Overview
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 C 18 H 13 ON 3 CI 4 •HNO 3 , a molecular weight of 492.
Mechanism of Action
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/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% 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.
Indications
- INDICATIONS AND USAGE Oxiconazole nitrate cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum , Trichophyton mentagrophytes , or Epidermophyton floccosum . Oxiconazole nitrate cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES ).
Common Doses
- Refer to label
Dosage
DOSAGE AND ADMINISTRATION Oxiconazole nitrate cream should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Oxiconazole nitrate cream should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed.
Contraindications
- CONTRAINDICATIONS Oxiconazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of their components.
Side Effects
- ADVERSE REACTIONS During clinical trials, of 955 patients treated with oxiconazole nitrate cream , 1%, 41 (4.3%) reported adverse reactions thought to be related to drug therapy. These reactions included pruritus (1.6%); burning (1.4%); irritation and allergic contact dermatitis (0.4% each); folliculitis (0.3%); erythema (0.2%); and papules, fissure, maceration, rash, stinging, and nodules (0.1% each). 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.
Interactions
- Drug Interactions Potential drug interactions between oxiconazole nitrate cream and other drugs have not been systematically evaluated.