econazole nitrate 10 MG/ML Topical Foam

INDICATIONS AND USAGE Econazole nitrate topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older. Econazole nitrate is an azole antifungal indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes , and Epidermophyton floccosum in patients 12 years of age and older. ( 1 )

DOSAGE AND ADMINISTRATION Sufficient econazole nitrate cream, 1%, should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis. Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, candidal 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 the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

WARNINGS AND PRECAUTIONS - Contents are flammable. Instruct the patient to avoid heat, flame, and/or smoking during and immediately following application. ( 5.1 ) 5.1 Flammability Econazole nitrate topical foam is flammable. Avoid heat, flame, and smoking during and immediately following application. Contents under pressure. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C) even when empty. Do not store in direct sunlight.

CONTRAINDICATIONS Econazole Nitrate Cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

CLINICAL PHARMACOLOGY After topical application to the skin of normal subjects, systemic absorption of econazole nitrate is extremely low. Although most of the applied drug remains on the skin surface, drug concentrations were found in the stratum corneum, which, by far, exceeded the minimum inhibitory concentration for dermatophytes . Inhibitory concentrations were achieved in the epidermis and as deep as the middle region of the dermis. Less than 1% of the applied dose was recovered in the urine and feces. Microbiology: Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. ———————————————————————————————————— Dermatophytes Yeasts Epidermophyton floccosum Trichophyton mentagrophytes Candida albicans Microsporum audouini Trichophyton rubrum Malassezia furfur Microsporum canis Trichophyton tonsurans Microsporum gypseum ————————————————————————————————————— Econazole nitrate exhibits broad-spectrum antifungal activity against the following organisms in vitro , but the clinical significance of these data is unknown . ———————————————————————————————————— Dermatophytes Yeasts Trichophyton verrucosum Candida guillermondii Candida parapsilosis Candida tropicalis ————————————————————————————————————