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:

Proficient Rx LP

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 indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum . Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of clotrimazole and betamethasone dipropionate cream for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis ) has not been established. Several cases of treatment failure of clotrimazole and betamethasone dipropionate cream in the treatment of infections caused by Microsporum canis have been reported Clotrimazole and betamethasone dipropionate cream is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or i

Product summary:

Clotrimazole and Betamethasone Dipropionate Cream USP is supplied as follows: 15 gram tube in a carton (NDC 63187-095-15) 45 gram tube in a carton (NDC 63187-095-45) Store at 25°C (77(F); excursions permitted to 15(-30(C (59(-86(F) [See USP Controlled Room Temperature]. Manufactured by Actavis Mid Atlantic LLC 1877 Kawai Road Lincolnton, NC 28092 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA FORM NO. 0379 Rev. 9/08 VC3206 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE- CLOTRIMAZOLE AND
BETAMETHASONE DIPROPIONATE CREAM
PROFICIENT RX LP
----------
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM USP
RX ONLY
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL
USE. NOT RECOMMENDED FOR PATIENTS UNDER THE AGE OF 17 YEARS AND
NOT RECOMMENDED FOR DIAPER DERMATITIS.
DESCRIPTION
Clotrimazole and Betamethasone Dipropionate Cream USP contains a
combination of
clotrimazole, a synthetic antifungal agent, and betamethasone
dipropionate, a synthetic
corticosteroid, for dermatologic use.
Chemically, clotrimazole is 1-(_o_-chloro-α,α-diphenylbenzyl)
imidazole, with the empirical
formula C
H
ClN , a molecular weight of 344.84, and the following structural
formula:
Clotrimazole is an odorless, white crystalline powder, insoluble in
water and soluble in
ethanol.
Betamethasone dipropionate has the chemical name
9-fluoro-11(,17,21-trihydroxy-16(-
methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the
empirical formula
C
H
FO , a molecular weight of 504.59, and the following structural
formula:
Betamethasone dipropionate is a white to creamy white, odorless
crystalline powder,
insoluble in water.
22
17
2
28
37
7
insoluble in water.
Each gram of Clotrimazole and Betamethasone Dipropionate Cream
contains 10 mg
clotrimazole and 0.643 mg betamethasone dipropionate (equivalent to
0.5 mg
betamethasone), in a hydrophilic cream.
INACTIVE INGREDIENTS
Cetereath-30, cetyl alcohol, mineral oil, propylene glycol, purified
water, sodium
phosphate monobasic, stearyl alcohol and white petrolatum; benzyl
alcohol as
preservative.
Clotrimazole and betamethasone dipropionate cream is smooth, uniform,
and white to
off-white in color.
CLINICAL PHARMACOLOGY
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Clotrimazole and betamethasone dipropionate cream has been shown to be
at least as
effective as clotrimazole alone in a different cream vehicle. Use of
corticosteroids in the
treatment of fungal infection may lead to suppression of host
inflammation leading to