Prescription Drugs

CLINICAL PHARMACOLOGY Miconazole nitrate is a synthetic antifungal agent which inhibits the growth of the common dermatophytes, Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum, the yeastlike fungus, Candida albicans, and the organism responsible for tinea versicolor (Malassezia furfur).

Monistat-Derm (miconazole nitrate 2%) Cream DESCRIPTION MONISTAT-DERM (miconazole nitrate 2%) Cream contains miconazole nitrate* 2%, formulated into a water-miscible base consisting of pegoxol 7 stearate, peglicol 5 oleate, mineral oil, benzoic acid, butylated hydroxyanisole and purified water. *Chemical name: 1-[2,4-dichloro-b-{(2,4-dichlorobenzyl)oxy}phenethyl]imidazole mononitrate.

INDICATIONS For topical application in the treatment of tinea pedis (athlete's foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis (moniliasis), and in the treatment of tinea versicolor. DOSAGE AND ADMINISTRATION Sufficient MONISTAT-DERM (miconazole) Cream should be applied to cover affected areas twice daily (morning and evening) in patients with tinea pedis, tinea cruris, tinea corporis, and cutaneous candidiasis, and once daily in patients with tinea versicolor. If MONIESTAT-DERM Cream is used in intertriginous areas it should be applied sparingly and smoothed in well to avoid maceration effects. Early relief of symptoms (2 to 3 days) is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, Candida infections and tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after a month of treatment, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment. HOW SUPPLIED MONISTAT-DERM (miconazole nitrate 2%) Cream containing miconazole nitrate at 2% strength is supplied in 15g, 1 oz. and 3 oz. tubes.

PATIENT INFORMATION See CONTRAINDICATIONS and PRECAUTIONS.

OVERDOSE CONTRAINDICATIONS MONISTAT-DERM (miconazole nitrate 2%) Cream has no known contraindications.

WARNINGS PRECAUTIONS If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. For external use only. Avoid introduction of MONISTAT-DERM (miconazole) Cream into the eyes.