Country: United States
Language: English
Source: NLM (National Library of Medicine)
ECONAZOLE NITRATE (UNII: H438WYN10E) (ECONAZOLE - UNII:6Z1Y2V4A7M)
Preferred Pharmaceuticals Inc.
TOPICAL
PRESCRIPTION DRUG
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, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor. Econazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.
Econazole Nitrate Cream, 1% contains econazole nitrate. The smooth white to off-white cream is available as follows: NDC-68788-7346-1 carton containing one 15 g tube NDC-68788-7346-3 carton containing one 30 g tube Store econazole nitrate cream below 86°F. To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215 U.S.A. 141025-0718 Revised: 7/2018 DPT:ECONCR:R4 Relabeled By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
ECONAZOLE NITRATE- ECONAZOLE NITRATE CREAM PREFERRED PHARMACEUTICALS INC. ---------- DESCRIPTION Econazole nitrate cream contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol- 7 stearate, and purified water. The smooth white to off-white cream is for topical use only. Chemically, econazole nitrate is (±)-1-[2,4-Dichloro-_β_-[(_p_-chlorobenzyl)oxy]phenethyl]-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. 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 YEAS TS _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 YEAS TS _Trichophyton verrucosum_ _Candida guillermondii_ _Candida parapsilosis_ _Candida tropicalis_ INDICATIONS AND USAGE 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, M Read the complete document