NIZORAL 200 mg tablet PATIENT INFORMATION A.20.2.2 Antimicrobial (chemotherapeutic) agents. Fungicides.NIZORAL is a synthetic imidazole dioxolane derivative, active in vitro against dermatophytes, yeasts and other pathogenic fungi. Mean peak plasma levels of approximately 3,5 micrograms/mL are reached within 1 to 2 hours, following oral administration of a single 200 mg dose taken with a meal. Subsequent plasma elimination is biphasic with a rapid elimination phase with a half-life of 2 hours followed by a slower elimination phase with a half-life of 8 hours. Following absorption from the gastro-intestinal tract, ketoconazole is converted into several inactive metabolites. The major identified metabolic pathways appear to be oxidation and degradation of the imidazole and piperazine rings, oxidative O-dealkylation and aromatic hydroxylation. Concentrations of active drug in the urine is very low. The major route of excretion is through the bile into the faeces.
