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:

Preferred Pharmaceuticals Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ECONAZOLE NITRATE CREAM 1% 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 1% is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

Product summary:

ECONAZOLE NITRATE CREAM 1% is supplied in tubes of; 15 grams (NDC68788-7046-1) 30 grams (NDC68788-7046-3) Store at controlled room temperature 20° - 25°C (68° - 77°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ECONAZOLE NITRATE- ECONAZOLE NITRATE CREAM
PREFERRED PHARMACEUTICALS INC.
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ECONAZOLE NITRATE CREAM 1%
RX ONLY
FOR TOPICAL, DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE.
PRESCRIBING INFORMATION
DESCRIPTION
Econazole Nitrate Cream 1% 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
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_
INDICATIONS AND USAGE
ECONAZOLE NITRATE CREAM 1% is indicated for topical application in the
treatment of
tinea pedis, tinea cruris