"What are the possible side effects of Clotrimazole and Betamethasone Dipropionate Cream and Lotion?

This dose is approximately one-fifth the maximum human dose.


ADVERSE EVENTS CONSISTENT WITH CORTICOSTEROID USE HAVE BEEN OBSERVED IN PATIENTS TREATED WITH CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, USP FOR DIAPER DERMATITIS. Clotrimazole and Betamethasone Dipropionate Cream and Lotion are medications used on the skin to treat fungal infections of the feet, groin and body, as diagnosed by your doctor. "Can Clotrimazole and Betamethasone Dipropionate be used for hemorrhoids?" "How do Clotrimazole and Betamethasone Dipropionate Cream and Lotion work?Who should NOT use Clotrimazole and Betamethasone Dipropionate Cream or Lotion?How should I use Clotrimazole and Betamethasone Dipropionate Cream or Lotion?What other important information should I know about Clotrimazole and Betamethasone Dipropionate Cream and Lotion?What are the possible side effects of Clotrimazole and Betamethasone Dipropionate Cream and Lotion?Can Clotrimazole and Betamethasone Dipropionate Cream or Lotion be used if I am pregnant or plan to become pregnant or if I am nursing?How should Clotrimazole and Betamethasone Dipropionate Cream or Lotion be stored?Clotrimazole and Betamethasone Dipropionate Cream should be stored at 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) [see USP Controlled Room Temperature].Clotrimazole and Betamethasone Dipropionate Lotion should be stored at 25°C (77°F) in the upright position only; excursions permitted between 15°C and 30°C (59°F and 86°F).Shake well before using Clotrimazole and Betamethasone Dipropionate Lotion.Clotrimazole and Betamethasone Dipropionate Cream, USP Clotrimazole dosed at 200 mg/kg/day (30 times the maximum human dose) was maternally lethal and therefore fetuses were not evaluated in this group. Use the medicine exactly as directed.Do not take by mouth. In addition, two separate studies in pediatric patients demonstrated adrenal suppression as determined by cosyntropin testing (see Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (See 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.Betamethasone was negative in the bacterial mutagenicity assay (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. Talk to your doctor if your fungal infection does not have these symptoms.

Clotrimazole works against fungus. 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.

Clotrimazole and Betamethasone Dipropionate Cream or 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 Cream or Lotion, can be absorbed in sufficient amounts to produce systemic effects (see 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 with occlusive dressings.Clotrimazole and Betamethasone Dipropionate Cream, USP is supplied in 15-gram (NDC 21695-333-15) and 45-gram (NDC 21695-333-45) tubes; boxes of one.

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.

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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.Amounts greater than 45 g/week of Clotrimazole and Betamethasone Dipropionate Cream, USP or 45 mL/week of Clotrimazole and Betamethasone Dipropionate Lotion should not be used.