CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

NuCare Pharmaceuticals,Inc.

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Clotrimazole and betamethasone dipropionate cream USP 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

Produkt oppsummering:

Clotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base) is supplied as: NDC 68071-4134-4 Box of 45 g. 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]. Rx only

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE- CLOTRIMAZOLE AND
BETAMETHASONE DIPROPIONATE CREAM
NUCARE PHARMACEUTICALS,INC.
----------
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 USP, 1%/0.05%
(BASE), FOR
TOPICAL USE
INITIAL U.S. APPROVAL: 1984
INDICATIONS AND USAGE
Clotrimazole and betamethasone dipropionate cream USP contains a
combination of clotrimazole USP, an
azole antifungal, and betamethasone dipropionate USP, 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% ( 3)
Each gram of clotrimazole and betamethasone dipropionate cream,
1%/0.05% (base) contains 10 mg of
clotrimazole and 0.643 mg 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 hi