UNIGYL Tablet Ref.[115712] Active ingredients: Methronidazole

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

5.1. Pharmacodynamic properties

Metronidazole is an antimicrobial agent acting against a wide range of anaerobic bacteria and protozoa including Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia.

5.2. Pharmacokinetic properties

Metronidazole is rapidly absorbed from the gastro-intestinal tract. Peak plasma concentrations occur between twenty minutes and three hours.

The elimination half-life is 8.5 ± 2.9 hours. Metronidazole can be used in chronic renal failure; it is rapidly removed from the plasma by dialysis. Metronidazole is excreted in milk but the intake of a suckling infant of a mother receiving normal dosage would be considerably less than the therapeutic dosage for infants.

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.