ECONAVIX- econazole nitrate

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. Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro Dermatophytes Yeasts Epidermophyton floccosum Candida albicans Microsporum audouini Malassezia furfur Microsporum canis Microsporum gypseum Trichophyton mentagrophytes Trichophyton rubrum Trichophyton tonsurans 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.
Microbiology
Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro Dermatophytes Yeasts Epidermophyton floccosum Candida albicans Microsporum audouini Malassezia furfur Microsporum canis Microsporum gypseum Trichophyton mentagrophytes Trichophyton rubrum Trichophyton tonsurans 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

Econazole Nitrate 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, Epidermophyton floccosum,

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.

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. To report SUSPECTED ADVERSE REACTIONS

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

Pregnancy
Econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. Fetotoxic or embryotoxic effects were observed in Segment I oral studies with rats receiving 10 to 40 time the human dermal dose. Similar effects were observed in Segment II or Segment III studies with mice, rabbits and/or rats receiving oral doses 80 or 40 time the human dermal dose.
Nursing Mothers
It is not known whether econazole nitrate is excreted in human milk. Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. Also, in lactating rats receiving large oral doses (40 or 80 times the human dermal dose), there was a reduction in post partum viability of pups and survival to weaning; however, at these high doses, maternal toxicity was present and may have been a contributing factor. Caution should be exercised when econazole nitrate is administered to a nursing woman.

Econazole Nitrate Cream is not for ophthalmic use.

Primary Pharmaceuticals, Inc.

ECONAVIX- econazole nitrate Product manual source documgent