Uses for clotrimazole and betamethasone dipropionate cream usp

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- Betamethasone And Clotrimazole (Topical Route) Description and Brand Names - Mayo Clinic



  localhost › drugs-supplements › description › drg This combination product contains two medications: betamethasone and clotrimazole. It is used to treat itchy, inflamed skin rashes caused by certain types of. Lotrisone (clotrimazole / betamethasone) is a combination medication used to treat skin conditions, like athlete's foot, ringworm, and jock itch.     ❾-50%}

 

Taro-Clotrimazole/Betamethasone dipropionate - Uses, Side Effects, Interactions - localhost - User Reviews & Rating



    The safety of Clotrimazole and Betamethasone Dipropionate Cream or Lotion has not been demonstrated in the treatment of diaper dermatitis. Common side effects may include: numbness, tingling, or stinging; skin dryness or rash; swelling; or new infections.

Topical corticosteroids can be absorbed from normal intact skin. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. 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. Therefore use is not recommended in patients less than 17 years of age, in diaper dermatitis, and under occlusion.

In the treatment of tinea pedis twice daily for 4 weeks, clotrimazole and betamethasone dipropionate lotion was shown to be superior to vehicle in relieving symptoms of erythema, scaling, pruritus, and maceration at week 2.

Clotrimazole and betamethasone dipropionate lotion was also shown to have a superior mycological cure rate compared to vehicle 2 weeks after discontinuation of treatment. It is unclear if the relief of symptoms at 2 weeks in this clinical study with clotrimazole and betamethasone dipropionate lotion was due to the contribution of betamethasone dipropionate, clotrimazole, or both. In the treatment of tinea cruris twice daily for 2 weeks, clotrimazole and betamethasone dipropionate lotion was shown to be superior to vehicle in the relief of symptoms of erythema, scaling, pruritus after 3 days.

It is unclear if the relief of symptoms after 3 days in this clinical study with clotrimazole and betamethasone dipropionate lotion was due to the contribution of betamethasone dipropionate, clotrimazole, or both. The comparative efficacy and safety of clotrimazole and betamethasone dipropionate lotion versus clotrimazole alone in a lotion vehicle have not been studied in the treatment of tinea pedis or tinea cruris or tinea corporis. The comparative efficacy and safety of clotrimazole and betamethasone dipropionate lotion and clotrimazole and betamethasone dipropionate cream have also not been studied.

Clotrimazole and betamethasone dipropionate lotion is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum.

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 lotion for the treatment of infections caused by zoophilic dermatophytes e. Clotrimazole and betamethasone dipropionate lotion is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations.

General: 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 lotion 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 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 period. 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.

If irritation develops, clotrimazole and betamethasone dipropionate lotion should be discontinued and appropriate therapy instituted. Information for Patients: Patients using clotrimazole and betamethasone dipropionate lotion should receive the following information and instructions:. Laboratory Tests: If there is a lack of response to clotrimazole and betamethasone dipropionate lotion, appropriate confirmation of the diagnosis, including possible mycological studies, is indicated before instituting another course of therapy.

The following tests may be helpful in evaluating HPA axis suppression due to the corticosteroid components: Urinary free cortisol test, Morning plasma cortisol test, ACTH stimulation test.

Carcinogenesis, Mutagenesis, Impairment of Fertility: There are no adequate laboratory animal studies with either the combination of clotrimazole and betamethasone dipropionate or with either component individually to evaluate carcinogenesis. It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

This pattern of response is similar to that of dexamethasone and hydrocortisone. Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1. These doses are approximately 5- and fold the maximum human dose based on body surface areas, respectively.

No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted. Pregnancy: Teratogenic Effects: Category C : There have been no teratogenic studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate.

Corticosteroids are generally teratogenic in laboratory animals when administered at relatively low dosage levels. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.

Clotrimazole and betamethasone topical combination is used to treat fungus infections. Clotrimazole works by killing the fungus or preventing its growth. Betamethasone, a corticosteroid cortisone-like medicine or steroid , is used to help relieve redness, swelling, itching, and other discomfort of fungus infections. There is a problem with information submitted for this request.

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This combination product contains two medications: betamethasone and clotrimazole. It is used to treat itchy, inflamed skin rashes caused by certain types of fungus e.

Betamethasone belongs to the group of medications called corticosteroids and it works by decreasing inflammation. Clotrimazole belongs to the group of medications called antifungals and it works by killing certain types of fungus. Once treatment is started, itching and redness are usually relieved within 3 to 5 days.

If relief does not occur after 1 week of use for jock itch or ringworm, contact your doctor. If relief does not occur after 2 weeks of use for athlete's foot, contact your doctor. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor.

Do not stop using this medication without consulting your doctor. Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

Each 1 g of smooth white cream contains 10 mg of clotrimazole USP and 0. Nonmedicinal ingredients: purified water, cetostearyl alcohol, white petrolatum, mineral oil, cetomacrogol , phosphoric acid, monobasic sodium phosphate, propylene glycol, benzyl alcohol as preservative and sodium hydroxide to adjust the pH. Apply a thin film of cream to completely cover the affected and surrounding skin areas twice daily, in the morning and at night or as directed by your doctor.

The cream is usually used for a period of 2 to 4 weeks depending on the condition being treated. Using the cream for more than 4 weeks is not recommended.

This cream should not be covered with bandages or other coverings after application. Do not use this medication in or near the eyes. If you are pregnant or breastfeeding, apply this medicine to the smallest skin area and for the shortest amount of time possible to treat your condition. This medicine is not approved for use by anyone younger than 17 years old.

Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. This is not a complete list of side effects and others may occur.

Call your doctor for medical advice about side effects. Do not use betamethasone and clotrimazole topical to treat any skin condition that has not been checked by your doctor. Avoid using other topical steroid medications on the areas you treat with betamethasone and clotrimazole, unless your doctor tells you to. Use Betamethasone And Clotrimazole Topical Lotrisone exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Wash your hands before and after using betamethasone and clotrimazole, unless you are using this medicine to treat the skin on your hands.

If you are a consumer or patient please visit this version. Clotrimazole and betamethasone dipropionate lotion contains combinations of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic use. Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate lotion contains 10 mg clotrimazole and 0.

Clotrimazole and betamethasone dipropionate lotion is opaque and white in color. No comparative studies have been conducted with clotrimazole and betamethasone dipropionate lotion and clotrimazole alone. Use of corticosteroids in the treatment of a 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 lotion have not been studied.

Only 0. Mechanism of Action: Clotrimazole is an imidazole antifungal agent. The methylsterols may affect the electron transport system, thereby inhibiting growth of fungi. Activity In Vitro: In vitroclotrimazole has been shown to have activity against many dermatophytes, but the clinical significance of this information is unknown. 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 Candida species.

No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Trichophyton mentagrophytes. Betamethasone dipropionate, a corticosteroid, has been shown to have topical dermatologic and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. 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.

Therefore use is not recommended in patients less than 17 years of age, in diaper dermatitis, and under occlusion. In the treatment of tinea pedis twice daily for 4 weeks, clotrimazole and betamethasone dipropionate lotion was shown to be superior to vehicle in relieving symptoms of erythema, scaling, pruritus, and maceration at week 2.

Clotrimazole and betamethasone dipropionate lotion was also shown to have a superior mycological cure rate compared to vehicle 2 weeks after discontinuation of treatment. It is unclear if the relief of symptoms at 2 weeks in this clinical study with clotrimazole and betamethasone dipropionate lotion was due to the contribution of betamethasone dipropionate, clotrimazole, or both.

In the treatment of tinea cruris twice daily for 2 weeks, clotrimazole and betamethasone dipropionate lotion was shown to be superior to vehicle in the relief of symptoms of erythema, scaling, pruritus after 3 days. It is unclear if the relief of symptoms after 3 days in this clinical study with clotrimazole and betamethasone dipropionate lotion was due to the contribution of betamethasone dipropionate, clotrimazole, or both.

The comparative efficacy and safety of clotrimazole and betamethasone dipropionate lotion versus clotrimazole alone in a lotion vehicle have not been studied in the treatment of tinea pedis or tinea cruris or tinea corporis. The comparative efficacy and safety of clotrimazole and betamethasone dipropionate lotion and clotrimazole and betamethasone dipropionate cream have also not been studied. Clotrimazole and betamethasone dipropionate lotion is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosumTrichophyton mentagrophytesand Trichophyton rubrum.

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 lotion for the treatment of infections caused by zoophilic dermatophytes e. Clotrimazole and betamethasone dipropionate lotion is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations.

General: 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 lotion 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 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 period.

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

Information for Patients: Patients using clotrimazole and betamethasone dipropionate lotion should receive the following information and instructions:. Laboratory Tests: If there is a lack of response to clotrimazole and betamethasone dipropionate lotion, appropriate confirmation of the diagnosis, including possible mycological studies, is indicated before instituting another course of therapy.

The following tests may be helpful in evaluating HPA axis suppression due to the corticosteroid components: Urinary free cortisol test, Morning plasma cortisol test, ACTH stimulation test. Carcinogenesis, Mutagenesis, Impairment of Fertility: There are no adequate laboratory animal studies with either the combination of clotrimazole and betamethasone dipropionate or with either component individually to evaluate carcinogenesis. It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

This pattern of response is similar to that of dexamethasone and hydrocortisone. Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1. These doses are approximately 5- and fold the maximum human dose based on body surface areas, respectively. No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted.

Pregnancy: Teratogenic Effects: Category C : There have been no teratogenic studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. Corticosteroids are generally teratogenic in laboratory animals when administered at relatively low dosage levels.

Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0. This dose is approximately one-fifth the maximum human dose. The abnormalities observed included umbilical hernias, cephalocele and cleft palates.

Betamethasone dipropionate has not been tested for teratogenic potential by the dermal route of administration. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. There are no adequate and well-controlled studies in pregnant women of the teratogenic effects of topically applied corticosteroids.

Therefore, clotrimazole and betamethasone dipropionate lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when clotrimazole and betamethasone dipropionate lotion is administered to a nursing woman. Pediatric Use: Adverse effects consistent with corticosteroid use have been observed in patients under 12 years of age treated with clotrimazole and betamethasone dipropionate cream.

In open-label studies, 17 of 43 In another open-label study, 8 of 17 Because of higher ratio of skin surface to body mass, pediatric patients under the age of 12 years are at higher risk with clotrimazole and betamethasone dipropionate lotion. The studies described above suggest that pediatric patients under the age of 17 years may also have this risk. They are at increased risk of developing Cushing's syndrome while on treatment and adrenal insufficiency after withdrawal of treatment.

Adverse effects, including striae and growth retardation, have been reported with inappropriate use of clotrimazole and betamethasone dipropionate cream in infants and children. Hypothalamic-pituitary-adrenal HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Geriatric Use : Clinical studies of clotrimazole and betamethasone dipropionate lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Caution should be exercised with the use of these corticosteroid containing topical products on thinning skin.

Adverse reactions reported for clotrimazole and betamethasone dipropionate lotion in clinical trials were burning and dry skin in 1. 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, miliaria, capillary fragility ecchymosestelangiectasia, and sensitization local reactions upon repeated application of product. 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. Acute overdosage with topical application of clotrimazole and betamethasone dipropionate lotion is unlikely and would not be expected to lead to life-threatening situation.

Clotrimazole and betamethasone dipropionate lotion should not be used for longer than the prescribed time period. Topically applied corticosteroids, such as the one contained in clotrimazole and betamethasone dipropionate lotion can be absorbed in sufficient amounts to produce systemic effects. Gently massage sufficient clotrimazole and betamethasone dipropionate lotion into the affected skin areas twice a day, in the morning and evening.

Clotrimazole and betamethasone dipropionate lotion should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 mL per week of clotrimazole and betamethasone dipropionate lotion should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after one week of treatment with clotrimazole and betamethasone dipropionate lotion, the diagnosis should be reviewed. Clotrimazole and betamethasone dipropionate lotion should not be used longer than 4 weeks in the treatment of tinea pedis, and amounts greater than 45 mL per week of clotrimazole and betamethasone dipropionate lotion should not be used.

If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate lotion, the diagnosis should be reviewed. What is clotrimazole and betamethasone dipropionate lotion? Clotrimazole and betamethasone dipropionate lotion is a medication used on the skin to treat fungal infections of the feet, groin, and body, as diagnosed by your doctor. Talk to your doctor if your fungal infection does not have these symptoms.

localhost › drugs-supplements › description › drg This combination medication is used to treat a variety of inflamed fungal skin infections such as ringworm, athlete's foot, and jock itch. Betamethasone and clotrimazole topical (for the skin) is a combination medicine used to treat fungal skin infections such as athlete's foot. Clotrimazole works against fungus. Betamethasone dipropionate, a corticosteroid, is used to help relieve redness, swelling, itching, and other discomforts of. CLOTRIMAZOLE; BETAMETHASONE (kloe TRIM a zole; bay ta METH a sone) is a corticosteroid and antifungal cream. It treats ringworm and infections like jock itch. Speak to your doctor about how any drug interactions are being managed or should be managed.

Clotrimazole and Betamethasone Dipropionate Cream and Lotion contain combinations of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic use. Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Clotrimazole and betamethasone dipropionate cream is smooth, uniform and white to off-white in color.

Each gram of Clotrimazole and Betamethasone Dipropionate Lotion contains Clotrimazole and Betamethasone Dipropionate Cream, USP has been shown to be at least as effective as clotrimazole alone in a different cream vehicle. No comparative studies have been conducted with Clotrimazole and Betamethasone Dipropionate Lotion and clotrimazole alone. Use of corticosteroids in the treatment of a 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 or Lotion have not been studied. Only 0. Clotrimazole is an imidazole antifungal agent. The methylsterols may affect the electron transport system, thereby inhibiting growth of fungi. In vitro, clotrimazole has been shown to have activity against many dermatophytes, but the clinical significance of this information is unknown. Strains of dermatophytes having a natural resistance to clotrimazole have not been reported.

Resistance to azoles including clotrimazole has been reported in some Candida species. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Trichophyton mentagrophytes. Betamethasone dipropionate, a corticosteroid, has been shown to have topical dermatologic and systemic pharmacologic and metabolic effects characteristic of this class of drugs. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. 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. Therefore, use is not recommended in patients less than 17 years of age, in diaper dermatitis, and under occlusion.

In clinical studies of tinea corporis, tinea cruris, and tinea pedis, patients treated with Clotrimazole and Betamethasone Dipropionate Cream, USP showed a better clinical response at the first return visit than patients treated with clotrimazole cream. In tinea corporis and tinea cruris, the patient returned 3 to 5 days after starting treatment, and in tinea pedis, after 1 week.

Mycological cure rates observed in patients treated with Clotrimazole and Betamethasone Dipropionate Cream, USP were as good as or better than in those patients treated with clotrimazole cream. In these same clinical studies, patients treated with Clotrimazole and Betamethasone Dipropionate Cream, USP showed better clinical responses and mycological cure rates when compared with patients treated with betamethasone dipropionate cream. In the treatment of tinea pedis twice daily for 4 weeks, Clotrimazole and Betamethasone Dipropionate Lotion was shown to be superior to vehicle in relieving symptoms of erythema, scaling, pruritus, and maceration at week 2.

Clotrimazole and Betamethasone Dipropionate Lotion was also shown to have a superior mycological cure rate compared to vehicle 2 weeks after discontinuation of treatment. It is unclear if the relief of symptoms at 2 weeks in this clinical study with Clotrimazole and Betamethasone Dipropionate Lotion was due to the contribution of betamethasone dipropionate, clotrimazole, or both. In the treatment of tinea cruris twice daily for 2 weeks, Clotrimazole and Betamethasone Dipropionate Lotion was shown to be superior to vehicle in the relief of symptoms of erythema, scaling, and pruritus after 3 days.

It is unclear if the relief of symptoms after 3 days in this clinical study with Clotrimazole and Betamethasone Dipropionate Lotion was due to the contribution of betamethasone dipropionate, clotrimazole, or both. The comparative efficacy and safety of Clotrimazole and Betamethasone Dipropionate Lotion versus clotrimazole alone in a lotion vehicle have not been studied in the treatment of tinea pedis or tinea cruris or tinea corporis.

The comparative efficacy and safety of Clotrimazole and Betamethasone Dipropionate Lotion and Clotrimazole and Betamethasone Dipropionate Cream have also not been studied. Clotrimazole and Betamethasone Dipropionate Cream and Lotion are indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum.

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 or Lotion for the treatment of infections caused by zoophilic dermatophytes e. Microsporum canis has not been established. Several cases of treatment failure of Clotrimazole and Betamethasone Dipropionate Cream, USP in the treatment of infections caused by Microsporum canis have been reported.

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

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 or Lotion 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. Three of the eight normal subjects on whom Clotrimazole and Betamethasone Dipropionate Cream, USP 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. If irritation develops, Clotrimazole and Betamethasone Dipropionate Cream or Lotion should be discontinued and appropriate therapy instituted. Patients using Clotrimazole and Betamethasone Dipropionate Cream or Lotion should receive the following information and instructions:.

If there is a lack of response to Clotrimazole and Betamethasone Dipropionate Cream or Lotion, appropriate confirmation of the diagnosis, including possible mycological studies, is indicated before instituting another course of therapy.

The following tests may be helpful in evaluating HPA-axis suppression due to the corticosteroid components:. There are no adequate laboratory animal studies with either the combination of clotrimazole and betamethasone dipropionate or with either component individually to evaluate carcinogenesis.

It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay. This pattern of response is similar to that of dexamethasone and hydrocortisone. Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1. These doses are approximately 5- and fold the maximum human dose based on body surface areas, respectively.

No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted. There have been no teratogenic studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. Corticosteroids are generally teratogenic in laboratory animals when administered at relatively low dosage levels.

Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0. This dose is approximately one-fifth the maximum human dose. The abnormalities observed included umbilical hernias, cephalocele and cleft palates.

Betamethasone dipropionate has not been tested for teratogenic potential by the dermal route of administration. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

There are no adequate and well-controlled studies in pregnant women of the teratogenic effects of topically applied corticosteroids. Therefore, Clotrimazole and Betamethasone Dipropionate Cream or Lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroids production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.

Because many drugs are excreted in human milk, caution should be exercised when Clotrimazole and Betamethasone Dipropionate Cream or Lotion is administered to a nursing woman. Adverse events consistent with corticosteroid use have been observed in patients under 12 years of age treated with Clotrimazole and Betamethasone Dipropionate Cream, USP. In open-label studies, 17 of 43 In another open-label study, 8 of 17 Because of higher ratio of skin surface area to body mass, pediatric patients under the age of 12 years are at a higher risk with Clotrimazole and Betamethasone Dipropionate Cream or Lotion.

The studies described above suggest that pediatric patients under the age of 17 years may also have this risk. They are at increased risk of developing Cushing's syndrome while on treatment and adrenal insufficiency after withdrawal of treatment.

Hypothalamic-pituitary-adrenal HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Clinical studies of Clotrimazole and Betamethasone Dipropionate Cream or Lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Postmarket adverse events reporting for Clotrimazole and Betamethasone Dipropionate Cream in patients aged 65 and above includes reports of skin atrophy and rare reports of skin ulceration.

Caution should be exercised with the use of these corticosteroid-containing topical products on thinning skin. Adverse reactions reported for Clotrimazole and Betamethasone Dipropionate Cream in clinical trials were paresthesia in 1. Adverse reactions reported for Clotrimazole and Betamethasone Dipropionate Lotion in clinical trials were burning and dry skin in 1.

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, capillary fragility ecchymoses , and sensitization local reactions upon repeated application of product.

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.

Acute overdosage with topical application of Clotrimazole and Betamethasone Dipropionate Cream or Lotion is unlikely and would not be expected to lead to a life-threatening situation.

Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used for longer than the prescribed time period. Gently massage sufficient Clotrimazole and Betamethasone Dipropionate Cream or Lotion into the affected skin areas twice a day, in the morning and evening. Clotrimazole and Betamethasone Dipropionate Cream or Lotion 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, USP or amounts greater than 45 mL per week of Clotrimazole and Betamethasone Dipropionate Lotion should not be used.



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