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CLOTRIMAZOLE

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Overview

What is CLOTRIMAZOLE?

Clotrimazole Cream USP, 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula CHClN; 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, 2-octyldodecanol, purified water, and benzyl alcohol (1%) as preservative.



What does CLOTRIMAZOLE look like?



What are the available doses of CLOTRIMAZOLE?

Sorry No records found.

What should I talk to my health care provider before I take CLOTRIMAZOLE?

Sorry No records found

How should I use CLOTRIMAZOLE?

Clotrimazole Cream is indicated for the topical treatment of candidiasis due to and tinea versicolor due to .

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 , , , and .

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 pruritus, 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.


What interacts with CLOTRIMAZOLE?

Clotrimazole Cream is contraindicated in individuals sensitive to its components.



What are the warnings of CLOTRIMAZOLE?

Sorry No Records found


What are the precautions of CLOTRIMAZOLE?

Sorry No Records found


What are the side effects of CLOTRIMAZOLE?

The following adverse reactions have been reported in connection with the use of this product: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, burning, and general irritation of the skin.


What should I look out for while using CLOTRIMAZOLE?

Clotrimazole Cream is contraindicated in individuals sensitive to its components.


What might happen if I take too much CLOTRIMAZOLE?

Acute overdosage with topical application of clotrimazole is unlikely and would not be expected to lead to a life-threatening situation.


How should I store and handle CLOTRIMAZOLE?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Clotrimazole Cream USP, 1% is supplied in 15, 30, 45, and (2 × 45) gram tubes.Store between 2°- 30°C (36°- 86°F).CAUTION: Federal law prohibits dispensing without prescription.Mfd. by: Bramalea, Ontario, Canada L6T 1C3Revision Date: June, 1996Clotrimazole Cream USP, 1% is supplied in 15, 30, 45, and (2 × 45) gram tubes.Store between 2°- 30°C (36°- 86°F).CAUTION: Federal law prohibits dispensing without prescription.Mfd. by: Bramalea, Ontario, Canada L6T 1C3Revision Date: June, 1996Clotrimazole Cream USP, 1% is supplied in 15, 30, 45, and (2 × 45) gram tubes.Store between 2°- 30°C (36°- 86°F).CAUTION: Federal law prohibits dispensing without prescription.Mfd. by: Bramalea, Ontario, Canada L6T 1C3Revision Date: June, 1996Clotrimazole Cream USP, 1% is supplied in 15, 30, 45, and (2 × 45) gram tubes.Store between 2°- 30°C (36°- 86°F).CAUTION: Federal law prohibits dispensing without prescription.Mfd. by: Bramalea, Ontario, Canada L6T 1C3Revision Date: June, 1996Clotrimazole Cream USP, 1% is supplied in 15, 30, 45, and (2 × 45) gram tubes.Store between 2°- 30°C (36°- 86°F).CAUTION: Federal law prohibits dispensing without prescription.Mfd. by: Bramalea, Ontario, Canada L6T 1C3Revision Date: June, 1996


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Clinical Information

Chemical Structure

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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 . The primary action of clotrimazole is against dividing and growing organisms.

In vitro

Trichophyton rubrum

Trichophyton mentagrophytes

Epidermophyton floccosum

Microsporum canis

Candida

Candida albicans

in vitro

Trichophyton

Microsporum

Epidermophyton

Candida

in vivo

in vitro

Candida albicans

Strains of fungi having a natural resistance to clotrimazole are rare. Only a single isolate of has been reported to have primary resistance to clotrimazole.

No single-step or multiple-step resistance to clotrimazole has developed during successive passages of and . No appreciable change in sensitivity was detected after successive passage of isolates of , , or in liquid or solid media containing clotrimazole. Also, resistance could not be developed in chemically induced mutant strains of polyene-resistant isolates of . Slight, reversible resistance was noted in three isolates of tested by one investigator. There is a single report that records the clinical emergence of strain with considerable resistance to flucytosine and miconazole, and with cross-resistance to clotrimazole, the strain remained sensitive to nystatin and amphotericin B.

In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. Both these events began rapidly and extensively after addition of the drug.

Clotrimazole appears to be well absorbed in humans following oral administration and is eliminated mainly as inactive metabolites. Following topical and vaginal administration, however, clotrimazole appears to be minimally absorbed.

Six hours after the application of radioactive clotrimazole 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of clotrimazole varied from 100 mcg/cm in the stratum corneum to 0.5 to 1 mcg/cm in the stratum reticulare, and 0.1 mcg/cm in the subcutis. No measurable amount of radioactivity (≤0.001 mcg/mL) was found in the serum within 48 hours after application under occlusive dressing of 0.5 mL of the solution or 0.8 g of the cream. Only 0.5% or less of the applied radioactivity was excreted in the urine.

Following intravaginal administration of 100 mg C-clotrimazole vaginal tablets to nine adult females, an average peak serum level, corresponding to only 0.03 ug equivalents/mL of clotrimazole, was reached one to two days after application. After intravaginal administration of 5 g of 1% C-clotrimazole vaginal cream containing 50 mg active drug, to five subjects (one with candidal colpitis), serum levels corresponding to approximately 0.01 ug equivalents/mL were reached between 8 and 24 hours after application.

Non-Clinical Toxicology
Clotrimazole Cream is contraindicated in individuals sensitive to its components.

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

Clotrimazole Cream is not for ophthalmic use.

The following adverse reactions have been reported in connection with the use of this product: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, burning, and general irritation of the skin.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

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Tips

Tips

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Interactions

Interactions

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