INFORMATION FOR HEALTH PROFESSIONALS
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POLARAMINE Repetabs
POLARAMINE Tablets
POLARAMINE Syrup
POLARAMINE Repetabs: Dexchlorpheniramine maleate 6 mg; red, sugar-coated tablets, marked with company logo.
POLARAMINE Tablets: Dexchlorpheniramine maleate 2 mg; dark pink oval tablets, marked with company logo.
POLARAMINE Syrup: Dexchlorpheniramine maleate 2 mg/5mL; red syrup.
Dexchlorpheniramine is the dextro-isomer of chlorpheniramine and is an effective histamine antagonist.
POLARAMINE is indicated for symptomatic treatment of perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis, mild uncomplicated allergic skin manifestations of urticaria and angioedema. Skin conditions such as allergic eczema, pruritus ani, pruritus vulvae, atopic dermatitis, contact dermatitis, insect bites, dermographism and drug reactions, including serum sickness, are often relieved by POLARAMINE.
Adults and children 12 years and over: One Repetabs every 12 hours. REPETABS should not be crushed or chewed, but swallowed whole.
Adults and children 12 years and over: One tablet every 6 hours
Children 6 to12 years: ½ tablet every 6 to 8 hours
| Adults and children 12 years and over | 5 mL every 6 hours |
| Children 6-12 years | 2-4 mL every 6 to 8 hours |
| Children 4-6 years | 1.75-2 mL every 6 to 8 hours |
| Children 2-4 years | 1.25-1.75 mL every 6 to 8 hours |
| Children 1-2 years | 1-1.25 mL every 6 to 8 hours |
| Children 6-12 months | 0.5 - 1 mL every 6 to 8 hours |
For children up to 1 year of age, use on the advice of a doctor or pharmacist.
POLARAMINE is contraindicated in newborn and premature infants, in patients receiving Monoamine oxidase inhibitor (MAOI) therapy and in those who have shown hypersensitivity to dexchlorpheniramine maleate or to other drugs of similar chemical structure.
Drowsiness can occur. Patients should be cautioned against engaging in mechanical operations that require alertness until the initial response to the drug has been observed.
POLARAMINE should be used with caution in narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy or bladder neck obstruction, cardiovascular disease including hypertension, in those with increased intraocular pressure or hyperthyroidism.
Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients (approximately 60 years or older).
POLARAMINE may cause excitability, especially in children.
Overdose of antihistamines may cause hallucinations, convulsions or death, especially in infants and children.
POLARAMINE should be used in the first two trimesters of pregnancy only if clearly needed. Dexchlorpheniramine maleate should not be used in the third trimester of pregnancy because newborn and premature infants may have severe reactions to antihistamines.
It is not known if the ingredients of POLARAMINE products are excreted in human milk and therefore caution should be exercised when administered to nursing mothers.
Antihistamines should be discontinued approximately 48 hours prior to skin testing procedures since these drugs may prevent or diminish otherwise positive reactions to dermal reactivity indicators.
Slight to moderate drowsiness is the most frequent side effect of dexchlopheniramine maleate.
Other reported reactions associated with antihistamine therapy in general include:
General:
Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, hypothermia, dryness of mouth, nose and throat.
Cardiovascular:
Headache, tachycardia, palpitations, extrasystoles, hypotension, hypertension.
Haematological:
Haemolytic anaemia, hypoplastic anaemia, thrombocytopenia, agranulocytosis.
Nervous System:
Sedation, dizziness, vertigo, tinnitus, acute labyrinthitis, disturbed coordination, fatigue, confusion, lassitude, depression, restlessness, inability to concentrate, excitation, nervousness, tremor, irritability, insomnia, euphoria, paraesthesia, blurred vision, diplopia, dilated pupils, hysteria, hypereflexia, hyporeflexia, neuritis, convulsions.
Gastrointestinal:
Epigastric distress, anorexia, nausea, vomiting, diarrhoea, constipation.
Genitourinary:
Urinary frequency, difficult urination, urinary retention, early menses.
Respiratory:
Thickening of bronchial secretions, tightness of chest, wheezing, nasal stuffiness.
Concomitant use with alcohol and CNS depressants (hypnotics, sedatives, tranquillisers, etc.) may potentiate the sedative effect of dexchlorpheniramine.
MAOIs prolong and intensify the effect of antihistamines.
The action of oral anticoagulants may be inhibited by antihistamines.
Tablets and Syrup: Store below 30°C.
Repetabs: Store below 25°C. Protect from moisture.
Restricted medicine
Repetabs: 20s, 40s
Tablets: 25s, 50s
Syrup: 100mL
Schering-Plough Pty Limited
33 Whakatiki Street
Upper Hutt
Wellington
NEW ZEALAND
14 December 2005