Oxiconazole Nitrate Cream

Dosage form: cream
Drug class:Topical antifungals

Medically reviewed by Drugs.com. Last updated on Oct 22, 2021.

* Potency expressed as Oxiconazole

Rx Only
FOR TOPICAL DERMATOLOGIC USE ONLY—
NOT FOR OPHTHALMIC OR INTRAVAGINAL USE

Oxiconazole Nitrate Cream Description

Oxiconazole Nitrate Cream, 1% contains the antifungal active compound oxiconazole nitrate. This formulation is for topical dermatologic use only.

Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4•HNO3, a molecular weight of 492.15, and the following structural formula:

Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water.

Oxiconazole Nitrate Cream, 1% contains 10 mg of oxiconazole per gram of cream in a white to off-white cream base of cetyl alcohol, polysorbate 60, propylene glycol, purified water, stearyl alcohol, white petrolatum, and benzoic acid 0.2% as a preservative.

Oxiconazole Nitrate Cream - Clinical Pharmacology

Pharmacokinetics

The penetration of oxiconazole nitrate into different layers of the skin was assessed using an in vitro permeation technique with human skin. Five hours after application of 2.5 mg/cm2 of oxiconazole nitrate cream onto human skin, the concentration of oxiconazole nitrate was demonstrated to be 16.2 μmol in the epidermis, 3.64 μmol in the upper corium, and 1.29 μmol in the deeper corium. Systemic absorption of oxiconazole nitrate is low. Using radiolabeled drug, less than 0.3% of the applied dose of oxiconazole nitrate was recovered in the urine of volunteer subjects up to 5 days after application of the cream formulation. Neither in vitro nor in vivo studies have been conducted to establish relative activity between the lotion and cream formulations.