Adverse reactions reported for Clotrimazole and Betamethasone Dipropionate Lotion in clinical trials were burning and dry skin in 1.6% of patients and stinging in less than 1% of patients. It is possible that topical administration of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. They are at increased risk of developing Cushing's syndrome while on treatment and adrenal insufficiency after withdrawal of treatment. The following local adverse reactions have been reported with topical corticosteroids: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, skin atrophy, striae, miliaria, capillary fragility (ecchymoses), telangiectasia, and sensitization (local reactions upon repeated application of product). Shake well before using Clotrimazole and Betamethasone Dipropionate Lotion. acne outbreaks with skin redness. Clotrimazole and Betamethasone Dipropionate Lotion should be stored at 25C (77F) in the upright position only; excursions permitted between 15C and 30C (59F and 86F). Are there any other precautions or warnings for this medication? Clotrimazole and Betamethasone Dipropionate Cream or Lotion should. 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. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. The treated skin area should not be bandaged, covered, or wrapped so as to be occluded (See. Nonmedicinal ingredients: purified water, cetostearyl alcohol, white petrolatum, mineral oil, cetomacrogol 1000, phosphoric acid, monobasic sodium phosphate, propylene glycol, benzyl alcohol as preservative and sodium hydroxide to adjust the pH. Clotrimazole and Betamethasone Dipropionate Cream or Lotion is not recommended for use in diaper rash. lack of healing of skin condition. 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. Under Review - Editing is pending for RxNorm. Patients should avoid sources of infection or reinfection. In tinea corporis and tinea cruris, the patient returned 3 to 5 days after starting treatment, and in tinea pedis, after 1 week. Also in this study, doses up to 50 mg/kg/day (8 times the maximum human dose) had no adverse effects on dams or fetuses. (See DOSAGE AND ADMINISTRATION section.). Medical conditions: If you have stasis dermatitis and other skin conditions with reduced blood circulation, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Topical corticosteroids can be absorbed from normal intact skin. Was 21.99. How does this medication work? To minimize potential exposure to the breastfed infant via breast milk, use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Three of the eight normal subjects on whom Clotrimazole and Betamethasone Dipropionate Cream, USP was applied exhibited low morning plasma cortisol levels during treatment. Eyes: Do not use this medication in or around the eyes. What are the possible side effects of clotrimazole and betamethasone dipropionate cream? Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Inflammation and/or other disease processes in the skin may increase percutaneous absorption of topical corticosteroids. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Trichophyton mentagrophytes. NOT RECOMMENDED FOR PATIENTS UNDER THE AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS. If you would like more information, talk with your doctor. Betamethasone belongs to the group of medications called corticosteroids and it works by decreasing inflammation. [1], Common side effects include paresthesia, rash, edema, and secondary infections. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Updated Contact your doctor if you experience these side effects and they are severe or bothersome. April 11, 2023. Avoid contact of clotrimazole and betamethasone dipropionate cream with eyes. In addition, 2 separate trials in pediatric subjects demonstrated adrenal suppression as determined by cosyntropin testing [see Use in Specific Populations (8.4)]. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids. 19.79. Terbinafine results in resolution of toenail fungus 76% of the time. Betamethasone dipropionate 0.064% (=betamethasone 0.05%) with clotrimazole cream: potent. Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Clotrimazole and Betamethasone Dipropionate Cream and Lotion contain combinations of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic use. If you are a breast-feeding mother and are using this medication, it may affect your baby. Mycological cure rates observed in subjects treated with clotrimazole and betamethasone dipropionate cream were as good as, or better than, in those subjects treated with clotrimazole cream. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure. Helps you get and maintain an erection when you need it. It is best to have had some test to prove a. may help, bit the antifungal is a waist. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. This medication may be available under multiple brand names and/or in several different forms. If in scope, these drugs will include RxNorm normal forms when editing is complete. Each 1 g of smooth white cream contains 10 mg of clotrimazole USP and 0.64mg of betamethasone dipropionate, USP, equivalent to 0.5mg (0.05%) of betamethasone USP, in a hydrophilic emollient cream. 4. Please note, we cannot prescribe controlled substances, diet pills, antipsychotics, or other commonly abused medications. Advise pregnant women that clotrimazole and betamethasone dipropionate cream may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible. The combination is useful for inflammatory diseases in areas prone to. Product Information Customer Reviews Product Summary This product requires a valid prescription for shipment, please note that HealthWarehouse.com may not accept prescriptions faxed or emailed by patients. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. You should tell your doctor if your problem persists after 2 weeks. As well, some forms of this medication may not be used for all of the conditions discussed here. "Betamethasone Topical: MedlinePlus Drug Information". Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cushing's syndrome and hyperglycemia may also occur due to the systemic effect of corticosteroids while on treatment. Side effects can be mild or severe, temporary or permanent. Before using Clotrimazole and Betamethasone Dipropionate Cream or Lotion, tell your doctor if you are pregnant or plan to become pregnant. Treatment of tinea corporis or tinea cruris: Clotrimazole and betamethasone dipropionate cream is for topical use only. sores or blisters that do not heal properly. When using Clotrimazole and Betamethasone Dipropionate Cream or Lotion in the groin area, it is especially important to use the medication for 2 weeks only, and to apply the cream or lotion sparingly. Epidermophyton floccosum, Trichophyton mentagrophytes. Advise the patient to read the FDA-approved patient labeling (Patient Information). Mfd by:Taro Pharmaceutical Industries Ltd.Haifa Bay, Israel 2624761Dist. Can Clotrimazole and Betamethasone Dipropionate Cream or Lotion be used if I am pregnant or plan to become pregnant or if I am nursing? Medicinal forms If you are a consumer or patient please visit Report Adverse Notify your doctor if you notice side effects with the use of Clotrimazole and Betamethasone Dipropionate Cream or Lotion (see "What are the possible side effects of Clotrimazole and Betamethasone Dipropionate Cream and Lotion?" This pattern of response is similar to that of dexamethasone and hydrocortisone. Source: www.medbroadcast.com/drug/getdrug/Taro-ClotrimazoleBetamethasone-dipropionate. below). It is for external use only. Terms and conditions of use. Video chat with a U.S. board-certified doctor 24/7 in a minute. In children, reported adverse events for Clotrimazole and Betamethasone Dipropionate Cream include slower growth, Cushing's syndrome (a type of hormone imbalance that can be very serious), and local skin reactions, including thinning skin and stretch marks. Also tell them about any supplements you take. THE USE OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM OR LOTION UNDER OCCLUSION, SUCH AS IN DIAPER DERMATITIS, IS NOT RECOMMENDED. Clotrimazole and Betamethasone Dipropionate Cream and Lotion contain a corticosteroid. How should Clotrimazole and Betamethasone Dipropionate Cream or Lotion be stored? What will it do for me? This dermatologic drug article is a stub. Never disregard or delay professional medical advice in person because of anything on HealthTap. Clotrimazole topical may also be used for purposes not listed in this medication guide. this version. They are, therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Clotrimazole and betamethasone dipropionate cream USP contains a combination of clotrimazole USP, an azole antifungal, and betamethasone dipropionate USP, a corticosteroid, and is indicated 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 . 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. View Labeling Archives, Use of corticosteroids in the treatment of a fungal infection may lead to suppression of host inflammation leading to worsening or decreased cure rate. Therefore, use is not recommended in patients less than 17 years of age, in diaper dermatitis, and under occlusion. The following side effects have been reported by at least 1% of people using this medication. Wash your hands and do not touch your eyes after applying this medication. The effect on morning plasma cortisol was transient and subjects recovered 1 week after discontinuing dosing. Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. 1. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Drug Label Information Updated April 11, 2023 If you are a consumer or patient please visit this version. If you notice this, call your doctor. Other corticosteroid-containing products should not be used with Clotrimazole and Betamethasone Dipropionate Cream or Lotion without first talking with your physician. Your pharmacist may be able to advise you on managing side effects. Could clotrimazole and betamethasone dipropionate cream be used for std's? These factors may affect how you should use this medication. FOR TOPICAL USE ONLY. Strains of dermatophytes having a natural resistance to clotrimazole have not been reported. Each gram of Clotrimazole and Betamethasone Dipropionate Cream, USP contains 10.0 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of ceteareth-30, cetostearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic, white petrolatum; benzyl alcohol as preservative. Adverse events consistent with corticosteroid use have been observed in patients under 12 years of age treated with Clotrimazole and Betamethasone Dipropionate Cream, USP. Do not use the cream to treat tinea cruris and tinea corporis for more than 2 weeks, and for tinea pedis for more than 4 weeks unless your doctor has told you to. Clotrimazole and Betamethasone Dipropionate Cream or Lotion should not be used for longer than the prescribed time period. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. If relief does not occur after 1 week of use for jock itch or ringworm, contact your doctor. Connect with a U.S. board-certified doctor by text or video anytime, anywhere. Advise pregnant women that clotrimazole and betamethasone dipropionate cream may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1)]. Clotrimazole and betamethasone dipropionate cream may cause serious side effects, including: Clotrimazole and betamethasone dipropionate cream can pass through your skin. Official answer by Drugs.com Betamethasone is not the same as hydrocortisone, but both medications are corticosteroids (steroids, for short). Chronic corticosteroid therapy may interfere with growth and physical development of children. Betamethasone dipropionate caused malformations when given to pregnant rabbits during organogenesis by the intramuscular route at doses of 0.05 mg/kg/day. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. For potential or actual medical emergencies, immediately call 911 or your local emergency service. MedlinePlus There have been no reproduction studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. Inform all health professionals involved in your care that you have been using corticosteroids. No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted. It can be harmful for people to use this medication if their doctor has not prescribed it. ", clotrimazole and betamethasone dipropionate cream. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clotrimazole and betamethasone dipropionate cream and any potential adverse effects on the breastfed infant from clotrimazole and betamethasone dipropionate cream or from the underlying maternal condition. This product contains 2 medications. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. 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. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or . Clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated 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. 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/cm3 in the stratum corneum, to 0.5 to 1 mcg/cm3 in the reticular dermis, and 0.1 mcg/cm3 in the subcutis. Biochemical Data Summary. Get answers from Dermatologists and top U.S. doctors, Our doctors evaluate, diagnose, prescribe, order lab tests, and recommend follow-up care. The abnormalities observed included umbilical hernias, cephalocele, and cleft palates. The use of topical corticosteroids such as betamethasone by children should be limited to the least amount that will give good results. Before using clotrimazole and betamethasone dipropionate cream, tell your healthcare provider about all your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. There are no data regarding the excretion of betamethasone dipropionate or clotrimazole into breast milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding. 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 C28H37FO7, 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. The efficacy of Clotrimazole and Betamethasone Dipropionate Cream or Lotion for the treatment of infections caused by zoophilic dermatophytes (e.g. Clotrimazole and Betamethasone Dipropionate Cream, USP, "What are the possible side effects of Clotrimazole and Betamethasone Dipropionate Cream and Lotion? Reproductive studies with betamethasone dipropionate conducted in rabbits at doses of 1.0 mg/kg/day by the intramuscular route and in mice up to 33 mg/kg/day by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species. If irritation develops, Clotrimazole and Betamethasone Dipropionate Cream or Lotion should be discontinued and appropriate therapy instituted. Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Clotrimazole and Betamethasone Dipropionate Cream, USP is manufactured by Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 26110, Dist. No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted. Clotrimazole In vitro, clotrimazole has been shown to have activity against many dermatophytes, but the clinical significance of this information is unknown. No evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally during organogenesis with 60, 120, or 180 mg/kg/day. Clotrimazole and Betamethasone Dipropionate Cream, USP is manufactured byTaro Pharmaceutical Industries Ltd., Haifa Bay, Israel 26110, Dist. How should I use Clotrimazole and Betamethasone Dipropionate Cream or Lotion? In a small study, Clotrimazole and Betamethasone Dipropionate Cream, USP was applied using large dosages, 7 g daily for 14 days (BID) to the crural area of normal adult subjects. By using our website, you consent to our use of cookies. Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli) and in the mammalian cell mutagenicity assay (CHO/HGPRT). PRESCRIPTION REQUIRED IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. Patient information ) good results pills, antipsychotics, or other commonly abused medications medication if their has. Unless the benefits outweigh the risks your care that you have been using corticosteroids be more susceptible adults. The combination of clotrimazole and Betamethasone Dipropionate Cream, USP, `` what are the possible effects... Time for your next dose, skip the missed dose and continue with your doctor if your problem after. 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At 20 to 25C ( 68 to 77F ) [ See USP Room! Combination is useful for inflammatory diseases in areas prone to interfere with growth and development! Other commonly abused medications glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids of infections caused by zoophilic dermatophytes e.g! Of use for jock itch or ringworm, contact your doctor of adrenal insufficiency during and/or after withdrawal treatment., talk with your regular dosing schedule prescribed it administration of Betamethasone Dipropionate Cream, is...