CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)

可用日期:

REMEDYREPACK INC.

INN（国际名称）:

CLOTRIMAZOLE

组成:

CLOTRIMAZOLE 10 mg in 1 g

处方类型:

PRESCRIPTION DRUG

授权状态:

Abbreviated New Drug Application

产品特点

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE- CLOTRIMAZOLE AND
BETAMETHASONE DIPROPIONATE CREAM
REMEDYREPACK 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 area or to