Dextromethorphan Polistirex Extended Release Suspension is indicated in:

• Chronic dry cough
• Unproductive cough
• Acute dry cough that interferes with normal function or sleep

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

Dextromethorphan Hydrobromide is a cough suppressant that acts centrally on the cough center in the medulla. Although it is structurally related to morphine, it has no analgesic properties and generally shows little sedative effect. No addiction has been observed even after prolonged use of relatively high doses. It is rapidly absorbed from the gastrointestinal tract, with onset of action within 15–30 minutes after oral administration. In Polistirex formulation, a matrix surrounds the dextromethorphan particles, slowing dissolution in the gastrointestinal tract and allowing gradual and prolonged release into the bloodstream. The duration of action is approximately 12 hours in the extended release suspension form. Dextromethorphan is extensively metabolized in the liver and excreted in urine as unchanged drug and demethylated metabolites, including Dextrorphan, which also has some cough suppressant activity. Urinary excretion of the parent drug and metabolites accounts for up to 50% of the administered dose within 24 hours. About 8% of the dose is excreted unchanged in urine within the first 6 hours.

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.

Two fatal interactions have been reported in patients receiving therapeutic doses of phenelzine and dextromethorphan together.

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

Adverse effects with Dextromethorphan are rare, but nausea and dizziness may occasionally occur. The drug does not produce analgesia, addiction, or significant central nervous system (CNS) depression. However, overdosage may cause excitation, confusion, and respiratory depression.

There is limited information regarding the use of this drug during pregnancy; therefore, it should be avoided during the first three months of pregnancy. No data are available on its secretion into breast milk, so breastfeeding mothers should avoid its use.

Dextromethorphan Polistirex is extensively metabolized in the liver and should be used with caution in patients with liver disease.

Cough suppressant

Store below 30°C in a dry place. Protect from light. Keep out of the reach of children.