Indications

Brofex TS Extended Release Suspension is indicated in-
. Chronie dry cough
. Unproductive cough
. Acute dry cough, which is interfering with normal function or sleep.

Composition

Extended Release Suspension: Each 5 mL contains Dextromethorphan Polistirex INN equivalent to Dextromethorphan Hydrobromide 30 mg.

Pharmacology

Dextromethorphan Hydrobromide is a cough suppressant, which has a central action on the cough center in the medulla. Although structurally related to morphine, it has no analgesic properties and in general,
it has little sedative activity. Addiction has not been observed after the administration of rather large doses for prolonged period. It is rapidly absorbed from the Gl tract and exerts its effects in 15-30 minutes
ater oral administration. Polistirex forms a matrix around the Dextromethorphan particles, which slows down the dissolution of the Dextromethorphan in the gastrointestinall tract, leading to a gradual and
prolonged release of Dextromethorphan into the bloodstream. The duration of action is 12 hours with extended release suspension dosage form. Dextromethorphan Hydrobromide is extensively metabolized in
the liver and excreted in the urine as unchanged Dextromethorphan and de-methylated metabolites including Dextrophan, which has some cough suppressant activity. Urinary excretion of parent and
metabolites accounts for up to 50% of the ingested dose over 24 hours. About 8% of the dose is exereted unchanged in the urine over the first & hours.

Dosage & Administration

Adults and children 12 years of age and over: 10 ml every 12 hours. Do not exceed 20 ml in 24 hours.

Children (06-12 years): 5 ml every 12 hours. Do not exceed 10 ml in 24 hours.

Children (04-06 years): 2.5 ml every 12 hours. Do not exceed 5 ml in 24 hours.

Children under 04 years of age: Not Recommended.

Interaction

Two fatal interactions hove been reported in patients taking therapoutic doses of phenelzine and dextromethorphan.

Contraindications

Concomitant use of monoamine oxidase inhibitors is contraindicated with Dextromethorphan Polistirex.

Side Effects

Adverse effects with Brofex TS are rare, but nausea and dizziness sometimes occur. The drug produces no analgesia or addiction and little or no CNS depression. Excitation, confusion and respiratory depression
may occur after over dosage.