Clotrimazole and Betamethasone (Clotrimazole / Betamethasone Dipropionate Topical) - Indications and Dosage

INDICATIONS AND USAGE

Clotrimazole and betamethasone dipropionate cream is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of clotrimazole and betamethasone dipropionate cream for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis) has not been established. Several cases of treatment failure of clotrimazole and betamethasone dipropionate cream in the treatment of infections caused by Microsporum canis have been reported

DOSAGE AND ADMINISTRATION

Gently massage sufficient clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day, in the morning and evening.

Clotrimazole and betamethasone dipropionate cream should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after one week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.

Clotrimazole and betamethasone dipropionate cream should not be used longer than 4 weeks in the treatment of tinea pedis, and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.

Clotrimazole and betamethasone dipropionate cream should not be used with occlusive dressings.

HOW SUPPLIED

Clotrimazole and Betamethasone Dipropionate Cream USP is supplied in 15-gram and 45-gram tubes; boxes of one.

Store between 2°C and 30°C (36°F and 86°F).

Manufactured by

Actavis Mid Atlantic LLC

1877 Kawai Road

Lincolnton, NC 28092 USA

FORM NO. 0379

Rev. 5/06

VC2842

ATTENTION PHARMACISTS: Detach “Patient Information Leaflet

Patient Package Insert

ATTENTION PHARMACISTS: Detach “Patient Information Leaflet” from package insert and dispense with product.

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM USP

Patient Information Leaflet

What is Clotrimazole and Betamethasone Dipropionate Cream?

Clotrimazole and Betamethasone Dipropionate Cream is a medication used on the skin to treat fungal infections of the feet, groin and body, as diagnosed by your doctor. Clotrimazole and Betamethasone Dipropionate Cream should be used for fungal infections that are inflamed and have symptoms of redness and/or itching. Talk to your doctor if your fungal infection does not have these symptoms. Clotrimazole and Betamethasone Dipropionate Cream contains a corticosteroid. Notify your doctor if you notice side effects with the use of Clotrimazole and Betamethasone Dipropionate Cream (see “What are the possible side effects of Clotrimazole and Betamethasone Dipropionate Cream?” below). Clotrimazole and Betamethasone Dipropionate Cream is not to be used in the eyes, in the mouth, or in the vagina.

How does Clotrimazole and Betamethasone Dipropionate Cream work? Clotrimazole and Betamethasone Dipropionate Cream is a combination of an antifungal agent (clotrimazole) and a corticosteroid (betamethasone dipropionate). Clotrimazole works against fungus. Betamethasone dipropionate, a corticosteroid, is used to help relieve redness, swelling, itching, and other discomforts of fungal infections.

Who should NOT use Clotrimazole and Betamethasone Dipropionate Cream? Clotrimazole and Betamethasone Dipropionate Cream is not recommended for use in patients under the age of 17 years. Clotrimazole and Betamethasone Dipropionate Cream is not recommended for use in diaper rash.

Patients who are sensitive to clotrimazole and betamethasone dipropionate, other corticosteroids or imidazoles or any ingredients in the preparation should not use Clotrimazole and Betamethasone Dipropionate Cream.