CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Tasman Pharma Inc.

给药途径:

TOPICAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Prescription clotrimazole topical solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product 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 fluoccosum , and Microsporum canis . Topical antifungal agents are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

產品總結:

Clotrimazole topical solution USP, 1% is supplied in 30 mL plastic bottles (NDC 72641-001-30); boxes of one. Store between 2° to 30°C (36° to 86°F).

授权状态:

Abbreviated New Drug Application

产品特点

CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% - CLOTRIMAZOLE TOPICAL SOLUTION
USP,
1% SOLUTION
TASMAN PHARMA INC.
----------
CLOTRIMAZOLE TOPICAL SOLUTION USP, 1%
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
This product is also available without a prescription.
RX ONLY
DESCRIPTION
Clotrimazole topical solution USP, 1% contains 10 mg clotrimazole USP,
a synthetic antifungal agent
having the chemical name 1-(o-Chloro-α,α-diphenylbenzyl) imidazole
with the following structural
formula:
MOLECULAR FORMULA C
H CIN
MOLECULAR WEIGHT 344.85
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 mL of clotrimazole topical solution USP, 1% contains 10 mg
clotrimazole USP in a nonaqueous
vehicle of polyethylene glycol 400.
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
22
17
2
_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