POLARAMINE Film-coated tablet / Syrup Ref.[8573] Active ingredients: Dexchlorpheniramine

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2017  Publisher: Bayer New Zealand Limited, 3 Argus Place, Hillcrest, North Shore, Auckland 0627, P. O. Box 2825, Shortland Street, Auckland 1140, Freephone 0800 229 379

Therapeutic indications

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. Polaramine may relieve itching due to skin conditions such as allergic eczema, pruritus ani, pruritus vulvae, atopic dermatitis, contact dermatitis, insect bites, dermographism and medicine reactions, including serum sickness.

Posology and method of administration

Polaramine Tablets

Adults and children over 12 years: One tablet every 6 hours.

Polaramine Syrup

Adults and children over 12 years: 5 mL every 6 hours.

Children 6-12 years: 2-4 mL every 6-8 hours.

Children 4 – 6 years: 1.75-2 mL every 6-8 hours.

Children 2-4 years: 1.25-1.75 mL every 6-8 hours.

Polaramine Syrup is not to be used in children under 2 years of age.

Paediatric Population

Polaramine Syrup can be used for children from 2 years of age.

Dosages are:

Children over 12 years: 5 mL every 6 hours.

Children 6-12 years: 2-4 mL every 6-8 hours.

Children 4 – 6 years: 1.75-2 mL every 6-8 hours.

Children 2-4 years: 1.25-1.75 mL every 6-8 hours.

Overdose

Manifestations

Antihistamine overdosage effects may vary from central nervous system depression (apnoea, arrhythmias, cardiovascular collapse, cyanosis, diminished mental alertness, sedation) to stimulation (convulsions, hallucinations, insomnia or tremors) to death. Other signs and symptoms may be ataxia, blurred vision, dizziness, hypotension and tinnitus. Stimulation is particularly likely in children, as are atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing; gastrointestinal symptoms and hyperthermia).

Treatment

Dialysis is of little value in antihistamine poisoning. Treatment of the signs and symptoms of an over dosage are symptomatic and supportive. Consider standard measures to remove any unabsorbed medicine. There is no specific antidote. Measures to enhance excretion (urinary acidification, haemodialysis) are not recommended.

Shelf life

Polaramine Tablets: 36 months (3 years) from date of manufacture.

Polaramine Syrup: 36 months (3 years) from date of manufacture.

Special precautions for storage

Tablets: Store at or below 25°C.

Syrup: Store at or below 25°C.

Nature and contents of container

Polaramine Tablets: Available in blister packs of 20 and 40 tablets.

Polaramine Syrup: Available in a glass bottle of 100 mL.

Special precautions for disposal and other handling

Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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