Clobetasol

DESCRIPTION Clobetasol propionate topical solution, USP contains the active compound clobetasol propionate, USP 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 (11β,16β)-21-chloro-9‑fluoro‑11‑hydroxy‑16‑methyl‑17‑(1‑oxo-­propoxy) pregna-1,4-diene-3,20-dione, and it has the following structural formula: Clobetasol propionate, USP has the molecular formula C 25 H 32 ClFO 5 and a molecular weight of 466.97. It is a white to cream-colored crystalline powder, soluble in acetone, in dimethyl sulfoxide, in chloroform, in methanol, and in dioxane. Sparingly soluble in ethanol; slightly soluble in benzene and diethyl ether; practically insoluble in water. Clobetasol propionate topical solution, USP contains clobetasol propionate, USP 0.5 mg/g in a base of carbomer 974P, isopropyl alcohol (40% w/w), purified water, and sodium hydroxide. clobetasol-structure

INDICATIONS AND USAGE Clobetasol propionate topical solution, USP 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.

CONTRAINDICATIONS Clobetasol propionate topical solution 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 is generally well tolerated when used for 2-week treatment periods. The most frequent adverse events reported for clobetasol propionate topical solution 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’s 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 Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE Topically applied clobetasol propionate can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).