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:

E. Fougera & Co. a division of Fougera Pharmaceuticals 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, 1%/0.05% (base) 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, 1%/0.05% (base) 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, 1%/0.05% (base)may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate crea

Product summary:

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) is supplied as follows: NDC 0168-0258-15, 15 gram tubes NDC 0168-0258-46, 45 gram tubes 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE- CLOTRIMAZOLE AND
BETAMETHASONE DIPROPIONATE CREAM
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS 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, 1%/0.05% (BASE) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (BASE).
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
CREAM, 1%/0.05% (BASE) FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1984
INDICATIONS AND USAGE
Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base)
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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions reported for clotrimazole and
betamethasone dipropionate cream, 1%/0.05% (base) were
paraesthesia in 1.9% of patients and rash, edema, and secondary
infections each in less than 1% of patients. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FOUGERA PHARMACEUTICALS
INC. AT 1-800-645-9833 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 8/2019
_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)
Cream, 1%/0.05%. (3