and children over 12 years of age, 4 teaspoonfuls (20 ml)
- Children aged 10 to 11 years, 2 teaspoonfuls (10 ml)
- Children aged 5 to 9 years, 1 teaspoonful (5 ml)
It is recommended to drink another glass of water (240 ml) after the solution
is administered.
Bowel Do not administer to children under 18 years of age.

preparation
Adult, start to take Casen Phospho-soda the day before hospital
for surgery, X-
appointment. For appointments before 12:00 h, recommendations for
rays or
morning appointments should be followed. For appointments after 12:00 h,
endoscopy
recommendations for afternoon appointments should be followed.
Morning appointments Afternoon appointments
The day before examination The day before examination:

7:00 h: Drink a glass of clear liquid or water as 13:00 h: Lunch: eat a light snack, and then no
breakfast; several glasses are recommended if solids until after the examination.
possible. Clear liquid is defined as water, a
19:00 h: Eat nothing for dinner. Drink instead
diluted soup, fruit juices with no pulp, black
at least 1 glass of clear liquid or water. A
greater volume may also be drunk.
tea or coffee, clear carbonated drink or non- 1st dose: Directly dilute 3 tablespoonfuls (45
carbonated beverages. ml) in half a glass of cold water (±120 ml)
followed by 1 glass (240 ml) or more of cold
1st dose: Directly dilute 3 tablespoonfuls (45
water. Drink as much liquid as possible to
ml) in half a glass of cold water (±120 ml)
replace fluid loss during bowel emptying.
followed by 1 glass (240 ml) or more of cold
Drink in the night at least 3 glasses (720 ml)
water. Drink as much liquid as possible to
of clear liquid water. A greater volume may
replace fluid loss during bowel emptying.
also be drunk.
13:00 h: Eat nothing for lunch. Drink instead
at least 3 glasses (720 ml) of clear liquid or
water. A greater volume may also be drunk. On the study day:
19:00 h: Eat nothing for dinner. Drink instead 7:00 h: Drink a glass of clear liquid or water
at least 1 glass of clear liquid or water. A as breakfast; several glasses are
greater volume may also be drunk. recommended if possible.
2nd dose: Directly dilute 3 tablespoonfuls (45 2nd dose: Directly dilute 3 tablespoonfuls (45
ml) in half a glass of cold water (±120 ml) ml) in half a glass of cold water (±120 ml)
followed by 1 glass (240 ml) or more of cold followed by 1 glass (240 ml) or more of cold
water. Drink as much liquid as possible until water. Drink as much liquid as possible to
midnight, if needed. Drinking large amounts replace fluid loss during bowel emptying.
of clear liquid helps to clean the bowel for the Drinking large amounts of clear liquid helps to
intervention. clean the bowel for the intervention.
Alternative: bowel cleansing dosing(9)
Morning procedure: ~8-9 am Afternoon procedure: ~1 pm
Day before procedure Day before procedure

1st dose: 1 bottle (45 ml) in 120 ml of clear 7 pm: 240 ml of clear liquids
liquids + 240 ml of clear liquids
1st dose: 1 bottle (45 ml) in 120 ml of clear
2 pm: 3 x 240 ml of clear liquids liquids + 240 ml of clear liquids
8 pm: 240 ml of clear liquids 3 x 240 ml of clear liquids
2nd dose: 1 bottle (45 ml) in 120 ml of clear Day of procedure
liquids + 2 x 240 ml of clear liquids
6 am: 240 ml of clear liquids
* No food intake from 2 pm day before nd
2 dose: 1 bottle (45 ml) in 120 ml of clear
procedure
liquids + 240 ml of clear liquids
* No food intake from 2 pm day before
procedure
- 8 glasses of clear liquids (1 glass = 240 ml) are the minimum required, however, patients
should drink as much liquid as possible.
- You are only allowed to take clear fluids during bowel preparation.
o Clear fluids include all the following that are not colored red or purple, strained
juices without pulp (apple, white grape, lemonade), water, clear broth or soup,
black coffee or tea, non-carbonated soft drink, 100 Plus, plain jelly (without added
fruit or toppings).
o Avoid fluids that are colored red or purple, fruits, vegetables, milk, milk products,
cereal, solid food and non-dairy creamer.
- This product is effective in the bowel from half an hour to 6 hours after intake.
- Ninety minutes after intake of 45 ml, a mean increase of 2.2 mEq of sodium per liter is
seen, corresponding to approximately 50 mg of Na per liter.
- Administer with caution to patients with cardiac conditions, latent risk of renal failure,
acute myocardial infarction, unstable angina, electrolyte disorder, high risk of suffering
disorders (dehydration, gastric retention, colitis, inability to swallow liquid, or intake of
drugs that may cause dehydration, weak or elderly people). In patients with clinically
documented hypotension or hypotension associated to hypovolemia, measurement of
sodium, potassium, calcium, chloride, bicarbonate, phosphate, urea, nitrogen, and
creatinine levels before and after treatment should be considered.
- Patients should be encouraged to drink as much liquid as possible to prevent dehydration.
When too little liquid is drank when using a laxative, there is a risk of dehydration and
hypovolemia.
Adverse effects(9)
- There is a risk of increased sodium and phosphate levels and decreased potassium and
calcium levels and thus, of hyperphosphatasemia, hypernatremia, hypocalcemia,
hypokalemia and acidosis.
- Rare cases of nephrocalcinosis combined with transient renal failure and disorder have
been reported with use of sodium phosphate for bowel cleansing. Phosphate-induced
nephropathy, sometimes leading to irreversible chronic renal failure, has rarely been
reported with use of the product for bowel cleansing.
Storage(9)
HTAR practice
Day before examination
You CAN Take: You CAN’T take
Water Drink that are colored red or purple

Strained juices pulp that are not colored red Milk or milk product/non-dairy creamer
or purple
Vegetable
Black coffee
Cereal
Tea (strictly no milk)
Fruits
Carbonated and non-carbonated soft drinks
Food that are difficult to digest
that are not colored red or purple
Plain Jello® (without added fruit or toppings)
Clear broth
Clear soup
Morning Appointment Afternoon Appointment
DAY BEFORE EXAMINATION: DAY BEFORE EXAMINATION:

First dose: 2pm – Add 45 ml of Fleet Phospho- First dose: 7pm – Add 45 ml of Fleet Phospho-
soda to one-half glass of clear liquid drink. soda to one-half glass of clear liquid drink.
Follow immediately with 3 glasses of clear Follow immediately with 3 glasses of clear
liquid. Individual responses to laxatives vary. liquid. Individual responses to laxatives vary.
This prep often works within 30 minutes but This prep often works within 30 minutes but
may take as long as 6 hours. Remain close to may take as long as 6 hours. Remain close to
toilet facilities as multiple bowel movements toilet facilities as multiple bowel movements
may occur. may occur.
Second dose: 8pm – Take Fleet exactly the Note: Drink at least three (3) additional
procedure as above. glasses of clear liquids. Nothing to eat or drink
after midnight.
Note: Drink at least three (3) additional
glasses of clear liquids. Nothing to eat or drink ROCEDURE DAY:
after midnight.
Second dose: 7am – Take Fleet exactly the
procedure as above.
Fortrans
- A passion fruit flavored isotonic PEG 4000 containing electrolytes solution.(9)
- Per sachet: Macrogol 4000 64 g, KCl 0.75 g, saccharin Na 0.1 g, Na bicarbonate 1.68 g,
NaCl 1.46 g, anhydrous Na sulphate 5.7 g.(9)
Indication Dosage
Clearing of The contents of each sachet are dissolved in about one liter of drinking water.
bowels in
When morning surgery is planned, the oral solution is given in the late
preparation for
afternoon the day prior. If surgery is scheduled for the afternoon, the oral
endoscopic &
solution should be given on the same day for ingestion to be completed three
radiological
hours before surgery.
exam & colonic
surgery Three to four liters of oral solution are required to produce an effective
lavage. In all cases, you must strictly comply with your doctor’s prescription.
When and how to do?(9)

Fortrans® pure isotonic solution = 1 sachet of Fortrans® + 1 liter of water
** Fortrans® pure isotonic solution needs to be consumed within an hour**
Day before procedure
Time Dosage recommendation Remark
6:00 pm / 8:00 pm 1st dose of Fortrans® pure isotonic solution No dietary restriction
(encourage low fiber and
8:00 pm / 10:00 pm 2nd dose of Fortrans® pure isotonic solution
residual diet)
Procedure date
6:00 am / 9:00 am 3rd dose of Fortrans® pure isotonic solution Colonoscopies shall be
performed within 4-6
hours after last intake of
fluid.
Your doctor may advise you to take ONE (1) additional dose of Fortrans® pure isotonic solution.
Strictly comply with your doctor’s prescription.
OR
Fortrans® pure isotonic solution = 1 sachet of Fortrans® + 1 liter of water
** Fortrans® pure isotonic solution needs to be consumed within an hour**
Day before procedure
6:00 pm 1st dose of Fortrans® pure isotonic solution No dietary restriction

(encourage low fiber and
8:00 pm 2nd dose of Fortrans® pure isotonic solution
residual diet)
10:00 pm 3rd dose of Fortrans® pure isotonic solution Colonoscopies shall be

performed in the next
morning
Your doctor may advise you to take ONE (1) additional dose of Fortrans® pure isotonic solution.
Strictly comply with your doctor’s prescription.
Can I continue to have food?(9)
Not allowed Allowed
Milk product, red meat, Low fiber food:

fruits, vegetables, whole-
Plain porridge, white fish, skinless chicken, white bread, egg,
meal bread, oat, cereals,
potato without skin and clear liquid.
seeds, nuts, colored
beverage. Clear liquid:
Plain water, strained fruit juices without pulp, tea or coffee
(without milk or creamer), clears soup, glucose drinks.
Procedure day – Recommended only plain water before the colonoscopy.
What to expect?(9)
- Frequent bowel movements within 1-2 hours.
- Stay within easy reach to the toilet.
- Some people may encounter: nausea, vomiting, bloating.
Important(9)
- It is important to finish the Fortrans® pure isotonic solution in order to have a clean bowel
for examination.
- A companion must be able to escort you home after the examination because some
medication given during the procedure may make you drowsy.
- You are not allowed to have any food intake after bowel cleansing.
- The amount of bowel preparation prescribe may vary with different patients.
- Advise to take a glucose drink if feel dizzy.
Contraindications(9)
- In cases of severe impair of general condition such as dehydration or severe heart failure;
- In patients presenting an active carcinoma or any other colonic disease-causing fragility
of mucosa;
- In patients likely to present ileus or intestinal occlusion
- In the absence of appropriate studies, this product is contraindicated in children under 15
years old
Special precautions/ special warnings of uses(9)

- In elderly subjects in poor health, this product should only be administered under medical
supervision.
- FORTRANS contains polyethylene glycol. Very rare cases allergic reactions (rash, urticarial,
edema) have been reported with preparations based upon polyethylene glycol. Extremely
rare cases of anaphylactic shock have been reported. FORTRANS should therefore not
prescribed in patients with known sensitivity to polyethylene glycol.
Drug interactions and other interactions(9)

- Diarrhea provided by administration of FORTRANS is likely to result in considerable
perturbation of the absorption of simultaneously administered drugs.
Adverse effects(9)
- Nausea and vomiting have been reported at the beginning of the administration, but
generally stop as treatment is continued. A sensation of fullness has been reported.
- Feeling of intestinal distension have also been described.
- Rare cases of allergic skin reactions in the form of rash, urticarial and edema.
- Extremely rare cases of anaphylactic shock have been reported.
Storage(9)
- Do not store FORTRANS above 25°C.
- Do not exceed the expiry date plainly indicated on the packaging.
- Keep out of reach of children.
MOH recommendation(11)
- Dilute 1 sachet (3 in total) of FORTRANS with 1 L of water (3 L in total). This should be
drunk within 5-6 hours.
- To improve the flavor, the solution may be chilled or lemon juice added.
- Dosing time
o Early morning procedure: First dose taken at 4 pm, second dose at 6 pm, and third
dose at 8 pm, one day before procedure.
o Afternoon (or later) procedure: First dose taken at 6 pm, second dose at 8 pm,
one day before procedure and third dose at 6 am on the day of procedure.
Alternative(9)
Early morning procedure
Day Before Examination
Breakfast, Lunch Take plain white bread, plain porridge or fish porridge
and Dinner
DO NOT consume any vegetables, fruits or red meats
DO NOT take milk/milk products
DO NOT take ‘wholemeal’ bread, cereals & oats
No solid food is to be taken after 4pm. You are only allowed to drink clear
fluids (i.e. glucose, barley water, clear soup, 100 plus with gas stir out, tea
or coffee without milk) when necessary.
5-6 pm 1 sachet of Fortrans + 1 liter of water
Drink glassful by glassful in 1 hour
Bowel evacuation will begin within 1-2 hours after consuming Fortrans
solution.


Mid-morning (or later) procedure
Day Before Examination
Breakfast, Lunch Take plain white bread, plain porridge or fish porridge
and Dinner
DO NOT consume any vegetables, fruits or red meats
DO NOT take milk/milk products
DO NOT take ‘wholemeal’ bread, cereals & oats
No solid food is to be taken after 4pm. You are only allowed to drink clear
fluids (i.e. glucose, barley water, clear soup, 100 plus with gas stir out, tea
or coffee without milk) when necessary.

Bowel evacuation will begin within 1-2 hours after consuming Fortrans
solution.

Examination Day
5-6 am 1 sachet of Fortrans + 1 liter of water

* Fortrans has a pleasant flavor. Patient may also find Fortrans solution more palatable if chilled
in refrigerator.
Important
- You are not allowed to have any food intake after bowel cleansing.
- It is important to finish the Fortrans solution within the time limit to have clean bowel for
examination.
- You are reminded not to drive or operate any machinery after procedure. Please ensure
that you are accompanied by a responsible adult to bring your home after examination.
Pico-salax
- Per sachet: Sodium picosulphate 10 mg, magnesium oxide 3.5 g, and citric acid 12 g
[orange or cranberry flavor].(12)
Indication Dosage
Bowel Adult, early colonoscopy (before 12 PM): One sachet (mixed and dissolved in
cleansing water) in the evening (5 PM) the day prior to the procedure, followed by a
second dose of one sachet 5 hours later (10 PM) the night before the
procedure.
Adult, late colonoscopy (after 12 PM): One sachet (mixed and dissolved in
water) in the late evening (7 PM) the day prior to the procedure, followed by
a second dose of one sachet in the morning (6 AM) on the day of the
procedure.
Children 1 to 5 years, ¼ of 1 sachet (mixed and dissolved in water) in the
evening (6 PM) the day prior to the procedure, followed by a second dose
of ¼ of 1 sachet in the morning (8 AM) on the day of the procedure.
Children 6 to 12 years, ½ of 1 sachet (mixed and dissolved in water) in the
evening (6 PM) the day prior to the procedure, followed by a second dose
of ½ of 1 sachet in the morning (8 AM) on the day of the procedure.
Note: Correct fluid and electrolyte imbalances prior to administration.
- CrCl <30 mL/minute: Use is contraindicated.
Mechanism of action
Sodium picosulfate, a prodrug, is hydrolyzed by colonic bacteria to an active metabolite which
stimulates colonic peristalsis.(12)
Magnesium oxide and citric acid react to create magnesium citrate which induces catharsis by
the osmotic effects of the unabsorbed ions in the GI tract.(12)
At least 3 days prior to the procedure: Avoid eating seeds, nuts, fresh fruits and vegetables, and
multigrain bread.(12)
Day prior to the procedure: Consume clear liquids only (e.g., water, clear power drinks, apple
juice, white [not red] cranberry juice, white [not purple] grape juice, ginger ale, broth, tea
[without milk, cream, or soy]), and no solid food. Patients with diabetes may drink a fiber-free
supplement.(12)
Add 1 sachet to 5 oz (150 ml) of cold water; stir for 2 to 3 minutes until dissolved; after
preparation, divide dose as appropriate for administration.(12)
Following each dose: Adults should drink 1.5 to 2 L of a variety of clear fluids (including a balanced
electrolyte solution) over 4 hours up until 2 hours prior to the procedure; children should drink
one 8-ounce drink every hour while awake and up until 2 hours prior to the procedure.(12)
Advise patient to avoid taking oral medications within 1 hours of initiating this drug.(4)
Adverse effects
Side effects may include nausea, headache and dizziness.(4)
Tell patient to report significant vomiting or symptoms of dehydration or if altered consciousness
or seizures occur after taking the drug.(4)
Advise patient to delay the administration of the second dose until symptoms resolve if severe
bloating, distention, or abdominal pain occurs following the first dose.(4)
Serious arrhythmias have occurred rarely with the use of ionic osmotic laxative products; use
caution in patients at increased risk for arrhythmias (e.g., recent MI, unstable angina,
cardiomyopathy, history of prolonged QT, HF, uncontrolled arrhythmias); consider baseline and
postcolonoscopy ECGs in patients at increased risk for arrhythmias.(12)
May cause fluid and electrolyte disturbances, particularly in patients at increased risk (e.g., renal
impairment, concomitant medications that alter electrolyte balance). Any preexisting electrolyte
abnormalities should be corrected prior to use and patients should be adequately hydrated
before, during, and after use. Consider evaluating for and treating postcolonoscopy electrolyte
abnormalities in patients who develop significant vomiting, dehydration, or orthostatic
hypotension.(12)
Seizures associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia,
hypocalcemia, hypomagnesemia) and low serum osmolality have occurred; use with caution in
patients with underlying electrolyte disturbances and in patients at increased risk for seizures
(e.g., concomitant medications that lower seizure threshold, withdrawal from alcohol or
benzodiazepines).(12)
Storage
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).(12)
Additional counseling points
What are the additional counseling points that you can provide to the patients about bowel
preparation besides counseling bowel preparation medicine?(11)
Indication - This medicine is used as part of a bowel cleansing procedure before x-

ray of the bowel or colonoscopy or before a bowel operation.
- It works by producing bowel motions. It usually works within 30
minutes; however, it may take as long as 6 hours to produce the effect.
Expect frequent liquid stools.
- The patients need to stay close to a toilet until the cleansing effect is
complete.
7 days before - Stop taking iron preparation. People with iron deficiency often require
procedure colonoscopy to investigate the cause of their anemia. However, oral
iron can turn stools black and sticky. This is problematic for visualizing
the bowel during lower gastrointestinal endoscopy as the sticky black
stools coats the colon and obscures the endoscopist’s view.(13)
- Persons taking antiplatelet agents, e.g. aspirin, ticlopidine, should
discontinue them upon a prior consultation with the prescribing
physician.
- Persons taking anticoagulants, e.g. warfarin, should contact their
attending physician and change the drugs to low molecular heparin.
2 days before - Eat a low residue and low fiber diet. Avoid fruits and vegetables,
procedure particularly those with fine seeds, red meat, high fiber breads or high
fiber cereals.
1 day before - Milk or milk products, red/purple-colored drink or meal, alcohol and
procedure carbonated drink should not be taken.
- No solid food after lunch.
- Drink plenty of clear water before midnight. Avoid taking food and
drink after midnight.
On the day of - Continue taking other medications except for antidiabetic medication.
procedure
Clear fluid list - Water, tea or coffee (no milk or non-dairy creamer), sweeteners are
acceptable.
- Carbonated or non-carbonated soft drinks (not red- or purple-
colored).
- Fruit flavored cordial (not red- or purple-colored)
- Strained fruit juices without pulp.
- Do not drink any alcoholic beverages.
- Clear soups.
- Strained low-sodium chicken or beef soup without solid material.
Special - Frequent bowel movement within 1-2 hours, stay within easy reach to
precaution the toilet.
- Some people will encounter nausea, vomiting and bloating.
- It is advisable to bring a responsible adult to accompany patient before
and after procedure.
Cholestyramine 4 g powder sachets
Mode of action(2)
Binds bile acids in intestinal lumen, preventing reabsorption, and increases bile acid excretion in
the feces. The resulting increased demand for cholesterol for bile acid synthesis increases hepatic
LDL uptake and removal from plasma.
In partial biliary tract obstruction, increased bile acid excretion reduces bile acid deposited in
dermal tissue, decreasing itch.
Indications and dosage(5, 10)
Indication Dosage
Hyperlipidemias, particularly Adult, initially 4 g daily, increased in steps of 4 g every week;

type IIa, in patients who have not increase to 12-24 g daily in 1-4 divided doses, adjusted
responded adequately to diet according to response; maximum 36 g per day.
and other appropriate
measures; Primary prevention of
coronary heart disease in men
aged 35-59 years with primary
hypercholesterolemia who have
not responded to diet and other
appropriate measures
Familial hypercholesterolemia Child 6-11 years, initially 4 g once daily, then increased to 4
g up to 3 times a day, adjusted according to response.
Child 12-17 years, initially 4 g daily, increased in steps of 4
g every week; increase to 12-24 g daily in 1-4 divided doses,
adjusted according to response; maximum 36 g per day.
Reduction of serum folate concentrations has been
reported in children with familial hypercholesterolemia.
Supplementation with folic acid should be considered in
these cases.(6)
Pruritus associated with partial Adult, 4-8 g once daily.

biliary obstruction and primary
biliary cirrhosis
Indication Dosage
Child 1-11 months, 1 g once daily, adjusted according to

response, total daily dose may alternatively be given in 2-4
divided doses; maximum 9 g per day.
Child 1-5 years, 2 g once daily, adjusted according to
Child 12-17 years, 4-8 g once daily, adjusted according to
Relief of itch usually occurs within 1-3 weeks.(2)
Diarrhea associated with Crohn’s Adult, initially 4 g daily, increased in steps of 4 g every week;
disease, ileal resection, increase to 12-24 g daily in 1-4 divided doses, adjusted
vagotomy, diabetic vagal according to response, if no response within 3 days, an
neuropathy, and radiation alternative therapy should be initiated; maximum 36 g per
day.
Child 1-11 months, 1 g once daily, adjusted according to
divided doses, if no response within 3 days, an alternative
therapy should be initiated; maximum 9 g per day.
Child 12-17 years, 4-8 g once daily, adjusted according to
Indication Dosage

Accelerated elimination of Adult, 8 g 3 times a day for 11 days; reduced to 4 g 3 times

teriflunomide a day, dose should only be reduced if not tolerated.
Accelerated elimination of Adult, 8 g times a day for 11 days.

leflunomide (washout
procedure)
- Dose of more than 24 g a day of cholestyramine resin may interfere with normal fat
absorption, preventing absorption of fat-soluble vitamins (e.g. vitamins A, D, E, K);
consider supplements for patients taking high doses over a long period of time.(2, 6)
- Children 6-12 years: The initial dose is determined by the formula below. Subsequent
dosage adjustment may be necessary where clinically indicated. To minimize potential
gastrointestinal side effects, it is desirable to begin all therapy in children with one dose
cholestyramine sachet 4 g daily. The dosage is then increased gradually, every five to
seven days to the desired level for effective control.(6)
𝐶ℎ𝑖𝑙𝑑′ 𝑠 𝑊𝑒𝑖𝑔ℎ𝑡 𝑖𝑛 𝑘𝑔 × 𝐴𝑑𝑢𝑙𝑡 𝐷𝑜𝑠𝑒
70
- Patient should take with meals.(4)
- Encourage patients to increase fluid intake during therapy.(4)
- Powder should not be used in dry form; always dissolve in liquid before taking.(4)
- The content of each sachet should be mixed with at least 150 ml of water or other suitable
liquid such as fruit juice, skimmed milk, thin soups and pulpy fruits with a high moisture
content.(10)
- Reduce the gritty texture by mixing dose and standing it in the refrigerator for at least 4
hours or overnight.(2)
- Advise patient to not sip or hold resin in mouth for prolonged periods because it may
cause discoloration of teeth and erosion or decay of tooth enamel.(4)
- Manufacturer advises take other drugs at least 1 hours before, or 4-6 hours after,
cholestyramine.(10)
Adverse effects
- This drug may cause abdominal discomfort, constipation, flatulence, nausea or
vomiting.(4)
- Instruct patient to report signs/symptoms of bleeding.(4)
Storage
- Do not store above 30°C.(6)
Contraception
Emergency contraception
Emergency contraception is intended for occasional use, to reduce the risk of pregnancy after
unprotected sexual intercourse. It does not replace effective regular contraception.(10)
Women who do not wish to conceive should be offered emergency after unprotected
contraception that has taken place on any day of a natural menstrual cycle. Emergency
contraception should also be offered after unprotected sexual intercourse from day 21 after
childbirth (unless the criteria for lactational amenorrhea are met), and from day 5 after abortion,
miscarriage, ectopic pregnancy or uterine evacuation for gestational trophoblastic disease.(10)
Emergency contraception should also be offered to women if their regular contraception has
been compromised or has been used incorrectly.(10)
When to start emergency contraception(2)
Oral Give levonorgestrel as soon as possible after unprotected intercourse, as its

levonorgestrel efficacy decreases with time. Give it within 96 hours (4 days) afterwards, but
preferably within 72 hours (3 days). Levonorgestrel can still be considered
96–120 hours (4-5 days) afterwards (as its risks are minimal) but its efficacy is
uncertain.
Ulipristal Give ulipristal as soon as possible, up to 120 hours (5 days) after unprotected
acetate course.
Copper IUD May be inserted up to 120 hours (5 days) after unprotected intercourse. It
may still be appropriate to use if intercourse occurred >5 days ago, depending
on estimated time of ovulation, seek specialist advice.
Drug choice(2)
Regimen Efficacy1 Comments

1 estimated percentage of pregnancies prevented (probability of pregnancy after unprotected
intercourse varies during the menstrual cycle from negligible to 30%)
Levonorgestrel tablets
1.5 mg single dose (as 84% if taken within - no absolute contraindications

1x1.5 mg tablet or 72 hours of unprotected - convenient, well tolerated
50x30 mcg tablets) intercourse - vomiting affects 1–5%
Regimen Efficacy1 Comments
Ulipristal tablets
30 mg single dose similar to levonorgestrel - no absolute contraindications

- convenient, well tolerated
- vomiting affects 1%
Copper IUD
1 device, remove after 99% if inserted within - inserted and removed by doctor
next period or retain for 5 days of unprotected - several contraindications (e.g.
ongoing contraception intercourse untreated symptomatic PID)
- not affected by drug interactions or
GI problems
- option of long-term contraception
Insertion of a copper intra-uterine device is the most effective form of emergency contraception
and should be offered (if appropriate) to all women who have had unprotected sexual
intercourse and do not want to conceive. Antibacterial cover should be considered for copper
intra-uterine contraceptive device insertion if there is a significant risk of sexually transmitted
infection that could be associated with ascending pelvic infection.(10)
A copper intra-uterine device is not known to be affected by body mass index (BMI) or body-
weight or by other drugs.(10)
Hormonal emergency contraceptives (includes levonorgestrel and ulipristal acetate) should be
offered as soon as possible after unprotected intercourse if a copper intra-uterine device is not
appropriate or is not acceptable to the patient; either drug should be taken as soon as possible
after unprotected intercourse to increase efficacy. Hormonal emergency contraception
administered after ovulation is ineffective.(10)
Ulipristal acetate has been demonstrated to be more effective than levonorgestrel for
emergency contraception. It is possible that a higher body-weight or BMI could reduce the
effectiveness of oral emergency contraception, particularly levonorgestrel; if BMI is greater than
26 kg/m2 or body-weight is greater than 70 kg, it is recommended that either ulipristal acetate or
a double dose of levonorgestrel [unlicensed indication] is given. It is unknown which is more
effective.(10)
Counseling points
Oral levonorgestrel(2, 4, 14)
- The use of levonorgestrel for emergency contraception does not protect sexually
transmitted infections (STIs).
- Advise patients there is clear evidence that EC is not 100% effective. Levonorgestrel
should be taken as promptly as possible and is not approved use >72 hours after
intercourse.
- Side effects may include nausea, vomiting, abdominal pain, dizziness, headache, breast
pain, menstrual changes or fatigue.
- If you vomit within 2 hours of taking the tablets, go back to your doctor/clinic/pharmacy
so that you can obtain more.
- Your next period is likely to be on time but it may be slightly early or late. If more than
1 week late, or if it is unusually light, you should have a pregnancy test.
- Emergency hormonal contraception methods do not provide ongoing contraception.
After taking levonorgestrel, women should start suitable hormonal contraception
immediately. They must use condoms reliably or abstain from intercourse until
contraception becomes effective.(10)
Ulipristal(2, 4)
- Warn patient that drug does not prevent against HIV or other sexually transmitted
diseases.
- Advise patient to take ulipristal acetate as soon as possible but no later than 120 hours (5
days) following unprotected intercourse or known or suspected contraceptive failure.
- This dug may cause acne, nausea, dizziness, headache, dysmenorrhea or fatigue.
- If you vomit within 3 hours of taking the tablet, go back to your doctor/clinic so that you
can obtain more.
- Advise patient to report severe abdominal pain 3 to 5 weeks following ulipristal acetate
use; may indicate ectopic pregnancy.
- Your next period is likely to be on time but it may be slightly early or late. If it is more than
1 week late, or is unusually light or heavy, you should have a pregnancy test.
- Wait at least 5 days before taking hormonal contraception. Use a barrier method (e.g.
condoms) during this time and for another 7 days with a combined hormonal
contraceptive (9 days for Qlaira®) or 2 days for progestogen-only pills.
- Do not use ulipristal and levonorgestrel together for emergency contraception
(levonorgestrel may reduce the effectiveness of ulipristal).
Contraception
Choice of method(2)
Failure rate1 Advantages Disadvantages

1 estimated percentage of women with an unintended pregnancy within first year of use; the
lower number is for perfect use, the higher number is for typical use
2based on combined data for COCs and progestogen-only pills (POPs); efficacy of POPs likely
to be lower than COCs as less likely to be taken perfectly; no data for vaginal ring (failure rate
assumed to be similar to COC)
3replace Copper TT380 Short®, Multiload-Cu375® and Load 375® every 5 years or
Copper TT380 Standard® every 10 years; the Copper T 380A® (no longer available) should be
replaced after 8 years
COCs
0.3–9%2 - regular, lighter, less painful - efficacy affected by some drugs,

periods vomiting and severe diarrhea
- can choose when periods - need to be taken each day
occur - may cause spotting, nausea, vomiting,
- improve acne and breast enlargement and tenderness,
menstrual disorders headache, fluid retention, increase in
- reduce risk of PID, anemia, BP, mood changes, VTE (rare)
ovarian and endometrial - increase risk of MI and stroke in
cancer smokers >35 years or those with
hypertension
Combined hormonal vaginal ring
0.3–9%2 - no daily tablets - requires monthly insertion and

- regular periods (and can removal
choose when they occur) - may cause vaginal irritation, infection
- woman inserts and or discharge
removes - ring may be expelled
Progestogen-only contraceptives
Levonorgestrel or norethisterone tablets
0.3–9%2 - useful when COC is - needs to be taken at the same time

contraindicated/less every day (within 3 hours)
appropriate (e.g. - efficacy affected by some drugs,
breastfeeding, migraine, vomiting and severe diarrhea
history of VTE, - may cause amenorrhea, irregular

smokers >35 years) or not bleeding, breast tenderness, acne
tolerated
Medroxyprogesterone IM depot
0.2–6% - no daily tablets - injection every 12 weeks

- prolonged contraception - cannot be removed
(12 weeks) - return to fertility may be delayed after
- efficacy unaffected by drug stopping (rarely >12 months)
interactions - may cause amenorrhea, irregular
bleeding, breast tenderness, acne,
weight gain, decreased BMD
Etonogestrel implant
0.05% - no daily tablets - doctor inserts and removes

- long-term contraception - efficacy affected by some drugs
(3 years) - may cause amenorrhea, irregular
bleeding, acne, breast tenderness
Levonorgestrel IUD
0.2% - lighter, less painful periods - doctor inserts and removes

- efficacy unaffected by drug - may cause amenorrhea, irregular
interactions bleeding
- no daily tablets - increases risk of pelvic infection for
- long-term contraception 3 weeks after insertion, device may be
(5 years) expelled (especially in first year)
Copper IUD3
0.6–0.8% - efficacy unaffected by drug - doctor inserts and removes

interactions - may cause heavy periods, period pain
- long-term contraception - increases risk of pelvic infection for
(5 or 10 years) 3 weeks after insertion, device may be
expelled (especially in first year)
Barrier methods
2–18% (male - condoms are easy to use, - condoms may break or slip off
condom) readily available - diaphragm initially fitted by nurse or
doctor; woman needs to be taught how
5–21% (female - condoms reduce risk of to use it; needs refitting if weight
condom) most STIs including HIV change >3 kg or after pregnancy,
- polyurethane male or miscarriage or abortion; effectiveness
6–12%
female condoms suitable in may be increased by use with a
(diaphragm)
latex allergy or with oil- spermicide (not available in Australia)
based products - oil-based products (e.g. petroleum
jelly, baby oil) can damage latex
- latex may rarely cause allergy
Postpartum(2)
Contraception is not necessary in the first 20 days after delivery.
Barrier methods: condoms can be used immediately. A diaphragm can be fitted and used from
6 weeks postpartum when vaginal tone returns.
Progestogen-only contraceptives: if used before 3 weeks postpartum may cause heavy, irregular
bleeding.
COCs: delay use until at least 21 days postpartum as there may be an increased risk of thrombosis
before this time.
IUD (including levonorgestrel): do not insert until >4 weeks after delivery as there is an increased
rate of uterine perforation if inserted before this time (usually inserted >6 weeks after delivery).
Breastfeeding(2)
The efficacy of all methods is increased due to lactation-induced anovulation. Progestogen-only
contraceptives, barrier methods and IUDs can be used. Avoid using COCs as estrogens may
decrease milk supply. They may be considered if breastfeeding is established and other
contraceptive methods are unacceptable. In women <6 months postpartum who are
amenorrhoeic and fully breastfeeding the lactational amenorrhea method can be >98% effective
in preventing pregnancy.
>40 years(2)
Contraception should generally be continued for 1 year after the last period if >50 years (for
2 years if <50). HRT is not contraceptive. Progestogen-only pills, etonogestrel implant and IUDs
can be used until menopause has occurred. COCs can be used until 50 if there are no
cardiovascular risk factors. Depot medroxyprogesterone should not be used after 50 due to its
effect on BMD.
If a copper IUD is inserted at age 40 or more, it may be used until menopause without being
replaced. If a levonorgestrel IUD is inserted at age 45 or more, it may be used until age 55 (or if
amenorrhoeic, until menopause occurs) without being replaced.
In women using hormonal contraceptives or HRT it may be difficult to determine when
menopause has occurred and contraception should be continued until age 55 (when about 96%
of women will be postmenopausal).
Combined oral contraceptives
Mode of action(2)
All COCs contain an estrogen and progestogen. They inhibit ovulation, reduce receptivity of
endometrium to implantation and thicken cervical mucus to form a barrier to sperm.
Indications(2)
- Contraception
- Acne
- Menstrual disorders, e.g. heavy menstrual bleeding, dysmenorrhea
- Endometriosis
- Premenstrual syndrome
Precautions(2)
Unexplained vaginal bleeding—investigate cause before starting COC.
Breast cancer (current or recent)—contraindicated (breast cancer is hormonally sensitive and
COC use may worsen its prognosis).
Migraine—may be exacerbated or relieved by COCs; contraindicated in migraine with aura (due
to an increased risk of stroke) and generally not recommended in women >35 years who have
migraine without aura.
Diabetes—conflicting data on effects on glucose metabolism but no increased incidence of
clinical diabetes; avoid use if there is end organ damage; additional risk of thrombosis.
Smoking—increases risk of thromboembolism and cardiovascular events; advise smokers
<35 years about increased risk and support smoking cessation; avoid use in smokers >35 years
(unacceptable risk).
BMI >30—risk of thromboembolism increases with increasing BMI.
Malabsorption syndromes—efficacy may be reduced due to poor absorption.
Systemic lupus erythematosus—may be exacerbated by COCs although they do not appear to
increase the risk of flare in inactive or moderately active, stable disease. Avoid use if
antiphospholipid antibodies are positive as there is an increased risk of thrombosis.
Antiphospholipid syndrome—avoid use as risk of thrombosis is increased.
Hereditary angioedema—may be exacerbated by COCs; progestogen-only pill may be considered.
Postpartum—increased risk of VTE that returns to baseline by day 42 postpartum. As COCs may
further increase the risk, delay use until at least 21 days postpartum if there are no other risk
factors for VTE or until day 42 if other risk factors are present.
>40 years – risk of cardiovascular and VTE may be increased. COCs can be used until age 50 if
there are no other cardiovascular factors.
Cardiovascular(2)
- Contraindicated with a history of cerebrovascular or coronary artery disease.
- Contraindicated with a history of VTE or thrombogenic mutations. Avoid use or seek
specialist advice about thrombophilia screening if a first-degree relative had a VTE when
<45 years.
- Contraindicated in complicated valvular disease (pulmonary hypertension, AF, history of
subacute bacterial endocarditis) as COCs may further increase the risk of arterial
thrombosis.
- Hypertension increases risk of MI and stroke; avoid use if BP is not controlled although it
is uncertain that controlling BP decreases the risk. COCs may also increase BP; monitor
regularly.
- Assess cardiovascular risk factors; the presence of multiple risk factors may contraindicate
COC use.
Hepatic(2)
Contraindicated when liver function is compromised, including in acute viral hepatitis, severe
(decompensated) cirrhosis and liver tumors.
Cholestasis during pregnancy may increase the risk of COC-related cholestasis. COC-related
cholestasis increases the risk with subsequent COC use.
COCs increase the secretion of cholic acid in bile and may worsen existing gall bladder disease.
Surgery(2)
COCs may increase the risk of VTE. Stop the COC 4 weeks before major elective surgery where
prolonged immobilization is expected; a progestogen-only contraceptive may be considered.
Restart COC at least 2 weeks after full mobilization. If still taking a COC at the time of surgery,
VTE prophylaxis may be appropriate.
Pregnancy(2)
No increased risk of birth defects from inadvertent use (except for a theoretical risk with
cyproterone-containing pills).
Breastfeeding(2)
Estrogens may decrease milk supply; avoid use (progestogen-only contraceptive preferred). May
be considered if breastfeeding is established and other contraceptive methods are unacceptable.
Adverse effects(2)
Tolerance to some adverse effects may develop during the first 3 months of use. The benefits of
oral contraception often outweigh the risks; benefits include prevention of pregnancy and its
complications, regular and reduced menstrual loss (reducing the risk of iron deficiency anemia)
and reduced risk of ovarian cysts and PID. There is also a reduced risk of ovarian and endometrial
carcinoma, which persists for 15 or more years after stopping.
Common (>1%) Breakthrough bleeding, amenorrhea, nausea, vomiting, breast

enlargement and tenderness, headache, mood changes, changes in
libido, increased BP, fluid retention, chloasma, acne, thrush
Infrequent (0.1–1%) Contact lens intolerance, rash, hirsutism, alopecia, altered lipid profiles,
hyperinsulinemia (especially with levonorgestrel-containing COCs) and
insulin resistance but no evidence of increased incidence of clinical
diabetes
Rare (<0.1%) Allergy (e.g. urticaria, angioedema), hypertension, VTE, stroke,

jaundice, pancreatitis, liver cancer, cervical cancer, photosensitivity
Breakthrough bleeding(2)
If breakthrough bleeding still occurs after >3 months of use and another cause cannot be
identified (e.g. missed pills, drug interaction), the following suggestions may be tried (in order):
- Change to a monophasic COC if taking a multiphasic COC
- Change the progestogen or increase the dose (especially if bleeding occurs late in cycle)
- Change to a standard dose COC (with 30–35 micrograms ethinyloestradiol or
50 micrograms mestranol) if taking a low-dose COC (with 20 micrograms
ethinyloestradiol or 1.5 mg estradiol)
- Change the progestogen again
- Change to a high-dose COC (with 50 micrograms ethinyloestradiol).
VTE(2)
The risk of VTE depends on the dose of estrogen, the progestogen and the presence of other risk
factors. Risk is highest in the first year of use. The incidence of VTE per 10 000 patient-years has
been estimated to be:
- 1–5 in non-pregnant non-users
- 5–7 for COCs containing either levonorgestrel or norethisterone with 35 micrograms or
less of ethinyloestradiol
- 6–12 for COCs containing etonogestrel
- 9–12 for COCs containing cyproterone, desogestrel, drospirenone or gestodene
- 10–16 for COCs containing 50 micrograms or more of ethinyloestradiol
- the incidence for COCs containing dienogest or nomegestrol is unknown
- 5–29 per 10 000 pregnancies (incidence even higher in first 6 weeks postpartum).
Breast cancer(2)
It is still unclear whether there is an increased risk of breast cancer among users of the COC.
A 1996 pooled analysis of 54 epidemiological studies with data on 53 297 women with breast
cancer found a small increase in risk in current users, which declined to that of never users
10 years after stopping.
A 2002 population-based case-controlled study involving 4575 women with breast cancer (aged
35–64) did not find an increased risk in current or past users of COCs, women who started COCs
before the age of 20 years or those with a family history of breast cancer.
Further study is required to determine the risk associated with use of COCs in the
perimenopause.
Cervical cancer(2)
COC use may be associated with a small increased risk of cervical cancer, which increases with
duration of use. This risk declines to that of never users 10 years after stopping.
Regimen(2)
Brand® Estrogen Progestogen
packs contain 21 active tablets followed by 7 inactive tablets unless specified

1 24 active tablets followed by 4 inactive tablets
2 30 active tablets
3 26 active tablets followed by 2 inactive tablets
4 84 active tablets followed by 7 very low dose estrogen tablets
Monophasic
Low dose
Yaz1, Yaz Flex2 ethinyloestradiol 20 mcg drospirenone 3 mg
Femme-Tab 20/100, Lenest 20, levonorgestrel 100 mcg

Loette, Microgynon 20,
Microlevlen, Micronelle 20
Zoely1 estradiol 1.5 mg nomegestrol 2.5 mg
Standard dose
Madeline, Marvelon ethinyloestradiol 30 mcg desogestrel 150 mcg
Valette dienogest 2 mg
Petibelle, Yasmin drospirenone 3 mg
Minulet gestodene 75 mcg
Eleanor 150/30, Evelyn 150/30, levonorgestrel 150 mcg

Femme-Tab 30/150, Levlen,
Microgynon 30, Micronelle 30,
Monofeme, Nordette
Brenda-35, Carolyn-35, ethinyloestradiol 35 mcg cyproterone 2 mg

Chelsea-35, Diane-35, Estelle-35,
Jene-35, Juliet-35, Laila-35
Brevinor, Norimin norethisterone 0.5 mg
Brevinor-1, Norimin-1 norethisterone 1 mg
Norinyl-1 mestranol 50 mcg norethisterone 1 mg
Brand® Estrogen Progestogen
High dose
Microgynon 50 ethinyloestradiol 50 mcg levonorgestrel 125 mcg
Multiphasic
Logynon, Trifeme, Triphasil, ethinyloestradiol levonorgestrel

Triquilar 30 mcg/40 mcg/30 mcg 50 mcg/75 mcg/125 mcg
Qlaira3 estradiol dienogest nil/2 mg/3 mg/nil

3 mg/2 mg/2 mg/1 mg
Other
Seasonique4 ethinyloestradiol levonorgestrel 150 mcg

30 mcg/10 mcg
Most COCs are available as 28-day regimens, where active tablets are taken for 21, 24 or 26 days
followed by inactive tablets. A hormone-free interval <7 days is thought to reduce the incidence
of hormone withdrawal symptoms and, in some cases, it may increase contraceptive
effectiveness by further suppressing ovarian function. Regimens are either monophasic or
multiphasic. In general, start with a monophasic regimen containing a standard dose of
ethinyloestradiol (30–35 micrograms) and either levonorgestrel or norethisterone.
Monophasic regimens(2)
- Each active tablet contains the same doses of estrogen and progestogen. May be further
classified by the dose of estrogen.
o Standard dose: 30–35 micrograms ethinyloestradiol or 50 micrograms mestranol.
Generally, the preferred strength of COC; as effective as those containing
50 micrograms ethinyloestradiol (high dose); the lower dose of estrogen reduces
the risk of adverse effects. Associated with a higher incidence of intermenstrual
bleeding initially than high-dose products.
o Low dose: 20 micrograms ethinyloestradiol or 1.5 mg estradiol. Low-dose
products appear to be as effective as standard dose, with a slightly higher
incidence of breakthrough bleeding, especially at first.
o High dose: 50 micrograms ethinyloestradiol. Increased risk of adverse effects
compared with lower dose products.
Multiphasic regimens(2)
- The progestogen, or both estrogen and progestogen, content varies throughout the cycle.
These regimens are more complex and may be associated with cyclical symptoms, e.g.
fluid retention, premenstrual syndrome. No advantage over monophasic regimens has
been demonstrated and the variable dose makes it difficult to change the timing of
withdrawal bleeds.
Extended cycles(2)
- Are where active tablets (of a monophasic COC) are taken for >28 days in a row; active
tablets may be followed by a 4- or 7-day hormone-free interval, either regularly or when
breakthrough bleeding occurs for 3–4 days. Alternatively, there may be no hormone-free
interval (e.g. Seasonique®)
- Extended cycles may be:
o Used to eliminate or decrease the frequency of withdrawal bleeds
o Particularly useful for women with headaches or other symptoms in the
withdrawal week, heavy or painful periods or endometriosis.
Estrogen(2)
Most COCs contain ethinyloestradiol. Others contain mestranol (which is metabolized to
ethinyloestradiol) or estradiol. There is no evidence that estrogen choice offers any clinical
benefits.
Progestogen(2)
Cyproterone
Progestogenic and anti-androgenic. It is used with an estrogen to treat women with
androgenization; the combination also provides effective contraception. This combination may
be associated with a higher incidence of VTE compared with other COCs and is not indicated as a
COC in the absence of androgenization.
Desogestrel, gestodene
Although they have less androgenic activity than levonorgestrel, COCs containing gestodene or
desogestrel have almost twice the risk of VTE compared with COCs containing levonorgestrel or
norethisterone. They are generally not first choice for new users but may be used for those not
tolerating other progestogens.
Dienogest
Dienogest has anti-androgenic activity. There are limited data regarding its VTE risk and it is
unclear whether COCs containing dienogest have any advantages over other COCs.
Drospirenone
Related to spironolactone, this progestogen has anti-mineralocorticoid (mild diuretic and
potassium retention) and anti-androgenic activity. Evidence suggests the risk of VTE with COCs
containing drospirenone is higher than that with COCs containing levonorgestrel and may be
similar to COCs containing desogestrel or gestodene. There is no compelling evidence for any
particular benefit (e.g. reduced androgenic effect) for COCs containing drospirenone.
Levonorgestrel, norethisterone
COCs containing these progestogens have been used for many years and are associated with a
lower risk of VTE than other COCs.
Nomegestrol
Nomegestrol has some anti-androgenic activity. Although there are no data regarding its VTE risk
when used in COCs, some data suggest an increased risk of VTE when used in HRT (in higher
doses).
Counselling(2)
- If any of the following symptoms occur while on the pill, stop taking it and seek urgent
medical advice: severe and sudden pain in the chest, severe headache, sudden blurred
vision or loss of sight, unexplained tenderness or pain and swelling in one leg.
- When to start
o Make sure you know which are active (hormonal) pills and which are inactive.
Packets vary in presentation; some brands recommend starting with inactive pills,
depending on the day of the week.
o If no preceding hormonal contraception: for immediate contraception start with
an active pill within the first 5 days of your period starting. If you start active pills
after this, use additional contraceptive methods until you have taken active pills
for 7 days.
o If changing from another COC: start taking active pills the day after you stop your
old pill (on any day of your cycle). Additional contraception is not required.
o If changing from a progestogen-only pill: start taking the active pills without any
interval and use additional contraceptive methods until you have taken active pills
for 7 days.
o After taking levonorgestrel or ulipristal emergency contraception: start taking the
active pills within 12 hours after taking levonorgestrel; wait at least 5 days before
taking the active pills after taking ulipristal.
- What to expect
o While taking inactive pills (or during the pill-free interval for Yaz Flex®), a
withdrawal bleed (similar to a period) should start. However, sometimes this may
not occur. Continue taking the pills as normal but consider the possibility of
pregnancy if the pill has not been taken correctly or if 2 withdrawal bleeds in a
row are missed.
o Irregular bleeding or spotting is common at first but this usually settles down after
2–3 months.
- When is it less effective?
o Effectiveness may be reduced by:
▪ Some medicines; check with your doctor or pharmacist before starting or
stopping any medicines, including herbal (particularly St John’s wort) and
over-the-counter products
▪ Vomiting or diarrhea (which also may be caused by some medications) or
forgetting to take an active pill.
- Missed active pills, vomiting or diarrhea
o If you vomit within 2 hours of taking an active pill, take another active pill as soon
as possible.
o If you are less than 24 hours late taking an active pill, take it as soon as you
remember and take the next pill at the usual time; contraception will not be
affected.
o If you are more than 24 hours late taking an active pill, or if you have vomiting or
severe diarrhea for more than 24 hours, the pill will not be as effective:
▪ If you are late taking an active pill take it as soon as you remember and
take the next pill at the usual time (this may mean taking 2 pills on the
same day or at the same time)
▪ Continue with the daily pill and use another contraceptive method until
you have taken active pills for 7 days in a row (if the missed pill was in the
last 7 days of active pills, finish the active pills in your present pack, then
start the active pills in a new pack without any break). If the missed pill was
in the first 7 days of active pills and you had unprotected sex during or after
that time, seek emergency contraception.
Practice points(2)
- Although indicated for premenstrual syndrome (PMS), COCs can also worsen or cause
PMS (may be more likely with multiphasic regimens); using extended cycles may
sometimes help
- Before prescribing a COC take a thorough history and examination, including BP
- Ensure users of COCs are included in cervical screening program
- There may be a delay of up to 3 months before return of menstrual periods after stopping
the COC
- There is no evidence to support the belief that anti-infectives (other than rifampicin,
rifabutin, griseofulvin and some antiretrovirals) alter the effectiveness of COCs
Progestogens
Oral progestogen-only contraceptives are also known as the minipill.(2)
Mode of action(2)
When used as contraceptives, progestogens thicken cervical mucus to impede the passage of
sperm and change endometrium, reducing the potential for implantation. They act on the
hypothalamus and suppress pituitary LH surge and may inhibit ovulation. Depot injection and
implant reliably suppress ovulation; oral progestogen-only contraceptive suppresses ovulation in
<50% of women. Progestogens also induce atrophy within ectopic endometrium.
Indications(2)
- Contraception
- Menstrual disorders
- Endometriosis
- HRT (as adjunct to estrogen)
Precautions(2)
Breast cancer (current or recent)—generally contraindicated although medroxyprogesterone is
used to treat breast cancer in selected patients.
Unexplained vaginal bleeding—avoid until fully investigated, as progestogens can cause irregular
vaginal bleeding.
Current VTE—use with caution as progestogens may increase the risk of thromboembolism
(although risk is substantially less than with COCs). May be used in women with a history of VTE.
Systemic lupus erythematosus—use with caution if antiphospholipid antibodies are positive as
progestogens may increase the risk of VTE (although risk is substantially less than with COCs).
Postpartum—if used as contraceptive before 3 weeks postpartum may cause heavy, irregular
bleeding.
Hepatic(2)
Avoid when liver function is compromised, including in severe (decompensated) cirrhosis and
liver tumors. Some manufacturers contraindicate use in severe impairment.
Surgery(2)
May be continued perioperatively (including major surgery); minimal risk of thromboembolic
events unless other cardiovascular risk factors are present.
Breastfeeding(2)
Progestogens used for contraception, endometriosis or heavy menstrual bleeding are safe; they
are the preferred hormonal contraceptives as they do not inhibit lactation.
Adverse effects(2)
Common (>1%) Menstrual irregularity, prolonged bleeding, spotting, amenorrhea,

breast tenderness, depression, acne
Infrequent (0.1–1%) Nausea, vomiting, headache, dizziness, lethargy
Rare (<0.1%) Cholestatic jaundice, decreased libido, androgenic effects (hirsutism,

greasy hair), hypersensitivity (e.g. anaphylactic reaction)
Counselling points for norethisterone or levonorgestrel(2)

- It is important to take the pills at the same time every day (not more than 3 hours late).
Choose a time when you are most likely to remember.
- The pills are taken continuously; there are no inactive (sugar) pills or 7-day break as with
the combined pill.
- Changes in bleeding pattern can include spotting, irregular or prolonged bleeding or
periods stopping.
- When to start
o If no preceding hormonal contraception: for immediate contraception start taking
pills within the first 5 days of your period starting. If you start at any other time,
use additional contraceptive methods for the next 48 hours.
o If changing from a COC, start taking the new pills the day after you stop your old
pill (on any day of your cycle). Additional contraception is not required.
- When is it less effective?
o Effectiveness may be reduced by some medicines; check with your doctor or
pharmacist before starting or stopping any medicines, including herbal
(particularly St John’s wort) and over-the-counter products
o If you vomit within 2 hours of taking a pill, take another pill as soon as possible.
o If you are more than 3 hours late taking a pill, or if you have persistent vomiting
or severe diarrhea, the pill will not be as effective:
▪ If you are late taking a pill take it as soon as you remember and take the
next pill at the usual time (this may mean taking 2 pills on the same day or
at the same time)
▪ Continue with the daily pill and use another contraceptive method for the
next 48 hours (if you have unprotected sex during this time, seek
emergency contraception).
Practice points for norethisterone or levonorgestrel(2)

- May be less effective than the COC as less likely to be taken perfectly
- Consider the possibility of ectopic pregnancy in contraceptive failure; progestogen-only
contraceptives do not reliably inhibit ovulation and therefore offer less protection against
ectopic than intrauterine pregnancy (in trials for 1 brand up to 10% of pregnancies were
ectopic)
- There is no evidence of a delay in return of fertility after stopping
Dabigatran (Pradaxa)
- 75 mg, 110 mg, 150 mg capsule
Indication Dosage
Prevention of Treat for 10 days after knee replacement and 28–35 days after hip
VTE after replacement.
knee/hip
Adult, initially 110 mg within 1–4 hours of completed surgery, then 220 mg
replacement
once daily. If dabigatran cannot be started on the day of surgery, give
220 mg once daily.
With amiodarone or verapamil, 150 mg once daily.
CrCl 30–50 mL/minute, 150 mg once daily.
AF, acute VTE For VTE, treat with a parenteral anticoagulant for at least 5 days before
and prevention starting dabigatran. Continue dabigatran for at least 3 months.
of subsequent
Adult, 150 mg twice daily.
VTE
>75 years, 110 mg twice daily.
Increased risk of major bleeding or CrCl 30–50 mL/minute, consider
reducing dose to 110 mg twice daily.
With amiodarone, dabigatran dose does not need alteration.
With verapamil, dabigatran dose does not need alteration. However, if
adding verapamil to dabigatran or starting both drugs on the same day, the
manufacturer states that dabigatran should be given at least 2 hours before
verapamil for the first 3 days.
Indication Dosage
Switching From dabigatran to parenteral anticoagulant

anticoagulants
- Prevention of VTE after knee/hip replacement, wait for 24 hours
after the last dabigatran dose.
- Prevention of emboli in AF, wait for 12 hours after the last
dabigatran dose.
From dabigatran to warfarin
- CrCl >50 mL/minute, start warfarin 3 days before stopping
dabigatran.
- CrCl 30–50 mL/minute, start warfarin 2 days before stopping
dabigatran.
- CrCl 15–30 mL/minute, start warfarin the day before stopping
dabigatran.
From parenteral anticoagulant to dabigatran
- Start dabigatran within the 2 hours before the due time of the next
dose of parenteral anticoagulant.
From warfarin to dabigatran
- Stop warfarin and start dabigatran when INR <2.
- Reduce dosage if CrCl 30-50ml/minute.

- Contraindicated if GI hemorrhage within previous 12 months, prosthetic heart valve, CrCl
<30ml/minute, liver enzymes are > 2 times ULN or if hepatic disease may affect survival.
- Stop dabigatran before elective surgery or procedures: 1–3 days before if
CrCl >50 mL/minute or 3–5 days before if CrCl 30–50 mL/minute. Consider increasing the
time if complete hemostasis is required. Bridging IV heparin or SC LMWH may be
appropriate in high-risk patients.
- Avoid in pregnancy and breastfeeding.
- Swallow capsules whole with a glass of water and take some food too; do not chew, crush
or open capsules or empty pellets from capsules as this will increase your risk of bleeding.
- Bioavailability of dabigatran may increase by up to 75% (with subsequent increased risk
of bleeding) if the pellets are removed from the capsule; dabigatran capsules should
always be swallowed whole.
- Take at about the same time(s) every day; use a calendar to keep a record and to mark
off the date after taking a dose.
- Instruct patient to take a missed as soon as possible, but if next dose is less than 6 hours,
skip the missed dose. Patient should not take 2 doses at the same time.(4)
Adverse effects
feces.(2)
- Instruct patient to report symptoms of dyspepsia or gastritis (i.e. upset stomach, burning,
nausea, abdominal pain or discomfort, epigastric discomfort).(4)
- Counsel patient to report symptoms of spinal or epidural hematoma (i.e. back pain,
tingling, numbness, muscle weakness).(4)
medicine.
Dandruff (Pityriasis capitis)
Dandruff
Dandruff is considered to be a mild form of seborrheic dermatitis.(10) It is often seen as socially
unsightly and a source of embarrassment. The scalp will be dry, itchy and flaky. Flakes of dead
skin are usually visible in the hair close to the scalp and are visible on the shoulders and collars
of clothing.(15)
Treatments
The use of a hypoallergenic shampoo on a daily basis will usually control mild symptoms. In more
persistent and severe cases, a ‘medicated’ shampoo can be used to control the symptoms.
Treatment options include coal tar, selenium sulphide, zinc pyrithione and ketoconazole.(15)
All antidandruff shampoos can cause local irritation. If this is severe, the product should be
discontinued. Any patient group can use them, although some manufacturers stat these products
should be avoided during pregnancy. However, there appear to be no data to substantiate this
precaution.(15)
Shampoos containing antimicrobial agents such as pyrithione zinc (which are widely available)
and selenium may have beneficial effects. Shampoos containing tar extracts may be useful and
they are also used in psoriasis. Ketoconazole shampoo should be considered for more persistent
or severe dandruff or for seborrheic dermatitis of the scalp.(10)
Corticosteroid gels and lotions can also be used.(10)
Shampoos containing coal tar with salicylic acid may also be useful. A cream or an ointment
containing coal tar with salicylic acid is very helpful in Psoriasis that affects the scalp. Patients
who do not respond to these treatments may need to be referred to exclude the possibility of
other skin conditions.(10)
Selsun selenium sulfide 25 mg/ml (2.5%) suspension
Selenium is thought to work by its antifungal action. It is accepted that selenium is effective as
an antidandruff agent, and studies have shown it to be significantly better than placebo and
nonmedicated shampoo.(15)
Indications and dosage
Seborrheic Child 5-17 years and adult, apply twice weekly for 2 weeks, then apply once
dermatitis; weekly for 2 weeks, then apply as required.(10) The hair should be thoroughly
Dandruff wet before applying the shampoo and left in contact with the scalp for 2 to 3
minutes before rinsing out.(15)
Pityriasis Adult, apply once daily for 7 days apply to the affected area and leave on for 10
versicolor minutes before rinsing off. The course may be repeated if necessary. Diluting with
a small amount of water prior to application can reduce irritation.(10)
- For external use only.(6)
- Patient should avoid contact with broken skin, inflamed areas, eyes, genital areas or skin
fold.(4)
- Avoid use 48 hours before or after applying hair coloring, straightening or waving
preparations.(10)
- Gold, silver and other metallic jewelry should be removed before use because it can be
discolored. It also has an unpleasant odor.(15)
Important information
- This drug may cause alopecia, transient contact dermatitis, greasy hair, hair discoloration
or skin irritation.(4)
- Manufacturers state to avoid in pregnancy and while breastfeeding due to lack of safety
data. However, safety data show it to be OK when used on small areas over a limited time.
No evidence to say it would be absorbed into breast milk.(15)
Storage
Sebitar shampoo
Sebitar contains pine tar 1%, coal tar solution 1%, salicylic acid 2%, undecylenamide dea 1% in a
mild base. It has a pH of 5.5.(9)
Indication Dosage
Scalp cleansing treatment for use Wet hair, apply to affected area and massage well. Apply
in psoriasis, seborrhea (including more to remainder of the scalp, work into a lather and
severe dandruff), seborrheic leave for 5 min. Rinse thoroughly with water, repeat if
dermatitis, eczema, itching. necessary. Use daily if needed; frequency treatment
depends on the severity of the condition.
Precautions
Avoid contact with eyes. If contact occurs, rinse eyes with clean water.(9)
Tips
Always use a good hair rinse or hair rinse or conditioner after using a scalp cleansing
treatment.(9)
Ketoconazole 2% w/w shampoo
Ketoconazole inhibits Malassezia replication by interfering with cell membrane formation. It
helps in controlling the itching and flaking associated with dandruff. Studies have shown it to be
an effective treatment. It has been shown to be significantly better than zinc pyrithione and has
similar efficacy to selenium. Ketoconazole has also been shown to act as a prophylactic agent in
preventing relapse.(15)
Indications and dosage – for child 12-17 years and adult(10)
Indication Dosage
Seborrheic dermatitis Treatment Apply twice weekly for 2-4 weeks, leave preparation
and dandruff on for 3-5 minutes before rinsing.
Prophylaxis Apply every 1-2 weeks, leave preparation on for 3-5

minutes before rinsing.
Pityriasis versicolor Treatment Apply once daily for maximum 5 days, leave
preparation on for 3-5 minutes before rinsing.
Prophylaxis Apply once daily for up to 3 days before sun exposure,

leave preparation on for 3-5 minutes before rinsing.
Adverse effects
Ketoconazole 2% w/w shampoo can cause local itching or a burning sensation on application and
may discolor hair.(15)
Precautions
In patients who have been on prolonged treatment with topical corticosteroids, it is
recommended that the steroid therapy be gradually withdrawn over a period of 2-3 weeks, while
using ketoconazole 2% w/w shampoo, to prevent any potential rebound effect.(6)
Ketoconazole 2% w/w shampoo may be irritating to mucous membranes of the eyes and contact
with this area should be avoided. If ketoconazole 2% w/w shampoo does get into the eyes, they
should be bathed gently with cold water.(6)
Ketoconazole 2% w/w shampoo is not detected in plasma after chronic shampooing or topical
application. It is not contraindicated for pregnancy or lactation, but caution should be
exercised.(6)
Storage(6)
- Store in original container.
- Keep container tightly closed.
Deferasirox dispersible tablet (Exjade)
- Tablets for oral suspension: 125 mg, 500 mg
Mode of action(2)
Chelate iron and promote iron excretion by forming a complex with non-transferrin-bound iron;
elimination is predominantly biliary (fecal). This decreases the amount of stored iron and
prevents continuous distribution of iron to key tissues via plasma non-transferrin-bound iron.
Indication Dosage
Treatment of chronic iron Adult, child >2 years, oral 20 mg/kg (rounded up to the
overload: nearest whole tablet size) once daily. Use 30 mg/kg once
daily for patients receiving >14 mL/kg/month of packed
- due to blood transfusions
red blood cells or 10 mg/kg once daily for patients
(transfusional
receiving <7 mL/kg/month of packed red blood cells.
hemosiderosis)
- in children aged 2–5 years Moderate hepatic impairment (Child-Pugh class B), halve
who are unable to take starting dose.
desferrioxamine or for
Severe hepatic impairment (Child-Pugh class C), avoid.
whom it is ineffective
- in non-transfusion- Maintenance, adjust the dose by 5–10 mg/kg every 3–
dependent thalassemia 6 months based on serum ferritin, up to a maximum of
syndromes (seek specialist 40 mg/kg once daily.
advice)
Renal impairment, limited data; contraindicated by
manufacturer when CrCl <40ml/minute.
- Conversion from deferasirox dispersible tablet to film coated tablet: the dose for film
coated tablet should be ~30% lower.(12)
Administer at same time each day on an empty stomach, at least 30

minutes before food.
Administer tablets by making an oral suspension; do not chew or swallow

tablets whole.
Do not take with aluminium-containing antacids.(4)
Completely dissolve in water, orange juice, or apple juice (use 105 ml for
total doses <1 g, 210 ml for doses ≥1 g).
Avoid dispersion of tablets in milk (due to slow dissolution) or carbonated
drinks (due to foaming).
Stir to form a find suspension and drink entire contents.
Rinse remaining residue with more fluid, drink.
- Deferasirox film coated tablet(12)

o Swallow with water or other liquids at the same time each day. Administer on an
empty stomach or with a light meal (contains <7% fat content and ~250 calories).
For patients who have difficulty swallowing whole tablets, may crush tablets and
mix with soft foods (e.g., yogurt, applesauce); consume entire mixture
immediately after preparation (do not store for future use). Commercial crushers
with serrated surfaces should be avoided for crushing a single 90 mg tablet.
Adverse reactions(4)
- Side effects may include abdominal pain, diarrhea, nausea and vomiting.
- Tell patient to report symptoms of hepatic failure or renal failure.
- Advise patient to report symptoms of serious skin reactions, including Stevens-Johnson
syndrome and erythema multiforme and drug reaction with eosinophilia and systemic
symptoms (DRESS).
- Counsel patient to report symptoms of gastrointestinal ulceration, or hemorrhage.
- Warn patient to avoid activities requiring mental alertness or coordination until drug
effects are realized, as drug may cause dizziness.
- Instruct patient to report auditory disturbances (e.g. high frequency hearing loss,
decreased hearing) or ocular changes (e.g. lens opacities, cataracts, elevations in ocular
pressure, retinal disorders).
Practice points(2)
Hepatic failure (sometimes fatal) has been reported, mostly in people >55 years, and often
involves significant comorbidities, e.g. pre-existing cirrhosis.
Baseline ophthalmic and auditory examinations are recommended; repeat annually.
Monitoring
- Check serum creatinine at baseline, then each month. If renal function is impaired,
monitor weekly for the first month (and after a dose increase), then monthly. If non-
progressive elevations in serum creatinine occur for 2 consecutive months, reduce dose
by 10 mg/kg:
o in adults, when creatinine rises >33% above baseline
o in children, when creatinine rises above the age-appropriate ULN
o if serum creatinine continues to rise, stop treatment
- Check urine protein and urinary protein–creatinine ratio at baseline, then monthly
- Check liver function at baseline, fortnightly for the first month, then monthly; elevations
in serum aminotransferases (>5 times ULN) may occur. If progressive increases in ALT/AST
occur, stop treatment. Cautious re-introduction at a lower dose may be considered
Diabetes mellitus
Diabetes mellitus
Diabetes mellitus (DM) is a group of metabolic disorders characterized by hyperglycemia and
abnormalities in carbohydrate, fat, and protein metabolism. It may result in chronic
microvascular, macrovascular, and neuropathic complications.(16)
Hyperglycemia
Hyperglycemia doesn’t cause symptoms until glucose values are significantly elevated – usually
above 180-200 mg/dL or 10-11 mmol/L. Symptoms of hyperglycemia develop slowly over several
days or weeks. The longer blood sugar levels stay high, the more serious the symptoms become.
However, some people who have had type 2 diabetes for a long time may not show any
symptoms despite elevated blood sugars.(17)
- Early signs and symptoms: frequent urination, increased thirst, blurred vision, fatigue,
headache.
- Later signs and symptoms: fruity-smelling breath, nausea and vomiting, shortness of
breath, dry mouth, weakness, confusion, coma, abdominal pain.
Pathophysiology
Type 1 DM (5%–10% of cases) results from autoimmune destruction of pancreatic β-cells, leading
to absolute deficiency of insulin. It usually presents in children and adolescents but can occur at
any age. The autoimmune process is mediated by macrophages and T lymphocytes with
autoantibodies to β-cell antigens (e.g., islet cell antibody, insulin antibodies). Amylin (a hormone
cosecreted from pancreatic β-cells with insulin) suppresses inappropriate glucagon secretion,
slows gastric emptying, and causes central satiety; amylin is also deficient in type 1 DM due to β-
cell destruction.(16)
Type 2 DM (90% of cases) is characterized by multiple defects:(16)
- Impaired insulin secretion is a hallmark finding; β-cell mass and function are both
reduced, and β-cell failure is progressive.
- Normally, the gut incretin hormones glucagon-like peptide-1 (GLP-1) and glucose
dependent insulinotropic peptide (GIP) are released and stimulate insulin secretion when
nutrients enter the stomach and intestines. Patients with type 2 DM have a reduced
incretin effect due to decreased concentrations of or resistance to the effects of these
incretin hormones.
- Insulin resistance is manifested by excessive hepatic glucose production, decreased
skeletal muscle uptake of glucose, and increased lipolysis and free fatty acid production.
- Excess glucagon secretion occurs because type 2 DM patients fail to suppress glucagon in
response to meals because of GLP-1 resistance/deficiency and insulin
resistance/deficiency, which directly suppress glucagon.
- Sodium-glucose cotransporter-2 (SGLT-2) upregulation in the kidney increases
reabsorption of glucose by proximal renal tubular cells, which may worsen hyperglycemia.
The metabolic syndrome involves multiple metabolic abnormalities and confers a higher risk for
developing type 2 DM and subsequent cardiovascular disease (CVD). The current definition
includes central obesity (defined as waist circumference with ethnicity-specific values) plus any
two of these four factors:(16)
- raised triglycerides (≥ 150 mg/dL [1.7 mmol/L]);
- reduced HDL cholesterol (< 40 mg/dL [1.03 mmol/L] in males or < 50 mg/dL [1.29 mmol/L]
in females);
- increased blood pressure (systolic BP ≥ 130 mm Hg, diastolic BP ≥ 85 mm Hg, or treatment
of previously-diagnosed hypertension); and
- raised fasting plasma glucose (≥ 100 mg/dL [5.6 mmol/L] or previous diagnosis of type 2
DM.
Uncommon causes of diabetes (less than 5% of cases) include gestational diabetes mellitus
(GDM), maturity onset diabetes of youth (MODY), endocrine disorders (e.g., acromegaly, Cushing
syndrome), pancreatic exocrine dysfunction, infections, and medications (e.g., glucocorticoids,
thiazides, niacin).(16)
Microvascular complications include retinopathy, neuropathy, and nephropathy. Macrovascular
complications include coronary heart disease, stroke, and peripheral vascular disease.(16)
Clinical presentation
Type 1 diabetes mellitus(16)
- The most common initial symptoms are polyuria, polydipsia, polyphagia, weight loss, and
lethargy accompanied by hyperglycemia.
- Individuals are often thin and are prone to develop diabetic ketoacidosis if insulin is
withheld or under conditions of severe stress.
- Between 20% and 40% of patients present with diabetic ketoacidosis after several days
of polyuria, polydipsia, polyphagia, and weight loss.
- Patients are often asymptomatic and may be diagnosed secondary to unrelated blood
testing.
- Lethargy, polyuria, nocturia, and polydipsia can be present. Significant weight loss is less
common; most patients are overweight or obese.
Treatment
Goals of treatment: Ameliorate symptoms, reduce risk of microvascular and macrovascular
complications, reduce mortality and improve quality of life. Desirable plasma glucose and A1c
levels are listed in table below.(16)
Biochemical index American Diabetes American Association of Clinical

Association Endocrinologists and American
College of Endocrinology
A1c <7%a (<53mmol/mol Hb) ≤6.5% (≤48 mmol/mol Hb)
Pre-prandial plasma 80-130mg/dL (4.4-7.2 <110mg/dL (<6.1mmol/L)

glucose mmol/L)
Post-prandial plasma <180mg/dLb (<10mmol/L) <140mg/dL (<7.8mmol/L)
glucose
a More stringent glycemic goal may be appropriate if accomplished without significant
hypoglycemia or adverse effects. Less-stringent goals may be appropriate in some situations.

b Postprandial glucose measurements should be made 1 to 2 hours after the beginning of the
meal, generally the time of peak levels in patients with diabetes.

HbA1c indicates glycemic control during preceding 2-3 months; there is an association between
the risk of microvascular complications and level of glycated hemoglobin. Monitor every 3–
6 months.(2)
General approach
- Early treatment to near-normal glycemia reduces risk of microvascular disease
complications, but aggressive management of cardiovascular risk factors (i.e., smoking
cessation, treatment of dyslipidemia, intensive blood pressure [BP] control, and
antiplatelet therapy) is needed to reduce macrovascular disease risk.(16)
- Appropriate care requires goal setting for glycemia, BP, and lipid levels; regular
monitoring for complications; appropriate food choices; maintaining a healthy weight;
engaging in regular physical activity; wise medication selection and use; appropriate self-
monitoring of blood glucose (SMBG); and laboratory assessment of appropriate
parameters.(16)

- Consider referrals to dietitian, diabetes educator, ophthalmologist, endocrinologist and
podiatrist.(2)
Nonpharmacologic therapy(16)
- Medical nutrition therapy is recommended for all patients. For type 1 DM, the focus is
on physiologically regulating insulin administration with a balanced diet to achieve and
maintain healthy body weight. The meal plan should be moderate in carbohydrates, low
in saturated fat (less than 7% of total calories), with all of the essential vitamins and
minerals. Weight loss is recommended for all insulin-resistant/overweight or obese
patients with type 2 DM.
- Aerobic exercise can improve insulin sensitivity and glycemic control and may reduce
cardiovascular risk, contribute to weight control, and improve well-being. Physical
activity goals include at least 150 min/week of moderate (50%–70% maximal heart rate)
exercise spread over at least 3 days/week with no more than 2 days between activity.
Resistance/strength training is recommended at least 2 times/week for patients without
proliferative diabetic retinopathy.
- Ongoing diabetes education should emphasize self-care behaviors including healthy
eating, being active, monitoring blood glucose (BG) levels, taking medication, problem
solving for diabetes control, reducing risk of complications, and healthy coping with
stress. Patients must be involved in decision making and have strong knowledge of the
disease and associated complications.
- All patients receiving insulin should be instructed on how to recognize and treat
hypoglycemia. To minimize overtreatment and avoid rebound hyperglycemia, patients
should follow the “rule of 15.” If hypoglycemia occurs, the patient should consume 15 g
of simple carbohydrate (e.g., 8 oz [240 mL] orange juice or milk, 4 glucose tables, or 1
tube of glucose gel and then retest BG 15 minutes later. If BG is < 70 mg/dL (3.9 mmol/L),
the patient should repeat the rule of 15 until the BG normalizes.
- Islet cell and whole pancreas transplantation is occasionally used in patients who require
immunosuppression for other reasons (e.g., kidney transplants). Although many patients
are able to stop insulin or require minimal other therapy, at least 80% need to reinitiate
some form of insulin therapy within two years after transplantation.
- All patients with type 1 DM require insulin, but the type and manner of delivery differ
based on patient preference, lifestyle behaviors, clinician preference, and available
resources. Therapy should attempt to match carbohydrate intake with glucose-lowering
processes (usually insulin) and physical activity. The goal is to allow the patient to live as
normal a life as possible.
- The timing of insulin onset, peak, and duration of effect must match meal patterns and
exercise schedules to achieve near-normal blood glucose values throughout the day.

- The simplest regimen that can approximate physiologic insulin release uses “split-mixed”
insulin, consisting of twice-daily premixed doses of an intermediate-acting insulin (e.g.,
NPH) and regular insulin or a rapid-acting insulin analog (lispro, aspart, or glulisine) given
before the morning and evening meals. The morning intermediate-acting insulin provides
basal insulin during the day and provides “prandial” coverage for the midday meal. The
evening intermediate-acting insulin dose provides basal insulin throughout the evening
and overnight. Nocturnal hypoglycemia may occur with this regimen; moving the evening
NPH dose to bedtime may improve glycemic control and reduce the risk of nocturnal
hypoglycemia. Most patients are not sufficiently predictable in their schedule and food
intake to allow tight glucose control with this approach, but it may be useful in those who
are unable to implement more intense insulin regimens.
- Basal-bolus regimens using multiple daily injections (MDI) attempt to replicate normal
insulin physiology with a combination of intermediate (NPH) or long-acting insulin
(detemir, glargine, or degludec) as the basal component and a rapid-acting insulin
(regular insulin or the analogs lispro, aspart, or glulisine) to provide prandial coverage.
The patient determines the bolus insulin dose based on the preprandial glucose level,
anticipated carbohydrate intake from the meal, and anticipated activity in the next 3 to
4 hours. Carbohydrate counting is an effective tool for determining the amount of rapid-
acting insulin to be injected for each meal. In type 1 DM, the average daily insulin
requirement is 0.5 to 0.6 units/kg, with approximately 50% delivered as basal insulin and
the remaining 50% given as bolus insulin divided among meals (e.g., 20% before breakfast,
15% before lunch, and 15% before dinner). Requirements may fall to 0.1 to 0.4 units/kg
in the honeymoon phase. Higher doses are commonly needed during acute illness or
ketosis.
- Continuous subcutaneous insulin infusion (CSII) pump therapy using a basal infusion and
rapid acting insulin analog bolus doses (lispro, aspart, or glulisine) is more likely to
achieve excellent glycemic control than MDI. CSII can calculate recommended bolus
insulin doses based on carbohydrate intake. It can also be paired with continuous glucose
monitoring (CGM) to calculate a correction insulin dose and alert the patient to hypo-
and hyperglycemia. Patients must still verify that the calculated bolus dose and basal
infusion rates are appropriate. The basal insulin infusion rate can be varied throughout
the day based on changes in insulin requirements. These features of CSII enable more
precise insulin dosing and help patients achieve greater glycemic control. However, it
requires greater attention to detail and more frequent SMBG than basal-bolus MDI
regimens.
- Erratic gastric emptying can hinder the ability to match insulin with meals. The
amylinomimetic pramlintide may be appropriate in patients who continue to have erratic
postprandial control despite these strategies and proper insulin use. When taken prior
to each meal, it can modestly improve postprandial glucose control but is not a substitute
for bolus insulin and cannot be mixed with insulin. At initiation of therapy, each dose of

prandial insulin should be reduced by 30% to 50% to prevent hypoglycemia. Pramlintide
should be titrated based on GI adverse effects and postprandial glycemic goals.
- Symptomatic patients may initially require insulin or combination oral therapy. Patients
with A1C 7.5% (0.075, 58 mmol/mol Hb) or less are usually treated with an
antihyperglycemic that is unlikely to cause hypoglycemia. Those with A1C above 7.5%
but less than 8.5% (0.085, 69 mmol/mol Hb) could be treated initially with a single oral
agent or combination therapy. Patients with higher initial A1C values require two agents
or insulin.
- Obese patients without contraindications are often started on metformin, titrated to
2000 mg/day. Metformin also works in nonobese patients, but they are more likely to be
insulinopenic, necessitating drugs that increase insulin secretion. The durability of
metformin response is suboptimal, and patients often require additional therapy over
time.
- If the individualized target A1C is not reached with single-drug therapy, adding a second
drug to metformin is the next step:
o An insulin secretagogue (e.g., sulfonylurea) is often added second. They are
inexpensive but may cause weight gain and hypoglycemia. They also do not
produce a durable glycemic response.
o Dipeptidyl dipeptidase-4 (DPP-4) inhibitors, GLP-1 receptor agonists, and SLGT-2
inhibitors are better choices but they also have therapeutic and safety limitations.
o Thiazolidinediones (TZDs) produce a more durable glycemic response and are
unlikely to cause hypoglycemia, but weight gain, fluid retention, risk of new onset
heart failure, and other long-term safe concerns limit their use.
o Insulin may also be used with metformin.
- If the individualized A1C target is not reached after 3 months of dual-drug therapy, a third
drug may be added. Multiple variations are available, and the preferred combination
depends on patient- and disease-specific factors.
- If the A1C target is not achieved after about 3 months of triple therapy, further options
depend on what the patient is receiving:
o If on oral therapy, move to injectables;
o If on a GLP-1 receptor agonist, add basal insulin;
o If on optimally titrated basal insulin, add a GLP-1 receptor agonist or mealtime
insulin; in refractory patients, consider adding a TZD or SLGT-2 inhibitor.
- Nearly all patients ultimately become relatively insulinopenic and require insulin therapy.
Higher doses than those used for type 1 DM are required for patients with significant
insulin resistance.
- Patients often transition to insulin by using a bedtime injection of an intermediate- or
long-acting basal insulin while continuing oral agents or GLP-1 receptor agonists for

daytime control. This strategy is associated with equal efficacy with less weight gain and
lower risk of hypoglycemia than starting prandial insulin or split-mix twice-daily insulin.
Patients using basal insulin should be monitored for signs/symptoms of hypoglycemia
(e.g., nocturnal sweating, poor sleep, nightmares, palpitations, tremulousness) as well as
SMBG.
- If there is inadequate control with basal or bedtime insulin, giving a bolus insulin dose
prior to the largest meal of the day (“basal plus”) may be simpler than implementing MDI.
When prandial insulin is added to the evening meal, reducing the bedtime basal insulin
dose may be warranted. An alternative to starting prandial insulin is to add a GLP-1
receptor agonist.
- If a biphasic mixed insulin is used (e.g., 70/30 NPH/regular insulin), they should be given
twice daily before the first and third meal. If adequate control is not achieved, a third
dose of mix insulin may be given with the midday meal.
Drug treatment(2)
Class/drug Expected Effect on Hypoglycemia Comments

decrease in weight
HbA1c1,2
(mmol/mol)
1with monotherapy; also depends on other factors such as duration of diabetes, baseline HbA1c and previous
therapy
2 HbA1c(mmol/mol) = 10.93 x HbA1c (%) – 23.5
3 dipeptidyl peptidase-4 inhibitors
4 sodium-glucose co-transporter 2 inhibitors
5 glucagon-like peptide-1 analogues
Oral
metformin 10–20 nil (or - not with monotherapy - first-line drug treatment
decrease) - reduces diabetes-related
events and mortality in the
overweight
- GI adverse effects common

decrease in weight
HbA1c1,2
(mmol/mol)
sulfonylureas 10–20 Increase - Common - often added to metformin

(glibenclamide, - risk increased in elderly if glycemic control
gliclazide, glimepiride, or renal or hepatic inadequate on metformin
glipizide) impairment alone
- least likely with
gliclazide or glipizide
DPP-4 inhibitors3 5–10 nil - not with monotherapy - long-term safety and
(alogliptin, linagliptin, - may increase risk of efficacy data are limited
saxagliptin, sitagliptin, hypoglycemia with a
vildagliptin) sulfonylurea
thiazolidinediones 5–15 increase - not with monotherapy - reserve for patients unable
(pioglitazone, to take other antidiabetics
rosiglitazone) - ineffective in up to 30% of
patients
- adverse effects include
edema, heart failure,
increased fracture risk
- rosiglitazone may increase
risk of ischemic
cardiovascular events
acarbose 5–10 nil - not with monotherapy - poorly tolerated due to GI

effects
- reduces postprandial
hyperglycemia
- limited role
SGLT2 inhibitors4 5–10 decrease - low risk with - efficacy depends on

(dapagliflozin, monotherapy adequate renal function
empagliflozin) - may increase risk of - increase urinary glucose;
hypoglycemia with a adverse effects include
sulfonylurea or insulin vaginal candidiasis and UTI
- long-term safety and
efficacy data are lacking

decrease in weight
HbA1c1,2
(mmol/mol)
Parenteral
insulin 15–40 increase - common - greater risk of

hypoglycemia and weight
gain than sulfonylureas
GLP-1 analogues5 5–15 decrease - rare with monotherapy - GI adverse effects very
(exenatide, liraglutide) - increase risk of common (usually transient)
hypoglycemia with a - long-term safety and
sulfonylurea or insulin efficacy data are limited

Oral anti-diabetic agents
Formulation and Dosage(18)
Drug Class Drugs Formulation Minimum Dose Maximum Dose
Alpha-glucosidase Acarbose 50mg / 100mg Initial dose: 50mg OD 100mg TDS

inhibitors
Usual dose: 50-100mg
during main meals
Biguanides Metformin 500mg Initial dose: 500mg OD 1000mg TDS

Usual dose: 1500mg OD
Metformin SR 850mg Usual dose: 850mg BD 850mg TDS
Metformin XR 500mg / 750mg Initial dose: 500mg OD 2000mg OD

Usual dose: 2000mg OD
Dipeptidyl Sitagliptin 25mg / 50mg / 25mg OD 100mg OD

Peptidase-4 (DDP- 100mg
4) Inhibitors
Vildagliptin 50mg 25mg BD 50mg BD
Saxagliptin 2.5mg / 5mg 2.5mg OD 5mg OD
Linagliptin 5mg 5mg OD 5mg OD
Alogliptin 6.25mg / 12.5mg 6.25mg OD 25mg OD

/ 25mg
Meglitinides Repaglinide 0.5mg / 1mg / 0.5mg with main meals 4mg with main meals
2mg (not exceeding 16mg
daily)
Nateglinide 120mg 60mg with main meals 120mg with main

meals (not exceeding
360mg daily)
Sodium-glucose Dapagliflozin 5mg / 10mg 5mg OD 10mg OD

cotransporter 2
Canagliflozin 100mg / 300mg 100mg OD 300mg OD
inhibitor
Empagliflozin 10mg / 25mg 10mg OD 25mg OD
Sulphonylureas Glibenclamide 5mg 2.5mg OD 10mg BD
Gliclazide 80mg 40mg OM 160mg BD

Drug Class Drugs Formulation Minimum Dose Maximum Dose
Gliclazide MR 60mg 30mg OM 120mg OM
Glipizide 5mg 2.5mg OM 10mg BD
Glimepiride 2mg / 3mg 1mg OM 6mg OM
Thiazolidinediones Rosiglitazone 4mg / 8mg 4mg OD 8mg OD
Pioglitazone 15mg / 30mg 15mg OD 45mg OD

Insulin
Sources of insulin
The insulin currently used in Malaysia is recombinant human insulin, either directly derived from
the native human insulin, i.e. regular human insulin or structurally modified, i.e. insulin analogue.
Both types of insulin are further divided into prandial, basal and premixed insulin according to
their pharmacokinetic profiles.(19)
Insulin type Conventional Analogue
Prandial Short-acting regular human insulin Rapid-acting

- Actrapid® - Novorapid® (Aspart)
- Humulin R® - Humalog® (Lispro)
- Apidra® (Glulisine)
Basal Intermediate-acting or Neutral Long-acting

Protaminated Hagedorn (NPH) insulin
- Lantus® (Glargine)
- Insulatard® - Levemir® (Detemir)
- Humulin N®
Premixed Combination of short & intermediate- Combination of rapid-acting &

acting: 30% regular insulin + 70% NPH protaminated analogue
- Mixtard® 30 - NovoMix® 30 (30% aspart +
- Humulin® 30/70 70% aspart protamine)
- HumalogMix® 25 (25% lispro +
75% lispro protamine)
Brand (Generic) Name Onset Peak (Hr) Duration Timing of

(Hr) insulin
Short-acting, regular 30 mins

before meal
- Actrapid® 30 min 1-3 8
- Humulin®
30 min 2-4 6-8

Brand (Generic) Name Onset Peak (Hr) Duration Timing of
(Hr) insulin
Rapid-acting analogue 5-15 mins

before or
- Novorapid® (Aspart) 10-20 min 1-3 3-5
immediately
- Humalog® (Lispro)
0-15 min 1 3.5-4.5 after meals
- Apidra® (Glulisine)
5-15 min 1-2 3-5
Intermediate-acting, NPH Pre-

breakfast/
- Insulatard® 1.5 Hr 4-12 18-23
pre-bed
- Humulin N®
1 Hr 4-10 16-18
Long-acting analogue Same time

every day at
- Glargine® 2-4 Hr Peakless 20-24
any time of
- Detemir®
1 Hr Peakless 17-23 the day
Premixed human (30% regular insulin + 30-60 mins

70% NPH) before meals
- Mixtard® 30
30 min Dual 18-23
- Humulin® 30/70
30 min Dual 16-18
Premixed analogue 5-15 mins

before meals
- NovoMix® 30 (30% aspart + 70% 10-20 min Dual 18-23
aspart protamine)
- Humalog Mix® 25 (25% lispro +
75% lispro protamine) 0-15 min Dual 16-18
Insulin regimens
An ideal insulin regimen should mimic the physiological insulin response to meals and
endogenous hepatic glucose production. The choice of insulin regimen should be individualized,
based on the patient’s glycemic profile, dietary pattern, personal lifestyle as well as desired
flexibility. Apart from insulin pump therapy, basal bolus therapy using the combination of long-
acting basal and rapid-acting analogue offers the regimen that most closely mimics the
endogenous insulin action at the expense of increased number of injections.(19)

No. of Insulin regimen Type of insulin and timing
injections
per day
1 Basal Intermediate acting (NPH) insulin pre-bed
Basal Long-acting analogue once daily
Premixed OD Premixed/premixed analogue pre-dinner
2 Basal Intermediate acting (NPH) pre-breakfast and pre-dinner
Premixed BD Premixed insulin pre-breakfast and pre-dinner
Basal-plus (1) Basal insulin once daily + 1 prandial insulin
3 Basal-plus (2) Basal insulin once daily + 2 prandial insulin
Prandial Prandial insulin pre-breakfast, pre-lunch and pre-dinner
Premixed TDS Premixed analogue pre-breakfast, pre-lunch and pre-dinner
Premixed-plus Premixed insulin pre-breakfast, pre-dinner + 1 prandial insulin

pre-lunch
Premixed-plus Prandial insulin pre-breakfast and pre-lunch + premixed insulin

pre-dinner
4 Basal-bolus Basal insulin once daily + prandial insulin pre-breakfast, pre-

lunch and pre-dinner
5 Basal-bolus Intermediate acting (NPH) insulin pre-breakfast and pre-dinner

+ prandial insulin pre-breakfast, pre-lunch and pre-dinner
Algorithm of insulin, optimization and intensification(19, 20)

- Metformin should be continued while on insulin therapy unless contraindicated or
intolerant.
- Sulphonylureas/meglitinides should be withdrawn once prandial insulin is used regularly
with meals.
- Insulin dose should be optimized prior to switching/intensifying regimens.

Administration of insulin(10)
Insulin is inactivated by gastrointestinal enzymes and must therefore be given by injection; the
subcutaneous route is ideal in most circumstances. Insulin should be injected into a body area
with plenty of subcutaneous fat – usually the abdomen (fastest absorption rate) or outer
thighs/buttocks (slower absorption compared with the abdomen or inner thighs).
Absorption from a limb site can vary considerably (by as much as 20-40 %) day-to-day, particularly
in children. Local tissue reactions, changes in insulin sensitivity, injection site, blood flow, depth

of injection, and the amount of insulin injected can all affect the rate of absorption. Increased
blood flow around the injection site due to exercise can also increase insulin absorption.
Lipohypertrophy can occur due to repeatedly injecting into the same small area, and can cause
erratic absorption of insulin, and contribute to poor glycemic control. Patients should be advised
not to use affected areas for further injection until the skin has recovered. Lipohypertrophy can
be minimized by using different injection sites in rotation. Injection sites should be checked for
signs of infection, swelling, bruising, and lipohypertrophy before administration.
- Drinking alcohol decreases your blood glucose. It can also mask warning symptoms of
hypoglycemia (low blood glucose). Avoid binge drinking and have something to eat when
you drink alcohol.
- Make sure that you, and your friends and family, know how to recognize and treat
hypoglycemia; ask your doctor or diabetes educator if you are unsure.
- Insulin is injected under the skin (subcutaneous injection) usually in the abdomen, or less
commonly in the thigh, upper arm or buttock. Pinch the skin to reduce the chance of
injecting into a blood vessel. Rotate injection sites in the same general area to prevent
damage to the fat and tissues under the skin (called lipodystrophy).
- Use short-acting insulin 30 minutes before meals. Use ultra-short-acting insulin
immediately before or soon after meals when necessary.
- Before using insulin, allow it to stand at room temperature for about 30 minutes (cold
insulin may be more painful to inject).
- Gently rotate vials and cartridges of cloudy insulin in hands before use to ensure it is
evenly mixed (it should look white and uniformly cloudy).
- When mixing insulins, draw up short-acting insulin into the syringe first to avoid
contaminating the vial with long-acting insulin. Do not mix insulin detemir or insulin
glargine with other insulins.

Pen needles
The needle lengths available in Malaysia are 4, 5, 6 and 8mm with different gauge.(20)
- Shorter needles (4, 5, 6mm) provide equal efficacy and safety when compared with the
longer needle (8mm), even in obese individuals.
- 4, 5 and 6mm needles are suitable for all people with diabetes regardless of body mass
index.
- Injections with shorter length needles (4, 5, 6mm) should be administered in adults at 90°
to the skin surface. The safest pen needle for all individuals with diabetes is 4mm in
length.
- For extremely thin adults with diabetes (BMI <19), the proper injection technique is to
use the 4mm needle accompanied with lifting of skin fold when injecting to avoid the
intramuscular injection.
- Shorter and finer-gauge needles help to reduce pain. The 5-bevel needle tip has less
penetration force in a skin hence provides more comfort and easier to insert.
- 8mm needles should be discouraged to prevent the risk of intramuscular injection.
Pediatric considerations(20)
- Many children and adolescents are emaciated at the time of diagnosis. Furthermore, lean
and slim children especially teenage boys have minimal subcutaneous fat tissues.
- All these factors are very challenging in ensuring that the appropriate insulin injection
and correct dose are administered. Proper injection techniques are key to achieve
optimal blood glucose control.
- HCPs should perform an individualized assessment to determine the amount of
subcutaneous fat thickness at each injection site. This will guide the choice of needle
length and administration technique.
- Insulin pens are the injection device of choice as they fit shorter needle lengths (4, 5 or 6
mm); 4 mm needles are the safest needle length currently available. A 4 mm needle can
be inserted at a 90° angle without a skin fold in most children above 6 years old and
adolescents. However, children aged 2 to 6 years may need a skin lift to avoid an
intramuscular injection with the 4 mm needle.
- If the children are lean, a 5 or 6 mm needle may require a 45° angle for injection with a
skin lift.
Pen needles and syringes should only be used once. There is a probable association between
reused needle and the presence of lipohypertrophy, although a direct causal relationship has not
been proven. Reused needles and syringes may cause pain, bleeding and bruising at injection
sites. (20)
- Reused needles may cause the insulin in the barrel to crystalize and block its flow during
the next injection.

- Reusing pen needles and syringes is not an optimal injection practice. People with
diabetes should be discouraged from doing so.
- Needle should be disposed immediately after use. It should not be left attached to the
pen. This allows the entry of air and other contaminants into the cartridge or leakage of
insulin from the cartridge, which can affect subsequent dose accuracy.
Angle of injection
The angle of insertion of the needle used for injection should be determined according to the
needle length, injection site and anticipated thickness of SC tissue, and use of a skinfold lift.
Needles 8mm or longer should usually be inserted at 45 degrees with a skinfold to reduce the
risk of IM injection. Shorter needles can usually be injected at 90 degrees in adults, however for
children, slim adults and when injecting into the arms or thigh, a 45 degrees angle and/ or lifted
skinfold may be required to avoid IM injections with 5mm and 6mm needles. A 4mm needle can
be injected at 90 degrees in most cases.(21)
Use of lifted skin fold

The purpose of using a lifted skin fold is to reduce the risk of IM injection by increasing the space
between the skin and muscle fascia. The decision to use a lifted skin fold should be assessed
individually, taking into account the likely composition of skin and subcutis relative to needle
length, injection site, age, size and body composition. Some individuals (particularly young
children and lean adults) may require a lifted skinfold for all injection sites and needle lengths,
while for others this will only be needed at injection sites with less SC tissue (e.g. thighs and arms)
and with longer (≥ 6mm) needle lengths.(21)
A guide to needle length(21)

Injection sites
For consistent absorption, insulin and non-insulin injectable agents should be injected into the
subcutaneous layer in the abdomen, buttocks and thighs if self-administered, or arms and
buttocks if given by caregivers. For ease of self-injection, the abdomen and thighs are the two
main recommended injections sties for adults.(20)
Rotation of injection sites(20)

- Individuals with diabetes should be educated on the importance of injection site rotation
to prevent lipohypertrophy and ensure the consistency of insulin absorption.
- The pattern of site rotation that has been shown to be effective involves dividing the
injection site into quadrants (or halves when using thighs and buttocks). Use one
quadrant per week and rotate in a consistent direction (e.g. clockwise).
- Injection sites rotation within any quadrant or half should be done systematically with
spacing of at least 1 cm apart from each injection in order to prevent repeat tissue trauma.
Insulin Absorption
Optimal absorption of insulin depends on injection into subcutaneous tissue. Absorption rate can
be affected by various factors such as type of insulin, insulin storage, skin temperature, site of
injection and exercising.(20)
- Type of insulin

Insulin type affects the rate of absorption from the injection site. Rapid and short-acting
insulin are absorbed faster than intermediate- and long-acting insulin.
- Site of insulin injection
Insulin absorption is fastest and most consistent when injected on the abdomen,
followed by moderate absorption rate in the upper arm and lateral thigh. The slowest
rate of absorption is at the buttock area. However, insulin absorption also differs based
on the type of insulin.
Prandial insulin Basal insulin Premixed insulin
Short-acting, regular: Intermediate-acting, NPH: Human or analogue, morning dose:

Abdomen preferred due Thigh and buttocks preferred Abdomen preferred to increase
to fastest absorption due to slowest absorption speed of absorption to cover post-
rate. rate. breakfast glycemic excursion.
Rapid analogue: May be Long-acting analogue: May Human or analogue, evening dose:
given at any of the be given at any of the Preferred in the thigh or buttock for
recommended sites of recommended sites of slower absorption and to lower the
injection; absorption injection; absorption rates do risk of nocturnal hypoglycemia for
rates do not appear to not appear to be site specific. high-risk individuals.
be site specific.
- Others Factors:
o Rotation of injection sites within the selected area is crucial to ensure optimal and
consistent insulin absorption.
o Intramuscular injection may accelerate the absorption rate of insulin.
o Massaging the site before or after injection may speed up the absorption. Hence,
it is not recommended.
o Higher skin temperature (e.g. sauna or hot bath) may increase the absorption rate
of insulin.
o Injecting into an exercising limb may increase the absorption of insulin which may
fasten blood glucose-lowering effect.

Insulin storage and disposal
Injection storage(20)
- All injectable medications have expiry dates printed on them. The expiry date indicates the
date before which the unopened vial, pen or cartridge should be used.
- Unopened injectable medications should be stored at refrigeration temperature (between 2-
8°C. Check the manufacturer’s storage instructions as there may be possible differences from
one manufacturer to the other).
- Store the new (unopened) insulin cartridge in the fridge, not at the door side of fridge. Do not
put inside the freezer.(11)
- Once insulin is opened, it should not be used for more than 28 days, except for insulin detemir
(Levemir), insulin glargine 300 IU/ml (Toujeo), insulin regular (Actrapid, Insugen-R), insulin
NPH (Insulatard, Insugen-N), and insulin NPH and insulin regular (Mixtard, Insugen 30/70),
which may be used for up to 42 days when stored below 30°C (Follow the manufacturer’s
recommendation).(9)
- Do not store non-prefilled insulin pen in the fridge. DO not remove insulin cartridge from the
insulin pen while in use.
- Write the opening date on the injectable medications to keep track of the date.
- In-use insulin pen can be stored at room temperature of <30°C. However, if the room
temperature is >30°C, in-use insulin pen should be stored in the refrigerator. It should be
taken out and kept at room temperature for at least 30 minutes before use.
- Insulin or non-insulin injectable medications should never be frozen or exposed to extreme
heat (>30°C) for prolonged periods; this will affect its potency and action. Avoid extreme
temperatures such as direct sunlight, kitchen, closed cars, top of a radiator or a television.
- Keep the caps on insulin pens to protect the insulin from light.
- Never leave the pen needle attached to the injectable pen as varying temperatures may cause
leakage from the pen or possible air entry into pen hence affecting dosage delivery.
- Injectable medications should never be used after the product expiry date.
- Injectable medications should be kept out of reach of children.
Disposal of injection material/sharps(20)

- All healthcare professionals, individuals with diabetes and caregivers should be aware of
proper disposal of sharps and the consequences of inappropriate disposal (e.g. needle
stick injury).
- Proper disposal technique should be demonstrated at initiation of injection therapy and
reinforced at subsequent visits.
- Needle recapping should not be done for insulin syringes.
- To discard pen needles, recap the outer needle cap using the scoop technique as shown
in picture above, followed by careful removal of the pen needle and disposal into a sharp
bin or a puncture proof container (for home user).
- Sharp materials should never be disposed into public trash bins.
- Use a sharp container or a puncture proof/metal container with lid to store used pen
needles. Seal the container properly and label as “SHARP” before disposal. Keep the
container out of the reach of children.
- Empty pen devices can be disposed in normal household refuse after the needle is
removed.

Special considerations in injectable therapy
People with diabetes who are on injectable medications may experience some important issues
that may affect the medication absorption and also their daily function. HCPs should educate all
people with diabetes who are prescribed with insulin treatment on the symptoms and early
management of hypoglycemia. Other injection issues such as pain, bruising, bleeding and
lipodystrophy need to be explored and assessed.(20)
Hypoglycemia
Hypoglycemia is defined by either one of the following two conditions:(20)
- Low plasma glucose level (<4.0 mmol/L)
- Development of autonomic or neuroglycopenic symptoms in people with diabetes
treated with insulin or oral antidiabetic agents which are reversed by caloric intake.
Autonomic Neuroglycopenic
- Trembling - Difficulty concentrating

- Palpitation - Confusion
- Sweating - Weakness
- Anxiety - Drowsiness
- Hunger - Vision changes
- Nausea - Difficulty speaking
- Tingling - Headache
- Dizziness
It may happen if the patient did not take a meal after injection or he/she has a sudden change in
diet, alcohol consumption, excessive physical activity, excessive dose, ill-timing or wrong type of
insulin. If sign and symptoms such as shivering, palpitation, sweating, dizziness, hungry,
paresthesia appear, advise patient to take sugary drinks (i.e. 2 teaspoons of sugar in ½ glass of
water), orange juice or other fruit juices or sweets.(11)
Bleeding and bruising

Local bruising, bleeding or pain will occasionally occur at the injection site. This does not appear
to be associated with specific needle length or site but more likely to be affected by injection
technique. People with diabetes should be reassured that local bleeding and bruising do not have
adverse clinical consequences on the absorption of insulin or overall diabetes management.
People with diabetes on anticoagulant therapy may experience bruises after insulin injection and
are advised to apply direct pressure to the injection site once the needle is removed.(20)

Painful Injection
Tips for making injections less painful:(20)
- Keeping injectable therapy that is in use at room temperature.
- Using needles of shorter length and smaller diameter.
- Using a new needle at each injection.
- Insert the needle in a quick smooth movement into the skin.
- Inject slowly and ensure that the plunger (syringe) or thumb button (pen) has been fully
depressed.
- Remove at same angle and keep hand steady.
- If bruising occurs repeatedly, revising the injection technique with the person with
diabetes (or the caregivers) is recommended.
- Sites with bleeding and bruising should be avoided until fully recovered.
- Reassure the person with diabetes that bleeding and bruising do not have adverse effects
on the absorption of insulin or overall diabetes management.
- To prevent bleeding and bruising, avoid injecting into visible blood vessels and hair roots.
Hypersensitivity Reaction
Localized skin reaction such as rash or itch around the injection area may indicate that the person
with diabetes is allergic to a certain type of insulin. Filling up an adverse drug reaction form will
help the pharmacist to investigate further to determine the probability of the allergic reaction.
People with diabetes who develop hypersensitivity reaction may be admitted to the hospital and
restarted on insulin at a lower dose before gradually increasing the dose (desensitization).(20)
Lipohypertrophy
Lipohypertrophy is the most common lipodystrophy found at injection sites. Lipohypertrophic
areas may be visible or palpable, and identified as thickened or rubbery lesions that may feel
hard when palpated with the finger tip. Lipohypertrophy is formed when injections of insulin or
other injectable therapy are repeatedly given in the same localized area. Microtrauma caused by
the injection, combined with the effect of insulin on the repairing cells, causes fatty lumps to
build up at the trauma site, causing lipo formation over time. This can be exacerbated if needles
are reused.(20)
Prevention: Teach people with diabetes to rotate injections sites using the zone system and to
never reuse needles.(20)

Effects of lipohypertrophy(20)
- Insulin is a growth factor and plays a role in the development of lipohypertrophy.
Injecting or infusing medication into a lipohypertrophic site may decrease or cause
variability in the rate of insulin absorption resulting in variable glycemic response and the
development of disfiguring anatomical lesions.
- Some people with diabetes may repeatedly choose lipohypertrophic sites for injections
or infusions, as these areas have limited nerve innervations and thereby render the
injections to be relatively painless.
- Majority of lipohypertrophy in people with diabetes are due to a lack in injection site
rotation.
- Higher HbA1c levels have been reported in people with diabetes who administer
injections into lipohypertrophic sites. Pen devices and syringes (all needle lengths and
gauges) and insulin pump cannulae have all been reported to be associated with
lipohypertrophy.
- Switching injections from lipohypertrophic to normal tissues often requires a decrease in
the dose of insulin injected. The amount of insulin reduction varies from one individual
to another and should be guided by frequent blood glucose measurements. Reduction
often exceeds 20% of their original dose.

Foot care for people with diabetes
Over time, diabetes can lead to various complications, many of which can be serious if they are
not identified and addressed promptly. Foot problems are a common complication in people with
diabetes.(3)
Foot examinations
Regular foot exams to check for problems or changes are a critical part of managing your
diabetes.(3)
Self-exams
It is important to examine your feet every day. This should include looking carefully at all parts of
your feet, especially the area between the toes. Look for broken skin, ulcers, blisters, areas of
increased warmth or redness, or changes in callus formation; let your health care provider know
if you notice if any of these changes or have any concerns. It may help to make the foot exam a
part of your daily bathing or dressing routine. You might need to use a mirror to see the bottoms
of your feet clearly. If you are unable to reach your feet or see them completely, even with a
mirror, ask another person (such as a spouse or other family member) to help you.(3)
Clinical exams
During your routine medical visits, your health care provider will check the blood flow and
sensation in your feet. The frequency of these clinical exams will depend on which type of
diabetes you have.(3)
- In people with type 1 diabetes, annual foot exams should begin five years after diagnosis.
- In people with type 2 diabetes, annual foot exams should begin at the time of diagnosis.
During a foot exam, your health care provider will check for poor circulation, nerve damage, skin
changes, and deformities. They will also ask you about any problems you have noticed in your
feet. An exam can check for decreased or absent reflexes or decreased ability to sense pressure,
vibration, pin pricks, and changes in temperature.(3)
Special devices, including a monofilament or tuning fork, can help determine the extent of nerve
damage. A monofilament is a very thin, flexible thread that is used to determine if you are able
to sense pressure in different parts of the foot. A tuning fork is used to determine you can sense
vibration in different areas, especially the foot and toe joints.(3)
Preventing foot problems in diabetes

There are several things you can do to reduce your chances of developing foot problems. In
addition to managing your blood sugar, practicing good foot care habits and checking your feet
daily are important for preventing complications.(3)
Quit smoking — Smoking can worsen heart and vascular problems and reduce circulation to the
feet. If you smoke, quitting is one of the most important things you can do to improve your health
and reduce your risk of complications.(3)
Avoid activities that can injure the feet — Certain activities increase the risk of foot injury or
burns and are not recommended. These include walking barefoot (since you could step on
something without realizing it), using a heating pad or hot water bottle on your feet, and stepping
into a hot bath before testing the temperature.(3)
Use care when trimming the nails — Trim your toenails straight across, and avoid cutting them
down the sides or too short. You can use a nail file to remove any sharp edges to prevent the
toenail from digging into your skin. Never cut your cuticles or allow anyone else (e.g., a
manicurist) to do so. See a foot care provider (such as a podiatrist) if you need treatment of an
ingrown toenail or callus.(3)
Wash and check your feet daily — Use lukewarm water and mild soap to clean your feet.
Thoroughly dry your feet, paying special attention to the spaces between the toes, by gently
patting them with a clean, absorbent towel. Apply a moisturizing cream or lotion.(3)
Check the entire surface of both feet for skin breaks, blisters, swelling, or redness, including
between and underneath the toes where damage may not be easily visible. Do not pop blisters
or otherwise break the skin on your feet. Let your health care provider know right away if you
notice any changes or problems.(3)
Choose socks and shoes carefully — Wear cotton socks that fit loosely, and be sure to change
your socks every day. Select shoes that are snug but not tight, with a wide toe box, and break
new shoes in gradually to prevent any blisters. It may be helpful to rotate several different pairs
of comfortable, well-fitting shoes to avoid consistent pressure on one part of your foot. If you
have foot deformities or ulcers, ask your provider about customized shoes; this can reduce your
chances of developing foot ulcers in the future. Shoe inserts may also help cushion your step and
decrease pressure on the soles of your feet.(3)

Gestational diabetes mellitus
Pregnant women are screened for diabetes at 24 to 28 weeks of gestation and an increasing
number will be diagnosed with gestational diabetes mellitus (GDM), concomitant with the
obesity epidemic.(3)
Complications of pregnancy are more common in GDM include:(3)
- Large for gestational age (LGA) infant and macrosomia
- Preeclampsia
- Polyhydramnios
- Stillbirth
- Neonatal morbidity including hypoglycemia, hyperbilirubinemia, hypocalcemia,
hypomagnesemia, polycythemia, respiratory distress and/or cardiomyopathy.
Risks associated with GDM extend beyond the pregnancy and neonatal period. GDM may affect
the offspring's risk of developing obesity, impaired glucose tolerance, or metabolic syndrome.
GDM is also a strong marker for maternal development of type 2 diabetes, including diabetes-
related vascular disease.(3)
Insulins
Insulin requirement will change as the pregnancy advances. There will be insulin dose
adjustments to achieve the blood glucose target recommended in pregnancy. The abdomen is a
safe site for insulin administration in pregnancy. The thigh may be used as an alternative area. It
is important to reassure pregnant women that there is no indication to change the insulin
injection site or technique in the first trimester of pregnancy.(20)
The lateral sides of the abdomen are the recommended zones for injections when the skin is taut
over the central abdomen during the second and third trimesters while ensuring that the skin
fold is properly raised. The use of skin fold and shorter needles (4 mm, 5 mm) decreases the
potential for intramuscular injection due to the thinning in abdominal fat from uterine expansion.
Avoid injections within 2–3 cm around the umbilicus or areas of the abdomen with taut skin.(20)

Oral antidiabetic agents
Metformin and glibenclamide are OAD that have been used in GDM. Glibenclamide has limited
human data and should only be used if potential benefit outweighs the potential risk. Metformin
is labelled as FDA pregnancy category B while glibenclamide is in category C.(22)
A meta-analysis showed that compared with glibenclamide, metformin had significantly lower
maternal weight gain, neonatal birth weight, macrosomia and LGA. However, there was no
significant difference in glycemic control (FPG and postprandial plasma glucose), caesarean
section, preterm birth, stillbirth and neonatal hypoglycemia.(22)
In four meta-analyses on GDM, there was no significant difference in glycemic control between
OAD and insulin. Compared with insulin, metformin was associated with less maternal weight
gain but higher incidence of premature birth (<37 weeks gestation).(22)
Two of the above meta-analyses compared glibenclamide and insulin. Glibenclamide was
associated with less maternal hypoglycemia but higher maternal weight gain. For neonatal
outcomes, it was associated with higher incidence of macrosomia, neonatal birth weight and
neonatal hypoglycemia.(22)
NICE guidelines state that metformin should be offered to women with GDM if diet and exercise
do not control the blood glucose adequately within 1-2 weeks.(22)

Normal syringe
Insulin syringes are available by prescription in 3 sizes, 0.3ml, 0.5ml and 1ml. Choose a syringe
size based on the dose (units) of insulin you require. It is easier and more accurate to measure
smaller doses with a smaller volume syringe.(23)
A 6mm and 8mm needle is recommended over a 12.7mm needle due to a higher risk of
intramuscular injection.(20)
Before injecting, the insulin vial should be taken out from the refrigerator 30 minutes prior to
injection to ensure that the insulin is at room temperature.(20)
Steps for injecting insulin using syringe and vial(11, 20, 23)
Wash your hands before handling syringe and vial.

Warm the insulin by rolling the insulin vial between your hands.
When injecting cloudy insulin (e.g. NPH and premixed insulin), the vial
needs to be gently rolled 10 times and inverted 10 times until it
becomes evenly milky white.
Do not shake the vial.
Wipe the top of the insulin bottle/vial with an alcohol swab.
Remove the cap from the plunger and the shield from the needle.
Pull the plunger back to draw air into the syringe equal to the dose of
insulin to be injected.
Insert the needle through the rubber stopper of the insulin vial at a 90°
angle.
Press down the plunger to inject the air into the vial.

Turn the vial upside down.
Pull the plunger back to draw the desired dose into the syringe. Make
sure that the point of the needle inside the vial is well beneath the
surface of the insulin. Slowly pull the plunger, drawing the correct
amount of insulin, plus a little extra, into the syringe.
To remove air bubbles (if present) in the syringe, draw up several more
units of insulin, tap the barrel to move them to the top then expel them
by pushing the plunger.
Note: Although air bubbles are not dangerous if injected, they may
affect the accuracy of your insulin dose. If air bubbles remain, inject all
of the insulin back into the vial and start again.
Remove the needle straight out of the vial.
Site of administration
- Abdomen (inject at any place 3 fingers width away from the
navel).
- Arms (inject between 4 fingers width away from the shoulder
and 4 fingers width away from the elbow). Not advisable to
inject in the arm if the insulin is to be self-administered.
- Thigh (inject between fingers width away from the knee and 5
fingers width away from groin).
- Rotate the injection site between 2 fingers width away from
previous site of injection.
- Advise to rotate injection sites within the same part of the body,
not to change the injection part of body too frequent due to
different absorption of insulin at different parts of the body.
Clean the site of injection with an alcohol swab. Wait till alcohol has
completely dry before injecting.
Gently pinch up the skin using your thumb and index finger.

Inject the insulin at 45° angle for needle length ≥8mm.
Depress the plunger in completely and hold the needles for 10 seconds.
Remove the syringe quickly and then release the pinch.
If a slight bleeding occurs after injection, gently press the injection site
with alcohol swab.
Dispose the syringe according to local regulation.

Syringe should only be used once.

Novopen 4

Differences between Novopen 3 and Novopen 4
Differences between Novopen 3 and Novopen 4(9)
Novopen 3 Novopen 4
Can deliver from 2 to 70 units of insulin, in 1- Can deliver insulin doses from 1 to 60 units, in
unit increment. increments of 1 unit.
If the piston rod is sticking out: turn the end of Can push in the piston rod, by gently pressing
the reset mechanism in a clockwise direction the piston head in until it stops.
until it is no longer sticking out. Never push
the piston rod back in.
If you use Novolin 70/30 or Novolin N insulin, Before you inject your insulin suspension
use the windows to check if there is enough (white and cloudy insulin), make sure there is
insulin left for proper mixing. at least 12 units of insulin left in the cartridge,
this helps to make sure the remaining insulin
Check the amount of insulin:
is evenly mixed. If there is less than 12 units
If the rear rubber stopper cannot be seen in left in the cartridge, use a new 3mL PenFill
the inspection window, you have enough cartridge.
insulin for mixing left in the cartridge.
- If the rear rubber stopper cannot be
If the rear rubber stopper can be seen in the seen in the cartridge window, you
inspection window, you do not have enough have enough insulin for mixing left in
insulin left in the cartridge and must insert a the PenFill cartridge.
new PenFill 3ml cartridge. - If the rear rubber stopper can be seen
in the cartridge holder window, you do
not have enough insulin left in the
PenFill cartridge and must use a new
PenFill 3mL cartridge.

Novopen 3 Novopen 4
To remix the suspension insulin, turn the When using cloudy insulin in your Novopen 4,
Penfill cartridge or Novopen 3 up and down
Roll the pen between your palms times – it is
between positions A and B. Repeat this mixing
important that the pen is kept horizontal.
step at least 10 times or until the insulin looks
uniformly white and cloudy.
Move the pen up and down 10 times between

the 2 positions as shown (this should move
the glass ball inside the cartridge from one
end to the other).
Continue rolling and moving until the liquid

appears white and cloudy (resuspended)
To do the air shot, you turn the dial-a-dose to To do the air shot, turn the dose button to
2 units. select:
- 4 units with a new PenFill cartridge.
- 1 unit with a cartridge already in use

Novopen 3 Novopen 4
If you dial more than 2 units, DO NOT turn the If you select a different dose that you need,
dial back to zero (0). If you do, the extra insulin turn the dose button until the correct dose
will squirt out of the needle. You may lines up with the dose indicator.
complete the air shot with the number of
units you have dialed or to reset to zero.
To reset to zero:
- Grasp the cartridge holder with your
thumb and forefinger.
- Grasp the barrel between your thumb
and middle finger.
- Pull the cartridge holder down from
the barrel as far as It will go (arrow #1)
- Press the push button down with your
index finger to reset the dose to zero
(0) (arrow #2).
- Check the dose indicator to make sure
you have reset it all the way to zero (0).
- If you have not, repeat steps above.
When you get near the end of a PenFill The cartridge scale on the PenFill cartridge
cartridge, you may need to give yourself two holder shows the approximate number of
injections to receive your full dose. If, after insulin units left in the PenFill cartridge. Do
giving an injection, zero does not appear in not use the cartridge scale to measure the
the dose indicator window, you did not amount of insulin to be injected.
receive your full dose. The dose indicator
If the PenFill cartridge has less than 60 units in
window shows the number of units that you
it, the exact number of units left can be read
did not receive.
in the display. To do this, pull out the dose
button, if it is not already pulled out, and turn

Novopen 3 Novopen 4
it until it stops. The number of units left will

line up with the dose indicator.
If the dose indicator is positioned between
two lines, adjust to the lower of the two dose
amounts. You cannot select a dose larger than
the number of units let in the PenFill cartridge.
Do not force the dose button to turn as this
can damage your Novopen 4.
Dose button cannot be locked Dose button can be locked.
The mean injection force required to operate Novopen 4 was reduced to 50% compared to
Novopen 3, and the mean dosage display for Novopen 4 was over four times larger than for
Novopen 3. Based on these findings, patients with diabetes who have manual or visual
impairment should find it easier to dose insulin with Novopen 4.(24)

Novopen 5

Allstar pen
Before you start

AllStar is a reusable pen for the injection of insulin.
Read these instructions and follow them completely each time you use AllStar to ensure that you
inject the correct dose.
- If you do not follow these instructions completely, you may get too much or too little
insulin, which may affect your blood glucose levels.
- If you are not able to follow all the instructions on your own, only use AllStar if you have
help from a person who is able to follow the instructions completely.
- Please retain these instructions for future reference.
Cold insulin is more painful to inject. If your insulin cartridge is in cool storage (for example
refrigerator) take it out 1 to 2 hours before you inject.
AllStar can only be used with Sanofi 3ml (300 units) insulin cartridges (100 units per ml).
- You can set doses from 1 to 80 units in steps of 1 unit.
- The insulin cartridge can be used for multiple injections until it is empty, reaches its expiry
date, or 28 days have passed after its first use (whichever comes first).
- The plunger will only reach the end of the cartridge when all 300 units have been given.
AllStar has been designed to be used for up to 3 years after first use.
Do not use your AllStar pen for more than 3 years. After 3 years contact your healthcare provider
or pharmacist to get a new AllStar pen.
Reading the dose remaining scale
The approximate number of units remaining in the cartridge is shown on the scale by the end of
the rubber stopper nearest to the needle.

You cannot select more units than what is remaining in the cartridge.
- If less than 80 units are left, the exact number can be found by:
o Turning the dose button as far as it will turn easily
o Reading the number in the dose window.
Important information for use of AllStar

- If you are giving an injection to another person, take special care not to touch the needle
tip to avoid accidental needle injury and passing of infectious diseases.
- Each AllStar, each cartridge and each needle are only for one person's use. Do not share
with anyone else.
- For use in a multi-patient environment, e.g. hospital or nursing home, special caution
must be taken to ensure identification of the correct pen for each patient.
- If you use different types of insulin, you should use a different color or different type of
pen for each insulin.
- Never use AllStar or an insulin cartridge if it is damaged or if you are not sure that it is
working properly.
Before each injection, always:
- Check the label of your insulin cartridge.
- Attach a new needle - Use only compatible Type A pen needles available from Becton
Dickinson.

- Perform a safety test.
Storage and maintenance of AllStar
Keep your AllStar pen and insulin cartridges out of sight and reach of children.
- It is recommended to store AllStar in the carry case provided.
Your AllStar should be stored with the insulin cartridge attached, ready for your next injection.
- Do not store AllStar with a needle attached.
- Do not store AllStar in the refrigerator.
- Lantus, Apidra and Insuman cartridges can be safely stored at temperatures up to 25°C
(77°F) for up to 28 days.
Your AllStar is designed to work accurately and safely. It should be handled with care. Avoid
situations where AllStar might be damaged.
- Do not use excessive force when turning or pressing the dose button or when pushing the
plunger back in.
- Protect your AllStar from dust, dirt, high temperatures and direct sunlight.
- Do not soak, wash or lubricate AllStar as this may cause damage.
o You can clean the outside surfaces of AllStar by wiping it with a damp cloth.
- If your AllStar is broken or damaged then it is no longer safe to use.
o Never attempt to repair a broken AllStar.
o If you are not sure whether or not your AllStar is broken or damaged, contact your
healthcare professional or call Sanofi on +91-22-28278000.
AllStar: Giving injections with your reusable insulin delivery device
Step 1. Insert a new insulin cartridge (or replace a cartridge)
- If your AllStar pen already contains an insulin cartridge you can go straight to Step 2.
A. Pull off the pen cap from AllStar.
B. Unscrew the cartridge holder from the pen body.

If there is an insulin cartridge that needs to be replaced, remove it and discard it.

C. Check the label of your insulin cartridge for insulin type and expiry date.
D. Insert the new cartridge, narrow end first, into the cartridge holder.
Do not insert a partially used cartridge.
E. If the plunger is extended, use the cartridge's rubber stopper to push it back.
Do not press on the dose button whilst pushing back the plunger. This will cause the plunger
to jam.
F. Screw the cartridge holder firmly back on to the pen body until it clicks into place.

The alignment marks on the cartridge holder and the pen body must line up as shown.
Step 2. Check your insulin before every injection

A. Check your insulin cartridge.
Make sure you have the correct insulin. Using the wrong insulin may result in unwanted
changes in your blood sugar levels that could be harmful to your health.
Do not use an insulin cartridge if it is damaged or after the expiry date on the cartridge label.
B. For clear insulins (e.g. Lantus, Apidra or Insuman Rapid):
Check the appearance of your insulin.
Do not use the cartridge if the insulin is cloudy, colored or has particles.
OR
For Suspension insulins (e.g. Insuman Basal, Insuman Comb 25/75 or Insuman Comb 50/50):
Turn the pen gently up and down at least 10 times to mix the insulin.
After mixing, check your insulin. Insulin suspensions must have an even milky-white
appearance.

Step 3. Attach a new needle before every injection
Always use a new sterile needle for every injection. This helps to prevent contamination,
inaccurate dosing and needle blockage.
A. Remove the protective seal from a new needle.
B. Line up the needle with the pen and keep it straight as you screw it onto the cartridge holder.
If the needle is not kept straight, it can damage the cartridge or the needle.
Do not over-tighten. This will make it difficult to remove the needle after the injection.
C. Pull off the outer needle cap.

Keep it safe to unscrew the needle after the injection.
D. Pull off the inner needle cap and discard it.
Make sure that the needle is properly attached.

Step 4. Perform a safety test before every injection
Always perform a safety test before each injection to make sure that you get the correct dose of
insulin.
The safety test removes air bubbles and checks that your pen and needle are working properly.
A. Select a dose of 2 units by turning the dose button.
B. Holding the pen with the needle pointing upwards, tap the cartridge holder so that any air
bubble rises up towards the needle.

C. Press the dose button all the way in and hold it in for 10 seconds.
- Check that insulin comes out of the needle tip.

- Check that the dose window returns to "0".
- If not, repeat the safety test (Step 4).
You may have to repeat the safety test several times before you see insulin.
If still no insulin comes out of the needle tip:

- The needle may be blocked. Remove the needle (Step 7) and replace with a new needle
(Step 3).
- Check that the cartridge is properly inserted (Step 1) and is not damaged. If it is damaged,
use a new one (Step 1).
After doing all this repeat the safety test again (Step 4). If still no insulin comes out, do not use
this AllStar. Contact your healthcare professional or call Sanofi on +91-22-28278000.
Step 5. Select your dose
The maximum dose you can dial is 80 units. If you need a dose greater than 80 units, you should
give it as two or more injections.

A. Check that the dose window shows "0" following the safety test (see Step 4).
B. Select your required dose by turning the dose button.

If you turn past your dose, you can turn back in the reverse direction without losing insulin.
Do not push the dose button while turning, as insulin will come out.
If the dose button does not turn easily do not force it. AllStar will not let you select more units
than what is left in the cartridge.
If your dose is more than what is left you can either:
- Inject what is left (Steps 6-7), then replace the cartridge with a new one (Step 1)
and complete your dose (Steps 2-7).
- Or discard what is left and use a new cartridge for your full dose (Steps 1-7).
Step 6. Inject your dose
Inject your dose exactly as shown by your healthcare provider.
A. Insert the needle into the skin.
B. Inject your dose by pressing the dose button, slowly, all the way in.

C. Keep the dose button pressed all the way in. Slowly count to 10.
D. Remove the needle from the skin.
You have received your full dose only if the dose window shows "0".
If not, repeat Step 6.
Each cartridge can be used for multiple injections up to a total of 300 units.
The rubber stopper reaches the end of the cartridge only when all 300 units have been used.
Step 7. Remove the needle after every injection and dispose of it safely

- Always remove the needle after every injection. Do not store AllStar with a needle
attached. This helps to prevent air from entering the cartridge, insulin leakage,
contamination, inaccurate dosing and needle blockage.
- If you are giving an injection to another person take extra special care not to touch the
needle tip. This is to reduce the risk of accidental needle injury and passing of infectious
diseases.
- Never replace inner needle cap. The inner needle cap is small and difficult to replace
safely.
A. Carefully put the outer needle cap back on to the needle.
B. Hold the cartridge holder and outer needle cap.
Pull off the needle.
C. Dispose of the needle safely in a puncture resistant container.

There may be local or state laws for disposing of used needles.
Needle containers should be sealed and disposed of properly.
Step 8. Store AllStar until your next injection

A. Replace the pen cap back on AllStar after use. Store the pen safely until your next injection.
- You do not need to remove the cartridge after the injection unless it is empty.
- Each insulin cartridge is reusable. Your AllStar should be stored with the insulin cartridge
inserted, ready for your next injection.
- You should not store AllStar in the refrigerator.
- Lantus, Apidra and Insuman cartridges can be safely stored at temperatures up to 25°C
(77°F) for up to 28 days.

INSUPen EZ
• INSUPen EZ is 37% lighter than INSUPen. It also has better insulation to temperature
variation, good visibility and high durability.(9)
• INSUPen EZ is a reusable grey-colored pen that can deliver insulin doses from 1 unit
(0.01ml) to 60 unit (0.60ml) in increments of 1 unit (0.01ml) with insulin preparations of
100IU/ml.(9)
• To minimize the risk of transmission of infectious diseases, your INSUPen EZ should not
be shared with anyone else.(9)
• INSUPen EZ is designed to be used for 2 years but not later than the expiry date
mentioned on the pen carton (with 2 years warranty). Dispose the pen as directed by your
health care professional when this time has passed, even if it seems to be in good working
condition.(9)
• Needles are available in different lengths and gauges. Ask your healthcare professional to
determine which needle is best for you. INSUPen EZ is recommended for use with sterile
disposable pen needles (4mm, 32G) manufactured by Becton Dickinson & Company BD.
Use a new sterile needle for each injection.(9)
• Ensuring a clean, safe injection(9)
o Wash your hands with soap and water before handling the pen.
o Select a location for injection as recommended by your healthcare professional.
o Always store the pen with the pen cap attached.

Instructions(9)
STEP 1: Remove the cap

Take INSUPen EZ out of the case. Pull off the pen cap.
Step 2: Remove cartridge holder

Unscrew the cartridge holder from the pen body.

Step 3: Reset the plunger rod
Grip the plunger return ring. With the other hand rotate the pen body
so that the plunger moves into the pen body. Continue rotating until
the plunger rod stops against the plunger return ring.
NOTE: Before inserting a new cartridge, make sure the plunger rod is
fully screwed back. Failure to do so can damage the pen. Do not load
a partially used cartridge.
CAUTION: Do not force or push the plunger rod.
Step 4: Check the cartridge

Remove the cartridge from the pack.
Check that the cartridge is not cracked or broken.
Ensure that you have the right type of insulin as prescribed by your
healthcare professional.
CAUTION: This pen is designed to hold only cartridges that have
Biocon’s label. Do not use a cartridge if it is damaged. Check that the
cartridge has not expired. Do not use other brands of insulin cartridges
with INSUPen EZ (recommended for Biocon’s cartridges only) to avoid
inaccurate dosing.
For insulin solution (clear solution), proceed directly to insert the
cartridge as mentioned in Step 6. Only for insulin suspension (cloudy
insulin) ensure to mix (resuspend) it as follows.

Step 5: Mix (resuspend) cloudy insulin
Bring the cartridge to room temperature.
Roll the cartridge between your palms 10 times. These steps should
be done with the cartridge in a flat (horizontal) position.
Hold the cartridge in your hand and then turn the cartridge up and
down between positions A and B so the glass bead moves from one
end of the cartridge to the other.
Do this at least 10 times. Repeat step 5 until insulin looks uniformly
white and cloudy.
Step 6: Insert the cartridge

Insert the cartridge into the cartridge holder with the metal end first.
Step 7: Fix the pen body

Screw the pen body back into the cartridge holder.

Step 8: Attach a new needle
CAUTION: Always use a new sterile disposable pen needle for each
injection. Re-using a needle which is designed for single use will cause
infection and contamination of drug. Use of a contaminated needle
and drug can cause serious health issues. Also check the expiry date
of needle on its protective tab, prior to use. Do not use an expired
needle.
Remove the protective seal from the outer needle cap.
CAUTION: Do not attempt to pull out needle by hand.
Attach and screw the needle assembly firmly onto the cartridge
holder. Keep the needle firm and straight while attaching.
The needle could bend/fall off if not kept straight while attaching.
Remove the outer needle cap and save for later use in step 13.
Carefully pull off the inner needle cap and throw it away. You may see
a droplet of insulin at the needle.
Step 9: Priming
Turn until you see ‘2’ in the dose window.
NOTE: If you turn the dose knob past the required dose of 2 units,
simply turn it in the opposite direction to correct the dose.

Step 10: Removal of air bubbles
Hold INSUPen EZ with the needle end pointing straight up.
Tap the cartridge holder gently with your finger to raise any air
bubbles to the top of the insulin cartridge. There may be a few small
air bubbles still seen.
With the needle pointing upwards, press the dose button in until it
stops. The dose window should show ‘0’. You should see 2-3 drops of
insulin come out of the needle tip. Priming is complete when 2-3 drops
of insulin appear at the needle tip. If no insulin comes out of the
needle, repeat step 10 up to a maximum of five times, until 2-3 drops
of insulin are visible.
CAUTION: It is important that you complete the priming steps before
preparing for each injection. It ensures dose accuracy and shows that
the needle is not blocked. If the injection button becomes hard to
push, change the needle and try again.
STEP 11: Set the dose
Turn the dose knob to set the required dose.
Doses with even numbers are indicated as digits against short lines
and doses with odd numbers are indicated by long lines between the
digits.
CAUTION: When turning the dose knob to set the dose, be careful not
to push the injection button, as insulin will come out.
Dose correction
This step needs to be performed only if the dose has been set
incorrectly prior to injection and a different dose is required.
NOTE: INSUPen EZ can deliver up to 60 units in one injection. For more
than 60 units, you will need two (or more injections). The scale on the
cartridge older is only an indicator of the amount of insulin left in the
cartridge. Read the number in the dose window for the dose size that
is available for injection.
CAUTION: If the dose knob does not turn to your required dose, the
cartridge does not have enough insulin left. Do not try to force the
knob.

STEP 12: Inject the dose
Do not inject with the needle placed an angle.
Holding injection button.
Place your thumb on the injection button as shown, pressing sideways
may result in an inaccurate dose.
Insert the needle and follow the injection technique as advised by
your health care professional.
CAUTION: Select a location for injection as recommended for injection

as recommended by your healthcare professional.
Press the injection button down slowly and firmly until you see a ‘0’ in
the dose window. Hold injection button down and count to 10 slowly
(10 seconds) before withdrawing the needle from the skin.
CAUTION: If you do not keep the injection button pressed for 10
seconds after ‘0’ has been displayed in the dose window, it could
result in an inaccurate dose. You may also observe insulin coming out
of the needle.
Step 13: Remove and dispose needle

Carefully place the outer needle cap over the needle.
Unscrew the capped needle and dispose it as directed by your

CAUTION: To discard used needles, follow local regulations in your
country concerning the handling of potentially infectious materials.
CAUTION: Do not attempt to remove the needle without the outer
needle cap in place.

STEP 14: Storing INSUPen EZ
Replace the pen cap.
Align the body of the pen with the pen cap as shown in the picture for
safe storage. Store INSUPen EZ for your next use.
Instruction for repeat use.

Pull off the pen cap.
For insulin solution (clear solution) repeat steps 8 to 14 to get your
desired dose.
For insulin suspension (cloudy insulin) before every subsequent
injection (repeat use) ensure that the cartridge containing an insulin
suspension (cloudy insulin) is uniformly white and cloudy, when
resuspended. Roll the pen between your palms 10 times. These steps
should be done with the pen in a flat (horizontal) position.
Resuspend the cloudy insulin by holding the pen in your hand and
turning it up and down between position A & B so the glass beads
moves from one end of the cartridge to the other with the insulin
cartridge inside the cartridge holder.
Repeat steps 8 to 14 to get your desired dose.
Storage and handling(9)
- Keep INSUPen EZ away from moisture, dust, direct sunlight and places where the
temperature may get too high or low.
- When a cartridge is inserted in INSUPen EZ, store your INSUPen EZ as mentioned in the
package insert that comes with the cartridge.
- It is recommended to keep your INSUPen EZ in the pen case supplied.
- Remove the needle after every use. Do not store the pen with the needle attached as
this will help ensure sterility. It will also help prevent leakage of insulin, keep out air
bubbles and reduce needle clogs.

- Do not use alcohol, hydrogen peroxide, bleach or any other solvent to clean the pen. Also,
do not apply lubrication such as oil, as this could damage the pen.
- Keep/store INSUPen EZ out of reach and sight of children.
- Your pen is designed to work accurately and safely. It must be handled with care. Avoid
dropping the pen, as this may cause cartridge breakage or damage the pen.
- Do not share your pen with others. This pen is intended and recommended for use by
one person only.
- Clean the outside of your pen by wiping it with a damp cloth.
Mark your INSUPen EZ with different types of insulin label sticker(9)
- Select the sticker according to the type of insulin (Insugen® and/or Basalog® cartridge
you have been prescribed.
- Peel off insulin label sticker.
- Paste the sticker on the cartridge holder of INSUPen EZ. Continue with the steps as
mentioned.
Frequently asked questions(9)
What do I do if air bubbles are present in the cartridge?
The presence of air bubbles can affect the amount of insulin delivered. A small air bubble might
remain in the container after tapping; this small air bubble will not affect your dose. Ensure that
you remove the air bubbles as mentioned in Step 10.
What do I do if there are no drops visible while checking the insulin flow (priming)?
The needle may be blocked. Replace the needle and check for insulin flow. A few drops of insulin
will appear.
Why is it important to check the insulin flow and prime before every injection?
Priming ensures that the pen and needle are working properly. Once the pen is properly primed,
insulin will flow from the needle. If you do not prime, you may not get the accurate amount of
insulin.
Why can it take several attempts at priming before I see a drop of insulin with a new cartridge?
There may be a slight gap between the plunger rod and the plunger stopper. Repeating the
priming steps will move the plunger rod into contact with the cartridge plunger stopper. Once in

contact the plunger rod will push the cartridge plunger stopper forward, forcing insulin to flow
through the needle.
What do I need to do if the set dose is higher than the desired dose?
Turn the dose knob to a lower number until the correct dose is set. Check on the dose window
that the desired dose has been reached. Dose correction takes place without any drug loss.
Ensure to do this before you press the injection button. Do not push the injection button while
turning, as insulin will come out. The dose cannot be changed during injection.
What do I need to do if the set dose is lower than the desired dose?
Turn the dose knob to a higher number until the correct dose is set. Check on the dose window
What should I do if the dose knob stops rotating before it reaches the required number of
units?
This is because either you are trying to select more units of insulin than is left in the cartridge or
you are trying to select a dose larger than 60 units.
For example, 22 units are required and only 15 units are left in the cartridge, the dose knob
cannot be dialed beyond 15 units. If the dose knob is forced beyond 15 units (in this case), the
pen can be damaged. Inject the 15 units remaining in this cartridge. Then insert a new cartridge
and follow steps 1 to 13 to deliver another 7 units, so that in total you receive 22 units.
What do I do if the injection button stops during the injection and “0″ is not indicated after an
injection?
This means that you have not received the selected dose of insulin. Do not try to force the
injection button down. There may be several reasons for such an incident:
- During the injection you may have not pressed the injection button long enough. Ensure
that you press the injection button for 10 seconds. Pressing on the edge of the dose
button can lead to injection blockage.
- Your needle may be blocked. Change the needle and check the insulin flow (prime). Select
the number of remaining units you need to complete your previous dose and inject.
- If the step above does not work then it is possible that the cartridge is blocked. In this
case, use a new cartridge.

Why can I not dial the dose to use the small amount of insulin that remains in my cartridge?
INSUPen EZ is designed to deliver at least 300 units of insulin. INSUPen EZ design prevents the
cartridge from being completely emptied because the small amount of insulin that remains in the
cartridge cannot be delivered.
What is the shelf life of insugen?
Store insugen refill cartridge in a refrigerator at temperatures between 2°C and 8°C. It should not
be allowed to freeze. The suspension can be kept at room temperatures (below 25°C) for up to
42 days once the cartridge has been put to use.
Is Insugen safe in breastfeeding and pregnancy?
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin odes
not pass the placental barrier.
Both hypoglycemia and hyperglycemia, which can occur in inadequately controlled diabetes
therapy, increase the risk of malformations and death in utero. Intensive control in the treatment
of pregnant women with diabetes is therefore recommended throughout pregnancy and when
contemplating pregnancy. Insulin requirements usually fall in the first trimester and subsequently
increase during the second and third trimesters.
After delivery, insulin requirements return rapidly to pre-pregnancy values. Insulin treatment of
the nursing mother presents no risk to the baby. However, the Insugen-R dosage may need to be
adjusted.

INSUPen Pro
• INSUPen Pro is a reusable green-colored pen that can deliver insulin doses from 1 unit
(0.01ml) to 60 unit (0.60ml) in increments of 1 unit (0.01ml) with insulin preparations of
100IU/ml.(9)
• To minimize the risk of transmission of infectious diseases, your INSUPen Pro should not
be shared with anyone else.(9)
• INSUPen Pro is designed to be used for 3 years but not later than the expiry date
mentioned on the pen carton. Dispose the pen as directed by your health care
professional when this time has passed, even if it seems to be in good working
condition.(9)
• Needles are available in different lengths and gauges. Ask your healthcare professional to
determine which needle is best for you. INSUPen Pro is recommended for use with sterile
disposable pen needles (4mm, 32G) manufactured by Becton Dickinson & Company BD.
Use a new sterile needle for each injection.(9)
• Ensuring a clean, safe injection(9)
o Wash your hands with soap and water before handling the pen.
o Select a location for injection as recommended by your healthcare professional.
o Always store the pen with the pen cap attached.
Instructions(9)
STEP 1: Remove the cap

Take INSUPen Pro out of the case. Pull off the pen cap.

Step 2: Remove cartridge holder
Detach the cartridge holder by twisting and pulling gently away from
the pen with a “click”.
Step 3: Reset the plunger rod
Grip the pen body in one hand and gently push back the plunger rod
with the other hand into the injection mechanism section of the pen.
NOTE: Before inserting a new cartridge, make sure the plunger rod is
fully pushed back.
Step 4: Check the cartridge
Remove the cartridge from the pack.
Check that the cartridge is not cracked or broken.
Ensure that you have the right type of insulin as prescribed by your
CAUTION: This pen is designed to hold only cartridges that have
Biocon’s label. Do not use a cartridge if it is damaged. Check that the
cartridge has not expired. Do not use other brands of insulin cartridges
with INSUPen Pro (recommended for Biocon’s cartridges only) to
avoid inaccurate dosing.
For insulin and/or insulin analogue proceed directly to insert the
cartridge as mentioned in Step 6. Only for insulin suspension (cloudy
insulin) ensure to mix (resuspend) it as follows.
Step 5: Mix (resuspend) cloudy insulin
Bring the cartridge to room temperature.
Roll the cartridge between your palms 10 times. These steps should
be done with the cartridge in a flat (horizontal) position.
Hold the cartridge in your hand and then turn the cartridge up and
down between positions A and B so the glass bead moves from one
end of the cartridge to the other.
Do this at least 10 times. Repeat step 5 until insulin looks uniformly
white and cloudy.

Step 6: Insert the cartridge
Insert the cartridge into the cartridge holder with the metal end first.
Step 7: Fix the pen body

Screw the pen body back into the cartridge holder, this is attached
properly when you again hear a “click”.

Step 8: Attach a new needle
CAUTION: Always use a new sterile disposable pen needle for each
injection. Re-using a needle which is designed for single use will cause
infection and contamination of drug. Use of a contaminated needle
and drug can cause serious health issues. Also check the expiry date
of needle on its protective tab, prior to use. Do not use an expired
needle.
Remove the protective seal from the outer needle cap.
CAUTION: Do not attempt to pull out needle by hand.
Attach and screw the needle assembly firmly onto the cartridge
holder. Keep the needle firm and straight while attaching.
The needle could bend/fall off if not kept straight while attaching.
Remove the outer needle cap and save for later use in step 13.
Carefully pull off the inner needle cap and throw it away. You may see
a droplet of insulin at the needle.
Step 9: Priming (checking the insulin flow)

Turn until you see ‘2’ in the dose window.
NOTE: If you turn the dose knob past the required dose of 2 units,
simply turn it in the opposite direction to correct the dose.

Step 10: Removal of air bubbles
Hold INSUPen Pro with the needle end pointing straight up.
Tap the cartridge holder gently with your finger to raise any air
bubbles to the top of the insulin cartridge. There may be a few small
air bubbles still seen.
With the needle pointing upwards, press the dose button in until it
stops. The dose window should show ‘0’. You should see 2-3 drops of
insulin come out of the needle tip. Priming is complete when 2-3 drops
of insulin appear at the needle tip. If no insulin comes out of the
needle, repeat step 10 up to a maximum of five times, until 2-3 drops
of insulin are visible.
CAUTION: It is important that you complete the priming steps before
preparing for each injection. It ensures dose accuracy and shows that
the needle is not blocked. If the injection button becomes hard to
push, change the needle and try again.
STEP 11: Set the dose
Turn the dose knob to set the required dose.
Doses with even numbers are indicated as digits against short lines
and doses with odd numbers are indicated by thin lines between the
digits.
CAUTION: When turning the dose knob to set the dose, be careful not
to push the injection button, as insulin will come out.
Dose correction
This step needs to be performed only if the dose has been set
incorrectly prior to injection and a different dose is required.
NOTE: INSUPen Pro can deliver up to 60 units in one injection. For
more than 60 units, you will need two (or more injections). The scale
on the cartridge older is only an indicator of the amount of insulin left
in the cartridge.

STEP 12: Inject the dose
Do not inject with the needle placed an angle.
Holding injection button.
Place your thumb on the injection button as shown, pressing sideways
may result in an inaccurate dose.
Insert the needle and follow the injection technique as advised by
your health care professional.
CAUTION: Select a location for injection as recommended for injection

as recommended by your healthcare professional.
Press the injection button down slowly and firmly until you see a ‘0’ in
the dose window. Hold injection button down and count to 10 slowly
(10 seconds) before withdrawing the needle from the skin.
CAUTION: If you do not keep the injection button pressed for 10
seconds after ‘0’ has been displayed in the dose window, it could
result in an inaccurate dose. You may also observe insulin coming out
of the needle.
Step 13: Remove and dispose needle
Carefully place the outer needle cap over the needle.
Unscrew the capped needle and dispose it as directed by your

CAUTION: To discard used needles, follow local regulations in your
country concerning the handling of potentially infectious materials.
CAUTION: Do not attempt to remove the needle without the outer
needle cap in place.

STEP 14: Storing INSUPen Pro
Replace the pen cap.
Align the body of the pen with the pen cap for safe storage. Store
INSUPen Pro for your next use.
Last dose & Cartridge replacement
If the injection button stops during the injection and 0 is not indicated.
DO NOT TRY to force the injection button down. This may happen due
to nonavailability of insulin in the cartridge. Replace the exhausted
cartridge with a new insulin cartridge of the same type you use and
follow the steps from 1 to 14.
NOTE: Carry additional cartridge of the same insulin type along with
the pen to avoid delay in taking insulin dose.
Instruction for repeat use.
Pull off the pen cap.
For insulin solution (clear solution) repeat steps 8 to 14 to get your
desired dose.
For insulin suspension (cloudy insulin) before every subsequent
injection (repeat use) ensure that the cartridge containing an insulin
suspension (cloudy insulin) is uniformly white and cloudy, when
resuspended. Roll the pen between your palms 10 times. These steps
should be done with the pen in a flat (horizontal) position.
Resuspend the cloudy insulin by holding the pen in your hand and
turning it up and down between position A & B so the glass beads
moves from one end of the cartridge to the other with the insulin
cartridge inside the cartridge holder.
Repeat steps 8 to 14 to get your desired dose.
Storage and handling(9)
- Keep INSUPen Pro away from moisture, dust, direct sunlight and places where the
temperature may get too high or low.
- When a cartridge is inserted in INSUPen Pro, store your INSUPen Pro as mentioned in the
package insert that comes with the cartridge.
- It is recommended to always keep INSUPen Pro in the pen case supplied.

- Remove the needle after every use. Do not store the pen with the needle attached as
this will help ensure sterility. It will also help prevent leakage of insulin, keep out air
bubbles and reduce needle clogs.
- Do not use alcohol, hydrogen peroxide, bleach or any other solvent to clean the pen. Also,
do not apply lubrication such as oil, as this could damage the pen.
- Store/keep INSUPen Pro out of reach and sight of children.
- Your pen is designed to work accurately and safely. It must be handled with care. Avoid
dropping the pen, as this may cause cartridge breakage or damage the pen.
- Do not share your pen with others. This pen is intended and recommended for use by
one person only.
- Clean the outside of your pen by wiping it with a damp cloth.
Mark your INSUPen Pro with different types of insulin label sticker(9)
- Select the sticker according to the type of insulin (Insugen® and/or Basalog® cartridge
you have been prescribed.
- Peel off insulin label sticker.
- Paste the sticker on the cartridge holder of INSUPen Pro. Continue with the steps as
mentioned.
Frequently asked questions(9)
What do I do if air bubbles are present in the cartridge?
The presence of air bubbles can affect the amount of insulin delivered. A small air bubble might
remain in the container after tapping; this small air bubble will not affect your dose. Ensure that
you remove the air bubbles as mentioned in Step 10.
What do I do if there are no drops visible while checking the insulin flow (priming)?
The needle may be blocked. Replace the needle and check for insulin flow. A few drops of insulin
will appear.
Why is it important to check the insulin flow and prime before every injection?
Priming ensures that the pen and needle are working properly. Once the pen is properly primed,
insulin will flow from the needle. If you do not prime, you may not get the accurate amount of
insulin.
Why can it take several attempts at priming before I see a drop of insulin with a new cartridge?

There may be a slight gap between the plunger rod and the plunger stopper. Repeating the
priming steps will move the plunger rod into contact with the cartridge plunger stopper. Once in
contact the plunger rod will push the cartridge plunger stopper forward, forcing insulin to flow
through the needle.
What do I need to do if the set dose is higher than the desired dose?
Turn the dose knob to a lower number until the correct dose is set. Check on the dose window
What do I need to do if the set dose is lower than the desired dose?
Turn the dose knob to a higher number until the correct dose is set. Check on the dose window
What should I do if the dose knob stops rotating before it reaches the required number of
units?
This is because you are trying to select a dose larger than 60 units.
What do I do if the injection button stops during the injection and 0 is not indicated after an
injection?
injection button down.
There may be several reasons for such an incident:
- This may be because of not having sufficient insulin available in the cartridge. Example:
if 20 units are required and insulin left in the cartridge is 10 units. Pen dose knob can be
dialed to 20 units & during injection, dose knob stops at 10 unit. Then insert a new
cartridge and follow steps 1 to 13 to deliver another 10 units from the new cartridge, so
in total you receive 20 units.
- During the injection, you may have not pressed the injection button for long enough.
Ensure that you press the injection button for 10 seconds as directed. Pressing on the
edge of the dose button can lead to injection blockage.

What do I do if the injection button stops during the injection and “0″ is not indicated after an
injection?
injection button down. There may be several reasons for such an incident:
- During the injection you may have not pressed the injection button long enough. Ensure
that you press the injection button for 10 seconds. Pressing on the edge of the dose
button can lead to injection blockage.
Why can I not dial the dose to use the small amount of insulin that remains in my cartridge?
INSUPen Pro is designed to deliver at least 300 units of insulin. INSUPen Pro design prevents the
cartridge from being completely emptied because the small amount of insulin that remains in the
cartridge cannot be delivered.
What is the shelf life of insugen?
Store insugen refill cartridge in a refrigerator at temperatures between 2°C and 8°C. It should not
be allowed to freeze. The suspension can be kept at room temperatures (below 25°C) for up to
42 days once the cartridge has been put to use.
Is Insugen safe in breastfeeding and pregnancy?
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin odes
not pass the placental barrier.
Both hypoglycemia and hyperglycemia, which can occur in inadequately controlled diabetes
therapy, increase the risk of malformations and death in utero. Intensive control in the treatment
of pregnant women with diabetes is therefore recommended throughout pregnancy and when
contemplating pregnancy. Insulin requirements usually fall in the first trimester and subsequently
increase during the second and third trimesters.

After delivery, insulin requirements return rapidly to pre-pregnancy values. Insulin treatment of
the nursing mother presents no risk to the baby. However, the Insugen-R dosage may need to be
adjusted.

Differences between INSUPen EZ and INSUPen PRO
Differences between INSUPen EZ and INSUPen PRO(9)
INSUPen EZ INSUPen PRO
Grey-colored pen Green-colored pen
INSUPen EZ is designed to be used INSUPen Pro is designed to be used for 3 years but not
for 2 years but not later than the later than the expiry date mentioned on the pen carton.
expiry date mentioned on the pen
carton.
Reset the plunger rod Reset the plunger rod

Grip the plunger return ring. With Grip the pen body in one hand and gently push back the
the other hand rotate the pen body plunger rod with the other hand into the injection
so that the plunger moves into the mechanism section of the pen.
pen body. Continue rotating until the
plunger rod stops against the
plunger return ring.
What should I do if the dose knob What should I do if the injection button stops halfway
stops rotating before it reaches the and zero is not indicated?
required number of units?
This means that you have not received the selected
This is because either you are trying dose of insulin. Do not try to force the injection button
to select more units of insulin than is down.
left in the cartridge or you are trying
There may be several reasons for such an incident:
to select a dose larger than 60 units.
- This may be because of not having sufficient insulin
For example, 22 units are required
available in the cartridge. Example: if 20 units are
and only 15 units are left in the
required and insulin left in the cartridge is 10 units.
cartridge, the dose knob cannot be
Pen dose knob can be dialed to 20 units & during
dialed beyond 15 units. If the dose
injection, dose knob stops at 10 unit. Then insert a
knob is forced beyond 15 units (in
new cartridge and follow steps 1 to 13 to deliver
this case), the pen can be damaged.
another 10 units from the new cartridge, so in total
Inject the 15 units remaining in this you receive 20 units.
cartridge. Then insert a new - During the injection, you may have not pressed the
cartridge to deliver another 7 units, injection button for long enough. Ensure that you
so that in total you receive 22 units. press the injection button for 10 seconds as
directed. Pressing on the edge of the dose button
can lead to injection blockage.

INSUPen EZ INSUPen PRO
- Your needle may be blocked. Change the needle

and check the insulin flow (prime). Select the
number of remaining units you need to complete
your previous dose and inject.
- If the step above does not work then it is possible
that the cartridge is blocked. In this case, use a new
cartridge.
NOTE: with INSUPen Pro, you can select more units of
insulin than is left in the cartridge.

Differences between Novopen 4, Allstar pen and INSUPen EZ
Differences between Novopen 4, Allstar pen and INSUPen EZ(9)
Novopen 4 All Star pen (Sanofi) INSUPen EZ (Biogen)
The dose button can be locked The dose button cannot be locked Has a separate dose knob and
injection button
Metal-made outer casing Plastic-made outer casing Plastic-made outer casing
Injection has a click sound Injection does not have a click sound Injection does not have a click sound.
Can deliver insulin doses from 1 to 60 Doses can be set from 1 to 80 units in Can deliver insulin doses from 1 to 60
units, in increments of 1 unit. steps of 1 unit. units, in increments of 1 unit.
NovoPen 4 comes with a 3-year AllStar pen has been designed to be INSUPen EZ is designed to be used for
guarantee. The NovoPen 4 life used for up to 3 years after first use. 2 years but not later than the expiry
expectancy is five years when the pen date mentioned on the pen carton
is used for three daily injections. (with 2 years warranty). Dispose the
pen as directed by your health care
professional when this time has
passed, even if it seems to be in good
working condition.
When using cloudy insulin in your For suspension insulins, turn the pen For insulin suspension (cloudy insulin)
Novopen 4, gently up and down at least 10 times before every subsequent injection
to mix the insulin. After mixing, check (repeat use) ensure that the cartridge
Roll the pen between your palms 10
your insulin. Insulin suspensions must containing an insulin suspension
times – it is important that the pen is
have an even milky-white (cloudy insulin) is uniformly white and
kept horizontal.
appearance. cloudy, when resuspended. Roll the
pen between your palms 10 times.
These steps should be done with the
pen in a flat (horizontal) position.
Resuspend the cloudy insulin by
holding the pen in your hand and
Move the pen up and down 10 times turning it up and down between
between the 2 positions as shown position A & B so the glass beads
(this should move the glass ball inside moves from one end of the cartridge
the cartridge from one end to the to the other with the insulin cartridge
other). inside the cartridge holder.

Continue rolling and moving until the

liquid appears white and cloudy
(resuspended)
To do the air shot, turn the dose Safety test of 2 units each time Priming of 2 units each time
button to select:
- 4 units with a new PenFill
cartridge.
- 1 unit with a cartridge already
in use
NOTE: in Novopen 5, safety test of 2
units each time is suggested.
Can push in the piston rod, by gently If the plunger is extended, use the Reset the plunger rod
pressing the piston head in until it cartridge's rubber stopper to push it
Grip the plunger return ring. With the
stops. back. Do not press on the dose button
other hand rotate the pen body so
whilst pushing back the plunger. This
that the plunger moves into the pen
will cause the plunger to jam.
body. Continue rotating until the
plunger rod stops against the plunger
return ring.
Before you inject your insulin If the dose button does not turn What should I do if the dose knob
suspension (white and cloudy easily, do not force it. AllStar will not stops rotating before it reaches the
insulin), make sure there is at least 12 required number of units?

units of insulin left in the cartridge, let you select more units than what is This is because either you are trying
this helps to make sure the remaining left in the cartridge. to select more units of insulin than is
insulin is evenly mixed. If there is less left in the cartridge or you are trying
If your dose is more than what is left
than 12 units left in the cartridge, use to select a dose larger than 60 units.
you can either:
a new 3mL PenFill cartridge.
For example, 22 units are required
- Inject what is left, then
- If the rear rubber stopper and only 15 units are left in the
replace the cartridge with a
cannot be seen in the cartridge, the dose knob cannot be
new one and complete your
cartridge window, you have dialed beyond 15 units. If the dose
dose.
enough insulin for mixing left knob is forced beyond 15 units (in this
- Or discard what is left and use
in the PenFill cartridge. case), the pen can be damaged.
a new cartridge for your full
- If the rear rubber stopper can
dose. Inject the 15 units remaining in this
be seen in the cartridge
cartridge. Then insert a new cartridge
holder window, you do not
to deliver another 7 units, so that in
have enough insulin left in
total you receive 22 units.
the PenFill cartridge and must
use a new PenFill 3mL
cartridge.

FlexPen

InnoLet

HumaPen

Glucagon-like peptide-1 (GLP-1) receptor agonists
GLP-1 receptor agonists(25)
Drug Name Recommend dose Physiological Advantages Disadvantages Administration

actions
Exenatide IR Immediate release ↑glucose- No Nausea, Given

dependent hypoglycemia vomiting, subcutaneously
5μg/20μL Min dose: 5μg BD
insulin diarrhea are
10μg/40μL Max dose: 10μg BD secretion common side
Weight loss effects
Exenatide XR Extended release ↓

2mg inappropriate
Min dose: 2mg once
glucagon
weekly
secretion
Max dose: 2mg once
weekly
slows gastric
Liraglutide Initial dose: 0.6mg OD
emptying
6mg/ml
Max dose: 1.8mg OD
Lixisenatide Min dose: 10μg OD

50μg/ml Max dose: 20μg OD
100μg/ml
Step-by-step injection technique (GLP-1 receptor agonist)(25)

GLP-1 RA may be injected at any of the usual injection sites as the pharmacokinetics does not
appear to be site-specific.(20)
The injection technique for exenatide IR (immediate release) and liraglutide are similar to insulin
injection technique. However, they do not require priming.
The injection technique for exenatide XR (extended release) involves three steps:

Prepare
Remove one pen from the refrigerator. Wait for 15 minutes.
Medicine at room temperature is easily mixed well.
Attach the needle to the pen and do not remove the needle
cover.
Combine the medicine by holding the pen upright and slowly
turning the knob. Stop when you hear the click and the green
label disappears.
Mix
Hold the pen by the end with the orange label and tap the
pen firmly against the palm of your hand to mix. Rotate the
pen every ten taps.
Hold your pen up to the light and look through both sides of
the mixing window to make sure the medicine is mixed well.
To get your full dose, the medicine must be mixed well. If not
mixed well, tap longer and more firmly.
Inject
Twist the knob until the injection button is released.
Pull the needle cover straight off.
Choose the needle size: 4mm, 5mm and 6mm needles are
suitable for all people with diabetes regardless of BMI. 4mm
needles do not require pinching. 5mm and 6mm may require
pinching is very slim adults.
Once the injecting area is chosen, inject the dose by pressing
the push-button all the way in until ‘0’. Keep the push-button
fully depressed and the needle must remain under the skin
for at least 10 seconds or count 1-10 to ensure that the full
dose has been injected. Pull out pen.
Lead the needle tip into the big outer needle cap and cover.
Unscrew and dispose the needle into a puncture proofed
container (e.g. Milo tin).

Accu-Chek Instant S

Accu-Chek Guide

OneTouch Delice Plus lancing device

OneTouch Verio Flex

Ear drops
Instruction(14, 26)
Wash your hands thoroughly with soap and water.
Gently clean your ear with a damp facecloth and then dry
your ear.
Warm the drops to near body temperature by holding

the container in the palm of your hand for a few minutes.
This also reduces the viscosity of the liquid for easier use.
If the drops are a cloudy suspension, shake the bottle

well for 10 seconds.
Check the dropper tip to make sure that it is not chipped

or cracked.
Draw the medication into the dropper or hold the

dropper-top bottle with the dropper tip down.
Adult Children Sit or lie down with the affected ear facing upwards. Pull
the ear backwards then upwards (or if giving to a child
younger than 3 years of age, pull backwards then
downwards) to open the ear canal.
Place drops directly into the ear canal (if there is minimal
swelling), then remain in position for several minutes.
Gently press on the small skin flap over the ear to help
the drops to run into the ear canal.

Insert a gauze wick saturated with drops into the ear if
there is swelling that narrows the canal. The wick should
be replaced every 24 hours until the swelling settles.
Replace and tighten the cap or dropper right away.
Wash your hands to remove any medication.

Enoxaparin (Clexane) pre-filled syringes
- Enoxaparin sodium 20 mg/0.2 ml, 40 mg/0.4 ml, 60 mg/0.6 ml.
- Enoxaparin sodium 20 mg/0.2 ml and 40 mg/0.4 ml syringes are not graduated.(27)
- 1mg equivalent to 100 IU anti-Xa activity.(10)
Mode of action(2)
Inactivate clotting factors IIa (thrombin) and Xa by binding to antithrombin III; LMWHs and
danaparoid have a much greater effect on factor Xa than on thrombin.
Indication Dosage
Prevention of VTE Birth (at term) – 2 months, SC 0.75 mg/kg twice daily.
2 months – 18 years, SC 0.5 mg/kg (maximum 20 mg) twice daily.
Adult
Surgical patients, moderate risk, SC 20 mg once daily for 7–10 days or
until mobilized, starting 2 hours before surgery.
Surgical patients, high risk, SC 40 mg once daily for 7–10 days or until
mobilized, starting 12 hours before surgery. May be continued up to
30 days after total hip replacement.
Medical patients, SC 40 mg once daily for 6–14 days or until mobilized.
CrCl <30 mL/minute, SC 20 mg once daily.
Treatment of VTE Birth (at term) – 2 months, SC 1.5 mg/kg twice daily.
2 months – 18 years, SC 1 mg/kg twice daily.
Adult
SC, 1 mg/kg twice daily, or 1.5 mg/kg once daily until adequate oral
anticoagulation is established.
Use the twice-daily dose for high-risk patients, e.g. those with recurrent
VTE, cancer, symptomatic pulmonary embolism, obesity.
CrCl <30 mL/minute, SC 1 mg/kg once daily.

Indication Dosage
During Adult, 1 mg/kg into the arterial line of the dialysis circuit at the start of
hemodialysis session; reduce dose in patients at high risk of hemorrhage.
Unstable angina, Give for 2–8 days, with aspirin.

non-STEMI
Adult, SC 1 mg/kg twice daily.
CrCl <30 mL/minute, SC 1 mg/kg once daily.
STEMI Give with aspirin.

With thrombolysis
Give enoxaparin between 15 minutes before and 30 minutes after the
start of treatment. Treat for up to 8 days.
<75 years, IV 30 mg bolus plus SC 1 mg/kg, then SC 1 mg/kg every
12 hours (maximum 100 mg for the first 2 SC doses).
>75 years, SC 0.75 mg/kg every 12 hours (maximum 75 mg for the first
2 doses).
<75 years, CrCl <30 mL/minute, IV 30 mg bolus plus SC 1 mg/kg, then SC
1 mg/kg once daily (maximum 100 mg for the first SC dose).
>75 years, CrCl <30 mL/minute, SC 1 mg/kg once daily (maximum 75 mg
for the first dose).
PCI
If the last SC enoxaparin dose was >8 hours before balloon inflation, give
IV bolus 0.3 mg/kg.
- Use at the same time every day.(11)

- If self-administering, advise patient to rotate injection sites.(4)
- If missed a dose for more than 8 hours, to skip the dose and take the next dose (do not
double the dose).(11)
- Patient should avoid concurrent anticoagulants, including NSAIDs and aspirin, without
healthcare professional approval.(4)
- To inform health care professionals (dentists, surgeon, doctor, pharmacists) if the patient
is planning to get a tooth extraction when consulting for medication, supplement or
herbal remedies.(11)

Clexane Syringes should not be administered by the intramuscular route.
For the prophylaxis of venous thrombo-embolic disease following surgery, treatment of DVT and
PE, treatment of unstable angina and NSTEMI, enoxaparin sodium should be administered by SC
injection.
For acute STEMI, treatment is to be initiated with a single IV bolus injection immediately followed
by a SC injection.
For the prevention of thrombus formation in the extra corporeal circulation during hemodialysis,
it is administered through the arterial line of a dialysis circuit.
Subcutaneous injection technique(6, 11)
Before injecting yourself with Clexane

- Collect together the items that you need: syringe,
alcohol swab or soap and water, and sharps container.
- Check the expiry date on the medicine. Do not use if
the date has passed.
- Check the syringe is not damaged and the medicine in
it is a clear solution. If not, use another syringe.
- Make sure you know how much you are going to inject.
- Check your abdomen to see if the last injection caused
any redness, change in skin color, swelling or oozing or
is still painful. If so, talk to your doctor or nurse.
Wash your hands with soap and water and dry it.
Sit or lie in a comfortable position where the injection area

(abdominal) is clearly viewed, ideally on a lounge chair, recliner
or bed (propped up with pillows).
Select an area on the right or left side of the abdominal, at least

2 inches from the navel and out toward the sides. Do not inject
less than 2 inches (5 cm) of the naval or near scars or bruises.
Administration should be alternated between the left and right
anterolateral and left and right posterolateral abdominal walls.

Clean (do not rub) the injection area with the alcohol swab or
soap and water. Allow the area to dry.
Carefully pull of the needle cap from the enoxaparin sodium

syringe and discard cap. The syringe is prefilled and ready to
use.
Once you have removed the cap, do not allow the needle to
touch anything. This is to make sure the needle stays clean
(sterile).
Do not press on the plunger before injecting yourself to get rid

of air bubbles. This can lead to a loss of the medicine.
When the amount of medication in the syringe already
matches your prescribed dose, there is no need to adjust the
dose. You are now ready to inject.
When the dose depends on your body weight, you may need
to adjust the dose in the syringe to match the prescribed dose.
In that case, you can get rid of any extra medicine by holding
the syringe pointing down (to keep the bubble in the syringe)
and ejecting the extra amount into a container.
A drop may appear at the tip of the needle. If this occurs,
remove the drop before injecting by tapping on the syringe
with the needle pointing down. You are now ready to inject.
Hold the syringe in the hand you write with (like a pencil). With
your other hand, gently pinch the cleaned area of your
stomach between your forefinger and thumb to make a fold in
the skin.
Make sure you hold the skin fold throughout the injection.
Hold the syringe so that the needle is pointing straight down

(vertically at a 90° angle). Insert the full length of the needle
into the skin fold.

Press down on the plunger with your thumb. This will send the
medication into the fatty tissue of the stomach. Complete the
injection using all of the medicine in the syringe.
Hold for 10 seconds and remove the needle from the injection
site by pulling it straight out.
To avoid bruising, do not rub the injection site after

administration.
Drop the used syringe, needle first, into an empty thick plastic
container such as empty liquid laundry detergent bottle, empty
bleach bottle or something similar. When the container is full,
cap tightly, wrap in a trash bag and throw in your household
trash.
Adverse effects
- This drug may cause edema, diarrhea, nausea, hematoma, confusion, pain, dyspnea or
fever.(4)
- Tell your doctor immediately if you have any signs of bleeding (e.g. nosebleeds, black or
tarry bowel motions, or unexplained bruising) during and after treatment.(2)
- Instruct patient to report signs/symptoms of bleeding, pulmonary edema, skin necrosis
or atrial fibrillation.(4)
- Advise patients who have received epidural or spinal anesthesia to report
signs/symptoms of neurological impairment, as drug increases risk for development of
an epidural or spinal hematoma.(4)
- Additional information about specific side effects(10)

Hemorrhage If hemorrhage occurs, it is usually sufficient to withdraw
unfractionated or low molecular weight heparin, but if rapid
reversal of the effects of the heparin is required, protamine
sulfate is a specific antidote (but only partially reverses the effects
of low molecular weight heparins).
Heparin-induced Clinically important heparin-induced thrombocytopenia is

thrombocytopenia immune-mediated and does not usually develop until after 5-10
days; it can be complicated by thrombosis. Signs of heparin-
induced thrombocytopenia include a 30% reduction of platelet
count, thrombosis or skin allergy. If heparin-induced
thrombocytopenia is strongly suspected or confirmed, the
heparin should be stopped and an alternative anticoagulant, such
as danaparoid, should be given. Ensure platelet counts return to
normal range in those who require warfarin.
Hyperkalemia Inhibition of aldosterone secretion by unfractionated or low

molecular weight heparin can result in hyperkalemia; patients
with diabetes mellitus, chronic renal failure, acidosis, raised
plasma potassium or those taking potassium-sparing drugs seem
to be more susceptible. The risk appears to increase with duration
of therapy.
Storage
- Do not store above 25°C. Do not freeze.(6)

Eye
General principles of topical eye drugs
Topical drugs act either within the eye or on its surface. Those with an intraocular site of action
(e.g. drugs for glaucoma) require a balance of lipid- and water-solubility to cross into the aqueous
humor.(2)
Designing ocular drug delivery formulations requires an understanding of what can be tolerated
by the eye. Physiological and biochemical mechanisms exist to protect the eye from harmful
stimuli. Tears contain lysozymes and immunoglobulins, which impart an antiinfectious activity.
While these mechanisms are protective, they do sometimes present a barrier to drug absorption.
The lacrimal system of the eye is extremely dynamic. The tear volume in the normal eye is 5 µL
to 9 µL. Basal tears are continuously secreted by the lacrimal glands at an average rate of 1.2 µL
min-1, thus giving a tear turnover rate of approximately 17% per minute. Reflex tears are triggered
by irritants, and their secretion rate ranges from 3 µL min-1 to 400 µL min-1, the intention being
rapidly to eliminate the stimulus. Another protective mechanism is the eyelid movements
associated with blinking. Blinking moves tear fluids and foreign matter to the nasal corner of the
lid surface, where the liquid exits via the puncta and is then drained away by the nasolacrimal
ducts into the inferior nasal passage – often called the lacrimal pump. Some of the drug can end
up rapidly entering the systemic circulation by absorption through the vascular nasal mucosa,
being inhaled as an aerosol or through absorption from the gastrointestinal tract after being
swallowed.(29)
The combined mechanisms of lacrimal drainage and blinking mean that administered eye drops
are rapidly cleared, with residence times ranging from 4 to 23 minutes. Moreover, the rate of
drainage from the eye has a positive, linear correlation with the instilled volume. It has been
found that the conjunctival sacs are capable of accommodating only 20 µL to 30 µL of added fluid
temporarily without spilling; however, the typical drop volume from eye drop bottles made by
different manufacturers ranges from 34 µL to 63 µL. Not only is this variability large but it also
exceeds the volume that can be accommodated by the eye if several drops are administered at
once.(29)
Excess drug drains over the lids onto the cheek, and through the tear duct to the nasal mucosa
where it is absorbed into the systemic circulation (without first pass through the liver) and may
lead to systemic adverse effects.(2)
Ideally, administered eye drops should be spaced by at least 5 minutes to minimize washout.
Punctal occlusion by the closing of the eye and gently pressing of the inside corner for at least 1
minute maximizes local absorption and minimizes systemic exposure by up to 70%. To reduce
the elimination rate of administered eye drops, it is important that the topical preparations do
not cause irritation.(29)

The tear film is lubricating and protective. Changes in its structure and composition can lead to
damage to the surface of the eye.(2)
Choice of form
Adverse effects due to systemic absorption are more common with eye drops than with
ointments.(2)
Ointments have a longer duration of effect than drops as drug dilution and drainage is slower.
They are appropriate to use at night, in children, and when action depends on sustained drug
concentrations. However, they are often difficult to self-administer, and blur vision.(2)
Preservatives
Preservatives are required to reduce contamination in most multidose eye drops. Single-use units
are preservative free but may be more difficult to use.(2)
Preservatives can irritate and damage the corneal and conjunctival epithelium, particularly if it is
already inflamed. Normally, tears quickly dilute and remove preservatives, but if tear secretion
decreases, the risk of preservative toxicity increases.(2)
Adverse effects include mild irritation (burning or stinging), symptoms of dry eye syndrome (with
disruption of tear film), severe conjunctivitis and, rarely, corneal scarring. Toxicity is related to
the type and concentration of preservative, the frequency and duration of use and whether the
tear film is intact.(2)
Patients with chronic ocular diseases, e.g. glaucomas or dry eye syndrome, may need to use
several eyes drops each day. Using less irritant or preservative-free eye drops reduces the risk of
damage to the conjunctiva and cornea without affecting efficacy.(2)
Benzalkonium chloride is the most frequently used preservative in ophthalmic products, but is
the most irritant:(2)
- consider drops containing benzalkonium chloride only if used infrequently or for short
periods
- consider the number of drops containing this preservative being used
- stopping drops containing benzalkonium chloride may not improve irritation
immediately because of its accumulation in ocular tissues.
Polyquaternium, sodium chlorite, stabilized oxychloro complex and sodium perborate are less
irritant than benzalkonium chloride and may be used when drops are required more frequently.
However, they may still be irritating, especially in severe dry eye syndrome.(2)

Several multidose bottles have been developed that maintain sterility without the use of a
preservative; one of these is the ABAK® patented filter system, which uses a 0.2 µm polyether
sulphone membrane with both hydrophilic and hydrophobic properties to prevent bacteria from
entering the bottle. The Airless Antibacterial Dispensing System (AADS™, Pfizer) works by
preventing air, and therefore bacteria, from entering the container on dispensation.
Furthermore, a silver coil is included in the bottle tip. Silver has antibacterial properties and
therefore any bacteria contacting the tip do not contaminate the contents. This system
guarantees 3 months of sterility.(29)
- It is important to write the date on the bottle or tube when you first open it and to discard
it 28 days later (unless told otherwise).
- Before using eye medications, wash your hands then sit or lie down. Tilt your head back,
look up and gently pull down your lower eyelid to form a pouch. Avoid letting the tip of
the dropper or tube touch your eyes, skin or any other surface.
- Use a clean tissue to mop up any excess.
- Some people find it easier to use eye medications properly if they have someone help
them or if they use a mirror.
Contact lenses(2)
Do not wear contact lenses when using eye ointments or if there is an infection.
Soft contact lenses
- Wearing soft contact lenses (other than those disposed of daily) is generally not
recommended while using eye drops containing preservatives. They may be removed
before using an eye drop, then reinserted after at least 15 minutes. If drops are used
twice daily you can insert the lens after putting in the morning drop and remove the lens
before the evening drop.
- If drops are used accidentally while soft lenses are in, remove them and rinse well with
an appropriate solution before reinserting.
Practice points(2)
- Do not use topical drugs in open eye injuries.

- Hospital pharmacies may prepare eye drops, which are not available commercially, for
specialist treatment (e.g. cefazolin 5%, ciclosporin, gentamicin 0.9–1.4%, mitomycin,
povidone-iodine 2.5%, vancomycin 5
- In general, there are 20 drops in each mL of an eye drop.
Storage
- The shelf life for preserved eye products is 28 days after opening, unless otherwise stated;
each hospital may have its own discard policy.(2)
- The 28 days policy is based on research from earlier times when drops were dispensed
in glass bottles with glass pipettes, and many eye drops did not contain preservatives.(30)
- Systane Hydration, Systane Gel Drops
o Discard any remaining solution three months after first opening.(9)
- Systane Ultra, Systane Balance
o Discard any remaining solution six months after first opening.(9)
- Hylo-comod eye drops, Hylo-gel
o Can be used for 6 months after opening.(9)
- Allergo-comod 2% eye drops, Timo-comod 0.5% eye drops
o To be used within 12 weeks after opening.(9)
- Xalatan (latanoprost) and Xalacom (latanoprost + timolol) eye drop
o Store unopened bottle(s) under refrigeration at 2°C to 8°C. Once a bottle is
opened for use, it may be stored at room temperature up to 25°C for 4 weeks.(9)

Eye drops
Method of administration(2, 14, 26)
- Wash your hands thoroughly with soap and water.
- Sit or lie down.
- Check the dropper tip to make sure that it is not chipped or cracked.
- Avoid touching the dropper tip against your eye or anything else - eye drops and droppers
must be kept clean.
- Shake suspension (cloudy liquids) gently before use.
- While tilting your head back, gently pull down the lower lid of your eye with your index
finger to form a pouch.
- Hold the eye drop container (tip down) with your other hand, as close to the eye as
possible without touching it.
- Brace the remaining fingers of that hand against your face.
- While looking up, gently squeeze the dropper so that a single drop falls into the pouch
made by the lower eyelid. If you think the first drop missed your eye, put in another.
Remove your index finger from the lower eyelid.
- Close your eye for 2 to 3 minutes and tip your head down as though looking at the floor.
Do not blink, rub or squeeze the eyelid.
- Apply gentle pressure with a finger against the inner corner of the eye (over the tear duct)
for a few minutes. This increases the medicine efficacy by reducing the amount drained
from the eye and helps reduce the amount of medicine that gets into the rest of your
body where it may cause side effects.
- Wipe any excess liquid from your face with a tissue.
- The eye pouch will be full after a single drop. If you are to use more than one drop in the
same eye, wait at least 5 minutes (AMH: at least 3 minutes) before instilling the next drop.
- If eye drops are being used at the same time of day as eye ointments or gels, the eye
ointment should be used last. Eye ointments may blur vision and generally used at night.

- If you find it difficult to tell whether a drop has gone into your eye and you don’t have
someone to help, try storing your eye drops in a refrigerator, so you can feel when the
cold drop goes in your eye.
- Replace and tighten the cap on the dropper bottle. Do not wipe or rinse the dropper tip.
- Wash your hands to remove any medication.
The ‘traditional’ method and ‘one-handed’ method of instilling eye drops(30)
‘Traditional’ method ‘One-handed’ method
The bottle is held upside down in one hand Patients hold the bottle between the thumb
between the thumb and index finger and with and index finger of their dominant then rest
the other hand, the lower eyelid is gently their little finger and use it to pull the lid out
pulled down to form a pouch. The head is and create a pocket. Then tilting their head
tilted back, the patient looks up and, placing back, they look up and squeeze the bottle.
the tip of the bottle close to their lower eyelid,
It is almost impossible to miss as the tip of the
gently squeezes the bottle to release one drop
bottle is within two or three centimeters of
into the pouch formed between the eye and
the eye.
lid.
Children(2)
- Hold the child’s eyelids open between the index finger and thumb of one hand and put
drops in with the other. If this is difficult, put a couple of drops onto the skin at the inner
corner of the eye and wait for the eyes to open.
- Infants and toddlers may need to be held still during administration. If you don’t have
someone to help you may need to swaddle the child with a sheet or lay them on the floor
and gently hold their head still between your knees.

Eye ointments and gels
Method of administration(2, 14, 26)
- Wash your hands thoroughly with soap and water.
- Sit or lie down.
- Avoid touching the tip of the tube against your eye or anything else – the medication and
its container must be kept clean.
- Holding the tube between your thumb and forefinger, place it as near to your eye lid as
possible without touching it.
- Brace the remaining fingers of that hand against your face.
- Tilt your head forward slightly.
- While tilting your head back, pull down the lower lid of your eye with your index finger
to form a pocket.
- Squeeze a small amount of ointment or gel (about 1 cm length) into the pocket made by
the lower lid, but do not let the tip of the tube touch eye, skin or lashes. Remove your
index finger from the lower eyelid.
- Blink your eye gently several times to spread the ointment, then close your eye for 1 to
2 minutes; OR
Gently close the eye and roll the eye ball in all directions to spread the medication. Try
not to blink and do not rub the eye.(9)
- With a tissue, wipe any excess ointment or gel from the eyelids and lashes. With another
clean tissue, wipe the tip of the tube clean.
- Replace and tighten the cap right away.
- Wash your hands to remove any medication.

- If you need to use to drops at the same time of day, use the ointment last. Eye ointments
may blur vision and generally used at night.

Multiple eye drops and/or ointment
Where multiple drops and/or ointment are prescribed for one or both eyes, the order of
administration is important to ensure maximum therapeutic effect of each. Only one drop of
each drug is required; more than this will create overflow onto the cheek. Ideally, five minutes
should elapse between administration of a different eye drop to achieve maximum therapeutic
effect.(31)
Order Drug
A Local anesthetics Mydriatics and cycloplegics

- Oxybuprocaine hydrochloride - Atropine
- Proxymetacaine - Cyclopentolate
- Homatropine
Miotics
- Tropicamide
- Pilocarpine (eye drops)
B Sympathomimetics Tear deficiency products

- Phenylephrine - Acetylcysteine
- Adrenaline - Carbomers
- Apraclonidine - Hydroxyethylcellulose
- Brimonidine - Hypromellose
- Polyvinyl alcohol
- Sodium chloride
C Non-steroidal preparations Steroids

- Diclofenac - betamethasone
- ketorolac - dexamethasone
- fluorometholone
- prednisolone

Order Drug
D Antibiotics Carbonic anhydrase inhibitors

- cefuroxime - dorzolamide
- chloramphenicol (eye drops)
Prostaglandin analogues
- ciprofloxacin
- fusidic acid - bimatoprost
- gentamicin - latanoprost
- neomycin - tafluprost
- penicillin - travoprost
Antifungals Ointments
- miconazole - acyclovir
- atropine
Anti-inflammatory
- betamethasone
- antazoline - chloramphenicol
- lodoxamide - chlortetracycline
- sodium cromoglicate - gentamicin
- hydrocortisone
Beta-blockers
- liquid paraffin
- betaxolol - pilocarpine
- carteolol
- levobunolol
- metipranolol
- timolol

Glaucoma
Glaucoma is characterized by optic neuropathy, optic disc changes and irreversible progressive
visual field loss. They are primarily classified as either open-angle or angle-closure.(2)
Open-angle glaucoma
Increased intraocular pressure (IOP) or ocular hypertension (although not a defining
characteristic) is the only modifiable risk factor for glaucoma. Though not all people with raised
IOP will develop glaucoma, it is more likely in those with major risk factors, such as older age,
strong family history. Early treatment preserves the visual field and reduces rate of glaucoma
progression whether or not IOP is raised.(2)
A target IOP for treatment is determined based upon the patient’s risk factors for glaucoma
progression, the amount of initial damage and the rate of deterioration.(2)
Laser or surgical interventions are considered if drug treatment is inadequate or intolerable.(2)
Drug choice(2)
- Topical drugs are first-line treatment (either alone or in combination). They reduce IOP
by decreasing production of aqueous humor and/or by increasing its outflow.
- Consider starting, changing or adding medications to just one eye, using the other as a
control; assess IOP within 2–4 weeks before treating the other eye.
- Since glaucoma is usually asymptomatic, compliance is a major problem (up to 50% of
patients fail to use their medication correctly); check compliance when considering
changing dose or adding a new agent to an existing regimen.
- Consider the preservative in eye drops as some, especially benzalkonium chloride, can
irritate and damage the cornea and may cause symptoms similar to those of dry eye
syndrome. These may improve after swapping to less irritant or preservative-free
products.
- Acetazolamide may be used if topical treatment, laser or surgical interventions are not
possible or have poor outcomes.
Class Doses per Comments

day
Prostaglandin analogues 1 (evening − first line

(bimatoprost, for optimal − increase aqueous outflow
latanoprost, tafluprost, effect) − the most effective class
travoprost) − may cause iris hyperpigmentation (color of iris
appears darker) and eyelash changes

Class Doses per Comments
day
Beta- 1–2 − first line

blockers (betaxolol, − decrease aqueous production
timolol) − may cause systemic adverse effects, e.g.
bradycardia
− generally avoided in severe or poorly
controlled asthma (betaxolol is less likely to
cause bronchospasm than timolol but still has
to be used with caution in asthmatics.)
Alpha2 agonists 2–3 − second line

(apraclonidine, − increase aqueous outflow and decrease its
brimonidine) production
− apraclonidine can only be used short term (up
to 3 months) as effect usually declines after a
month
Carbonic anhydrase 2–3 − second line

inhibitors (brinzolamide, − decrease aqueous production
dorzolamide) − Your eye may feel uncomfortable for a little
while after you have put in the drop. If you
have blurred vision, avoid driving or operating
machinery until your sight improves.
Cholinergic (pilocarpine) 3–4 − rarely used (e.g. angle-closure glaucoma and

some secondary glaucomas), seek specialist
advice
− increases aqueous outflow
− high incidence of adverse effects, e.g. blurred
vision, headache
Angle-closure glaucoma
Up to 75% of patients with angle-closure glaucoma will have intermittent or chronic angle closure
with asymptomatic progressive loss of visual field rather than an acute crisis. Initial treatment is
iridotomy (laser or surgical); if unsuccessful, surgical procedures are considered. Topical
treatment may be used, particularly in those with persistent raised IOP despite laser or surgical
procedures.(2)

Risk factors include Asian ethnicity, small eye, narrow angle of anterior chamber, shallow anterior
chamber, long sight, age and female gender. Use of some drugs may precipitate acute angle-
closure crisis.(2)
Acute angle-closure crisis

This is a rare ophthalmic emergency: treatment is by laser iridotomy. Oral, IV and topical
medication may be necessary to stabilize the eye and lower IOP before laser iridotomy. IV
acetazolamide, topical pilocarpine, a topical beta-blocker, IV mannitol or oral glycerol may be
used; seek specialist advice.(2)

Allergic conjunctivitis
Allergic conjunctivitis
A common condition characterized by itchy eyes; other symptoms may include redness, swelling
and tearing. It may occur in association with allergic rhinitis. There are 2 main types, seasonal
(hay fever) and perennial. Drug treatment is aimed at symptom control.(2)
Before starting treatment(2)

Identify and avoid triggers (e.g. pollens, animal dander, house dust mites) where possible.
Refer patients who wear contact lenses or who have eye pain, photophobia, visual disturbance
or severe conjunctivitis to an eye specialist for further investigation.
Topical treatment(2)
When selecting treatment, consider potential adverse effects, convenience (including frequency
of use), cost and patient preferences.
General measures include:
- application of cold compress to eyelids as required
- irrigation with sodium chloride 0.9% solution (e.g. twice daily)
- use of ocular lubricants.
Antihistamines: topical antihistamines are preferred to oral antihistamines (particularly for
isolated ocular symptoms) as they have a more rapid onset; however, they can sting on
instillation. Antihistamines with mast cell stabilizing properties (azelastine, ketotifen and
olopatadine) may also prevent symptoms of allergic conjunctivitis.
Mast cell stabilizers are not useful for acute symptoms as they can take up to 2 weeks to reach
full effect. They may be useful if started 2–4 weeks before hay fever season or if used with a
topical antihistamine for initial symptom control.
Ketorolac or diclofenac are NSAIDs occasionally used for seasonal allergic conjunctivitis when
response to other treatments is inadequate and additional anti-inflammatory effects are
required.
Corticosteroids should only be used under specialist supervision for severe symptoms
unresponsive to other treatments. They have serious adverse effects that require monitoring
(e.g. raised intraocular pressure).

Vasoconstrictors are available in combination with antihistamines. They are not recommended
as their benefit is doubtful and rebound hyperemia can lead to overuse.
Practice points
Treatment for allergic rhinitis, e.g. intranasal corticosteroids, may also relieve the symptoms of
allergic conjunctivitis.(2)

Fondaparinux sodium solution for injection 2.5 mg/0.5
ml (Arixtra)
Indication Dosage
Prevention of VTE SC, 2.5 mg once daily for 5–9 days; give first dose 6 hours after surgical
closure provided hemostasis has been established; may be continued up
to 31 days after orthopedic surgery.
CrCl 30–50 mL/minute, SC 1.5 mg once daily.
Treatment of VTE Continue treatment until adequate oral anticoagulation is established.

<50 kg, SC 5 mg once daily.
50–100 kg, SC 7.5 mg once daily.
>100 kg, SC 10 mg once daily.
>100 kg and CrCl 30–50 mL/minute, SC initial dose 10 mg, then 7.5 mg
once daily.
Treatment of high- SC, 2.5 mg once daily for up to 8 days.

risk NSTEACS
- Use at the same time every day.(11)

- Advise patient to rotate injection sites.(4)
- If missed a dose for more than 8 hours, to skip the dose and take the next dose (do not
double the dose).(11)
- To inform health care professionals (dentists, surgeon, doctor, pharmacists) if the patient
is planning to get a tooth extraction when consulting for medication, supplement or
herbal remedies.(11)
Method of administration(6, 11)

There are two types of safety syringes used for Arixtra, designed to protect you from needle stick
injuries following injection. One type of syringe has an automatic needle protection system and
the other has a manual needle protection system.
Parts of the syringes:

1. Needle shield
2. Plunger
3. Finger-grip
4. Security sleeve
Syringe with an automatic needle protection system.
Syringe with a manual needle protection system
Syringe with a manual needle protection system showing security sleeve being pulled over needle
after use
Wash your hands thoroughly with soap and water and dry them with
water.
Remove the syringe from the carton and check that:

- the expiry date has not passed
- the solution is clear and colorless and does not contain
particles
- the syringe has not been opened or damaged.

Sit or lie down in a comfortable position so you can easily see the area
of the stomach where you will be injecting. A lounge chair, recliner or
bed (propped with pillows) is ideal.
Choose a place in the lower abdominal (tummy) area, at least 5cm

below your belly button. Alternate the left and right side of the lower
abdominal area at each injection. This will help to reduce the
discomfort at the injection site.
Do not inject yourself within about 2 inches of your belly button, near
scars, bruises or stretch mark.
Clean the area you have selected for your injection with soap and
water or with alcohol swab. Allow the area to dry.
Hold the security sleeve firmly in one hand. Pull off the cap that
protects the plunger. Discard the plunger cap.
Remove the needle shield by first twisting it and then pulling it in a

straight line away from the body of the syringe. Discard the needle
shield.
Important note:
- Do not touch the needle or allow it to touch any surface before
the injection to prevent infection.
f
- It is normal to see a small air bubble in this syringe. Do not try
to remove this air bubble before making the injection – you
may lose some of the medicine if you do.

Gently pinch the skin that has been cleaned to make a fold. Hold the
fold between the thumb and the forefinger of one hand during the
entire injection.
Hold the syringe firmly in your other hand using the finger grip. Insert
the full length of the needle (at an angle of 90°) into the skin fold.
Inject all of the medicine in the syringe by pressing down on the

plunger as far as it goes.

For syringe with automatic needle protection system:
Release the plunger. The needle will withdraw automatically from the
skin and pull back (retract) into the security sleeve where it will be
locked permanently.
For syringe with manual needle protection system:

After the injection, hold the syringe in one hand by gripping the
security sleeve. Use the other hand to hold the finger grip and pull
firmly back. This unlocks the sleeve. Slide the sleeve up the body of the
syringe until it locks into position over the needle.
Do not rub the injection site after administration.
Drop the used syringe, needle first, into an empty thick plastic
container such as empty liquid laundry detergent bottle, empty bleach
bottle or something similar. When the container is full, cap tightly,
wrap in a trash bag and throw in your household trash.
Adverse effects
- This drug may cause fever or anemia.(4)
- Advise patients who have received epidural or spinal anesthesia to report
signs/symptoms of neurological impairment, as drug increases risk for development of
an epidural or spinal hematoma.(4)
- Instruct patient to report signs/symptoms of bleeding such as bruises with unknown
cause, blood in urine/dark colored urine, black stools, gum bleeding or heavy menstrual
bleeding, especially if concomitant anticoagulants.(4, 11)
Storage(6)
- Keep this medicine out of the sight and reach of children.
- Store below 25°C. Do not freeze.
- Arixtra does not need to be kept in the fridge
- Do not use this medication if
o After the expiry date shown on the label and carton

o If you notice any particles in the solution or if the solution is discolored
o If you notice that the syringe is damaged.
o If you have opened a syringe and you do not use it straight away.

Glyceryl trinitrate sublingual spray, 400 mcg
Indication Dosage
Acute angina Adult, 400-800 micrograms (1 or 2 sprays); repeat after 5

minutes if necessary to a maximum of 3 sprays.
Prevention of acute angina before Adult, 400 micrograms (1 spray) 5-10 minutes before
a precipitating activity activity.
- Use during episodes of angina or before an activity expected to bring on angina.(2)
- When using GTN, especially for the first time, patient should sit down or have something
to hold on to in case of dizziness/light headedness due to hyptension. Other side effects
inlcude headahce and flushing.(8)
- Prime the spray before using it for the first time by pressing the nozzle 5 times, spraying
it into the air. Prime it with 1 spray if it hasn’t been used for 7 days. Prime it with 5 sprays
if it hasn’t been used for more than 4 months. When ready to use, aim the spray under
the tongue and press the nozzle once; do not inhale the spray. When ready to use, aim
the spray under the tongue and press the nozzle once; do not inhale the spray.(2)
- During application, the patient should rest, ideally in the sitting position. Advise patient
to hold breath prior spray. The canister should be held vertically with the valve head
uppermost and the spray orifice as close to the mouth as possible. Press down the button
firmly. The spray should not be inhaled.(11)
- Patients should be instructed to familiarize themselves with the position of the spray
orifice, which can be identified by the finger rest on top of the valve, in order to facilitate
orientation, for administration at night.(11)
- Call an ambulance if symptoms are severe, get worse quickly or last for 10 minutes.(2)
- The onset of action is within two to five minutes and the duration of action is 15 to 30
minutes. Tolerance is not a problem with sublingual nitroglycerin because of its
intermittent administration, even in patients on chronic nitrate therapy.(3)
- The recommended nitroglycerin dose is 0.3 mg (1/200 grains) to 0.4 mg (1/150 grains).
One-half the dose (0.15 mg or 1/400 grains) can be used if the patient becomes
hypotensive or develops symptoms such as headache or flushing with the higher doses.

Elderly patients should be warned about potential lightheadedness, especially in warm
weather.(3)
- The traditional recommendation is for patients to take one nitroglycerin dose
sublingually every five minutes for up to three doses before calling for emergency
medical services (EMS) evaluation. However, studies suggest that this approach may
result in significant delays in obtaining EMS assistance. For patients known to their
providers to have frequent angina, physicians may consider a selected, more tailored
message that takes into account the frequency and character of the patient’s angina and
their typical time course of response to nitroglycerin.(3)
- Once opened, glyceryl trinitrate sublingual tablets have a short shelf life (3 months)
compared with the spray (2 years). The spray may be particularly useful for patients with
infrequent symptoms. Effects may be easier to adjust with sublingual tablets.(2)
- Serious hypotension can occur when nitrates are used with selective phosphodiesterase
type 5 inhibitors (PDE5 inhibitors). Nitrates should be avoided if the patient has used
sildenafil in the previous 24h or tadalafil in the previous 48h.(8)
Adverse effects
- Tell patient to avoid activities requiring mental alertness or coordination until drug
effects are realized as drug may cause dizziness.(4)
- Counsel patient to report severe hypotension.(4)
- Side effects may include headaches, flushing, rash and paresthesia.(4)
Storage
- Do not refrigerate or freeze.(11)
- Do not use GTN sprays if you are near a naked flame, e.g. a cigarette.(11)

Glyceryl trinitrate sublingual tablet, 500 mcg
Indication Dosage
Acute angina Adult, 300-600 micrograms repeated every 3-4 minutes

until pain is resolved, to a maximum of 1800 microgram.
Prevention of acute angina before Adult, 300-600 micrograms 5-10 minutes before activity.
a precipitating activity
- Use during episodes of angina or before an activity expected to bring on angina.(2)
- When using GTN, especially for the first time, patient should sit down or have something
to hold on to in case of dizziness/light headedness due to hyptension. Other side effects
inlcude headahce and flushing.(8)
- Place half to one tablet under your tongue; do not swallow it; after the pain has been
relieved, you may spit out or swallow what is left of the tablet to avoid adverse effects
such as headache.(2)
- If the sublingual nitroglycerin is potent, a slight tingling sensation should be felt under
the tongue. Tablets that crumble easily should not be used. The sublingual mucosa
should be moist for adequate dissolution and absorption of the tablet. A drink of water
in patients with dry sublingual mucosa prior to ingestion of the tablet may be
necessary.(3)
- Call an ambulance if symptoms are severe, get worse quickly or last for 10 minutes.(2)
- The onset of action is within two to five minutes and the duration of action is 15 to 30
minutes. Tolerance is not a problem with sublingual nitroglycerin because of its
intermittent administration, even in patients on chronic nitrate therapy.(3)
- The recommended nitroglycerin dose is 0.3 mg (1/200 grains) to 0.4 mg (1/150 grains).
One-half the dose (0.15 mg or 1/400 grains) can be used if the patient becomes
hypotensive or develops symptoms such as headache or flushing with the higher doses.
Elderly patients should be warned about potential lightheadedness, especially in warm
weather.(3)
- The traditional recommendation is for patients to take one nitroglycerin dose
sublingually every five minutes for up to three doses before calling for emergency
medical services (EMS) evaluation. However, studies suggest that this approach may

result in significant delays in obtaining EMS assistance. For patients known to their
providers to have frequent angina, physicians may consider a selected, more tailored
message that takes into account the frequency and character of the patient’s angina and
their typical time course of response to nitroglycerin.(3)
- A less popular but equally effective means of administering sublingual nitroglycerin is by
metered dose spray.(3)
- Once opened, glyceryl trinitrate sublingual tablets have a short shelf life (3 months)
compared with the spray (2 years). The spray may be particularly useful for patients with
infrequent symptoms. Effects may be easier to adjust with sublingual tablets.(2)
- Serious hypotension can occur when nitrates are used with selective phosphodiesterase
type 5 inhibitors (PDE5 inhibitors). Nitrates should be avoided if the patient has used
sildenafil in the previous 24h or tadalafil in the previous 48h.(8)
Adverse effects
- Tell patient to avoid activities requiring mental alertness or coordination until drug
effects are realized as drug may cause dizziness.(4)
- Counsel patient to report severe hypotension.(4)
- Side effects may include headaches, flushing, rash and paresthesia.(4)
Storage:
- It is important to store these tablets properly or they may not work as well. Keep them
in the original glass bottle away from moisture, heat and light; close lid tightly. Do not
carry them close to your body.(2)
- GTN tablets have a limited 8 weeks of shelf-life once opened (ensure patients are
informed).(8)

Head lice
Head lice
Head lice affect all ages, although they are much more prevalent in children aged 4 to 11 years,
especially girls. Head lice can occur at any time and do not show any seasonal variation. It can
only be transmitted by head-to-head contact. Fleeting contact will be insufficient for lice to be
transferred between heads.(15)
A moving louse must be found to confirm infestation (wet combing is better than visual
inspection for doing this). Itching or the presence of eggs (nits) does not necessarily indicate
active infestation.(2) Do note that only third of patients experience itching (caused due an allergic
response of the scalp to the saliva of lice and can take weeks to develop).(15)
Examine family members and close contacts for infestation. Family members with head lice
should be treated at the same time to prevent infestation.(2)
Drug choice
Common treatments of head lice(2)
Active ingredients Brand® Mode of Age Application time

action
1 preferred treatments in pregnancy
benzyl alcohol NeutraLice physical >6 months 10 minutes

Advance insecticide
dimeticone1 Hedrin 15 physical all ages 15 minutes (other

insecticide brands may differ)
isopropyl myristate Full Marks physical >2 years 10 minutes

Solution insecticide
malathion KP 24 neurotoxic >6 months foam, 30 minutes;

insecticide lotion, 12 hours
permethrin1 Quellada neurotoxic >2 months 10 minutes

insecticide
pyrethrins/piperonyl Banlice, neurotoxic all ages mousse, 10 minutes;

butoxide Paralice insecticide aerosol spray,
30 minutes

Neurotoxic insecticides: Permethrin 1%: safe and effective; short application time (10
minutes); treatment of choice in pregnancy and breastfeeding.(2)
Resistance is common;
check lice are killed the day Malathion: organophosphate insecticide, is an alternative, but
after the first treatment resistance has been reported.(10)
and repeat successful
Maldison: organophosphate pesticide; safe and effective when
treatment after 7 days; if
used as directed; avoid use in pregnancy and children <6 months;
lice are not killed, use a
smelly.(2)
different treatment as
soon as possible. Although Pyrethrins with piperonyl butoxide: probably as effective as other
they may kill some eggs, insecticide treatments.(2)
they do not remove
them.(2)
Physical insecticides: Benzyl alcohol 5%: little or no odor, well tolerated and safe in
children >6 months; has short application time (10 minutes); may
Kill lice via physical action
kill some eggs. Repeat treatment after 7 and 14 days.(2)
(e.g. by disrupting water
balance). Effective against Dimeticone 4%: odorless, well tolerated and safe in children,
resistant lice; resistance is pregnancy and breastfeeding; application time differs between
unlikely.(2) products; It coats head lice and interferes with water balance in
lice by preventing the excretion of water; it is less effective
against eggs and treatment should be repeated after 7 days.(2,
10)
Isopropyl myristate: odorless, well tolerated, and safe in children
>2 years; has short application time (10 minutes); does not kill
eggs. Repeat treatment after 7 days.(2)
Other treatment Wet combing: meticulous combing (using a fine-tooth comb) with
conditioner can be used to detect and treat head lice. Evidence is
unreliable, it does not kill lice or eggs, and it requires motivation
to be effective (as it relies on the physical removal of lice and
eggs). Repeat every 2 days until no head lice are seen for 10
consecutive days.(2)
Electronic comb: electrocutes lice and can also be used to detect
head lice. It does not kill or remove eggs. There is anecdotal
evidence that that repeated use of an electronic comb (available
at most pharmacies) may be a useful non-drug alternative. It is
less time-consuming than insecticides and other topical

treatments, does not damage hair and avoids the smell and
cosmetic problems associated with some topical products.(2)
Essential oils, herbal products: there is some evidence to suggest
that 3 applications, 1 week apart, of MOOV Head Lice Solution®
(eucalyptus oil 11%) or NeutraLice Lotion® (tea tree oil 10% and
Lavender oil 1%) are effective, however, they may cause adverse
effects (e.g. stinging or burning). Evidence supporting the use of
other products for treatment of headlice is insufficient.(2)
Ivermectin: specialists may use ivermectin for head lice refractory
to all other treatments.(2)
Treatment failure: may result from inadequate or incorrect application, reinfestation or

pediculicide resistance.(2)
Counseling(2)
- Check other family members for head lice. Treat only if a live louse is found.
- Treatment with insecticides requires 2 applications 7 days apart (3 applications of benzyl
alcohol are recommended). This ensures that lice that have hatched since the first
application are killed.
- Apply the insecticide to hair without conditioner or hair products in it. Avoid using a hair
dryer after insecticide treatment as heat may destroy the active ingredient.
- Do not overuse insecticide treatment or use them to prevent head lice infestation.
Overuse of insecticides may cause irritation and, in the case of neurotoxic insecticides,
result in resistant lice.
- The only way to remove nits is with a fine-tooth comb or by pulling them off with your
fingernails.
- Children can be sent back to school after the first treatment. Tell children not to share
hats and hairbrushes.
- Soak combs and hairbrushes in hot water (>60°C) for 30 seconds and wash pillowcases in
hot water or put in a clothes dryer for 15 minutes.
- Clothing, bedding, and towels used within 48 hours before treatment should be washed
in hot water and dried in an electric dryer on the hot setting. Dry cleaning is also effective.
You can use a vacuum to clean furniture, carpet, and car seats. Items that cannot be
washed or vacuumed can be sealed inside a plastic bag for two weeks. Items that the
person used more than two days before treatment are not likely to be infested because

head lice cannot survive off the body for more than 48 hours. You do not need to have
your home sprayed for lice.(3)

Gamma Benzene Hexachloride 1% lotion
Lindane lotion has been discontinued in the US for more than 1 year. It is not recommended for
first line-treatment; use should be reserved for patients who are intolerant to or have failed first-
line agents. Although FDA approved, lindane is not recommended as a treatment option for head
lice or scabies in pediatric patients <50 kg due to safety concerns and use should be avoided if
possible. Use in pregnant women has been associated with neural tube defects and mental
retardation. Nursing mother should interrupt breastfeeding, express and discard milk for at least
24 hours following use. In addition, skin-to-skin contact between the infant and affected area
should be avoided.(12)

Although FDA approved, lindane is not recommended as a treatment option for head lice or
scabies in pediatric patients <50 kg due to safety concerns and use should be avoided if possible.
Indication Dosage
Scabies Wait at least 1 hour after bathing or showering (wet or warm skin increases
absorption). Skin should be clean and free of any other lotions, creams, or oil prior
to lindane application. Apply a thin layer of lotion and massage it on dry, cool skin
from the neck to the toes; do not apply to face or eyes. Do not use on open
wounds or sores. Do not use occlusive dressings. After 8-12 hours, bathe and
remove the drug; most patients will require 30 ml; larger adults may require up to
60 ml. Do not retreat. Do not leave on for more than 12 hours. CDC STD guidelines
recommend an 8-hour application.
Head lice, Wait at least 1 hour after washing hair before applying lindane shampoo. Hair
crab lice should be washed with a shampoo not containing a conditioner; hair and skin of
head and neck should be free of any lotions, oils or creams prior to lindane
application. Apply shampoo to clean, dry hair and massage into hair for 4 minutes;
add small quantities of water to hair until lather forms, then rinse hair thoroughly
and comb with a fine-tooth comb to remove nits. Do not cover with shower cap
or towel. Amount of shampoo needed is based on length and density of hair; most
patients will require 30 ml (maximum: 60 ml). Do not retreat.
- Shake well prior to use. For topical use only; never administer orally. Caregivers should
apply with gloves (avoid natural latex; may be permeable to lindane). Rinse off with warm
(not hot) water.(12)
- Keep away from eyes and mouth; do not use in presence of open wounds, cuts or sores.(4)
- Instruct patient to apply lotion to clean skin free of cream, lotion or oil, as these products
can increase the risk of neurotoxicity. Patients using the shampoo formulation should

also avoid oil-based conditioners or treatments immediately before or after medication
application for the same reason.(4)
- Seizures and deaths have been reported with use (may occur with prolonged, repeated
or single use). Use is contraindicated in patients with uncontrolled seizure disorders and
in premature infants. Use with caution in infants, small children, the elderly, patients with
other skin conditions, patients weighing <50 kg, or patients with a history of seizures,
head trauma, or HIV infection; use caution with conditions which may increase risk of
seizures or medications which decrease seizure threshold.
- Lindane is contraindicated in premature infants; the skin of premature infants may be
more permeable and their liver enzymes may not be fully developed when compared to
full-term infants.
- Use in pregnant women has been associated with neural tube defects and mental
retardation.
- Nursing mother should interrupt breastfeeding, express and discard milk for at least 24
hours following use. In addition, skin-to-skin contact between the infant and affected
area should be avoided.

Malathion 0.5% lotion
Indications and dosage – Use is contraindicated in neonates and infants.(12)
Indication Dosage
Head lice (Pediculus humanus Children 2 to 5 years, limited data available: only use for head
capitis) lice resistant to permethrin/pyrethrins or previously failed
courses.
Children ≥6 years and adult, apply sufficient amount to cover
and thoroughly moisten dry hair and scalp; allow hair to dry
naturally and shampoo after 8 to 12 hours (typically overnight
application). If required, repeat with second application in 7
to 9 days. Note: in a blinded, comparative trial with
permethrin, a shorter application time of 20 minutes was
shown effective. Further treatment is generally not necessary.
It is indicated for adult and child >6 months in AMH.(2)
Pubic lice (Pediculosis pubis) Adolescent (limited data available) and adult, apply to
(following treatment failure of affected area. Wash off after 8 to 12 hours.
pediculicides) (off-label use)
For external use only; avoid contact with eyes. Apply to dry hair and scalp and rub gently until
thoroughly moistened; pay attention to the back of the head and neck. Allow hair to dry naturally;
do not use heat; leave hair uncovered. After 8-12 hours, the hair should be washed with a
nonmedicated shampoo; rinse and use a fine-toothed (nit) comb to remove dead lice and eggs.
Evaluate other family members to determine if infested and require treatment. Wash hands
immediately after use.(12)
Lotion is flammable. Patient should not expose lotion and wet hair to open flames or electric heat
sources (e.g. hair dryers, curling irons). Advise patient not to smoke when applying lotion or while
hair is wet.(4)
Patient should avoid drug contact with eyes. Instruct patient to report persistent eye irritation or
visual changes following accidental eye exposure.(4)
Malathion should be a portion of a whole household lice removal program, which should include
washing or dry cleaning all clothing, hats, bedding, and towels recently worn or used by the
patient and washing combs, brushes, and hair accessories in hot soapy water.(12)

Pregnancy
Avoid use; dimeticone or permethrin are preferred.(2)
Adverse effects
- This drug may cause skin irritation, stinging or burns (including second degree).(4)
- Advise patient to suspend use with skin irritation (until clear), and to report recurrence
of skin irritation following a secondary application.(4)
Storage
Store at room temperature 20°C to 25°C. Do not expose to heat and open flames.(12)

Permethrin 1% lotion.
Indication Dosage
Head lice Infants ≥2 months, children, adolescent and adult, prior to application,
wash hair with conditioner-free shampoo; rinse with water and towel dry.
Apply a sufficient amount of lotion or cream rinse to saturate the hair and
scalp (especially behind the ears and nape of neck). Leave on hair for 10
minutes (but no longer), then rinse off with warm water; remove
remaining nits with nit comb. A single application is generally sufficient;
however, may repeat 7 to 9 days after first treatment if lice or nits are still
present; optimal time to repeat is at day 9 based on the life cycle of lice.
# When treating scabies in elderly patients, also apply on the hairline,
neck, scalp, temple and forehead.
Pubic lice (off- Adolescent (limited data available) and adult, apply to affected areas and
label use) wash off after 10 minutes.
Avoid contact with eyes and mucous membranes during application. Because scabies and lice are
so contagious, use caution to avoid spreading or infecting oneself; wear gloves when applying.
For the treatment of head lice, use as a portion of a whole lice removal program, which includes
washing or dry cleaning all clothing, hats, bedding, and towels recently worn or used by the
patient and washing combs, brushes and hair accessories in hot water; items that cannot be
washed should be sealed in a plastic bag for ≥4 weeks.(12)
Pregnancy
Adverse effects have not been observed in oral animal reproduction studies. The amount of
permethrin available systemically following topical application is ≤2%. The CDC considers the use
of permethrin or pyrethrins with piperonyl butoxide the dugs of choice for the treatment of pubic
lice during pregnancy; permethrin is preferred treatment of scabies during pregnancy.(12)
Breastfeeding
Permethrin is present in breastmilk following environmental exposure (e.g., exposure to
pyrethroids used for agriculture or malaria control). It is not known if permethrin is present in

breast milk following topical administration for the treatment of scabies or lice. Permethrin
exhibits minimal systemic absorption following topical administration (≤2% of applied amount)
and any absorbed drug is rapidly metabolized to inactive metabolites. Therefore, breastfeeding
is not expected to result in significant exposure to a breastfed child. Although the manufacturer
recommends against breastfeeding during therapy, permethrin is considered to be a drug of
choice for the treatment of pubic lice and crusted scabies in patients who are breastfeeding a
child (CDC [Workowski 2015]).(12)
Adverse effects
This drug may cause or exacerbate pruritus, edema and erythema. Drug may also cause stinging
or burning of skin.(4)
Storage
Store at room temperature 20°C to 25°C.(12)

Hemophilia
Hemophilia and related conditions
The hemophilias and von Willebrand’s disease (vWD) account for 80% to 85% of inherited
bleeding disorders. Hemophilia A and B are X-linked, whereas vWD and rare bleeding disorders
(RBDs) are autosomal disorders.(32)
The diagnosis of hemophilia and other inherited bleeding disorders should be confirmed by
specific laboratory assays because screening tests such as prothrombin time (PT) and activated
partial thromboplastin time (aPTT) may be normal. Plasma levels of deficient factor determine
clinical severity and management.(32)
Major complications associated with hemophilia are inhibitor development, hemarthrosis, and
intracranial hemorrhage. Hemarthrosis is the most common and debilitating complication, and
central nervous system bleeding is the most common cause of mortality in hemophilia. Mucosal
bleeding and menorrhagia are the most common manifestations of vWD. Bleeding
manifestations of RBDs are mild, although homozygotes can present with severe disease.(32)
Early and effective treatment and prophylaxis can prevent repeated hemarthrosis and joint
destruction in persons with hemophilia. Patients should be tested annually for the presence of
inhibitors.(32)
Both plasma-derived and recombinant factor concentrates are effective for the treatment of
hemophilia. Cryoprecipitate is not recommended. For mild and moderate hemophilia A and von
Willebrand's disease, the use of desmopressin coupled with antifibrinolytics can obviate the use
of concentrates. Continued vigilance should be implemented for new and emerging blood-borne
pathogens.(32)
All patients with inherited bleeding disorders should be immunized against hepatitis A and B and
followed in close collaboration with the local hemophilia treatment center.(32)

Hemophilia
What is hemophilia?
Hemophilia is a condition that keeps blood from clotting normally. If blood doesn't clot normally,
people can bleed very easily or much more than normal. The bleeding can sometimes be life-
threatening.(3)
People with hemophilia are missing a protein in the blood called a "clotting factor." Without this,
the blood can't clot normally. There are 2 types of hemophilia (called "A" and "B"), depending on
which clotting factor is the problem:(3)
− In hemophilia A, factor 8 (also written as "factor VIII") is missing or very low.

− In hemophilia B, factor 9 (also written as "factor IX") is missing or very low.
Hemophilia is a life-long condition that a person is born with. It is caused by an abnormal gene.
Sometimes, parents pass this abnormal gene to their child. Other times, a child can get
hemophilia from a new gene abnormality that happens before they are born. In some of these
cases, parents might not know they have the abnormal gene, because they don't have any
symptoms. Boys and men are most likely to have hemophilia. It is very rare in girls or women.(3)
Hemophilia can be mild or severe. It can be managed with different treatments.(3)
What are the symptoms of hemophilia?

The clinical features of hemophilia A and B are generally indistinguishable from each other.(33)
The diagnosis of hemophilia is often made following a bleeding episode or because of a family
history; 30% of cases, however, have no family history. Based on the plasma levels of factor VIII
or IX (normal levels are 50%-150%) that correlate with severity and predict bleeding risk,
hemophilia is classified as mild (>5%), moderate (1%-5%) and severe (<1%).(32)
Hemophilia severity and clinical manifestations(32)
Characteristics Severe (50%-70%) Moderate (10%) Mild (30%-40%)
Factor VIII or IX activity <1% 1% - 5% >5%

(normal 50% - 150%)
Age of diagnosis At birth to 2y Childhood or Adolescence or adult

adolescence
Bleeding patterns 2-4/month 4-6/year Rare

Characteristics Severe (50%-70%) Moderate (10%) Mild (30%-40%)
Clinical manifestations Hemarthroses, Bleeding into joints or Surgical procedures

muscle, central muscle following (including dental) and
nervous system, minor trauma, major trauma
gastrointestinal surgical procedure,
bleeding, dental bleeding.
hematuria Rarely spontaneous.
Approximately 65% of persons with hemophilia have severe disease, 15% have moderate disease
and 20% have mild disease. Most severe disease manifests by 4 years of age; moderate or mild
disease is diagnosed later and often following bleeding secondary to trauma or surgery.(32)
Bleeding is most commonly seen in joints (knees, ankles, elbows), resulting in hot, swollen,
painful joints and subsequent crippling joint deformity. Bleeding can also occur into the muscles
and the gastrointestinal tract. Compartment syndrome can occur from large hematomas.
Hematuria may be present.(33)
Central nervous system (CNS) hemorrhage is a rare but serious complication with a 10%
recurrence rate and is the leading cause of mortality in hemophiliacs. Although most newborns
with severe hemophilia experience an uneventful course following vaginal delivery, vacuum
extraction is associated with an increased CNS bleeding risk. The incidence of intracranial
hemorrhage in newborns with hemophilia is 1% to 4%.(32)
Is there a test for hemophilia?

Yes. Your doctor or nurse can check for hemophilia by doing different blood tests.(3)
Hemophilia A and B are clinically indistinguishable, and specific factor assays are the only way to
differentiate and confirm the diagnosis. Both should be differentiated from von Willebrand’s
disease (vWD). (32)
What if I am pregnant?
Pregnant women who have the hemophilia gene have the chance of passing the gene along to
their baby. Genetic testing can show if you have the gene. If you do, doctors can do a few things
to help prevent problems:(3)
− Do an ultrasound to find out the sex of your baby – This is because only a male baby would
be at risk of having severe hemophilia. If the baby is male, doctors will avoid certain

procedures during labor and delivery that could cause bleeding. In most cases, the baby
is tested after birth to find out if he does have hemophilia.
− Prepare for a safe birth – Some women who carry the gene are at risk of abnormal
bleeding. Your doctor will test your clotting factor levels. This can help them avoid or
prepare for procedures that might cause bleeding. Depending on your levels, you might
also need treatment for bleeding after the baby is born.
How is hemophilia treated?

Nonpharmacologic therapy(33)
- Avoidance of contact sports.
- Patient education regarding the disease; promotion of exercises such as swimming.
- Avoidance of aspirin or other NSAIDs
- Orthopedic evaluation and physical therapy evaluation in patients with joint involvement
- Hepatitis vaccination.
Reversal and prevention of acute bleeding in hemophilia A and B are based on adequate
replacement of deficient or missing factor protein. The choice of the product for replacement
therapy is guided by availability, capacity, concerns, and cost. Recombinant factors cost two to
three times as much as plasma-derived factors, and the limited capacity to produce recombinant
factors often results in periods of shortage.(33) Plasma-derived and recombinant products
appear to have equivalent clinical efficacy. Cryoprecipitate is no longer recommended because
of concerns regarding pathogen safety.(32)
Treatment administered only during bleeding symptoms is known as episodic therapy, and
periodic administration of factor concentrates to prevent bleeding is known as prophylactic
therapy. Response to treatment is more effective when it is administered early. Although
prophylaxis prevents the development of joint disease, the high cost of factor replacement
coupled with the need for venous access makes it expensive and difficult and out of reach for
patients in the developing world.(32)
The goal of treatment is to raise factor levels to approximately 30% or more for minor bleeds
(hematomas or joint bleeds) and 100% for major bleeds (CNS or surgery). Giving 1 U/kg of factor
concentrate raises plasma factor VIII levels by 2% and factor IX levels by 1.5% (except with the
recombinant factor IX product, where it increases by 0.8%). The half-life of factor VIII is
approximately 8 to 12 hours and that of factor IX is up to 24 hours. Factor concentrates can also
be given by continuous infusion (3–4 U/kg/hour). The bolus dose varies from 25 to 50 U/kg
depending on the severity, site, and type of bleeding and is dosed to the available vial size
because of the cost of the products.(32)
Treatment of bleeding episodes and desired plasma levels in hemophilia A and B.(32)

Type of Desired Factor Factor Duration of Comments (Dose factor to
bleeding factor VIII Dose IX Dose treatment the closest vial)
level (%) (U/kg) (U/kg) (Days)
Persistent or 20-30 10-15 20-30 1-2 Local pressure,

profuse antifibrinolytics, fibrin glue
epistaxis, Oral for local control, nosebleed
mucosal QR for epistaxis. Sedation
bleeding in small children with
(including tongue laceration.
tongue and
mouth
lacerations)
Dental 30-50 15-25 30-50 1h before Antifibrinolytics for 7-10d

procedures procedure
Acute 30-60 15-50 30-60 1-3 Use lower doses if treated

hemarthrosis, early. Non-weight bearing
intramuscular on affected joint
hematomas
Physical 30-50 15-25 30-50 Treat Consider synovectomy

therapy before (surgical, radioisotope or
physical chemical) for target joints.
therapy
Life- 80-100 40-50 80-100 10-14d Bolus dose followed by

threatening continuous infusion (3-4
such as U/kg/h); may switch to
intracranial bolus before discharge
hemorrhage,
major surgery
and trauma
Gastrointestinal 30-50 15-25 30-50 2-3 May use oral

bleeding antifibrinolytics

Type of Desired Factor Factor Duration of Comments (Dose factor to
bleeding factor VIII Dose IX Dose treatment the closest vial)
level (%) (U/kg) (U/kg) (Days)
Persistent 30-50 15-25 30-50 1-2 Increase PO or IV fluids

painless gross with low-dose
hematuria antifibrinolytics; risk of
clotting in the urinary tract
with factor replacement
For short-term therapy (before dental procedures and minor bleeding episodes) in mild
hemophilia A and vWD, the synthetic vasopressin analogue desmopressin acetate (DDAVP
[Stimate]) is useful. It increases plasma concentrations of coagulation factor VIII and vWF three-
to fivefold by releasing the endothelial stores. A DDAVP trial to determine response is hlpeful in
selecting patients who might benefit from such therapy. For hemostatic purposes, intravenous
(0.3 μg/kg in 50 mL of normal saline infused over 15–30 min) or intranasal dose (150 μg) can be
used. The intranasal dose is 15 times larger than that recommended for diabetes insipidus. A
multidose intranasal spray formulation (Stimate nasal spray) delivers 150 μg per spray. The
recommended dosage is one spray for patients who weigh less than 50 kg and two sprays (one
in each nostril) for those who weigh more than 50 kg. Desmopressin is ineffective in hemophilia
B. (32)
Antifibrinolytics such as ε-aminocaproic acid (Amicar) and tranexamic acid (Cyklokapron or
Lysteda) are used as adjunct therapies and in mild hemophilia and can decrease the need for
factor concentrates. The recommended dosage for ε-aminocaproic acid is 75 to 100 mg/kg/dose
IV or orally every 4 to 6 hours (maximum 30 g/24 hours). The recommended dosage for
tranexamic acid is 10 mg/kg/dose IV or 25 mg/kg body weight orally, three times daily.(32)
For prophylaxis, factor VIII 25 to 40 U/kg administered every other day or factor IX 25 to 40 U/kg
twice weekly (because of the longer half-life of factor IX) is aimed at preventing joint disease.
Prophylaxis may begin at 1 to 2 years of age and is continued lifelong. Self-infusion before any
planned strenuous activity is recommended. Because of the complications of central venous
catheters (infections, thrombosis, and mechanical), use of a peripheral vein is encouraged. (32)
Complication of treatment
One of the most serious complications of hemophilia treatment is the development of inhibitors
or neutralizing antibodies (immunoglobulin [Ig]G) that inhibit the function of substituted factor
VIII and factor IX. Approximately 5% to 10% of all hemophiliacs and up to 30% of patients with
severe hemophilia A develop inhibitors. The incidence of inhibitors in hemophilia B is lower (1%-

3%). Most factor VIII inhibitors arise after a median exposure of 9 to 12 days in patients with
severe hemophilia A. They can be transient or permanent and should be suspected if a patient
fails to respond to an appropriate dose of clotting factor concentrate. Inhibitors can exacerbate
bleeding episodes and hemophilic arthropathy.(32)
Inhibitor levels, measured using Bethesda units (BU), are classified as high titer (>5 BU) or low
titer (<5 BU). In patients with low titer inhibitors, higher than normal doses of factor VIII or IX
may be used to treat bleeding. For those with high-titer inhibitors, agents that bypass factor VIII
or factor IX are used. These include recombinant activated factor VII and, in the case of
hemophilia A, activated prothrombin complex concentrates (APCC) or recombinant porcine
factor VIII (currently in prelicensure clinical trials). Immune tolerance induction, a long-term
approach designed to eradicate inhibitors, is effective in 70% to 85% of patients with severe
hemophilia A; the most important predictor of success of immune tolerance induction is an
inhibitor titer of less than 10 BU at the start of immune tolerance induction.(32)
Recombinant activated factor VII is useful to stop spontaneous hemorrhages and prevent
excessive bleeding during surgery in 75% of patients with inhibitors. Recommended dose is 90
µg/mg of body weight every 2 to 3 hours for treatment of life-threatening hemorrhage. It is,
however, very expensive.(33)
Although inhibitors are rare in hemophilia B, they can result in anaphylaxis with exposure to
factor IX–containing products. Immune tolerance regimens are associated with nephrotic
syndrome and are successful in eradicating the inhibitor only in 40% of cases.(32)
Another important complication of treatment is the transmission of bloodborne pathogens such
as hepatitis B and C viruses and HIV. In the 1970s, lyophilized plasma factor concentrates of low
purity resulted in the transmission of HIV, causing the deaths of many hemophiliacs. Currently,
donor screening for pathogens coupled with viral attenuation by heat or solvent detergent
technology make these products pathogen safe. However, nonenveloped virus (parvovirus and
hepatitis A) and prions can resist inactivation and can be potentially transmitted. Routine
vaccination against hepatitis A and B is recommended.(32)
What else can people with hemophilia do to avoid bleeding problems?

To avoid bleeding problems, people with hemophilia should:(3)
− See their doctor for regular visits

− Let every doctor who takes care of them know they have hemophilia, and which type ("A"
or "B")
− Follow their doctor's instructions about treatment and which activities or sports to avoid
(if any)
− Learn the signs and symptoms of bleeding, and how to treat it

− Not take aspirin or medicines called NSAIDs without the input of a doctor - Common
NSAIDs include ibuprofen and naproxen.
− Plan ahead for any procedures or surgery that could cause bleeding
− Take good care of their teeth and see their dentist for regular visits
− Take their replacement therapy with them when travelling
If your child has hemophilia, you should let caregivers, daycare, or the school know. Teach them
which symptoms to watch for, and how to treat a bleed.(3)

HIV/AIDS
HIV/AIDS
What is HIV?
HIV is an enveloped, single-stranded RNA virus belonging to the family Retroviridae.(32) It is a
virus that weakens your body's immune system, making it difficult to fight infections and certain
cancers. People who are infected with HIV may have no signs or symptoms of their illness but can
still pass the infection to others through sexual contact or through exposure to contaminated
needles. If HIV is not treated, you will eventually become very ill and may die. The advanced stage
of HIV infection is called AIDS (acquired immune deficiency syndrome).(3)
Two human immunodeficiency viruses exist: HIV-1 and HIV-2. HIV-1 has worldwide distribution,
accounts for most infections outside western Africa. HIV-2 infection is endemic in West Africa
and has limited spread outside this area. It should be considered in infections in patients of West
African origin or those who have had sexual contact or shared needles with people of West
African origin. HIV-2 generally has a longer asymptomatic stage, lower plasma HIV-2 viral loads,
and overall lower mortality rate. Approximately 25-30% of patients with HIV-2 not receiving ART
will have HIV-2 RNA levels below the rate of detection and some will also have clinical progression
and CD4 cell count decline. HIV-2 can progress to AIDS over time. HIV-1 and HIV-2 coinfection
may occur and should be a consideration in patients from HIV-2 high-prevalence areas. Patients
diagnosed with HIV-2 infection should be managed by an HIV specialist.(32)
What is AIDS?
HIV infection does not necessarily mean a person has AIDS. AIDS (acquired immunodeficiency
syndrome) is a disorder caused by infection with the human immunodeficiency virus (HIV) and
marked by progressive deterioration of the cellular immune system, leading to secondary
(opportunistic) infections and/or malignancies. AIDS is diagnosed if the CD4 cell count is <200 or
<14% of total lymphocyte in the presence of proven HIV infection, even in the absence of other
infections.(33)
Who is at risk for HIV?

HIV infection is usually acquired through sexual intercourse or exposure to infected blood or body
fluids. This may occur:(3)
- During sexual contact with an infected person, especially if you have unprotected vaginal
or anal sex
- By sharing needles or syringes used by an infected person

Transmission from a pregnant woman to her baby may occur during pregnancy, birth, or
breastfeeding, although this is uncommon with the use of HIV medications during and after
pregnancy.(3)
HIV infection is NOT spread by casual contact.(3)
Certain individuals may have an increased risk of HIV infection, including the following:(3)
- Men who have sex with men
- Injection drug users who share needles or "works"
- Sexual partners of people who are infected with HIV
- People with a history of a sexually transmitted disease
- Victims of sexual assault
- Men and women who have unprotected sex with multiple partners
- Men and women who exchange sex for money or drugs or have sex partners who do
- Anyone who is accidentally stuck with a needle or sharp in a health care facility
- People who received a blood transfusion or other blood products before 1984
What if I am pregnant or want to get pregnant?

If you have untreated HIV, your baby can become infected with HIV during pregnancy, birth, or
through breastfeeding. If you are pregnant or want to get pregnant, talk with your doctor about
ways to reduce the chance of passing HIV on to your baby.(3)

Symptoms of HIV infection
Symptoms of early HIV infection
Early symptoms of HIV infection develop in 50 to 90 percent of people who are infected, usually
beginning two to four weeks after exposure to HIV. The initial group of signs and symptoms is
referred to as primary or acute HIV infection. Because the signs and symptoms of primary HIV
may be similar to other common illnesses such as the flu, most people do not initially realize that
they have HIV. However, HIV infection is highly contagious at this early stage because there are
large amounts of the virus in the blood and other bodily fluids. Recognizing symptoms early,
being tested for HIV, and starting HIV treatment as soon as possible can help to decrease the risk
of transmitting HIV to another person.(3)
Body-wide symptoms: The most common body-wide signs and symptoms of acute HIV include
fever (temperature above 100.4°F or 38°C), sore throat, headache, and muscle and joint pain.
These flu-like symptoms last approximately two weeks. During the second week of the illness,
most people also have painless swelling of certain lymph nodes, including those in the armpits
and in the neck. Although the lymph nodes decrease in size after the first few weeks, swelling
can linger.(3)
Skin, mouth, genital symptoms: Many people also develop a rash of the skin about two to three
days after fever. The rash usually affects the face, neck, and upper chest or may be more
widespread. The rash usually lasts approximately five to eight days. One characteristic feature of
acute HIV infection is open sores or ulcers. These sores or ulcers can develop in the mouth, the
esophagus (the tube that extends from the mouth to the stomach), the anus, or the penis. The
ulcers are usually painful. However, only a small proportion of those with acute HIV develop these
sores.(3)
Digestive symptoms: Many people with acute HIV infection develop nausea and vomiting,
diarrhea, lack of appetite, and weight loss.
Respiratory symptoms: A dry cough is usually the only respiratory symptom associated with
primary HIV infection.
Symptoms of advanced HIV infection

If HIV is not treated, the virus will cause progressive weakening of the immune system, a process
which occurs at different rates in different people. Once significant damage to the immune
system has occurred, which typically takes at least several years, patients with HIV can become
infected with other organisms that usually don’t cause illness in people with normal immunity.
These “opportunistic infections” can cause serious disease in patients with advanced HIV
infection. Depending on the opportunistic infection, symptoms may include shortness of breath,
blurred vision, fevers, and weight loss.(3)

One of the most common opportunistic infections is yeast infection of the mouth or esophagus.
Yeast infections are caused by Candida, a fungal organism that is normally found on the skin and
in the mouth, intestinal tract, and vagina in healthy individuals. Certain yeast infections can occur
in people without HIV, (e.g., vaginal yeast infections) although people with HIV are at a higher
risk for this and other types of opportunistic infections.(3)
- Candidiasis of the mouth, also known as thrush, causes cream-colored, slightly raised
patches in the mouth, soreness, and easy bleeding.
- Candidiasis of the esophagus may cause difficulty swallowing.
However, with diagnosis and treatment of HIV, the immune system can improve. Then the risk
of opportunistic infections goes down. While the immune system is recovering, certain
medications can help prevent any opportunistic infections from occurring in the first place.(3)

Testing for HIV
HIV testing overview
HIV testing is the only way to determine if you are infected with HIV. Some avoid testing because
they are worried about the possibility of a positive result. However, testing is encouraged
because treatment for HIV is highly effective and is generally well tolerated. In addition, learning
about the infection can improve your chance of living longer and being healthier. Furthermore,
knowing your HIV status and taking precautions can greatly reduce your risk of transmitting the
virus to others.(3)
Several tests can be used to diagnose HIV infection, such as antibody only tests, combination
antigen-antibody tests and tests that measure HIV RNA. Most involve testing your blood. The
preferred tests are antigen-antibody tests.(3)
HIV testing can be performed in different ways (e.g., rapid (provide result within 5 to 40 minutes)
versus standard (results are usually available in a few days)), and in different settings (e.g., in a
doctor’s office or clinic versus at home). All positive screening tests should be confirmed with
another test. Test results are reported as being positive, negative, or indeterminate. The chances
of having an inaccurate result are very small.(3)
If you have a negative blood test, you are unlikely to be infected with HIV. However, if you were
exposed to HIV recently (i.e., within a few weeks), you should be retested. Diagnosing early HIV
infection is important; that is the time when a person is most likely to transmit HIV to someone
else since virus levels are high. The frequency and duration of follow-up testing depend on the
type of HIV test being used:(3)
- If an antibody-antigen test is negative, follow-up testing should be performed at six
weeks and four months after the exposure.
- If an antibody-only test is negative, repeat HIV testing should occur at six weeks, three
months, and six months following the exposure since it can take up to six months for your
body to make antibodies to the HIV virus.
The Centers for Disease Control and Prevention recommend an HIV test for all people between
age 13 and 64 and a repeat test if you have new risk factors, such as a new sexual partner who is
known to be at risk of HIV. People who are at high risk for HIV, such as men who have sex with
men, injection drug users, and those with multiple sex partners or a partner known to be HIV-
infected, should be tested every 6 to 12 months.(3)
How can I prevent HIV?

In addition to testing, you should learn how to prevent HIV infection. This includes:(3)
- Encouraging your sexual partners to be tested for HIV

- Using a latex or polyurethane condom with every sexual encounter
- Avoiding drugs or alcohol that can affect your judgment about sexual activities
- Avoiding activities such as sharing needles and syringes that have been used by other IV
drug users
To help prevent infection after a possible exposure to HIV, your provider may prescribe antiviral
medications (i.e., medications used to treat HIV). If you had unprotected sex or shared needles
with someone who has (or is at risk for) HIV, these medications may reduce your risk of getting
HIV. However, you must contact your doctor or nurse right away so you can start the medications
as early as possible, preferably within three days of being exposed to the virus. In addition, if you
are at high risk for getting HIV (e.g., if you are a man who has sex with men, or are an injection
drug user), you can ask your provider about “pre-exposure prophylaxis,” which means you take
antiviral medications before, and not just after each possible exposure.(3)
PrEP should be started within 72 hours of exposure and continued for 28 days with a three-drug
regimen.(34)
What can I do to prevent spreading HIV to other people?

To reduce the chance of spreading HIV to other people:(3)
- Get tested for HIV and start treatment as early as possible
- Tell anyone you plan to have sex with that you have HIV
- Use a condom every time you have vaginal, anal, or oral sex
- Do not share razors or toothbrushes with others
- Do not share drug needles or syringes with others

Initial treatment of HIV
Healthy lifestyle
Educate about healthy lifestyle:(35)
- For PRVD patients/caregiver, remind them to avoid mixing HAART medications into milk
- Encourage good nutrition; avoid raw eggs and unpasteurized dairy products.(34)
- Advise patients to eat only full-cooked meat, vegetable and boiled water – bacteria may
present in half cooked meals
- Discuss unknown and potential harmful effects of supplement use including drug-drug
interactions.(34)
- Maintain good general hygiene
- Encourage and motivate patient to be positive thinking
- Advise patients to avoid pet’s feces (dog/cat etc.)
- Proper storage of HAART medications
HIV treatment overview

Finding out you have HIV infection can be an overwhelming experience filled with worry about
the future, concern for loved ones, and fears of dying. However, current treatment regimens
have significantly improved the prognosis of HIV infection.(3)
Since 1996, the management of HIV infection has been revolutionizing highly active antiretroviral
therapy (HAART), usually consisting of three or more antiretroviral (ARV) drugs that act on
different targets in the virus. HAART is synonymous with antiretroviral therapy (ART) and
combination-antiretroviral therapy (cART). ART has dramatically reduced opportunistic infection-
related mortality among HIV infected persons, improved quality of life and survival. With ART,
HIV has become a chronic manageable disease. However, ARVs cannot eradicate HIV from the
human body nor cure HIV infection.(36)
General approach
Combination ART first became available in the mid-1990s and provided life-saving therapy for
millions of patients suffering from HIV and AIDS. While the early ART regimens were effective in
helping patients with AIDS recover, they were also associated with many toxicities and side
effects. In 2006, the U.S. Department of Health and Human Services, the International AIDS
Society-USA, and the British HIV Society recommended CD4 counts of 200 cells/mm3 as the
threshold for initiating ART treatment in asymptomatic patients. In the last decade, the paradigm
has shifted toward earlier initiation of ART based on accumulating evidence for the beneficial
effects of treatment initiation earlier in the course of infection. Antiretroviral therapies have

advanced significantly since their conception, consisting of multiple drug classes, less toxicities,
less pill burden, and overall improved tolerance. Failure to suppress viral loads on these
medications is more likely to be due to therapy nonadherence than medication failure. HIV
patients are now achieving normal life spans, and non-AIDS-defining illnesses are becoming more
prominent. Cardiovascular, renal, and hepatic disease complications are lower in patients who
started ART at higher CD4 thresholds (> 350 cells/mm3). Earlier initiation of ART is also associated
with reduced risk of transmission and improved immune restoration.(32)
ART is recommended for all HIV-infected individuals, regardless of CD4 count, to reduce the
morbidity and mortality associated with HIV infection. It is also to prevent HIV transmission. As a
priority, ART should be initiated in(36)
- All adults with severe or advanced HIV clinical disease (WHO clinical stage 3 or 4)
- Individuals with CD4 count ≤350 cells/mm3
- HIV-associated nephropathy (HIVAN)
- HIV/Hepatitis B virus co-infection
- HIV/Hepatitis C virus co-infection
- All pregnant ladies infected with HIV
Factors to consider before initiating ART(36)
- Patient’s willingness to start and adhere strictly to treatment and follow up
- Patient’s understanding of the possible adverse effects and the risk of immune
reconstitution inflammatory syndrome (IRIS)
- The ART options those are available
- Underlying medical diseases such as cardiovascular disease, diabetes mellitus,
hyperlipidemia, and depression
- Possible drug-drug interactions, dosing frequency and pill burden
- Risk of primary resistance, i.e. the acquisition of HIV infection from a partner who is
already on ART
- Individual factors that may hinder adherence such as irregular working hours and social
support
Starting ART in the event of acute opportunity infections (OIs) remains a great challenge. Delaying
ART till completion of OI therapy would increase the risk of progression to AIDS and death. Drug-
drug interactions, additive adverse effects, high pill burden, patient adherence and paradoxical
reactions may also pose problems.(36)
Malaysia guideline recommends clinical assessment at the end of 2 weeks of OI therapy. If patient
is stable and has improved with OI treatment, initiation of ART can be considered. In patients
with OIs for which no effective treatment is available (cryptosporidiosis, microsporidiosis,
progressive multifocal leukoencephalopathy and Kaposi’s sarcoma), ART itself can result in
improvement and hence should be initiated as soon as possible.(36)

However, in the following conditions, the timing of initiation of ART varies according to specific
circumstances.(36)
1. Tuberculosis
a. ART is recommended in all HIV-infected persons with TB.
b. For ART-naive patients, ART should be started within 2 weeks when the CD4 count
is <50 cells/mm3 and by 8 to 12 weeks for all others.
c. In patients with TB meningitis and low CD4 cell counts, early ART may pose a risk
that calls for careful monitoring and consultation with experts.
2. Cryptococcal Meningitis
a. Delay initiation of ART at least until after completion of antifungal induction
therapy (the first 2 weeks) and possibly until the total induction/consolidation
phase (10 weeks) has been completed. If effective ART is to begin prior to 10
weeks, the treating physicians should be prepared to aggressively address
complications caused by Immune Reconstitution Syndrome (IRIS), such as
elevated intracranial pressure (ICP).
b. Delay in ART may be particularly important in those with evidence of increased
intracranial pressure or in those with low CSF white blood cell counts.
c. For other forms of cryptococcosis, where the risk of IRIS appears to be much lower,
the optimal time to begin ART and antifungal therapy is not clear. However, it
would seem prudent to delay initiation of ART by 2 to 4 weeks after starting
antifungal therapy.
Once ART is started, you will need to take it for the rest of your life. Stopping treatment has no
clear benefit, and almost all people will develop an increased viral load (the amount of virus in
the body) and a decreased T cell count if they stop ART.(3)
In addition, taking HIV drugs inconsistently (e.g., not on time every day) can sometimes lead to
drug resistance, which may eventually limit the number of drugs that work to keep your disease
controlled. The likelihood of drug resistance depends upon which medicines you take and how
many days or weeks of pills you miss. If you feel that you are not able to take a daily medication,
your doctor or nurse can work with you on strategies to take your medication without missing
doses.(3)
Principle of selecting first line ART

The following factors should be considered to determine which ART regimen is the best for a
particular patient:(36)
- Co-morbids and organ dysfunction (e.g. renal insufficiency, Hepatitis B co-infection,
anemia, psychiatric conditions, heart disease, TB)

- Impact of regimen itself e.g. pill burden, pill size, potential for drug interactions,
anticipated side effects, food/ fasting requirements)
Currently, there are six classes of ARV drugs which target different phases in the HIV life cycle.(36)
Class Abbreviation
Nucleoside or nucleotide reverse transcriptase inhibitors (NRTI)
Abacavir ABC
Emtricitabine FTC
Lamivudine 3TC
Stavudine D4T
Tenofovir disoproxil fumarate TDF
Zidovudine AZT or ZDV
Non-nucleoside reverse transcriptase inhibitors (NNRTI)
Efavirenz EFV
Etravirine ETV
Nevirapine NVP
Rilpivirin RPV
Protease inhibitors (PI)
Atazanavir ATV
Darunavir DRV
Lopinavir/ritonavir LPV/r
Ritonavir RTV
Integrase inhibitors
Raltegravir RAL
Dolutegravir DTG
CCR5 Antagonist
Maraviroc MVC

Fusion inhibitor
Enfuvirtide T-20
Fixed dose combination (FDC) are multiple ARV drugs combined into a single tablet. FDCs reduce
pill burden and cost. Dosing simplification improves adherence and maintain durable virological
suppression.(36)
Fixed Dose Combinations Brane name (e.g.)
Abacavir/Lamivudine Kivexa
Abacavir/Lamivudine/Zidovudine Trivizir
Lopinavir/Ritonavir Kaletra
Tenofovir disoproxil fumarate/emtricitabine Truvada, Tenvir-EM
Zidovudine/Lamivudine Combivir, Zovilam
In most regions, a first-line ART regimen will generally consist of 2 NRTIs in combination with a
third agent (usually an INSTI if available, or an NNRTI or boosted PI); however, guidelines and
protocols may differ between countries and regions. Quadruple combination therapy has been
found to be no more effective than triple combination therapy with currently available drugs.
Guidelines now also recommend a two-drug regimen of dolutegravir plus lamivudine (an INSTI
plus an NRTI) as an initial regimen for most people with HIV, except in patients with pre-
treatment HIV RNA >500,000 copies/mL or active hepatitis B co-infection, or those who will
initiate ART before results of HIV genotype testing or hepatitis B virus testing are available.(37)
At Malaysia, 2NRTI +1 NNRTs are the preferred option for first line ART.(36)
Preferred first line ART Alternative regimes
Tenofovir + Emtricitabine + Efavirenz Zidovudine + Lamivudine + Efavirenz (or Nevirapine)

Abacavir + Lamivudine + Efavirenz (or Nevirapine)
Tenofovir + Emtricitabine + Nevirapine
Tenofovir + Emtricitabine + Raltegravir Tenofovir + Emtricitabine + Atazanavir/ritonavir

Tenofovir + Emtricitabine + Dolutegravir Tenofovir + Emtricitabine + Lopinavir/ritonavir
(if intolerant to NNRTI)

Considerations prior to starting treatment(36)
Medication Note
NRTI - Tenofovir and zidovudine are generally comparable in terms of efficacy;
however, some studies have shown better efficacy and less side effects
with tenofovir-based therapy compared to zidovudine.
- The use of stavudine is discouraged. For patients who are started on
stavudine, they should be switched to tenofovir or zidovudine after the
first 6 months to avoid its long term adverse effects.
- Tenofovir should be avoided in patients with chronic kidney disease with
CrCl <50ml/min. Tenofovir is preferred in patients with Hepatitis B co-
infection.
- Zidovudine should not be initiated in patients with baseline hemoglobin
<8.0 g/dL.
- Abacavir may be considered in special circumstances where the preferred
regimens are not suitable because of toxicities or anticipated drug-drug
interactions.
- However, abacavir is not recommended in cases where HIV viral load is >
100,000 copies/mL.
NNRTI - Nevirapine and Efavirenz have comparable clinical efficacy when used in
combination ART. However, Nevirapine is associated with higher risk of
rash, Steven-Johnson Syndrome and hepatotoxicity compared to EFV. In
case of severe hepatotoxicity or skin reactions, Nevirapine should be
permanently discontinued. Nevirapine must be avoided in women with
CD4 count >250 cells/mm3 and men with baseline CD count >400
cells/mm3 due to significant increase in incidence of symptomatic hepatic
events. Lead in dosing of 2 weeks for nevirapine should be practiced to
decrease risk of hepatitis and rash.
- Efavirenz is the NNRTI of choice in individuals with TB/HIV co-infection
who are receiving rifampicin-based TB treatment. Efavirenz should be
avoided in patients with severe psychiatric illness and in those whose daily
functional status is affected by its side effects.
- NNRTI has low genetic barrier to resistance with long half-lives. Abrupt
discontinuation of NNRTI without maintaining NRTIs backbone will
increase the risk of NNRTI resistance due to its long half-life. Hence, when
NNRTI is stopped, the backbone NRTIs should be continued for another 2
weeks before stopping all drugs.

Medication Note
INSTI and - Integrase strand transfer inhibitors (INSTI) or protease inhibitors (PI) may
PI/r be considered as the third agent in first line ART regime if the patient is
unable to tolerate the side effects of NNRTI. Patients who are unable to
tolerate ART or develop adverse reactions to ART should be referred to
infectious disease physicians.
Treatment outcome
Treatment outcome may be measured from three aspects:(36)
- Clinically by the reduction in the number and frequency of opportunistic infections (OIs)
and improvement of general wellbeing
- Immunologically by gradual and steady rise in CD4 T-cell counts
- Virologically by a decrease in VL, ideally to undetectable level at six months after
initiation of treatment (undetectable is defined as VL <20 copies/ml).

Adherence to ART
ART adherence is the key to successful HIV treatment. Current data shows that to maintain
successful viral suppression, 95% or more adherences to ART is required. Interventions to
improve adherence are most likely to be successful when they are comprehensive and tailored
to individual’s socio-demographics background and behavioral characteristic.(36)
Specific group at risk of poor adherence includes:(36)
- Poor family support
- Intravenous drug users
- Adolescence
- Pregnant mothers
- Underlying psychiatric illness
Method of counselling on improvement of adherence must always be individualized.(36)
Assessment of adherence is crucial at every clinic visit.(36)
Strategies to improve adherence to antiretroviral therapy(36)
Strategies Examples
Multidisciplinary - Provide an accessible, trusting relationship between the patients
team approach and physicians, nurse counsellors, family members, social
workers, peer support group and pharmacists.
Establish patients’ - Assess patient’s attitude and belief regarding ART and
readiness to start adherence
ART - Practice adherence to planned ART regime using ‘vitamin
training’
- Pill organizers and medication reminder aids (e.g. alarm clock
using mobile phone)
- Review source of social support (positive and negative) and
discuss ways to enhance support for adherence
Assess and simplify - Preferably once a day regime

the regimen

Strategies Examples
Identify potential - Psychosocial issues (e.g. housing problems, legal issues,
barriers to disrupted family)
adherence - Active substance abuse or at high risk of relapse
- Low literacy
- Busy daily schedule and/or travel away from home
- Nondisclosure of HIV diagnosis - the need of ‘treatment buddy’
- Skepticism about ART
- Lack of continuous access to medication
Provide resources - Referrals for mental health and/or substance abuse treatment
for the patient - Continuous pill supply - e.g. SPUB “Sistem Pendispensan Ubat
Bersepadu” to nearest government clinic, postage of medication
to patient’s home, pre-packaged medications
- ‘drive-through counter’
- Pillboxes
Assess adherence - Use a simple checklist that the patient can complete in the
at every clinic visit waiting room
- Ensure that other members of the health care team also assess
adherence
- Ask the patient open-ended questions (e.g., In the last 3 days,
please tell me how you took your medicines)
Identify the type of - Failure to fill the prescription(s)

non-adherence - Failure to take the right dose(s) at the right time(s)
Identify reasons for - Adverse effects from medications

non-adherence - Complexity of regimen (pill burden, dosing frequency, etc.)
- Difficulty swallowing large pills
- Forgetfulness
- Failure to understand dosing instructions
- Inadequate understanding of drug resistance and its relationship
to adherence
- Pill fatigue
- Other potential barriers

Assessment of adults with HIV infection
Doctors monitor people with HIV by doing regular exams and talking to them, and by doing tests.
Among the tests doctors use, 2 are especially important in keeping track of whether HIV
treatment is working. These are called the "viral load test" and the "CD4 cell count." The results
of your viral load tests will tell your doctor whether your HIV treatment is helping. The results of
your CD4 tests will tell your doctor how well your immune system is working. Although viral load
is mostly affected by your HIV treatment, CD4 counts can go down because of a lot of things,
including infections (other than HIV), alcohol abuse pregnancy and liver disease.(3)
T helper cells, also known as CD4 T cells, are white blood cells that help to organize the immune
system. A person with HIV infection gradually develops lower T cell counts over time as the
immune system weakens. A low T cell count indicates that your immune system is not healthy
and that there is a significant risk of developing an opportunistic infection.(3)
- The normal T cell count is 500 to 1400 cells/microL.
- When it falls below 350 cells/microL, the risk of serious infectious disease complications
increases, and this risk further increases the more the T cell count drops.
- Opportunistic infections are more likely to occur in people with T cell counts
<200 cells/microL.
- When the T cell count drops below 200 cells/microL, the person is said to have AIDS.
Viral load is the amount of virus in your blood. If you have HIV, it's important to have your viral
load tested often. This test helps your doctors check on your infection. It can also show whether
your treatment is working. The goal of treatment is to get your viral load below "detectable
levels." That means there is so little virus in your blood that the test cannot even pick it up.(3)
CD4 Count
Successful therapy is defined as an increment in CD4 cell counts that averages 50 -150 cells/mm
per year until a threshold is reached. However, some patients may experience a slower increase
of CD4+ T cell counts particularly when anti-retroviral therapy (ART) were initiated at very low
baseline CD4 count levels.(36)
CD4 counts should be monitored 4-6 months after initiation of ARV to:(36)
- Assess immunologic response to antiretroviral therapy
- Assess the need to discontinue prophylaxis for opportunistic infections
Once the HIV viral load is suppressed and CD4 counts >350cells/mm3 on 2 occasions 6 months
apart, further repeat of CD4 count is not needed. (Unless treatment failure is suspected)(36)
HIV viral load

HIV viral load is more accurate and reliable than CD4+ T-cell count to monitor treatment response
and for early detection of treatment failure.(36)
HIV Viral Load is Recommended of ART:(36)
- Just before initiation of ART**
- Every 4 to 6 months after initiation of ART to assess treatment response and for early
detection of treatment failure
- Every 6 to 12 months in patients who have achieved virological suppression for ≥1 year.
- Before changing treatment regimes.
**subjected to resource availability
Effective therapy should generally result in a 10-fold (1.0 log10) decrease in HIV-1 RNA copies/mL
in the first month and suppression to less than 20 copies/mL by 6 months. A rebound in plasma
HIV-1 RNA level after achieving an undetectable level should prompt a careful evaluation of the
patient’s adherence to the treatment regimen and drug interactions.
Other monitoring while on antiretroviral therapy

The frequency of monitoring depends on the response to ART and the choice of drugs. At the
minimum monitoring should take place at 2- 4, 8, 12 and 24 weeks after ART initiation and should
subsequently be performed every 4-6 months once the patient has been stabilized on therapy.
At each visit, monitoring need to be complemented by assessment of treatment side effects and
adherence.(36)
Evaluation Investigations Specific tests Entry to Pre- At Follow-up Comments

Care HAART on HAART
HIV Disease All referred

cases of HIV
infection need
a confirmatory
test.
Plasma HIV HIV viral load See X Every 4 to 6 Not for routine
RNA comment months after baseline if
initiation of resources are
ART. limited.
CD4 / / Refer section

above

Care HAART on HAART
Co-infection Syphilis VDRL/RPR/TPHA / X Annual Consider more

serology screening if at frequent
risk
Hep A Hep A Ig G At risk
Serology for group
Risk group: MSM;
“at risk group”
Vaccination if non-
if facility
immune
available for
testing
Hep B Hep. Bs Ag / X Annual Vaccinate if non-

Serology (HbsAg); Anti- screening if at immune. Consider
Hep. Bs (HbsAb) risk testing for Anti-
Hep core antibody
Hep C HCV Antibody / X Annual
(HBc Ab total) if
Serology screening if at
Hep Bs Ag
risk
negative and liver
function
abnormal.
Measure HCV RNA
if HCV antibody
positive or acute
infection
suspected.
CXR / X When To look for active

clinically TB (consideration
indicated for isoniazid
preventive
therapy).
Hematology FBC / / Every 4 to 6 If on zidovudine –

months (only before initiation
if patient is and at week-4, 8 &
on 12 or symptomatic
zidovudine or
symptomatic)

Care HAART on HAART
Cardiovascular ECG / If on When If patient has

protease clinically other risk factors
inhibitors indicated for ischemic heart
disease
Metabolic Fasting lipid / X Every 6 to 12 Efavirenz, NRTIs,

profile months protease
inhibitors (with
Fasting blood / X Annually if
the exception of
sugar initial
unboosted
screening
atazanavir), can
results are
cause insulin
normal; 3-6
resistance and
monthly
dyslipidemia.
Liver ALP, AST, ALT, / / Every 4 to 6 NRTI and NNRTI

Bilirubin, months drugs can cause
Albumin hepatotoxicity. If
on nevirapine, ALT
need to be
monitored more
frequently; at
baseline, 2, 4, 12
weeks and then
every 3-6 months.
Obtain ALT in
patients with new
onset of rash.
Renal Renal function / / At week 4, 8 Tenofovir may

test/GFR & 12 upon cause renal

Care HAART on HAART
Dipstick / If initiation of tubular

clinically tenofovir; 4 dysfunction;
indicated to 6 monthly Routine
if stable monitoring of
calculated
creatinine
clearance should
be performed for
all patients on
tenofovir during
follow up.
Others Serum Lactate X X As clinically Lactic acidosis is a

indicated rare but severe
complication of
NRTI therapy
caused by
mitochondrial
dysfunction.
Cervical PAP Pap smear / Annually, if the results of the 3

smear for consecutive Pap tests are normal,
women follow up Pap tests should be
every 3 years.
Co-Trimoxazole Preventive Prophylaxis

Co-trimoxazole is recommended for Pneumocystis Jiroveci Pneumonia (PJP) prophylaxis to all
susceptible individuals as it has been shown to decrease the risk of PJP by nine-fold in this
population. Co-Trimoxazole is absolutely contraindicated in severe allergy to sulfa drugs and
relatively contraindicated in severe liver disease, severe anemia or severe pancytopenia. As an
alternative, dapsone at a dose of 100 mg daily may be used.(36)

When to start What to start When to stop
- CD4 count of <200/µL or CD4 One double-strength (DS) When CD4 > 200 for two
percentage of <14% tablet or two single-strength consecutive readings
- Oropharyngeal candidiasis SS) tablets once daily
or
- Opportunistic infections / AIDS
Total daily dose is 960 mg
defining illness when CD4 100-200 AND
(800 mg sulfamethoxazole
- Patient who has completed HIV-VL is undetectable
plus 160 mg trimethoprim)
successful treatment for PCP more than once
Antiretroviral therapy (ART) drug interactions

Drug-drug interactions with ART are unfortunately common and can be devastating. It is
important that all interactions are checked before anything is started. Commonly used by
Infectious Diseases physicians is the “HIV iChart” created by the University of Liverpool. This can
be downloaded from the App Store or found at www.hiv-druginteractions.org.(36)

Adverse events of ARVs
Adverse events of ARVs occur with all antiretroviral agents and are a major reason for switching
or discontinuation of therapy and poor adherence. Differentiating between antiretroviral-related
toxicities and disease complications can be difficult.(36)
Principles of Managing Adverse Events(36)
1. Identify the adverse event and assess its possible cause: antiretroviral agents, other
medications or other illnesses.
2. Assess severity of toxicities.
3. If the reaction is mild or moderate, do not discontinue ART (except for NVP-induced rash
/ hepatotoxicity). Implement symptomatic therapy. Counsel and monitor patients, stress
the importance of adherence despite toxicity.
4. Moderate or severe toxicities may require substitution of the drug with another of the
same ARV class, but with a different toxicity profile.
5. Severe life-threatening toxicity requires discontinuation of ALL ARV drugs until the patient
is stabilized and the toxicity is resolved.
6. If there is intolerance due to an individual drug, a single drug substitution can be made;
however, a single drug substitution should not be made if the patient is a known case of
virological failure.
7. If there is a need to discontinue ART, all antiretroviral medications must be stopped
together. Stopping only one drug can lead to resistance.

Management of treatment failure: after first line therapy
The aim of antiretroviral therapy is to achieve durable HIV virologic suppression, which leads to
good treatment outcomes. Conversely, antiretroviral treatment failure can be defined as a
suboptimal response to therapy leading to loss of virologic control. This is most accurately
recognized by measuring and detecting a significantly raised HIV viral load (plasma HIV-1 RNA
levels) while the patient is on highly active antiretroviral therapy.(36)
Successful virological suppression is defined as having a sustained viral load that is undetectable
(e.g. viral load <20 copies/mL where 20 is the lower limit of viral load detection).(36)
The viral load level to define virologic failure is not fully agreed on worldwide. WHO defines
virologic failure as either an incomplete virologic response which is a failure to achieve HIV viral
load <1000 copies/ml 4–6 months after starting therapy or a virologic rebound where after
previous virologic suppression, there is a persistent HIV viral load to >1000 copies/mL while on
the same regiment.(36)
Diagnosing treatment failure through other means like a drop in CD4 or on a clinical basis would
lead to delays in diagnosis of failure and this predisposes to the selection of more drug resistance
mutations, especially in the NRTI component.(36)
When to Switch
There is limited long term clinical data to guide us on the optimal time to switch therapy. Our
recommended approach allows detectable viremia up to a level of 1,000 copies/mL, in keeping
with WHO recommendations before considering switching. Below is an algorithm from the WHO
guidelines on when to decide to switch.(36)

The decision to switch should also be guided by the availability of second line treatment options
which are likely to suppress viral load to undetectable levels and which the patient is able to
tolerate.(36)
Treatment-Experienced Patients with Limited or No Therapeutic Options

For extensively treatment experienced patients with limited or no options, maintaining a CD4
above 200 becomes the main focus. Viral load of up to 20 000 copies/mL may be acceptable in
this group of patients.(36)
In a failing patient with no other ART option, the decision whether to continue the failing regime
or not will be based on cost and side effect of the drugs in the failing regime. If the patient is
currently on therapy, continuing the failing regime rather than stopping it has been shown to be
beneficial provided that the patient has not developed any side effects to the drugs and is
clinically well. This has to be balanced with the fact that there is accumulation of mutations in
the long term (as early as 1 year) which may negatively impact future treatment options should

they become available. Hence if a potentially viable regime should become available, it must be
commenced as soon as possible. Discussion with an ID physician is strongly encouraged in the
management for these patients.(36)

Liquid medications

Nose
Rhinitis
Rhinitis is an inflammation of the lining of the nose causing congestion, rhinorrhea, sneezing and
itching; classified as allergic (hay fever) or non-allergenic (including drug-induced, irritant,
occupational). Infectious rhinitis usually involves the nasal passages and paranasal sinuses and is
often referred to as rhinosinusitis.(2)
Allergic rhinitis
Typical allergic symptoms due to immunoglobulin E-mediated response to inhaled allergens
include clear rhinorrhea, sneezing and red and watery eyes. Allergic rhinitis can be classified
according to the pattern of allergen exposure, e.g. seasonal (pollen) or perennial (dust mites,
mould), or by symptom frequency (intermittent or persistent), or severity (mild, moderate,
severe).(2)
Where possible, identify and avoid allergen. Environmental controls, such as general measures
to reduce house dust mites, may help improve symptoms.(2)
Sodium chloride 0.9% nasal irrigation may help clear nasal passages by washing out allergens and
sticky mucus, and reduce congestion and irritation.(2)
Mild allergic rhinitis is controlled by antihistamines or topical nasal corticosteroids; systemic
nasal decongestants are of doubtful value. Topical nasal decongestants can be used for a short
period to relieve congestion and allow penetration of a topical nasal corticosteroid.(10)
More persistent symptoms and nasal congestion can be relieved by topical nasal corticosteroids;
sodium cromoglicate is an alternative, but may be less effective. The topical antihistamine
azelastine hydrochloride is useful for controlling breakthrough symptoms in allergic rhinitis.
Topical antihistamines are considered less effective than topical corticosteroids but probably
more effective than cromoglicate. In seasonal allergic rhinitis (e.g. hay fever), treatment should
begin 2 to 3 weeks before the season commences and may have to be continued for several
months; continuous treatment may be required for years in perennial rhinitis.(10)
Montelukast is less effective than topical nasal corticosteroids; montelukast can be used in
patients with seasonal allergic rhinitis and concomitant asthma.(10)
Sometimes allergic rhinitis is accompanied by vasomotor rhinitis. In this situation, the addition of
topical nasal ipratropium bromide can reduce watery rhinorrhea.(10)
Very disabling symptoms occasionally justify the use of systemic corticosteroids for short periods,
for example, in students taking important examinations. They may also be used at the beginning

of a course of treatment with a corticosteroid spray to relieve severe mucosal edema and allow
the spray to penetrate the nasal cavity.(10)
If a pregnant women cannot tolerate the symptoms of allergic rhinitis, treatment with nasal
beclomethasone dipropionate, budesonide, fluticasone, or sodium cromoglicate may be
considered.(10)
Drug choice Note

Intranasal Reduce inflammation, decrease mucus production and may improve ocular
corticosteroids symptoms. Although maximum effect is achieved after several days of
regular use, they have an effect on symptoms such as blocked nose and
rhinorrhea within 3–12 hours of starting treatment. They are still effective
if used on an as-needed basis for episodic symptoms. (2)
Corticosteroids should be avoided in presence of untreated nasal infections,
after nasal surgery (until healing has occurred), and in pulmonary
tuberculosis. Patients transferred from systemic corticosteroids may
experience exacerbation of some symptoms. Systemic absorption may
follow nasal administration particularly if high doses are used or if
treatment is prolonged; for cautions and side effects of systemic
corticosteroids. The risk of systemic effects may be greater with nasal drops
than with nasal sprays; drops are administered incorrectly more often than
sprays. The height of children receiving prolonged treatment with nasal
corticosteroids should be monitored; if growth is slowed, referral to a
pediatrician should be considered.(10)
Antihistamines Relieve histamine-induced symptoms (itching, sneezing, rhinorrhea and

ocular symptoms), but are less effective for nasal congestion than intranasal
corticosteroids.(2)
Oral antihistamines work within 1–2 hours of administration. Sedating
antihistamines have limited use due to their CNS effects (less sedating drugs
are preferred). There is no additional benefit if added to treatment with an
intranasal corticosteroid.(2)
Intranasal antihistamines have a rapid onset of action (15–30 minutes) and
may help relieve nasal congestion but have no effect on extra-nasal
symptoms. They may be used with an intranasal corticosteroid if symptoms
are not adequately controlled with one agent (a fixed-dose combination
nasal spray is available).(2)

Drug choice Note
Other treatment Intranasal cromoglycate (mast cell stabilizer) is well tolerated and may be
options an option for intermittent mild symptoms.(2)
Intranasal ipratropium (anticholinergic) may be useful when rhinorrhea is
the dominant problem.(2)
Montelukast may be beneficial for patients who suffer from both allergic
rhinitis and asthma. However, it is less effective than intranasal
corticosteroids (for rhinitis).(2)
Intranasal decongestants produce local vasoconstriction and relieve nasal
congestion within minutes but have no effect on other symptoms. If nasal
congestion is severe, short-term treatment (3–5 days) may allow a more
effective use of intranasal corticosteroids. Prolonged use of intranasal
decongestants causes rebound congestion.(2)
Oral decongestants are generally not recommended for regular use
because they have limited effect on symptoms and commonly cause CNS
stimulation, e.g. insomnia, irritability.
Oral corticosteroids (short course) are used rarely for disabling symptoms
or if polyps are present.(2)
Immunotherapy Sublingual or subcutaneous immunotherapy (e.g. house dust mites or a mix

of grass pollens) may be tried if an allergen is identified and other
treatments have failed. It is usually started by an allergy specialist.(2)
Symptomatic treatment of allergic rhinitis in adults(2)
Itch/sneeze Nasal discharge Nasal blockage Eye symptoms
+++ very effective, ++ moderately effective, + marginally effective, +/– little or no effect,
– ineffective
Intranasal corticosteroids
+++ +++ ++ ++
Oral/intranasal antihistamines
++ ++ +/– ++ (oral)
- (intranasal)

Itch/sneeze Nasal discharge Nasal blockage Eye symptoms
Oral/intranasal decongestants
– – + (oral) –
+++ (intranasal)
Cromoglycate
+ + +/– –
Ipratropium
– +++ – –
Montelukast
– + ++ ++
Indicative of referral: rhinitis(15)
Symptoms/signs Possible danger/reason for referral
Failed medication Requires involvement of doctor for further

medicine treatment
Medicine-induced rhinitis
Nasal obstruction that fails to clear Suggest a polyp
Unilateral discharge, especially in children Possible trapped foreign body
* Nasal polyps – short-term use of corticosteroid nasal drops helps to shrink nasal polyps; to be
effective, the drops must be administered with the patient in the ‘head down’ position. A short
course of a systemic corticosteroid may be required initially to shrink large polyps. A
corticosteroid spray can be used to maintain the reduction in swelling and also for the initial
treatment of small polyps.(10)
Non-allergic rhinitis
May be due to environmental irritants (e.g. heat, cold, smoke, dust); hormonal causes (no
treatment advised during pregnancy); drug-induced rhinitis (e.g. beta-blockers, oral
contraceptives, aspirin, NSAIDs, ACE inhibitors); diet (e.g. alcohol, spicy foods); and emotional
factors.(2)

Response to drug treatment is variable. Management involves identifying and avoiding
precipitating factors.(2)
Ensure symptoms are not due to excessive use of intranasal decongestants, causing rebound
congestion.(2)
Intranasal corticosteroids and/or antihistamines and, in some cases, ipratropium nasal spray,
may be useful if non-drug measures fail.(2)
Practice points
Rhinitis is a major risk factor for developing asthma; effective management of rhinitis is
associated with better asthma control.(2)
Ensure that patients know how to use the intranasal device correctly (for example, aiming spray
away from the septum to reduce nose bleeding from intranasal corticosteroid).(2)
Treat allergic rhinitis for at least 4 weeks before considering specialist referral.(2)

Rhinosinusitis
Rhinosinusitis usually involves inflammation of the paranasal sinuses (sinusitis) and the nasal
mucosa (rhinitis).(2)
Acute rhinosinusitis
Acute rhinosinusitis is often caused by viral infection (common cold) with rapid onset of
symptoms, e.g. sinonasal inflammation, nasal discharge and congestion, facial pain or pressure,
that last up to 4 weeks. Only about 2% of viral rhinosinusitis episodes are complicated by bacterial
infection; generally, initial management should be symptomatic.(2)
Analgesics, e.g. paracetamol or NSAIDs, relieve pain and fever. Intranasal corticosteroids may
improve symptoms, while sodium chloride 0.9% nasal irrigation or decongestants may relieve
congestion. Intranasal ipratropium may decrease rhinorrhea.(2)
Consider antibacterials, in addition to intranasal corticosteroids, if there is:(2)
- poor response to decongestants and intranasal corticosteroids
- mucopurulent discharge, sinus tenderness or maxillary toothache for >1 week
- prolonged fever, or
- symptoms worsen after initial improvement.
Amoxicillin is preferred in uncomplicated cases; alternatives include cefuroxime or doxycycline.
Treat for 5 days; if unresponsive to amoxicillin within 2–3 days, use amoxicillin with clavulanic
acid for 7–14 days, depending on clinical response.(2)
Seek ENT specialist advice if:(2)
- there is poor response to antibacterial treatment
- signs of abscess formation or infection spread beyond sinuses
- frequent acute attacks, e.g. 3–6 per year (depending on severity), or persistent (chronic)
symptoms.
Chronic rhinosinusitis
It is an inflammatory disease with persistent symptoms (>3 months), including nasal congestion
or discharge. Chronic allergic rhinitis and/or infection with anaerobic bacteria or fungi may be
involved (bacteria may be different from those found in acute rhinosinusitis). The presence of
nasal polyps may affect management.(2)
First-line treatment includes daily use of an intranasal corticosteroid and sodium chloride 0.9%
nasal irrigations for at least 8 weeks; ensure proper administration technique.(2)

For chronic rhinosinusitis associated with:(2)
- nasal polyps, if first-line treatment is unsuccessful (or nostrils too obstructed to use
sprays), consider giving an oral corticosteroid for 1–3 weeks
- allergic symptoms, manage as for allergic rhinitis
- mucopurulent discharge, ideally choose antibacterial after culture results, otherwise use
amoxicillin with clavulanic acid or cefuroxime for up to 14 days.
If symptoms are persistent or severe despite optimized drug therapy, consider specialist review
for further investigation and more intensive management, including surgery.(2)

Nasal sprays
Blow your nose gently before using the spray.
Insert the nozzle tip just inside one nostril, aiming towards the
outside wall. Press on the other side of your nose with one finger
to close off the other nostril.
Keep your head upright.

Sniff in gently while squeezing the bottle. Avoid sniffing too hard
as the dose is likely to go down the throat.
Repeat for the other nostril.

Nasal pump sprays
Blow your nose gently before using the spray.
Hold the bottle with your thumb at the bottom and the first two
fingers at the top on either side of the nozzle. Prime the pump
bottle by spraying it into the air a few times.

Tilt your head slightly forward. Insert the nozzle tip just inside
one nostril, aiming towards the outside wall. Press on the other
side of your nose with one finger to close off the other nostril.
Sniff in gently while squeezing down on the bottle. Avoid sniffing

too hard as the dose is likely to go down the throat.
Repeat for the other nostril.
Do not blow your nose right after using the spray.


Avamys nasal spray (Fluticasone furoate, 27.5 mcg)
Indication Dosage
Treatment of Adults and adolescents (≥12 years), recommended starting dose: 2 sprays
seasonal and (27.5 mcg/spray) in each nostril once daily (total daily dose is 110 mcg). Once
perennial adequate control is achieved, dose reduction to 1 spray in each nostril once
allergic rhinitis daily (total daily dose, 55 mcg) may be effective for maintenance.
Children (2-11 years), recommended starting dose: 1 spray (27.5 mcg/spray)
in each nostril once daily (total daily dose is 55 mcg). Patients not adequately
responding to 1 spray in each nostril once daily (total daily dose is 55 mcg)
may use 2 sprays in each nostril once daily (total daily dose is 110 mcg). Once
adequate control of symptoms is achieved, dose reduction to 1 spray in each
nostril once daily (total daily dose, 55 mcg) is recommended.
- Avamys nasal spray is for administration by the intranasal route only.(9)

- For full therapeutic effect, regular scheduled usage is recommended.(9)
- Onset of action has been observed as early as 8 hours after initial administration. It may
take several days of treatment to achieve maximum benefit. An absence of immediate
benefit should be explained to the patient.(9)
- The safety in children under 6 years has not been well established. Frequency, type and
severity of adverse reactions observed in the pediatric population are similar to those in
the adult population.(6)
The nasal spray

The nasal spray comes in an amber glass bottle inside plastic. It will contain either 30, 60 or 120
sprays, depending on the pack size that has been prescribed for you. The window in the plastic
casing lets you see how much medicine is left in the bottle. You will be able to see the liquid level
for a new 30 or 60 spray bottle, but not in a new 120 spray bottle because the liquid level is above
the window.(6)

Six important things you need to know about using the nasal spray:(6)
- Avamys comes in an amber glass bottle. If you need to check how much is left, hold the
nasal spray upright against a bright light. You will then be able to see the level through
the window.
- When you first use the nasal spray, you will need to shake it vigorously with the cap on
for about 10 seconds. This is important as Avamys is a thick suspension that becomes
liquid when you shake it well. It will only spray when it becomes liquid.
- The mist-release button must be pressed firmly all the way in, to release the mist through
the nozzle.
- If you have difficulty pressing the button with your thumb, you can use two hands.
- Always keep the cap on the nasal spray when you are not using it. The cap keeps the dust
out, seals in the pressure and stops the nozzle from blocking up. When the cap is in place,
the mist release button cannot be pressed accidentally.
- Never use a pin or anything sharp to clear the nozzle. It will damage the nasal spray.
Preparing the Nasal Spray

You must prepare the nasal spray:(6)
- Before you use it for the first time

- If you have left the cap off for 5 days or the intranasal device has not been used for 30
days or more.
Preparing the nasal spray helps to make sure you always get the full dose of medicine.(6)
Shake the nasal spray vigorously with the cap on for about 10 seconds.
Remove the cap by squeezing firmly on the sides of the cap with your
thumb and forefinger.
Hold the nasal spray upright, then tilt and point the nozzle away from
you.
Press the button firmly all the way in. Do this at least 6 times until it
releases a fine mist of spray into the air.
The nasal spray is now ready for use.
Using the Nasal Spray
1. Shake the nasal spray vigorously.
2. Remove the cap.
3. Blow your nose to clear your nostrils, then tilt your head
forward a little bit.

4. Place the nozzle in one of your nostrils. Point the end of the
nozzle slightly outwards, away from the center ridge of your
nose. This helps to get the medicine to the correct part of your
nose.
5. Press the button firmly all the way in, while you breath in
through your nose.
6. Take the nozzle out and breathe out through your mouth.
7. If your dose is 2 sprays in each nostril, repeat steps 4 to 6.
8. Repeat steps 4 to 7 to treat the other nostril.
9. Replace the cap on the nasal spray.
Cleaning Nasal Spray

After each use(6)
Wipe the nozzle and inside of the cap with a clean, dry
tissue.
Do not use water to clean the device.
Never use a pin or anything sharp on the nozzle.
Always replace the cap once you have finished.

Adverse effects
- Systemic adverse effects are rare with nasal products used at recommended doses.(2)
- Side effects may include candidiasis, epistaxis, nasal ulceration, impaired wound healing,
and nasal septal perforation.(4)
- Instruct patient to report symptoms of infection or hypersensitivity (anaphylaxis,
angioedema, rash and urticaria).(4)
- Advise patient to report any changes in vision, as drug may cause glaucoma and
cataracts.(4)
- Caregivers of pediatric patients should monitor for and report decreased growth.(4)
- Instruct patient to report symptoms of systemic corticosteroid effects such as adrenal
suppression or hypercorticism (weight gain, fatigue, muscle weakness, facial rounding,
fragile or thin skin). Patient on long-term are at increased risk.(4)
Storage(6)
- It is best to store your nasal spray upright. Always keep the cap on.
- Do not use this medicine after the expiry date which is stated on the label and carton.
The expiry date refers to the last day of the month.
- Avamys nasal spray should be used within 2 months after first opening.
- Do not refrigerate or freeze.
Practice points(2)
- Nasal sprays contain different fluticasone esters, therefore do not have the same
dose/spray.
- All intranasal corticosteroids have similar efficacy and onset of action, with optimum
effect after several days of regular use.
- Effective on an as-needed basis; some symptoms of allergic rhinitis may start to improve
within hours of intranasal administration.
- Patients transferred from oral to intranasal corticosteroids may have impaired adrenal
function; intranasal corticosteroids have little systemic effect.

Desmospray (Desmopressin, 10 mcg)
Mode of action
Increases tubular reabsorption of water; increases factor VIII and von Willebrand’s factor
coagulation activity.(2)
Indication Dosage
Diabetes insipidus Adult, 10-40 micrograms daily in 1 or 2 doses.

Child, 2.5-20 micrograms daily in 1 or 2 doses.
Renal function Adult, up to 40 micrograms.

Child, up to 20 micrograms.
Infant, up to 10 micrograms.
Empty bladder at time of administration and limit fluid intake to 500
ml from 1 hour before until 8 hours after administration to avoid fluid
overload.(10)
- Contraindicated if hyponatremia, SIADH, polydipsia, Type IIb von Willebrand’s disease or

CrCl <50ml/minute.(2)
- Should not be given intranasally for nocturnal enuresis due to an increased incidence of
side effects.(10)
Remove the protective cap.
When first used, prime the spray by pressing several times until a consistent,
fine spray is seen.

Ensure that the dip-tube submerged in the liquid when using Desmospray.
With your head tilted slightly back, place the nozzle just inside the nostril.
Hold your breath (DO NOT SNIFF) and press the spray once.
Repeat this procedure using alternate nostrils until the prescribed dose is
reached.
Replace the protective cap after use.
Do not store above 25°C. keep container in the outer carton.
If the spray is not used within 7 days of the previous dose, re-prime by
pressing the spray at least once before using.
Do not use more than the prescribed dose in any 24-hour period.
Adverse effects
- Nasal side effects may include nasopharyngitis, nasal discomfort or congestion, rhinitis,
bronchitis, epistaxis, sneezing or conjunctivitis.(4)
- Tell your doctor immediately if you have headache, nausea, vomiting or weight gain.(2)
- Advise patient to report symptoms of hyponatremia, water intoxication or fluid
retention.(4)
- Tell patient to report nasal conditions that may increase absorption, including nasal
congestion, blockage, or discharge, atrophy and acute/chronic rhinitis.(4)
Storage(9)
- Keep out of the reach and sight of children.
- Do not store above 25°C. Keep container in the outer carton.

Nasonex nasal spray (Mometasone furoate, 50 mcg)
Indications and dosage
Indication Dosage
Allergic Adult, child >12 years, initially 2 sprays into each nostril once daily, reduce to 1
rhinitis spray into each nostril once daily when symptoms controlled.(2) If symptoms
are inadequately controlled, the dose may be increased to a maximum daily
dose of four actuations in each nostril once daily (total dose 400 micrograms).
Dose reduction is recommended following control of symptoms.(6)
2-12 years, 1 spray into each nostril once daily.(2) The safety and efficacy of
Nasonex nasal spray in children under 3 years of age have not been
established.(6)
Nasal polyps Adult, initially 2 sprays into each nostril once daily for 5-6 weeks, may be
increased to 2 sprays into each nostril twice daily if necessary, consider
alternative treatment if no improvement after further 5-6 weeks, reduce to the
lowest effective dose when control achieved.(2, 10)
Rhinosinusitis Adult, child >12 years, 2 sprays into each nostril twice daily.(2)
- Each bottle contains 60 sprays or 140 sprays.(6)
Preparing your nasal spray for use(6)

Your Nasonex nasal spray has a dust cap which protects the nozzle and keeps it clean. Remember
to take this off before using the spray and to replace it after use.
If you are using the spray for the first time you need to ‘prime’ the bottle by pumping the spray
10 times until a fine mist is produced:
1. Gently shake the bottle.
2. Put your forefinger and middle finger either side of the nozzle and your thumb
underneath the bottle. Do not pierce the nasal applicator.
3. Point the nozzle away from you and then press down with your fingers to pump the spray
10 times until a fine mist is produced.
If you have not used the spray for 14 days or more, you need to “re-prime” the bottle by pumping
the spray 2 times until a fine mist is produced.

How to use your nasal spray(6)
Shake the bottle gently and remove the dust cap.
Gently blow your nose.
Close one nostril and put the nozzle into the other nostril as shown.
Tilt your head forward slightly, keeping the bottle upright.
Start to breathe in gently or slowly through your nose and whilst

you breathing in, squirt a spray of fine mist into your nose by
pressing once with your fingers.
Breathe out through your mouth. Repeat step 4 to inhale a second

in the same nostril if applicable.
Remove the nozzle from this nostril and breathe out through the
mouth.
Repat steps 3 to 6 for the other nostril.

After using the spray, wipe the nozzle carefully with a clean
handkerchief or tissue and replace the dust cap.
Cleaning your nasal spray(6)

- It is important to clean your nasal spray regularly, otherwise it may not work properly.
- remove the dust cap and gently pull off the nozzle.
- Wash the nozzle and dust cap in warm water and then rinse under a running tap.
- Do not try to unblock the nasal applicator by inserting a pin or other sharp object as this
will damage the applicator and cause you not to get the right dose of medicine.
- Allow the dust cap and nozzle to dry in a warm place.
- Push the nozzle back onto the bottle and replace the dust cap.
- The spray will need to be primed again with 2 sprays when first used after cleaning.
Adverse effects
- Side effects include headaches, pharyngitis, cough, nasal or oral candidiasis, epistaxis,
nasal ulceration, impaired wound healing, or nasal septal perforation.(4)
- Caregivers of pediatric patients should monitor for and report decreased growth.(4)
- Instruct patient to report symptoms of hypercorticism and adrenal suppression (e.g.
fatigue, muscle weakness, loss of appetite, weight loss, nausea, vomiting, diarrhea,
hypotension).(4)
Storage(6)
- Keep this medicine out of the sight and reach of children.
- Do not store the bottle above 25°C. Do not freeze.
- Do not use this medicine after the expiry day, which is stated on the bottle and carton
after EXP. The expiry date refers to the last day of the month.
- Each bottle should be used within 2 months of first opening. Only open one bottle at a
time.
Practice points(2)


Oxynase nasal spray (Oxymetazoline hydrochloride)
Indication Strength Dosage
For the relief of 0.05% Adult and children over 6 years, 2 to 3 sprays into each nostril
nasal twice daily, morning and evening.
congestion
Adult, child >6 years, 1 or 2 sprays into each nostril up to 3 times
daily.(2)
0.025% Children 2-6 years of age, 2 to 3 sprays into each nostril twice
daily, in the morning and evening.
- Do not use this medicine more than recommended or for more than 5 days (BNF not
more than 7 days; AMH not more than 5 days; product leaflet not more than 3 days) at a
time as it can worsen your symptoms when you stop using it.(2, 9, 10)
Before using this product for the first time, it is necessary to load the spray. For this purpose,
hold the bottle away from your body, push the spray several times pointing down until pulverized
liquid comes out.
Nasal fluids should be eliminated before the application by blowing the

nose.
Remove the protection cap of the bottle.

Hold the bottle and put middle and index fingers in the upper zone and
the thumb underneath.
Aim the bottle into the nose and press.
After each use and before closing the bottle, the applicator should be
cleaned with a clean and damp cloth.
Administration of Afrin nasal spray(9)
To open new child resistant cap

- Place bottom of bottle on flat surface.
- Push firmly down a cap and turn counter clockwise.
- Secure cap after use.

To spray, squeeze bottle quickly and firmly
Spray 2 or 3 times in each nostril not more often than every 10 to 12

hours. Do not exceed 2 doses in any 24-hour period.
Do not tilt head backward while spraying.
Wipe nozzle clean after use.
Administration of Afrin pump mist(9)

To open new child resistant cap:
- Hold white tabs.
- Push firmly down on grooved area of cap and turn
counterclockwise.
- Secure cap after use.
Shake well before use.
Before using the first time, remove the cap and prime the metered
pump by depressing firmly several times.
To spray, hold bottle with thumb at base and nozzle between first
and second fingers. Fully depress rim with a firm, even stroke and
sniff deeply.

Do not tilt head while spraying.
Spray 2 or 3 times in each not more often than every 10 to 12 hours.

Do not exceed 2 doses in any 24-hour period.
Wipe nozzle clean after use.
Adverse effects(2)
Common (>1%): transient burning, stinging, increased nasal discharge, rebound congestion with
prolonged use (>4–5 days)
Rare (<0.1%): hypertension, nausea, nervousness, dizziness, insomnia, headache
Storage(9)

- Do not use this medicine after the expiry date which is stated on the label after EXP. The
expiry date refers to the last day of that month.
- Use within 30 days of first opening.
Practice points(2)
- Do not use for the common cold in children <6 years of age.
- Encourage use of sodium chloride 0.9% solution (nose drops, irrigation or spray) in
preference to an intranasal sympathomimetic, especially for children
- If nasal congestion impairs feeding in infants, use sodium chloride 0.9% nose drops (a
few drops in each nostril just before feed) to loosen and liquefy mucus secretions
- Keep dose and length of treatment (up to 5 days) to a minimum to reduce risk of rebound
congestion (may take several weeks to reverse)
- Oral products, e.g. pseudoephedrine, are preferred for prolonged use

Rhinocort® aqua nasal spray (Budesonide, 64 mcg)
Indication Dosage
Allergic rhinitis Adult, child >6 years, initially 128 micrograms into each nostril once daily or
64 micrograms into each nostril twice daily; maintenance 32-64 micrograms
into each nostril once daily.
Nasal polyps Adult, 64 micrograms into each nostril twice daily.
- Treatment of seasonal rhinitis should, if possible, start before exposure to the allergens.
Treatment can be continued for up to 3 months. The dose should be titrated to the lowest
dose at which effective control of symptoms is achieved.(6)
- There are insufficient to recommend the use of this medicine in children and adolescents
under 18 years of age.(6)
- Each bottle is fitted with a spray pump and contains either 60 or 120 or 240 sprays.(6)
Instruction for use(6)
Priming the nozzle

Before using Rhinocort Aqua for the first time, you must prime the nozzle (that
is, fill it with the medicine). To do this:
- Shake the bottle and remove the protective cap.
- Hold the bottle upright as shown in the picture.
- Pump the nozzle up and down several times (5 to 10 times), spraying
into the air until you see an even mist.
- The priming effect remains for about 24 hours. If you leave a gap of
more than a day before the next dose, you will need to prime the
nozzle again. This time spray it into the air just once.

Using Rhinocort Aqua
- Blow your nose. Shake the bottle. Remove the protective cap.
- Hold the bottle as shown in the picture.
- Put the tip of the nozzle into your nostril, as shown. Direct the nozzle
to the side of the nose, and away from the middle of the nose (the
‘nasal septum’). Spray once (or twice if using the nasal spray once a
day). Use the spray in the other nostril in the same way. Note, you do
not need to breathe in at the same time as you spray.
- Wipe the nozzle with a clean tissue and replace the protective cap.
Store the bottle in an upright position.
Cleaning the nozzle

It is best to clean the plastic nozzle of Rhinocort Aqua regularly. Also clean it if
you notice that the spray is not coming out as it should. If this happens, first
check the nozzle is primed with medicine. If after priming the nozzle again, the
pump is still not working, clean the nozzle as follows:
- Remove the plastic nozzle with a clean tissue and wash it in warm (not
hot) water.
- Rinse the nozzle thoroughly, dry it and then replace it on the top of the
bottle. Never try to unblock the nozzle by using a pin or other sharp
object.
- Prime the nozzle again (by filling it with medicine) before use.
Adverse effects
- Side effects may include nasal irritation and septal perforation.(4)
- Side effects may include rhinitis, pharyngitis, coughing, otitis media, impaired wound
healing, vomiting, diarrhea, abdominal pain, epistaxis and rash.(4)
- Counsel patient to report vision changes or signs of nasal or oropharyngeal candidiasis.(4)
- Instruct patient to report symptoms of hypercorticism or adrenal suppression.(4)
- Advise caregivers of pediatric patients to monitor for reduced growth velocity.(4)
Storage(6)
- Do not freeze or store in the fridge.
- Store the bottle in an upright position.

- Use within 2 months of opening the bottle. You may find it useful to write on leaflet when
you first opened the bottle.
Practice points(2)

Nasal drops
Blow your nose gently.
Check the dropper tip to make sure that it is not chipped or cracked.
Avoid touching the dropper tip against your clean nose.
Tilt your head as far back as possible or lie down on your back on a
flat surface (such as a bed) and hang your head over the edge.
Place the correct number of drops into your nose.

Bend your head forward toward your knees and gently move it left
and right.
Remain in this position for a few minutes.
Rinse the dropper tip after each use. Cap the bottle right away.
Wash your hands to remove any medication.
Oxynase nasal drops
Indication Strength Dosage
For the relief of 0.05% Adult and children over 6 years, 2 to 3 drops in each nostril
nasal twice daily, morning and evening.
congestion
0.025% Children above 1 year, 1 to 2 drops. Doses to be given twice or
three times daily.
- Do not use this medicine more than recommended or for more than 5 days (BNF not
more than 7 days; AMH not more than 5 days; product leaflet not more than 3 days) at a
time as it can worsen your symptoms when you stop using it.(2, 9, 10)

Alkaline nasal douche
- Dissolve ½ teaspoon of sodium bicarbonate powder and ½ teaspoon of salt in ½ pint of
warm clean water (around 1 glass of warm water).
- HTAR practice: Dissolve 1 teaspoon of sodium bicarbonate powder in ½ glass of warm
water.
- Mix the ingredients together.
- Fill a large syringe or the neilMed Sinus Rinse bottle.
- Stand over a sink or in the shower/bath.
- Keep your head straight.
- Put the nozzle of the syringe/bottle in one nostril.
- Try to aim the nozzle towards the back of your head.
- Squirt half the mixture into one nostril and then repeat on the other side.
- The mixture should come into your mouth – spit this out.
- If you swallow the mixture, it will do you no harm.
- Blow your nose gently.
- Rinse your nose in this way, two or three times a day.
- After douching, rinse the syringe/bottle in warm, soapy water.
- Alternatively, pour some of the solution into the palm of your hand and sniff it up into
each nostril over a sink.

Steam inhalations
- When prepared extemporaneously, the BP states menthol and eucalyptus inhalation, BP
1980 consists of racementhol or levomenthol 2 g, eucalyptus oil 10 ml, light magnesium
carbonate 7 g, water to 100 ml.(10)
- Child 3 months-17 years and adult, Add one teaspoonful to a pint of hot, not boiling,
water and inhale the vapor; repeat after 4 hours if necessary.(10)
Practical points
These can be useful, although a systematic review found insufficient evidence to judge whether
there might be a benefit. The steam helps to liquefy lung secretions and patients find the warm
moist air comforting. While there is no evidence that the addition of medications to water
produces a better clinical effect than steam alone, some may prefer to add a preparation such as
menthol and eucalyptus or a proprietary inhalant. One teaspoonful of inhalant should be added
to a pint of hot (not boiling) water and the steam inhaled. Apart from the risk of scalding, boiling
water volatilizes the constituents too quickly. A cloth or towel can be put over the head to trap
the steam. A change in advice is not to use this method in young children because of the risk of
scalding; sitting in the bathroom with a running hot shower is a safer option.(39)

Nicotine dependence
Nicotine dependence
Nicotine is the major pharmacologically active alkaloid in tobacco. It is rapidly absorbed through
the skin and mucosal surfaces in the GI and respiratory tracts. It is a CNS stimulant: regular
smoking produces feelings of pleasure, relief of anxiety, improved memory and task
performance, wakefulness and anorexia. It also alters heart rate, constricts coronary blood
vessels and increases likelihood of thromboembolism.(2)
Smoking tobacco is the main cause of preventable illness and premature death in the UK. It is
linked to a number of diseases such as cancer (primarily lung cancer), chronic obstructive
pulmonary disease, and cardiovascular disease, and can lead to complications during pregnancy.
Smoking cessation reduces the risk of developing or worsening of smoking-related illnesses, and
the benefits begin as soon as a person stops smoking.(10)
Smoking cessation may be associated with temporary withdrawal symptoms caused by nicotine
dependence, making it difficult for people to stop. These symptoms include nicotine cravings,
irritability, depression, restlessness, poor concentration, light-headedness, sleep disturbances,
and increased appetite. Weight gain is a concern for many people who stop smoking, however it
is less likely to occur when drug treatment is used to aid smoking cessation.(10)
All smokers, including those who smoke e-cigarettes should be advised to stop smoking and be
offered support to facilitate smoking cessation. They should also be advised that stopping in one
step (‘abrupt quitting’) offers the best chance of lasting success and that a combination of drug
treatment and behavioral support is likely to be the most effective approach. ‘Abrupt quitting’ is
when a smoker makes a commitment to stop smoking on or before a particular date (the quit
date), rather than by gradually reducing their smoking.(10)
Polycyclic aromatic hydrocarbons found in tobacco smoke increase the metabolism of some
drugs by inducing hepatic enzymes, often requiring an increase in dose.(10)
Before starting treatment

Assess determination to quit (e.g. health concerns, incentives, previous attempts). Those
motivated to give up are more likely to succeed. As most people need several attempts before
stopping, reserve use of bupropion or varenicline for those who are dependent on nicotine and
are committed to quit.(2)
Obtain history of smoking habits, particularly:(2)
- number of cigarettes smoked daily
- time to first cigarette after waking

- attempts to stop
- confidence and motivation to quit.
Regular smoking increases nicotine concentration during the day, which falls during sleep.
Individuals dependent on nicotine are likely to have withdrawal effects, such as craving on
waking, and tend to smoke more heavily in the morning than the rest of the day:(2)
- high dependence: waking at night to smoke or smoking within first 5 minutes after
waking; usually >30 cigarettes daily
- moderate dependence: smoking within 30 minutes after waking; usually 20–
30 cigarettes daily
- low-to-moderate dependence: no need to smoke within the first 30 minutes after waking;
usually 10–20 cigarettes daily
- low dependence: no need to smoke in the first hour after waking; usually <10 cigarettes
daily.
Consider nicotine replacement therapy (NRT), bupropion or varenicline for those who smoke at
least 10 cigarettes daily, as there is no evidence that drug treatment will benefit people with low
nicotine dependence. Use with non-drug treatment.(2)
Non-drug treatment
Provide counselling and discuss behavioral techniques to aid and encourage smoking cessation
(with or without drug treatment). Encourage use of support services. Nutritional advice (e.g. fruit
for snacks) and an exercise program may also help, and may reduce weight gain.(2)
Drug choice
Use non-drug treatment with a drug to increase patient’s chance of quitting.(2)
Nicotine replacement therapy (NRT), varenicline and bupropion hydrochloride are effective drug
treatments to aid smoking cessation. The choice of drug treatment should take into consideration
the smoker’s likely adherence, preferences, and previous experience of smoking-cessation aids,
as well as contraindications and side effects of each preparation. Varenicline, or a combination
of long-acting NRT (transdermal patch) and short-acting NRT (lozenges, gum, sublingual tablets,
inhalator, nasal spray and oral spray), are the most effective treatment options and thus the
preferred choices. If these options are not appropriate, bupropion hydrochloride or single
therapy NRT should be considered instead.(10)
Bupropion

- Originally developed as an antidepressant; it doubles the chance of quitting compared
with placebo in academic and primary care settings. Efficacy is improved when NRT is
also used.(2)
- It causes insomnia in >40% of patients (20% with placebo); its potential to cause seizures
limits its use.(2)
NRT
- Nicotine transdermal patches are generally applied for 16 hours, with the patch removed
overnight; if smokers experience strong nicotine cravings upon waking, a 24-hour patch
can be used instead.(10)
- Short-acting nicotine preparations are used whenever the urge to smoke occurs or to
prevent cravings; there is no evidence that one form of NRT is more effective than
another.(10)
- The use of NRT combined with varenicline or bupropion hydrochloride is not
recommended, and both varenicline and bupropion hydrochloride should not be
prescribed together.(10)
- A quit date should be agreed when drug treatments prescribed for smoking cessation,
and treatment should be available before the person stops smoking. Smokers should be
prescribed enough treatment to last 2 weeks after their agreed quit date and be re-
assessed shortly before their supply finishes.(10)
- Smokers who are unwilling or not ready to stop smoking may also benefit from the use
of NRT as part of a ‘harm reduction approach’, because the amount of nicotine in NRT is
much lower and less addictive than in smoking tobacco. Harm reduction approaches
include stopping smoking whilst using NRT to prevent relapse, and smoking reduction or
temporary abstinence with or without the use of NRT. These smokers should be advised
that NRT will make it easier to reduce how much they smoke and improve their chance
of stopping smoking in the long-term.(10)
- As monotherapy, NRT almost doubles the number of people quitting compared with
placebo. Efficacy is higher when nicotine patches are used with a faster-acting NRT
product (gum, film, inhaler, lozenges, spray).(2)
- When used by people with moderate or severe nicotine dependence it causes few minor
and transient adverse effects, such as local irritation.(2)
- There is no evidence that one form of NRT is more effective than another, but higher
strength products are more suitable for heavy smokers.(2)
Varenicline
- Partial agonist at nicotine receptors; it reduces withdrawal symptoms and the
pleasurable effects of smoking. Varenicline more than doubles the number of people
quitting compared with placebo and appears to have similar efficacy to combination NRT
(nicotine patches with a faster-acting NRT) and to be more effective than bupropion.(2)

- It causes mild-to-moderate nausea in 30% of patients (10% with placebo), which is usually
transient but sometimes requires dose reduction. When varenicline is stopped, there
may be an increase in nicotine withdrawal symptoms and urge to smoke.(2)
E-cigarettes
E-cigarettes deliver nicotine without the toxins found in tobacco smoke. Evidence suggests that
e-cigarettes are substantially less harmful to health than tobacco smoking, but long-term effects
are still largely unknown.(10)
Practice points(2)
- Nicotine dependence is a chronic condition with a high rate of relapse (most former
smokers average 5 or 6 serious attempts to quit)
- Regular counselling and support increases quit rates (with or without drug treatment); it
aids motivation and provides behavioral skills to enable continued abstinence
- People can expect some nicotine withdrawal symptoms (e.g. craving, anxiety, irritability)
whether or not they have drug treatment, especially in the first 3 weeks after stopping
smoking
- smokers who have made many unsuccessful attempts to stop or have cravings and/or
withdrawal symptoms with monotherapy may particularly benefit from combination
treatment with nicotine patches and a faster-acting nicotine product (e.g. spray, gum,
inhaler, film)

Modified Fagerstrom Test for Cigarette Dependence
Modified Fagerstrom test for evaluating of physical dependence on nicotine(40)
1. How soon after you wake up, do you smoke your first cigarette?
a. Within 5 minutes – 3 points
b. 5 to 30 minutes – 2 points
c. 31 to 60 minutes – 1 point
d. After 60 minutes – 0 points
2. Do you find it difficult to smoke in places where you should not, such as in church or
school, in a movie, at the library, on a bus, in court or in a hospital?
a. Yes – 1 point
b. No – 0 points
3. Which cigarette would you most hate to give up; which cigarette do you treasure the most?
a. The first one in the morning – 1 point
b. Any other one – 0 points
4. How many cigarettes do you smoke each day?
a. 10 or fewer – 0 points
b. 11 to 20 – 1 point
c. 21 to 30 – 2 points
d. 31 or more – 3 points
5. Do you smoke more during the first few hours after waking up than during the rest of the
day?
a. Yes – 1 point
b. No – 0 points
6. Do you still smoke if you are so sick that you are in bed most of the day, or if you have a
cold or the flu and have trouble breathing?
a. Yes – 1 point
b. No – 0 points
Scoring: 7 to 10 points = highly dependent; 4 to 6 points = moderately dependent; less than 4
points = minimally dependent.

Bupropion
Indication Dosage
To aid smoking Adult, initially 150 mg daily for 6 days, then 150 mg twice daily (max.
cessation in per dose 150 mg), minimum 8 hours between doses; period of
combination with treatment 7-9 weeks, start treatment 1-2 weeks before target stop
motivational support date, discontinue if abstinence not achieved at 7 weeks, consider
in nicotine-dependent maximum 150 mg daily in patients with risk factors for seizures;
patients maximum 300 mg per day.
Elderly, 150 mg daily for 7-9 weeks, start treatment 1-2 weeks before
target stop date, discontinue if abstinence not achieved at 7 weeks;
maximum 150 mg per day.
- Contraindications: acute alcohol withdrawal; acute benzodiazepine withdrawal; bipolar

disorder; CNS tumour; eating disorders; history of seizures; severe hepatic cirrhosis.(10)
- Swallow tablets whole (do not crush, cut or chew).(2)
- Dose should be taken at the same time each day.(4)
- Start taking this medicine for at least a week before you stop smoking because it takes
this long for it to become effective. It is best if you start by taking it in the morning for
the first few days to minimize sleep disturbance.(2)
- If insomnia is marked, take the PM dose earlier (in the afternoon, at least 8 hours after
the first dose) may provide some relief.(40)
- Drink only small quantities of alcohol when you are taking this medicine, as it can increase
the risk of fits and other unpleasant effects.(2)
Adverse effects
- Side effects include tachyarrhythmia, constipation, nausea, confusion, dizziness,
insomnia, tremor, agitation, anxiety or xerostomia.(4)
- This medication may have side effects (like dizziness and difficulty in concentrating),
which could affect your ability to drive and operate machinery; avoid these activities until
you know how bupropion affects you.(2)
- Instruct patient to report symptoms of seizures, new or worsening depression, suicidal
ideation, unusual behavior changes, psychosis, mania, or hypomania; discontinue if
patient is using drug for smoking cessation.(4)

- If you develop a rash, swelling of the lips or mouth, or difficulty in breathing, contact your
doctor immediately and stop taking bupropion.(2)

Nicotine replacement therapy
Dosage
Gum(40)
- Nicotine gum is available in 2mg and 4mg (per piece) doses.
- The 2mg gum is recommended for patients smoking less than 20 cigarettes per day, while
the 4mg gum is recommended for patients smoking 20 or more cigarettes per day.
- Generally, the gum should be used for up to 12 weeks with no more than 24 pieces per
day.
- Clinicians should tailor the dosage and duration of therapy to fit the needs of each patient.
- AMH: High nicotine dependence, usually chew 6–10 pieces of 4 mg gum daily.
Avoid >1 piece/hour. After 4–8 weeks reduce to 2 mg, then stop or taper use over a
further 4 weeks to zero. Moderate nicotine dependence, usually chew 8–12 pieces of
2 mg gum daily.(2)
Inhaler
- Inhale according to craving or withdrawal symptoms for 3 months then gradually reduce
use over next 2 months to zero. (2)
- Individuals should not exceed 12 cartridges of the 10-mg strength daily, or 6 cartridges
of the 15-mg strength daily.(10)
Lozenge(2)
- Moderate-to-high nicotine dependence, use 4 mg lozenges; low-to-moderate nicotine
dependence, use 1.5 mg or 2 mg lozenges.
- Weeks 1–6, oral 1 lozenge every 1–2 hours (up to 15 lozenges/24 hours for 2 mg and
4 mg strengths; and 20 lozenges/24 hours for 1.5 mg).
- Weeks 7–9, oral 1 lozenge every 2–4 hours.
- Weeks 10–12, oral 1 lozenge every 4–8 hours.
- Weeks 12–24, oral 1 lozenge when there is a strong temptation to smoke.
Patch(40)
- Treatment of at least 8 weeks has been shown to be as efficacious as longer periods. 16-
and 24- hour patches are of comparable efficacy. Clinicians should consider
individualizing treatment based on specific patient characteristics such as previous
experience with the patch, amount smoked, degree of addictiveness, etc. Finally,
clinicians should consider starting treatment on a lower patch dose in patients smoking
10 or fewer cigarettes per day.
- Niquitin (21, 14 and 7mg): If smoking 10 cigarettes or more a day, start with step 1 (21mg)
and gradually move to step 2 (14mg) after 6 weeks and then step 3 (7mg) for 2 weeks, as

directed on pack over 10 weeks. If smoking less than 10 cigarettes a day, start at step 2
and follow the 8-week programme described on the pack.
- Nicorette (25, 15 and 10mg): 15mg x 8 weeks, then 10mg x 2 weeks and finally 5mg x 2
weeks.
- AMH: Moderate-to-high nicotine dependence, apply 1 patch daily of either
21 mg/24 hours or 15–25 mg/16 hours. Stop (abruptly or by reducing strength of patches)
within 12 weeks. Low-to-moderate nicotine dependence, apply 1 patch daily of
14 mg/24 hours or 10–15 mg/16 hours. Stop within 12 weeks.(2)
Gum(41)
- Gum should be chewed slowly until a peppery or minty taste emerges, then parked
between cheek and gum to facilitate nicotine absorption through the oral mucosa.
- Gum should be slowly and intermittently chewed and parked for about 30 minutes or
until the taste dissipates.
- If the gum is too bulky, pieces may be cut in half and used more often.(2)
- Excessive chewing causes salivation, which can cause indigestion.(2)
- Eating and drinking anything except water should be avoided for 15 minutes before and
during chewing as acidic beverages (e.g. coffee, juices, and soft drinks) interfere with the
buccal absorption of nicotine. Do not eat or drink while gum is in the mouth.
- Patients often do not use enough gum to get the maximum benefit; they chew too few
pieces per day and they do not use the gum for a sufficient number of weeks. Do not eat
or drink while gum is in the mouth. Instructions to chew the gum on a fixed schedule (at
least one piece every 1-2 hours during waking hours) for at least 1-3 months may be more
beneficial than when necessary.
Inhaler(10)
- Insert the cartridge into the device and draw in air through the mouthpiece; each session
can last for approximately 5 minutes. The amount of nicotine from 1 puff of the cartridge
is less than that from a cigarette, therefore it is necessary to inhale more often than when
smoking a cigarette.
- A single 10 mg cartridge lasts for approximately 20 minutes of intense use; a single 15 mg
cartridge lasts for approximately 40 minutes of intense use.
Lozenge(2)
- Let the lozenge dissolve in your mouth; try not to chew or swallow it (which will slightly
reduce the amount of nicotine that you absorb). It may take up to 30 minutes to dissolve
completely; try not to eat or drink during this time.

Patch
- Patches should be applied on waking to dry, non-hairy skin on the hip, trunk or upper
arm and held in position for 10-20 seconds to ensure adhesion; place next patch on a
different area and avoid using the same site for several days.(10)
- Patches may be applied as soon as the patient wakes up. In patients who experience
sleep disruption, advise the patient to remove the 24-h patch prior to bedtime or use the
16-h patch. Smokers with time-to-first cigarette of 30 minutes of less may benefit from
putting the patch immediately before sleeping, so that the plasma nicotine level is
highest upon waking up 6 to 8 hours post application of the patch. Remove the patch
after 16 or 24 h.(40)
Pregnancy
The use of nicotine replacement therapy in pregnancy is preferable to the continuation of
smoking but should be used only if smoking cessation without nicotine replacement fails.
Intermittent therapy is preferable to patches but avoid liquorice-flavored nicotine products.
Patches are useful, however, if the patient is experiencing pregnancy-related nausea and
vomiting. If patches are used, they should be removed before bed.(10)
Breastfeeding
Nicotine is present in milk; however, the amount to which the infant is exposed is small and less
hazardous than second-hand smoke. Intermittent therapy is preferred.(10)
Adverse effects
Adverse effects are usually minor and transient; some (such as sleep disturbance, dizziness,
weight gain and headache) may be related to stopping smoking.(2)
Adverse effects include local irritation (for example from patches, lozenges, nasal spray) or
gastrointestinal upset with oral nicotine. Palpitations and abnormal dreams may occur.(13)
Practice points(2)
- Continue treatment for up to 12 weeks (6–8 weeks for most people), including the taper
period. Treatment for longer periods may be useful in some cases
- For smokers who want to smoke less, but are not ready to stop, nicotine replacement
can help to reduce smoking, which increases their chances of quitting in the future

- Generally, these products provide lower levels of nicotine than smoking; ensure that the
dose of nicotine is sufficient to reduce craving and withdrawal symptoms
- Fast-acting products (e.g. film, inhaler, lozenges, spray) can be used when a strong
cigarette craving occurs; they may also be used in this way by patients using bupropion,
varenicline or nicotine patches.
- Smokers with severe nicotine dependence and those who have made many unsuccessful
attempts to stop may benefit from combining patches and faster-acting nicotine
products (e.g. spray, film, inhalation) for cravings; if this is also unsuccessful, consider
adding a second patch.
Gum
- Cutting gum into smaller pieces or substituting with ordinary chewing gum may be useful
when tapering dose.
- Not suitable for those with dentures or other complicated dental work.
Inhalation
- Inhalation or puffing on the mouth piece releases nicotine and menthol; concentrations
of nicotine achieved are reportedly similar to those with 2 mg gum.
- It may be useful for those who miss the hand-to-mouth movements associated with
smoking.
Patch
- Often better tolerated and easier to use than gum.
- Patches worn for 16 hours daily are as effective as those worn for 24 hours.
- The 24-hour patch is useful for those who need to smoke shortly after waking but is more
likely to cause vivid dreams.
- The 16-hour release patch may be preferred if sleep disturbance is troublesome.
- If adverse effects (such as nausea) occur, consider changing to a lower strength patch.

Varenicline
Mode of action
Partial agonist at a subtype of neuronal nicotinic acetylcholine receptors. It blocks nicotine
binding to these receptors, preventing the pleasurable effects of smoking, while its partial agonist
activity reduces symptoms of nicotine withdrawal.(2)
Dosing(2)
Start varenicline at least 7 days before stopping smoking. If nausea is intolerable, consider
reducing the dose to 1mg once daily.
Adult, oral, initially 0.5 mg once daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg
twice daily for 11-23 weeks, as tolerated.
CrCl <30ml/minute, oral initially 0.5 mg once daily for 3 days, then increase 1 mg once daily, if
tolerated.
- Start taking this medicine for at least a week before you stop smoking because it takes
this long for it to become effective.(2)
- Take after eating and with a full glass (8 ounces) of water.(4)
- Swallow tablets whole.(2)
- Tell patient to limit alcohol use.(4)
Adverse effects
- Side effects may include nausea, constipation, flatulence, vomiting, insomnia, or vivid,
unusual or strange dreams.(4)
- Warn patient to avoid activities requiring mental alertness or coordination until drug
effects are realized due to dizziness, somnolence or difficulty concentrating.(4)
- You may feel nauseous when taking this medicine. Contact your doctor if this is severe,
because it may improve with dose reduction.(2)
- Encourage patient to report agitation, hostility, depression, suicidal ideation, or unusual
changes in behavior.(4)
- Counsel patient to immediately report seizures.(4)
- Instruct patient to report symptoms of angina, myocardial infarction, or stroke.(4)
- Advise patient to report symptoms of erythema multiforme or Stevens-Johnson
syndrome.(4)

- After finishing this treatment, some people have found a temporary increase in cigarette
craving, irritability and insomnia. It may be useful to have a fast-acting nicotine product
at hand in case you have an overwhelming urge to smoke.(2)
Practice points(2)
- Clinical studies have not shown an increased risk of neuropsychiatric adverse events in
patients taking varenicline compared to placebo; there are postmarketing reports of
suicide and of new or worsening neuropsychiatric symptoms, but it is unclear if they are
associated with varenicline.
- Initial dose titration aims to reduce the incidence of nausea
- Use with nicotine replacement improves effectiveness; using a fast-acting product (e.g.
film, inhaler, lozenge, spray) is particularly helpful when strong cigarette craving occurs
- After stopping varenicline, there is often an increased urge to smoke and nicotine
withdrawal symptoms

Additional counseling points
Using 5Ds strategy to cope with nicotine withdrawal symptoms(41)
Delay Reaching for cigarettes until urges pass
Distract Yourself – call a friend to go for a walk, take after meal walks, fruits
after meal, shower, exercise, yoga or take sweets
Drink water To fight off cravings
Deep breaths Relax – close your eyes and take 10 deep breaths
Discuss your feelings With someone close to you or at a support forum
Using DEAD strategy to cope with nicotine withdrawal symptoms(41)
Delay Delay reaching for cigarettes
Escape E.g. reject offers for cigarettes, throw away cigarettes/ lighters/ ashtrays
Avoid Triggers factors like smoking zones, food/beverage that will trigger urge to smoke
(hot & spicy food, strong caffeinated drinks)
Distract After meal walks, take fruits after meal, shower, exercise, yoga, sweets
Addressing withdrawal symptoms/side effects(41)
Symptoms Coping Strategies
Constant - Follow 5Ds strategy

cravings
Feeling - Do relaxation exercises

irritable - Listen to soothing music
- Watch a movie
- Warn family and friends of potential irritability
- Do light exercises e.g. brisk walking to release endorphins in the body
Headaches - Get enough sleep

- Stay in quiet, relaxed surroundings
- Don’t stress the eyes. Read and watch television with the lights on.
Feeling tired - Get enough sleep

- Don’t tire yourself out

- Do light exercises e.g. brisk walking
- Take small regular meals to regulate your blood sugar level and boost
energy level
- Replace coffee with ginger or herbal tea to perk up
Coughing - Suck on sugar-free cough drops

- Sip warm water
Tingling hands - Distract yourself with a book or a walk

and feet - Go for stretching exercises such as yoga
- Go foot or hand massages
Problems encountered by smokers(41)
Problems Responses
Lack of - Schedule follow-up visits or telephone calls with the patient

support for - Urge the patient to call the national quit line network or other local quit line.
cessation - Help the patient identify sources of support within his or her environment
- Refer the patient to an appropriate organization or support
Negative - If significant, provide counseling, prescribe appropriate medication or refer

mood or the patient to a specialist
depression
Strong or - Consider extending the use of an approved medication or adding/combining

prolonged medications to reduce strong withdrawal symptoms
withdrawal - Use 5Ds strategy
symptoms

Problems Responses
Weight - Recommend starting or increasing physical activity ~30 minutes 5 times a

gain week or more
- Emphasize the importance of a healthy diet and active lifestyle
- Reassure the patient that some weight gain after quitting is common and
usually is self-limiting
- Emphasize the health benefits of quitting relative to the health risks of
modest weight gain
- Low-calorie substitutes such as sugarless chewing gum, vegetables, mints,
fresh fruits or crunchy vegetables
- Drink at least 8 glasses of water daily
- Maintain the patient on medication known to delay weight gain (e.g. NRTs –
particularly 4 mg nicotine gum and lozenge)
- Refer the patient to a nutritional counselor or program
Smoking - Suggest continued use of medications, which can reduce the likelihood that
lapses a lapse will lead to a full relapse
- Encourage another quit attempt or a recommitment to total abstinence
- Reassure that quitting may take multiple attempts, and use the lapse as a
learning experience
- Provide or refer for intensive counseling
- Reassure the patient that these feelings are common
- Recommend rewarding activities
- Probe to ensure that patient is not engaged periodic tobacco use
- Emphasize that beginning to smoke (even a puff) will increase urges and
make quitting more difficult

Nystatin oral suspension 100,000 units/ml
Indication Dosage
Oropharyngeal candidiasis Adult, child, oral liquid 100,000 units 4 times daily for 7-14 days
for treatment. Higher doses, e.g. 500,000 units 4 times daily, can
be used.
Method of administration: adult & children

- Shake well before using.(12)
- 400,000 – 600,000 units 4 times/day; swish in the mouth and retain for as long as possible
(several minutes) before swallowing.(12)
- Should be administered after food.(13)
- Patients should avoid taking food or drink earlier than one hour after a dose.(9)
- Most doctors recommend that you continue to use the drops for two days after your
symptoms have gone – a typical course of treatment will last around seven days.(7)
- If the patient wear dentures, they should remove them to expose affected areas for
treatment.(13)
Method of administration: infants

- Infants: 200,000-400,000 units 4 times/day or 100,000 units to each side of mouth 4
times/day.(12)
- Shake well before using.(12)
- In infants and children, apply one half of dose in each side of mouth.(9)
- Avoid feeding for 5 to 10 minutes.(12)
Adverse effects(2)
- Common (>11%), nausea, vomiting, diarrhea (more severe with doses > 5 million units
daily)
Practice points(2)
- Nystatin oral liquid is effective treatment for minor oral fungal infections.

- Treatment with oral itraconazole or fluconazole is often required in
immunocompromised people, especially with HIV.
Storage(7)
- Keep out of the reach and sight of children.
- Store in a cool, dry place, away from direct heat and light.

Opioid dependence
Opioid dependence
Opioid dependence is a chronic, frequently relapsing illness.(2)
Using opioids can produce euphoric effects but tolerance to these develops rapidly, causing users
to repeatedly increase dosage and to use more dangerous routes of administration such as
injecting or smoking. Providing the dose is not excessive (resulting in overdose), opioids are not
particularly toxic. Opioid dependence causes problems because:(2)
- opioids are often used with other substances, e.g. alcohol, benzodiazepines, and aspirin,
ibuprofen or paracetamol from opioid-containing combination analgesics; these may
cause toxic effects
- criminal or high-risk activity may be necessary to finance the habit
- it may be impossible to maintain usual activities, e.g. employment, education, social
interaction
- the identity and the strength of illicit drugs may be unknown; they are often diluted with
chemicals (sometimes toxic) of similar appearance or taste
- they may be used IV and regular use may cause phlebitis and collapsed veins
- sharing needles or equipment increases risk of infection by blood-borne viruses
(hepatitis B and C, HIV)
- non-sterile equipment and drug increases risk of abscess, septicemia, endocarditis, chest
infections.
Long-term effects include irregular menstruation, impotence and mood changes.(2)
The management of opioid dependence requires medical, social and psychological treatment;
access to a multidisciplinary team is recommended. Treatment for opioid dependence should be
initiated under the supervision of an appropriately qualified prescriber.(10)
Opioid withdrawal symptoms

Stopping opioids usually causes symptoms such as dilated pupils, goose pimples, diarrhea,
cramps, muscle aches, extreme anxiety, restlessness, insomnia, nausea or vomiting, sweating,
tearing, tachycardia, increased BP. Opioid withdrawal reactions, although unpleasant, are not
life-threatening.(2)
Onset of withdrawal symptoms is related to the duration of action of the drug. When short-acting
opioids, e.g. heroin, are stopped, symptoms begin within a few hours of the last dose, are most
severe after 2-4 days, then gradually subside after a week of abstinence. A milder, protracted
withdrawal syndrome (e.g. craving, sleep disturbance) may last for several months.(2)

Methadone hydrochloride or buprenorphine withdrawal occurs later, with longer-lasting
symptoms.(10)
Opioid substitution therapy

Before starting treatment, consider other conditions that may complicate treatment, e.g.
pregnancy, misuse of other substances (e.g. alcohol, benzodiazepines), chronic pain syndromes,
personality disorder, schizophrenia, infections (especially hepatitis B and C, HIV), hepatic or renal
disease.(2)
Methadone hydrochloride and buprenorphine are used as substitution therapy in opioid
dependence. Substitute medication should be commenced with a short period of stabilization,
followed by either a withdrawal regimen or by maintenance treatment. Maintenance treatment
enables patients to achieve stability, reduces drug use and crime, and improves health; it should
be regularly reviewed to ensure the patient continue to derive benefit. The prescriber should
monitor for signs of toxicity, and the patient should be told to be aware of warning signs of
toxicity on initiation and during titration.(10)
A withdrawal regimen after stabilization with methadone hydrochloride or buprenorphine
should be attempted only after careful consideration. Enforced withdrawal is ineffective for
sustained abstinence, and it increases the risk of patients relapsing and subsequently overdosing
because of loss of tolerance. Complete withdrawal from opioids usually takes up to 4 weeks in
an inpatient or residential setting, and up to 12 weeks in a community setting. If abstinence is
not achieved, illicit drug use is resumed, or the patient cannot tolerate withdrawal, the
withdrawal regimen should be stopped and maintenance therapy should be resumed at the
optimal dose. Following successful withdrawal treatment, further support and monitoring to
maintain abstinence should be provided for a period of at least 6 months.(10)
Missed doses
Patients who miss 3 days or more of their regular prescribed dose of opioid maintenance therapy
are at risk of overdose because of loss of tolerance. Consider reducing the dose in these
patients.(10)
If the patient misses 5 or more days of treatment, an assessment of illicit drug use is also
recommended before restarting substitution therapy; this is particularly important for patients
taking buprenorphine because of the risk of precipitated withdrawal.(10)
Buprenorphine

Buprenorphine is preferred by some patients because it is less sedating than methadone
hydrochloride; for this reason, it may be more suitable for employed patients or those
undertaking other skilled tasks such as driving.(10)
Buprenorphine is safer than methadone hydrochloride when used in conjunction with other
sedating drugs and has fewer drug interactions. Dose reductions may be easier than with
methadone hydrochloride because the withdrawal symptoms are milder, and patients generally
require fewer adjunctive medications; there is also a lower risk of overdose.(10)
Buprenorphine can be given on alternate days in higher doses and it requires a shorter drug-free
period than methadone hydrochloride before induction with naltrexone hydrochloride for
prevention of relapse.(10)
Patients dependent on high doses of opioids may be at increased risk of precipitated withdrawal.
Precipitated withdrawal can occur in any patient if buprenorphine is administered when other
opioid agonist drugs are in circulation. Precipitated opioid withdrawal, if it occurs, starts within
1-3 hours of the first buprenorphine dose and peaks at around 6 hours. Non-opioid adjunctive
therapy, such as lofexidine hydrochloride, may be required if symptoms are severe.(10)
To reduce the risk of precipitated withdrawal, the first dose of buprenorphine should be given
when the patient is exhibiting signs of withdrawal, or 6-12 hours after the last use of heroin (or
other short-acting opioid), or 24-48 hours after the last dose of methadone hydrochloride. It is
possible to titrate the dose of buprenorphine within one week — more rapidly than with
methadone hydrochloride therapy—but care is still needed to avoid toxicity or precipitated
withdrawal; dividing the dose on the first day may be useful.(10)
A combination preparation containing buprenorphine with naloxone (Suboxone®) can be
prescribed for patients when there is a risk of dose diversion for parenteral administration; the
naloxone hydrochloride component precipitates withdrawal if the preparation is injected, but it
has little effect when the preparation is taken sublingually.(10)
When there is a risk of opioid substitution medicines, or difficulties with adherence to daily
supervised opioid substitution medication, buprenorphine prolonged-release injection may be
an option.(10)
Methadone
Methadone hydrochloride, a long-acting opioid agonist, is usually administered in a single daily
dose as methadone hydrochloride oral solution 1 mg/ml. Patients with a long history of opioid
misuse, those who typically abuse a variety of sedative drugs and alcohol, and those who
experience increased anxiety during withdrawal of opioids may prefer methadone hydrochloride
to buprenorphine because it has a more pronounced sedative effect.(10)

Methadone hydrochloride is initiated at least 8 hours after the last heroin dose, provided that
there is objective evidence of withdrawal symptoms. A supplementary dose on the first day may
be considered if there is evidence of persistent opioid withdrawal symptoms. Because of the long
half-life, plasma concentrations progressively rise during initial treatment even if the patient
remains on the same daily dose (it takes 3-10 days for plasma concentrations to reach steady-
state in patients on a stable dose); a dose tolerated on the first day of treatment may become a
toxic dose on the third day as cumulative toxicity develops. Thus, titration to the optimal dose in
methadone hydrochloride maintenance treatment may take several weeks.(10)
Opioid substitution during pregnancy

Acute withdrawal of opioids should be avoided in pregnancy because it can cause fetal death.
Opioid substitution therapy is recommended during pregnancy because it carries a lower risk to
the fetus than continued use of illicit drugs. If a woman who is stabilized on methadone
hydrochloride or buprenorphine for treatment of opioid dependence becomes pregnant, therapy
should be continued [buprenorphine is not licensed for use in pregnancy]. Many pregnant
patients choose a withdrawal regimen, but withdrawal during the first trimester should be
avoided because it is associated with an increased risk of spontaneous miscarriage. Withdrawal
of methadone hydrochloride or buprenorphine should be undertaken gradually during the
second trimester, with dose reductions made every 3-5 days. If illicit drug use occurs, the patient
should be re-stabilized at the optimal maintenance dose and consideration should be given to
stopping the withdrawal regimen.(10)
Further withdrawal of methadone hydrochloride or buprenorphine in the third trimester is not
recommended because maternal withdrawal, even if mild, is associated with fetal distress,
stillbirth, and the risk of neonatal mortality. Drug metabolism can be increased in the third
trimester; it may be necessary to either increase the dose of methadone hydrochloride or change
to twice-daily consumption (or a combination of both strategies) to prevent withdrawal
symptoms from developing.(10)
The neonate should be monitored for respiratory depression and signs of withdrawal if the
mother is prescribed high doses of opioid substitute.(10)
Signs of neonatal withdrawal from opioids usually develop 24-72 hours after delivery but
symptoms may be delayed for up to 14 days, so monitoring may be required for several weeks.
Symptoms include a high-pitched cry, rapid breathing, hungry but ineffective suckling, and
excessive wakefulness; severe, but rare symptoms include hypertonicity and convulsions.(10)
Opioid substitution during breastfeeding

Doses of methadone and buprenorphine should be kept as low as possible in breast-feeding
mothers. Increased sleepiness, breathing difficulties, or limpness in breast-fed babies of mothers
taking opioid substitutes should be reported urgently to a healthcare professional.(10)
Adjunctive therapy and symptomatic treatment

Adjunctive therapy may be required for the management of opioid withdrawal symptoms.
Loperamide hydrochloride may be used for the control of diarrhea; mebeverine hydrochloride
for controlling stomach cramps; paracetamol and non-steroidal anti-inflammatory drugs for
muscular pains and headaches; metoclopramide hydrochloride or prochlorperazine may be
useful for nausea or vomiting. Topical rubefacients can be helpful for relieving muscle pain
associated with methadone hydrochloride withdrawal. If a patient is suffering from insomnia,
short-acting benzodiazepines or zopiclone may be prescribed, but because of the potential for
abuse, prescriptions should be limited to a short course of a few days only. If anxiety or agitation
is severe, specialist advice should be sought.(10)
Lofexidine
Lofexidine hydrochloride may alleviate some of the physical symptoms of opioid withdrawal by
attenuating the increase in adrenergic neurotransmission that occurs during opioid withdrawal.
Lofexidine hydrochloride can be prescribed as an adjuvant to opioid substitution therapy,
initiated either at the same time as the opioid substitute or during withdrawal of the opioid
substitute. Alternatively, lofexidine hydrochloride may be prescribed instead of an opioid
substitute in patients who have mild or uncertain dependence (including young people), and
those with a short history of illicit drug use.(10)
Opioid-receptor antagonists
Patients dependent on opioids can be given a supply of naloxone hydrochloride to be used in
case of accidental overdose.(10)
Naltrexone hydrochloride precipitates withdrawal symptoms in opioid-dependent subjects.
Because the effects of opioid-receptor agonists are blocked by naltrexone hydrochloride, it is
prescribed as an aid to prevent relapse in formerly opioid-dependent patients.(10)
Opioid dependence in children

In younger patients (under 18 years), the harmful effects of drug misuse are more often related
to acute intoxication than to dependence, so substitution therapy is usually inappropriate.
Maintenance treatment with opioid substitution therapy is therefore controversial in young
people; however, it may be useful for the older adolescent who has a history of opioid use to
undergo a period of stabilization with buprenorphine or methadone hydrochloride before
starting a withdrawal regimen.(10)
Relapse prevention
After successful withdrawal some symptoms may continue, e.g. craving, anxiety, insomnia;
resumption of opioid use is very common and may carry increased risk of overdose due to
reduced opioid tolerance. Strategies to avoid cues associated with situations, people and places
connected with drug use may be necessary for many years.(2)
Naltrexone may be used after withdrawal to assist abstinence; it does not relieve persistent
withdrawal symptoms such as anxiety or insomnia. It may be suitable for those with a high
motivation to be opioid free, with a good support network and those with a short history of
opioid use.(2)

Methadone
Indication Dosage
Opioid dependence Oral, initially 20-30mg daily, then increase by small increments
according to local protocols, to a maintenance dose around 60-80mg
daily in most patients.
Pregnancy
Increased doses (or twice daily administration) of maintenance methadone may be needed due
to increased metabolism. Withdrawal symptoms may occur in the neonate at birth. Methadone
maintenance is safer for the mother and child than the continued use of illicit opioids.(2)
Breastfeeding
Breastfeeding is considered safe.(2)
Adverse effects
- Side effects may include nausea, vomiting, sweating, lightheadedness, asthenia, dizziness
or sedation.(4)
- Methadone may cause drowsiness particularly when starting treatment or if the dose is
increased; do not drive or operate machinery if you are affected.(2)
- Tell patient to report symptoms of severe constipation, respiratory depression, adrenal
insufficiency, severe hypotension or an arrhythmia.
Counseling points
- It takes a few days to gain the full effect of a dose of methadone. In the meantime, you
may feel uncomfortable but should not take opioids, alcohol or benzodiazepines as this
increase the risk of overdose, can affect assessment of your symptoms, and it will take
longer to tailor your dose.(2)
- Tell any doctor or dentist who is treating you that you are on the methadone program so
they can prescribe appropriately.(2)
- Advise patient against sudden discontinuation of drug.(4)
- Advise patient to avoid other CNS depressants while taking this drug.(4)
- Patient should not drink alcohol while taking this drug.(4)

Practice points(2)
- Withhold methadone dose if the patient is intoxicated (e.g. with opioid or alcohol);
reconsider supply after a number of hours if no longer intoxicated.
- Tolerance develops to methadone’s sedative effects (after 4–6 weeks), enabling normal
activities (e.g. employment, education) to be resumed; encourage patients to continue
treatment for at least 18–24 months.
- Assess patients daily for at least the first 5 days of methadone maintenance for signs of
withdrawal or intoxication and adjust dose accordingly (fatal drug toxicity is most
common in the first 2 weeks).
- Methadone’s long half-life (24–36 hours) means that it takes up to 5 days to reach
steady-state concentrations for a particular dose.
- Doses >60 mg daily will reduce craving and block the euphoric effects of other opioids
- If someone on methadone maintenance has a painful condition requiring opioid
analgesics, higher than standard doses may be needed for pain relief (in addition to
regular methadone).

Naltrexone
Adjunct in treatment of alcohol dependence or maintenance of abstinence from opioids after
opioid detoxification.
Indications Dosage
Alcohol dependence Adult, oral 50mg once daily
Maintenance of opioid Adult, oral, initial dose 25mg daily; if no withdrawal symptoms
dependence occur, use 50mg once daily.
- Contraindications:(2)
o Physically dependent on opioid or in acute withdrawal
o in acute hepatitis, liver failure or when liver enzymes >3 times ULN
Pregnancy
Avoid use if possible.(2)
Adverse effects
- This drug may cause nausea, loss of appetite, diarrhea, constipation, or an opioid
withdrawal like symptom complex (e.g. tearfulness, abdominal cramps, restlessness,
bone or joint pain, myalgia nasal symptoms).(4)
- This medicine can make you feel dizzy or sleepy when you first start taking it; avoid
driving or operating machinery if you are affected.(2)
- If you notice yellowing of the whites of your eyes, dark urine or pale bowel motions, stop
taking naltrexone and tell your doctor at once.(2)
- Instruct patient to report signs/symptoms of opioid withdrawal (e.g. confusion,
somnolence, visual hallucinations, vomiting, diarrhea), depression, worsening
depression, suicidal ideation, acute hepatitis or other hepatic dysfunction.(4)
- Tell your dentist, pharmacist, a new doctor or hospital doctor that you are taking
naltrexone. If you need a new medicine they will make sure it is compatible with your
treatment.
- After opioid withdrawal

o Do not try to overcome the blockade effect of naltrexone by using higher doses of
opioids, potentially fatally.
o After taking naltrexone you will be more sensitive to the effects of opioids and will
be at great risk of fatal overdose if you stop taking naltrexone and use opioids
again.
o Naltrexone continues to block the effects of opioids for some time after you stop
taking it. People have overdosed on opioids when they used them shortly after
stopping naltrexone, found the opioid didn’t work so tried a bigger dose some
time later when the naltrexone blockade was reduced.
Practice points(2)
- Monitor liver function (especially total bilirubin) before starting treatment, then each
month for the first 3 months then, if normal, every 3 months
- If daily dosing is difficult, try dosing 3 times a week, e.g. 100 mg Monday, 100 mg
Wednesday and 150 mg Friday (but this may increase the risk of hepatotoxicity)
Alcohol dependence
- Naltrexone does not influence intoxication or the withdrawal effects of alcohol (may
reduce craving, aid reduction of drinking and associated problems, and assist abstinence);
it produces modest improvements in the outcome of conventional treatment
- When starting treatment, if you need to confirm an individual is drug-free (some
alcoholics also use opioids), give a naloxone challenge or test urine
- Assess benefit of treatment; quantify alcohol consumption before and at stages during
treatment
Maintenance of opioid abstinence
- Consider only if patient is highly motivated to stop opioids; unlike methadone
maintenance treatment, naltrexone use has not been shown to reduce mortality
- Appears to offer only modest benefits; achieving long-term abstinence is uncommon
(retention low, relapse common); after stopping naltrexone:
o patients are more sensitive to the effects of opioids (tolerance is reduced)
o risk of overdose and death are increased
- Before starting naltrexone, patient should have been free from short-acting opioids for
about 7 days (at least 2 weeks for long-acting opioids such as methadone)
- Consider using naloxone challenge: if mild response, delay naltrexone and rechallenge
after 24 hours; severe withdrawal response, give 10 mg morphine IM and advise
detoxification

- Patients need support (e.g. medication administration observed by a relative or friend)
to continue to take naltrexone; self-administration is less likely to succeed
- Opioid receptor blockade with naltrexone will block the effects of small doses of opioids
but may be overwhelmed by high doses, potentially fatally

Osteoporosis
Osteoporosis
Osteoporosis is a progressive bone disease characterized by low bone mass measured by bone
mineral density (BMD), and microarchitectural deterioration of bone tissue. This leads to an
increased risk of fragility fractures as a result. Osteoporosis is considered severe if there have
been one or more fragility fractures.(10)
Many preventable and inherent risk factors exist. Osteoporosis-related fracture sites primarily
include the vertebrae, distal radius and hips.(1)
Pathophysiology
Bone loss occurs when resorption exceeds formation, usually from high bone turnover when the
number or depth of bone resorption sites greatly exceeds the ability of osteoblasts to form new
bone. Accelerated bone turnover can increase the amount of immature bone that is not
adequately mineralized.(16)
Men and women begin to lose bone mass starting in the third or fourth decade because of
reduced bone formation. Estrogen deficiency during menopause increases osteoclast activity,
increasing bone resorption more than formation. Men are at a lower risk for developing
osteoporosis and osteoporotic fractures because of larger bone size, greater peak bone mass,
increase in bone width with aging, fewer falls, and shorter life expectancy. Male osteoporosis
results from aging or secondary causes.(16)
Age-related osteoporosis results from hormone, calcium, and vitamin D deficiencies leading to
accelerated bone turnover and reduced osteoblast formation.(16)
Drug-induced osteoporosis may result from systemic corticosteroids, thyroid hormone
replacement, antiepileptic drugs (e.g., phenytoin and phenobarbital), depot
medroxyprogesterone acetate, and other agents.(16)
Risk factors associated with the development of osteoporosis(1)
↑Age Predisposing medical problems (e.g., chronic liver

disease, chronic renal failure, hyperthyroidism, primary
Female sex
hyperparathyroidism, Cushing syndrome, insulin
Caucasian or Asian dependent diabetes, gastrointestinal resection,
malabsorption, irritable bowel disease, chronic
Family history
obstructive pulmonary disease, and acquired immune
Small stature deficiency syndrome or human immunodeficiency virus)

Low weight Drugs (e.g., corticosteroids, long-term anticonvulsant
therapy [phenytoin or phenobarbital], excessive use of
Early menopause or oophorectomy
aluminum-containing antacids, long-term high-dose
Sedentary lifestyle heparin, furosemide, excessive levothyroxine therapy)
↓Mobility
Low calcium intake
Excessive alcohol intake
Cigarette smoking
Treatment
Prevention and treatment focus on modifying preventable risks, providing adequate dietary
supplementation of calcium and vitamin D, increasing bone mineral density, and reducing
fracture rates.(1)
Pharmacologic therapy is reserved for patients with a hip or vertebral fracture, a T-score ≤−2.5
at the femoral neck or spine, or low bone mass with a 10-year probability of ≥3% risk of hip
fracture or ≥20% risk of major osteoporotic fracture.(1)
Preventative measures include adequate intake of calcium (1,000–1,200 mg daily from diet or
supplementation for all adults >50 years of age) and vitamin D (800–1,000 international units
daily in postmenopausal women), weight-bearing exercise (at least 30 minutes three times
weekly), cessation of smoking, and limiting alcoholic beverages.(1)
Postmenopausal osteoporosis
The therapeutic options for the prevention and treatment of osteoporosis in postmenopausal
women are the same.(10)
Oral bisphosphonates, alendronic acid and risedronate sodium are considered as first-line
choices for most patients with postmenopausal osteoporosis due to their broad spectrum of anti-
fracture efficacy. Alendronic acid and risedronate sodium have been shown to reduce occurrence
of vertebral, non-vertebral and hip fractures. Intravenous bisphosphonates (ibandronic acid or
zoledronic acid), denosumab, or raloxifene hydrochloride are alternative options in women who
are intolerant of oral bisphosphonates or in whom they are contra-indicated.(10)
Hormone replacement therapy (HRT) is an additional option. The use of HRT for osteoporosis is
generally restricted to younger postmenopausal women with menopausal symptoms who are at

high risk of fractures. This is due to the risk of adverse effects such as cardiovascular disease and
cancer in older postmenopausal women and women on long-term HRT therapy.(10)
Teriparatide is reserved for postmenopausal women with severe osteoporosis at very high risk
for vertebral fractures. Its duration of treatment is limited to 24 months.(10)
Corticosteroid-induced osteoporosis
Glucocorticoid therapy is associated with bone loss and increased risk of fractures. The greatest
rate of bone loss occurs early after initiation of glucocorticoids and increases with dose and
duration of therapy. Bone-protection treatment should be started at the onset of therapy in
patients who are at a high risk of fracture.(10)
If glucocorticoid therapy is stopped, the need to continue bone-protection treatment should be
reviewed. However, bone-protection treatment should be continued with long-term
glucocorticoid therapy. Complex cases of glucocorticoid-induced osteoporosis should be referred
to a specialist.(10)
Women aged 70 years or over, or with a previous fragility fracture, or taking large doses of
glucocorticoids (prednisolone ≥7.5 mg daily or equivalent) are at high risk of fractures and should
be assessed for prophylactic bone-protection. Some younger patients, particularly those with a
previous history of fracture or receiving high doses of glucocorticoids can also be considered for
bone-protection treatment.(10)
The therapeutic options for prophylaxis and treatment of glucocorticoid-induced osteoporosis
are the same; oral bisphosphonates, alendronic acid, or risedronate sodium are first-line options.
Intravenous zoledronic acid or teriparatide are alternatives in patients intolerant of oral
bisphosphonates or in whom they are contra-indicated.(10)
Osteoporosis in men
Oral bisphosphonates, alendronic acid or risedronate sodium are recommended as first-line
treatments for osteoporosis in men. Intravenous zoledronic acid or denosumab are alternatives
in men who are intolerant of oral bisphosphonates or in whom they are contra-
indicated; teriparatide is an additional option.(10)
Men having long-term androgen deprivation therapy for prostate cancer have an increased
fracture risk. Fracture risk should be assessed when starting this therapy. A bisphosphonate can
be offered to men with confirmed osteoporosis; denosumab is an alternative if bisphosphonates
are contra-indicated or not tolerated.(10)

Bisphosphonates: treatment duration
There is some evidence to suggest that patients can benefit from a bisphosphonate-free period
as their therapeutic effects last for some time after cessation of treatment.(10)
Bisphosphonate treatment should be reviewed after 5 years of treatment with alendronic
acid, risedronate sodium or ibandronic acid, and after 3 years of treatment with zoledronic acid.
Patients over 75 years of age, or with a history of previous hip or vertebral fracture, or patients
who have had one or more fragility fractures during treatment, or who are taking long-term
glucocorticoid therapy can continue bisphosphonates beyond this period.(10)

Fosamax (Alendronate) 70 mg
Indication Dosage
Treatment of postmenopausal osteoporosis Oral, 70 mg once a week.

and osteoporosis in men
Treatment and prevention of corticosteroid- Oral, 70 mg once a week.

induced osteoporosis
- Available in fixed dose combination cholecalciferol (vitamin D3).
- Take in the morning with a full glass (at least 180ml) of plain water (not coffee, juice,
mineral water or milk) at least 30 minutes before consuming any food, supplements or
medications. Remain upright during this time and until after you eat. Swallow whole; do
not chew or suck on the tablet.(2, 16)
- Drug should not be taken at bedtime or before arising.(4)
- Do not take antacids, calcium, iron or mineral supplements within 30 minutes of
alendronate as they may interfere with its absorption.(2)
- If patient misses a weekly dose, it can be taken the next day. If more than 1 day has
elapsed, that dose is skipped until the next scheduled ingestion. (16)
Adverse effects
- Drug may cause abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia,
musculoskeletal pain or nausea. Drug may cause esophageal bleeding, perforation,
stricture or ulceration.(4)
- Stop tablets and see your doctor immediately if you have pain on swallowing, or new or
worsening heartburn.(2)
- Tell your doctor if you have severe pain in your bones, joints or muscles and symptoms
of osteonecrosis of the jaw (pain, swelling, infection of jaw/gums, numbness, gum loss)
while taking this medicine.(2, 4)
Counseling points

- There are rare complications with some dental procedures in people taking
bisphosphonates; tell your doctor if you require any dental work and tell your dentist
that you are taking this medicine (or have taken it in the past).(2)
Practice points from bisphosphonates(2)

- Ensure adequate intake of calcium and vitamin D; if necessary prescribe supplements (to
be taken at a different time of day to oral bisphosphonates).
- For hypercalcemia, start bisphosphonate treatment as soon as possible as a response
requires 2–4 days; the nadir in plasma calcium usually occurs 4-7 days after treatment;
restore and maintain adequate hydration with parenteral sodium chloride 0.9% before,
during and after use.
- In Paget’s disease, a single bisphosphonate course will often induce a long-lasting
remission; consider re-treatment if clinically indicated (limited data).
- Consider full dental assessment and complete any dental procedures before starting
treatment to minimize risk of osteonecrosis.
- Consider the possibility of femoral fracture if the patient develops thigh, hip or groin pain;
if an atypical femoral fracture is identified, stop bisphosphonate and check contralateral
femur (these fractures are often bilateral).
Duration of treatment in postmenopausal osteoporosis
- There is limited evidence of additional protective effect after 5 years treatment in
postmenopausal women. Optimal duration of treatment is uncertain:
o alendronate: women who stopped treatment after 5 years had a gradual fall in
BMD over the next 5 years, but not to pre-treatment levels; there was an
increased risk of clinical vertebral (but not non-vertebral) fractures.
o zoledronic acid: women who stopped treatment after 3 years had a slight
reduction in BMD after a further 3 years, but it remained above pre-treatment
levels; there was no significant difference in clinical fractures.
o risedronate: the few data available suggest that its effects on bone may not persist
for as long as those of alendronate or zoledronic acid.
- Based on this evidence, some commentators suggest that a break in treatment of up to
5 years may be considered for postmenopausal women who respond well to treatment
(i.e. BMD T score above –2.0 after 5 years of alendronate or 3 years of zoledronic acid),
and who are not at high risk of vertebral fracture. Those at high risk of fracture (e.g. BMD
T score of –2.5 or less, or an existing vertebral fracture) appear to benefit most from
continued treatment.
- If treatment is stopped, ensure regular follow-up which may include falls risk assessment;
the value and optimal timing of BMD monitoring is not established, seek specialist advice.

Bonviva (Ibandronic acid) 150 mg
Indications Dosage
Reduction of bone damage in bone Adult, 50 mg daily, alternatively (by

metastases in breast cancer intravenous infusion) 6 mg every 3-4 weeks.
Treatment of postmenopausal osteoporosis Adult (female), 150 mg once a month,
alternatively (by intravenous injection) 3 mg
every 3 months, to be administered over 15-
30 seconds.
- Each oral tablet should be taken in the morning with at least 180ml of plain water (not
coffee, juice, mineral water, or milk) at least 60 minutes before consuming any food,
supplements, or medications.(16)
- The patient should remain upright (sitting or standing) for at least 1 hour after
ibandronate administration to prevent esophageal irritation and ulceration.(16)
- Swallow tablet whole without chewing or sucking it.(2)
- Instruct patient on monthly dosing to take a missed dose the morning of the day it is
remembered and then return to the regularly scheduled day the following month.
However, if the next dose is less than 7 days away, skip the missed dose and resume the
regular schedule.(4)
Adverse effects
- This drug may cause abdominal pain, diarrhea, dyspepsia, nausea, arthralgia, back pain,
myalgia, headache, or bronchitis.(4)
- Stop tablets and see your doctor if you have pain on swallowing, or new or worsening
heartburn.(2)
- Tell your doctor if you have severe pain in your bones, joints or muscles while taking this
medicine.(2)
Counseling points
- Instruct patient to maintain adequate intake of calcium and vitamin D during therapy.(4)

- There are rare complications with some dental procedures in people taking
bisphosphonates; tell your doctor if you require any dental work and tell your dentist
that you are taking this medicine (or have taken it in the past).(2)
Practice points(2)
- In initial placebo-controlled trials ibandronic acid significantly reduced skeletal-related
events and bone pain scores in breast cancer patients with bone metastases; however,
long-term safety and efficacy data are lacking.
- In hypercalcemia, restore and maintain adequate hydration with IV sodium chloride 0.9%.
- Monitor plasma concentrations of calcium, phosphate and magnesium during treatment.
- Although nephrotoxicity was not evident in clinical trials, the manufacturer recommends
monitoring renal function during treatment with ibandronic acid.

Protaxos (Strontium ranelate) 2 g
Indication Dosage
Reduction of fracture risk in severe 2 g once daily at bedtime.

postmenopausal osteoporosis when other
agents are unsuitable
Treatment of severe osteoporosis in men

when other agents are unsuitable
- This medication is best taken at bedtime, at least 2 hours after eating, because food and
drink (especially calcium-containing products such as milk) can reduce its absorption. Mix
the granules in water and drink immediately.(2)
- The granules in the sachets must be taken as a suspension in a glass containing a
minimum of 30 ml (approximately one third of a standard glass) of water.(6)
- Although in-use studies have demonstrated that strontium ranelate is stable in
suspension for 24 hours after preparation, the suspension should be drunk immediately
after being prepared.(6)
Adverse effects(2)
Seek medical advice promptly if you develop a rash while taking this medicine.
- Common (>1%): nausea, diarrhea, headache, dermatitis
- Infrequent (0.1-1%): CNS effects (including disturbed consciousness, memory loss,
seizures, confusion), VTE, increased creatinine kinase concentration
- Rare (<0.1%): severe hypersensitivity reactions including Stevens-Johnson syndrome and
multiorgan hypersensitivity syndrome, peripheral edema, alopecia, bronchial hyper-
reactivity.
Practice points(2)
- Strontium distribution in bone and increased x-ray absorption compared with calcium
amplify BMD measurements; this may account for approximately 50% of measured
changes.

- Ensure adequate intake of calcium and vitamin D; if necessary, prescribe supplements to
be taken at a different time of day
- Assess cardiovascular risk before starting strontium ranelate and regularly during
treatment.
- Efficacy and safety data in men are limited, particularly regarding reduction of fracture
risk.
- Do not confuse with radioactive strontium-89, which is used in the palliative treatment
of metastatic bone pain.

Miacalcic (Synthetic salmon calcitonin) nasal spray
Indication Dosage
Treatment of postmenopausal osteoporosis 1 spray puff (200 IU daily). It is recommended

that you administer Miacalcic spray to
alternating nostrils.
- Each 2 ml bottle of Miacalcic nasal spray contains at least 14 metered doses of 200 IU.
One IU (International Unit) corresponds to 0.167 micrograms of calcitonin (salmon,
synthetic).
- Advise patient to maintain adequate calcium and vitamin D intake.(4)
How to take Miacalcic nasal spray(9)

Unopened calcitonin salmon nasal spray should be stored in the refrigerator. Before you start
using it, you should let the spray reach room temperature. You should then store Miacalcic nasal
spray at room temperature.
The different part of the spray bottle
1. Protective cap: Keeps the nozzle clean and protects the jet.
Always replace the protective cap after you have used the nasal
spray.
2. Jet: The tiny hole from which the medicine sprays out.
3. Nozzle: The part you insert into your nostril.
4. Pump: The part you press down to operate the spray.
5. Counter: The dose counter window on a new nasal spray shows
as shown in this picture. The display will change as you use the
pump.
6. Dip tube: The tube inside the spray bottle that draws up the
medicine when you press the pump.
7. Bottle: Contains enough medicine for at least 14 metered doses.
Prepare a new nasal spray for use

** Never shake the nasal spray bottle as this could cause air bubbles which may affect your dose.

The dose counter window of a new nasal spray bottle is in the
position marked in the picture.
First, remove the protective cap.
Hold the nasal spray upright in one or two hands and press down
firmly on the pump 3 times.
This primes the new spray by clearing air out of the dip tube. You
will only need to do this once when you start a new spray. Do not
worry if a little medicine sprays out; this is normal.
As you press the pump, watch the changes in the dose

counter window:
When the green is showing in the dose counter
window, your new nasal spray is ready to use.
Using Nasal Spray
After removing the protective cap, bend your head forward slightly
and insert the nozzle into one of your nostrils. Try to hold the nasal
spray upright, as shown in the picture.
Press the pump firmly once only.
Remove the nasal spray from your nose and breathe in deeply
through your nostril to help keep the medicine in your nose.
If your doctor has told you to take two puffs at a time, repeat this
procedure in your other nostril.

After use, clean the nozzle with a dry tissue and replace the
protective cap.
Checking the counter:
Every time you use the nasal spray, the number in the dose counter
window will change.
The number displayed tells you how many puffs you have already taken.
The Nasal Spray is guaranteed to deliver 14 metered doses. You may be
able to obtain 2 additional doses.
When the dose counter window shows a red and displays the number
(16) as shown in this picture, you have taken 16 spray puffs and the spray
is finished. You may notice that a little liquid is left in the nasal spray
bottle, but this is normal.
If the spray mechanism becomes blocked, this may be fixed by pressing the pump forcefully; do
not attempt to unblock it using a sharp pointed object as this may cause damage. If you think
your nasal spray is not working properly, return it to your supplier. Never try to fix the nasal spray
yourself or take it apart, as this may affect your dose.
If you forget to use Miacalcic nasal spray If you forget to use your nasal spray, take the spray as
soon as you remember unless it is less than 4 hours before the next dose. If so, wait and take
your next dose at the usual time. Do not take a double dose to make up for a forgotten one.
Adverse effects(4)
- Advise patient of the potential increased risk of malignancy with use.
- Nasal spray side effects may include rhinitis, sinusitis, epistaxis and back pain.
- Instruct patient to immediately seek medical attention if signs of allergic reaction occur.
- Counsel patient to report significant nasal irritation.
Storage(9)
- Store in a refrigerator (2°C-8°C). Do not freeze.
- Once opened, the nasal spray must be kept at room temperature (not above 25°C).
- The nasal spray must be used within 1 month after opening.

- Keep the bottle upright at all times to reduce the risk of air bubbles getting into the dip
tube.
- Do not shake the bottle.

Pessaries and vaginal creams
Vaginal tablets, suppositories and creams
It is best to use these products just before your bedtime. Lying

down will reduce leakage of the medication from your vagina
that could possibly occur while standing or walking around.
Wash your vaginal area with a mild soap and water and dry
thoroughly. If the product comes as a pre-filled applicator, skip
to step 5.
For vaginal cream products: Attach the applicator to the opening

of the tube of cream and twist until firmly attached. Squeeze the
cream from the tube into the applicator until it reaches the level
indicated for your dose. Twist and remove the applicator from
the tube.

For tablets or suppositories: Remove the medication from the
wrapper and place it into the end of the applicator.
Gently insert the applicator into your vagina while you position
your body in one of the two ways. Insert the applicator only as
far as it will comfortably go. You can stand with your feet apart
and your knees bent.
Or lie on your back with your knees bent and legs slightly apart.
Push the plunger of the applicator until it stops. Remove the

applicator from the vagina.

If the applicator is reusable, clean it as directed by the
manufacturer. This usually involves pulling the two pieces apart
and washing them with a mild soap and water. Discard the
applicator if it is disposable.
Wash your hands thoroughly with soap and warm water.
Continue to use the medication for as long as directed by your

doctor or on the product labeling. Use the product without
skipping any days, even during your menstrual period. You
should use sanitary pads if you have your period while using this
medication. Do not use tampons as they can absorb some of the
medication and make your treatment less effective.

Ramadan
Ramadan
Ramadan
A few religions worldwide practice the fasting ritual. Non-Ramadan fasting is undertaken by
Muslims and people of other faith as either a single day or a few consecutive days of fasting.(42)
Ramadan is the ninth month of the Muslim calendar and the daylight fasting that accompanies it
is one of the five pillars of Islam. The month-long (29-30 day) fast is obligatory for all healthy
Muslims who have reached puberty and is a time for spiritual contemplation and seeking
nearness to God. Followers must refrain from eating and drinking between dawn and sunset, and
must also abstain from using oral medications, sexual activity and smoking. It is believed that
spiritual rewards for good deeds are multiplied during Ramadan, and there is an intense desire
to participate in fasting, even among those who could seek exemption, such as the elderly,
children, the infirm, and pregnant women. Missed fasts should be completed at other times; for
example, when health is restored or after the delivery of a baby. Fasting outside of Ramadan
(when the rest of the community is not observing a fast) can be challenging, and this may
discourage people from taking advantage of granted exemptions. Those who are permanently
incapacitated can compensate by Fidya, a donation of food or money to the poor, for every day’s
fast that is missed.(43)
The timing of Ramadan is based on the lunar calendar (355 days per lunar year), which is shorter
than the Gregorian (Western) calendar, and therefore Ramadan occurs 10–11 days earlier every
year. This means that the duration of daylight fasting varies according to the time of year in which
Ramadan falls. In some parts of the world, daylight can be as long as 20 hours in the peak of
summer. Climate conditions also vary according to the date of Ramadan, with people fasting in
very dry and hot weather some years and cold temperatures in others.(43)
Groups exempted from fasting(44)

- Children (under the age of puberty)
- Elderly
- The sick
- Those who are traveling (journey >89km)
- Pregnant or breastfeeding women
The following drug administration route do not nullify fasting(44)

- Eye, nasal and ear drops (as long as does not reach the eardrum)

- Sublingual tablets (placed under the tongue) provided is not swallowed.
- All kinds of injections
- All substances absorbed into the body through the skin, such as creams, ointments, and
medicated plasters
- Mouthwash or gargle, provided nothing is swallowed
- Nasal spray, provided no inhalation
- Partial or local anesthesia, involving injection or sprays
The following drug administration route nullify fasting(44)

- Oral tablet or capsules
- Liquid medications
- Inhalers
- Pessaries
- Suppositories and enema
- General anesthesia, involving anesthetic gases
Dosing schedule(45)
Frequency Time of taking

Before food After food
Once daily dosing Before sahur After iftar
Twice daily dosing Before sahur After sahur

After breaking the fast, but After iftar
before main meal
Three times daily Before sahur After sahur

dosing
After breaking the fast, but After iftar
before main meal
Before sleep
Before sleep
Four times daily Depending on type of disease and discussion with prescriber for
dosing alternatives.
For medication taken at night time, there is no change in administration time.

Diabetes management in Ramadan
Background
Fasting during Ramadan is obligatory for all healthy adult Muslims. Fasting in certain individuals
with diabetes may be associated with adverse outcomes; hence they are not obliged to fast.
However, many diabetic patients choose to fast as shown in the Epidemiology of Diabetes and
Ramadan (EPIDIAR) study, despite a clear instruction from the Quran on individuals who are
exempted from fasting. These include individuals with chronic diseases such as diabetes mellitus.
(Surah Al Baqarah Verse 184-185).(18)
Medical benefits of fasting during Ramadan

Potential benefits of fasting may include:(42)
- Decrease in body weight.
- Increase in high-density lipoprotein (HDL) cholesterol, with or without any changes in
total cholesterol and triglycerides levels.
- Improvement in glycemic control in diabetics.
- Decrease in daytime average systolic and diastolic blood pressures in hypertensive
patients.
- Improvement in immunity by elimination of toxins; reducing insulin-like growth factor 1
(IFG-1) which allows the regeneration of stem cells in the bone marrow.
- Reduce cardiovascular disease markers such as high sensitive C-reactive protein (hs-CRP)
and plasminogen activator inhibitor type-1 (PAI-1).
Risks of fasting in diabetes during Ramadan

Fasting in diabetes during Ramadan may associated with adverse outcomes in certain individuals
which include(42)
- Hypoglycemia
- Hyperglycemia/ketoacidosis
- Dehydration
Patients who are at risk of developing complications during fasting

For diabetic patients, fasting represents an important personal decision that should be made
based on religious recommendation with careful considerations of the associated risks and
possible detrimental effects of fasting. Therefore, diabetic patients should consult their
healthcare providers prior to fasting.(42)

Categories of risk in patients with Type 1 or Type 2 diabetes mellitus who fast during
Ramadan.(42)
Very high risk
- History of severe diabetes complications within 3 months prior to fasting

o Severe hypoglycemia
o Ketoacidosis
o Hyperosmolar hyperglycemic coma
o Recurrent hypoglycemia
- Hypoglycemia unawareness
- Acute illness
- Sustained poor glycemic control (HbA1c >9%)
- Pregnancy
- Advanced renal failure/chronic dialysis
High risk
- Moderate hyperglycemia (HbA1c 7.5-9.0%)

- Moderate renal failure
- Advanced macrovascular complications
- Living alone and treated with insulin or sulfonylureas
- Patients with co-morbid conditions that present additional risk factors
- Old age with ill health
- Treatment with drugs that may affect mentation
Moderate risk
- Well-controlled diabetes treated with short-acting insulin secretagogues
Low risk
- Well-controlled diabetes treated with lifestyle therapy, metformin, acarbose,

thiazolidinediones, and/or incretin-based therapies in otherwise healthy patients
Note: this classification is based largely on expert opinion and not on scientific data derived from
clinical studies.
Those who fall in the “very high” and “high risk” group are advised to abstain from fasting.
This table is a modification of Table 2 from “Recommendations for management of diabetes
during Ramadan: update 2010” by Al-Arouj et al. (2010).
Preparation prior to Ramadan

A pre-Ramadan medical assessment of general well-being, glycemic control, comorbidities and
complications should be performed to categorize the patient in terms of the risks from fasting as
well as to optimize their management.(18)
Patients and care-givers should receive education concerning self-care on the following:(18)
- Risks from fasting:
o Hypoglycemia – symptoms and signs, response
o Hyperglycemia – symptoms and signs, response
o Dehydration
- Blood glucose monitoring – during fasting and non-fasting hours
- When to stop the fast
- Adequate fluid intake
- Meal planning and food choices
- Physical activity – timing and intensity
- Medication administration – timing and dosing
- Management of acute complications
Self-monitoring of blood glucose (SMBG) during Ramadan

Timing and frequency of SMBG based on treatment(42)
Therapy Frequency of SMBG
Oral anti- Monitor when symptomatic

diabetic (OAD)
Insulin Diabetic patients who are in the moderate to high risk categories are advised
to monitor their blood glucose.
- Pre-meal and 2-hour post pre-dawn meal (sahur)
- Mid-day
- Pre-meal and 2-hour post sunset-meal (iftar)
- bedtime
Timing of SMBG could reflect adequacy of insulin dose(42)
Timing of SMBG Insulin timing Type of insulin
Mid-day Pre-sahur Premixed/bolus/basal insulin
Pre-iftar Pre-sahur Premixed/basal insulin

Timing of SMBG Insulin timing Type of insulin
2-hour post-iftar or bedtime Pre-sahur Premixed/bolus insulin
Pre-sahur Pre-iftar/ Pre-bed Premixed/basal insulin
2-hour post-sahur Pre-sahur Premixed/bolus insulin
Conditions to stop fasting:(42)

- Blood glucose <3.3 mmol/L at any time during the fast.
- Blood glucose <3.9 mmol/L in the first few hours of fasting (especially if the patient is
taking sulfonylureas, meglitinides, or insulin).
- Blood glucose >16.7 mmol/L.
- Experience symptoms of hypoglycemia (patients without SMBG).
- Symptoms suggestive of severe dehydration such as syncope and confusion.
Lifestyle and diet management during Ramadan

Appropriate meal planning is important to avoid postprandial hyperglycemia. The diet during
Ramadan should not differ from a healthy balanced diet. It is encouraged to consume slow
energy-release food (such as wheat, beans and rice) and to distribute calories over two to three
smaller meals during the non-fasting interval.(42)
Adjustment of the diet protocol for Ramadan fasting(42)
- Never skip sahur (pre-dawn meal). Sahur should consist of a balanced meal with
adequate carbohydrate taken as late as possible just before Imsak (dawn) to avoid
unnecessarily prolonged fasting.
- Do not delay “berbuka”, i.e. the breaking of the fast at sunset, also known as iftar. Limit
intake of high-sugar foods e.g. kuih. However, 1-2 kurma (dates) at the start of iftar
according to Sunnah may be taken as part of carbohydrate exchange. Main meal is
encouraged after Maghrib prayers.
- Supper after Tarawih (supererogatory prayers) can be taken as replacement of pre-bed
snack.
- Include fruits and vegetables at both sahur and iftar. High fiber carbohydrates are
encouraged at all meals.
- Limit fried of fatty foods.
- Limit intake of highly salty foods to reduce risk of dehydration.
- Sufficient fluid must be taken to replenish fluid loss during the day. Aim for 8 glasses of
fluid a day. Choose sugar-free drinks. Drink adequately at sahur.

- Dietary indiscretion during the non-fasting period with excessive binging, compensatory
consumption of carbohydrates especially sweetened and fatty foods contributes to the
risk of hyperglycemia and weight gain.
Appropriate modification in intensity and timing of physical activity is important to maintain
optimal glycemic control and optimal weight. Physical activities and exercise need to be adjusted
during Ramadan. The following are recommended:(42)
- Light and moderate intensity exercise on a regular basis.
- Avoid rigorous exercise during daytime because of the risk of hypoglycemia.
- The timing of exercise is preferably performed 1-2 hours after the break of fast.
- Performance of Tarawih night prayers helps to maintain physical activity.
Oral anti-diabetic therapy in patients with Type 2 diabetes who are fasting during Ramadan
In principle, the non-fasting morning dose should be taken during iftar, and the non-fasting
evening dose should be taken during sahur.(18)
Regimen Drugs Pre-dawn meal Sunset meal

(sahur) (iftar)
Alpha-glucosidase Acarbose 50mg, 100mg No changes No changes

inhibitors
Biguanides Metformin 500mg No changes No changes

Metformin SR 850mg
Metformin XR 500mg, 750mg
Dipeptidyl Sitagliptin 25mg, 50mg, Switch timing to iftar

peptidase-4 100mg
inhibitors
Vildagliptin 50mg
Saxagliptin 2.5mg, 5mg
Linagliptin 5mg
Alogliptin 6.25mg, 12.5mg,
25mg
Meglitinides Repaglinide 0.5mg, 1mg, 2mg No changes No changes

Nateglinide 120mg

Regimen Drugs Pre-dawn meal Sunset meal
(sahur) (iftar)
Sulphonylureas Glibenclamide 5mg Glibenclamide/ No changes

Gliclazide:
Gliclazide 80mg
reduce/omit
Gliclazide MR 60mg
Gliclazide MR/
Glipizide 5mg
Glimepiride: switch
Glimepiride 2mg, 3mg timing to iftar
Sodium-glucose Dapagliflozin 5mg, 10mg Switch timing to iftar

transporter 2
Canagliflozin 100mg, 300mg
inhibitors
Empagliflozin 10mg, 25mg
Thiazolidinediones Rosiglitazone 4mg, 8mg No changes

Pioglitazone 15mg, 30mg
Non-insulin anti-diabetic injectables(18)
Regimen Drugs Pre-dawn meal Sunset meal (iftar)

(sahur)
Glucagon-like peptide- Exenatide IR 5μg/20μL, Switch timing to iftar

1 receptor agonists 10μg/40μL
Exenatide XR 2mg
Dulaglutide 0.75mg,
1.5mg
Liraglutide 6mg/ml
Lixisenatide 50μg/ml,
100μg/ml
Insulin therapy during Ramadan

In the Epidemiology of Diabetes and Ramadan (EPIDIAR) study, both Type 1 and Type 2 diabetics
on insulin had an increased complication rate of severe hypoglycemia and hyperglycemia. Few
small studies have been conducted among Type 1 diabetics to assess the safety and efficacy of
various insulin type and regimens. For patients with Type 1 diabetes mellitus who wish to fast
during Ramadan, basal bolus insulin therapy is the preferred regime.(42)
Insulin analogues were shown to be safe with fewer episodes of hypoglycemia and smaller post
prandial glucose rise after sunset meal (iftar). The conventional regular short acting human
insulin and Neutral Protamine Hagedorn (NPH) insulin are more widely used. Insulin glargine can
be given once daily any time after iftar. Insulin Levemir and NPH insulin can be given either once
daily at bedtime or divided into twice daily during pre-dawn meal (sahur) and iftar.(42)
Individualized adjustments of insulin dose and timing will need to be implemented when fasting
during Ramadan. Self-monitoring of blood glucose (SMBG) will aid in determining the appropriate
insulin dose. Based on the evaluation of Muslim T2DM patient observing Ramadan, the switch
from human premix to mid mix analog insulin at iftar resulted in improvement in glycemic control
without an increase in hypoglycemia.(42)
Insulin adjustments during Ramadan(42)
Insulin regimen Type 1 diabetes mellitus Type 2 diabetes mellitus
Basal insulin only Not applicable. Basal Insulin to be taken at bedtime or

after iftar meals. May need dose
reduction if there is a risk of daytime
hypoglycemia.
Premixed insulin Not applicable. Inject usual dose at iftar.

once daily
Premixed insulin Reverse doses – Morning dose Reverse doses – Morning dose given at
twice daily given at iftar and evening dose iftar and evening dose at sahur.
at sahur.
Insulin dose at sahur reduced by 20-
Insulin dose at sahur reduced 50% to prevent daytime hypoglycemia.
by 20-50% to prevent daytime
or
hypoglycemia.
Change to short/rapid acting. *
* Lafe afternoon hypoglycemia may
occur.

Insulin regimen Type 1 diabetes mellitus Type 2 diabetes mellitus
Basal bolus
insulin
Basal Insulin Taken at bedtime or any time after iftar meals. May require a dose
reduction if there is daytime hypoglycemia.
Bolus/Prandial Sahur – Usual pre-Ramadan breakfast or lunch dose. May require a dose
Insulin reduction to avoid daytime hypoglycemia.
Lunch – Omit.
Iftar – Usual pre-Ramadan dinner dose. May require dose increment.
* Total insulin requirement for Type 1 diabetics who are on basal bolus
insulin regimen while fasting during Ramadan may require dose reduction
by 15-30% of their pre-Ramadan dose requirements.
Insulin Pump Basal insulin rate: Unchanged or may require reduction of up to 25%.
Prandial bolus: According to individualized insulin-to-carbohydrate ratio
(ICR).

Panduan berpuasa bagi pesakit [2013]

Puasa & ubat [2012]

e
Penjagaan pesakit diabetes pada bulan Ramadan [2015]

Respiratory
Asthma
Asthma
Asthma is a chronic lung disease, which can be controlled but not cured. In clinical practice,
asthma is defined by the presence of both the following:(46)
- excessive variation in lung function (‘variable airflow limitation’, i.e. variation in
expiratory airflow that is greater than that seen in healthy people)
- respiratory symptoms (e.g. wheeze, shortness of breath, cough, chest tightness) that vary
over time and may be present or absent at any point in time.
In young children in whom lung function testing is not feasible, including most preschool children,
asthma is defined by the presence of variable respiratory symptoms.(46)
Untreated asthma is usually characterized by chronic inflammation involving many cells and
cellular elements, airway hyperresponsiveness, and intermittent airway narrowing (due to
bronchoconstriction, congestion or edema of bronchial mucosa, mucus, or a combination of
these).(46)
Asthma probably represents a spectrum of conditions with different pathophysiological
mechanisms. In older patients, there may be substantial overlap with the features of COPD.(46)
The diagnosis of allergic asthma is more likely when the person also has allergy and a family
history of asthma.(46)
Assessment of symptom control and future risk

Good asthma control is having, in the previous 4 weeks:(2)
- daytime symptoms <2 days a week
- need for reliever <2 days a week (not including doses for preventing exercise-induced
bronchoconstriction)
- no limitation of activity and
- no symptoms during the night or on waking.
Having uncontrolled asthma symptoms is an important risk factor for exacerbations. Additional
potentially modifiable risk factors for exacerbations, even in patients with few asthma symptoms,
include:(47)
- Medications: ICS not prescribed; poor adherence; incorrect inhaler technique; high short-
acting-b2-agonist use with increased mortality if >1x200-dose canister/month)

- Comorbidities: obesity; chronic rhinosinusitis; gastro-esophageal reflux disease;
confirmed food allergy; anxiety; depression; pregnancy
- Exposures: smoking; allergen exposure if sensitized; air pollution
- Setting: major socioeconomic problems
- Lung function: low FEV1, especially if <60% predicted; higher reversibility
- Other tests: sputum/blood eosinophilia; elevated exhaled nitric oxide in allergic adults
on inhaled corticosteroids
Other major independent risk factors for flare-ups (exacerbations) include:(47)
- Ever being intubated or in intensive care for asthma; Having ≥1 severe exacerbations in the
last 12 months
Risk factors for developing fixed airflow limitation include:(47)

- Preterm birth, low birth weight, greater infant weight gain
- Lack of ICS treatment
- Exposures: tobacco smoke, noxious chemicals or occupational exposures
- Low FEV1
- Chronic mucus hypersecretion
- Sputum or blood eosinophilia.
Risk factor for medication side effects include:(47)
- Systemic: frequent oral corticosteroids; long term, high dose and/or potent ICS; also
taking P450 inhibitors
- Local: high dose or potent ICS; poor inhaler technique
General asthma management

The long-term goals of asthma management are risk reduction and symptom control. The aim is
to reduce the burden to the patient and to reduce their risk of asthma-related death,
exacerbations, airway damage, and medication side effects. The patient’s own goals regarding
their asthma and its treatment should also be identified.(47)
Identify and manage trigger factors, e.g. cigarette smoke, allergens, irritants, certain drugs or
food, infections or comorbidities.(2)
Influenza and pneumococcal vaccinations should be considered in patients with severe asthma,
although evidence of benefit is lacking.(2)
Antibacterials are rarely indicated; reserve for treatment of specific infections.(2)

Immunotherapy (desensitization) may be helpful for some patients but is costly and time-
consuming; seek specialist advice.(2)
In addition to medications, other therapies and strategies may be considered where relevant, to
assist in symptom control and risk reduction. Some examples with consistent high quality
evidence are:(47)
- Smoking cessation advice
- Physical activity
- Investigation for occupational asthma
- Identify aspirin-exacerbated respiratory disease
Although allergens may contribute to asthma symptoms in sensitized patients, allergen

avoidance is not recommended as a general strategy for asthma. These strategies are often
complex and expensive, and there are no validated methods for identifying those who are likely
to benefit.(47)
Drug treatment - adult

Asthma management for adults(2)
Usual choice Comments
ICS = inhaled corticosteroid; LABA = long-acting beta2 agonist; SABA = short-acting

beta2 agonist
1 use a fixed-dose combination inhaler if possible
2 SABA not required if using budesonide with formoterol (eformoterol) fixed-dose combination
inhaler for maintenance and symptom relief
Initially
- SABA when required for symptom relief - cromones or montelukast are less
- add low-dose ICS when: effective than low-dose ICS
o symptoms >twice a month or - if symptoms are severe, consider:
o waking due to asthma in previous o adding a short course of oral
month or corticosteroid or
o exacerbation requiring systemic o using medium-dose ICS initially
corticosteroids in the previous year (reduce later) or
o starting at the next step
If still symptomatic

- low-dose ICS + LABA1 for maintenance - adding montelukast to low-dose ICS is

- SABA2 when required for symptom relief less effective than adding a LABA
- medium-dose ICS + LABA1 for - consider referral to specialist

maintenance
- SABA2 when required for symptom relief
- high-dose ICS + LABA1 for maintenance - refer to specialist

2
- SABA when required for symptom relief
* If using a LABA for asthma, always use with an ICS(2)
Choose initial treatment according to recent symptom control, risk factors for poor outcomes,
e.g. hospitalizations, and patient preference. Review 4–8 weeks after starting or adjusting
treatment, assessing compliance and inhaler technique.(2)
Inhaled corticosteroid doses for asthma(2)
Drug Low daily dose Medium daily dose High daily dose
(all ages) (adults only)
child adult
1fluticasone furoate is not available without vilanterol; it should not be used in children
<12 years.
beclomethasone 100–200 mcg 200–400 mcg >200 mcg >400 mcg
budesonide 200–400 mcg 400–800 mcg >400 mcg >800 mcg
ciclesonide 80–160 mcg 160–320 mcg >160 mcg >320 mcg
fluticasone propionate (FP) 100–200 mcg 200–500 mcg >200 mcg >500 mcg
fluticasone furoate1 not available 100 mcg (equivalent 100 mcg1 200 mcg
to FP 500 mcg)
Treatment reduction: after good control for 2–3 months, and if there is a low risk of
exacerbations, it may be possible to slowly reduce dose of inhaled corticosteroid (ICS), e.g. by
25–50% at intervals of 2–3 months. Once a low dose has been reached, the long-acting
beta2 agonist (LABA) may be stopped (however, stopping the LABA may lead to deterioration). In

adults with well-controlled asthma, continuing low-dose ICS reduces the risk of exacerbations
compared to stopping treatment.(2)
Pregnancy
It is most important to keep asthma well controlled. Treatment of asthma is less risky for the
mother and fetus than poorly controlled asthma or severe asthma attacks. Review asthma
regularly (e.g. monthly) and intervene early during exacerbations to minimize risk of fetal
hypoxia.(2)
Drug treatment – children

Asthma management for children(2)

beta2 agonist
1SABA not required if on budesonide with formoterol (eformoterol) fixed-dose combination
for maintenance and symptom relief (this option unsuitable for children <12 years)
Initially
1–2 years
- SABA when required for symptom relief - consider low-dose ICS if symptoms disrupt
- add cromoglycate for persistent asthma sleep or play, or if inadequate response to
cromone after 2–4 weeks
>2 years
- SABA when required for symptom relief - consider a cromone if unable to tolerate
- add montelukast for frequent Montelukast
intermittent or mild persistent asthma or - consider stopping ICS if good control
- add low-dose ICS for persistent asthma for >3 months, particularly if aged <6 years
<6 years

- change from montelukast or cromone to - refer to specialist

low-dose ICS
- if already on ICS, add Montelukast
- SABA when required for symptom relief
>6 years
- change from montelukast to low-dose - montelukast may be more effective for

ICS exercise-induced bronchoconstriction
- if already on ICS, increase the dose, or - consider referral to specialist
add montelukast or LABA (use in fixed-
dose combination with ICS if possible)
- SABA when required for symptom relief1
* Most studies in children have shown that inhaled corticosteroids have only a small impact on
final adult height; poorly controlled asthma may also reduce growth.(2)
Choose initial treatment based on age and pattern of symptoms. Children with infrequent
intermittent asthma (symptom-free for at least 6 weeks at a time) do not require regular
preventer treatment. Children <1 year should be managed by respiratory specialists.(2)
Review within 2–4 weeks of starting or adjusting treatment. If, despite good compliance and
inhaler technique, good control is not achieved with a low-dose ICS, consider referral to a
specialist, especially if <6 years.(2)
Treatment reduction: after >3 months of good control, it may be possible to gradually reduce ICS
dose, e.g. by 25–50% at intervals of 2–3 months. For children (particularly preschoolers) whose
symptoms remain well controlled after dose reduction, consider stopping low-dose ICS or
replacing with montelukast or cromone, and reviewing in 4 weeks. If still well controlled after
3 months, montelukast or cromone may be ceased, with adequate monitoring for any symptom
recurrence.(2)
Global Initiative for Asthma (GINA) Pocket Guide for Asthma Management and Prevention (for
Adults and Children Older than 5 Years), 2020
For safety reasons, GINA no longer recommends treatment with short-acting beta2-agonist
(SABA) alone. Although SABA provides quick relief of symptoms, SABA-only treatment is
associated with increased risk of exacerbation and lower lung function. On the other hand, all
adults and adolescents with asthma should receive inhaled corticosteroid (ICS)-containing
controller treatment to reduce their risk of serious exacerbations and to control symptoms.
These options now include:(47)

- (for mild asthma) as-needed low dose ICS-formoterol, or if not available, low dose ICS
taken whenever SABA is taken, or
- regular ICS or ICS-LABA every day, plus as-needed SABA or
- maintenance and reliever treatment with ICS-formoterol (i.e. with low-dose
beclomethasone-formoterol or budesonide-formoterol inhalers).

Exercise-induced bronchoconstriction
SABAs (inhaled 15 minutes before exercise) are first-line treatment. However, tolerance
(decreasing duration and degree of protection) may develop with regular use; if this occurs or if
SABA is required most days, start regular low-dose ICS treatment. Maximum effect of ICS usually
occurs within 2–4 weeks (but could take up to 12 weeks), after which pre-exercise SABA may no
longer be required.(2)
Montelukast may be used instead of, or in addition to, low-dose ICS; it is generally less effective
than SABAs or ICS, but tolerance does not develop.(2)
Cromoglycate and nedocromil offer some protection but are less effective than SABAs.(2)
LABAs, although as effective as SABAs, are not appropriate alone (use with ICS); tolerance may
develop.(2)
Acute asthma in hospital

Inhaled SABAs are first-line; an MDI with a large-volume spacer is usually as effective as a
nebulizer.(2)
Give oxygen for respiratory distress or if oxygen saturation is low.(2)
Ipratropium: if symptoms are severe, or if there is poor response to SABAs, add repeated doses
of ipratropium.(2)
Systemic corticosteroids should be given to all adults. They may not be required for children
(particularly if aged <6 years) with only mild-to-moderate wheezing and a good response to
bronchodilators. Oral corticosteroids, e.g. prednisolone, can be stopped without tapering if used
short term (e.g. <14 days).(2)
IV magnesium sulfate may be considered for severe or life-threatening acute asthma
unresponsive to other treatment. There are limited data for use of IV salbutamol, but it may be
considered (in intensive care) where adverse effects can be closely monitored.(2)
Before discharge, arrange ongoing treatment. For most patients, prescribe regular controller
therapy (or increase current dose) to reduce the risk of further exacerbations. Continue increased
controller doses for 2-4 weeks, and reduce reliever to as-needed dosing. Check inhaler technique
and adherence. Provide an interim written asthma action plan.(47)
Arrange early follow-up after any exacerbation, within 2-7 days (for children, within 1-2 working
days). Consider early referral for specialist advice after hospitalization, or for patients with
repeated ED presentations.(47)
Exacerbations often represent failures in chronic asthma care, and they provide opportunities to
review the patient’s asthma management. All patients must be followed up regularly by a health
care provider until symptoms and lung function return to normal.(47)

Chronic obstructive pulmonary disease
Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable and treatable disease
that is characterized by persistent respiratory symptoms and airflow limitation that is due to
airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles
or gases. The most common respiratory symptoms include dyspnea, cough and/or sputum
production. These symptoms may be under-reported by patients.(48)
The main risk factor for COPD is tobacco smoking but other environmental exposures such as
biomass fuel exposure and air pollution may contribute. Besides exposures, host factors
predispose individuals to develop COPD. These include genetic abnormalities, abnormal lung
development and accelerated aging.(48)
Combined COPD assessment

An understanding of the impact of COPD on an individual patient combines the symptomatic
assessment with the patient’s spirometric classification and/or risk of exacerbations. The “ABCD”
assessment tool of the 2011 GOLD update was a major step forward from the simple spirometric
grading system of the earlier versions of GOLD because it incorporated patient-reported
outcomes and highlighted the importance of exacerbation prevention in the management of
COPD. However, there were some important limitations. Firstly, the ABCD assessment tool
performed no better than the spirometric grades for mortality prediction or other important
health outcomes in COPD. Moreover, group “D” outcomes were modified by two parameters:
lung function and/or exacerbation history, which caused confusion. To address these and other
concerns (while at the same time maintaining consistency and simplicity for the practicing
clinician), a refinement of the ABCD assessment tool is proposed that separates spirometric
grades from the “ABCD” groups. For some therapeutic recommendations, ABCD groups are
derived exclusively from patient symptoms and their history of exacerbation. Spirometry, in
conjunction with patient symptoms and history of moderate and severe exacerbations, remains
vital for the diagnosis, prognostication and consideration of other important therapeutic
approaches.(48)
In the revised assessment scheme, patients should undergo spirometry to determine the severity
of airflow limitation (i.e., spirometric grade). They should also undergo assessment of either
dyspnea using mMRC or symptoms using CAT™. Finally, their history of moderate and severe
exacerbations (including prior hospitalizations) should be recorded. The number provides
information regarding severity of airflow limitation (spirometric grade 1 to 4) while the letter
(groups A to D) provides information regarding symptom burden and risk of exacerbation which
can be used to guide therapy.(48)

General measures
Identify and reduce risk factors such as smoking, dust, fumes, indoor and outdoor pollutants.
Smoking cessation decreases the rate of lung function decline by 50% and prolongs survival; it is
the most effective intervention for COPD. Encourage and support patients to stop smoking at
every opportunity.(2)
Check immunization status: pneumococcal and influenza vaccines are recommended in COPD.
Influenza vaccination decreases the risk of exacerbations, hospitalization and death, but the
value of pneumococcal vaccination has not been unequivocally established.(2)
Pulmonary rehabilitation improves exercise capacity, dyspnea and quality of life, and reduces
hospitalization. It should be offered to all COPD patients with functional impairment.(2)
Long-term oxygen therapy (ideally >18 hours daily) improves quality of life and survival in COPD
patients with hypoxemia.(2)
Surgery may be considered in selected patients for symptom relief (e.g. bullectomy, lung volume
reduction).(2)
Drug treatment for stable COPD

Australian Medicines Handbook 2018 - Management of stable COPD(2)
Steps Comments

beta2 agonist
1stop ipratropium when starting a long-acting anticholinergic (also known as long-acting
antimuscarinic or LAMA)
2 FEV1<50% and >2 exacerbations annually
start with a SABA or ipratropium when using a SABA with ipratropium may be more
required for symptom relief effective, but it is preferable to move to the next
step
add or switch to a LABA or long-acting try a drug from one class, then swap to the other if
anticholinergic1 for persistent needed
symptoms
continue SABA when required
use a LABA with a long-acting

anticholinergic if still symptomatic

Steps Comments
add an ICS if still symptomatic2(LABA + don’t double-up: when starting fixed-dose

long-acting anticholinergic + ICS) combination inhalers, stop all previous inhalers
containing drugs from the same class
continue SABA when required
* Although there is no clear evidence to guide initial drug choice, long-acting anticholinergics are
often used first as they may be slightly more effective than LABAs in preventing exacerbations in
stable COPD. However, there appears to be little difference in mortality or overall quality of
life.(2)
* Inhaled corticosteroid use has been associated with an increased risk of pneumonia in COPD
patients. If there is no symptomatic benefit, some studies suggest it may be safe to withdraw
inhaled corticosteroid treatment, provided long-acting bronchodilators (a LABA, long-acting
anticholinergic or both) are maintained. However, close follow-up is recommended. There is no
role for inhaled corticosteroid monotherapy or long-term oral corticosteroids in the treatment
of COPD.(2)
* Controlled release theophylline is effective in COPD compared to placebo, but not as effective
or as well tolerated as inhaled long-acting bronchodilators. It has a narrow therapeutic range,
potential for drug interactions, and requires concentration monitoring.(2)
Drug treatment of COPD exacerbations

Short-acting bronchodilators: increase dose and/or frequency of use during exacerbations.
Inhaled SABAs and ipratropium may be used together until symptoms improve, although
ipratropium is not recommended in the long term if the patient is already on a long-acting
anticholinergic (additive anticholinergic adverse effects).(2)
Short courses of oral corticosteroids shorten recovery time and reduce exacerbation severity and
risk of early relapse. Although the optimum treatment duration has not yet been established,
5-day regimens may suffice; courses >14 days provide no further benefit and increase the risk of
adverse effects. Consider osteoporosis prevention in patients who require frequent courses.(2)
Antibacterials are beneficial in exacerbations with clinical signs of infection. Although there is
some evidence that antibacterial prophylaxis may reduce exacerbation frequency in some
patients, it is not recommended because it has no effect on hospitalizations or mortality, and
there are concerns regarding adverse effects and antibacterial resistance.(2)
GOLD 2020(48)

Effective pulmonary drug delivery
Terminology
Definition of key terms used in aerosol drug delivery(49)
- Emitted dose: the mass of medication leaving an aerosol generator as aerosol
- Fine-particle fraction (FPF): percentage of aerosol between 1-5μm that deposits in the
lung.
- Mass median aerodynamic diameter (MMAD): average aerosol particle size as measured
by a cascade impactor.
- Nominal dose: the total drug dose placed in the nebulizer.
Mechanisms of aerosol deposition and particle sizes

The major mechanisms of aerosol deposition include inertial impaction, gravitational
sedimentation (settling) and diffusion. Inertial impaction occurs with larger (>3 μm), fast-moving
particles. Gravitational settling is a function of particle mass and time, with the rate of settling
proportional to particle size and mass. Diffusion occurs with particles smaller than 1 μm. These
mechanisms come into play as aerosol particles are inhaled orally or through the nose. Larger
particles (>10μm) are filtered in the nose and/or the oropharynx, largely by inertial impaction;
particles of 5-10μm generally reach the proximal generations of the lower respiratory tract, and
particles of 1-5μm reach to the lung periphery.(49)
Particle size plays an important role in lung deposition, along with particle velocity and settling
time. As particle size increases above 3 μm, aerosol deposition shifts from the periphery of the
lung to the conducting airways. Oropharyngeal deposition increases as particle size increases
above 6 μm. Exhaled loss is high with very small particles of 1 μm or less. Consequently, particle
sizes of 1–5 μm are best for reaching the lung periphery, whereas 5–10 μm particles deposit
mostly in the conducting airways, and 10–100 μm particles deposit mostly in the nose.(49)

Where does an inhaled aerosol drug go?
Lung deposition may range from 1-50% with clinical aerosol delivery systems. Deposition is
dependent on a variety of factors such as the device, the patient, the drug and the disease.(49)
Inhalers
The pressurized metered-dose inhaler and dry-powder inhaler are medical aerosol delivery
devices that combine a device with a specific formulation and dose of drug. Each actuation of the
inhaler is associated with a single inspiration of the patient. These are typically single-patient-use
devices dispensed from the pharmacy with a specific quantity of medication and disposed of
when the medication has been depleted.(49)
Factors affecting MDI performance and drug delivery(49)
- Shaking the canister
- Storage temperature
- Nozzle size and cleanliness
- Timing of actuation intervals
- Priming
- Characteristics of the patient
- Breathing technique – open-mouth vs closed-mouth technique
Factors affecting DPI performance and drug delivery(49)
- Intrinsic resistance and inspiratory flow
- The patient’s inspiratory flow ability
- Exposure to humidity and moisture

Inhaler technique for people with asthma or COPD
Poor inhaler technique results in poor control and flare-ups
High rates of incorrect inhaler use have been reported among children and adults, including
experienced inhaler users. Groups most likely to make errors in inhaler technique include young
children, older adults, people with severe airflow limitation, and people using more than one
type of inhaler device. Regardless of the type of inhaler device prescribed, patients of any age
are unlikely to use inhalers correctly unless they are given clear instruction, including a physical
demonstration, and have their inhaler technique checked regularly.(50)
When inhalers are used incorrectly, the full dose may fail to reach the target area in the lung:(50)
- When using a reliever, this could mean the patient fails to achieve good symptom relief,
or maximal bronchodilation and improvement in lung function.
- When using an inhaled corticosteroid preventer, this could mean that the medicine does
not reach sites of inflammation, including in the small airways, and it increases the risk of
local side-effects such as dysphonia and oral thrush.
Certain critical errors could result in no medicine being inhaled at all. These include breathing out
when actuating a pressurized metered-dose inhaler, loading a Turbuhaler when it is horizontal,
failing to slide the lever on an Accuhaler, or not piercing the capsule in a single-dose dry-powder
inhaler.(50)
Incorrect inhaler technique can lead to poor asthma symptom control and overuse of relievers
and preventers. In patients with asthma or COPD, incorrect technique is associated with a 50%
increased risk of hospitalization, increased emergency department visits and increased use of
oral corticosteroids. Among people with COPD, those who make critical errors are twice as likely
to experience severe flare-ups than those who do not.(50)
Correcting patients’ inhaler technique can improve asthma control, asthma-related quality of life
and lung function.(50)
How to train patients and carers in correct inhaler technique

The best way to train patients to use their inhalers correctly is one-to-one training by a health
professional (e.g. nurse, pharmacist, GP) that involves both verbal instruction and physical
demonstration. Patients do not learn to use their inhalers properly just by reading the
manufacturer’s leaflet.(50)
An effective method is to assess the individual’s technique by comparing each step to a checklist
specific to the type of inhaler, and then provide written instructions highlighting the steps that
were incorrect (e.g. a sticker attached to the device). This helps patients maintain correct
technique longer.(50)

Even after achieving correct technique through training, patients can lose these skills within 2–3
months. Inhaler technique must be rechecked and training must be repeated regularly to help
children and adults maintain correct technique.(50)
Common errors with pressurized metered dose inhalers include:(50)
- Failing to shake the inhaler before actuating
- Holding the inhaler in wrong position (e.g. not upright)
- Failing to exhale fully before actuating the inhaler
- Exhaling into the inhaler
- Actuating the inhaler too early or during exhalation (the medicine may be seen escaping
from the top of the inhaler)
- Actuating the inhaler too late while inhaling
- Actuating more than once while inhaling
- Inhaling too rapidly (this can be especially difficult for children to overcome)
- Failing to hold breath long enough after inhaling
- Multiple actuations without shaking between doses
- Using the inhaler when empty
Common errors for dry powder inhalers include:(50)
- Tilting the device while loading the dose instead of keeping it in the correct position
(horizontal for accuhaler and vertical for turbuhaler)
- Shaking the device
- Failing to exhale fully before inhaling
- Failing to inhale completely
- Inhaling too slowly and weakly
- Exhaling into the device mouthpiece before or after inhaling
- Failing to close the inhaler after use
- Using past the expiry date or when empty
Choosing an inhaler device to suit the individual

When prescribing inhaled medicines, make sure the inhaler is appropriate for the patient’s age,
developmental stage, cognitive function, inspiratory effort and dexterity. For patients who may
find it difficult to use an inhaler (e.g. older patients with arthritis or weakness or people with
disabilities), check the person’s technique to work out which inhaler type will be easiest to
use.(46)
Considerations for choice of inhaler device type when prescribing inhaled medicines(46)

Clinical situations Consideration
Acute asthma (all patients) Recommend use of spacer when using reliever via
pMDI for acute asthma
Any patient using a pMDI for an Recommend use of a spacer every time (except for
inhaled corticosteroid breath-actuated pMDIs)
Infants and small children Use a spacer with facemask
Poor manual dexterity (e.g. weak Consider either of:

hands or arthritis)
- A Haleraid device with relevant pMDIs
(available for salbutamol, fluticasone,
fluticasone/salmeterol)
- A breath-actuated inhaler
Difficulty connecting spacer to pMDI Leave spacer connected: pharmacist can attach spacer
(e.g. elderly patient with weakness or to inhaler each time canister is replaced, and leave
poor coordination) attached until medicine is used up. (if patient uses
more than one pMDI, provide a separate spacer for
each device.
Consider a breath-actuated inhaler.
Inability to form a good seal around Consider a spacer plus age-appropriate facemask
the mouthpiece of the inhaler or
spacer (e.g. person with cognitive
impairment or facial weakness)
Difficulty speaking or reading English Give a physical demonstration

Use videos
Use an interpreter or provide written instructions in
the person’s first language
Using multiple inhalers Choose the same type of each medicine, if possible, to
avoid confusion.
If not possible, train person in the correct inhaler
technique for each of their devices, emphasizing any
key differences (e.g. speed of inhalation, shake pMDIs
but not dry-powder inhalers).

Peak flow meter
A peak flow meter is small portable device with a measuring gauge. It measures the force and
speed that air is blown out of the lungs. This measurement is referred to as the peak expiratory
flow rate (PEFR).(51)
“Normal” peak flow rate

Normal peak flow rate is based on a person’s age, height, sex and race. A personal best normal
may be obtained from measuring the patient’s own peak flow rate. Therefore, it is important that
patients discuss with their health care provider on what is considered as “normal”. Once patients
have learned their usual and expected peak flow rate, changes or trends of their disease
condition can easily be recognized.(51)
Measuring reversibility of airflow obstruction

To measure the degree of reversibility (usually increased in asthma) of airflow obstruction,
perform peak flow meter measurement before and approximately 15 minutes after
administering a bronchodilator by metered dose inhaler or nebulizer. Short acting beta agonist
(e.g. salbutamol, terbutaline) are generally considered the benchmark bronchodilator.(51)
Determine a “normal” peak flow rate

Three zones of measurement are commonly used to interpret peak flow rates. In general, a
normal peak flow rate can vary much as 20 percent.(51)

Directions for use(51)
STEP 1:
Place the mouthpiece on the peak flow meter.
NOTE: Alternatively, the originally supplied plastic mouthpiece may be
detached and replaced with a disposable mouthpiece.
STEP 2:
Reset the marker to the bottom of the scale (zero or the lowest number
on the scale).
STEP 3:
Hold the peak flow meter in the way that the scale and marker is not
obstructed by the fingers of the patient.

STEP 4:
Stand in an upright position and breathe in as deep as possible, filling
the lungs completely.(11)
STEP 5:
Hold your breath while you place the peak flow meter in your mouth
horizontally and close lips around the mouthpiece.(11)
Make sure the opening of the mouthpiece is not blocked by the tongue.
STEP 6:
Blow as hard and fast as possible.
DO NOT tilt the head forward while blowing.
STEP 7:
Record the measurement and reset the marker to its original position
at the bottom of the scale.

STEP 8:
Breathe normally and repeat step 2-7 two more times.
Note down the date, time and highest of the 3 peak flow
measurements.
DO NOT average the numbers.
NOTE: the highest of the 3 readings will be used to assess a patient’s
PEFR.
Maintenance(51)
Most peak flow meters need to be cleaned. Follow the cleaning instructions which are available
when the unit is purchased.

In-Check DIAL G16
Guiding correct DPI & pMDI inhalation rate
In-Check DIAL G16 enables healthcare professionals to coach patients to use their inhalers
correctly. The device measures peak inspiratory flow rate and can simulate the resistance
characteristics of the specific inhaler of a patient, providing the device is set on the correct
setting. The patient can then be trained to inhale at a flow rate known to be suitable for their
personal DPI or pMDI.(52)
The changes made

The former In-Check DIAL has been revised, now grouping inhalers as a function of their internal
airflow resistance, in order to accommodate information on the new devices. There are six
resistance groups, five of which relate to dry powder inhalers (DPIs) and one of which to
pressurized metered dose inhalers (pMDIs).(52)

Clinical efficacy

The aim is to encourage flow rates that are within the green band indicating the range of flows
consistent with clinical efficacy. The arrows within the bands indicate that for DPIs a stronger
flow is generally to be aimed for and for pMDIs the opposite applies, a gentle technique is better.
Having acquired the correct flow rate patients can then apply this to their inhaler.(52)
How to use adapters

Specific adapters are available for the following devices:(52)
- HandiHaler / Easyhaler M
- NEXThaler / Twisthaler / Easyhaler C / Turbuhaler
- Turbuhaler S / Clickhaler / Spiromax / GenuAir / AirFluSal
- Ellipta / TurboSpin / Diskhaler / Accuhaler
- Breezhaler / k-haler / Respimat / pMDI
To use adapters the In-Check DIAL must be set to position O (pMDI) and the adapter connected
between the IN-Check DIAL and the disposable mouthpiece.(52)

Metered dose inhaler
The pMDI consists of a canister, the medication, the propellant, excipient, a metering valve, the
mouthpiece and actuator. The medication represents only 1-2% of the mixture emitted from the
pMDI and is either suspended or dissolved in the propellant/excipient mixture. The propellant of
the pMDI makes up 80% of the mixture. These agents prevent aggregation of the drug particles
and lubricate the metering valve. They also ensure that the drug is well suspended in the canister.
The metering valve acts to prepare a pre-measured dose of medication along with the propellant.
The volume of metering valve changes from 25-100µL and provides 50µg to 5mg of drug per
actuation, depending on the drug formulation.(49)
The conventional pMDI has a press-and-breathe design. Depressing the canister into the actuator
releases the drug-propellant mixture, which then expands and vaporizes to convert the liquid
medication into an aerosol. The initial vaporization of the propellant cools the aerosol
suspension. The canister aligns the hole in the metering valve with the metering chamber when
it is pressed down. Then, the high propellant vapor pressure forces a pre-measured dose of
medication out of this hole and through the actuator nozzle. Last, releasing the metering valve
refills the chambers with another dose of the drug-propellant mixture. The propellants used with
pMDIs are HFAs. HFAs are pharmacologically inert and do not contain surfactant or use alcohol
for this purpose.(49)
STEP 1:
Remove the mouthpiece cover. Remain standing or seated upright
to obtain the full dose of each actuation.

STEP 2:
Hold the inhaler in an upright position.
NOTE: May use both hands for patients with difficulty in handling the
device.
STEP 3:
Shake the MDI 3-5 times in an up-down motion before each puff to
mix the contents of the canister.
If the device is being used for the first time, prime it by actuating the
canister mid-air until an even spray is obtained.
NOTE: Each shake constitutes from top to bottom, back to top again.
STEP 4:
Exhale slowly and completely through your mouth before holding
your breath. DO NOT exhale into the mouthpiece.
STEP 5:
Device should be held at an upright position.
Insert into mouth with no obstruction to the mouthpiece with the
head slightly tilted. DO NOT bite the mouthpiece.
Ensure the lips are tightly sealed to the mouthpiece.(11)
STEP 6:
Begin inhaling slowly through the mouth (NOT nose) and
simultaneously actuate the MDI ONCE. Continue inhalation for
about 3-5 seconds until the lungs are full.

STEP 7:
Remove the inhaler (pMDI) from mouth and hold breath for 5-10
seconds.(11)
NOTE:
- Ability to hold breath for less than 4 seconds, consider use
of spacer.
- No extra benefit for holding breath more than 10 seconds.
STEP 8:
Breathe out gently, away from inhaler.(11)
STEP 9:
Wait 30 seconds to 1 minute before repeating step 3-8 if subsequent
doses are required.
STEP 10:
After using, wipe the mouthpiece with dry cloth and replace the cap
on the mouthpiece. (11) Keep the inhaler in a dry place.
**Note
- Patient should be advised to gargle with water after using certain types of MDIs e.g.
anticholinergic and inhaled corticosteroids (ICS).(51)
- If on two types of inhalers (steroid & bronchodilator), it is recommended to use the
bronchodilator first and wait for 5 minutes before using the steroid. (51) (Note: there is no
need to take a short-acting beta2 agonist reliever routinely before taking a preventer. Relievers
should only be used for treating symptoms, or before exercise if required.(50))
Maintenance(51)
It is important to keep the device clean to
- Prevent medication accumulation.
- Prevent blockage over the nozzle.
Clean the plastic mouthpiece only, not the metal canister.
Clean at least ONCE A WEEK or whenever necessary.(11)

Note: Certain pMDI cannot be removed out from the canister and cannot be cleaned with water,
please refer product leaflet.(11)
Remove the mouthpiece cover and canister from the actuation body.
DO NOT use detergent or soap.
Wash the actuator from the top with running tap water for 30 seconds.
Repeat by running tap water through the mouthpiece of the actuator
for 30 seconds.
Left the actuator dry overnight after shaking off as much water as
possible.
NOTE: If the patient needs to use the MDI during exacerbation, shake
the actuator dry and then actuate twice away from face to ensure no
blockage. The inhaler is ready for use.

When the actuator has dried, assemble the canister to the actuator
body. Ensure a tight fit.
Shake the device well and actuate twice away from face to ensure no
blockage.
Replace the cap and store the device safely before the next use.
National Asthma Council Australia recommendation on puffer and inhaler care:(53)

A standard puffer consists of a plastic case or holder with a cap, and a metal canister. The plastic
case needs to be cared for differently depending on the type of medication you are using the
puffer for. The metal canister does not need to be cleaned and should be removed if you are
washing the case.
- Reliever medication (e.g. Asmol, Ventolin)
o Wash the blue plastic case around once a week. Make sure it’s completely dry
before using again.
- Cromone preventer medication (e.g. Intal, Intal Forte, Tilade)
o Puffers for these medications must be washed every day to avoid clogging. Many
people who take these medications get two puffers at a time so that they always
have a clean and dry one handy.
o Wash the white or yellow plastic case every day. Allow it to dry for 24 hours before
using again.
- Corticosteroid-containing preventer medication (e.g. Alvesco, Flixotide, Flutiform, Qvar,
Seretide, Symbicort)
o These puffers need to stay dry, so must never be washed. The mouthpiece can be
wiped with a dry tissue if needed.
Priming
For inhalers that are not used for more than 2 weeks, it should be primed before use.(51)
Priming is releasing one or more sprays into the air. Initial and frequent priming of pMDIs is
required in order to provide an adequate dose. The drug may be separated from the propellant
and other ingredients in the canister and metering valve when the pMDI is new or has not been
used for a while. Because shaking the pMDI will mix the suspension in the canister but not the
metering chamber, priming of the pMDI is required. The recommended guidelines for priming
the pMDI on the market are different.(49)

- Ventolin evohaler GSK brand – If you have not used the inhaler for 5 days or more, shake
it well and release two puffs of medicine into the air.(6)
- Flixotide evohaler GSK brand – if you have not used the inhaler for a week or more,
release two puffs of medicine into the air.(6)
Determining Content of a MDI Canister

- It is hard to determine the remaining content of the MDI.(51)
- After the MDI delivers the number of puffs stated on their label, it may look, taste and
feel like it is still working, but the dose delivered may be very low. This “tailing off effect”
may last long after the MDI is “empty of drug”. Also, the MDI without a dose counter
could lead to waste if the inhaler is discarded prematurely.(49)
- Indirect methods such as floating the canister in water are misleading and can reduce the
ability of pMDI to work properly. Therefore, they should not be used to determine the
amount of medication remaining in the canister.(49)
- MOH recommendation: Keep a spare one. The shaking method can be done to estimate
the remaining content of the MDI canister but it does not reflect the actual content of
the canister.(51)
- The only reliable method to determine the number of doses remaining in a pMDI is
counting the doses given either manually or with a dose counter. Manual methods
include reading the label to determine the total number of doses available in the pMDI
and using a log to indicate every individual actuation given (including both priming and
therapy doses). This tally is subtracted from the number of actuations on the label until
all have been used. At that time, the pMDI should be properly discarded. Unfortunately,
manually counting doses may be impractical and undependable, especially in patients
who use reliever medications on the go. Therefore, the U.S. Department of Health and
Human Services FDA requires new pMDI to have integrated dose counters and
recommends that all pMDIs have dose counting devices that indicate when the pMDI is
approaching its last dose.(49).

BI tube
STEP 1:
Remove the mouthpiece cover from the metered dose inhaler (MDI).
STEP 2:
Attach the large end of the BI tube to the mouthpiece of the MDI.
STEP 3:
Shake the MDI 3-5 times in an up-down motion (as shown in diagram)
before use.(11)
NOTE: Step 2 and 3 is interchangeable.(11)
STEP 4:
Exhale slowly and completely through your mouth before holding your
breath.
DO NOT exhale into the BI tube

STEP 5:
Place the mouthpiece between the lips and slightly tilt the head back.
STEP 6:7
Breathe in slowly through mouth and at the same time, press down firmly
on canister. Keep breathing in slowly and deeply.(11)
STEP 7:
Remove the tube and inhaler (pMDI) from mouth and hold breath for 5-
10 seconds.(11)
STEP 8:
Wait 30 seconds to 1 minute before repeating steps 3-7 if subsequent
doses are required.
STEP 9:
After use, remove the BI tube and replace the mouthpiece cover on the
MDI.
NOTE: The BI Tube may be left attached to the MDI.
Maintenance
- Clean up the tube at least once a week or whenever necessary.(11)
- Wash with water, do not scrub.(11)
- Air-dry the plastic parts overnight.(11)
- It is not recommended to wipe the BI tube dry after washing.(51)

Spacer
A spacer is a holding chamber shaped like a football or tube. It makes it easier to take asthma or
COPD medication from the type of puffer called an MDI (metered dose inhaler). Spacers help the
medication get straight to where it’s needed in your lungs, with less medication ending up in your
mouth and throat where it can lead to irritation or mild infections. A spacer can also make it
easier to coordinate breathing in and pressing your puffer.(54)
All the latest research shows that a puffer with spacer works just as well as a nebulizer for treating
asthma symptoms, including during an asthma attack. A puffer with spacer is also simpler,
cheaper and handier, is much more portable, and has fewer side-effects.(54)
Clean your spacer about once a month and after you have recovered from any cold or respiratory
infection. Your spacer may become a bit cloudy over time, but it shouldn’t be mouldy or brown.
To clean your spacer:(54)
- Dismantle your spacer, if necessary.
- Wash all the parts in clean warm water with liquid dishwashing detergent.
- Allow the parts to air dry without rinsing – drying with a cloth or paper towel can result
in static building up on the inside of the spacer, which makes the medication stick to the
sides.
- Wipe the mouthpiece clean of detergent, if needed.
- When completely dry, reassemble if necessary.
New plastic spacers (e.g. Able Spacer Universal, Breath-ATech, Volumatic) also need to be washed
before you use them for the first time. If a new spacer has to be used immediately, you can
‘prime’ the spacer by firing multiple (at least 10) puffs into it to begin with to help reduce the
static build-up inside. You can then take your medication dose as usual.(54)
Spacers made from antistatic polymers (e.g. Able A2A, AeroChamber Plus, Breathe Eazy, La Petite
E-Chamber, La Grande E-Chamber, OptiChamber Diamond) do not need to be primed or washed
before first use, nor do disposable cardboard spacers.(54)
Your spacer should be checked by your pharmacist, nurse or asthma educator every 6–12 months
to check the structure is intact (e.g. no cracks) and the valve is working properly.(54)
Chamber with mask(51)

STEP 1:
Visually check for foreign objects, damage or missing parts before each
use.(11)
STEP 2:
Remove the mouthpiece cover from the MDI.
STEP 3:
Insert the MDI into the adaptor of the chamber.
STEP 4:
While holding the chamber with MDI firmly, shake the MDI for 3-5 times
in an up-down motion.(11)
Note: Step 3 and 4 is interchangeable.(11)
STEP 5:
Apply mask to face and ensure that there is a good seal.

STEP 6:
Press MDI ONCE at beginning of normal breath.
Breathe normally between 5 – 10 breaths while holding the mask firmly
to your face.(51)
- For AeroChamber, breathe normally between 5-6 breaths while
holding the mask firmly to your face.(11)
- For OptiChamber, breathe normally between 3-6 breaths while
holding the mask firmly to your face.(11)
STEP 7:
Slow down inhalation if the WHISTLE sound is heard.
STEP 8:
Wait 30 seconds to 1 minute before repeating steps 4-7 if subsequent
doses are required.
Chamber with mouthpiece(51)

STEP 1:
Visually check for foreign objects, damage or missing parts before each
use.(11)
STEP 2:
Remove the cap from the MDI and the mouthpiece cover of the chamber.
STEP 3:
Insert the MDI into the adaptor of the mouthpiece.
While holding the mouthpiece with MDI firmly, shake the unit for 3-5
times in an up-down motion.(11)
STEP 4:
Place the mouthpiece between lips and slightly tilted the head back.

STEP 5:
Simultaneously press the MDI ONCE at the beginning of a slow and deep
inhalation.
Hold breath as long as possible, between 4 – 10 seconds before breathing
out through the nose. Alternatively, the mouthpiece may be kept tightly
in the mouth. Inhale slowly through the mouth and exhale through the
nose for 5 times after pressing the MDI.(51)
- For AeroChamber, hold breath for 5-10 seconds. Alternatively,
breathe in normally through the chamber for 2-3 times.(11)
- For OptiChamber, hold breath for 8 seconds and take out the
mouthpiece.(11)
STEP 6:
Slow down inhalation if a WHISTLE sound is heard.
STEP 7:
Wait 30 seconds to 1 minute before repeating steps 3–6 if subsequent
doses are required.
Maintenance(51)
** It is recommended to clean once a week or whenever necessary.(11)
Remove the backpiece only.

DO NOT remove the mask or valve assembly.

Soak both parts for 15 minutes in a mild solution of
liquid dish detergent and warm clean water.
Agitate gently.
DO NOT rinse the chamber as shown, as this may lead

to static build up.
If concern about potential for contact dermatitis,
rinse only the mouthpiece / mask portion in water.
Shake out excess water and allow to air dry in a

vertical position.
DO NOT rub dry.
Drying with a cloth or paper towel can result in static
building up on the inside of the spacer, which makes
the medication stick to the sides.(54)
To reassemble, center the alignment feature on the

back piece.
**Note: Cleaning of the product varies between the different variants of the spacer. Please refer
to each individual product information leaflet.(51)
Soak both parts in water with mild solution of liquid dish detergent for 15 minutes and agitate
gently.(11)
- For AeroChamber, rinse parts by submerging in clean water.
- For OptiChamber, rinse each part under running tap water.

AeroTrach Plus antistatic valved holding chamber (aVHC)

1. Prior to use, carefully examine the product. Replace immediately if any defect is noticed.
2. Remove cap from pMDI. Before use, ensure the instructions supplied with the pMDI have
been read.
3. Shake the pMDI immediately before each use as per the instructions supplied with the
pMDI, and insert into the back piece of the chamber.
4. Carefully connect the trach adapter of the VHC to the tracheostomy tube connection.
5. Press the pMDI at the beginning of a slow inhalation. Hold in place for 4-6 breaths.
6. Follow instructions supplied with the pMDI regarding the amount of time to wait before
removing the pMDI and repeating instructions 4-5 as prescribed.
Cleaning instructions(11)
1. Remove the back piece only. Do not remove the adapter assembly.
2. Soak both parts for 15 minutes in a mild solution of liquid dish detergent and lukewarm
clean water. Agitate gently.

3. Rinse parts in clean water.
4. Shake out excess water and allow to air dry in a vertical position. Ensure parts are dry
before reassembly.
5. To reassemble, centre the back piece on the chamber and press firmly to secure.
Note(11)
- AeroTrach Plus aVHC is designed for use with 15 mm tracheostomy tubes with
spontaneously breathing patients only.
- This device is designed as a slip fit onto the tracheostomy tube connection. It must be
held in place during administration of medication.
- Do not spray more than one puff into the chamber at a time.
- Warning: remove device if patients shows signs of difficulty.

Turbuhaler
Turbuhaler® is an easy-to-use, multiple-dose, inspiratory flow-driven dry powder inhaler.
Currently there are 4 types of Turbuhaler® which are Budesonide (Pulmicort®), combination of
Budesonide/Formoterol (Symbicort®), Formoterol (Oxis®) and Terbutaline (Bricanyl®).(51)
Preparing a new Turbuhaler® (Priming)(51)
Unscrew and lift off the cover.
Hold the Turbuhaler® upright with the grip facing downwards.

Turn the grip as far as it will go and then turn it back as far as it will go in
the opposite direction until a “CLICK” sound is heard.
Perform this procedure TWICE.
Delivering the Medication(51)

STEP 1:
Unscrew and lift off the cover.
STEP 2:
Hold the Turbuhaler® upright with the grip facing downwards.
DO NOT hold the mouthpiece when turning the grip.
STEP 3:
To load the Turbuhaler with a dose, turn the grip as far as it will go in one
direction.
STEP 4:
Then turn it back again as far as it will go in the opposite direction until a
“CLICK” sound is heard.
The Turbuhaler® is now loaded with the desired dose and is ready for use.
NOTE: If the Turbuhaler® is accidentally dropped, a new dose should be
loaded and inhaled.

STEP 5:
Breathe out away from the mouthpiece.
STEP 6:
Place the mouthpiece gently between the lips.
Ensure a tight seal around it.
Do not chew or bite on the mouthpiece.(11)
STEP 7:
Breathe in forcefully and deeply through the mouth only.
NOTE: Holding breath after inhalation is optional.
STEP 8:
Remove the Turbuhaler® from the mouth before breathing out again.
DO NOT breathe into the mouthpiece.

STEP 9:
Repeat step 2 – 8 if more than one dose is required.
STEP 10:
Replace the cover and store Turbuhaler® in a dry place.
**Note
- Patients should be advised to gargle with water using steroid containing Turbuhaler®.
- If on two types of Turbuhaler® (steroid & bronchodilator), it is recommended to use the
bronchodilator first and wait for 5 minutes before using the steroid.
Maintenance(51)
- Clean the outside of the mouthpiece at least once a week or whenever necessary with
a dry cloth or tissue.(11, 51)
- Never use water or any other fluid when cleaning the mouthpiece.
How To Know When The Turbuhaler® Is Empty?(51)
Turbuhaler® has a dose indicator that shows how many doses are left in the inhaler. It moves
slowly when each time a dose is loaded.

For example, Budesonide/Formoterol (Symbicort®) Turbuhaler® dose indicator marks every 10th
dose, and every 20th dose is displayed numerically. When the red color first appears in dose
indicator, it shows that there are only 20 doses left.
Terbutaline (Bricanyl®), Budesonide (Pulmicort®) and Formoterol (Oxis®) Turbuhaler®
dose indicators are not displayed numerically. When the red color first appears in dose
indicator, it shows that there are only 20 doses left.
The Turbuhaler® can be safely disposed of when the dose indicator window has turned red
completely. The sound heard when the device is shaken is produced by a drying agent, and not
the medication. Turbuhaler® cannot be re-filled with drug and should be discarded.
Determining the Functionality of the Device When In Doubt(51)
Turbuhaler® makes no sound when the drug is released. Moreover, since the amount of drug
delivered by Turbuhaler® is small, there is either no or only a faint taste in the mouth when the
drug is delivered. This can, in some cases, lead to patients being uncertain as to whether they
have received the required dose. The correct functionality of the Turbuhaler® can easily be
checked by inhaling through a piece of dark cloth.

Accuhaler (Diskus)
The combination of Salmeterol and Fluticasone Propionate (Seretide®) Accuhaler® is a moulded

plastic inhaler device containing a foil strip with 60 blisters. Each blister contains lactose as a
carrier. The blister protect the inhalation powder from the effects of atmosphere.(51)
There is a dose counter on the device (total 60 doses). When left with 5 doses, the counter will
show “5” (red in color); the subsequent count i.e. 4, 3, 2, 1, 0 are all red in color. Do not use the
Accuhaler if the dose counter read 0. It means the Accuhaler is empty and should get new supply
of Accuhaler.(11)
STEP 1:
Hold the outer case in one hand and put the thumb of the other hand on
the thumb grip to open the Accuhaler®.
STEP 2:
Push the thumb grip as far as it will go until a “CLICK” sound is heard. The
mouthpiece should now be fully visible.
STEP 3:
Hold the device horizontally with the mouthpiece towards the patient.
NOTE: Never hold the inhaler with the mouthpiece pointing downwards
during or after loading a dose, as the medication can be dislodged. Always
keep it horizontal.

STEP 4:
Slide the level as far as it will go as in diagram until another “CLICK” sound
is heard to load a dose in the device.
The number in the dose-counter window will be reduced by one.
STEP 5:
Hold the Accuhaler® away from mouth and breathe out completely.
NOTE: DO NOT breathe into the device.
STEP 6:
Put the mouthpiece into mouth and ensure a good seal. Breathe in
forcefully and deeply through the mouth only.
STEP 7:
Remove the Accuhaler from the mouth and hold breath for 10 seconds
or as long as possible.
STEP 8:
Close the device by sliding the thumb grip back to its original position
until a “CLICK” sound is heard.
The level will return to its original position and will be reset.
STEP 9:
Repeat step 1-8 if more than one dose is required.

STEP 10:
Gargle and rinse mouth and throat after using inhaled corticosteroids and
spit it out.(11)
Maintenance(51)
Wipe the mouthpiece of the Accuhaler® with a dry cloth or tissue to clean it.
The Accuhaler® is recommended to be cleaned at least ONCE A WEEK.
The content of the device is susceptible to moisture. For this reason, keep it in a dry place away
from humidity.

Easyhaler
The Easyhaler® is a new generation, multidose dry powder inhaler preloaded with 200 doses of
asthma medications. Easyhaler® has been designed to resemble a MDI in terms of the small size
of the device, but importantly avoids the need to coordinate drug release and inhalation. The
Easyhaler® product range currently includes four products; anti-inflammatory inhaled
corticosteroids Budesonide (Giona®) Easyhaler® and Beclomethasone (Beclomet®) Easyhaler® as
well as bronchodilators Formoterol Easyhaler® and Salbutamol (Buventol®) Easyhaler®.
Salbutamol via Easyhaler® is at least as effective as salbutamol via Turbuhaler® in the treatment
of histamine-induced bronchoconstriction. The efficacy via Easyhaler® is unaffected by low
inspiratory flow.(51)
Preparing the powder inhaler for first use(51)
Remove the powder inhaler from the laminated pouch.

Insert the powder inhaler into the protective cover.
The dust cap on the mouthpiece prevents accidental actuation of the inhaler
when inserting it into the protective cover.
Delivering the medication(51)
STEP 1:
Remove the dust cap.
STEP 2:
Shake the device 3-5 times (1 shake = up and down) prior to each dose to
allow proper powder flow and a correct dose.(11)
After shaking, hold the device in the upright position.
STEP 3:
Press the device only ONCE between the thumb and forefinger until a
“CLICK” sound is heard.
Release the inhaler to return to the original position.(11)
Keep holding the device in the upright position.
NOTE: If you press the device by accident, or if you have released more
than one dose, tap the mouthpiece to empty the powder onto a table top
or the palm of your hand. Then, repeat steps 2-3 again.

STEP 4:
Breathe out normally, away from the mouthpiece.
STEP 5:
Place the mouthpiece between lips and close tightly around the
mouthpiece.
Breathe in forcefully and deeply through the mouth only.
STEP 6:
Remove the Easyhaler from mouth and hold breath for 5-10 seconds, and
then breathe out away from the Easyhaler.
STEP 7:
Repeat step 2-6 if more than one dose is required.
STEP 8:
Put the dust cap back on the mouthpiece.
Store Easyhaler® in a dry place.
**Note
- Patient should be advised to gargle with water after using steroid containing Easyhaler ®.
- If on two types of Easyhaler® (steroid and bronchodilator), it is recommended to use the
bronchodilator first and wait for 5 minutes before using the steroid.

Maintenance(51)
The mouthpiece can be cleaned with a dry cloth or tissue.

Never use water or any other fluid when cleaning the mouthpiece.
Inhalation powder should not be exposed to humidity. It the powder
becomes damp, it is not suitable for use and should be disposed of.
Bufomix Easyhaler can be kept for 4 months after the laminate pouch has
been opened. Salflumix 50/250 micrograms can be kept for 1 month and
50/500 micrograms can be kept for 2 months. Buventol, Giona and Beclomet
Easyhalers can be kept for 6 months. Easyhaler should be stored at room
temperature and in a dry place. It is available with and without a cover.(9)
How do you know when your Easyhaler® is empty?(51)
Easyhaler® has a dose counter which indicates the number of remaining doses. The counter turns
after every five actuations. When the counter turns red, there are 20 doses left. A clear window
on the back of the inhaler allows viewing of the powder. The device must be replaced when the
dose counter indicates zero.

Handihaler
HandiHaler® is a device to deliver Tiotropium bromide (Spiriva®) into the lung. Tiotropium
bromide (Spiriva®) comes in light green, hard gelatine capsule-containing powder form and
contains 18 mcg tiotropium blended with lactose monohydrate as a carrier. Spiriva® capsules
should not be swallowed and must be used with HandiHaler® device only. Spiriva® is not a rescue
medicine and should not be used for acute exacerbation.(51)
STEP 1:
Open the dust cap by pressing the green piercing button.
NOTE: Some HandiHaler® devices may require the dust cap to be
manually opened upwards.
STEP 2:
Pull the dust cap upwards away to expose the mouthpiece.

STEP 3:
Open the mouthpiece by pulling it upwards.
STEP 4:
The blister cards are perforated in the middle.
Tear the card along the perforation.
NOTE:
- Store Spiriva® capsules in a dry place.
- Keep away from extreme hear or moisture.
STEP 5:
Carefully open the blister cavity by peeling back the aluminum foil until
ONE capsule is fully visible.
DO NOT exceed the STOP line.
NOTE:
- In case a second capsule is exposed to air accidentally, it has to
be discarded.
- The capsule should be removed from the blister pack just
before using it.
STEP 6:
Remove the capsule from the blister pack.
NOTE: DO NOT swallow the capsule.

STEP 7:
Place the capsule in the center of the chamber.
STEP 8:
Close the mouthpiece firmly until a “CLICK” sound is heard.
STEP 9:
Hold the HandiHaler® device with the mouthpiece pointed upright.
Press the green piercing button completely as shown in the diagram
before releasing it.
This will make holes in the capsules to allow the medication to be
delivered when inhaled.
NOTE: The piercing of the spiriva capsule may produce small gelatin
pieces. Some of these small pieces may pass through the screen of your
handihaler device into your mouth or throat when you breathe in your
medicine. This is normal. The small pieces of gelatin should not harm
you.(9)
STEP 10:
Breathe out completely.

STEP 11:
Place the HandiHaler® horizontally to the mouth and close the lips
tightly around the mouthpiece. DO NOT block the air intake vents.
Breathe in slowly and deeply at a rate sufficient to hear the CAPSULE
VIBRATE.
STEP 12:
Remove device from the mouth and hold breath for 5 – 10 seconds or
as long as possible.
Then resume normal breathing.
STEP 13:
To ensure that all the medicine is inhaled, repeat step 10 – 12.
Remember: To get your full medicine dose each day, you must breathe
in 2 times from the same spiriva capsule. Make sure you breathe out
completely each time before you breathe in from your handihaler
device.(9)
STEP 14:
Open the mouthpiece and dispose the empty capsule into rubbish bin
as in diagram.
STEP 15:
Close the mouthpiece and dust cap for storage.

If you do not hear or feel the spiriva capsule rattle as you breathe in your medicine:(9)
Do not press the green piercing button again.

Hold your handihaler device with the mouthpiece pointed up and tap
your handihaler device gently on a table.
Check to see that the mouthpiece is completely closed. Breathe out
completely before deeply breathing in again with the mouthpiece in
your mouth.
If you still do not hear or feel the spiriva capsule rattle after repeating
the above steps:
- Throw away the spiriva capsule
- Open the base by lifting the green piercing button and check
the center chamber for pieces of the spiriva capsule. Spiriva
capsule pieces in the center chamber can cause a spiriva
capsule not to rattle.
- Turn your handihaler device upside down and gently, but
firmly, tap to remove the spiriva capsule pieces. Call your
doctor for instructions.
Maintenance(51)
Always use the new handihaler device provided with your medicine. Clean you handihaler device
as needed.(9)
MOH recommendation: It is recommended to clean the device EVERY MONTH.(51)
Look in the center chamber for SPIRIVA capsule pieces or powder buildup.
If seen, tap out.(9)
Open the dust cap, mouthpiece and chamber as in diagram.

Rinse all parts with warm water to remove any powder.
Pressing the green piercing button a few times so that the center chamber
and the piercing needle is under the running water. Check that any powder
buildup or spiriva capsule pieces are removed.(9)
DO NOT use cleaning agents or detergents.
Dry the HandiHaler® thoroughly by shaking off the excess water and air-
drying it.
Leaving the dust cap, mouthpiece, and base open by fully spreading it out
so that it dries completely. Do not use a hair dryer to dry your handihaler
device.(9)
It takes 24 hours to air dry, so clean it immediately after use.

Do not use your handihaler device when it is wet. If needed, you may clean
the outside of the mouthpiece with a clean damp cloth.(9)

Soft-mist inhaler (Respimat®)
The Respimat® (Boehringer Ingelheim Pharmaceuticals, Ridgeﬁeld, CT) is a propellant-free soft-
mist inhaler. The Respimat® utilizes mechanical energy in the form of a tensioned spring to
generate the soft aerosol plume. The energy from turning the transparent base to the right one-
half turn draws a predetermined metered volume of solution from the medication cartridge
through a capillary tube into a micro-pump. When the dose release button is depressed, the
energy from the spring forces solution to the mouthpiece, creating a soft aerosol plume that lasts
approximately 1.5 seconds. Similar to pMDIs, the Respimat® will need to be primed before use
and at times when the device has had no use. If not used for more than 3 days, actuate the inhaler
once. After more than 21 days of no use, it is recommended to actuate the device until aerosol
is seen, then actuate 3 more times. Since the device is propellant free, there is no need to shake
it. The Respimat® has a dose indicator and will lock once all medication is used.(49)

Note: Healthcare providers can have assurance that the use of the soft mist inhaler with
AeroChamber Plus® Flow-Vu Anti-Static VHCs should deliver a similar fine particle mass of active
pharmaceutical ingredients compared to the soft mist inhaler alone.(55)
Prepare for first use(9)
STEP 1: Remove clear base

Keep the cap closed.
Press the safety catch while firmly pulling off the
clear base with your other hand. Be careful not
to touch the piercing element.
Write the discard by date on the label (3 months
from the date the cartridge is inserted).
STEP 2: Insert cartridge

Insert the narrow end of the cartridge into the
inhaler.
Place the inhaler on a firm surface and push
down firmly until it clicks into place.
STEP 3: Replace clear base

Put the clear base back into place until it clicks.
Do not remove the clear base or the cartridge
after it has been put together.
STEP 4: Turn
Turn the clear base in the direction of the arrows
on the label until it clicks (half a turn).

STEP 5: Open
Open the cap until it snaps fully open.
STEP 6: Press
Point the inhaler toward the ground.
Press the dose-release button.
Close the cap.
If you do not see a mist, repeat steps 4 to 6 until
a mist is seen.
After a mist is seen, repeat steps 4 to 6 three
more times.
After complete preparation of your inhaler, it
will be ready to deliver the number of puffs on
the label.
NOTE:
- The discard by date is 3 months from the date the cartridge is inserted into the inhaler. (9)
- If Respimat® has not been used for more than 7 days, release one puff towards the
ground.(11)
- If Respimat® has not been used for more than 21 days, repeat steps 4 to 6 three more
times after a mist is seen.(11)
Daily use(9)

Turn
Turn the clear base in the direction of the arrows on the
label until clicks (half a turn).
Open
Open the cap until it snaps fully open.
Press
Breathe out slowly and fully.
Close your lips around the mouthpiece without covering
the air vents.
Point the inhaler to the back of your throat.
While taking a slow, deep breath through your mouth,
press the dose-release button and continue to breathe in.
Hold your breath for 10 seconds or for as long as
comfortable.
Repeat “Turn, Open, Press (TOP)” for a total of 2 puffs.
Close the cap until you use your inhaler again.
Note:

- Clean up the Respimat® mouthpiece with damp cloth or tissue daily after use. (11)
- The dose indicator shows approximately how much medication is left. When the pointer
enters the red area of the scale, there is approximately, medication for 7 days left (14
puffs).(11)
- Once the dose indicator has reached the end of the red scale, Respimat® inhaler is empty
and locks automatically. The base of Respimat® cannot be turned any further.(11)
Answers to Common Questions(9)

1. It is difficult to insert the cartridge deep enough:
a. Did you accidentally turn the clear base before inserting the cartridge? Open the
cap, press the dose-release button, then insert the cartridge.
b. Did you insert the cartridge with the wide end first? Insert the cartridge with the
narrow end first.
2. I cannot press the dose-release button:
a. Did you turn the clear base? If not, turn the clear base in a continuous movement
until it clicks (half a turn).
b. Is the dose indicator on the SPIRIVA RESPIMAT pointing to 0 (zero)? The SPIRIVA
RESPIMAT inhaler is locked after the labeled number of puffs have been used.
Prepare and use your new SPIRIVA RESPIMAT inhaler.
3. I cannot turn the clear base:
a. Did you turn the clear base already? If the clear base has already been turned,
follow steps “Open” and “Press” under “Daily use” to get your medicine.

Breezhaler
How to use your inhaler(9)
Pull off the cap.
Open inhaler:
Hold the base of the inhaler firmly and tilt the mouthpiece.
This opens the inhaler.
Prepare capsule:
Immediately before use, with dry hands, remove one capsule from
the blister (for Onbrez®).
Note: for Seebri® and Ultibro®, separate one of the blisters from the
blister card by tearing along the perforation. Take one blister and peel
away the protective packing to expose the capsule. Do not push
capsule through the foil.(11)

Insert capsule:
Place the capsule into the capsule chamber.
Do not swallow the capsule.(11)
Never place a capsule directly into the mouthpiece.
Close the inhaler:

Close the inhaler until you hear a “click”.
Pierce the capsule:

- Hold the inhaler upright with the mouthpiece pointing up.
- Pierce the capsule by firmly pressing together both side
buttons at the same time. Do this only once.
- You should hear a “click” as the capsule is being pierced.
Release the side buttons fully.
Breathe out:
Before placing the mouthpiece in your mouth, breathe out fully.
Do not blow into the mouthpiece.

Inhale the medicine
To breathe the medicine deeply into your airways:
- Hold the inhaler as shown in the picture. The side buttons
should be facing left and right. Do not press the side buttons.
- Place the mouthpiece in your mouth and close your lips firmly
around it.
- Breathe in rapidly but steadily and as deeply as you can.
Note:
As you breathe in through the inhaler, the capsule spins around in the
chamber and you should hear a whirring noise. You will experience a
sweet flavor as the medicine goes into your lungs.
Additional information
Occasionally, very small pieces of the capsule can get past the screen
and enter your mouth. If this happens, you may be able to feel these
pieces on your tongue. It is not harmful if these pieces are swallowed
or inhaled. The chances of the capsule shattering will be increased if
the capsule is accidentally pierced more than once (step 6).
If you do not hear a whirring noise:
The capsule may be stuck in the capsule chamber. If this happens:
- Open the inhaler and carefully loosen the capsule by tapping
the base of the inhaler. Do not press the side buttons.
- Inhale the medicine again by repeating steps 8 and 9.
Hold breath:
After you have inhaled the medicine:
- Hold your breath for at least 5-10 seconds or as long as you
comfortably can while taking the inhaler out of your mouth.
- Then breathe out, away from the mouthpiece.(11)
- Open the inhaler to see if any powder is left in the capsule.
If there is powder left in the capsule:
- Close the inhaler.
- Repeat steps 8, 9, 10 and 11.

Most people are able to empty the capsule with one or two
inhalations.
Additional information
Some people may occasionally cough briefly soon after inhaling the
medicine. If you do, don't worry. As long as the capsule is empty, you
have received enough of your medicine.
After you have finished taking your medicine:

- Open the mouthpiece again, remove the empty capsule by
tipping it out of the capsule chamber. Put the empty capsule
in your household waste.
- Close the inhaler and replace the cap.
Do not store the capsules in the breezhaler inhaler.
Mark daily dose tracker:

On the inside of the pack there is a daily dose tracker. Put a mark in
today's box if it helps to remind you of when your next dose is due.
Note:(9)
- Do not swallow breezhaler capsules.
- Breezhaler capsules must always be stored in the blister, and only removed immediately
before use.
- Do not press the side buttons more than once.
- Do not store the capsules in the breezhaler inhaler.
How to clean your inhaler(9)

Clean your inhaler once a week.
- Wipe the mouthpiece inside and outside to remove any powder with a clean, dry lint-
free cloth.
- Do not wash the breezhaler with water. Keep it dry.
- Do not take the inhaler apart.

Storage(9)
- Do not store above 30°C
- Store in the original package in order to protect from moisture and do not remove until
immediately before use.
- Do not use this medicine if you notice that the pack is damaged or show signs of
tampering.
- Each inhaler should be disposed of after 30 days of use. Always use the new breezhaler
inhaler that comes with new breezhaler medication pack.

Ellipta
An Ellipta is used with a number of different medications. These include:(9)

- Trelegy (fluticasone furoate 92 mcg, umeclidinium 55 mcg, vilanterol 22 mcg)
- Anoro (umeclidinium 55 mcg plus vilanterol 22 mcg)
- Breo or Relvar (fluticasone furoate 184 mcg or 92 mcg plus vilanterol 22 mcg)
- Incruse (umeclidinium 55 mcg)
Only open the package when you are ready to begin using your inhaler. Once you tear open
the foil you should use your Ellipta inhaler within 6 weeks.(9)
To remind you of when to dispose of your medicine we recommend you write the date in 6 weeks
from the time that you open your medicine in a place that you can easily reference.
Your Ellipta inhaler contains a 30 dose supply and is to be used every day, one inhalation once
daily at the same time each day.(9)
Do not use your Ellipta inhaler to relieve a sudden attack of breathlessness or wheezing, if you
get this sort of attack you should use a quick-acting inhaler (such as salbutamol).(9)
Getting started(9)

Before your patient starts using their active inhaler, you should consider the following:
- The Ellipta® demonstration inhaler is packaged in a tray containing a desiccant gel sachet,
which should be thrown away with the other packaging.
- When it is taken out of the tray, the inhaler will be in the ‘closed’ position (the cover will
be shut). It is ready to use straight from the packaging, so there is no need to prepare it
for use in any special way.
You do not need to prepare your Ellipta inhaler in any special way, just follow these step-by-
step instructions.(9)
Please Note(9)
- It may not be possible to taste or feel the medicine, even when using the inhaler correctly
- Do not shake the inhaler, block the air vents with your fingers, or breathe out into the
inhaler.
- The dose counter will count down by one unit at a time.

- If the dose counter does not count down as you hear the ‘click’, the inhaler will not deliver
the required dose. If this happens, take your inhaler back to the pharmacy.
Step-by-step instruction(9)
Each time you fully open the cover of the inhaler (you will hear a clicking sound), a dose is
ready to be inhaled. This is shown by a decrease in the number on the counter.
If you open and close the cover without inhaling the medicine, the dose will be lost. The lost
dose will be held in the inhaler, but it will no longer be available to be inhaled. It is not possible
to accidentally take a double dose or an extra dose in 1 inhalation.
Only open the cover once you are ready to take a dose. To avoid wasting doses after the inhaler
is ready, do not close the cover until after you have inhaled the medicine.
Write the “Tray opened” and “Discard” dates on the inhaler label. The “Discard” date is 6 weeks
from the date you open the tray.
Check the counter

Before the inhaler is used for the first time, the counter should show the
number 30 (14 if you have a sample or institutional pack). This is the
number of doses in the inhaler.
Each time you open the cover, you prepare 1 dose of medicine.
The counter counts down by 1 each time you open the cover.
Open the cover of the inhaler

Slide the cover down to expose the mouthpiece. You should hear a “click.”
The counter will count down by 1 number. You do not need to shake this
kind of inhaler. Your inhaler is now ready to use.
If the counter does not count down as you hear the click, the inhaler will
not deliver the medicine. Call your healthcare provider or pharmacist if
this happens.

Breathe out
While holding the inhaler away from your mouth, breathe out (exhale)
fully. Do not breathe out into the mouthpiece.
Inhale your medicine

Put the mouthpiece between your lips and close your lips firmly around it.
Your lips should fit over the curved shape of the mouthpiece.
Take one long, steady, deep breath in through your mouth. Do not breathe
in through your nose.
Do not block the air vent with your fingers.
Remove the inhaler from your mouth and hold your breath for about 3 to
4 seconds (or as long as comfortable for you).
Breathe out slowly and gently.

You may not taste or feel the medicine, even when you are using the
inhaler correctly.
Do not take another dose from the inhaler even if you do not feel or taste
the medicine.

Close the inhaler
You can clean the mouthpiece if needed, using a dry tissue, before you
close the cover. Routine cleaning is not required.
Slide the cover up and over the mouthpiece as far as it will go.
Rinse your mouth (if needed)

Rinse your mouth with water after you have used the inhaler and spit the
water out. Do not swallow the water.
Important Note: When should you get a refill?(9)
When you have less than 10 doses remaining in your inhaler, the left half
of the counter shows red as a reminder to get a refill.
After you have inhaled the last dose, the counter will show “0” and will
be empty.
Throw the empty inhaler away in your household trash out of reach of
children and pets.
Storage(9)
- Store ellipta at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry
place away from heat and sunlight.
- Store ellipta in the unopened tray and only open when ready for use.
- Safely throw away ellipta in the trash 6 weeks after you open the tray or when the
counter reads “0”, whichever comes first. Write the date you open the tray on the label
on the inhaler.

Nexthaler
Before using a new Nexthaler inhaler(6)
Open the pouch and take out your inhaler

Do not use your inhaler if the pouch is not sealed or it is damaged -
return it to the person who supplied it and get a new one.
Use the label on the box to write down the you open the pouch.
Inspect your inhaler

If your inhaler looks broken or damaged, return it to the person who
supplied it and get a new one.
Check the dose counter window. If your inhaler is brand new, you
will see “120” in the dose counter window.
Do not use a new inhaler if the number is less than “120” – return it to
the person who supplied it and get a new one.
How to use your Nexthaler inhaler(6)

Open
1. Hold your inhaler firmly in the upright position.
2. Check the number of doses left: any number
between “1” and “120” shows that there are
doses left.
a. If dose counter window shows “0”,
there are no doses left – dispose of your
inhaler and get a new one.
3. Open the cover fully.
4. Before inhaling, breathe out as far as is
comfortable.
a. Do not breathe out through your
inhaler.
Inhale
1. Whenever possible, stand or sit in an upright
position when inhaling.
2. Lift your inhaler up, bring it to your mouth and
place your lips around the mouthpiece.
a. Do not cover the air vent when holding
your inhaler.
b. Do not inhale through the air vent.
3. Take a forceful and deep breath through your
mouth.
a. You may notice a taste when you take
your nose.
b. You may hear or feel a click when you
take your dose.
c. Do not inhale through your nose.
d. Do not remove your inhaler from your
lips during the inhalation.
4. Remove your inhaler from your mouth.
5. Hold your breath for 5 to 10 seconds or as long
as is comfortable.
6. Breathe out slowly.
a. Do not breathe out through your
inhaler.

Close
1. Move your inhaler back to the upright position
and close the cover fully.
2. Check that the dose counter has gone down by
one.
3. If you need to take another dose, repeat the
steps again.
Note: If you are not sure the dose counter has gone down by one after inhalation, wait your next
scheduled dose and take this as normal. Do not take an extra dose.
Cleaning(6)
Normally, it is not necessary to clean your inhaler.
If necessary, you may clean your inhaler after use with a dry cloth or tissue.
Do not clean your inhaler with water or other liquids. Keep it dry.

Diskhaler
Zanamivir (Relenza™) 5mg/dose powder for inhalation(6)
Indication Dosage
Treatment of influenza Adult and children ≥5 years, 2 inhalations (2 x 5mg) twice daily for
five days, providing a total daily inhaled dose of 20mg.
Treatment should begin as soon as possible, within 48 hours after
onset of symptoms for adults, and within 36 hours after onset of
symptoms for children.
Prevention of influenza Post-exposure prophylaxis, 2 inhalations (2 x 5mg) once daily for 10

days. Therapy should begin as soon as possible and within 36 hours
of exposure to an infected person.
Seasonal prophylaxis during a community outbreak, 2 inhalations (2
x 5mg) once daily for up to 28 days.
Relenza powder is contained in the four blisters on the silver-colored foil disk, called a Rotadisk.
Each blister contains 5 mg of zanamivir. The medicine is inhaled through the mouth from the
Rotadisk using a plastic device called a Diskhaler.
Relenza is supplied in two types of pack:
- a 1-day starter pack containing one Relenza Rotadisk and one Diskhaler
- a 5 -day treatment pack containing five Relenza Rotadisks and one Diskhaler
Not all pack sizes may be marketed.
The Diskhaler has three parts. Don’t take it apart until you have looked at the step-by-step guide

The Rotadisk fits into the Diskhaler. The Rotadisk consists four blisters. Each blister contains 5mg
of zanamivir. A dose is normally two blisters (10mg).
Important:
- Don’t pierce any of the blisters on the Rotadisk before you load it onto the Diskhaler.
- You can keep a Rotadisk on the Diskhaler between doses, but don’t pierce a blister until
just before you inhale your dose.
- Keep the Diskhaler clean. Wipe the mouthpiece with a tissue after you use it and replace
the blue cover between uses.
To load a Rotadisk into the Diskhaler
STEP 1:
Remove the blue cover
Check that the mouthpiece is clean, inside and outside.
STEP 2:
Hold the white sliding tray as shown and pull it out until it stops.
STEP 3:
Gently squeeze the finger grips on the sides of the white tray. Remove
the tray from the main body.
The white tray should come out easily.

STEP 4:
Place a new Relenza Rotadisk on the wheel.
Make sure the printed side is up, with the blisters facing downwards.
The blisters fit into the holes in the wheel.
STEP 5:
Push the white tray back into the main body.
If you’re not ready to inhale a dose of Relenza straight away, replace the
blue cover.
To get your dose ready to inhale
STEP 6:
Don’t do this until just before you inhale a dose.
Hold the Diskhaler horizontally.
Keep the diskhaler horizontal.
Flip the lid up as far as it will go.
The lid must be fully vertical, to make sure that the blister is pierced at
both the top and bottom.
Push the lid back down.
Your Diskhaler is now ready for use. Keep it horizontal until you have
inhaled your dose.
To inhale the medication

STEP 7:
Don’t put the Diskhaler into your mouth yet.
Breathe out as far as is comfortable, keeping the Diskhaler away from
your mouth. Don’t blow into the Diskhaler. If you do, you’ll blow the
powder out of the Rotadisk.
Keep the Diskhaler Place the mouthpiece between your teeth. Close your lips firmly around
horizontal the mouthpiece. Don’t bite the mouthpiece. Don’t block the air holes on
the side of the mouthpiece.
Take one quick, deep breath in through the mouthpiece. Hold this
breath for a few seconds.
Remove the Diskhaler from your mouth.
Carry on holding your breath for a few more seconds or as long as is
comfortable.
To prepare the next blister (the second part of your dose)
STEP 8:
Pull the white tray out as far as it will go (don’t remove it completely), then
push it back in again. This will turn the wheel so the next blister will appear.
Repeat if necessary until a full blister is positioned under the piercing
needle.
Repeat steps 6 and 7 to inhale the medicine.
STEP 9:
After you’ve inhaled the full dose (normally two blisters):
Wipe the mouthpiece with a tissue and replace the blue cover. It’s
important to keep the Diskhaler clean.
To replace the Rotadisk
STEP 10:
When all four blisters are empty, remove the Rotadisk from the Diskhaler
and insert a new one, using steps 1 to 5.

Storage
- Don’t store Relenza above 30 °C.

Rectum
Suppositories
Suppositories are sensitive to changes in ambient temperature, which can affect handling and
ease of insertion. They can soften in hot weather. To cool and harden the wrapped suppository,
refrigerate for a few minutes or place under cold water. In cold weather, wrapped suppositories
can be warmed in the hands for a minute or so.(14)
Wash your hand thoroughly with soap and water.
If the suppository is soft, hold it under cool water or place it

in a refrigerator for a few minutes to harden it before
removing the wrapper.
Remove the wrapper, if present.
If you were told to use half of the suppository, cut it

lengthwise with a clean, single-edge razor blade.
Put on a finger cot or disposable glove, if desired (available

at a pharmacy).

Lubricate the suppository tip with a water-soluble lubricant
such as K-Y Jelly, not petroleum (Vaseline). If you do not
have this lubricant, moisten your rectal area with cool tap
water.
Lie on your side with your lower leg straightened out and
your upper leg bent forward toward your stomach.
Lift upper buttock to expose the rectal area.
Insert the suppository, pointed end first, with your finger

until it passes the muscular sphincter of the rectum, about
1-2cm in infants and 2-3cm in adults. (if not inserted past
this sphincter, the suppository may pop out.)
Lower the leg, press the buttocks together and roll over
onto the stomach.

Remain lying down for about 5 minutes to allow the
suppository to dissolve in the rectum and to avoid having
the suppository come out.
Resist the urge to expel the suppository.
Discard used materials and wash your hands thoroughly

with soap and water.

Enema
Enemas are liquid rectal preparations that are sometimes administered using an enema syringe,
in a similar way to suppositories(14)
- Lie on one side with the lower leg straight and pull the upper leg towards the stomach.
- Lubricate the enema tip or nozzle with a small amount of the enema liquid.
- Insert the enema tip gently, approximately 3cm into the rectum.
- Squeeze the enema gently, allowing the solution to flow into the rectum slowly, until all
the liquid is expelled.
- Keep the chamber compressed while withdrawing the empty enema container (to
prevent liquid being drawn back into the container).
- Lower the legs, press the buttocks together and roll over onto the stomach, remaining
still for a few minutes to prevent the medicine from leaking out.
- Retain the liquid in the rectum for as long as possible before opening the bowel.

Pentasa enema (Mesalazine 1 g/100 ml enema)
- Each bottle contains 100 ml of a colorless to faint yellow suspension containing 1 g
mesalazine (mesalamine).
Indication Dosage
Treatment of acute Child 12 -17 years, 1 g once daily, dose to be administered at

attack of mild to bedtime.
moderate ulcerative
colitis affecting the
rectosigmoid region
Treatment of acute Adult, 1 g once daily, dose to be administered at bedtime.

attack of mild to
moderate ulcerative
colitis or maintenance of
remission
- Different brands of mesalazine are not interchangeable due to differences in formulation

and release characteristics.(2)
For adult use only, not recommended in children.
Immediately before use, take the enema bottle out of the

aluminium foil pack and shake it well.

To break the seal, twist the nozzle clockwise one full turn (the
nozzle should then be in the same direction as before turning).
Put your hand in one of the plastic disposal bags provided in

the pack.
Hold the container as shown in the picture.
To administer the enema, lie on your left side with the left leg
straight and the right leg bent forward for balance. Carefully
insert the applicator tip into the rectum. Maintain sufficient
steady hand pressure while dispersing the bottle content. The
bottle content should be applied within max. 30-40 seconds.
Once the bottle is empty, withdraw the tip with the bottle still
compressed.
The enema should be retained in the bowel. Remain relaxed

in the administration position for 5-10 minutes or until the
urge to pass the enema has disappeared.

Roll the plastic disposal bag over the empty bottle. Discard it
and wash your hands.
- Note: Pentasa Mesalazine may cause permanent staining on contact with clothing or
fabrics.
- Contraindicated in patients with known hypersensitivity to salicylates or any of the
excipients.(6)
- Contraindicated in patients with severe liver and/or renal impairment.(6)
- Patients receiving aminosalicylates, and their carers, should be advised to report any
unexplained bleeding, bruising, purpura, sore throat, fever or malaise that occurs during
treatment.(10)
Storage

Rivaroxaban (Xarelto)
- 10 mg, 15 mg, 20 mg tablet
Indication Dosage
Prevention of VTE Adult, 10 mg once daily, starting 6–10 hours after surgery provided
after hip/knee hemostasis has been established. Continue for 2 weeks after knee
replacement replacement or 5 weeks after hip replacement.
Treatment of Adult, 15 mg twice daily for 3 weeks, then 20 mg once daily.

acute VTE and
prevention of
subsequent VTE
Prevention of Adult, 20 mg once daily.

emboli in AF
CrCl 30–49 mL/minute, adult, 15 mg once daily.
Switching From rivaroxaban to parenteral anticoagulant, give first dose of

anticoagulants parenteral anticoagulant when the next rivaroxaban dose would have
been due.
From rivaroxaban to warfarin, limited data. Give warfarin with
rivaroxaban until INR >2; use standard warfarin dose for the first 2 days,
then adjust dose according to INR. While both drugs are being taken,
check INR at least 24 hours after the previous rivaroxaban dose. See also
Practice points below.
From parenteral anticoagulant to rivaroxaban, start rivaroxaban within
the 2 hours before the due time of the next dose of parenteral
anticoagulant or when an infusion is stopped.
From warfarin to rivaroxaban
- Prevention of emboli in AF, stop warfarin and start rivaroxaban
when INR <3.
- Treatment of DVT, stop warfarin and start rivaroxaban when INR
<2.5.
- Renal impairment: Limited data, manufacturer recommends:

o CrCl <15 mL/minute, contraindicated.

o CrCl 15–30 mL/minute, contraindicated for AF or for treatment of VTE (and
prevention of subsequent VTE); use with caution for prevention of VTE after
surgery.
o CrCl 30–49 mL/minute, reduce dose for AF. Use with caution if taking drugs that
may increase rivaroxaban concentration.
- Manufacturer contraindicates use in pregnancy, breastfeeding.
- Contraindicated in severe active bleeding or disease states with an increased risk of
severe bleeding, e.g. severe uncontrolled hypertension, severe thrombocytopenia,
bleeding disorders and severe renal impairment.
- Administer doses ≥15 mg with food; doses of 2.5 mg and 10 mg may be administered
without regard to meals. For nonvalvular atrial fibrillation, administer with the evening
meal.
- For patients who cannot swallow whole tablets, the tablets may be crushed and mixed
with applesauce immediately prior to use; immediately follow administration of the 15
mg and 20 mg tablets with food (2.5 mg and 10 mg tablets may be administered without
regard to food).
- Missed doses:
o Patients receiving 15 mg twice daily dosing who miss a dose should take a dose
immediately to ensure 30 mg of rivaroxaban is administered per day (two 15 mg
tablets may be taken together); resume therapy the following day as previously
taken.
o Patients receiving 2.5 mg twice daily who miss a dose should take a single 2.5 mg
dose at the next scheduled time; then resume therapy as usual.
o Patients receiving once-daily dosing who miss a dose should take a dose as soon
as possible on the same day; resume therapy the following day as previously taken.
Adverse effects
feces.(2)
- Side effects may include serious, life-threatening bleeding, syncope, pruritus, extremity
pain, and muscle spasms.(4)
- Advise patient who has received neuraxial anesthesia or spinal puncture to immediately
report symptoms of epidural or spinal hematoma, such as back pain, tingling, numbness,
muscle weakness, and stool or urine incontinence.(4)

medicine.

Scabies
Scabies
Scabies can be defined as a pruritic skin condition caused by the mite Sarcoptes scabiei. It is easily
missed or misdiagnosed as dermatitis. The diagnostic burrows are small and scratching often
makes them difficult to see.(15)
Scabies usually is passed by direct, prolonged skin-to-skin contact with an infected person.
However, a person with crusted (Norwegian) scabies can spread the infestation by brief skin-to-
skin contact or by exposure to bedding, clothing, or even furniture that he/she has used.(56)
Mating occurs on the skin surface after which the female mite burrows into the stratum corneum
to lay eggs. The fecal pellets she leaves in the burrow cause a local hypersensitivity reaction and
is assumed to cause the release of inflammatory mediators that trigger an allergic reaction
invoking intense itching. This normally takes 15 to 20 days in a primary infestation but can take
up to 6 weeks to develop. In subsequent infestations this hypersensitivity reaction develops
much more quickly. During the asymptomatic period the mite can be passed onto others
unknowingly. The eggs hatch and mature in 14 days after which the cycle can begin again. (15)
The affected person, all household/family members and close contacts should be treated at the
same time to avoid reinfestation and further transmission. Even contacts who do not have any
symptoms need to be treated.(2)
Treatment
The efficacy and safety of scabicidal agents is difficult to determine due to limited trial data.
Benzyl benzoate, crotamiton, permethrin and malathion have all been used. A 2007 Cochrane
review found permethrin to have high cure rates and be more effective than any other scabicidal
agent.(15)
The efficacy of malathion is questionable, as no randomized controlled trials appear to have been
conducted. However, case reports have suggested malathion is effective in curing scabies, with
a cure rate of approximately 80%.(15)
Benzyl benzoate has been used to treat scabies for many years. However, its efficacy has not
been demonstrated in randomized controlled trials. In uncontrolled trials benzyl benzoate has
been shown to provide cure rates of approximately 50%.(15) It commonly cause irritation when
first applied; it should be diluted for use in children but this reduces efficacy.(2)
Crusted (Norwegian) scabies is a rare but severe and highly contagious form;
immunocompromised or incapacitated patients are more susceptible. Combination treatment
with ivermectin, a topical scabicide and a keratolytic may be required; seek specialist advice.(2)

Improvement usually occurs within 1 or 2 days of treatment.(2)
The itch and eczema of scabies persists for some weeks after the infestation has been eliminated
and treatment of pruritus and eczema may be required. Application of crotamiton can be used
to control itching after treatment with more effective acaricides. A topical corticosteroid may
help to reduce itch and inflammation after scabies has been treated successfully; however,
persistent symptoms suggest that scabies eradication was not successful. Oral administration of
a sedating antihistamine at night may also be helpful.(10)
Secondary bacterial infection is a common complication in scabies due to disruption of the
epidermal barrier caused by excoriations. Treat with systemic antibiotics which covers gram
positive organism for a minimum of 7 days. The timing of antibiotic commencement depends on
the condition of the patient; it can be started concurrently with scabicides or delayed for 48 hours
to allow partial healing of the erosions. Use antiseptic soaks/bath e.g. KMnO 4 (1:10,000) in
impetiginized scabies. Topical antibiotic is not indicated in patients who are already treated with
systemic antibiotics.(57)
Repeat visits 2 weeks and 4 weeks after initial treatment are recommended. Patients should be
reviewed again at the end of one month to ensure that he/she is cured from scabies. This is the
length of time taken for lesions to heal and in case where there is inadequate treatment, for
residual eggs and mites to reach maturity causing symptoms to reappear. Patients can be re-
treated if necessary.(57)
Some causes of treatment failure include incorrect application, reinfestation from untreated
contacts, poor penetration of drug into hyperkeratotic skin and drug resistance (resistance to
ivermectin has been reported after repeated use).(2)
Counseling points
Although acaricides have traditionally been applied after a hot bath, this is not necessary and
there is even evidence that a hot bath may increase absorption into the blood, removing them
from their site of action on the skin.(10)
Treatment should be applied to clean, cool, dry skin from the chin down. Also apply to the scalp,
neck, face and ears in children < 2 years, elderly or immunocompromised people, people who
have had treatment failure or with atypical or crusted scabies. Remember to also apply between
fingers and toes, under nails, in skin folds, to belly button, between the buttocks and to groin
area. If the hands or any other body part are washed during the treatment period, reapply the
lotion/cream to the washed areas.(2)
It is now recommended that malathion and permethrin should be applied twice, one week apart;
in the case of benzyl benzoate in adults, up to 3 applications on consecutive days may be needed.

Patients with hyperkeratotic scabies may require 2 or 3 applications of acaricide on consecutive
days to ensure that enough penetrate the skin curst to kill all the mites.(10)
Soft toys, bed linen and clothing that has been in contact with the person in the previous 48-72
hours should be washed and dried on hot machine settings the morning after each treatment or
stored in tightly sealed plastic bags for several days to a week (at least 3 days).(2) Scabies mites
generally do not survive more than 2 to 3 days away from human skin.(56)
Rooms used by a patient with crusted scabies should be thoroughly cleaned and vacuumed after
use. Environmental disinfestation using pesticide sprays or fogs generally is unnecessary and is
discouraged.(56)
School leave or medical leave to patients for proper administration of medication and reduce risk
of transmission to others (as patients remains infective 24 hours after application). The school
should be notified of the case, and parents of other children who may have been exposed to
scabies should be notified by letter from the school. Mass screening of school contacts is not
useful, as it is quite possible to be infected without having signs or symptoms.(57)

Crotamiton 10% cream
Indication Dosage
Scabies Child and adult, apply from the chin down once a day for 2-5 days; do not wash
off until next application is due.
Also apply to the scalp, neck, face and ears in children <2 years, elderly or
immunocompromised people, people who have had treatment failure or those
with atypical or crusted scabies.
Itch Child and adult, apply 2 or 3 times a day.
- BNF recommendation in pruritus (including pruritus after scabies):(10)

o Child 1 month-2 years (on doctor’s advice only), apply once daily.
o Child 3-17 years, apply 2-3 times a day.
o Adult, apply 2-3 times a day.
- Avoid use in buccal mucosa; avoid use near eyes; avoid use on broken skin; avoid use on
very inflamed skin; use on doctor’s advice for children under 3 years..(10)
Pruritus, Apply to the affected area 2-3 times daily. Crotamiton 10% cream will provide relief
from irritation for 6 to 10 hours after each application.(6)
Scabies, After the patient has taken a warm bath, the skin should be well dried and crotamiton
10% cream rubbed into the entire body surface (excluding the face and scalp) until no traces of
preparation remain visible on the surface. The application should be repeated once daily,
preferably in the evening, for a total of 3-5 days. Depending on the response, special attention
should be paid to sites that are particularly susceptible to infestation by the mites (e.g. interdigital
spaces, wrists, axillae and genitalia). Areas where there is pus formation should be covered with
a dressing impregnated with crotamiton 10% cream. While the treatment is in progress, the
patient may take a bath shortly before the next application. After completion of the treatment,
a cleansing bath should be taken followed by a change of bed linen and underclothing.(6)
Pregnancy
Manufacturer advises avoid, especially during the first trimester – no information available.(10)
AMH suggests safe to use.(2)

Breastfeeding
No information available; avoid application to nipple area.(10)
AMH suggests safe to use; wash from nipples before breastfeeding and reapply afterwards.(2)
Adverse effect
Instruct patient to report severe skin irritation.(4)
Practice points(2)
- Other more effective agents, e.g. permethrin 5%, are preferred for eradicating scabies.
- The mechanisms of the scabicidal and antipruritic actions of crotamiton are not known.(4)
- Claims of crotamiton’s antipruritic activity are based largely on uncontrolled studies.

Emulsion Benzyl Benzoate 25%
Dosage for scabies(2, 10, 58)
Reference Dosage
Australian Adult, apply undiluted.

Medicines
Child <12 years, dilute with an equal quantity of water.
Handbook
Infant, dilute with 3 parts of water.
Test on small area of skin for 10 minutes before using. If excessive stinging occurs:
- for adults, dilute with an equal quantity of water, then retest before using
- for children and infants, use an alternative agent (efficacy reduced by
further dilution).
Apply from chin down and wash off 24 hours later. Repeat after 5 days (reduces
possibility of treatment failure).
Also apply to the scalp, neck, face and ears in children <2 years, elderly or
immunocompromised people, people who have had treatment failure or those
with atypical or crusted scabies.
Avoid contact with eyes, mouth and inside your nose.
British Adult, apply over the whole body; repeat without bathing on the following day
National and wash off 24 hours later; a third application may be required in some cases.
Formulary
Avoid contact with eyes and mucous membranes; children (not recommended);
do not use on broken or secondarily infected skin.
Some manufacturers recommend application to the body but to exclude the head
and neck. However, application should be extended to the scalp, neck, face and
ears. Note – dilution to reduce irritant effect also reduces efficacy.
Martindale A 25% emulsion is applied to the whole body, usually from the neck down. If the
application is thorough, one treatment may suffice, although the possibility of
failure is lessened by a second application within 5 days. Alternatively, three
applications at 12-hour intervals, without bathing, may be made, following by
bathing 12 hour after the last application.

Reference Dosage
Malaysia Benzyl benzoate 10-25%(57)

Clinical
- Rinse off after 24 hours then reapply. To be kept on the skin surface
Practice
continuously for 24 hours for 2-3 days (with baths taken between each
Guideline
application).
- Contraindicated in pregnant and breastfeeding women and infants less
than 2 years.
Pregnancy
Although no problems have been documented with benzyl benzoate in humans, permethrin is
preferred.(2)
Breastfeeding
AMH – Data lacking, permethrin preferred.(2)
BNF – Suspend feeding until product has been washed off.(10)
Adverse effects(2)
- Common (>1%), stinging, burning sensation (usually transient)
- Infrequent (0.1–1%), itch and dermatitis
- Rare (<0.1%), CNS stimulation, e.g. seizures (excessive use), allergic reaction
Practice points(2)
- Traditionally applied after a hot bath, but this is unnecessary and may increase
transdermal absorption (removes drug from site of action and increases risk of systemic
toxicity).
- Application to the face and genitals is irritant; an alternative agent may be preferable.
- Although benzyl benzoate is marketed for treatment of body lice, other agents are
preferred.
- Effective & inexpensive. Compliance is an issue.(57)

Gamma Benzene Hexachloride (Lindane) 1% lotion
Lindane lotion has been discontinued in the US for more than 1 year. It is not recommended for
first line-treatment; use should be reserved for patients who are intolerant to or have failed first-
line agents. Although FDA approved, lindane is not recommended as a treatment option for head
lice or scabies in pediatric patients <50 kg due to safety concerns and use should be avoided if
possible. Use in pregnant women has been associated with neural tube defects and mental
retardation. Nursing mother should interrupt breastfeeding, express and discard milk for at least
24 hours following use. In addition, skin-to-skin contact between the infant and affected area
should be avoided.(12)
It is also not used in UK or Australia. Resistance to lindane has been reported.(57)

Although FDA approved, lindane is not recommended as a treatment option for head lice or
scabies in pediatric patients <50 kg due to safety concerns and use should be avoided if possible.
Indication Dosage
Scabies Wait at least 1 hour after bathing or showering (wet or warm skin increases
absorption). Skin should be clean and free of any other lotions, creams, or oil prior
to lindane application. Apply a thin layer of lotion and massage it on dry, cool skin
from the neck to the toes; do not apply to face or eyes. Do not use on open
wounds or sores. Do not use occlusive dressings. After 8-12 hours, bathe and
remove the drug; most patients will require 30 ml; larger adults may require up to
60 ml. Do not retreat. Do not leave on for more than 12 hours. CDC STD guidelines
recommend an 8-hour application.
Head lice, Wait at least 1 hour after washing hair before applying lindane shampoo. Hair
crab lice should be washed with a shampoo not containing a conditioner, hair and skin of
head and neck should be free of any lotions, oils or creams prior to lindane
application. Apply shampoo to clean, dry hair and massage into hair for 4 minutes;
add small quantities of water to hair until lather forms, then rinse hair thoroughly
and comb with a fine-tooth comb to remove nits. Do not cover with shower cap
or towel. Amount of shampoo needed is based on length and density of hair; most
patients will require 30 ml (maximum: 60 ml). Do not retreat.
- Shake well prior to use. For topical use only; never administer orally. Caregivers should
apply with gloves (avoid natural latex; may be permeable to lindane). Rinse off with warm
(not hot) water.(12)
- Keep away from eyes and mouth; do not use in presence of open wounds, cuts or sores.(4)

- Instruct patient to apply lotion to clean skin free of cream, lotion or oil, as these products
can increase the risk of neurotoxicity.(4)
- A toothbrush may be used to apply lotion under fingernails; immediately wrap
toothbrush in paper and dispose of in trash.(4)
- All recently worn clothing and used linens should be washed in very hot water or dry
cleaned.(4)
- Inform patient that itching occurs after the successful killing of scabies and is not
necessarily and indication for retreatment with lindane.
- Seizures and deaths have been reported with use (may occur with prolonged, repeated
or single use). Use is contraindicated in patients with uncontrolled seizure disorders and
in premature infants. Use with caution in infants, small children, the elderly, patients with
other skin conditions, patients weighing <50 kg, or patients with a history of seizures,
head trauma, or HIV infection; use caution with conditions which may increase risk of
seizures or medications which decrease seizure threshold.
- Lindane is contraindicated in premature infants; the skin of premature infants may be
more permeable and their liver enzymes may not be fully developed when compared to
full-term infants.
- Use in pregnant women has been associated with neural tube defects and mental
retardation.
- Nursing mother should interrupt breastfeeding, express and discard milk for at least 24
hours following use. In addition, skin-to-skin contact between the infant and affected
area should be avoided.

Permethrin 5% cream/lotion
Indication Dosage
Scabies Infants ≥2 months, children, adolescents and adult, thoroughly massage

(30 g for average adult) from head to soles of feet; leave on for 8 to 14
hours before removing (shower or bath); for infants and the elderly, also
apply on the hairline, neck, scalp, temple and forehead; may repeat if
living mites are observed 14 days after first treatment; one application is
generally curative.
Both AMH and BNF suggest to repeat after 7 days.(2, 10)
- Tell patient to wash clothes, bedding and personal items in hot, soapy water to prevent
reinfection.(4)
Avoid contact with eyes and mucous membranes during application. Because scabies and lice are
so contagious, use caution to avoid spreading or infecting oneself; wear gloves when applying.
Apply to skin from to soles of feet. Remove after 8 to 14 hours (shower or bath).(12)
Pregnancy
Adverse effects have not been observed in oral animal reproduction studies. The amount of
permethrin available systemically following topical application is ≤2%. The CDC considers the use
of permethrin or pyrethrins with piperonyl butoxide the dugs of choice for the treatment of pubic
lice during pregnancy; permethrin is preferred treatment of scabies during pregnancy.(12)
Breastfeeding
Permethrin is present in breastmilk following environmental exposure (e.g., exposure to
pyrethroids used for agriculture or malaria control). It is not known if permethrin is present in
breast milk following topical administration for the treatment of scabies or lice. Permethrin
exhibits minimal systemic absorption following topical administration (≤2% of applied amount)
and any absorbed drug is rapidly metabolized to inactive metabolites. Therefore, breastfeeding
is not expected to result in significant exposure to a breastfed child. Although the manufacturer
recommends against breastfeeding during therapy, permethrin is considered to be a drug of

choice for the treatment of pubic lice and crusted scabies in patients who are breastfeeding a
child (CDC [Workowski 2015]).(12)
Adverse effects
This drug may cause or exacerbate pruritus, edema and erythema. Drug may also cause stinging
or burning of skin.(4)
Storage
Store at room temperature 20°C to 25°C.(12)

Skin – bacterial skin infections
Antibacterial preparations
Cellulitis, erysipelas and leg ulcer infections require systemic antibacterial treatment.(10)
In the community, acute impetigo on small areas of the skin may be treated by short-term topical
application of fusidic acid; mupirocin should be used only to treat methicillin-resistant
Staphylococcus aureus. If the impetigo is extensive or longstanding, an oral antibacterial such
as flucloxacillin (or clarithromycin in penicillin allergy) should be used. Mild antiseptics can be
used to soften crusts.(10)
Although many antibacterial drugs are available in topical preparations, some are potentially
hazardous and frequently their use is not necessary if adequate hygienic measures can be taken.
Moreover, not all skin conditions that are oozing, crusted, or characterized by pustules are
actually infected.(10)
To minimize the development of resistant organisms it is advisable to limit the choice of
antibacterial applied topically to those not used systemically. Unfortunately, some of these, for
example neomycin sulfate, may cause sensitization, and there is cross-sensitivity with other
aminoglycoside antibiotics, such as gentamicin. If large areas of skin are being treated,
ototoxicity may also be a hazard with aminoglycoside antibiotics, particularly in children, in the
elderly, and in those with renal impairment. Resistant organisms are more common in hospitals,
and whenever possible swabs should be taken for bacteriological examination before beginning
treatment.(10)
Mupirocin is not related to any other antibacterial in use; it is effective for skin infections,
particularly those due to Gram-positive organisms but it is not indicated for pseudomonal
infection. Although Staphylococcus aureus strains with low-level resistance to mupirocin are
emerging, it is generally useful in infections resistant to other antibacterial. To avoid the
development of resistance, mupirocin or fusidic acid should not be used for longer than 10 days
and local microbiology advice should be sought before using it in hospital. In the presence of
mupirocin-resistant MRSA infection, a topical antiseptic such as povidone-iodine, chlorhexidine,
or alcohol can be used; their use should be discussed with the local microbiologist.(10)
Tedizolid is licensed for the treatment of acute bacterial skin and skin structure infections.(10)
Silver sulfadiazine is used in the treatment of infected burns.(10)
Antibacterial preparations also used systemically

Fusidic acid is a narrow-spectrum antibacterial used for staphylococcal infections. Fusidic
acid has a role in the treatment of impetigo.(10)

An ointment containing fusidic acid is used in the fissures of angular cheilitis when associated
with staphylococcal infection.(10)
Metronidazole is used topically for rosacea and to reduce the odor associated with anaerobic
infections; oral metronidazole is used to treat wounds infected with anaerobic bacteria.(10)

Fusidic acid 2% cream/ointment
Indication and dosage(2, 10)
Indication Dosage
Staphylococcal skin infection (on specialist AMH, adult and child, apply 2 or 3 times daily
advice if other options unsuitable) for 7 days. If using a protective dressing, apply
once daily.
BNF, child, apply 3-4 times a day, usually for 7
days; adult, apply 3-4 times a day.
Adverse effects(2)
- Infrequent (0.1–1%), rash, contact dermatitis, itch, erythema, burning, irritation
- Rare (<0.1%), hypersensitivity reactions, e.g. angioedema, urticaria
Counseling points
Avoid contact with eyes.(2)
Practice points
To avoid the development of resistance, fusidic acid should not be used for longer than 10 days
and local microbiology should be sought before using it in hospital.(10)
Studies comparing topical sodium fusidate with mupirocin show no significant difference in
efficacy in staphylococcal skin infections; mupirocin is preferred for mild impetigo.(2)

Metronidazole 0.75% gel
Indication Dosage
Rosacea Rub a thin film into affected areas twice a day.
Fungating wounds Apply to affected area 1 or 2 times a day when

dressing is changed.
Adverse effects
Side effects may include local reactions (dryness, scaling, pruritus, stinging, burning) or contact
dermatitis. Face exposure may cause conjunctivitis and eye irritation.(4)
Counseling points
Rosacea: apply to clean, dry skin. Avoid eye area.(2)
Practice points
Rosacea should improve within 2–4 weeks; continue treatment for 6–12 weeks; long-term
treatment may be needed.(2)
Oral or topical metronidazole is used to reduce unpleasant odor of fungating wounds; treatment
may need to be prolonged as odor usually returns after treatment is stopped; topical
metronidazole is more expensive.(2)

Mupirocin 2% cream/ointment
Indication Dosage
Bacterial skin infections, particularly those Child and adult, apply up to 3 times a day for
caused by Gram-positive organisms (except up to 10 days.
pseudomonal infection)
* Bactroban® cream not recommended for
use in children under 1 year.
Adverse effects
Side effects may include burning, stinging, pain, dry skin, swelling or tenderness.(4)
Advise patient to report irritation, severe itching or rash.(4)
Counseling points
Avoid contact with eyes and mouth.(2)
Tell patient to contact a healthcare professional if condition has not improved after 3 to 5 days.(4)
Children with impetigo should be kept home until appropriate treatment is started. Sores on
exposed surfaces must be covered with a watertight dressing when the child returns to school or
child care.(2)
Practice points
To avoid the development of resistance, mupirocin should not be used for longer than 10 days
and local microbiology should be sought before using it in hospital.(10)
In the presence of mupirocin-resistant MRSA infection, a topical antiseptic such as povidone-
iodine, chlorhexidine, or alcohol can be used; their use should be discussed with the local
microbiologist.(10)

Neomycin sulfate 0.5% w/w cream
Indication Dosage
Bacterial skin infections Child and adult, apply up to 3 times a day, for
short-term use.
Contraindicated in neonates.
Adverse effects
If larges areas of skin are being treated, ototoxicity may be a hazard, particularly children and
elderly and in those with renal impairment.(10)
Frequency not known, sensitization (cross sensitivity with other aminoglycosides may occur).(10)

Silver sulfadiazine 1% cream
Indication Dosage
Prevention and treatment of infection in Adult, child >2 months, apply a 3-5mm thick
severe burns layer once a day, or more frequently if needed
(e.g. with large volume exudate).
Treatment of infection in leg ulcers and
pressure sores
Apply under sterile conditions
Burn areas should be covered at all times with cream; reapply whenever necessary.
Reapply immediately after hydrotherapy.
Dressings are not required but may be used.
Adverse effects
This drug may cause pruritus or skin irritation.(4)
G6PD deficiency – increases risk of hemolysis.(2)
Systemic adverse effects of sulfadiazine or propylene glycol may occur if applied to large areas
or to extensive burns. Silver toxicity may also occur if applied to large areas or over prolonged
periods.(2)
Leucopenia developing 2–3 days after starting treatment of burns patients is reported usually to
be self-limiting and silver sulfadiazine need not usually be discontinued provided blood counts
are monitored carefully to ensure return to normality within a few days.(10)
Pregnancy
Avoid use during last month of pregnancy if possible because of the theoretical risk of
kernicterus, jaundice and hemolytic anemia in the neonate.(2)
Counseling points

Tell patient to avoid using this medicine on newborn infants under 2 months of age.(4)
Advise patient to apply drug to skin only. Patients should avoid exposure of cream to the eyes.(4)
Instruct patient on proper skin or wound preparation prior to application of drug.(4)
Practice points(2)
Silver dressings are generally preferred to silver sulfadiazine cream for burns because they
require less frequent dressing changes.
Prolonged use of silver sulfadiazine can delay healing of superficial or partial thickness burns;
limit use for the prevention of infection to the first 3 days after the burn.
Silver sulfadiazine may inactivate enzymatic debriding agents.
Contraindicated in preterm infants and in babies <2 months of age due to the possibility of
kernicterus.
Serious allergic reaction to sulfonamides—contraindicated.

Skin – fungal skin infections
Antifungal preparations
Most localized fungal infections are treated with topical preparations. To prevent relapse, local
antifungal treatment should be continued for 1-2 weeks after the disappearance of all signs of all
infection. Systemic therapy is necessary for scalp infection or if the skin infection is widespread,
disseminated, or intractable; although topical therapy may be used to treat some nail infections,
systemic therapy is more effective. Skin scrapings should be examined if systemic therapy is being
considered or where there is doubt about the diagnosis.(10)
Dermatophytoses
Ringworm infection can affect the scalp (tinea capitis), body (tinea corporis), groin (tinea cruris),
hand (tinea manuum), foot (tinea pedis, athlete’s foot) or nail (tinea unguium). Scalp infection
requires systemic treatment; additional application of a topical antifungal, during the early stages
of treatment, may reduce the risk of transmission. A topical antifungal can also be used to treat
asymptomatic carriers of scalp ringworm. Most other local ringworm infections can be treated
adequately with topical antifungal preparations (including shampoos). The imidazole antifungals
clotrimazole, econazole nitrate, ketoconazole, and miconazole are all effective. Terbinafine
cream is also effective but it is more expensive. Other topical antifungals include griseofulvin and
the undecenoates. Compound benzoic acid ointment (Whitfield’s ointment) has been used for
ringworm infections but it is cosmetically less acceptable than proprietary preparations. Topical
preparations for athlete’s foot containing tolnaftate are on sale to the public.(10)
Antifungal dusting powders are of little therapeutic value in the treatment of fungal skin
infections and may cause skin irritation; they may have some role in preventing reinfection.(10)
In management of tinea, good personal hygiene is an important adjunct to antifungal treatment,
e.g. drying between toes, using a separate towel for infected area, wearing thongs in public
showers and change rooms, changing socks (preferably cotton) daily, avoiding sharing combs,
hats and towels. Discard old shoes that may have a high density of fungal spores. Family members
should be evaluated for asymptomatic carriage, particularly if infection is persistent or
recurrent.(2)
Antifungal treatment may not be necessary in asymptomatic patients with tinea infection of the
nails. If treatment is necessary, a systemic antifungal is more effective than topical therapy.
However, topical application of amorolfine or tioconazole may be useful for treating early
onychomycosis when involvement is limited to mild distal disease, or for superficial white
onychomycosis, or where there are contra-indications to systemic therapy.(10)

Pityriasis versicolor
Pityriasis (tinea) versicolor can be treated with ketoconazole shampoo. Alternatively, selenium
sulfide shampoo [unlicensed indication] can be used as a lotion (diluting with a small amount of
water can reduce irritation) and left on the affected area for 10 minutes before rinsing off; it
should be applied once daily for 7 days, and the course repeated if necessary.(10)
Topical imidazole antifungals such as clotrimazole, econazole nitrate, ketoconazole, and
miconazole, or topical terbinafine are alternatives, but large quantities may be required.(10)
If topical therapy fails, or if the infection is widespread, pityriasis versicolor is treated systemically
with a triazole antifungal. Relapse is common, especially in the immunocompromised.(10)
Candidiasis
Candidal skin infections can be treated with a topical imidazole antifungal, such as clotrimazole,
econazole nitrate, ketoconazole, or miconazole; topical terbinafine is an alternative. Topical
application of nystatin is also effective for candidiasis but it is ineffective against
dermatophytosis. Refractory candidiasis requires systemic treatment generally with a triazole
such as fluconazole; systemic treatment with terbinafine is not appropriate for refractory
candidiasis.(10)
In management of cutaneous candidiasis, give advice about good hygiene, keeping the skin as
clean and dry as possible (particularly the groin, armpits and skin folds) and avoiding occlusion.(2)
Angular cheilitis
Miconazole cream is used in the fissures of angular cheilitis when associated with Candida.(10)
Compound topical preparations

Combination of an imidazole and a mild corticosteroid (such as hydrocortisone 1%) may be of
value in the treatment of eczematous intertrigo and, in the first few days only, of a severely
inflamed patch of ringworm.(10)
Combination of a mild corticosteroid with either an imidazole or nystatin may be of use in the
treatment of intertrigo associated with candida.(10)

Azoles (skin)
Medication Indication Dosage
Clotrimazole 1% cream Fungal skin infections Child and adult, apply 2-3 times a day.
Econazole nitrate 1% Fungal skin infections Child and adult, apply twice daily.
cream
Fungal nail infections Child and adult, apply once daily, applied
occlusive dressing.
Ketoconazole 2% cream Tinea pedis Adult, apply twice daily.
Fungal skin infections Adult, apply 1-2 times a day.

(not Tinea pedis)
Miconazole 2% cream Fugal skin infections Child and adult, apply twice daily
continuing for 10 days lesions have healed.
Fungal nail infections Child and adult, apply 1-2 times a day.
Adverse effects(2)
Topical azoles are generally well tolerated.
- Infrequent (0.1-1%), burning, stinging, itch, erythema
- Rare (<0.1%), allergic reactions
Counseling points
- Apply a thin layer to the affected skin and surrounding area; pay particular attention to
skin folds.(2)
- Avoid contact with eyes and mucous membranes.(10)
- For this treatment to be successful, you have to use it regularly.(2)
- Continue using the treatment for 2 weeks after symptoms have gone.(2)
Practice points(2)
- Topical azoles alone are not usually successful in treating infections of the nails or hair.
- Intractable candidiasis may be the presenting symptom of undiagnosed diabetes;
consider this possibility in patients not responding to treatment.

Amorolfine 5% nail lacquer (Loceryl)
Indication Dosage
Fungal nail infections Child 12-17 years and adult, apply 1-2 times a week for 6 months to
treat finger nails and for toe nails 9-12 months (review at intervals
of 3 months), apply to infected nails after filing and cleansing, allow
to dry for approximately 3 minutes.
* Not licensed for use in children under 12 years.
Step 1: File the nail

Before the first application, file down the infected areas of nail, including
the nail surface, as much as possible using the nail file provided.
CAUTION: Do not use nail files used for infected nails on healthy nails,
otherwise you may spread the infection. To prevent the spread of
infection, take care that no one else uses the files from your kit.
Step 2: Clean the nail

Use one of the swabs provided to clean the nail surface. Repeat steps 1
and 2 for each affected nail.
Step 3: Take some lacquer from the bottle

Dip the applicator into the bottle of nail lacquer. The lacquer must not be
wiped off on the edge of the bottle before it is applied.
Step 4: Apply the lacquer

Apply the nail lacquer evenly over the entire surface of the nail. Repeat
steps 3 and 4 for each affected nail.

Step 5: Allow to dry
Let the treated nail(s) dry for approximately 3 minutes. Wait at least 10
minutes applying cosmetic nail varnish.
Step 6: Clean the applicator

The applicator provided is re-usable. However, it is important to clean it
thoroughly after completing each treatment procedure, using the same
swab you used for nail cleansing. Avoid touching newly treated nails with
swab.
Close the nail lacquer bottle tightly. Dispose of the swab carefully as it is
inflammable.
Step 7:
Before using Loceryl again, first remove the old lacquer from your nails
using a swab, then file down the nails again if necessary. Re-apply the
lacquer as described above.
When dry, the nail lacquer is unaffected by soap and water, so you may
wash your hands and feet as normal. If you need to use chemicals such as
paint thinners or white spirit, rubber or other impermeable (waterproof)
gloves should be worn to protect the lacquer on your fingernails.
It is important to carry on using Loceryl until the infection has cleared and
healthy nails have grown back. This usually takes 6 months for finger nails
and 9 to 12 months for toe nails. Your doctor will probably check how your
treatment is progressing every 3 months or so.
Adverse effects(2)
- Infrequent (0.1–1%), erythema, itch, burning
- Rare (<0.1%), allergic contact dermatitis
- Before first application, thoroughly file down, then clean and degrease the affected areas
of nail using the cleaning pad provided. Apply the lacquer to the entire surface of the
affected nails and allow to dry.

- Before repeat application, file affected nails as required and clean to remove any
remaining lacquer.
- If working with organic solvents, wear impermeable gloves to protect the lacquer or
reapply afterwards.
- Do not use cosmetic lacquers, artificial nails or occlusive dressings during treatment.
Practice points(2)
- Used for superficial and distal onychomycosis; not effective when the nail matrix is
involved.
- Penetrates the nail and remains there for several weeks.
- Limited data suggest the efficacy of once-weekly and twice-weekly application are similar.

Nystatin 100,000units/g Cream
Indication Dosage
Cutaneous candidiasis Apply liberally affected areas 2-4 times a day until infection resolved
(at least 14 days)
Adverse effects(2)
- Even after prolonged use, nystatin is virtually nontoxic, non-sensitizing and well tolerated
by all age groups.
- Rare (<0.1%), irritation, allergy.
Counseling points
- For this treatment to be successful you have to use it regularly.(2)
- Continue using the treatment for 2 weeks after symptoms have gone.(2)
Practice points(2)
- Symptomatic improvement usually occurs within 24–72 hours after starting treatment.
- Continue treatment of cutaneous candidal infections for at least 2 weeks after symptoms
resolve; additional courses may be necessary.
- Avoid occlusive dressings, especially in children, because they provide conditions that
favor growth of yeast and release of irritating endotoxin.
- In chronic paronychia, clinical and microbiological cure may require several months of
treatment; avoid wet work, trauma and irritants.

Skin – inflammatory skin conditions
Eczema
Eczema (dermatitis) has several causes, which may influence treatment. The main types of
eczema are irritant, allergic contact, atopic, venous and discoid; different types may co-exist.
Lichenification, due to scratching and rubbing may complicate any chronic eczema. Atopic
eczema is the most common type and is usually involves dry skin as well as infection and
lichenification.(10)
Management of eczema involves the removal or treatment of contributory factors including
occupational and domestic irritants. Known or suspected contact allergens should be avoided.
Rarely, ingredients in topical medicinal products may sensitize the skin.(10)
Potential triggers include:(2)
- Irritants, e.g. abrasive clothing, soaps/detergents (including bubble bath), raised
temperatures, sweating
- Allergens, e.g. preservatives, fragrances, lanolin, nickel, aeroallergens (e.g. house dust
mites, animal dander), foods (only avoid if confirmed by testing).
House dust mites may worsen eczema in patients who are allergic to them; reduction measures
(e.g. impermeable mattress covers) may be tried but achieving low levels of mites is difficult and
evidence that eczema is improved is conflicting.(2)
Treatment
Skin dryness and the consequent irritant eczema requires emollients applied regularly (at least
twice daily) and liberally to the affected area; this can be supplemented with bath or shower
emollients. The use of emollient use should continue even if the eczema improves or other
treatment is being used.(10) Although ointments are generally more effective than creams or
lotions, choice often depends on patient preference. Do not use moisturizers that contain sodium
lauryl sulfate (e.g. aqueous cream, emulsifying ointment) as they may worsen eczema by
damaging the skin barrier and causing irritation.(2)
Topical corticosteroids are also required in the management of eczema; the potency of the
corticosteroid should be appropriate to the severity and site of the condition. Mild
corticosteroids are generally used on the face and on flexures; potent corticosteroids are
generally required for use on adults with discoid or lichenified eczema or with eczema on the
scalp, limbs and trunk. Treatment should be reviewed regularly, especially if a potent
corticosteroid is required. In patients with frequent flares (2-3 per month), a topical
corticosteroid can be applied on 2 consecutive days each week to prevent further flares.(10)

Bandages (including those containing ichthammol with zinc oxide) are sometimes applied over
topical corticosteroids or emollients to treat eczema of the limbs. Dry-wrap dressings can be used
to provide a physical barrier to help prevent scratching and improve retention of emollients.(10)
Topical calcineurin inhibitors (e.g. pimecrolimus and tacrolimus) may be a useful alternative to
topical corticosteroids for patients who require treatment of sensitive areas (e.g. face). They are
best reserved for patients >2 years of age as there are some concerns about adverse effects in
infants.(2)
Infection
Bacterial infection (commonly with Staphylococcus aureus and occasionally with Streptococcus
pyogenes) can exacerbate eczema and requires treatment with topical or systemic antibacterial
drugs. Antibacterial drugs should be used in short courses (typically 1 week) to reduce the risk of
drug resistance or skin sensitization. Associated eczema is treated simultaneously with a topical
corticosteroid which can be combined with a topical antimicrobial.(10)
Eczema involving widespread or recurrent infection requires the use of a systemic antibacterial
that is active against the infecting organism. Products that combine an antiseptic with an
emollient application and with a bath emollient can also be used; antiseptic shampoos can be
used on the scalp.(10)
Intertriginous eczema commonly involves candida and bacteria; it is best treated with a mild or
moderately potent topical corticosteroid and a suitable antimicrobial drug.(10)
Widespread herpes simplex infection may complicate atopic eczema and treatment with a
systemic antiviral drug is indicated.(10)
Management of other features of eczema

Lichenification, which results from repeated scratching is treated initially with a potent
corticosteroid. Bandages containing ichthammol paste (to reduce pruritus) and other substances
such as zinc oxide can be applied over the corticosteroid or emollient. Coal tar and ichthammol
can be useful in some cases of chronic eczema.(10)
A non-sedating antihistamine may be of some value in relieving severe itching or urticaria
associated with eczema. A sedating antihistamine can be used if itching causes sleep
disturbance.(10)
Exudative (‘weeping’) eczema requires a potent corticosteroid initially; infection may also be
present and require specific treatment. Potassium permanganate solution (1 in 10,000) can be

used in exudating eczema for its antiseptic and astringent effects; treatment should be stopped
when exudation stops.(10)
Severe refractory eczema

Severe refractory eczema is best managed under specialist supervision; it may require
phototherapy or drugs that act on the immune system. Alitretinoin is licensed for the treatment
of severe chronic hand eczema refractory to potent topical corticosteroids; patients with
hyperkeratotic features are more likely to respond to alitretinoin than those with pompholyx.(10)
Nappy dermatitis
To treat and prevent nappy dermatitis:(2)
- change nappies frequently
- maximize nappy-free periods
- apply a barrier product (containing, e.g. zinc oxide, white soft paraffin, dimeticone) with
every nappy change; if other topical treatments are needed, apply barrier products last
- use highly absorbent disposable nappies (particularly when treating nappy dermatitis); if
using cloth nappies, avoid using plastic pants.
If inflammation is severe, causing discomfort, or is unresponsive to the above measures,
hydrocortisone ointment can be used until it settles (usually 3–5 days). If candidal infection is
suspected or confirmed, treat with a topical azole or nystatin.(2)
Seborrheic dermatitis
Seborrheic dermatitis (seborrheic eczema) is associated with species of the yeast Malassezia and
affects the scalp, paranasal areas, and eyebrows. Shampoos active against the yeast (including
those containing ketoconazole or coal tar) and combinations of mild corticosteroids with suitable
antimicrobials are used.(10)
In infants, seborrheic dermatitis of the scalp (cradle cap) resolves spontaneously within a few
months. Use a baby shampoo regularly to loosen the scales. If necessary, soften scales first by
applying an emollient (e.g. baby oil, vegetable oil, white soft paraffin) and then remove with a
soft brush. If it is severe or persistent, a short course of topical hydrocortisone or ketoconazole
may be useful.(2)
In adults, seborrheic dermatitis is a chronic, relapsing condition. Topical products containing
pyrithione zinc, coal tar, selenium sulfide, miconazole, ketoconazole or ciclopirox are used;

shampoos may also be used on areas other than the scalp. For treatment, apply 2 or 3 times a
week (daily if severe); to prevent relapse, weekly or fortnightly application may be useful. A short
course of topical corticosteroid may be added to reduce inflammation and itch. Products
containing salicylic acid and/or sulfur may be used to reduce scale.(2)

Eczema and psoriasis, drugs affecting the immune response
Drugs affecting the immune response are used for eczema or psoriasis. Systemic drugs acting on
the immune system are used under specialist supervision.(10)
Pimecrolimus by topical application is licensed for mild to moderate atopic eczema. Tacrolimus
is licensed for topical use in moderate to severe atopic eczema. Both are drugs whose long-term
safety is still being evaluated and they should not usually be considered first-line treatments
unless there is a specific reason to avoid or reduce the use of topical corticosteroids. Treatment
of atopic eczema with topical pimecrolimus or topical tacrolimus should be initiated only by
prescribers experienced in managing the condition. Topical tacrolimus and pimecrolimus have a
role in the treatment of psoriasis.(10)
A short course of a systemic corticosteroid can be given for eczema flares that have not improved
despite appropriate topical treatment.(10)
Ciclosporin by mouth can be used for severe psoriasis and for severe eczema. Azathioprine or
mycophenolate mofetil are used for severe refractory eczema [unlicensed indication]. Dupilumab
is licensed for the treatment of moderate to severe atopic eczema in patients requiring systemic
therapy. Dimethyl fumarate is licensed for the treatment of moderate to severe plaque
psoriasis.(10)
Methotrexate can be used for severe psoriasis, the dose being adjusted according to severity of
the condition and hematological and biochemical measurements. Folic acid should be given to
reduce the possibility of side-effects associated with methotrexate. Folic acid can be given once
weekly [unlicensed indication], on a different day from the methotrexate; alternative regimens
of folic acid may be used in some settings.(10)
Etanercept, adalimumab, and infliximab inhibit the activity of tumor necrosis factor (TNFα). They
are used for severe plaque psoriasis either refractory to at least 2 standard systemic treatments
and photochemotherapy, or when standard treatments cannot be used because of intolerance
or contra-indications; while either etanercept or adalimumab is considered to be the first choice
in stable disease, infliximab or adalimumab may be useful when rapid disease control is required.
Secukinumab and ixekizumab inhibit the activity of interleukin-17A, brodalumab inhibits the
activity of interleukin-17RA and guselkumab inhibits the activity of interleukin-23. They are used
for moderate to severe plaque psoriasis in patients who are candidates for systemic therapy.
Secukinumab is also licensed for psoriatic arthritis and ankylosing spondylitis. Ustekinumab (a
monoclonal antibody that inhibits interleukins 12 and 23) can be used for severe plaque psoriasis
that has not responded to at least 2 standard systemic treatments and photochemotherapy, or
when these treatments cannot be used because of intolerance or contra-indications.
Adalimumab is also licensed for the treatment of active moderate to severe hidradenitis
suppurativa (acne inversa) in patients who have had inadequate response to conventional

systemic therapy. Adalimumab, etanercept, infliximab, ixekizumab and ustekinumab are also
licensed for psoriatic arthritis.(10)

Psoriasis
Psoriasis is characterized by epidermal thickening and scaling. It commonly affects extensor
surfaces and the scalp. Occasionally, psoriasis is provoked or exacerbated by drugs such as
lithium, chloroquine and hydroxychloroquine, beta-blockers, non-steroidal anti-inflammatory
drugs, and ACE inhibitors. Psoriasis may not be seen until the drug has been taken for weeks or
months.(10) Other potential triggers include stress, trauma, smoking, alcohol and infections
(streptococcal throat infection may precipitate guttate psoriasis) should be minimized or
eliminated where possible.(2)
Emollients, in addition to their effects on dryness, scaling and cracking, may have an anti-
proliferative effect in psoriasis, and may be the only treatment necessary for mild psoriasis. They
are particularly useful in inflammatory psoriasis and in plaque psoriasis of palms and soles, in
which irritant factors can perpetuate the condition. Emollients are useful adjuncts to other more
specific treatment.(10) All emollients should be regularly and liberally applied with no upper limit
on how often they can be used. All are chemically inert and can therefore be safely used from
birth onwards by all patients.(15)
More specific topical treatment for chronic stable plaque psoriasis on extensor surfaces of trunk
and limbs involves the use of vitamin D analogues, coal tar, dithranol, and the retinoid
tazarotene. However, they can irritate the skin and they are not suitable for the more
inflammatory forms of psoriasis; their use should be suspended during an inflammatory phase of
psoriasis. The efficacy and the irritancy of each substance varies between patients. If a substance
irritates significantly, it should be stopped or the concentration reduced; if it is tolerated, its
effects should be assessed after 4 to 6 weeks and treatment continued if it is effective.(10)
Scalp psoriasis is usually scaly, and the scale may be thick and adherent; this will require softening
with an emollient cream, ointment, or oil. A tar-based shampoo is first-line treatment for scalp
psoriasis. A keratolytic, such as salicylic acid, should also be used if there is significant scaling, to
allow other treatments to work.(10) Although there appears to be no published evidence for their
efficacy, clinical practice suggests that they should be used first when significant scaling is present
before using other treatments.(15)
Some preparations prescribed for psoriasis affecting the scalp, combine salicylic acid with coal
tar or sulfur. The product should be applied generously, and an adequate quantity should be
prescribed. It should be left on for at least an hour, often more conveniently overnight, before
washing off. The use of scalp preparations containing a potent corticosteroid or a vitamin D
analogue, either alone or in combination, can also be helpful.(10)
Facial, flexural and genital psoriasis can be managed with short-term use of a mild or moderate
potency topical corticosteroid (a mild potency topical corticosteroid is preferred for the initial
treatment of facial psoriasis). Calcitriol or tacalcitol can be used for longer-term treatment, or if
the response to mild or moderate potency topical corticosteroids is inadequate; calcipotriol is

more likely to cause irritation. Low strength tar preparations can also be used. Pimecrolimus or
tacrolimus by topical application [unlicensed indication] can be used short-term, under specialist
supervision, in patients whose condition has not responded adequately to other treatments, or
who are intolerant of them.(10)
Widespread unstable psoriasis of erythrodermic or generalized pustular type requires urgent
specialist assessment. Initial topical treatment should be limited to using emollients frequently
and generously; emollients should be prescribed in quantities of 1 kg or more. More localized
acute or subacute inflammatory psoriasis with hot, spreading or itchy lesions, should be treated
topically with emollients or with a corticosteroid of moderate potency.(10)
Calcipotriol and tacalcitol are analogues of vitamin D that affect cell division and differentiation.
Calcitriol is an active form of vitamin D. Vitamin D and its analogues are used first-line for the
long-term treatment of plaque psoriasis; they do not smell or stain and they may be more
acceptable than tar or dithranol products. Of the vitamin D analogues, tacalcitol and calcitriol are
less likely to irritate.(10)
Coal tar has anti-inflammatory properties that are useful in chronic plaque psoriasis; it also has
antiscaling properties. Crude coal tar (coal tar, BP) is the most effective form, typically in a
concentration of 1 to 10% in a soft paraffin base, but few outpatients tolerate the smell and mess.
Cleaner extracts of coal tar included in proprietary preparations, are more practicable for home
use but they are less effective and improvement takes longer. Contact of coal tar products with
normal skin is not normally harmful and they can be used for widespread small lesions; however,
irritation, contact allergy, and sterile folliculitis can occur. The milder tar extracts can be used on
the face and flexures. Tar baths and tar shampoos are also helpful.(10)
Dithranol is effective for chronic plaque psoriasis. Its major disadvantages are irritation (for which
individual susceptibility varies) and staining of skin and of clothing. Dithranol is not generally
suitable for widespread small lesions nor should it be used in the flexures or on the face.
Proprietary preparations are more suitable for home use; they are usually washed off after 5 to
60 minutes (‘short contact’). Specialist nurses may apply intensive treatment with dithranol paste
which is covered by stockinette dressings and usually retained overnight. Dithranol should be
discontinued if even a low concentration causes acute inflammation; continued use can result in
the psoriasis becoming unstable.(10)
Tazarotene, a retinoid, has a similar efficacy to vitamin D and its analogues, but is associated with
a greater incidence of irritation. Although irritation is common, it is minimized by applying
tazarotene sparingly to the plaques and avoiding normal skin; application to the face and in
flexures should also be avoided. Tazarotene does not stain and is odorless.(10)
A topical corticosteroid is not generally suitable for long-term use or as the sole treatment of
extensive chronic plaque psoriasis; any early improvement is not usually maintained and there is
a risk of the condition deteriorating or of precipitating an unstable form of psoriasis (e.g.

erythrodermic psoriasis or generalized pustular psoriasis) on withdrawal. Topical use of potent
corticosteroids on widespread psoriasis can also lead to systemic as well as local side-effects.
However, topical corticosteroids used short-term may be appropriate to treat psoriasis in specific
sites such as the face or flexures (with a mild or moderate corticosteroid), and psoriasis of the
scalp, palms, and soles (with a potent corticosteroid). Very potent corticosteroids should only be
used under specialist supervision.(10)
Combining the use of a corticosteroid with another specific topical treatment may be beneficial
in chronic plaque psoriasis; the drugs may be used separately at different times of the day or
used together in a single formulation. Eczema co-existing with psoriasis may be treated with a
corticosteroid, or coal tar, or both.(10)
Phototherapy
Phototherapy is available in specialist centres under the supervision of a dermatologist.
Ultraviolet B (UVB) radiation is usually effective for chronic stable psoriasis and for guttate
psoriasis. It may be considered for patients with moderately severe psoriasis in whom topical
treatment has failed, but it may irritate inflammatory psoriasis.(10)
Photochemotherapy combining long-wave ultraviolet A radiation with a psoralen (PUVA) is
available in specialist centres under the supervision of a dermatologist. The psoralen, which
enhances the effect of irradiation, is administered either by mouth or topically. PUVA is effective
in most forms of psoriasis, including localized palmoplantar pustular psoriasis. Early adverse
effects include phototoxicity and pruritus. Higher cumulative doses exaggerate skin ageing,
increase the risk of dysplastic and neoplastic skin lesions, especially squamous cancer, and pose
a theoretical risk of cataracts.(10)
Phototherapy combined with coal tar, dithranol, tazarotene, topical vitamin D or vitamin D
analogues, or oral acitretin, allows reduction of the cumulative dose of phototherapy required to
treat psoriasis.(10)
Systemic treatment
Systemic treatment is required for severe, resistant, unstable or complicated forms of psoriasis,
and it should be initiated only under specialist supervision. Systemic drugs for psoriasis include
acitretin and drugs that affect the immune response (such as ciclosporin and methotrexate).(10)
Systemic corticosteroids should be used only rarely in psoriasis because rebound deterioration
may occur on reducing the dose.(10)

Acitretin, a metabolite of etretinate, is a retinoid (vitamin A derivative); it is prescribed by
specialists. The main indication for acitretin is psoriasis, but it is also used in disorders of
keratinization such as severe Darier’s disease (keratosis follicularis), and some forms of
ichthyosis. Although a minority of cases of psoriasis respond well to acitretin alone, it is only
moderately effective in many cases and it is combined with other treatments. A therapeutic
effect occurs after 2 to 4 weeks and the maximum benefit after 4 months. Consideration should
be given to stopping acitretin if the response is inadequate after 4 months at the optimum dose.
The manufacturers of acitretin do not recommend continuous treatment for longer than 6
months. However, some patients may benefit from longer treatment, provided that the lowest
effective dose is used, patients are monitored carefully for adverse effects, and the need for
treatment is reviewed regularly.(10)
Apart from teratogenicity, which remains a risk for 3 years after stopping, acitretin is the least
toxic systemic treatment for psoriasis; in women with a potential for child-bearing, the possibility
of pregnancy must be excluded before treatment and effective contraception must be used
during treatment and for at least 3 years afterwards (oral progestogen-only contraceptives not
considered effective).(10)
Topical treatment
The vitamin D and analogues, calcipotriol, calcitriol, and tacalcitol are used for the management
of plaque psoriasis. They should be avoided by those with calcium metabolism disorders, and
used with caution in generalized pustular or erythrodermic exfoliative psoriasis (enhanced risk of
hypercalcemia).(10)

Emollients (moisturizers)
Indications
Emollients soothe, smooth and hydrate the skin and are indicated for all dry or scaling disorders.
Their effects are short lived and they should be applied frequently even after improvement
occurs. They are useful in dry and eczematous disorders, and to a lesser extent in psoriasis. The
choice of an appropriate emollient will depend on the severity of the condition, patient
preference, and the site of application. Some ingredients rarely cause sensitization and this
should be suspected if an eczematous reaction occurs. The use of aqueous cream as a leave-on
emollient may increase the risk of skin reactions, particularly in eczema.(10)
Preparations such as aqueous cream and emulsifying ointment can be used as soap substitutes
for hand washing and in the bath; the preparation is rubbed on the skin before rinsing off
completely. The addition of a bath oil may also be helpful.(10)
Urea is occasionally used with other topical agents such as corticosteroids to enhance
penetration of the skin.(10)
Emollient bath additives should be added to bath water; hydration can be improved by soaking
in the bath for 10–20 minutes. Some bath emollients can be applied to wet skin undiluted and
rinsed off. In dry skin conditions soap should be avoided. The quantities of bath additives
recommended for adults are suitable for an adult-size bath. Proportionately less should be used
for a child-size bath or a washbasin; recommended bath additive quantities for children reflect
this.(10)
- Be aware that moisturizers (especially bath oils) may make some surfaces slippery.
- Products containing paraffin (e.g. emulsifying ointment, white soft paraffin) and the
fabrics they soak into, such as dressings, clothing and bedding, are flammable. Keep away
from naked flames, do not smoke (or be near others smoking), and regularly change
clothing and bedding (preferably daily) when using these products.
Practice points(2)
- Moisturizers come in various forms, including ointments, creams, lotions and bath oils.
In general, the heavier or greasier the preparation, the more effective the moisturizing
qualities. For best results apply creams and lotions to damp or wet skin and ointments
and oils to dry skin.

- Ideally, moisturizers should be cosmetically acceptable, free from common contact
allergens and easy to apply moisturizers may also be used as inert carriers for drugs.
- Cetomacrogol aqueous cream is also known as sorbolene cream.
- Do not use moisturizers that contain sodium lauryl sulfate (e.g. aqueous cream,
emulsifying ointment) as they can damage the skin barrier and cause irritation.
Emollients(2)
- Soft paraffin is the most occlusive, and therefore the best, emollient; however, it is not
widely used on its own due to its greasy feel.
- Silicones (e.g. dimeticone) are water repellent and are used in barrier preparations for
protecting the skin, e.g. nappy rash.
- Other emollients include liquid paraffin, lanolin, vegetable oils and beeswax. They are
usually not occlusive unless applied heavily and they have little or no effect on
transepidermal water loss.

Topical corticosteroids
Topical corticosteroids are used for the treatment of inflammatory conditions of the skin (other
than those arising from an infection), in particular eczema, contact dermatitis, insect stings, and
eczema of scabies. Corticosteroids suppress the inflammatory reaction during use; they are not
curative and on discontinuation a rebound exacerbation of the condition may occur. They are
generally used to relieve symptoms and suppress signs of the disorder when other measures such
as emollients are ineffective.(10)
Topical corticosteroids are not recommended in the routine treatment of urticaria; treatment
should only be initiated and supervised by a specialist. They should not be used indiscriminately
in pruritus (where they will only benefit if inflammation is causing the itch) and are not
recommended for acne vulgaris.(10)
Systemic or very potent topical corticosteroids should be avoided or given only under specialist
supervision in psoriasis because, although they may suppress the psoriasis in the short term,
relapse or vigorous rebound occurs on withdrawal (sometimes precipitating severe pustular
psoriasis).(10)
In general, the most potent topical corticosteroids should be reserved for recalcitrant
dermatoses such as chronic discoid lupus erythematosus, lichen simplex chronicus, hypertrophic
lichen planus, and palmoplantar pustulosis. Potent corticosteroids should generally be avoided
on the face and skin flexures, but specialists occasionally prescribe them for use on these areas
in certain circumstances.(10)
When topical treatment has failed, intralesional corticosteroid injections may be used. These are
more effective than the very potent topical corticosteroid preparations and should be reserved
for severe cases where there are localized lesions such as keloid scars, hypertrophic lichen
planus, or localized alopecia areata.(10)
Topical corticosteroid preparation potencies

The corticosteroid selection depends, to some extent, upon the condition being treated. In
general, it is best to start with the lowest potency agents needed and use for as short a period of
time as possible.(3)
Comparison of potency and uses of topical corticosteroids(2)
Corticosteroid Some indications
Potency is approximate and varies according to a number of factors (e.g. formulation).
Mild

Corticosteroid Some indications
Hydrocortisone (0.5–1%) Facial and flexural dermatitis and psoriasis; nappy

dermatitis
Hydrocortisone acetate (0.5–1%)
Moderate
Betamethasone valerate (0.02%, Mild-to-moderate atopic dermatitis, adjunctive treatment

0.05%) in extensive psoriasis
Clobetasone (0.05%)
Desonide (0.05%)
Triamcinolone (0.02%)
Potent
Betamethasone dipropionate Short-term use in severe inflammatory dermatoses

(0.05%)
Betamethasone valerate (0.1%)
Mometasone (0.1%)
Methylprednisolone (0.1%)
Very potent
Betamethasone dipropionate in Severe eczema and psoriasis, e.g. refractory lichen simplex
an optimized vehicle (0.05%) chronicus; also useful for eczema of hands and feet
(occlusion may be used but atrophy may occur)
Clobetasol (0.05%) Moderate-to-severe scalp psoriasis
* Topical steroids range in potency from hydrocortisone (least potent) to Eumovate

(Clobetasone), Betnovate (betamethasone) and Dermovate (clobetasol; most potent). Choice
depends upon severity, site and the patient’s age. It is important to remember that topical
steroids are absorbed systemically and may also cause thinning of the skin. For this reason, it is
important to use the appropriate strength depending on the site and severity of eczema.(59)
Potency: estimate is based on vasoconstrictive ability, inhibition of inflammation and potential
for causing adverse effects. Formulation affects absorption and potency (for the same
concentration of corticosteroid, ointments are generally more potent than creams due to better
absorption). Both absorption-enhancing ingredients (e.g. propylene glycol) and occlusion will
increase relative potency.(2)

Site: use hydrocortisone on face and flexures; avoid using more potent corticosteroids on these
areas (if unresponsive, methylprednisolone may be used under close supervision for 2–3 days
(maximum 7 days)). Use all topical corticosteroids with caution on eyelids because the skin is
particularly thin. More potent products may be used on palms, soles and lichenified areas.(2)
Application: Topical corticosteroids are usually applied twice a day, except for clobetasol,
mometasone and methylprednisolone, which are applied once a day. There is no benefit from
more frequent application; in some cases less frequent application may be adequate (e.g.
eczema).(2)
Use in children
Children, especially infants, are particularly susceptible to side-effects. However, concern about
the safety of topical corticosteroids in children should not result in the child being undertreated.
The aim is to control the condition as well as possible; inadequate treatment will perpetuate the
condition. A mild corticosteroid such as hydrocortisone 0.5% or 1% is useful for treating nappy
rash and hydrocortisone 1% for atopic eczema in childhood. A moderately potent or potent
corticosteroid may be appropriate for severe atopic eczema on the limbs, for 1–2 weeks only,
switching to a less potent preparation as the condition improves. In an acute flare-up of atopic
eczema, it may be appropriate to use more potent formulations of topical corticosteroids for a
short period to regain control of the condition. A very potent corticosteroid should be initiated
under the supervision of a specialist. Carers of young children should be advised that treatment
should not necessarily be reserved to ‘treat only the worst areas’ and they may need to be
advised that patient information leaflets may contain inappropriate advice for the patient’s
condition.(10)
Counselling
Apply enough to cover affected areas. Smooth gently into skin, preferably after bathing.(2)
Topical corticosteroids should not be applied within 30 minutes of emollient.(60)
Fingertip units
Fingertip units can be used to measure the amount of topical corticosteroid to apply to an area
of skin for adults and children. A fingertip unit is the amount of cream or ointment, squeezed out
of a tube (with a standard 5 mm nozzle), from the tip of an adult’s index finger to the first crease.
One fingertip unit (approximately 500 mg) is generally enough to cover an area twice the size of
a flat adult hand (with the fingers together).(2)

Number of adult fingertip units to apply each dose
Face and Entire arm Entire leg Front of chest Back and
Age of patient neck and hand and foot and abdomen buttocks
3–12 months 1 1 1½ 1 1½
1–3 years 1½ 1½ 2 2 3
3–6 years 1½ 2 3 3 3½
6–10 years 2 2½ 4½ 3½ 5
>10 years 2½ 4 8 7 7
(including adults)
Practice points(2)
- Use an appropriately potent product for the shortest time necessary to control skin
disorder
- Potential for systemic absorption increases with extent and activity of disease; monitor
strength and amount being used.
- To reduce adverse effects of topical corticosteroids during treatment of chronic
dermatoses, they may be used:
o to treat exacerbations only
o 2 or 3 times a week or on 2 consecutive days/week to maintain remission
o in combination with other agents
o continuously, after initial response, using a low-potency product
- It is unclear whether tachyphylaxis (loss of effectiveness with continued use) actually
occurs with topical corticosteroids or whether it reflects decreased use over time.

- Allow sufficient time for absorption between application of a topical corticosteroid and
a moisturizer; it is not clear which to apply first.
- Occlusion with polythene films may be used on a short-term basis on the palms and soles
or on limited areas of lichenification (use vinyl gloves for hands)

Calcipotriol
Calcipotriol is similar efficacy to potent or very potent corticosteroids and is more effective than
coal tar. May be used with topical corticosteroids (combination with betamethasone is more
effective than either agent used alone). Can irritate, particularly the face or flexures.(2)
Indication Dosage
Chronic plaque Apply to affected area twice a day. Less frequent application may be
psoriasis (includes adequate after initial period. Stop treatment after satisfactory
fixed combination improvement; restart if disease recurs.
with betamethasone)
- Adult, up to 5 mg calcipotriol each week (for all calcipotriol-
containing formulations).
- Child >12 years, up to 3.75 mg calcipotriol each week for up
to 8 weeks.
- Child 6–12 years, up to 2.5 mg calcipotriol each week for up
to 8 weeks.
Fixed combination with betamethasone
- Adult, apply to the affected area once daily. Maximum of 5
mg calcipotriol each week. Do not apply to >30% of body
surface.
- Do not mix with other preparations unless instructed; mixing can destroy the calcipotriol.
- Calcipotriol is unstable in the presence of salicylic acid or UVA; to avoid loss of efficacy:
o apply salicylic acid at a different time of day
o apply calcipotriol after UVA treatment
- Wash hands thoroughly after applying to avoid unintentional transfer to other body areas,
unless your hands are being treated.
- Do not apply to face; itch and redness occur.
Counseling point

Protect treated areas from sunlight with protective clothing or a broad-spectrum sunscreen,
preferably SPF 30 or SPF 50+, containing a physical agent (e.g. titanium dioxide). Avoid sunlamps
and tanning beds.(2)
Practice points
May need to use calcipotriol for 4–6 weeks for maximum improvement.(2)
Calcipotriol may be used with UVB, PUVA, acitretin and ciclosporin, allowing less frequent or
lower dosing of these agents, thus minimizing their adverse effects.(2)
Storage
Daivobet(9)
- Shelf-life: 2 years (unopened container). After first opening of container: 12 months.
Xamiol(9)
- Do not store above 30°C. Do not refrigerate. Protect from light.
- Shelf-life: unopened container, 2 years. Discard 3 months after first opening.

Coal tar
Coal tar has anti-inflammatory properties that are useful in chronic plaque psoriasis; it also has
antiscaling properties. Crude coal tar (coal tar, BP) is the most effective form, typically in a
concentration of 1 to 10% in a soft paraffin base, but few outpatients tolerate the smell and mess.
Cleaner extracts of coal tar included in proprietary preparations, are more practicable for home
use but they are less effective and improvement takes longer. Contact of coal tar products with
normal skin is not normally harmful and they can be used for widespread small lesions; however,
irritation, contact allergy, and sterile folliculitis can occur. The milder tar extracts can be used on
the face and flexures. Tar baths and tar shampoos are also helpful.(10)
Indication Dosage
Eczema, particularly chronic or Use the same way for adults and children.
lichenified eczema
Cream, foam, gel, lotion, ointment, apply 1–4 times a
Seborrheic dermatitis day.
Stable chronic plaque psoriasis Scalp conditions
Dandruff Ointment, shampoo, use once a week to once a day.
Precautions(2)
- Photosensitivity
o Contraindicated in conditions characterized by photosensitivity, e.g. lupus
erythematosus, polymorphic light eruption (coal tar is photosensitizing).
o Avoid treatment with other photosensitizers as they may increase the risk of
phototoxic reactions.
- Children
o Safety and efficacy of coal tar preparations have not been established. Should not
be used in children <2 years, except under the direction and supervision of a
dermatologist.
- Avoid contact with eyes.
- May stain skin, hair (especially fair, bleached or grey hair) and clothes.

- Cream, foam, gel, lotion, ointment: apply enough to cover affected area and rub in gently.
Avoid exposure to direct sunlight or sunlamps for at least 24 hours after application.
Completely remove coal tar preparations before exposure to sunlight.
- Scalp conditions
o Ointment: apply to the affected areas of the scalp and rub in gently; leave on for
about 1 hour before rinsing with warm water and usual shampoo.
o Shampoo: apply to wet hair and massage vigorously into scalp; leave on for several
minutes, rinse thoroughly and then repeat if necessary.
Practice points(2)
- Use low concentrations of coal tar solution (0.5–1%) on face, flexures and genitals to
reduce potential for irritation.
- Patient acceptance may be poor due to the messiness, smell and staining properties of
some preparations.
- May be used alone in treatment of psoriasis, or combined with dithranol and/or UVB
phototherapy.
- Salicylic acid, sulfur and allantoin have keratolytic properties and may be used with coal
tar to treat psoriasis, seborrheic dermatitis and dandruff.
- Available with zinc oxide (has astringent properties) in some products.
- Evidence of carcinogenicity is conflicting. Some epidemiological studies have raised the
possibility of skin malignancies in patients with psoriasis with very high exposure to tar
and/or ultraviolet radiation. Other studies have found no conclusive evidence of this.

Pimecrolimus 1% cream (Elidel)
Indication Dosage
Short-term treatment of mild to Child 2-17 years and adult, apply twice daily until
moderate atopic eczema (including symptoms resolve (stop treatment if eczema worsens
flares) when topical corticosteroids or no response after 6 weeks).
cannot be used (initiated by a
specialist)
Short-term treatment of facial, Adult, apply twice daily until symptoms resolve
flexural or genital psoriasis in (maximum duration of treatment 4 weeks).
patients unresponsive to or
intolerant of other topical therapy
(initiated by a specialist)
- Due to concerns about possible increased incidence of adverse effects (upper respiratory
tract infections, otitis media, diarrhea, asthma, irritability), pimecrolimus is not approved
for use in children <2 years in the USA or the UK.(2)
Apply a thin film twice a day to affected areas. If irritation occurs, apply less frequently; if it
persists or is severe, stop treatment.(2)
Advise patient to avoid drug exposure to eyes, nose, mouth or broken skin.(4)
Patient should not place occlusive dressings, cosmetics, or other skin care products on treated
skin.(4)
Avoid using continuously for >6 weeks at a time (3 weeks in children aged 3-23 months); stop
treatment if there is no improvement within this time.(2)
Adverse effect
Drug causes sun-sensitivity. Advise patient to limit sun exposure and to avoid sun lamps and
tanning beds.(4)
This drug may cause burning of skin, headache, or fever. Drug also places patient at higher risk
for basal/squamous cell carcinoma and malignant lymphoma.(4)

Practice point

Tacrolimus 0.03% and 0.1% ointment (Protopic)
Indication Dosage
Short-term treatment of moderate to Child 2-15 years, apply twice daily for up to 3 weeks
severe atopic eczema (including (consider other treatment if eczema worsens or if no
flares) in patients unresponsive to, or improvement after 2 weeks), 0.03% ointment to be
intolerant of conventional therapy applied thinly, then reduced to once daily until lesion
(initiated by a specialist) clears.
Child 16-17 years and adult, apply twice daily until
lesion clears (consider other treatment if eczema
worsens or no improvement after 2 weeks), initially
0.1% ointment to be applied thinly, reduce frequency
to once daily or strength of ointment to 0.03% if
condition allows.
Prevention of flares in patients with Child 2–15 years, apply twice weekly, 0.03% ointment
moderate to severe atopic eczema to be applied thinly, with an interval of 2–3 days
and 4 or more flares a year who have between applications, use short-term treatment
responded to initial treatment with regimen during an acute flare; review need for
topical tacrolimus (initiated by a preventative therapy after 1 year.
specialist)
Child 16-17 years and adult, apply twice weekly, 0.1%
ointment to be applied thinly, with an interval of 2–3
days between applications, use short-term treatment
regimen during an acute flare; review need for
preventative therapy after 1 year.
Short-term treatment of facial, Adult, apply twice daily until symptoms resolve, 0.1%
flexural, or genital psoriasis in ointment to be applied thinly, reduce to once daily or
patients unresponsive to, or switch to 0.03% ointment if condition allows,
intolerant of other topical therapy maximum duration of treatment 4 weeks.
(initiated under specialist
supervision)
Apply a thin layer to affected skin; rub in gently and completely.(4)
Do not use with occlusive dressings.(4)

Adverse effect
Counsel patient to limit sun and UV light exposure and to use appropriate sun protection as drug
may increase risk of skin cancer.(4)
Topical side effects may include burning, pruritus, flu-like symptoms, and erythema.(4)
Practice point

Potassium permanganate
Potassium permanganate, when diluted, is a mild antiseptic and astringent (something that dries
the skin). It is for external use only.(61)
Indication Dosage
Cleansing and deodorizing suppurating For wet dressings or baths, use approximately
eczematous reactions and wounds 0.01% (1 in 10000) solution.
- Potassium permanganate 0.1% solution to be diluted in 1 in 10 to provide 0.01% (1 in

10000) solution.(10)
- With potassium permanganate tablets for solution, 1 tablet dissolve in 4 liters of water
provides a 0.01% (1 in 10000) solution.(10)
- Potassium permanganate soaks
o The solution should be prepared freshly just before use, as if left it will start to
oxidize and go brown. Use a clean container lined with a clean white bin liner bag.
Fill with 4 liters of warm tap water and add one Permitabs (potassium
permanganate 400 mg) tablet (wearing gloves) and allow to dissolve completely.
The water should be light pink colored. If treating hands and feet, apply Vaseline
to the nails to prevent staining. If recommended for the limbs, then immerse area
to be treated. Occasionally it may be recommended that you soak some gauze
swabs with the diluted solution and apply the damp swabs to the weeping areas
of skin for example under the breasts or in the groin. Soak affected areas for 10-
15 minutes and then pat dry. Discard the solution and clean container thoroughly
after use.(61)

o Once the affected area has been soaked and dried apply any prescribed
cream/ointment and or dressings, and repeat as recommended by your
healthcare professional.(61)
- Potassium permanganate baths are effective for the treatment of infected eczema when
there are blisters, pus and/or oozing. Twice daily baths for two days help to dry out the
weeping sores and soothe the eczema.(62)
- The potassium permanganate may be used as wet soaks to blistering wounds such as
ulcers and abscesses. Strips of cotton or gauze should be soaked in the solution and
wrapped around the affected area for 20–30 minutes. The astringent action of potassium
permanganate helps to dry out the blister and prepare the wound for other
treatment.(62)
- A 1% solution (1 in 100) is used as a direct application to treat fungal infections such as
athlete's foot.(62)
Adverse effect
Contact with eyes and mucous membranes (inside of mouth, nose, ear, genitals and anus) may
cause irritation and should be avoided.(61)
Harmful when swallowed – eating and drinking should be avoided when using the product.(61)
Dryness.(61)
Can cause burns.(61)
Counseling point
Can stain clothing, skin and nails (especially with prolonged use).(10)
Potassium permanganate crystals and concentrated solutions are caustic and can burn the skin.
Even fairly dilute solutions can irritate skin and repeated use may cause burns. If redness or
irritation continues, notify your doctor. When preparing solutions, make sure that the crystals or
tablets are fully dissolved in water before using.(62)
Potassium permanganate soaks are not suitable for dry skin conditions.(62)
Note that potassium permanganate may leave a brown stain on skin and nails as well as the bath
or vessel holding the solution. Use nail varnish or by apply soft paraffin to fingernails and toenails
before treatment.(62)

Sodium valproate (Epilim)
Indication Dosage
Epilepsy Adult, initially, oral 600mg daily in 2 doses; increase every 3 days by
200mg daily according to response. Maintenance, oral/IV 1-2g (20-
30mg/kg) daily in 2 doses; maximum 2.5g daily.
Child >1 month, initially, oral 10g/kg daily in 2 doses; increase daily
dose by 5-10mg/kg at weekly intervals according to response.
Maintenance, oral/IV 20-40mg/kg daily in 2 doses (up to 60mg/kg
daily may be required). Maximum 2.5g daily.
Bipolar disorder Adult, oral, initially 600mg daily in 2 doses; increase every 3 days by
200mg daily according to response. Maintenance, oral/IV 1-2g (20-
30mg/kg) daily in 2 doses.
Prevention of migraine Adult, oral 200-400mg twice daily.
Pregnancy
Avoid if possible in those of child-bearing potential using inadequate contraception, due to
teratogenic risk; increased risk of neural tube defects (e.g. spina bifida) and other congenital
malformations including orofacial clefts and cardiac, urogenital and limb defects. Delay in motor
and cognitive development is also associated with valproate (in up to 30–40% of children) and
some data suggest an association with autism spectrum disorder and autism.(2)
If there is no effective alternative, minimize risk by using lowest possible dose (risk is dose-related
and appears to significantly increase at doses >1000 mg daily).(2)
Liver toxicity
Liver dysfunction (including fatal hepatic failure) has occurred in association with valproate
(especially in children under 3 years and in those with metabolic or degenerative disorders,
organic brain disease or severe seizure disorders associated with mental retardation) usually in
first 6 months and usually involving multiple antiepileptic therapy. Raised liver enzymes during
valproate treatment are usually transient but patients should be reassessed clinically and liver
function (including prothrombin time) monitored until return to normal—discontinue if
abnormally prolonged prothrombin time (particularly in association with other relevant
abnormalities).(10)

Concentration monitoring
There is poor correlation between therapeutic efficacy and plasma concentration but
concentrations may be useful to confirm toxicity or compliance. Epilepsy and acute mania:
therapeutic range, 40–100 mg/L (280–700 micromol/L); up to 150 mg/L (1000 micromol/L) in
some people. Measure as trough plasma concentration. Steady-state concentration may be
achieved after 3–5 days.(2)
Adverse effects
Take with food to reduce stomach upset. Swallow the enteric coated tablets whole; do not crush
or chew them.(2)
Valproate may make you feel drowsy; if affected, do not drive or operate machinery. This
medicine may also increase the effects of alcohol.(2)
Your appetite may increase when taking this medicine and you may need to pay more attention
to your diet to avoid weight gain.(2)
Side effects may include abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia,
asthenia, back pain, nausea and insomnia.(4)
Tell your doctor immediately if symptoms such as fever, rash, abdominal pain, vomiting, jaundice,
bruising or bleeding develop.(2)
Patients or their caregivers should be told how to recognize signs and symptoms of blood or liver
disorders and advised to seek immediate medical attention if symptoms develop.(10)
Patients or their caregivers should be told how to recognize signs and symptoms of pancreatitis
and advised to seek immediate medical attention if symptoms such as abdominal pain, nausea
or vomiting develop.(10)
Instruct patients to report worsening depression, suicidal ideation, or unusual changes in
behavior. (4)
Counseling points
Do not stop taking this medicine suddenly unless your doctor tells you to.(2)
Tell women of childbearing potential to avoid pregnancy during therapy and use effective
contraception.(4)

Practice points(2)
- Avoid abrupt withdrawal; if treatment with valproate is stopped, reduce the dose
gradually over at least 4 weeks.(10)
- stop treatment promptly if:
o there is loss of seizure control, anorexia, vomiting, ataxia, impaired consciousness,
jaundice or edema (may indicate hepatitis or pancreatitis)
o there are symptoms of hypersensitivity
o spontaneous bruising or bleeding occurs (may indicate thrombocytopenia, effect
on clotting factors or hepatotoxicity)
- use of enteric coated tablets may minimize GI adverse effects.
- may be used IV as an alternative to phenytoin in status epilepticus.
Monitoring
- check complete blood count (including platelets) before starting treatment.
- routine monitoring of liver aminotransferase concentrations does not predict the rare
occurrence of hepatic failure.
- valproate appears to reduce BMD and may increase fracture risk; consider BMD
monitoring during long-term treatment and ensure vitamin D status and calcium intake
are adequate.

Sunscreens
Sunscreens contain chemical agents, physical barrier agents or both. Chemical agents absorb a
particular range of UV wavelengths. Only the benzophenones (benzophenone-6, oxybenzone,
dioxybenzone, mexenone) absorb both UVA and UVB radiation. Physical barrier agents (titanium
dioxide, zinc oxide) are opaque and reflect most UV radiation providing broad protection against
UVA and UVB.(2)
Dosage – Sunscreens
Apply liberally to all exposed areas 20 minutes before sun exposure and reapply regularly (at least
every 2 hours), particularly after swimming, exercise, heavy perspiration or toweling dry.(2)
Children
Application to small areas of skin (e.g. face and hands) is safe for babies but primary sun
protection should be clothing, shade and avoidance of sun.(2)
Adverse effects
Rare (<0.1%): rash, skin irritation.(2)
- Avoid contact with eyes.
- If used correctly, sunscreen may be effective at preventing sunburn but it should not be
used to increase the amount of time you would normally spend in the sun.
- It is important to also wear protective clothing and a hat and to avoid or minimize time
spent in direct sunlight particularly between 10 am and 2 pm (11 am and 3 pm daylight
saving time) when UV radiation is most intense. Even in the shade, UV radiation is
reflected from surfaces such as concrete, snow, white sand and water.
Practice points(2)
- Select a sunscreen for its high SPF rating (preferably 50+), broad-spectrum cover (UVA
and UVB) and water resistance.

- Doubling the SPF does not mean doubling the safe exposure time: SPF 15 blocks about
94% UVB allowing 6% penetration; doubling the SPF to 30 reduces the penetration to
about 3% but blockage is only raised to 97%; SPF 50 blocks about 98% of UVB.
- A product’s SPF is tested using an application thickness that is up to 4 times the thickness
of a typical consumer application; testing does not compensate for factors such as wind,
humidity, sweating, rubbing, water immersion or sensitized skin.
- Sunlight protection is particularly important in patients taking photosensitizing drugs or
immunosuppressants or those with photodermatoses (e.g. polymorphic light eruption,
xeroderma pigmentosum and cutaneous porphyrias) or hypopigmentation disorders (e.g.
vitiligo and albinism).
- Evidence suggests that daily use of sunscreens may reduce the incidence of actinic
keratoses, squamous cell carcinoma and invasive melanoma.
- If a sunscreen and insect repellent need to be used at the same time, a combination
product containing a low concentration of diethyltoluamide (DEET) suitable for 2-hourly
application (ensuring maximal sun protection) may be preferable; applying separate
sunscreen and insect repellent products may reduce their efficacy and may increase
systemic absorption of active ingredients.
- The safety of sunscreens containing nanoparticles of titanium dioxide or zinc oxide has
been questioned; current evidence suggests the nanoparticles do not reach living cells
and are therefore unlikely to cause adverse effects.

Tinzaparin (Innohep)
Strength Indication Dosage
20,000 Extended treatment Adult, subcutaneous inj, 175units/kg once daily for 6
units/ml of venous months; the benefit of continued treatment beyond 6
thromboembolism months should be evaluated.
and prevention of
recurrence in
patients with active
cancer
Treatment of deep- Adult, subcutaneous inj, 175units/kg once daily until

vein thrombosis; adequate oral anticoagulation established, treatment
Treatment of regimens do not require anticoagulation monitoring.
pulmonary
embolism
Treatment of venous Adult, subcutaneous inj, 175units/kg once daily, dose

thromboembolism based on early pregnancy body-weight, treatment
in pregnancy regimens do not require anticoagulation monitoring.
10,000 Prophylaxis of deep- Adult, subcutaneous inj, 3500 units for 1 dose, dose to
units/ml vein thrombosis be given 2 hours before surgery, then 3500 units every
(general surgery) 24 hours.
Prophylaxis of deep- Adult, subcutaneous inj, initially 50 units/kg for 1 dose,

vein thrombosis dose to be given 2 hours before surgery, then 50
(orthopedic surgery) units/kg every 24 hours, alternatively initially 4500 units
for 1 dose, dose to be given 12 hours before surgery,
then 4500 units every 24 hours.
Prevention of Adult, to the device as a flush, consult product literature.

clotting in
extracorporeal
circuits
* Manufacturer advises caution if eGFR less than 30 ml/minute/1.73m2.

SubQ: Patient should be lying down or sitting. Administer by deep SubQ injection into the lower
abdomen (avoiding navel area), outer thigh, lower back, or upper arm. Do not administer IM.
Injection site should be varied daily. To minimize bruising, do not rub the injection site.
During hemodialysis, may be administered into the arterial side of the dialyzer circuit or IV in
patients with no hemorrhage risk. In patients at risk of hemorrhage, administer IV only (do not
add to the dialyzer circuit).
Adverse effects(4)
- Drug may cause erythema and pain or irritation at injection site.
- Advise patient to report any unusual bruising or bleeding.
Storage(12)
- Store at 15°C to 25°C.

Transdermal patches
Transdermal patches
Read the patient information for use before using your patch.
Each product will have specific instructions for use.
Wash your hands.
Select an area of skin to apply the patch. Be sure to follow any

specific instructions provided by your doctor or the product
instructions as to site selection or rotation. Prepare the skin area
and make sure the skin is clean and free of any powders, oils, and
lotions.

Carefully open the packaging. If using scissors, be careful not to
cut the patch. Never use a patch that has been cut or damaged
in any way.
Remove the protective liner according the product directions. Be

sure not to touch the sticky side of the patch. Some protective
liners are removed in two parts. If so, place the sticky half of the
patch on the area of skin and gently peel off remaining liner.
Press down on the patch firmly with the palm of your hand.
Go around the edges with your fingers to press them onto the
skin. Make sure that the patch is flat against the skin (there
should be no bumps or folds in the patch).
Throw away the empty pouch and the protective liner in a closed
trash can.

Wash your hands.
When it is time to remove the previous patch, use your fingers to

peel it off slowly. Fold the patch in half with and press firmly to
seal it shut.
Throw the used patch away in a closed trash. Used patches may
still contain some medication and may be dangerous to children,
pets, or adults.
Wash your hands.

Ask your doctor what to do if the patch loosens or falls off before
it is time to replace it. Generally, you should try to press it back
in place with your fingers. If the patch cannot be pressed back
on, throw it away and apply a fresh patch to a different area.
Replace the fresh patch at your regularly scheduled patch change
time.

Buprenorphine patch (Sevonor® patch)
- Transdermal system, 5 mcg/hour, 10 mcg/hour and 20 mcg/hour.
Indication Dosage
Moderate, non-malignant Adult, initially 5 micrograms/hour up to every 7 days, dose

pain unresponsive to non- adjustments – when starting, analgesic effect should not be
opioid analgesics evaluated until the system has been worn for 72 hours (to allow
for gradual increase in plasma-buprenorphine concentration) – if
necessary, dose should be adjusted at intervals of at least 3 days
using a patch of the next strength or a combination of 2 patches
applied in different places (applied at same time to avoid
confusion). Maximum 2 patches can be used at any one time.
- Transdermal buprenorphine patches are not suitable for acute pain or in those patients
whose analgesic requirements are changing rapidly because the long time to steady state
prevents rapid titration of the dose.(10)
- Transdermal patches are available as 72-hourly, 96-hourly and 7-day formulations;
prescribers and dispensers must ensure that the correct preparation is prescribed and
dispensed. Preparations that should be applied up to every 72 hours include Hapoctasin®
and Prenotrix®. Preparations that should be applied up to every 96 hours include
Bupeaze®, Buplast®, Relevtec®, and Transtec®. Preparations that should be applied up to
every 7 days include Bupramyl®, Butec®, BuTrans®, Panitaz®, Reletrans®, and
Sevodyne®.(10)
- Write the date and time of application on the patch with permanent marker, then apply
to dry, non-irritated, hairless skin on upper torso. Check the patch is still attached on the
days between patch changes.(2)
- Warn patient to avoid exposing application site or surrounding skin to a direct external
heat source due to potential for enhanced absorption.(4)
- Remove after 7 days and put a new patch on a different area (avoid re-using the same
area for at least 3 weeks).(2)
- When stopping patches, use alternative opioid cautiously (close monitoring and dose
titration) for about 2 days because:(2)
o buprenorphine concentration falls slowly (by about 50% 10-24 hours after
removing last patch)
o the effect of additional opioids may increase over time (as buprenorphine leaves
opioid receptors)

- Heat increases the release of buprenorphine from patch; avoid exposure to external heat
sources (including electric blankets, hot baths); monitor for increased adverse effects if a
fever develops.(2)
- Do not cut or divide patches as this may affect drug release characteristics.(2)
How to apply the patch(9)
Choose an area of non-irritated skin, intact skin on your

upper arm, outer arm, upper chest, upper back or side
of the chest. Ask for assistance if you cannot apply
yourself.
The buprenorphine patch should be applied to a
relatively hairless or nearly hairless skin site. If no
suitable hair free sites are available the hairs should be
cut off with a pair of scissors. Do not shave them off.
Avoid skin which is red, irritated or has any blemishes
for instance large scars.
The area of skin you choose must be dry and clean. If
necessary, wash it with cold or lukewarm water. Do not
use soap, alcohol, oil, lotions or other detergents. After
a hot bath of shower, wait until your skin is completely
dry and cool. Do not apply lotion, cream or ointment to
the chosen area. This might prevent your patch from
sticking properly
Each patch is sealed in a pouch. Just before use, open

the pouch by tearing where indicated. Take out the
patch. Do not use the patch if the pouch seal is broken.
The sticky side of the patch is covered with a silvery

protective foil. Carefully peel off half the foil. Try not to
touch the sticky part of the patch.
Stick the patch on the area of skin you have chosen and
remove the remaining foil.

Press the patch against your skin with the palm of your
hand and count slowly to 30. Make sure that the whole
patch is in contact with your skin, especially at the
edges.
Wearing the patch(9)

- You should wear the patch for seven days. Provided that you have applied the patch
correctly, there is little risk of it coming off. If the edges of the patch begin to peel off,
they may be taped down with a suitable skin tape.
- You may shower, bathe or swim whilst wearing it.
- Do not expose the patch to extreme heat (e.g. heating pads, electric blanket, heat lamps,
sauna, hot tubs, heated water beds, hot water bottle, etc.) as this may lead to larger
quantities of the active ingredient being absorbed into the blood than normal. External
heat may also prevent the patch form sticking properly.
- In the unlikely event that your patch falls off before it needs changing, do not use the
same patch again. Stick a new one on straight away.
Changing the patch(9)

- Take the old patch off.
- Fold it in half with the sticky side inwards.
- Open and take out a new patch. Use the empty pouch to dispose of the old patch. Now
discard the pouch safely.
- Even used patches contains some active ingredient that may harm children or animals, so
make sure your used patches are always kept out of the reach and sight of them.
- Stick a new patch on a different appropriate site. You should not apply a new patch to the
same site for 3-4 weeks.
- Remember to change your patch at the same time of the day. It is important that you
make a note of the time of day.
Adverse effects

- Side effects may include nausea, dizziness, headache, vomiting, application site rash,
erythema or pruritus.(4)
- Advise patient to avoid activities requiring mental alertness or coordination until drug
effects are realized, as drug may cause impaired mental and physical abilities.(4)
- Recommend patient report symptoms of respiratory depression, orthostatic hypotension
or syncope.(4)
- Instruct patient to report symptoms of serotonin syndrome, adrenal insufficiency or CNS
depression.(4)
- Advise patient to report severe constipation.(4)
Counseling points for opioid analgesics(2)

- This medication may make you feel drowsy and may increase the effects of alcohol. If you
are affected, do not drive or operate machinery. If you are very sleepy or have trouble
staying awake, stop taking the medication and tell your doctor immediately.
- Be careful when you stand up as this medicine might make you feel dizzy if you stand up
too quickly.
- Chronic use: look after your teeth and mouth, and get dental checks regularly, as opioids
may make your mouth dry which increases risk of dental caries.
Storage(9)
- Do not store above 25°C
- Do not use the patch if the pouch seal is broken.
- Used patches must be folded over on themselves with adhesive layers inwards and
discarded safely out of sight and reach of children.

Fentanyl transdermal system (Duragesic® patch)
- Transdermal system: 12 mcg/h, 25 mcg/h, 50 mcg/h, 75 mcg/h, 100 mcg/h
Indication Dosage
Chronic Child 16-17 years and adult, initially 12 micrograms/hour every 72 hours,
intractable pain alternatively initially 25 micrograms/hour every 72 hours, when starting,
not currently evaluation of the analgesic effect should not be made before the system
treated with a has been worn for 24 hours (to allow for the gradual increase in plasma-
strong opioid fentanyl concentration) – previous analgesic therapy should be phased
analgesic out gradually from time of first patch application, dose should be adjusted
at 48—72 hour intervals in steps of 12-25 micrograms/hour if necessary,
more than one patch may be used at a time (but applied at the same time
to avoid confusion) – consider additional or alternative analgesic therapy
if dose required exceeds 300 micrograms/hour (important: it takes 17
hours or more for the plasma-fentanyl concentration to decrease by 50%
- replacement opioid therapy should be initiated at a low dose and
increased gradually.
Chronic Child 2-17 years and adult, initial dose based on previous 24-hour opioid
intractable pain requirement (consult product literature).
currently treated
Patch takes about 24–72 hours to reach maximum effect; steady-state
with strong opioid
concentration may not be reached until the second patch is applied; wean
analgesic
other analgesics slowly after first patch is applied. When switching from
an oral opioid, apply the first fentanyl patch:(2)
- at the same time as the last dose of a 12-hour-controlled release
product
- 12 hours after the last dose of a 24-hour-controlled release
product

- Transdermal fentanyl patches are not suitable for acute pain or in those patients whose
analgesic requirements are changing rapidly because the long time to steady state
prevents rapid titration of the dose.(10)
- Write the date and time of application on the patch with permanent marker, then apply
it to dry, hairless, non-irritated skin on the upper part of your body or upper arm. Do not
apply straight after a hot bath or shower, wait until skin is cool and dry. Do not use if
patch is damaged or cut. Check the patch is still attached on the days between patch
changes.(2)
- Warn patient to avoid exposing application site or surrounding skin to a direct external
heat source due to potential for enhanced absorption.(4)
- Remove after 3 days (72 hours) and put a new patch on a different place. Make sure you
know how to dispose of patches safely.(2)
- Deaths have occurred in children accidentally exposed to patches, therefore ensure the
patient/carer understands:(2)
o how to store and dispose of patches safely (a substantial amount of fentanyl
(approximately 30–50% of original amount) remains in the patch after 3 days of
use)
o that the patch must always be firmly attached
- Heat increases the release of fentanyl from patch; avoid exposure to external heat
sources (including heated blanket, hot baths), monitor for increased adverse effects if a
fever develops.(2)
- After removing a patch, avoid exposing that area of skin to the sun for 2 days as it may
be more sensitive.(2)
Before applying DURAGESIC®(9)

- Each DURAGESIC® patch is sealed in its own protective pouch. Do not remove from the
pouch until you are ready to use it.
- Do not use a DURAGESIC® patch if the pouch is broken or the patch is cut, damaged or
changed in any way.
- DURAGESIC® patches are available in 5 different doses and patch sizes. Make sure you
have the right dose patch or patches that have been prescribed for you.
Applying a DURAGESIC patch(9)

Skin areas where the DURAGESIC® patch may be applied:
For adults: Put on the patch on the chest, back, flank (sides of the waist),
or upper arm in a place where is no hair (See Figures A-D).
For children (and adults with mental impairment): Put the patch on the
upper back (See Figure B). This will lower the chances that the child will
remove the patch and put it in their mouth.
For adults and children
- Do not put a DURAGESIC® patch on skin that is very oily, burned,
broken out, cut, irritated or damaged in any way.
- Avoid sensitive areas or those that move around a lot. If there is
hair, do not shave (shaving irritates the skin). Instead, clip hair as
close to the skin as possible (See Figure E).
- Talk to your health care provider if you have questions about skin
application sites.
Prepare to apply a DURAGESIC® patch:

- Choose the time of day that is best for you to apply DURAGESIC®.
Change it at about the same time of day (3 days or 72 hours after
you apply the patch) or as directed by your health care provider.
- Do not wear more than one DURAGESIC® patch at a time unless
your health care provider tells you to do so. Before applying a new
DURAGESIC® patch, remove the patch you have been wearing.
- Clean the skin area with clear water only. Pat skin completely dry.
Do not use anything on the skin such as soaps, lotions, oils, or
alcohol before the patch is applied.

Open the pouch: Fold and tear at slit, or cut at slit, taking care not to cut
the patch. Remove the DURAGESIC® patch. Each DURAGESIC® patch is
sealed in its own protective pouch. Do not remove the DURAGESIC® patch
from the pouch until you are ready to use it.
Peel: Peel off both parts of the protective liner from the patch. Each
DURAGESIC® patch has a clear plastic backing that can be peeled off in two
pieces. This covers the sticky side of the patch. Carefully peel this
protective liner off and throw the pieces away. Touch the sticky side of the
DURAGESIC® patch as little as possible.
Press: Press the patch onto the chosen skin site with the palm of your hand
and hold there for at least 30 seconds. Make sure it sticks well, especially
at the edges.
- DURAGESIC® may not stick to all patients. You need to check the
patches often to make sure that they are sticking well to the skin.
- If the patch falls off right away after applying, throw it away and
put a new one on at a different skin site.
If you have a problem with the patch not sticking
- Apply first aid tape only to the edges of the patch.
- If you continue to have problems with the patch sticking, you may
cover the patch with BioclusiveTM or TegadermTM. These are
special see-through adhesive dressings. Never cover a
DURAGESIC® patch with any other bandage or tape. Remove the
backing from the BioclusiveTM or TegadermTM dressing and place
it carefully over the DURAGESIC® patch, smoothing it over the
patch and your skin.
If you patch falls off later, but before 3 days (72hours) of use, dispose of
properly. Apply a new DURAGESIC® patch on at a different skin site. Be
sure to let your health care provider know that this has happened, and do
not replace the new patch until 3 days (72 hours) after you put it on (or as
directed by your health care provider).
Wash your hands when you have finished applying a DURAGESIC® patch.

Remove a DURAGESIC® patch after wearing it for 3 days (72 hours).
Choose a different skin site to apply a new DURAGESIC® patch. Repeat
Steps 2 through 6 above when applying a new DURAGESIC® patch.
Do not apply the new patch to the same place as the last one.
- You can bathe, swim or shower while you are wearing a DURAGESIC® patch. If the patch
falls off before 3 days (72 hours) after application, dispose of properly. Apply a new
DURAGESIC patch on at a different skin site. Be sure to let your health care provider know
that this has happened, and do not replace the new patch until 3 days (72 hours) after
you put it on (or as directed by your health care provider).(9)
- Contact with unwashed or unclothed application sites can result in secondary exposure
to DURAGESIC® and should be avoided. Examples of accidental exposure include transfer
of a DURAGESIC® patch from an adult’s body to a child while hugging, sharing the same
bed as the patient, accidental sitting on a patch and possible accidental exposure of a
caregiver’s skin to the medication in the patch while applying or removing the patch.(9)
- Instruct patients, family members, and caregivers to keep patches in a secure location
out of the reach of children and of others for whom DURAGESIC® was not prescribed.(9)
Disposal Instruction(9)
Fold the used DURAGESIC® patch in half so that the sticky side sticks to itself.
Flush the used DURAGESIC® patch down the toilet right away. A used
DURAGESIC® patch can be very dangerous for or lead to death in babies,
children, pets and adults who have not been prescribed DURAGESIC®.
Throw away any DURAGESIC® patches that are left over from your prescription
as soon as they are no longer needed. Remove the leftover patches from their
protective pouch and remove the protective liner. Fold the patches in half with
the sticky sides together and flush the patches down the toilet. Do not flush
the pouch or the protective liner down the toilet. These items can be thrown
away in a trash can.
- Failure to properly dispose of DURAGESIC has resulted in accidental exposures and

deaths.
Adverse effects
- Instruct patients to avoid activities requiring mental alertness or coordination until drug
effects are realized, as drug may cause dizziness and somnolence.(4)

- Risk for fatal respiratory depression, particularly in patients not previously treated with a
strong opioid analgesic; manufacturer recommends use only in opioid tolerant
patients.(10)
- Side effects may include nausea, vomiting, insomnia, hyperhidrosis, fatigue, feeling cold,
anorexia, headache or diarrhea.(4)
- Instruct patient to report symptoms of hypotension and syncope.(4)
- Tell patient to report symptoms of adrenal insufficiency (e.g. nausea, vomiting, anorexia,
fatigue, weakness, dizziness and hypotension), anaphylaxis and serotonin syndrome.(4)
- Instruct patient to report severe constipation.(4)
Counseling points for opioid analgesics(2)

- This medication may make you feel drowsy and may increase the effects of alcohol. If you
are affected, do not drive or operate machinery. If you are very sleepy or have trouble
staying awake, stop taking the medication and tell your doctor immediately.
too quickly.
- Chronic use: look after your teeth and mouth, and get dental checks regularly, as opioids
may make your mouth dry which increases risk of dental caries.
Storage(9)
- Store in original unopened pouch.
- Stored up to 25°C; excursions permitted to 15-30°C.

Rivastigmine patch (Exelon patch)
- Available in patch: 4.6 mg/24 hours, 9.5 mg/24 hours or 13.3 mg/24 hours
Indication Dosage
Mild to moderate dementia in Adult, apply 4.6 mg/24 hours daily for at least 4
Alzheimer’s disease weeks, increased if tolerated to 9.5 mg/24 hours daily
for a further 6 months, then increased if necessary to
13.3 mg/24 hours daily, increase to 13.3 mg/24 hours
patch if well tolerated and cognitive deterioration or
functional decline demonstrated; use caution in
patients with body-weight less than 50 kg, if
treatment interrupted for more than 3 days, retitrate
from 4.6 mg/24 hours patch.
* Dose equivalence and conversion

When switching from oral to transdermal therapy, patients taking 3–6mg by mouth daily should
initially switch to 4.6 mg/24 hours patch, then titrate as above. Patients taking 9 mg by mouth
daily should switch to 9.5 mg/24 hours patch if oral dose stable and well tolerated; if oral dose
not stable or well tolerated. Patients should switch to 4.6 mg/24 hours patch, then titrate as
above. Patients taking 12 mg by mouth daily should switch to 9.5 mg/24 hours patch. The first
patch should be applied on the day following the last oral dose.(10)
Apply patches to clean, dry, non-hairy, non-irritated skin on back, upper arm, or chest, removing
after 24 hours and siting a replacement patch on a different area (avoid using the same area for
14 days).(10)
Advise patient and/or caregiver to avoid direct exposure of patch to external heat sources, such
as excessive sunlight, saunas, or sun rooms, for long periods of time, as this may cause increased
release of drug from patch.
Adverse Reactions(4)
- Drug may cause nausea, vomiting, diarrhea, depression, and application site reactions
(dermatitis, eczema, irritation, erythema, pruritus).

- Advise patient or caregiver of symptoms of allergic contact dermatitis and to notify a
physician if application site reactions spread beyond the patch size, if there is a more
intense local reaction (e.g., edema, increasing erythema, papules, vesicles), and if little
symptomatic improvement is seen within 48 hours after patch removal.
- Drug may exacerbate or induce extrapyramidal symptoms, or worsen parkinsonian
symptoms, specifically tremor.
- Patient should avoid activities requiring mental alertness or coordination until drug
effects are realized.
- Instruct patient and/or caregiver to monitor any loss of appetite or weight reduction as
dose adjustment may be needed.
- Instruct patient and/or caregiver to report gastrointestinal adverse effects, which can be
severe at higher than recommended doses.
- Instruct patient and/or caregiver to apply the patch immediately and to replace patch
the following day at the usual application time. The patient should not apply 2 patches
to make up for a missed dose. If the patch has not been applied for more than 3 days,
the patient should call the doctor for instructions.
Storage(9)
- Store between 20°C to 25°C.
- Keep the patch in the individual sealed pouch until ready to use.
Practice point
The patch may be suitable for patients intolerant of oral therapy; nausea and vomiting are less
common with the patch than with oral rivastigmine.(2)

Rotigotine patch (Neupro)
- Transdermal System: 1 mg/24 hours, 2 mg/24 hours, 3 mg/24 hours, 4 mg/24 hours, 6
mg/24 hours and 8 mg/24 hours rotigotine
Indication Dosage
Parkinson’s disease Early stage, initially one 2 mg/24 hours patch applied once daily;
increase dose each week by 2 mg/24 hours, as required. Maximum
8 mg/24 hours once daily.
Advanced, initially one 4 mg/24 hours patch applied once daily;
increase dose each week by 2 mg/24 hours, as required. Maximum
16 mg/24 hours once daily.
Restless Leg Syndrome Adult, initially one 1 mg/24 hours patch applied once daily; if
necessary, increase dose each week by 1 mg/24 hours up to a
maximum 3 mg/24 hours once daily.
Educate patient on proper patch application, including shaving hairy skin 3 days before
application and washing site after removal.(4)
Apply at the same time each day to non-irritated, clean, dry, hairless skin on the hip, abdomen,
thigh, upper arm or shoulder. When changing the patch, remove the old patch and apply a new
one to a different place (avoid applying to the same place for 14 days). Make sure you know how
to dispose of patches safely.(2)
Advise patient to avoid exposing applied patch to direct heat due to possibility of increased drug
absorption.(4)
Impulse control disorder

Treatment with dopamine-receptor agonists is associated with impulse control disorders,
including pathological gambling, binge eating, and hypersexuality. Patients and their carers
should be informed about the risk of impulse control disorders. Ergot- and non-ergot-derived
dopamine-receptor agonists do not differ in their propensity to cause impulse control disorders,
so switching between dopamine receptor agonists will not control these side-effects.(10)

Adverse Reactions
- Drug may cause application site reactions, nausea, vomiting, dizziness, headaches,
insomnia, syncope, hallucinations, dyskinesias, hypertension, tachycardia, or peripheral
edema. Allergic reactions are possible if sensitive to sulfites.(4)
- This medicine may cause dizziness or drowsiness (up to 1 year after initiation); if affected,
do not drive or operate machinery.(2)
too quickly.(2)
- Take tablets with food to lessen the chance of nausea or stomach upset.(2)
- Tell your doctor if you notice any change in your behavior, e.g. overspending, gambling
or excessive sexual activity.(2)
Counseling points
- Inform patient that patch contains aluminum and should be removed prior to MRI or
cardioversion.(4)
- Advise patient against sudden discontinuation due to neuroleptic malignant syndrome-
like symptoms (confusion, hyperpyrexia).(4)
- Instruct patient to use caution when taking alcohol, sedating medications, or other CNS
depressants with drug.(4)
Storage
Do not store above 30°C.(6)
Practice points(2)
- Do not cut patches; 2 patches can be applied simultaneously to give
doses >8 mg/24 hours.
- Do not stop treatment abruptly; gradually reduce dose over several days.
- Manufacturer recommends regular ophthalmological monitoring.
- In clinical trials, rotigotine was more effective than placebo in reducing symptoms of
early Parkinson’s disease and in reducing ‘off’ time in advanced disease; although it was
similar to pramipexole in reducing ‘off’ time in advanced levodopa-treated Parkinson’s
disease, further comparative data are needed.

- Long-term safety and efficacy data are lacking.

Tuberculosis
Tuberculosis
Tuberculosis (TB) is a disease caused by the bacteria Mycobacterium tuberculosis. It most
commonly affects the lungs, although it can affect other parts of the body. TB can be fatal if not
recognized and treated. It also can spread from person to person to infect others. However, TB
is treatable and preventable. Identifying and treating those who are infected but who have not
yet become ill with active TB can prevent the disease and thus eliminate the spread of TB in the
community.(3)
How does tuberculosis occur?

It is usually acquired by inhalation of airborne bacilli from an individual with active tuberculosis
(TB). Bacilli multiply in alveoli and spread via macrophages, lymphatics and blood. Three possible
outcomes:(34)
- Eradication: tissue hypersensitivity halts infection within 10 weeks.
- Primary TB
- Latent TB
In general, individuals with pulmonary and laryngeal TB are infectious, whereas those with EPTB
are regarded as noninfectious. Amongst those with PTB, the infectiousness increases when the
sputum smear is positive or multiple pulmonary cavities are shown in the chest radiograph. The
risk of infection is also related to the degree of shared ventilation, physical distance and duration
of exposure between the index case and the contact. The risk increases if the contact has been
in close proximity and if the contact has spent a longer time together with the index case. In
addition, individuals who are immunocompromised are more susceptible to TB disease.(63)
High risk of tuberculosis exposure occurs among household contacts, prisoners, the homeless, IV
drug abusers, and immigrants from high-prevalence countries. Persons at highest risk for
progression include those with impaired immunity, such as HIV infection, silicosis, diabetes
mellitus, chronic renal insufficiency, malignancy, malnutrition, and immunosuppressive
medications, including therapy with tumor necrosis factor (TNF) antagonists.(64)
Latent tuberculosis infection is a misnomer referring to someone who has infection, but not
disease (clinical and radiological evidence of active disease). The lifetime risk of progression to
active disease is 10% (5% within 2 years of infection and an additional 5% thereafter). In poorly
controlled HIV and other immunosuppressed patients, the annual progression rate from latent
to active tuberculosis is 10%. Adequate treatment of LTBI can reduce the risk of disease up to
90%.(64)

What are the symptoms?
The most frequent clinical presentation is pulmonary disease. Symptoms are often indolent and
may include cough for >14 days, hemoptysis, dyspnea, fever, night sweats, weight loss or fatigue.
Misdiagnosis and treatment with a fluoroquinolone for presumed CAP can lead to treatment
delay and fluoroquinolone resistance.(64)
Adult patients presenting with unexplained cough lasting more than two weeks with or without
constitutional symptoms should be investigated for PTB. However, the typical symptoms may be
absent in the immunocompromised or elderly patients.(63)
Extrapulmonary disease can present as cervical lymphadenopathy, genitourinary disease,
osteomyelitis, military dissemination, meningitis, peritonitis, or pericarditis.(64) Symptoms and
signs due to EPTB vary according to the organs involved and may be non-specific. For example,
patients with TB meningitis may present with intermittent or persistent headaches for a few
weeks and subtle mental status changes, which may progress to coma over a period of days to
weeks.(63)
How to detect TB disease?

Chest radiography may reveal focal infiltrates, nodules, cavitary lesions, miliary disease, pleural
effusions, or hilar/mediastinal lymphadenopathy. Reactivation disease classically involves the
upper lobes.(64)
Three sputum specimens should be sent for AFB smears and cultures. A diagnosis of active TB is
made with a positive AFB smear along with a positive nucleic acid amplification test (NAAT) for
M. tuberculosis complex or positive culture. Nontuberculous mycobacteria (NTM) may be
positive on smear but negative on NAA test. On smear-negative samples, sensitivity of these
assays can be up to 90%, if 3 sputum samples are tested.(64)
M. tuberculosis can take several weeks to grow in culture, so if the clinical suspicion is high,
presumptive therapy even with negative smears may be indicated until cultures are negative.(64)
Antimicrobial susceptibility testing should be performed on all initial isolates and on isolates
obtained from patients who do not respond to standard therapy. Rapid detection of rifampin
resistance, possible with molecular techniques (Cepheid Gene Xpert MTB/RIF), correlates with
MDR-TB. Genetic testing on direct specimens is also available for selected cases through the CDC
(molecular detection of drug resistance).(64)
Latent TB may be diagnosed by a positive tuberculin skin test (TST) or interferon-γ release assay
(IGRA). Current guidelines recommend IGRA testing in all individuals 5 years or older, rather than
TST. Criteria for a positive TST are based on the maximum diameter of induration (not erythema)
and the patient population screened.(64)

- 5-mm induration is considered positive in patients with HIV infection, close contacts of a
known a case of TB, patients with chest radiographs indicative of healed tuberculosis,
and individuals with organ transplantation or other immunosuppression (TNF-α
inhibitors, chemotherapy, steroids).
- 10-mm induration is considered positive in immigrants from high-prevalence area (Asia,
Africa, Latin America, Eastern Europe), prisoners, the homeless, IV drugs users, nursing
home residents, patients with chronic medical illness (silicosis, diabetes, hemodialysis,
leukemia, lymphoma, malnutrition), and those people who frequent contact with these
groups (e.g. health-care personnel, correctional officers).
- 15-mm induration is considered positive for otherwise healthy individuals at low risk for
tuberculosis.

Treatment
Treatment of new cases
Presently, six-month regimen consisting of two months of daily EHRZ* (2EHRZ) followed by four
months of daily HR* (4HR) is recommended for newly-diagnosed pulmonary tuberculosis, based
on many years of well-designed randomized controlled trial (RCT). Regimen should contain six
months of rifampicin. Rifampicin should be rounded to higher recommended dose if tolerated. If
ethambutol is contraindicated, streptomycin can be substituted.(63)
There is considerable urgency to prevent the emergence of drug-resistant TB. Among the
important steps to prevent this situation is to ensure patients adhere to their treatment. Fixed-
dose combinations drugs incorporate two or more drugs in single tablet and offer reduction in
number of pills that need to consumed. The two FDCs available in MoH Drug Formulary for adults
are:(63)
- 4-drug combination: isoniazid 75mg, rifampicin 150mg, pyrazinamide 400mg and
ethambutol 275mg tablet
- 3-drug combination: isoniazid 75mg, rifampicin 150mg and pyrazinamide 400mg tablet
Body weight (kg) Recommended dose
30 - 37 2 tabs daily
>70 5 tabs daily

In patients who develop toxicity, intolerance or contraindication to specific component drugs,
FDCs can be substituted with separate drug regimens.(63)
Treatment of previously treated cases

Previously treated TB patients include those patients treated as new cases who have taken
treatment for more than one month and are currently smear or culture positive again (i.e. failure,
relapse or return after default). Drug sensitivity test (DST) must be done for the patients. When
the results become available , the drug regimen should be adjusted appropriately.(63)
When there is interruption in treatment, the treating doctor needs to ascertain reason and
duration of the interruption and then decide whether to restart the entire course, to continue
from the last dose or to stop the treatment. There is no retrievable evidence on treatment after
interruption. In most cases, the decision needs to be individualized, taking into consideration the
reason for the interruption, response to treatment up to the point of interruption and total
planned/expected doses of treatment. The following is recommended by the Development
Group:(63)
- Interruption in the intensive phase:
o If ≥14 days, to restart from the beginning i.e. Day 1
o If <14 days, to continue from the last dose
In either situation, the total number of planned doses for the intensive phase
should be given.
- Interruption in the maintenance phase:
o If interruption occurs after patient receives 80% of the total planned doses, the
treatment may be stopped If the sputum AFB smear was negative at the initial
presentation. If the sputum AFB smear was positive, the treatment should be
continued to achieve the total number of planned doses
o If patient receives <80% of total planned doses and interruption lapse is ≥2 months,
restart treatment from the beginning
o If patient receives <80% of total planned doses and interruption lapse is <2 months,
continue treatment from date it stops to complete full course
Extrapulmonary tuberculosis
Extrapulmonary tuberculosis is common but difficult to diagnose. With the current HIV epidemic,
the prevalence of the condition is increasing. The treatment of EPTB has mainly been
extrapolated from PTB. All extrapulmonary tuberculosis should be treated with anti-TB for a
minimum of 6 months except for bone (including spine) and joint tuberculosis for 6-9 months
and tuberculous meningitis for 9-12 months.(63)

Latent TB infection in adults
Patients with LTBI should be treated with one the following regimens.(63)
Medication counseling points(2)
Medication Counseling
Ethambutol Ethambutol may affect your vision, for instance, you may see less clearly or
colors may be affected. Stop taking it and tell your doctor as soon as possible
if there are any changes in your eye sights.
Isoniazid Isoniazid can affect your liver and vision, as well as occasionally causing allergy.
Stop treatment and tell your doctor if you get persistent nausea, omitting,
unusual tiredness or jaundice, changes in your vision, fever or rash.
It is absorbed best if you take it on an empty stomach (1 hour before or 2 hours
after a meal).
With tyramine- or histamine-rich foods: fast heartbeat, dizziness on standing,
flushing, itch, headache or sweating may rarely occur. If you have any of these
symptoms, avoid foods such as mature cheeses, red wine and dark-meat fish
(that is not fresh).
Rifampicin Rifampicin is absorbed best if you take it at least half an hour before food. Take
it regularly, as allergy is more likely with stop-start dosing.

Medication Counseling
Tell your doctor immediately if you get a rash, fever, or swollen glands.
Your urine, feces, sweat and tears may become orange-red and soft contacts
lenses may be permanently stained.
Tell your doctor if you have any loss appetite, nausea, vomiting, unusual
tiredness, jaundice, dark urine or pale feces.
This medication interacts with many drugs; tell your doctor and pharmacist
that you are taking this before starting or stopping any medicines, including
herbal and over-the-counter products.
Streptomycin Tell your doctor if you have any hearing loss or you are unsteady or dizzy
(especially when you sit up, stand up or walk).
Pyrazinamide Stop treatment and tell your doctor if you get continuous nausea, vomiting,
unusual tiredness, yellowing of the skin or whites of the eyes, dark urine or
pale feces.

TB in pregnancy, lactation & use of oral contraceptives
Maternal TB has been associated with increased risk of maternal mortality and perinatal
mortality, namely premature delivery, small-for-gestation age and low birth weight. A pregnant
or lactating woman should be advised that successful treatment of TB with the standard regimen
is important to ensure best outcome to the mother and her baby.(63)
Pregnancy
Women of child bearing age should be asked about current or planned pregnancy prior to starting
antiTB drugs.(63)
Isoniazid, rifampicin, ethambutol and pyrazinamide are safe to be used in pregnancy.(63)
Streptomycin should be avoided in pregnancy due to fetal ototoxicity.(63)
Pyridoxine (25 mg daily) should be given to all pregnant women on isoniazid to prevent fetal
neurotoxicity.(63)
The usage of 2nd line antiTB drug in pregnancy should be instituted after consultation with TB
specialist as little is known for their safety.(63)
Lactation
Breastfeeding mothers with TB should receive full course of antiTB drugs. Timely and proper
administration of such drugs is the best way to prevent TB transmission to the baby. First-line
antiTB drugs are safe in breast feeding.(63)
Mother and baby should stay together for continuation of breastfeeding. Once active TB in the
baby is ruled out, the baby should be given six months isoniazid prophylaxis followed by BCG
vaccination. Surgical mask should be used if the mother is deemed infectious. Separation of the
infant from the mother should be considered if the mother has MDR-TB or is non-complaint to
treatment.(63)
Pyridoxine supplementation is recommended for all pregnant or breastfeeding women taking
isoniazid.(63)
Use of oral contraceptive pills

Rifamycin drugs reduce the contraceptive efficacy of both combined oral contraceptives and
progesterone-only pills. Alternative contraceptive methods should be used during rifamycin

therapy and for one month after stopping the therapy even if it has been administered for less
than a week.(63)

Liver & renal impairment
Patients with liver and renal impairment may need frequent monitoring while on antiTB
treatment. They may develop side effects due to treatment or may end up receiving inadequate
therapy. Expert consultation is advisable when treating these patients.(63)
Liver impairment
In patients with unstable or advanced liver disease, baseline liver function tests should be done
at the beginning of treatment. Regular monitoring at weekly/biweekly intervals for the initial two
months should be done and followed by more widely spaced assessments all through the rest of
treatment.(63)
If baseline liver enzyme, alanine aminotransferase (ALT), is more than three times upper limit of
normal before the initiation of treatment, one of the following antiTB regimens should be
considered. The more unstable or severe the liver disease, the fewer hepatotoxic drugs should
be used:(63)
- Two hepatotoxic drugs (rather than three in the standard regimen)
o 9 months of isoniazid and rifampicin, plus ethambutol (until or unless isoniazid
susceptibility is documented)
o 2 months of isoniazid, rifampicin, streptomycin and ethambutol, followed by 6
months of isoniazid and rifampicin;
o 6 - 9 months of rifampicin, pyrazinamide and ethambutol.
- One hepatotoxic drug
o 2 months of isoniazid, ethambutol and streptomycin, followed by 10 months of
isoniazid and ethambutol.
- No hepatotoxic drugs
o 18 - 24 months of streptomycin, ethambutol and fluoroquinolones*.
*Newer fluoroquinolones such as levofloxacin and moxifloxacin are preferred
over the older generations.
Renal impairment
The recommended initial TB treatment regimen for patients with renal failure or severe renal
insufficiency is two months of isoniazid, rifampicin, pyrazinamide and ethambutol, followed by
four months of isoniazid and rifampicin.(63)
There is significant renal excretion of ethambutol and metabolites of pyrazinamide, and doses
should therefore be adjusted. Three times per week administration of these two drugs at the
following doses is recommended: pyrazinamide (25 - 30 mg/kg), and ethambutol (15 - 25 mg/kg).

This should provide adequate maximum plasma concentration of the drug (Cmax), avoid
accumulation of pyrazinamide metabolites and ethambutol.(63)
Pyrazinamide should be administered after hemodialysis to avoid premature drug removal. All
four antiTB drugs may be administered after hemodialysis to facilitate directly observed
therapy.(63)
Because of an increased risk of nephrotoxicity and ototoxicity, streptomycin should be avoided
in patients with renal failure. If streptomycin need to be used, the dosage is 15 mg/kg, 2 or 3
times per week, to a maximum of 1 gram per dose, and serum levels of the drug should be
monitored.(63)

Tuberculosis and public health
Directly observed therapy (DOT) is a program used by public health departments to ensure that
a patient safely takes his or her medication exactly as prescribed. This requires daily interaction
with a healthcare worker who makes sure medications are taken appropriately by watching the
patient swallow the medications and assesses the patient for symptoms and signs of an adverse
reaction to the medication or clinical worsening. This minimizes the risk of serious side effects.
With this program, a health worker watches a person swallow the TB medication every day. DOT
may help to improve cure rates.(3)
The health department can also help to identify people who have been in contact with a person
with active TB. Contacts are advised to have TB testing and treatment if necessary.(3)
Public health programs for TB are essential for several reasons:(3)
- To reduce the number of new cases of TB (by identifying and treating people with LTBI in
order to prevent disease from developing) and therefore
- To limit spread of the disease in the community (by monitoring and assuring safe,
complete treatment of people with active TB)

Warfarin
What is warfarin and why do I need it?
Warfarin is an oral anticoagulant – a medicine that increases the time it takes for your blood to
clot. Some people call it a “blood thinner” but your blood won’t actually look or feel any different
while you are taking warfarin.(65)
Warfarin helps to stop unwanted clots from forming inside blood vessels or to treat them if they
occur. A clot will not usually form inside a blood vessel, but if it does it is called a “thrombosis”.
A thrombosis can cause a stroke, a heart attack or a vein blockage in the legs or lungs. Warfarin
helps to prevent or treat thrombosis by making it more difficult for the blood to form a clot. The
reasons why people may need to take warfarin include:(65)
- Atrial fibrillation (“AF”), an irregular heartbeat that can cause blood clots and strokes;
- Blood clots in the legs (a “deep vein thrombosis” or “DVT”) or lungs (a “pulmonary
embolism” or “PE”);
- Certain blood clotting problems (for example, antiphospholipid syndrome, protein C
deficiency and Factor V Leiden); and
- Mechanical heart valves.
Your doctor will be able to tell you why you are taking warfarin and how long you will need to
take it. This varies according to the condition being treated and may vary from person to
person.(65)
Warfarin does not dissolve clots, but it keeps them from increasing in size and moving to another
part of the body. This allows the body's natural systems to break down a clot over time and helps
reduce the chance of clots developing in people with a higher risk of forming clots. Warfarin
prevents and treats serious medical problems caused by blood clots.(3)

Warfarin monitoring
The goal of warfarin therapy is to decrease the clotting tendency of blood, but not to prevent
clotting completely. Therefore, the blood's ability to clot must be carefully monitored while a
person takes warfarin. The dose of warfarin is adjusted to maintain the clotting time within a
target range, based on the results of periodic blood tests. These tests can be done in a laboratory
or using a portable device at home.(3)
The clotting test used to measure the effect of warfarin is the prothrombin time (called pro time,
or PT). The PT is a laboratory test that measures the time it takes for a clot to form. It is measured
in seconds. It is particularly sensitive to the clotting factors affected by warfarin.(3)
The International Normalized Ratio (INR) is a way of expressing the PT in a standardized way by
comparing it to a reference value; this ensures that results obtained by different laboratories in
different facilities can be compared reliably. It is expressed as a number without units.(3)
The longer it takes the blood to clot, the higher the PT and INR. The target INR range depends
upon the clinical situation. In most cases the target INR range will be between 2 and 3, although
other ranges may be chosen if there are special circumstances. In a person who is not taking
warfarin, the INR would be approximately 1.(3)
If the INR is below the target range (i.e., under-anticoagulated), there is an increased risk of
clotting. On the other hand, if the INR is above the target range (i.e., over-anticoagulated), there
is an increased risk of bleeding.(3)
The dose of warfarin is adjusted to get the PT/INR blood test into the correct range. The
prothrombin time/international normalized ratio (PT/INR) is monitored more often when the
dose is being changed, when the person starts or stops another medication, or when his or her
medical condition changes. It is monitored less often when the dose is stable. A typical frequency
of monitoring for stable dosing is approximately every four or six weeks. In addition to increased
monitoring, changes in your other medications or medical condition may result in the need for a
higher or lower daily warfarin dose.(3)

If your doctor increases your warfarin dose, your INR will increase. If your warfarin dose
decreases, your INR will decrease. These changes may not happen immediately. It may take 4 to
5 days before they are noticeable. It is not always possible for every INR test result to be within
your target INR range, but the more time you spend in this range, the lower your risk of bleeding
and clotting.(65)

Taking warfarin safely
The dose (strength) of warfarin that your doctor has prescribed for you is in milligrams (mg).
Make sure that you know what tablets you are meant to be taking to make up your dose. If you’re
unsure, don’t be afraid to ask.(65)
Warfarin comes in four strengths; has a different color and milligram (mg) dose to distinguish it.
Remind the patient not to remember the color, remember the dose prescribed instead.(11)
Strength Apo-warfarin Coumadin Orfarin
1 mg Brown Pink
2 mg Lavender Purple
3 mg Blue
5 mg Peach Peach Pink
Take your tablets at approximately the same time each day. Most people take their daily warfarin
dose in the evening. This allows the dose to be changed if necessary on the day that an INR result
is obtained, rather than waiting until the next day.(65)
Some people might need to take different doses every second day or on different days of the
week.(65)
Warfarin can be taken with or without food.(65)
Take the exact warfarin dose prescribed by your doctor. Don’t stop taking warfarin or change the
dose unless your doctor tells you to.(65)
Make warfarin part of your daily routine. Some people find that marking it off on a calendar or
in their INR record booklet after they have taken their warfarin dose makes it easier to remember.
Other people use pill boxes or blister packs. If you’re having problems remembering to take your
warfarin, talk to your pharmacist about how they can help.(65)
If you forget to take a dose of warfarin and then remember within 8 hours, you can still take your
tablets. If you forget for a longer time, do not take the tablets to catch up but take your next dose
when it is due. Keep a record of any missed doses and tell your doctor or pathology laboratory.
Never take a double dose.(11, 65)

Warfarin side effects
Possible side effects
The major complication associated with warfarin is bleeding. This includes serious, life-
threatening bleeding such as bleeding into the brain or internal bleeding, which is rare, and minor
bleeding such as easy bruising, gum bleeding, or nosebleeds, which are common and can occur
with any anticoagulant.(3)
The risk of bleeding is different in different people. Bleeding risk is greatest during the few weeks
warfarin is started and during periods of illness. In general, the risk of major internal bleeding is
about 1 to 3 percent per year; people who have tolerated warfarin well for at least six months
and are on a stable dose of warfarin usually have a risk for major internal bleeding that is closer
to 1 percent per year. Excessive bleeding, or hemorrhage, can occur from any area of the body
even if the warfarin is having the desired (rather than an excessive) effect, and people on warfarin
should report any falls or accidents, as well as signs or symptoms of bleeding or unusual
bruising.(3)
- Signs of internal bleeding include severe headache or changes in strength in one part of
the body, blood in the urine, bloody or dark stool, or vomiting blood. These signs should
prompt immediate discussion with your healthcare provider, who may order
a PT/INR test and an in-person evaluation.
- Minor bleeding includes bleeding from the gums, nosebleeds, or easy bruising. It is
important to report changes in the severity or frequency of these symptoms so that your
healthcare provider can decide on the appropriate steps to take.
Because the risk of bleeding increases as the INR rises, the INR is closely monitored and
adjustments are made as needed to maintain the INR within the target range.(3)
Warfarin can also cause a rare side effect called skin necrosis or gangrene, which can cause dark
red or black areas on the skin. This complication is more likely in people with an inherited clotting
disorder called protein C deficiency, which is very rare. When it occurs, it is most likely to be seen
during the first several days of warfarin therapy.(3)
When to seek help

If there are obvious or subtle signs of bleeding, including the following, you should call your
healthcare provider immediately.(3)
- Persistent nausea, stomach upset, or vomiting blood or other material that looks like
coffee grounds
- Headaches, dizziness, or weakness
- Nosebleeds

- Dark red or brown urine
- Blood in the bowel movement or dark-colored stool
- A serious fall or head injury, even if there are no other symptoms
- A car accident or other serious injury that could cause bleeding
It is also important to notify your healthcare provider if you have any of the following:(3)
- Bleeding from the gums after brushing the teeth
- Swelling or pain at an injection site
- Black and blue skin (bruising)
- Excessive menstrual bleeding or bleeding between menstrual periods
- Diarrhea, vomiting, or inability to eat for more than 24 hours
- Fever (temperature greater than 100.4°F or 38°C), which could be a sign of infection that
might alter the INR
- A new medication prescribed by another clinician, because some medications can alter
the INR in people taking warfarin
- A planned surgery or procedure, because it may be necessary to stop the warfarin for a
period of time to decrease your risk of bleeding during or after the procedure
It is important to remember that warfarin is taken to reduce the risk of a clotting condition(s),
such as a deep vein thrombosis (DVT), pulmonary embolism (PE), or stroke. If you develop any
symptoms of a clot, seek immediate medical attention.(3)
Reduce the risk of bleeding

There is a tendency to bleed more easily than usual while taking warfarin. Some simple measures
can decrease this risk. Examples of common sense precautions include:(3)
- Always use a seatbelt.
- Wear a helmet when riding a bicycle or motorcycle.
- Avoid using non-prescription medicines that contain a nonsteroidal anti-inflammatory
drug ("NSAID") as well as other over-the-counter remedies without discussing with your
healthcare provider.
- When seeing any healthcare provider (doctor, dentist, nurse), tell them you are taking
warfarin.
Keep in mind that any injury you get could bleed more than normal. This includes everything from
small cuts to the skin (such as nicks from a razor) to more serious injuries. To lower your risk, you
can take extra care when doing things that could cause bleeding. This might include shaving with
an electric razor rather than a razor blade, being careful when using knives or sharp objects, and
avoiding certain contact sports with a high risk of injury. Additional measures some people take
include avoiding ice and other slippery surfaces, removing tripping hazards around your home,

and reducing the risk of tripping over a pet using aids such as bell collars, obedience training, and
two-handed leash holds. Use your clinician as a resource to help you figure out the approaches
that work best for you.(3)

Pregnancy and warfarin
Birth defects
Warfarin passes from mother to baby across the placenta and can interfere with normal blood
clotting in the baby. Warfarin can also interfere with the formation of bone and cartilage in the
developing fetus. These effects on blood clotting and development before birth can lead to birth
defects and other problems. A woman who becomes pregnant while on warfarin should notify
her healthcare provider immediately. A woman taking warfarin who plans to become pregnant
should discuss a plan of action with her healthcare provider. Heparin or low molecular weight
heparin (sample brand name: Lovenox) are anticoagulants that do not cross the placenta from
mother to baby and can be used instead of warfarin during pregnancy. Warfarin can be restarted
after delivery.(3)
Breastfeeding
Although warfarin does not pass into breast milk, a woman who wishes to breastfeed while taking
warfarin should consult her healthcare provider. Warfarin is considered safe for use in
breastfeeding women and their infants.(3)

Warfarin interactions
Warfarin and food
Some foods and supplements can interfere with warfarin's effectiveness. Consult a healthcare
provider before making major dietary changes (e.g., starting a diet to lose weight, starting a
nutritional supplement or vitamin).(3)
- Vitamin K – The use of warfarin should not interfere with a healthy diet. However, it is
important not to have large day-to-day variations in the amount of vitamin K intake from
food, because changes in the daily amount of vitamin K intake can alter the INR. People
who take warfarin should aim to eat a relatively similar amount of vitamin K-containing
foods each week. Moderate daily intake of approximately the same amount of vitamin K
is likely to keep the INR more stable. Switching to a lower amount of vitamin K can
increase the INR, potentially increasing the risk of bleeding; and switching to a greater
amount of vitamin K can lower the INR, potentially increasing the risk of blood clots. Some
foods that have a high level of vitamin K include: kale, broccoli, spinach, collard or turnip
greens, lettuce, Brussels sprouts, and cabbage.
- Cranberry juice and grapefruit juice – There have been mixed reports on the effect of
cranberry juice or grapefruit juice in people who use warfarin to prevent blood clots.
Some clinicians suggest that people taking warfarin not consume more than one or two
glasses of either juice per day.
Warfarin and alcohol

Alcohol in low or moderate amounts (one or two servings per day) is unlikely to have major
effects on the INR. People who consume alcohol should limit intake to 1 to 2 servings per day. A
serving is equal to 1 beer (12 ounces), 1 glass of wine (5 ounces), or 1.5 ounces of spirits. People
on warfarin therapy should avoid drinking excessive amounts of alcohol over a short period of
time (e.g., with a single meal) because this can affect the INR and increase the risk of injury and
serious bleeding.(3)
Warfarin and medications

A number of medications, herbs, and vitamins can interact with warfarin. Interactions may
change (either increase or decrease) the action of warfarin or the other medication. The warfarin
dose may need to be adjusted (up or down) to maintain an optimal anticoagulant effect. Any
time a new medicine is started or an existing one is stopped, people taking warfarin should have
their medications carefully analyzed for possible interactions.(3)

People who take warfarin should consult with their clinician before taking any new medication,
including over-the-counter (non-prescription) drugs, herbal medicines, vitamins, supplements,
or any other products. Some of the most common over-the-counter pain relievers, including
those that contain aspirin or an NSAID such as ibuprofen (sample brand names: Advil, Motrin) or
naproxen (sample brand name: Aleve), may increase the risk of bleeding. Acetaminophen (brand
name: Tylenol) may interact with warfarin if taken in doses over the recommended maximum of
4000 mg per 24-hour period. If more than one or two doses of a fever reducer or over-the-
counter pain medication is needed, acetaminophen is preferable to aspirin or an NSAID.(3)
Some anticoagulation specialists recommend that people avoid taking natural medicines and
herbs while on warfarin because the ingredients in these products are not standardized and their
effects on INR are unpredictable. However, if you do take a natural product or herbal supplement,
more frequent INR monitoring may be necessary to ensure safety. It's a good idea to talk to your
healthcare provider before you try any new herbs or supplements.(3)

Other recommendations
Wear medical identification
People who require long-term warfarin should wear a bracelet, necklace, or similar alert tag at
all times. In addition, a medication wallet card placed next to a driver's license or other official
identification can be helpful. If an accident occurs and the person is too ill to explain their
condition, this will help responders provide appropriate care.(3)
The alert tag should include a list of major medical conditions and the reason warfarin is needed
(e.g., atrial fibrillation), as well as the name and phone number of an emergency contact. One
device, Medic Alert, provides a toll-free number that emergency medical workers can call to find
out a person's medical history, list of medications, family emergency contact numbers, and
healthcare provider names and numbers. (3)
Traveling
Contact your doctor before you set off on any extended trips. While travelling, try to keep your
diet and level of activity as close to normal as possible. You may need an INR test while you are
away. Ensure the information written in this booklet is up to date and take this booklet with you.
If you consult a doctor while you are away, inform them you are taking warfarin. Make sure you
take enough warfarin tablets with you to last the entire trip.(65)
Can I switch to a different anticoagulant?

Many people who take warfarin wonder if they could switch to one of the anticoagulants that
do not require regular blood test monitoring. Medicines in this group are called direct oral
anticoagulants (DOACs). These medications include dabigatran (brand name: Pradaxa),
rivaroxaban (brand name: Xarelto), apixaban (brand name: Eliquis), and edoxaban (brand names:
Savaysa, Lixiana). These medicines are not monitored with regular blood tests, and in many
people, they may be safer than warfarin (less risk of bleeding). However, these medicines are not
the best choice for everyone. For example, warfarin is used for people with a mechanical heart
valve. Every medication has risks and benefits, and the best choice for you depends on your
individual situation. Ask your doctor if you have concerns or questions about which anticoagulant
you should take.(3)

Warts
Warts
Warts (verrucas) are caused by a human papillomavirus, which most frequently affects the hands,
feet (plantar warts) and the anogenital region; treatment usually relies on local tissue
destruction. Warts may regress on their own and treatment is required only if the warts are
painful, unsightly, persistent or cause distress.(10) 30% disappear within 6 months and most
disappear within 3 years without treatment in immunocompetent individuals).(2)
* Assess pregnancy status: podophyllotoxin and podophyllum resin are contraindicated and
there are limited data for the use of imiquimod in pregnancy (other treatments preferred). (2)
* Encourage patients with anogenital warts to tell sexual partners and suggest that they seek
medical advice. Screening for other STIs may also be appropriate.(2)
Cutaneous warts
Salicylic acid: treatment of choice; inexpensive and may be used at home; relatively safe with few
complications. It is irritant and not suitable for application to the face or broken skin; reduce
frequency of application if discomfort occurs. Use caution in diabetes and peripheral vascular
disease. Also available in combination with trichloroacetic acid and lactic acid. The combination
with lactic acid has not been shown to be more effective than salicylic acid alone.(2)
Glutaral: reserve for plantar warts; irritant and not suitable for application to face or broken skin;
stains skin brown; rarely used.(2)
Podophyllum resin: other treatments are preferred as evidence of efficacy is lacking and close
supervision is required due to risk of systemic toxicity.(2)
Anogenital warts
The treatment of anogenital warts (condylomata acuminate) should be accomplished by
screening for other sexually transmitted infections.(10)
Podophyllotoxin (the major active ingredient of podophyllum) may be used for soft, non-
keratinized external anogenital warts. Patients with a limited number of external warts or
keratinized lesions may be better treated with cryotherapy or other forms of physical
ablation.(10)
Imiquimod cream is licensed for the treatment of external anogenital warts; it may be used for
both keratinized and non-keratinized lesions. It is also licensed for the treatment of superficial
basal cell carcinoma and actinic keratosis.(10)

Trichloroacetic acid has been used by specialists to treat internal and external genital warts;
highly irritant and not suitable for self-treatment; mainly used in pregnancy.(2)
Camellia sinensis ointment is licensed for the treatment of external anogenital warts.(10)
Inosine pranobex is licensed for adjunctive treatment of genital warts but it has been superseded
by more effective drugs.(10)
Other drug treatment

Monochloroacetic acid, formaldehyde, nitric acid and silver nitrate are rarely used for cutaneous
warts. Retinoids, intralesional bleomycin, interferon alfa or beta, contact immunotherapy, oral
colchicine and cimetidine have been used in the treatment of cutaneous and anogenital warts
but there is insufficient evidence of efficacy. There is some evidence of efficacy for topical
fluorouracil but it is not superior to simpler treatments.(2)
Non-drug treatment
Cryotherapy may be useful for cutaneous and anogenital warts; multiple treatments required;
painful (essentially preventing use in children); contraindicated in patients with cold intolerance;
may cause scarring, dyspigmentation, infection and rarely, damage to underlying nerves.(2)
Electrosurgery and curettage, blunt dissection, carbon dioxide laser are costly options for
cutaneous and anogenital warts without distinct advantages; may be tried if topical agents or
cryotherapy fail.(2)
Counseling points
- Warts are usually harmless but may be unsightly. Warts on the feet are called verrucas
(or verrucae) and are sometimes painful.(7)
- Spontaneous resolution is seen in 30% of people within 6 months and two-third of cases
within 2 years.(15)
- To reduce the chance of passing on warts to others:(7)
o Don’t share towels.
o When swimming, cover any wart or verruca with a waterproof plaster.
o If you have a verruca, wear flip-flops in communal shower rooms and don’t share
shoes or socks.
- To reduce the chance of warts spreading to other areas of your body:(7)
o Don’t scratch warts or pick them.
o Don’t bite nails or suck fingers that have warts.

o If you have a verruca, change your socks or tights daily.
Practice point(2)
- As some warts may regress spontaneously, no treatment may be an option.
- HPV persists after treatment and a degree of infectivity may remain even in the absence
of clinical lesions.
- Patients with cutaneous warts should be advised about ways to reduce the chance of
spreading the infection (individual towels and avoiding skin maceration).
- Plantar warts at pressure points should be treated with non-surgical methods to reduce
risk of painful scarring.
- In patients with diabetes, lesions may be best left untreated since poor circulation may
result in infection.
- Specialist referral is required for oral, laryngeal, urethral, anorectal, vaginal and cervical
(especially if cervical dysplasia present on Pap smear) warts.
Anogenital warts
- Patients with warts should use condoms, particularly with new sexual partners, as they
protect against other STIs; however, condoms may only reduce the risk of HPV
transmission.
- HPV types that cause external visible warts are rarely associated with cervical
abnormalities that can cause cancer; women should have regular cervical smears as part
of the usual cervical screening program.

Podophyllum resin 5-25% paint
Indication Dosage
Cutaneous warts Adult, child >2 years, apply paint once a day. Wash off with soap and water
after 6 hours.
- Contraindicated in infants and pregnancy. Avoid use during breastfeeding.

- CDC STD guidelines no longer recommend podophyllum resin as an option for the
treatment of external genital warts due to reports of systemic toxicity when applied
incorrectly, and because of the availability of safer alternative agents. Use may be
considered for provider-administered treatment under select conditions.(12)
- Malaysia Ministry of Health Medicines Formulary for podophyllum 10-20% paint for
external anogenital warts: apply 2-3 drops carefully to lesion after protecting
surrounding area with Vaseline. Wash off after 6 hours or if feel burning sensation and
repeat 2-3 times weekly or once weekly.
Adverse effects(2)
- Common (>1%), staining of skin, local irritation including burning, inflammation, pain,
tenderness, itch, erythema
- Systemic toxicity, may occur, particularly if applied to normal skin or mucous membranes
or to large areas in excessive amounts for a long time. Effects may be delayed and include
GI (e.g. nausea, vomiting, diarrhea), neurological (e.g. confusion, neuropathy) and
hematological (e.g. thrombocytopenia, leucopenia).
Counselling(2)
- Avoid contact with eyes, face and other sensitive areas.
- Treat only a small number of warts at any one time; avoid application to normal skin.
- Stop application if there is pain or inflammation.
- Before applying, abrade hard skin on wart surface with a pumice stone or emery board.
Protect surrounding skin with white soft paraffin, e.g. Vaseline®. Allow to dry after
application.
Practice points(2)
- Other treatments for cutaneous warts are preferred as evidence of efficacy is lacking and
close supervision is required due to risk of toxicity.

- Podophyllum resin has been superseded by podophyllotoxin for the treatment of
anogenital warts.

Salicylic acid
Use the same way for adults and children
Indication Dosage form Dosage
Psoriasis Cream Apply cream in a thin layer to affected areas 2 or 3 times a

day.
Scalp psoriasis, Shampoo Apply to wet hair and massage vigorously into scalp and
dandruff, leave for at least 3–5 minutes; rinse hair thoroughly after
seborrheic shampooing; repeat twice a week.
dermatitis
Lotion Massage into affected areas twice daily and leave for
15 minutes; remove by rinsing thoroughly or shampooing.
Warts, corns, Liquid Apply 1 or 2 times a day.

calluses
Common and 50% Child and adult, apply daily, treatment may need to be
plantar warts ointment continued for up to 3 months.(10)
- Avoid contact with eyes, lips, broken skin or in nostrils.
- Wash hands immediately after applying medication unless hands are being treated.
- Psoriasis, to remove thick, adherent scales, creams or lotions may be used under
occlusion overnight, e.g. using a plastic shower cap.
- Warts, avoid contact with face and other sensitive areas. Before application, clean
affected area, soak wart in warm water for 5 minutes, remove loose tissue with a blade,
pumice stone, cloth or emery board and dry thoroughly. Apply preparation to lesion only;
protect surrounding skin with soft paraffin or by using a plaster with a hole cut in it.
Adverse effects(2)
- Infrequent (0.1–1%), skin irritation
- Rare (<0.1%), skin ulceration, erosion, salicylate intoxication
- Salicylate intoxication: Topical use of salicylic acid has resulted in salicylate intoxication
(symptoms include confusion, dizziness, headache, rapid breathing, tinnitus); deaths
have occurred. The risk of salicylate intoxication is increased in children, when applied in

large amounts or when used under occlusion (either naturally in skin folds or as occlusive
dressings).
Practice points(2)
- Concentrations of 2–6% are used to treat dandruff, seborrheic dermatitis, ichthyosis,
psoriasis; concentrations up to 70% are used to remove warts, corns and calluses.
- To minimize systemic absorption following application, do not use for prolonged periods,
in high concentrations, on large areas of the body, or on inflamed or broken skin.
- May be used with other agents such as coal tar (in eczema and psoriasis), dithranol (in
psoriasis), lactic acid, trichloroacetic acid and podophyllum resin (for warts).
- Keratolytic activity of salicylic acid potentiates effects of topical corticosteroids, dithranol
and tar by increasing their penetration into skin.
- Cumulative irritant or drying effect with abrasive or medicated soaps or cleansers, acne
preparations, ethanol-containing preparations and medicated cosmetics.
- There is insufficient evidence that the combination of lactic acid and salicylic acid is any
more effective than salicylic acid alone in treating warts.
- Although widely used for acne, its effectiveness is questionable.

Imiquimod 5% cream
After application leave on for 6–10 hours.
Indication Dosage
External genital Adult, child, apply to affected area 3 times a week (e.g. Monday,
and perianal warts Wednesday, Friday). Continue until there is total clearance of warts or
for a maximum period of 16 weeks. The median time to total wart
clearance is 10 weeks.
Superficial basal Apply to affected area 5 times a week (on consecutive days). Treat for
cell carcinoma 6 weeks.
Actinic keratoses Apply to one contiguous area of face or scalp 3 times a week (e.g.
Monday, Wednesday, Friday). The treatment area should not exceed
25 cm2. Treat for 4 weeks; if any lesions are still present 4 weeks later,
repeat 4-week course.
Alternatively, treat continuously for up to 16 weeks.
- Apply before bedtime. Wash off with mild soap and water about 6–10 hours later.
- Before applying, wash affected area with mild soap and water and allow to dry.
- Wash hands before and after use; avoid bathing or showering after application.
- Warts: apply a thin layer to the wart. If you decide to have sex, apply the cream
afterwards or wash it off if you have already applied the cream. The cream may also
weaken condoms and diaphragms and should be washed off before they are used.
- Basal cell carcinoma: apply to the lesion and about 1 cm of the surrounding skin. Protect
treated area from sunlight with protective clothing. Avoid sunlamps and tanning beds.
Do not apply cream in or near the hairline, eyes, ears, nose or lips unless advised to do
so by your doctor.
- Actinic keratoses: apply to the entire treatment area as directed by the doctor (usually
the forehead, one cheek or a section of the scalp). Protect treated area from sunlight
with protective clothing or use sunscreen. Avoid sunlamps and tanning beds. Avoid
contact with eyes, lips and nostrils.
- Tell patient not to use occlusive dressings over treated areas.(4)
Adverse effects(4)

- This drug may cause edema, erythema, vesicles, ulcerations, weeping, flaking, scaling,
dryness, or crusting of the skin.
- Drug may cause phototoxicity. Advise patient to minimize exposure to natural and
artificial light, and to use protective clothing and sunscreen.
- Advice patient on treated skin may have localized hypopigmentation or
hyperpigmentation that may be permanent.
- Instruct patient to report severe local reactions or systemic flu-like symptoms (malaise,
fever or myalgia).
- Advise patient to report vulvar swelling. Therapy should be interrupted or discontinued
with severe vulvar swelling as it may lead to urinary retention.
- Advise patient that imiquimod is not a cure for genital warts and that new warts may
develop during treatment.
- Warn patient treating genital warts to avoid sex (genital, anal or oral) during treatment.
The cream may weaken condoms and vaginal diaphragms.
Practice points(2)
- Not approved for urethral, intravaginal, cervical, rectal or intra-anal warts.
- Patients being treated for basal cell carcinoma or actinic keratoses may require a rest
period of several days from treatment if skin reactions are severe or cause discomfort; it
is not necessary to make up the missed doses or prolong duration of treatment in these
patients.
- Although there are no studies directly comparing the 2 regimens for actinic keratoses,
short-term clearance rates appear to be similar.

References
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Pharmacist Counseling Guide (2020)

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1 APRIL 2020 Pharmacist Counseling Guide

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Mild Comedones with or without a few or several pustules or papules

Moderate Comedones, several pustules or papules, with or without a few or several

Very severe Acne variants such as acne conglobate or acne formation

8|Page Prepared by Rx Note

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Acne vulgaris (includes Apply once at night

Acne vulgaris, mild-to- Apply morning and night

Rosacea 50 mg once daily.

Treatment of Adult, 100 mg every 12 hours for 7 days with quinine.

Indications and dosage(5)

Hypophosphataemic Child 1 month-11 year, 25-50 nanograms/kg once daily, dose to

Persistent neonatal Neonate, 50-100 nanograms/kg once daily, dose to be adjusted

Prevention of vitamin D Neonate, 20 nanograms/kg once daily, dose to be adjusted as

- Half-drop doses should be rounded up to the next whole number of drops.(6)

Directions for using One-Alpha® drops:(7)

- remove cause if practical, e.g. insect sting, stop an IV infusion

- continue to give IM adrenaline every 3–5 minutes

If response still inadequate, consider

- nebulized adrenaline for upper airway tract obstruction (stridor)

Indication and dosage(9)

Emergency treatment of allergic reactions Selection of the appropriate dosage strength

Prevention of Adult, 2.5 mg twice daily.

Prevention of Adult, 5 mg twice daily.

- Renal impairment: Contraindicated when CrCl <25 ml/minute.

Indications and dosage(9)

Children under 6 Not recommended.

How to use the spray(9)

To use the spray, hold the bottle in an upright position.

Options of bowel preparation

Indications and dosage(9)

For relief of Single daily dosage.

Positions for using this enema:

With steady pressure, gently insert enema tip into the

Squeeze bottle until nearly all liquid is gone. It is not

Remove Comfortip from rectum and maintain position until

Indications and dosage(9)

Used for the relief of

12 years & Mix 1 tablespoon in a Drink at least 1 3

10 to 11 years Mix 1 tablespoon in a Drink at least 1 1

5 to 9 years Mix 1/2 tablespoon in Drink at least 1 ½

Under 5 years Do not use. Do not use. Do not use.

- Do not take more unless directed by a doctor.

Morning Appointments 8.00am – 12 Afternoon Appointments 12 noon – 5.00pm

Alternative administration regimen(9)

Common Vomiting, chest pain and headache

Rare A buildup of calcium in the kidneys

Indications and dosage(9)

Children 10 and 11 years 10 to 20 ml (2 to 4 teaspoons)

Children 5 and 9 years 5 to 10 ml (1 to 2 teaspoons)

Children under 5 years DO NOT USE

Indications and dosage(9)

Bowel Do not administer to children under 18 years of age.

Morning appointments Afternoon appointments

The day before examination The day before examination:

Alternative: bowel cleansing dosing(9)