CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION 30 ML
Generic: Clotrimazole and Betamethasone Dipropionate
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION 30 ML
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Identification
Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate
Sun Pharmaceutical Industries, Inc.
HUMAN PRESCRIPTION DRUG
Administration
LOTION
TOPICAL
ANDA076493
Active Ingredients
| Ingredient | Strength |
|---|---|
| BETAMETHASONE DIPROPIONATE | .5 mg/mL |
| CLOTRIMAZOLE | 10 mg/mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
Indications & Usage
INDICATIONS AND USAGE 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.g., Microsporum canis ) has not been established.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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. Clotrimazole and betamethasone dipropionate lotion should not be used with occlusive dressings.
Adverse Reactions
ADVERSE REACTIONS 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. 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 (ecchymoses), telangiectasia, 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.
Information for Patients
Information for Patients Patients using clotrimazole and betamethasone dipropionate lotion should receive the following information and instructions: The medication is to be used as directed by the physician and is not recommended for use longer than the prescribed time period. It is for external use only. Avoid contact with the eyes, the mouth, or intravaginally. This medication is to be used for the full prescribed treatment time, even though the symptoms may have improved. Notify the physician if there is no improvement after 1 week of treatment for tinea cruris or tinea corporis, or after 2 weeks for tinea pedis. This medication should only be used for the disorder for which it was prescribed. Other corticosteroid-containing products should not be used with clotrimazole and betamethasone dipropionate without first talking with your physician. The treated skin area should not be bandaged, covered, or wrapped so as to be occluded (see DOSAGE AND ADMINISTRATION ). Any signs of local adverse reactions should be reported to your physician. Patients should avoid sources of infection or reinfection. When using clotrimazole and betamethasone dipropionate lotion in the groin area, patients should use the medication for 2 weeks only, and apply the lotion sparingly. Patients should wear loose-fitting clothing. Notify the physician if the condition persists after 2 weeks. The safety of clotrimazole and betamethasone dipropionate lotion has not been demonstrated in the treatment of diaper dermatitis. The use of clotrimazole and betamethasone dipropionate lotion in the treatment of diaper dermatitis is not recommended.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.