IMPORTANT SAFETY INFORMATION
Indication:Locoid Lipocream® (hydrocortisone butyrate 0.1%) cream is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adults as well as the treatment of mild to moderate atopic dermatitis in patients 3 months to 18 years of age. Locoid® Lotion (hydrocortisone butyrate 0.1%) is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Safety and effectiveness in pediatric patients below 3 months of age have not been established. Adverse Events: The most common adverse reactions (≥1%) observed in Locoid Lipocream® clinical trials were HPA axis suppression and application site reactions including folliculitis, irritation, dermatitis, and/or erythema. The most common adverse reactions (≥1%) observed in Locoid® Lotion clinical trials were reversible HPA axis suppression, application site reactions, including burning, pruritus, dermatitis, erythema, eczema, inflammation, and/or irritation, infantile acne, and depigmentation. Warnings/Precautions: Reversible HPA axis suppression may occur, with the potential for corticosteroid insufficiency. Consider periodic evaluations for HPA axis suppression if applied to large surface areas or used under occlusion. Systemic effects of topical corticosteroids may also include manifestations of Cushing's syndrome, hyperglycemia, and glucosuria. Pediatric patients may be more susceptible to systemic toxicity due to their large skin surface-to-body mass ratios. Initiate appropriate therapy if concomitant skin infection develops. Discontinue use if irritation develops. Do not use in the eyes.
You are encouraged to report adverse effects of prescription drugs and medical devices to the FDA by calling 1-800-FDA-1088 or visiting the website at www.fda.gov/medwatch.
*IMS Dec. 2012
Locoid® is a registered trademark of Astellas Pharma Europe B.V. licensed to Onset Dermatologics
References: 1. Data on file, Onset Dermatologics 2. Locoid® Prescribing Information