ECONAZOLE NITRATE cream

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Econazole Nitrate (UNII: H438WYN10E) (Econazole - UNII:6Z1Y2V4A7M)

Beschikbaar vanaf:

Teligent Pharma, Inc.

Toedieningsweg:

TOPICAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 samenvatting:

Econazole Nitrate Cream 1% is supplied in the following: 15 gram tube (NDC 52565-022-15) 30 gram tube (NDC 52565-022-30) 85 gram tube (NDC 52565-022-85) Store at controlled room temperature 20° to 25°C (68° to 77°F).

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ECONAZOLE NITRATE- ECONAZOLE NITRATE CREAM
TELIGENT PHARMA, INC.
----------
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 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.
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_
_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
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,_
_Mi