CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65), BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)

Available from:

Prasco Laboratories

INN (International Name):

CLOTRIMAZOLE

Composition:

CLOTRIMAZOLE 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clotrimazole and Betamethasone Dipropionate 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. None. Risk Summary There are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify a clotrimazole and betamethasone dipropionate cream associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of potent or very potent topical corticosteroid during pregnancy. Advise pregnant women that clotrimazole and betamethasone dipropionate cream may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortes

Product summary:

Clotrimazole and betamethasone dipropionate cream is white to off-white and supplied in 15-gram (NDC 66993-898-15) and 45-gram tubes (NDC 66993-898-45), 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]. Rx only

Authorization status:

New Drug Application

Summary of Product characteristics

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE- CLOTRIMAZOLE AND
BETAMETHASONE DIPROPIONATE CREAM
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOTRIMAZOLE AND BETAMETHASONE
DIPROPIONATE CREAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR CLOTRIMAZOLE AND
BETAMETHASONE DIPROPIONATE CREAM.
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1984
INDICATIONS AND USAGE
Clotrimazole and Betamethasone Dipropionate cream contains a
combination of clotrimazole, an azole antifungal, and
betamethasone dipropionate, a 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. (1)
DOSAGE AND ADMINISTRATION
_Tinea pedis:_ Apply a thin film to the affected skin areas twice a
day for 2 weeks. Do not use longer than 4 weeks. (2)
_Tinea cruris and tinea corporis:_ Apply a thin film to the affected
skin area twice a day for 1 week. Do not use longer than
2 weeks. (2)
Do not use with occlusive dressings unless directed by a physician.
(2)
Not for ophthalmic, oral or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Cream, 1%/0.05% (3)
Each gram of clotrimazole and betamethasone dipropionate cream
contains 10 mg of clotrimazole and 0.643 mg of
betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Clotrimazole and Betamethasone Dipropionate cream can cause reversible
HPA axis suppression with the potential for
glucocorticosteroid insufficiency during and after withdrawal of the
treatment. Risk factor(s) are: use of high-potency
topical corticosteroid, use over a large surface area or to areas
under occlusion, prolonged use, altered skin barrier,
liver failure, and young age. Modify use should HPA axis suppression
develop. (5.1, 8.4