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:

Proficient Rx LP

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE- CLOTRIMAZOLE AND
BETAMETHASONE DIPROPIONATE CREAM
PROFICIENT RX LP
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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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•
•
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DOSAGE FORMS AND STRENGTHS
Cream, 1%/0.05%. (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). (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
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 (888) 721-
7115 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 1/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
_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