CLOBETASOL PROPIONATE

Clobetasol Propionate Topical Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25 H 32 ClFO 5 , and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure: Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of Clobetasol Propionate Topical Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid. Chemical Structure

Clobetasol Propionate Topical Spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. ( 1.1 ) Limitations of Use: Do not use on the face, axillae or groin. ( 1.2 ) Do not use if atrophy is present at the treatment site.( 1.2 ) Do not use for rosacea or perioral dermatitis. ( 1.2 ) 1.1 Indication Clobetasol Propionate Topical Spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. The total dosage should not exceed 50 g (59 mL or 2 fl. oz.) per week. Do not use more than 26 sprays per application or 52 sprays per day. Treatment should be limited to 4 consecutive weeks. Patients should be instructed to use Clobetasol Propionate Topical Spray, 0.05% for the minimum amount of time necessary to achieve the desired results [ see Dosage and Administration (2) ]. Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations. 1.2 Limitations of Use Clobetasol Propionate Topical Spray, 0.05% should not be used on the face, axillae, or groin. Clobetasol Propionate Topical Spray, 0.05% should not be used if there is atrophy at the treatment site. Clobetasol Propionate Topical Spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.

Clobetasol Propionate Topical Spray, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use. Clobetasol Propionate Topical Spray, 0.05% should be sprayed directly onto the affected skin areas twice daily and rubbed in gently and completely. The total dosage should not exceed 50 g (59 mL or 2 fluid ounces) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Do not use more than 26 sprays per application or 52 sprays per day. Clobetasol Propionate Topical Spray, 0.05% contains a topical corticosteroid; therefore treatment should be limited to 4 weeks. Therapy should be discontinued when control has been achieved. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with Clobetasol Propionate Topical Spray, 0.05%. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression. Use in pediatric patients younger than 18 years is not recommended because of the potential for HPA axis suppression [ see Use in Specific Populations (8.4) ]. Unless directed by physician, Clobetasol Propionate Topical Spray, 0.05% should not be used with occlusive dressings. Not for oral, ophthalmic, or intravaginal use. ( 1.2 ) Clobetasol Propionate Topical Spray, 0.05% should be sprayed directly onto the affected skin areas twice daily and rubbed in gently. ( 2 ) The total dosage should not exceed 50 g (59 mL or 2 fluid ounces) per week. Do not use more than 26 sprays per application or 52 sprays per day. ( 2 ) Clobetasol Propionate Topical Spray, 0.05% contains a super-high potent topical corticosteroid; therefore treatment should be limited to 4 weeks. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with Clobetasol Propionate Topical Spray, 0.05%. ( 2 )

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In controlled, clinical trials with Clobetasol Propionate Topical Spray, 0.05%, the most common adverse reactions (incidence > 2%) were burning, pruritus, nasopharyngitis, upper respiratory tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro 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 practice. In controlled, clinical trials with Clobetasol Propionate Topical Spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with Clobetasol Propionate Topical Spray, 0.05% and 47% of subjects treated with Spray Vehicle]. Other commonly reported adverse reactions for Clobetasol Propionate Topical Spray, 0.05% and Spray Vehicle, respectively, are noted in Table 1. Table 1 - Commonly Occurring Adverse Reactions (≥1% Incidence) Adverse Reaction Clobetasol Propionate Topical Spray, 0.05% (N=120) Vehicle Spray (N=120) System Organ Class General disorders and administration site conditions 50 (42%) 56 (47%) Application site burning 48 (40%) 56 (47%) Application site dryness 2 (2%) 0 (0%) Application site irritation 1 (1%) 0 (0%) Application site pain 1 (1%) 2 (2%) Application site pigmentation changes 1 (1%) 0 (0%) Application site pruritus 4 (3%) 3 (3%) Infections and infestations 17 (14%) 12 (10%) Nasopharyngitis 6 (5%) 3 (3%) Pharyngitis streptococcal 1 (1%) 0 (0%) Upper respiratory tract infection 10 (8%) 2 (2%) Skin and subcutaneous tissue disorders 4 (3%) 2 (2%) Eczema asteatotic 2 (2%) 0 (0%) Most local adverse reactions were rated as mild to moderate and they are not affected by age, race or gender. Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glycosuria in some patients. 6.2 Postmarketing Experience Because these 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. The following adverse reactions have been identified during post-approval use of Clobetasol Propionate Topical Spray, 0.05%. Skin: Burning, pruritus, erythema, pain, irritation, rash, peeling, urticaria, and contact dermatitis.

Storage: Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze, refrigerate or store above 30°C. Spray is flammable; avoid heat, flame or smoking when using this product.