BETAMETHASONE DIPROPIONATE

Betamethasone dipropionate spray contains 0.0643% betamethasone dipropionate (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid for topical use. The chemical name for betamethasone dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C 28 H 37 FO 7 and the molecular weight is 504.6. The structural formula is shown below. Each gram of betamethasone dipropionate spray contains 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, diazolidinyl urea, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, sorbitan monostearate. Betamethasone dipropionate spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients. Chemical Structure

Betamethasone dipropionate spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. Betamethasone dipropionate spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. ( 1 )

Shake well before use. Apply betamethasone dipropionate spray to the affected skin areas twice daily and rub in gently. Use betamethasone dipropionate spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended. Discontinue betamethasone dipropionate spray when control is achieved. Do not use if atrophy is present at the treatment site. Do not bandage, cover, or wrap the treated skin area unless directed by a physician. Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. Betamethasone dipropionate spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Apply to the affected skin areas twice daily. Rub in gently. ( 2 ) Use betamethasone dipropionate spray for up to 4 weeks and not beyond. ( 2 ) Discontinue treatment when control is achieved. ( 2 ) Do not use if atrophy is present at the treatment site. ( 2 ) Do not use with occlusive dressings unless directed by a physician. ( 2 ) Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )

None. None ( 4 )

The most common adverse reactions (≥1%) are application site reactions, including pruritus, burning and/or stinging, pain, and atrophy. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience 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 clinical practice. In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied betamethasone dipropionate spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied betamethasone dipropionate spray and 180 subjects applied vehicle spray. Adverse reactions that occurred in at least 1% of subjects treated with betamethasone dipropionate spray for up to 28 days are presented in Table 1. Table 1: Adverse Reactions Occurring in ≥1% of Subjects Treated with Betamethasone Dipropionate Spray for up to Four Weeks Betamethasone Dipropionate Spray b.i.d. Vehicle Spray b.i.d. (N=352) (N=180) Application site pruritus 6.0% 9.4% Application site burning and/or stinging 4.5% 10.0% Application site pain 2.3% 3.9% Application site atrophy 1.1% 1.7% Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with betamethasone dipropionate spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle. 6.2 Postmarketing Experience 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. Postmarketing reports for local adverse reactions to topical corticosteroids have also included striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria. Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported. Ophthalmic adverse reactions of cataracts, glaucoma, and increased intraocular pressure have been reported with the use of topical corticosteroids, including topical betamethasone products.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing. 16.2 Handling/Instructions for the Pharmacist Remove the spray pump from the wrapper. Remove and discard the cap from the bottle. Keeping the bottle upright, insert the spray pump into the bottle and turn clockwise until it is closed tightly. Dispense the bottle with the spray pump inserted. Include the date dispensed in the space provided on the carton.