Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Pharmacotherapeutic group: Gynecological anti-infectives and antiseptics
ATC code: G01AF01
Metronidazole is a synthetic antibacterial agent which also possesses amoebicidal activity. Zidoval vaginal gel has been shown in vivo to be active against the vaginal pathogens Gardnerella vaginalis and bacteroides species.
Significant increases in lactobacilli are observed in bacterial vaginosis patients following therapy with Zidoval.
Bioavailability studies on the administration of a single 5 gram dose of Zidoval vaginal gel into the vagina of 12 normal subjects showed a mean Cmax serum concentration of 237 nanogram/ml or about 2% of the mean maximum serum concentration of a 500 mg tablet taken orally (mean Cmax = 12,785 ng/ml). Under normal usage, the formulation therefore affords minimal serum concentrations of metronidazole.
Metronidazole has a large apparent volume of distribution and has the ability to penetrate the blood brain barrier and blood cerebro-spinal fluid barrier at concentrations similar to serum concentrations.
Metronidazole is metabolised in the liver by side chain oxidation and glucuronide formation and a large portion of the absorbed dose is excreted as metabolites. Both unchanged drug and metabolites are excreted mainly in the urine.
At high doses metronidazole has been found to be mutagenic in bacteria but not in mammalian cells in vitro or in vivo. A carcinogenic potential has been demonstrated in mouse and rat but not in hamster. In epidemiological studies, no evidence of increased risk of cancer as a consequence of exposure to metronidazole has been observed.
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