OXISTAT (oxiconazole nitrate) · ANI PHARMS

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/cm 2 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% o...

CLINICAL STUDIES The following definitions were applied to the clinical and microbiological outcomes in patients enrolled in the clinical trial that form the basis for the approval of OXISTAT Lotion. Definitions 1. Mycological Cure: No evidence (culture and KOH preparation) of the baseline (original) pathogen in a specimen from the affected area taken at the 2-week post-treatment visit (for tinea [pityriasis] versicolor, mycological cure was limited to KOH only). 2. Treatment Success: Both a global evaluation of 90% clinical improvement and a microbiologic eradication (see above) at the 2-week...

ADVERSE REACTIONS In a controlled, multicenter clinical trial of 269 patients treated with oxiconazole nitrate lotion , 1%, 7 (2.6%) reported adverse reactions thought to be related to drug therapy. These reactions included burning and stinging (0.7% each) and pruritus, scaling, tingling, pain, and dyshidrotic eczema (0.4% each). The following additional adverse experiences have been reported with the topical use of oxiconazole nitrate: irritation and allergic contact dermatitis, folliculitis, e...

CONTRAINDICATIONS OXISTAT Lotion is contraindicated in individuals who have shown hypersensitivity to any of their components.

Drug Interactions Potential drug interactions between OXISTAT and other drugs have not been systematically evaluated.