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:

Physicians Total Care, Inc.

INN (International Name):

ECONAZOLE NITRATE

Composition:

ECONAZOLE NITRATE 10 mg in 1 g

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 byTrichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, andEpidermophyton 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 as follows: NDC 54868-5042-0 30 gram tube Store Econazole Nitrate 1% Cream below 86°F (30°C). E. FOUGERA & CO. A division of Nycomed US Inc. MELVILLE, NEW YORK 11747 I2312A R12/07 #20 Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ECONAZOLE NITRATE - ECONAZOLE NITRATE CREAM
PHYSICIANS TOTAL CARE, INC.
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ECONAZOLE NITRATE CREAM, 1%
RX ONLY
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Econazole Nitrate Cream, 1% contains the antifungal agent, econazole
nitrate 1%, in a water-miscible
base consisting of pegoxyl 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 theINDICATIONS 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, 1% is indicated for topical application in
the treatment of tinea pedis, tinea
cruris, and tinea corporis caused by_Trichophyton rubrum, Trichophyton
mentagr