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Clotrimazole and Betamethasone Dipropionate (Cream)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1326

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Clotrimazole and Betamethasone Dipropionate (Cream)
dailymed-instance:dosage
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. If a patient with tinea corporis or tinea cruris shows no clinical improvement after one week of treatment with Clotrimazole and Betamethasone Dipropionate Cream, the diagnosis should be reviewed. 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. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with Clotrimazole and Betamethasone Dipropionate Cream, the diagnosis should be reviewed. Clotrimazole and Betamethasone Dipropionate Cream should not be used with occlusive dressings.
dailymed-instance:descripti...
Clotrimazole and Betamethasone Dipropionate Cream USP contains combinations of clotrimazole USP, a synthetic antifungal agent, and betamethasone dipropionate USP, a synthetic corticosteroid, for dermatologic use. Chemically, clotrimazole is 1-(o-chloro-��,��-diphenylbenzyl)imidazole, with the empirical formula CHCIN, a molecular weight of 344.84, 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-11��,17,21-trihydroxy-16��-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula CHFO, a molecular weight of 504.59, 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 USP, contains 10 mg clotrimazole and 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of purified water, mineral oil, white petrolatum, cetearyl alcohol 70/30, ceteareth-30, propylene glycol, sodium phosphate monobasic, and phosphoric acid; benzyl alcohol as a preservative. Clotrimazole and Betamethasone Dipropionate Cream USP, is smooth, uniform, and white to off-white in color.
dailymed-instance:clinicalP...
Clotrimazole and Betamethasone Dipropionate: 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 a fungal infection may lead to suppression of host inflammation leading to worsening or decreased cure rate.<br/>Clotrimazole: 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/cmin the stratum corneum, to 0.5 to 1 mcg/cmin the reticular dermis, and 0.1 mcg/cmin 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.<br/>Microbiology:<br/>Betamethasone Dipropionate: 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. Inflammation and/or other disease processes in the skin may increase percutaneous absorption of topical corticosteroids. Occlusive dressingssubstantially 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. Studies performed with Clotrimazole and Betamethasone Dipropionate Cream indicate that these topical combination anti-fungal/corticosteroids 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.
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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.
dailymed-instance:supply
Clotrimazole and Betamethasone Dipropionate Cream USP 1%/0.05% (base) is supplied as follows: Store at 25��C (77��F); excursions permitted to 15��C-30��C (59��-86��F) [see USP Controlled Room Temperature]. E. FOUGERA&CO.a division of Altana Inc., MELVILLE, NEW YORK 11747 I2258DR10/05#52 Remove this portion before dispensing
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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. 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. Clotrimazole and Betamethasone Dipropionate Cream was applied using large dosages, 7 g daily for 14 days (BID) to the crural area of normal subjects. Three of the eight normal subjects on whom Clotrimazole and Betamethasone Dipropionate Cream was applied exhibited low morning plasma cortisol levels during treatment. Oneof these subjects had an abnormal Cortrosyn test. The effect on morning plasma cortisol was transient and subjects recovered one week after discontinuing dosing. 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. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios . 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. Information for Patients: Patients using Clotrimazole and Betamethasone Dipropionate Cream should receive the following information and instructions: Laboratory Tests: If there is a lack of response to Clotrimazole and Betamethasone Dipropionate Cream, 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: Carcinogenesis, Mutagenesis, Impairment of Fertility: There are no laboratory animal studies with either the combination of clotrimazole and betamethasone dipropionate or with either component individually to evaluate carcinogenesis. Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). 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. In genotoxicity testing of clotrimazole, chromosomes of the spermatophores of Chinese hamsters, which had been exposed to five daily oral clotrimazole doses of 100 mg/kg body weight, were examined for structural changes during the metaphase. The results of this study showed that clotrimazole had no mutagenic effect. Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1.0 mg/kg by the intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species.These doses are approximately 5- and 38-fold the human dose based on a mg/mcomparison, respectively. Oral doses of clotrimazole in mice resulted in decreased litter size at doses of 120 mg/kg and higher. This dose is approximately 10-fold the human dose based on a mg/mcomparison. A Segment I (fertility and general reproduction) study of clotrimazole was conducted in rats. Males and females were dosed orally (diet admixture) at doses of 5, 10, 25, or 50 mg/kg/day for 10 weeks prior to mating. At 50 mg/kg (approximately 8 times the human dose based on a mg/mcomparison), there was an adverse effect on maternal body weight gain and rearing of the offspring. Doses of 25 mg/kg (approximately 4 times the human dose based on a mg/mcomparison) and lower were well tolerated and produced no adverse effects on fertility or reproduction. Pregnancy Category C: There have been no teratogenic studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. A Segment II (teratology) study in pregnant rats with intravaginal doses up to 100 mg/kg clotrimazole have revealed no evidence of harm to the fetus. This dose is approximately 17-fold the human dose based on a mg/mcomparison. Segment II (teratology) studies of clotrimazole were conducted by the oral (gavage) route in rats, mice, and rabbits. In rats administered 25, 50, 100, or 200 mg/kg/day, no increase in malformations was seen at doses up to 200 mg/kg. Doses of 100 and 200 mg/kg were embryotoxic (increased resorptions) as well as maternally toxic, while doses of 25 and 50 mg/kg were well tolerated by both the dams and the fetuses. These doses were approximately 4-, 8-, 17- and 34-fold the human dose based on a mg/mcomparison, respectively. In pregnant mice, clotrimazole at oral doses of 25, 50, 100, or 200 mg/kg/day was not teratogenic and was well tolerated by both the dams and the fetuses. These doses were approximately 2-, 4-, 8-, and 17-fold the human dose based on a mg/mcomparison, respectively. No evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally with 60, 120, or 180 mg/kg/day. These doses were approximately 20-, 40-, and 61-fold the human dose based on a mg/mcomparison, respectively. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately one-fifth the human dose based on a mg/mcomparison. 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. Other corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. 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 Cream is administered to a nursing woman. Pediatric Use: Adverse events 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 (39.5%) evaluable pediatric patients (aged 12 to 16 years old) using Clotrimazole and Betamethasone Dipropionate Cream for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing. In another open-label study, 8 of 17 (47.1%) evaluable pediatric patients (aged 12 to 16 years old) using Clotrimazole and Betamethasone Dipropionate Cream for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing. THE USE OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM IN THE TREATMENT OF PATIENTS UNDER 17 YEARS OF AGE OR PATIENTS WITH DIAPER DERMATITIS IS NOT RECOMMENDED. Because of higher ratio of skin surface to body mass, pediatric patients under the age of 17 years are at higher risk with Clotrimazole and Betamethasone Dipropionate Cream. 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 Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Post-market adverse event reporting for Clotrimazole and Betamethasone Dipropionate Cream in patients aged 65 and above includes reports of skin atrophy and extremely rare reports of skin ulceration. Caution should be exercised with the use of these corticosteroid containing topical products on thinning skin. THE USE OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM UNDER OCCLUSION, SUCH AS IN DIAPER DERMATITIS, IS NOT RECOMMENDED.
dailymed-instance:overdosag...
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.
dailymed-instance:genericMe...
Clotrimazole and Betamethasone Dipropionate
dailymed-instance:fullName
Clotrimazole and Betamethasone Dipropionate (Cream)
dailymed-instance:adverseRe...
Adverse reactions reported for Clotrimazole and Betamethasone Dipropionate Cream in clinical trials were paresthesia in 1.9% of patients, and rash, edema, and secondary infection, each in less than 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.
dailymed-instance:indicatio...
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 Epidermophyton floccosum, Trichophyton mentagrophytes , and Trichophyton rubrum in patients 17 years and older. 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., Microsporum canis) has not been established. Several cases of treatment failure of Clotrimazole and Betamethasone Dipropionate Cream in the treatment of infections caused by Microsporum canis have been reported.
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Clotrimazole and Betamethasone Dipropionate