UNIGYL Oral suspension Ref.[115710] Active ingredients: Methronidazole

Source: Registered Drug Product Database (NG)  Revision Year: 2025  Publisher: Unique Pharmaceuticals Limited, 11, Fatai Atere Way, Matori-Mushin Lagos, Tel: +234 8097421000, Email: mail@uniquepharm.com Drug product manufacturer: Unique Pharmaceuticals Limited, Km 38, Abeokuta Road, Sango-Ota, Ogun State, Nigeria, Tel: +234 8097421000, Email: mail@uniquepharm.com

5.1. Pharmacodynamic properties

The selective action of this compound against anaerobes and anoxic and hypoxic cells is due to the mode of action. The nitro group of metronidazole acts as electron acceptor and is thus reduced to a chemically reactive drug form. This produces biochemical lesions in the cells, thus causing death. The major site of action is believed to be DNA, where it causes loss of the helical structure and inhibits synthesis.

5.2. Pharmacokinetic properties

It is readily absorbed from the gastro-intestinal tract and widely distributed in body tissues. Half-life in plasma is about 8-10 hours. About 10% is bound to plasma proteins. It penetrates well into body tissues and fluids, including vaginal secretions, seminal fluid, saliva and breast milk. Therapeutic concentrations are also achieved in cerebrospinal fluid. Unchanged metronidazole and several metabolites are excreted in the urine, the liver is the main site of metabolism, and the major metabolites are because of side chain oxidation, forming glucuronides.

5.3. Preclinical safety data

Metronidazole has been shown to be carcinogenic in the mice and in the rat following chronic oral administration, however similar studies in the hamster have given negative results. Epidemiological studies have provided no clear evidence of an increased carcinogenic risk in humans.

Metronidazole has been shown to be mutagenic in bacteria in vitro. In studies conducted in mammalian cells in vitro as well as in rodent or humans in vivo, there was inadequate evidence of a mutagenic effect of metronidazole, with some studies reporting mutagenic effects, while other studies were negative.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.