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:

NORTHSTAR RX LLC

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 shortest

Product summary:

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% is a smooth white cream and supplied in 15-gram (NDC 16714-496-01) and 45-gram (NDC 16714-496-02) tubes; boxes of one. Store at 20° to 25°C (68° to 77°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
NORTHSTAR RX LLC
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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
0.64 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 areas under
occlusion, prolonged use, altered skin barrier, liver failure, and
young age. Modify use should HPA axis
suppression develop. (5.1, 8.4)
Ped