CLOTRIMAZOLE cream

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)

Saatavilla:

NuCare Pharmaceuticals,Inc.

Antoreitti:

TOPICAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

Clotrimazole Cream USP, 1% is supplied in 15 g ( NDC 68071-2315-5) Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

CLOTRIMAZOLE- CLOTRIMAZOLE CREAM
NUCARE PHARMACEUTICALS,INC.
----------
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.
22
17
2
_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 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 to ha