CLOBETASOL PROPIONATE EMOLLIENT FORMULATION

• Clobetasol Propionate Foam, 0.05% (Emulsion) has been shown to suppress the HPA axis. Systemic absorption of Clobetasol Propionate Foam, 0.05% (Emulsion) may produce reversible HPA axis suppression, Cushing’s syndrome, hyperglycemia, and unmask latent diabetes. ( 5.1 ) • Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. ( 5.1 ) • Modify use should HPA axis suppression develop. ( 5.1 ) • High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, and liver failure may predispose patients to HPA axis suppression. ( 5.1 ) • May increase the risk of cataract and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. ( 5.3 ) • Pediatric patients may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 ) • The propellant in Clobetasol Propionate Foam, 0.05% (Emulsion) is flammable. Avoid fire, flame, or smoking during and immediately following application. ( 5.5 ) 5.1 Effects on Endocrine System Clobetasol propionate foam, 0.05% (emulsion) has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Systemic absorption of clobetasol propionate foam, 0.05% (emulsion) has caused reversible HPA axis suppression with the potential for clinical glucocorticoid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. Use of clobetasol propionate foam, 0.05% (emulsion) for longer than 2 weeks may suppress the immune system [see Nonclinical Toxicology (13.1)] . In a trial including 37 subjects 12 years and older with atopic dermatitis of at least 30% body surface area (BSA), adrenal suppression was identified in 6 out of 37 subjects (16.2%) after 2 weeks of treatment with clobetasol propionate foam, 0.05% (emulsion) [see Clinical Pharmacology (12.2)] . Because of the potential for systemic absorption, use of clobetasol propionate foam, 0.05% (emulsion) may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure. An adrenocorticotrophic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than 1 corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses because of their larger skin surface-to-body mass ratios [see Use in Specific Populations (8.4)] . 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing. If irritation develops, treatment with Clobetasol Propionate Foam, 0.05% (Emulsion) should be discontinued and appropriate therapy instituted. 5.3 Ophthalmic Adverse Reactions Use of topical corticosteroids, including Clobetasol Propionate Foam, 0.05% (Emulsion), may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroids, including topical clobetasol products [see Adverse Reactions (6.2)] . Avoid contact of Clobetasol Propionate Foam, 0.05% (Emulsion) with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 5.4 Concomitant Skin Infections Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Clobetasol Propionate Foam, 0.05% (Emulsion) should be discontinued until the infection has been adequately treated. 5.5 Flammable Contents The propellant in Clobetasol Propionate Foam, 0.05% (Emulsion) is flammable. Avoid fire, flame, or smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).