Econazole Nitrate (econazole nitrate) - Dosing, PA Forms & Info (2026)
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    1. Home
    2. Econazole Nitrate - Econazole Nitrate cream

    Get your patient on Econazole Nitrate - Econazole Nitrate cream (Econazole Nitrate)

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    Prescribing informationPubMed™ news

    Econazole Nitrate - Econazole Nitrate cream prescribing information

    • Indications & usage
    • Dosage & administration
    • Contraindications
    • Adverse reactions
    • Drug interactions
    • Description
    • Pharmacology
    • How supplied/storage & handling
    • Data source
    • Indications & usage
    • Dosage & administration
    • Contraindications
    • Adverse reactions
    • Drug interactions
    • Description
    • Pharmacology
    • How supplied/storage & handling
    • Data source
    Prescribing Information
    Indications & Usage

    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, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.

    Dosage & Administration

    DOSAGE AND ADMINISTRATION

    Sufficient econazole nitrate cream, 1%, should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis.

    Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

    Contraindications

    CONTRAINDICATIONS

    Econazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

    Adverse Reactions

    ADVERSE REACTIONS

    During clinical trials, approximately 3% of patients treated with econazole nitrate cream 1% reported side effects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging and erythema. One case of pruritic rash has also been reported.

    Drug Interactions

    Drug Interactions

    Warfarin

    Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulation effect. Most cases reported product application with use under occlusion, genital application, or application to large body surface area which may increase the systemic absorption of econazole nitrate. Monitoring of International Normalized Ratio (INR) and/or prothrombin time may be indicated especially for patients who apply econazole to large body surface areas, in the genital area, or under occlusion.

    Description

    DESCRIPTION

    Econazole nitrate cream contains the antifungal agent, econazole nitrate USP 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglycerides PEG-6-32 stearate/glycol stearate 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:

    Referenced Image
    Pharmacology

    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
    How Supplied/Storage & Handling

    HOW SUPPLIED

    Econazole Nitrate Cream, 1% is supplied in tubes of 15 g (NDC 51672-1303-1), 30 g (NDC 51672-1303-2) and 85 g (NDC 51672-1303-8).

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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