ECONAZOLE NITRATE- econazole nitrate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ECONAZOLE NITRATE (UNII: H438WYN10E) (ECONAZOLE - UNII:6Z1Y2V4A7M)

Available from:

Mylan Pharmaceuticals Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Econazole Nitrate Cream, 1% contains econazole nitrate. The smooth white to off-white cream is available as follows: NDC-0378-7625-15 carton containing one 15 g tube NDC-0378-7625-49 carton containing one 30 g tube NDC-0378-7625-85 carton containing one 85 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ECONAZOLE NITRATE- ECONAZOLE NITRATE CREAM
MYLAN PHARMACEUTICALS INC.
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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, Micro