Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Gynecological anti-infectives and antiseptics ATC code: G01 AF01
Metronidazole is a synthetic antibacterial agent which also possesses amoebicidal activity.
Zidoval 7.5 mg/g 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 7.5 mg/g vaginal gel .

Pharmacokinetic Properties

5.2 Pharmacokinetic properties
Bioavailability studies on the administration of a single 5 gram dose of Zidoval 7.5 mg/g 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.