Daktarin Oral Gel Mechanism of Action

Pharmacotherapeutic Group: Antiinfectives and antiseptics for local oral treatment and Imidazole derivatives. ATC Code: A01A B09 and A07A C01.
Pharmacology: Pharmacodynamics: Mechanism of action: Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci.
Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis.
Pharmacokinetics: Absorption: Miconazole is systemically absorbed after administration as the oral gel. Administration of a 60 mg dose of miconazole as the oral gel results in peak plasma concentrations of 31 to 49 ng/mL, occurring approximately two hours post-dose.
Distribution: Absorbed miconazole is bound to plasma proteins (88.2%), primarily to serum albumin and red blood cells (10.6%).
Metabolism: The absorbed portion of miconazole is largely metabolized; less than 1% of an administered dose is excreted unchanged in the urine.
Elimination: The terminal half-life of plasma miconazole is 20 to 25 hours in most patients.
Special populations: Renal impairment: The elimination half-life of miconazole is similar in renally impaired patients. Plasma concentrations of miconazole are moderately reduced (approximately 50%) during hemodialysis.
Toxicology: Non-clinical information: 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.