ROBITUSSIN DRY COUGH MEDICINE Liquid for oral administration Ref.[49979] Active ingredients: Demorphan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Cough suppressant
ATC code: R05DA09

Dextromethorphan hydrobromide is a cough suppressant which has a central action on the cough centre in the medulla. It has no analgesic properties and little sedative activity.

5.2. Pharmacokinetic properties

Dextromethorphan hydrobromide is well absorbed from the gastrointestinal tract.

Dextromethorphan undergoes rapid and extensive first-pass metabolism in the liver after oral administration. Genetically controlled O-demethylation (CYD2D6) is the main determinant of dextromethorphan pharmacokinetics in human volunteers.

It appears that there are distinct phenotypes for this oxidation process resulting in highly variable pharmacokinetics between subjects. Unmetabolised dextromethorphan, together with the three demethylated morphinan metabolites dextrorphan (also known as 3-hydroxy-N-methylmorphinan), 3-hydroxymorphinan and 3-methoxymorphinan have been identified as conjugated products in the urine.

Dextrorphan, which also has antitussive action, is the main metabolite. In some individuals metabolism proceeds more slowly and unchanged dextromethorphan predominates in the blood and urine.

5.3. Preclinical safety data

There is no relevant information additional to that already contained elsewhere in the SmPC or of relevance to the prescriber.

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