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:

Preferred 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 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 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 d

Product summary:

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% is white to off-white, uniform and smooth cream and supplied in Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not keep in cold or hot weather conditions. Rx only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE- CLOTRIMAZOLE AND
BETAMETHASONE DIPROPIONATE CREAM
PREFERRED 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 SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM.
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, USP, 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
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DOSAGE FORMS AND STRENGTHS
Cream, 1%/0.05%. (ERROR! HYPERLINK REFERENCE NOT VALID.) (3)
Each gram of Clotrimazole and Betamethasone Dipropionate Cream USP,
1%/0.05% (base) contains 10
mg of clotrimazole, USP and 0.643 mg of betamethasone dipropionate,
USP (equivalent to 0.5 mg of
betamethasone). (ERROR! HYPERLINK REFERENCE NOT VALID.) (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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•
•
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ADVERSE REACTIONS
Most common adverse reactions reported for clotrimazole and
betamethasone dipropionate cream 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 GLENMARK
PHARMACEUTICALS INC., USA AT
1 [phone] OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 5/2023
_Tinea pedis: _Apply a thin film to the affected skin areas twice a
day for 2 weeks. Do not use longer
than 4 weeks. (ERROR! HYPERLINK REFERENCE NOT VALID.)
_Tinea cruris and tinea corporis: