CLOTRIMAZOLE cream

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Glenmark Pharmaceuticals Inc., USA

प्रशासन का मार्ग:

TOPICAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 is contraindicated in individuals sensitive to its components.

उत्पाद समीक्षा:

Clotrimazole cream USP, 1% is supplied in 15, 30, 45 and (2 x 45) gram tubes. NDC 68462-181-17 (15 g) NDC 68462-181-35 (30 g) NDC 68462-181-47 (45 g) NDC 68462-181-48 (2 x 45 g)

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

CLOTRIMAZOLE- CLOTRIMAZOLE CREAM
GLENMARK PHARMACEUTICALS INC., USA
----------
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 USP 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 USP,
dispersed in a vanishing cream
base of sorbitan monostearate, polysorbate 60, cetyl esters wax,
cetostearyl alcohol, octyldodecanol,
purified water, 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 micronazole 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 report