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LOTRISONE (BETAMETHASONE DIPROPIONATE, CLOTRIMAZOLE) CREAM: PRESCRIBING INFORMATION

DESCRIPTION

Lotrisone (Clotrimazole and Betamethasone Dipropionate) cream, 1%/0.05%, contains combinations of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, for topical use.

Chemically, clotrimazole is 1-(o-chloro-alpha,alpha-diphenylbenzyl) imidazole, with the empirical formula C22H17CLN2, a molecular weight of 344.84.

Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol.

Betamethasone Dipropionate has 9-fluoro-11-beta,17,21-trihydroxy-16-beta-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.59.

Betamethasone Dipropionate is a white to creamy-white, odorless crystalline powder, insoluble in water.

Each gram of Lotrisone cream contains 10 mg clotrimazole and 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), in a white to off-white, hydrophilic cream consisting of benzyl alcohol as a preservative, cetyl alcohol plus stearyl alcohol, ceteareth-30, mineral oil, propylene glycol, phosphoric acid, purified water, sodium phosphate monobasic monohydrate, and white petrolatum.


CLINICAL PHARMACOLOGY

Lotrisone cream clinical pharmacology


MICROBIOLOGY

Lotrisone cream microbiology


NONCLINICAL TOXICOLOGY

Lotrisone cream nonclinical toxicology


CLINICAL STUDIES

In clinical trials of tinea corporis, tinea cruris, and tinea pedis, subjects treated with Lotrisone cream showed a better clinical response at the first return visit than subjects treated with clotrimazole cream. In tinea corporis and tinea cruris, the subject returned 3 to 5 days after starting treatment, and in tinea pedis, after 1 week. Mycological cure rates observed in subjects treated with Lotrisone cream (Betamethasone Dipropionate, Clotrimazole) were as good as, or better than, in those subjects treated with clotrimazole cream. In these same clinical studies, patients treated with Lotrisone cream showed better clinical responses and mycological cure rates when compared with subjects treated with betamethasone dipropionate cream.


INDICATIONS AND USAGE

Lotrisone cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.


DOSAGE AND ADMINISTRATION

Lotrisone cream dosage and administration


DOSAGE FORMS AND STRENGTHS

Topical cream, 1%/0.05%. Each gram of Lotrisone cream contains 10 mg of clotrimazole and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a white to off-white cream base.


CONTRAINDICATIONS

None.


WARNINGS

Lotrisone cream warnings


PRECAUTIONS

Lotrisone cream precautions


ADVERSE REACTIONS

Lotrisone cream adverse reactions


USE IN PREGNANCY

Lotrisone cream use in pregnancy


USE IN SPECIFIC POPULATIONS

Lotrisone cream use in specific populations


HOW SUPPLIED / STORAGE AND HANDLING

Lotrisone topical cream is white to off-white and supplied in 15-gram and 45-gram tubes, boxes of one.

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Manufactured and distributed by Merck, Schering-Plough pharmaceutical companies and their divisions.

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