ECONAZOLE NITRATE cream

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Bryant Ranch Prepack

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

Econazole Nitrate Cream, 1% is available as follows: 15 g tube (NDC 72162-1410-4) 30 g tube (NDC 72162-1410-3) 85 g tube (NDC 72162-1410-2) Store at 20-25ºC (68-77ºF) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ECONAZOLE NITRATE- ECONAZOLE NITRATE CREAM
BRYANT RANCH PREPACK
----------
ECONAZOLE NITRATE CREAM, 1%
RX ONLY
FOR TOPICAL USE ONLY
DESCRIPTION
Econazole Nitrate Cream contains the antifungal agent, econazole
nitrate 1%, in a water-
miscible base consisting of benzoic acid, butylated hydroxyanisole,
mineral oil, peglicol 5
oleate, pegoxol-7 stearate, and purified water. The white to off-white
soft cream is for
topical use only.
Chemically, econazole nitrate is
1-[2-{(4-chlorophenyl)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.
_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_
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, M