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
Polaramine, Tablets, film-coated – dexchlorpheniramine maleate 2 mg.
Polaramine, Syrup – dexchlorpheniramine maleate 2 mg/5 mL (0.4 mg/mL).
| Pharmaceutical Form |
|---|
Polaramine TabletsFilm-coated, immediate release tablets for oral use. Off-white, round, bevelled tablets with a score-line on one side. The score line is not intended for breaking the tablet. Polaramine SyrupSyrup for oral use. A clear, red syrup with an orange-like odour. |
Qualitative Composition in terms of the active ingredient:
All formulations: dexchlorpheniramine maleate.
Quantitative Composition in terms of the active ingredient:
Polaramine Tablets: dexchlorpheniramine maleate 2 mg.
Polaramine Syrup: dexchlorpheniramine maleate 2 mg in 5 mL (0.4 mg/mL).
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dexchlorpheniramine |
Dexchlorpheniramine, the d-isomer of the racemic compound chlorpheniramine, is two times more active than chlorpheniramine. Dexchlorpheniramine does not prevent the release of histamine, but rather, competes with free histamine for binding at the H1-receptor sites, and competitively antagonizes the effects of histamine on H1-receptors in the GI tract, uterus, large blood vessels, and bronchial muscle. Blockade of H1-receptors also suppresses the formation of oedema, flare, and pruritus that result from histaminic activity. Since dexchlorpheniramine binds to central and peripheral H1-receptors, sedative effects are likely to occur. Dexchlorpheniramine has high antihistaminic activity, moderate anticholinergic effects and minimal sedative effects. |
| List of Excipients |
|---|
|
Polaramine Tablets: Lactose, starch-maize, starch – pregelatinised maize, magnesium stearate. Polaramine Syrup: Sodium citrate, sodium chloride, sucrose, sorbitol solution (70 per cent), methyl hydroxybenzoate, propyl hydroxybenzoate, menthol, ethanol, water, brilliant scarlet 4R, apricot flavour, blood orange flavour. |
Polaramine Tablets: Available in blister packs of 20 and 40 tablets.
Polaramine Syrup: Available in a glass bottle of 100 mL.
Bayer New Zealand Limited, 3 Argus Place, Hillcrest, North Shore, Auckland 0627, P. O. Box 2825, Shortland Street, Auckland 1140, Freephone 0800 229 379
31 December 1969
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