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BETAMETHASONE CLOTRIMAZOLE

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Overview

What is BETAMETHASONE CLOTRIMAZOLE?

Clotrimazole and Betamethasone Dipropionate Cream USP contains a combination of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic use.

Chemically, clotrimazole is 1-(-Chloro-α,α-diphenylbenzyl)imidazole, with the empirical formula CHClN, a molecular weight of 34484, and the following structural formula:

Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol.

Betamethasone dipropionate has the chemical name 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula CHFO, a molecular weight of 50460, and the following structural formula:

         

Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.

Each gram of Clotrimazole and Betamethasone Dipropionate Cream contains 10 mg clotrimazole and 064 mg betamethasone dipropionate (equivalent to 05 mg betamethasone), in a hydrophilic cream.

Cetereath-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, stearyl alcohol and white petrolatum; benzyl alcohol as preservative.

Clotrimazole and betamethasone dipropionate cream is smooth, uniform, and white to off-white in color.    



What does BETAMETHASONE CLOTRIMAZOLE look like?



What are the available doses of BETAMETHASONE CLOTRIMAZOLE?

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

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How should I use BETAMETHASONE CLOTRIMAZOLE?

Clotrimazole and betamethasone dipropionate cream is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis due to , , and . Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of clotrimazole and betamethasone dipropionate cream for the treatment of infections caused by zoophilic dermatophytes (e.g., ) has not been established. Several cases of treatment failure of clotrimazole and betamethasone dipropionate cream in the treatment of infections caused by have been reported.

Gently massage sufficient clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day, in the morning and evening.

Clotrimazole and betamethasone dipropionate cream should

not

be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used.

Clotrimazole and betamethasone dipropionate cream should not be used longer than 4 weeks in the treatment of tinea pedis, and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used.

Clotrimazole and betamethasone dipropionate cream should not be used with occlusive dressings.


What interacts with BETAMETHASONE CLOTRIMAZOLE?

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What are the warnings of BETAMETHASONE CLOTRIMAZOLE?

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What are the precautions of BETAMETHASONE CLOTRIMAZOLE?

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What are the side effects of BETAMETHASONE CLOTRIMAZOLE?

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What should I look out for while using BETAMETHASONE CLOTRIMAZOLE?

Clotrimazole and betamethasone dipropionate cream is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations.


What might happen if I take too much BETAMETHASONE CLOTRIMAZOLE?

Amounts greater than 45 g/week of clotrimazole and betamethasone dipropionate cream should not be used. Acute overdosage with topical application of clotrimazole and betamethasone dipropionate cream is unlikely and would not be expected to lead to life-threatening situation. Clotrimazole and betamethasone dipropionate cream should not be used for longer than the prescribed time period.

Topically applied corticosteroids, such as the one contained in clotrimazole and betamethasone dipropionate cream, can be absorbed in sufficient amounts to produce systemic effects (see section).


How should I store and handle BETAMETHASONE CLOTRIMAZOLE?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Clotrimazole and Betamethasone Dipropionate Cream USP is supplied in 15-gram and 45-gram tubes; boxes of one.Store between 2°C and 30°C (36°F and 86°F).Manufactured byActavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 0379Rev. 5/06VC2842Clotrimazole and Betamethasone Dipropionate Cream USP is supplied in 15-gram and 45-gram tubes; boxes of one.Store between 2°C and 30°C (36°F and 86°F).Manufactured byActavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 0379Rev. 5/06VC2842Clotrimazole and Betamethasone Dipropionate Cream USP is supplied in 15-gram and 45-gram tubes; boxes of one.Store between 2°C and 30°C (36°F and 86°F).Manufactured byActavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 0379Rev. 5/06VC2842Clotrimazole and Betamethasone Dipropionate Cream USP is supplied in 15-gram and 45-gram tubes; boxes of one.Store between 2°C and 30°C (36°F and 86°F).Manufactured byActavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 0379Rev. 5/06VC2842Clotrimazole and Betamethasone Dipropionate Cream USP is supplied in 15-gram and 45-gram tubes; boxes of one.Store between 2°C and 30°C (36°F and 86°F).Manufactured byActavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 0379Rev. 5/06VC2842Clotrimazole and Betamethasone Dipropionate Cream USP is supplied in 15-gram and 45-gram tubes; boxes of one.Store between 2°C and 30°C (36°F and 86°F).Manufactured byActavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 0379Rev. 5/06VC2842Clotrimazole and Betamethasone Dipropionate Cream USP is supplied in 15-gram and 45-gram tubes; boxes of one.Store between 2°C and 30°C (36°F and 86°F).Manufactured byActavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 0379Rev. 5/06VC2842Clotrimazole and Betamethasone Dipropionate Cream USP is supplied in 15-gram and 45-gram tubes; boxes of one.Store between 2°C and 30°C (36°F and 86°F).Manufactured byActavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 0379Rev. 5/06VC2842Clotrimazole and Betamethasone Dipropionate Cream USP is supplied in 15-gram and 45-gram tubes; boxes of one.Store between 2°C and 30°C (36°F and 86°F).Manufactured byActavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 0379Rev. 5/06VC2842


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Clotrimazole and betamethasone dipropionate cream has been shown to be at least as effective as clotrimazole alone in a different cream vehicle. Use of corticosteroids in the treatment of fungal infection may lead to suppression of host inflammation leading to worsening or decreased cure rate.

Skin penetration and systemic absorption of clotrimazole following topical application of clotrimazole and betamethasone dipropionate cream have not been studied. The following information was obtained using 1% clotrimazole cream and solution formulations. 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 05 to 1 mcg/cm in the reticular dermis, and 01 mcg/cm in the subcutis. No measurable amount of radioactivity (less than 0001 mcg/mL) was found in the serum within 48 hours after application under occlusive dressing of 05 mL of the solution or 08 g of the cream. Only 05% or less of the applied radioactivity was excreted in the urine.

Mechanism of Action: Clotrimazole is an imidazole antifungal agent. Imidazoles inhibit 14-α-demethylation of lanosterol in fungi by binding to one of the cytochrome P-450 enzymes. This leads to the accumulation of 14-α-methylsterols and reduced concentrations of ergosterol, a sterol essential for a normal fungal cytoplasmic membrane. The methylsterols may affect the electron transport system, thereby inhibiting growth of fungi.

Activity Clotrimazole has been shown to be active against most strains of the following dermatophytes, both and in clinical infections as described in the section: , , and .

Activity , clotrimazole has been shown to have activity against many dermatophytes,

Drug Resistance: Strains of dermatophytes having a natural resistance to clotrimazole have not been reported. Resistance to azoles including clotrimazole has been reported in some species.

No single-step or multiple-step resistance to clotrimazole has developed during successive passages of .

Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

Pharmacokinetics:

Once absorbed through the skin, the pharmacokinetics of topical corticosteroids are similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Studies performed with clotrimazole and betamethasone dipropionate cream indicate that this topical combination anti-fungal/corticosteroid may have vasoconstrictor potencies in a range that is comparable to high potency topical corticosteroids. Therefore use is not recommended in patients less than 17 years of age, in diaper dermatitis, and under occlusion.

Non-Clinical Toxicology
Clotrimazole and betamethasone dipropionate cream is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations.

Studies of drug interactions have not been conducted with DigiFab.

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Conditions which augment systemic absorption include use over large surface areas, prolonged use, and use under occlusive dressings. Use of more than one corticosteroid- containing product at the same time may increase total systemic glucocorticoid exposure. Patients applying clotrimazole and betamethasone dipropionate cream to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA-axis suppression. This may be done by using the ACTH stimulation, morning plasma cortisol, and urinary free cortisol tests.

If HPA-axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA-axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.

In a small study, clotrimazole and betamethasone dipropionate cream was applied using large dosages, 7 g daily for 14 days (BID) to the crural area of normal adult subjects. Three of the eight normal subjects on whom clotrimazole and betamethasone dipropionate cream was applied exhibited low morning plasma cortisol levels during treatment. One of these subjects had an abnormal Cortrosyn test. The effect on morning plasma cortisol was transient and subjects recovered one week after discontinuing dosing. In addition, two separate studies in pediatric patients demonstrated adrenal suppression as determined by cosyntropin testing. (See –Pediatric Usesection.)

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See – Pediatric Use section.)

If irritation develops, clotrimazole and betamethasone dipropionate cream should be discontinued and appropriate therapy instituted.

THE SAFETY OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM HAS NOT BEEN DEMONSTRATED IN THE TREATMENT OF DIAPER DERMATITIS. ADVERSE EVENTS CONSISTENT WITH CORTICOSTEROID USE HAVE BEEN OBSERVED IN PATIENTS TREATED WITH CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM FOR DIAPER DERMATITIS. THE USE OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM IN THE TREATMENT OF DIAPER DERMATITIS IS NOT RECOMMENDED.

Adverse reactions reported for clotrimazole and betamethasone dipropionate cream in clinical trials were paresthesia in 19% of patients, and rash, edema, and secondary infection, each in 1% of patients.

The following local adverse reactions have been reported with topical corticosteroids and may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. In the pediatric population, reported adverse events for clotrimazole and betamethasone dipropionate cream include growth retardation, benign intracranial hypertension, Cushing’s syndrome (HPA-axis suppression), and local cutaneous reactions, including skin atrophy.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Adverse reactions reported with the use of clotrimazole are as follows: erythema, stinging, blistering, peeling, edema, pruritus, urticaria 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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Professional

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Tips

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Interactions

Interactions

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