CLOTRIMAZOLE cream

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65)

Commercializzato da:

Taro Pharmaceuticals U.S.A., Inc.

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis . Clotrimazole cream USP is contraindicated in individuals sensitive to its components.

Dettagli prodotto:

Clotrimazole Cream USP, 1% is supplied in 15 g (NDC 51672-1275-1), 30 g (NDC 51672-1275-2), 45 g (NDC 51672-1275-6) and (2 × 45) g (NDC 51672-1275-7) tubes. Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

CLOTRIMAZOLE- CLOTRIMAZOLE CREAM
TARO PHARMACEUTICALS U.S.A., INC.
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CLOTRIMAZOLE
CREAM USP, 1%
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
RX ONLY
DESCRIPTION
Clotrimazole Cream USP, 1% contains clotrimazole, a synthetic
antifungal agent having the chemical
name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular
formula C
H ClN ; a molecular
weight of 344.84; and the structural formula:
Clotrimazole is an odorless, white crystalline substance. It is
practically insoluble in water, sparingly
soluble in ether and very soluble in polyethylene glycol 400, ethanol
and chloroform.
Each gram of clotrimazole cream USP contains 10 mg clotrimazole,
dispersed in a vanishing cream base
of cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol,
polysorbate 60, purified water, sorbitan
monostearate, and benzyl alcohol (1%) as preservative.
CLINICAL PHARMACOLOGY
Clotrimazole is a broad-spectrum antifungal agent that is used for the
treatment of dermal infections
caused by various species of pathogenic dermatophytes, yeasts, and
_Malassezia furfur_. The primary
action of clotrimazole is against dividing and growing organisms.
_In vitro_, clotrimazole exhibits fungistatic and fungicidal activity
against isolates of _Trichophyton rubrum,_
_Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum
canis_ and _Candida_ species
including _Candida albicans_. In general, the _in vitro_ activity of
clotrimazole corresponds to that of
tolnaftate and griseofulvin against the mycelia of dermatophytes
(_Trichophyton_, _Microsporum_, and
_Epidermophyton_), and to that of the polyenes (amphotericin B and
nystatin) against budding fungi
(_Candida_). Using an _in vivo_ (mouse) and an _in vitro_ (mouse
kidney homogenate) testing system,
clotrimazole and miconazole were equally effective in preventing the
growth of the pseudomycelia and
22
17
2
mycelia of _Candida albicans_.
Strains of fungi having a natural resistance to clotrimazole are rare.
Only a single isolate of _Candida_
_guilliermondi_ has been reported t