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ATC Code: A01AB09 and A07AC01.
Pharmacology: Pharmacodynamics: Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci.
Its activity is based on the inhibition of the ergosterol biosynthesis in fungi and the change in the composition of the lipid components in the membrane, resulting in fungal cell necrosis.
Pharmacokinetics: Absorption: Miconazole is systemically absorbed after administration. Administration of a 60-mg dose of miconazole as the oral gel results in peak plasma concentrations (Cmax) of 31-49 ng/mL, occurring approximately 2 hrs post-dose.
Distribution: Absorbed miconazole is bound to plasma proteins (88.2%), primarily to serum albumin and red blood cells (10.6%).
Metabolism and Elimination: The absorbed portion of miconazole is largely metabolized; <1% of an administered dose is excreted unchanged in the urine. The terminal half-life (t½) of plasma miconazole is 20-25 hrs in most patients. The elimination t½ of miconazole is similar in renally impaired patients. Plasma concentrations of miconazole are moderately reduced (approximately 50%) during hemodialysis.
Toxicology: Preclinical Safety Data: Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single- and repeated-dose toxicity, genotoxicity and toxicity to reproduction.
