BETAMETHASONE CLOTRIMAZOLE cream

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

clotrimazole (UNII: G07GZ97H65) (clotrimazole - UNII:G07GZ97H65), betamethasone dipropionate (UNII: 826Y60901U) (betamethasone - UNII:9842X06Q6M)

Disponible depuis:

Stat Rx USA

DCI (Dénomination commune internationale):

clotrimazole

Composition:

clotrimazole 10 mg

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 cortic

Descriptif du produit:

Clotrimazole and Betamethasone Dipropionate Cream USP is supplied in 15-gram and 45-gram tubes; boxes of one. Store between 2°C and 30°C (36°F and 86°F). Manufactured by Actavis Mid Atlantic LLC 1877 Kawai Road Lincolnton, NC 28092 USA FORM NO. 0379 Rev. 5/06 VC2842

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

BETAMETHASONE CLOTRIMAZOLE - BETAMETHASONE CLOTRIMAZOLE CREAM
STAT RX USA
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CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM
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-11β,17,21-trihydroxy-16β-methylpregna-
1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C
H FO , a molecular weight
of 504.60, and the following structural formula:
Betamethasone dipropionate is a white to creamy white, odorless
crystalline powder, insoluble in
22
17
2
28
37
7
water.
Each gram of Clotrimazole and Betamethasone Dipropionate Cream
contains 10 mg clotrimazole and
0.64 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 PHARMACOLOGYClotrimazole 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
worsening or decreased cure rate.
Clotrimazole
Skin penetration and systemic absorption of clotrimazole following
topical application of clotrimazole
and betamethasone dipropionate cream have not been studied. The
following information wa