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Monistat-Derm

Last reviewed on RxList: 12/8/2004
Drug Description

Monistat-Derm
(miconazole nitrate 2%) Cream

DESCRIPTION

MONISTAT-DERM (miconazole nitrate 2%) Cream contains miconazole nitrate* 2%, formulated into a water-miscible base consisting of pegoxol 7 stearate, peglicol 5 oleate, mineral oil, benzoic acid, butylated hydroxyanisole and purified water.

*Chemical name: 1-[2,4-dichloro-b-{(2,4-dichlorobenzyl)oxy}phenethyl]imidazole mononitrate.

For Consumers

What are the possible side effects of miconazole topical?

Serious side effects of miconazole topical use are not expected. Stop using miconazole topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at...

Indications & Dosage

INDICATIONS

For topical application in the treatment of tinea pedis (athlete's foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis (moniliasis), and in the treatment of tinea versicolor.

DOSAGE AND ADMINISTRATION

Sufficient MONISTAT-DERM (miconazole) Cream should be applied to cover affected areas twice daily (morning and evening) in patients with tinea pedis, tinea cruris, tinea corporis, and cutaneous candidiasis, and once daily in patients with tinea versicolor. If MONIESTAT-DERM Cream is used in intertriginous areas it should be applied sparingly and smoothed in well to avoid maceration effects.

Early relief of symptoms (2 to 3 days) is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, Candida 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 a month of treatment, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

HOW SUPPLIED

MONISTAT-DERM (miconazole nitrate 2%) Cream containing miconazole nitrate at 2% strength is supplied in 15g, 1 oz. and 3 oz. tubes.

Side Effects & Drug Interactions

SIDE EFFECTS

There have been isolated reports of irritation, burning, maceration, and allergic contact dermatitis associated with the application of MONISTAT-DERM (miconazole) .

DRUG INTERACTIONS

Warnings & Precautions

WARNINGS

PRECAUTIONS

If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. For external use only. Avoid introduction of MONISTAT-DERM (miconazole) Cream into the eyes.

Overdosage & Contraindications

OVERDOSE

CONTRAINDICATIONS

MONISTAT-DERM (miconazole nitrate 2%) Cream has no known contraindications.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

Miconazole nitrate is a synthetic antifungal agent which inhibits the growth of the common dermatophytes, Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum, the yeastlike fungus, Candida albicans, and the organism responsible for tinea versicolor (Malassezia furfur).

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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