Monistat-Derm

What is Monistat-Derm and how is it used?

Monistat-Derm (miconazole nitrate 2%) Cream is a prescription medicine used to treat the symptoms of fungal infections of the skin such as Jock Itch (tinea cruris), Ringworm (tinea corporis) and yeast infections of the skin (Cutaneous Candidiasis). Monistat-Derm may be used alone or with other medications.

Monistat-Derm belongs to a class of drugs called Antifungals, Topical.

It is not known if Monistat-Derm is safe and effective in children younger than 2 years of age.

What are the possible side effects of Monistat-Derm?

Monistat-Derm may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• severe blistering, andtin
• redness, or irritation of treated skin

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Monistat-Derm include:

• itching,
• peeling, and
• dry skin

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Monistat-Derm. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

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

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

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.

OVERDOSE

CONTRAINDICATIONS

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

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).

PATIENT INFORMATION

See CONTRAINDICATIONS and PRECAUTIONS.