CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

TruPharma LLC

Njia ya uendeshaji:

TOPICAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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.

Bidhaa muhtasari:

Clotrimazole topical solution USP, 1% is supplied in 30 mL plastic bottles (NDC 52817-800-30); boxes of one. Store between 2° to 30°C (36° to 86°F).

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

CLOTRIMAZOLE TOPICAL SOLUTION USP, 1%- CLOTRIMAZOLE TOPICAL SOLUTION
USP, 1% SOLUTION
TRUPHARMA LLC
----------
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 strctural 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
22
17
2
_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 pr