CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE- 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:

NuCare Pharamceuticals,Inc.

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. Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies with clotrimazole and betamethasone dipropionate cream in pregnant women. Therefore, clotrimazole and betamethasone dipropionate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There have been no teratogenic studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. Corticosteroids are generally teratogenic in laboratory animals when administered at relatively low dosage levels. Studies in pregnant rats with intravaginal doses up to 100 mg/kg (15 times the maximum

Product summary:

Clotrimazole and betamethasone dipropionate cream, USP is available as follows: NDC 68071-1593-4 Box of 45g Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE- CLOTRIMAZOLE AND
BETAMETHASONE DIPROPIONATE CREAM
NUCARE PHARAMCEUTICALS,INC.
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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. ( 2)
Tinea cruris and tinea corporis: Apply a thin film to the affected
skin area twice a day for 1 week. ( 2)
Clotrimazole and betamethasone dipropionate cream should not be used
longer than 2 weeks in the treatment of tinea
corporis or tinea cruris, and longer than 4 weeks in the treatment of
tinea pedis. ( 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% (base) ( 3)
Each gram of clotrimazole and betamethasone dipropionate cream,
contains 10 mg of clotrimazole and 0.64 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 a