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SPECTAZOLE
(econazole nitrate 1%)
Cream
631-11-331-1
For Topical Use Only
DESCRIPTION:
SPECTAZOLE Cream contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of pegoxol 7 stearate, peglicol 5 oleate, mineral oil, benzoic acid, butylated hydroxyanisole, and purified water. The white to off-white soft cream is for topical use only.
Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl) methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Its structure is as follows:
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.
INDICATIONS AND USAGE:
SPECTAZOLE Cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.
CONTRAINDICATIONS:
SPECTAZOLE Cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.
WARNINGS:
SPECTAZOLE is not for ophthalmic use.
PRECAUTIONS:
ADVERSE REACTIONS:
During clinical trials, approximately 3% of patients treated with econazole nitrate 1% cream reported side effects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging, and erythema. One case of pruritic rash has also been reported.
OVERDOSE:
Overdosage of econazole nitrate in humans has not been reported to date. In mice, rats, guinea pigs and dogs, the oral LD 50 values were found to be 462, 668, 272, and >160 mg/kg, respectively.
DOSAGE AND ADMINISTRATION:
Sufficient SPECTAZOLE Cream 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.
HOW SUPPLIED:
SPECTAZOLE (econazole nitrate 1%) Cream is supplied in tubes of 15 grams (NDC 0062-5460-02), 30 grams (NDC 0062-5460-01), and 85 grams (NDC 0062-5460-03).
Store SPECTAZOLE Cream below 86°F.
Ortho Dermatological, Division of
Ortho-McNeil Pharmaceutical, Inc.
Skillman, New Jersey 08558
© OMP 2001
Printed in U.S.A
Rev January 2001
631-11-331-1