Dosage form: cream
Drug class:Topical antifungals
Medically reviewed by Drugs.com. Last updated on Nov 1, 2021.
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Ketoconazole Cream Description
Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of propylene glycol, stearyl and cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl myristate, butylated hydroxyanisole, polysorbate 80 and purified water.
Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula:
Molecular Formula: C26H28Cl2N4O4
Molecular Weight: 531.44
Ketoconazole Cream - Clinical Pharmacology
When Ketoconazole Cream, 2% was applied dermally to intact or abraded skin of Beagle dogs for 28 consecutive days at a dose of 80 mg, there were no detectable plasma levels using an assay method having a lower detection limit of 2 ng/ml.
After a single topical application to the chest, back and arms of normal volunteers, systemic absorption of ketoconazole was not detected at the 5 ng/ml level in blood over a 72-hour period.
Two derma...
