SOMINEX Tablet Ref.[7734] Active ingredients: Promethazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Actavis Group PTC ehf, Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland

Pharmacodynamic properties

Pharmacotherapeutic group: R06AD02

Promethazine hydrochloride – sedative. The drug is an antihistamine with anticholinergic activity.

Pharmacokinetic properties

Promethazine hydrochloride is readily absorbed from the gastrointestinal tract, but undergoes extensive first pass metabolism in the liver. With only 25% of the oral dose reaching the systemic circulation unchanged. After oral therapy therapeutic effects are identifiable at 15-30 minutes and peak plasma concentrations at 2 to 3 hours. Estimates of terminal half-life in blood plasma have been quoted as 4-6 hours. It is extensively plasma protein bound. It is eliminated mainly as metabolites, predominantly by the faecal (via biliary) route, with <1% of the parent compound and CA 10% as the sulfoxide metabolite being excreted in the urine over a 72 hour period.

Preclinical safety data

None stated.

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