PRO-BANTHINE Tablet Ref.[27547] Active ingredients: Propantheline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Kyowa Kirin Limited, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

5.1. Pharmacodynamic properties

Pharmacotherapuetic group: Synthetic anticholinergics, quaternary ammonium compounds
ATC Code: A03AB05

Pro-Banthine inhibits parasympathetic activity by blocking the action of the neurohormone, acetylcholine, on the neuroeffector cell. This blocking action of Pro-Banthine is instrumental in reducing gastric acid secretion and gastrointestinal motor activity.

5.2. Pharmacokinetic properties

Propantheline bromide is extensively metabolised in man. Some enzymatic hydrolysis of the drug may occur in the gastrointestinal tract prior to its absorption.

Studies in healthy men demonstrated that peak plasma levels of unchanged drug were reached within 2 hours of a single, oral dose of propantheline bromide. Following single oral dosing the plasma elimination half-life was about 2 to 3 hours and some 1% to 10% of propantheline bromide was excreted in urine as unchanged drug.

In healthy men studies have shown onset of antimuscarinic effects within 1 hour of oral administration. Effects persisted for up to 6 hours after oral dosing.

5.3. Preclinical safety data

Not applicable.

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