Indications

This syrup is indicated as an antitussive, for the relief of persistent, dry, irritating cough and aids restful sleep.

Composition

Each 5 ml syrup contains-
  • Diphenhydramine Hydrochloride BP 14 mg
  • Dextromethorphan Hydrobromide BP 6.5 mg
  • Levomenthol BP 2 mg

Pharmacology

Dextromethorphan Hydrobromide is a non-opioid antitussive drug. It exerts its antitussive activity by acting on the cough center in the medulla oblongata, raising the threshold for the cough reflex. Levomenthol has mild local anesthetic and decongestant properties. Diphenhydramine Hydrochloride possesses antitussive, antihistaminic, anticholinergic properties.

Dosage & Administration

Adults and children over 12 years: 2 teaspoonfuls of syrup 4 times a day or as directed by the physicians. Do not take more than 8 teaspoonfuls of syrup in 24 hours.

Use in children & Adolescents: The efficacy and safely of Dextromethorphan Hydrobromide have not been established in pediatric patients and adolescents.

Interaction

This syrup contains Diphenhydramine Hydrochloride and therefore may potentiate the effects of alcohol, and other CNS depressants. As Diphenhydramine Hydrochloride possess some anticholinergic activity, the effects of anticholinergics (e.g. some psychotrophic drugs and atropine) may be potentiated by this product. This may result in tachycardia, mouth dryness, gastrointestinal disturbances (e.g. colic), urinary retention and headache. The concomitant use of a Dextromethorphan Hydrobromide containing product and monoamine oxidase inhibitors can occasionally result in symptoms such as hyperpyrexia, hallucinations, gross excitation or coma.

Contraindications

This syrup is contraindicated in individuals with known hypersensitivity to the product or any of its components. This medicine is contraindicated in individuals who are taking, or have taken, monoamine oxidase inhibitor within the preceding two weeks. Dextromethorphan, In common with other centrally acting antitussive agents, should not be given to subjects in, or at risk of developing respiratory failure.

Side Effects

This syrup may cause drowsiness, dizziness, nausea, vomiting, gastrointestinal disturbance, dry mouth, nose and throat difficulty in urination, or blurred vision.

Pregnancy & Lactation

Pregnancy: Both Diphenhydramine Hydrochloride and Dextromethorphan Hydrobromide have been in widespread use for many years without apparent ill consequences. However, there is insufficient information on the effects of the administration of Dextromethorphan Hydrobromide during human pregnancy.

Lactation: It is not known whether dextromethorphan or its metabolites are excreted in breast milk. Diphenhydramine Hydrochloride is known to cross the placenta and has also been detected in breast milk. The syrup should therefore only be used when the potential benefit of treatment to the mother exceeds any possible hazards to the developing fetus or suckling infant.

Precautions & Warnings

This syrup may cause drowsiness; if affected, individuals should not drive or operate machinery. Diphenhydramine Hydrochloride should not be taken by individuals with narrow-angle glaucoma or symptomatic prostatic hypertrophy. Caution is particularly recommended for adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances.

Overdose Effects

With higher doses, and particularly in children, hallucinations and convulsions may appear; with massive doses, coma or cardiovascular collapse may follow. Treatment of overdose should be symptomatic and supportive. Measures to promote rapid gastric emptying and in cases of acute poisoning the use of activated charcoal may be useful. Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in children. Convulsions may be controlled with diazepam and thiopental sodium.

Therapeutic Class

Combined cough expectorants, Combined cough suppressants

Storage Conditions

Store at a temperature not exceeding 30°C in a dry place. Protect from liqht & moisture. Keep out of the reach of children.