clobetasol propionate

INDICATIONS AND USAGE: Clobetasol propionate topical solution USP, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.

DOSAGE AND ADMINISTRATION: Clobetasol propionate topical solution USP, 0.05% should be applied to the affected scalp areas twice daily, once in the morning and once at night. Clobetasol propionate topical solution USP, 0.05% is potent; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 mL/week should not be used. Clobetasol propionate topical solution USP, 0.05% is not to be used with occlusive dressings. Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with clobetasol propionate topical solution, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

CONTRAINDICATIONS Clobetasol Propionate Topical Solution, 0.05% is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.

ADVERSE REACTIONS Clobetasol Propionate Topical Solution, 0.05% is generally well tolerated when used for 2-week treatment periods. The most frequent adverse events reported for Clobetasol Propionate Topical Solution, 0.05% have been local and have included burning and/or stinging sensation, which occurred in 29 of 294 patients; scalp pustules, which occurred in 3 of 294 patients; and tingling and folliculitis, each of which occurred in 2 of 294 patients. Less frequent adverse events were itching and tightness of the scalp, dermatitis, tenderness, headache, hair loss, and eye irritation, each of which occurred in 1 of 294 patients. The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glucosuria in some patients. In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have exacerbated the disease or provoked the pustular form of the disease, so careful patient supervision is recommended. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DESCRIPTION Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate USP is 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione17-propionate, and it has the following structural formula: Clobetasol propionate USP has the empirical formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a solution base composed of isopropyl alcohol, carbomer homopolymer type B, sodium hydroxide and purified water. Structure

OVERDOSAGE Topically applied Clobetasol Propionate Topical Solution, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

HOW SUPPLIED Clobetasol Propionate Topical Solution USP, 0.05% is supplied in 25 mL HDPE bottles (NDC 68462-532-28), and 50 mL HDPE bottles (NDC 68462-532-53). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not use near an open flame . Manufactured by: Glenmark Pharmaceuticals Limited Village : Kishanpura, Baddi Nalagarh Road District : Solan, Himachal Pradesh – 173205 India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkpharma.com/usa March 2017 R:\Regulatory Affairs\_Compliance\Drug Listings\Electronic\Pending approval\Apremilast Tablets\Version 1\Apremilast Tablets v1\image-02.jpg