CLOTRIMAZOLE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International Name):

CLOTRIMAZOLE

Composition:

CLOTRIMAZOLE 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clotrimazole Cream 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.

Product summary:

Clotrimazole Cream USP 1% is supplied in tubes as: 15 gram       NDC 0168-0133-15 30 gram       NDC 0168-0133-30 45 gram       NDC 0168-0133-46 Store between 2°- 30°C (36°- 86°F). E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. MELVILLE, NEW YORK 11747 I2133B R09/11 #130

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOTRIMAZOLE- CLOTRIMAZOLE CREAM
E. FOUGERA & CO. A DIVISION OF FOUGERA 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 contains 10 mg clotrimazole, 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 clotrimzole 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_
22
17
2
Strains of fungi hav