BIODRAMINA Medicated chewing-gum Ref.[51123] Active ingredients: Dimenhydrinate

Source: Medicines Authority (MT)  Revision Year: 2013  Publisher: J. Uriach & Cรญa. S.A., Av. Camรญ Reial 51-57, 08184 Palau-solitร  i Plegamans, Barcelona, Spain

5.1. Pharmacodynamic properties

Dimenhydrinate, an antihistamine derived from ethanolamine, is an equimolecular complex of diphenhydramine with 8-chlorotheophylline that acts by blocking the H1-receptors of histamine, impeding the propagation of emetogenic afferent impulses in the vestibular nuclei. It also interferes with the integration of such impulses in the nucleus of the solitary tract. In addition to this action, dimenhydrinate has peripheral anticholinergic properties and therefore, inhibits the manifestations of hypersecretion and gastric hypermotility. It also produces sedative effects that help alleviate the symptoms of kinetosis.

5.2. Pharmacokinetic properties

Absorption

Dimenhydrinate is readily absorbed following oral administration, with a tmax of 2 hours. The antiemetic effect occurs 15 to 30 minutes after oral administration. Its action lasts from 3 to 6 hours.

Distribution and elimination

Antihistamines are widely distributed in the body. It crosses the placenta and small amounts are excreted in breast milk. Dimenhydrinate is extensively metabolised in the liver and rapidly excreted in urine in its metabolised form.

5.3. Preclinical safety data

The safety of this product is high and does not indicate the need to cite such studies.

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