TRADE NAME: Neopulmolar syrup GENERIC NAME: dextromethorphan hydrobromide, chlorpheniramine maleate. COMPOSITION: Each 5 ml contains: Active ingredient: Dextromethorphan hydrobromide 6.25 mg Chlorpheniramine maleate 1 mg :Excipients Methyl paraben sodium, propyl paraben sodium, sugar, saccharin sodium, glycerin, sodium sulphite, sodium editate, sodium citrate, citric acid monohydrate, veltol plus, cherry flavour. PHARMACEUTICAL FORM: Syrup PHARMACODYNAMICS: Dextromethorphan is a non-opioid antitussive drug. It exerts its antitussive activity by acting on the cough centre in the medulla oblongata, raising the threshold for the cough reflex Chlorpheniramine antagonises competitively the effects of histamine on H1-receptors and also has weak antimuscarinic and moderate antiserotonin and local anaesthetic actions. It penetrates the brain and causes stimulation or sedation in animals. PHARMACOKINETICS: Dextromethorphan Absorption Dextromethorphan is well absorbed from the gut following oral administration. Due to individual differences in the metabolism of dextromethorphan, pharmacokinetic values are highly variable. After the administration of a 20 mg dose of dextromethorphan to healthy volunteers, the Cmax varied from < 1 mg/l to 8 mg/l, occurring within 2.5 hours of administration. Distribution Due to extensive pre-systemic metabolism by the liver, detailed analysis of the distribution of orally administered dextromethorphan is not possible. Metabolism and Elimination Dextromethorphan undergoes rapid and extensive first-pass metabolism in the liver after oral administration. Dextrorphan, which also has antitussive action, is the main metabolite. Chlorpheniramine Chlorpheniramine maleate is almost completely absorbed after administration by mouth, peak plasma concentrations occurring at about 2.5 to 6 hours. The drug is widely distributed including passage into the CNS, with a volume of distribution of between 1 and 10L/KG. About 70% of chlorpheniramine in the circulation is protein-bound. Chlorpheniramine undergoes some first pass metabolism and enterohepatic recycling. Chlorpheniramine is extensively metabolised, principally to inactive desmethylated metabolites which are excreted primarily in the urine, together with about 35% unchanged drug. Only trace amounts are excreted in the faeces. The mean elimination half life has been reported to be about 30 hours, with mean values ranging from 2 to 43 hours. INDICATIONS: Neopulmolar syrup is indicated as an antitussive, for the relief of persistent, dry, irritating, allergic cough. DOSAGE AND ADMINISTRATION: - This product should not be administered completely to children less than 6 years old. Adults and children aged 12 years and over: 10 ml syrup 4 times a day or as directed by the physician. Do not exceed the stated dose. Keep out of the reach and sight of children.
