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:

Padagis Israel Pharmaceuticals Ltd

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 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% is available as follows: 15 g tube (NDC 45802-466 -35) 30 g tube (NDC 45802-466 -11) 85 g tube (NDC 45802-466 -53) Store at 20-25ºC (68-77ºF) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Padagis® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions. Manufactured by Padagis® Yeruham, Israel www.padagis.com Rev 11-23 71D00 RC PH2

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ECONAZOLE NITRATE- ECONAZOLE NITRATE CREAM
PADAGIS ISRAEL PHARMACEUTICALS LTD
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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, Trichophyto