Journal of Clinical and Aesthetic Dermatology

MAY 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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Page 8 of 55

IMPORTANT SAFETY INFORMATION Warnings and Precautions Topical corticosteroids, including IMPOYZ Cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur du ring treatment or after withdrawal of treatment. This may requ ire that patients be evaluated periodically for evidence of HPA axis suppr ession. Factors that predispose to HPA axis suppression include , use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. If HPA axis suppression occurs, gradually withdraw t he drug, reduce frequency of application, or substitute with a less po - tent corticosteroid. If signs and symptoms of withdrawal occur, syst emic corticosteroids may be required. Recovery of HPA axis func tion is generally prompt and complete upon discontinuation of topi cal corticosteroids. Although rare, systemic effects of topical corticoste- roids may manifest as Cushing's syndrome, hyperglycemia, and glucosuria. Pediatric patients may be more susceptible to systemic toxicity because of their larger skin surface to body mass ratios. Local Adverse Reactions with Topical Corticosteroids - Local adverse reactions from topical corticosteroids may be more likely to occur with occlusion, prolonged use, or use of higher potency corti- costeroids. Some local adverse reactions may be irreversible. Concomitant Skin Infections - Use an appropriate antimicrobial agent if a skin infection is present or develops. If appropriate, discontinue use of IMPOYZ Cream. Allergic Contact Dermatitis - Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Adverse Events - The adverse reaction that occurred in at least 1% of subjects treated with IMPOYZ Cream and at a higher incidence than in subjects treated with vehicle cream was application sit e discoloration (2% versus 1%). Less common local adverse events occurring in < 1% of subjects treated with IMPOYZ Cream were ap plication site atrophy, telangiectasia and rash. IMPOYZ ™ (clobetasol propionate) Cream 0.025% is indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older. 1 (clobetasol propionate ) Cream , 0.025% TM 1. Impoyz Cream full Prescribing Information. CLB1214 4/18 Please see Brief Summary of Prescribing Information on the following page. A B R I G H T I D E A The Only FDA Approved Clobetasol Propionate 0.025%

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