Product Description.:
Betamethasone dipropionate cream (augmented), 0.05% contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone.
Each gram of betamethasone dipropionate cream (augmented), 0.05% contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in an emollient cream base of purified water, USP chlorocresol propylene glycol, USP white petrolatum, USP white wax, NF cyclomethicone sorbitol solution, USP glyceryl oleate/propylene glycol ceteareth-30 carbomer 940, NF and sodium hydroxide, NF.
INDICATIONS AND USAGE
Betamethasone dipropionate cream (augmented), 0.05% is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.
CONTRAINDICATIONS
Betamethasone dipropionate cream (augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
PRECAUTIONS
General
Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure.
DOSAGE AND ADMINISTRATION
Apply a thin film of betamethasone dipropionate cream (augmented), 0.05% to the affected skin areas once or twice daily. Treatment with betamethasone dipropionate cream (augmented), 0.05% should be limited to 45 g per week.
Betamethasone dipropionate cream (augmented), 0.05% is not to be used with occlusive dressings.
HOW SUPPLIED
Betamethasone dipropionate cream (augmented), 0.05% is supplied in 15-g and 50-g tubes boxes of one.
Store between 2? and 30?C (36? and 86? F).
