DIPROLENE (augmented betamethasone dipropionate) Ointment, 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. 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. Chemically, betamethasone dipropionate is 9-fluoro-11β, 17,21-trihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504.6 and the following structural formula: It is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol. Each gram of DIPROLENE Ointment, 0.05% contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone), in a white ointment base of propylene glycol; propylene glycol stearate; white petrolatum; and white wax. Chemical Structure

DIPROLENE ® Ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. DIPROLENE Ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older.

Ointment, 0.05%. Each gram of DIPROLENE Ointment, 0.05% contains 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a white to off-white ointment base. Ointment, 0.05%

Apply a thin film of DIPROLENE Ointment to the affected skin areas once or twice daily. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. DIPROLENE Ointment is a super-high-potency topical corticosteroid. Treatment with DIPROLENE Ointment should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis . DIPROLENE Ointment should not be used with occlusive dressings unless directed by a physician. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Avoid contact with eyes. Wash hands after each application. DIPROLENE Ointment is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Apply a thin film to the affected skin areas once or twice daily. Discontinue therapy when control is achieved. Limit therapy to no more than 2 consecutive weeks. Use no more than 50 g per week. Do not use with occlusive dressings unless directed by a physician. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Not for oral, ophthalmic, or intravaginal use.

Effects on endocrine system: DIPROLENE Ointment can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factor(s) include the use of high-potency topical corticosteroids, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. Ophthalmic Adverse Reactions: DIPROLENE Ointment may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. 5.1 Effects on Endocrine System DIPROLENE Ointment can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a trial evaluating the effects of DIPROLENE Ointment on the HPA axis, at 14 g per day, DIPROLENE Ointment was shown to suppress the plasma levels of adrenal cortical hormones following repeated application to diseased skin in subjects with psoriasis. These effects were reversible upon discontinuation of treatment. At 7 g per day, DIPROLENE Ointment was shown to cause minimal inhibition of the HPA axis when applied 2 times daily for 2 to 3 weeks in healthy subjects and in subjects with psoriasis and eczematous disorders. With 6 g to 7 g of DIPROLENE Ointment applied once daily for 3 weeks, no significant inhibition of the HPA axis was observed in subjects with psoriasis and atopic dermatitis, as measured by plasma cortisol and 24-hour urinary 17-hydroxy-corticosteroid levels. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Cushing's syndrome and hyperglycemia may also occur with topical corticosteroids. These events are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids. Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios

Ophthalmic Adverse Reactions Use of topical corticosteroids, including DIPROLENE Ointment, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroid products, including DIPROLENE Ointment . Avoid contact of DIPROLENE Ointment with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation

Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.