Clotrimazole Cream

Name: Clotrimazole Cream

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 C22H17ClN2; 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.

Warnings

Clotrimazole Cream is not for ophthalmic use.

Precautions

General:

If irritation or sensitivity develops with the use of Clotrimazole Cream, treatment should be discontinued and appropriate therapy instituted.

Information for Patients :

The patient should be advised to:

1. Use the medication for the full treatment time even though the symptoms may have improved. Notify the physician if there is no improvement after four weeks of treatment. 2. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization. 3. Avoid the use of occlusive wrappings or dressings. 4. Avoid sources of infection or reinfection.

Laboratory Tests

If there is lack of response to Clotrimazole Cream, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antimycotic therapy.

Drug Interactions

Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.

Carcinogenesis, Mutagenesis, Impairment of Fertility

An 18-month oral dosing study with clotrimazole in rats has not revealed any carcinogenic effect.

In tests for mutagenesis, chromosomes of the spermatophores of Chinese hamsters which had been exposed to clotrimazole were examined for structural changes during the metaphase. Prior to testing, the hamsters had received five oral clotrimazole doses of 100 mg/kg body weight. The results of this study showed that clotrimazole had no mutagenic effect.

Usage in Pregnancy: Pregnancy Category B

The disposition of 14C-clotrimazole has been studied in humans and animals. Clotrimazole is very poorly absorbed following dermal application or intravaginal administration to humans. (See CLINICAL PHARMACOLOGY )

In clinical trials, use of vaginally applied clotrimazole in pregnant women in their second and third trimesters has not been associated with ill effects. There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy.

Studies in pregnant rats with intravaginal doses up to 100 mg/kg have revealed no evidence of harm to the fetus due to clotrimazole.

High oral doses of clotrimazole in rats and mice ranging from 50 to 120 mg/kg resulted in embroyotoxicity (possible secondary to maternal toxicity), impairment of mating, decreased litter size and number of viable young and decreased pup survival to weaning. However, clotrimazole was not teratogenic in mice, rabbits and rats at oral doses up to 200, 180 and 100 mg/kg, respectively. Oral absorption in the rat amounts to approximately 90% of the administered dose.

Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly indicated during the first trimester of pregnancy.

Nursing Mothers

It is not known whether this drug is excreted in human milk, caution should be exercised when clotrimazole is used by a nursing woman.

Pediatric Use

Safety and effectiveness in children have been established for clotrimazole when used as indicated and in the recommended dosage.

Dosage and administration

Gently massage sufficient Clotrimazole Cream into the affected and surrounding skin areas twice a day, in the morning and evening.

Clinical improvement, with relief of pruritis, usually occurs within the first week of treatment with Clotrimazole Cream. If the patient shows no clinical improvement after four weeks of treatment with Clotrimazole Cream, the diagnosis should be reviewed.

Principal Display Panel

NDC 68462-181-35
Clotrimazole Cream USP, 1%
For external use only. Not for ophthalmic use.

CLOTRIMAZOLE 
Clotrimazole Cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68462-181
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
WATER  
CETOSTEARYL ALCOHOL  
OCTYLDODECANOL  
POLYSORBATE 60  
SORBITAN  
Packaging
# Item Code Package Description
1 NDC:68462-181-17 15 g in 1 TUBE
2 NDC:68462-181-35 30 g in 1 TUBE
3 NDC:68462-181-47 45 g in 1 TUBE
4 NDC:68462-181-48 2 TUBE in 1 CARTON
4 45 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090219 08/04/2010
Labeler - Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 ANALYSIS(68462-181), MANUFACTURE(68462-181)
Revised: 10/2015   Glenmark Pharmaceuticals Inc., USA
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