CLOTRIMAZOLE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

CLOTRIMAZOLE

Composition:

CLOTRIMAZOLE 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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 mycelia of Candida albicans . Strains

Product summary:

Clotrimazole Cream USP, 1% is supplied in Store between 2°- 30°C (36°- 86°F). CAUTION: Federal law prohibits dispensing without prescription. Mfd. by: TARO Pharmaceuticals Inc., Bramalea, Ontario, Canada L6T 1C3 Revision Date: June, 1996 Relabeling of "Additional barcode" label by: Physicians Total Care, Inc., Tulsa, OK      74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOTRIMAZOLE - CLOTRIMAZOLE CREAM
PHYSICIANS TOTAL CARE, INC.
----------
FOR EXTERNAL USE ONLY
ACTIVE INGREDIENT
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 contains 10 mg clotrimazole.
INACTIVE INGREDIENTS
Each gram of Clotrimazole Cream is dispersed in a vanishing cream base
of sorbitan monostearate,
polysorbate 60, cetyl esters wax, cetostearyl alcohol,
2-octyldodecanol, purified water, and benzyl
alcohol (1%) as preservative.
PURPOSE
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
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 have primary resistance