Hydrocortisone butyrate cream, 0.1% (lipophilic) is a topical corticosteroid indicated for the relief of the redness, swelling, itching and irritation cause by certain skin conditions that respond to treatment with corticosteroids adults, and the topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months to 18 years of age.
Important Safety Information
- Hydrocortisone butyrate cream, 0.1% (lipophilic) may reduce levels of hormones that regulate your body’s immune system and energy levels (reversible hypothalamic-pituitary-adrenal (HPA) axis suppression)). Consider periodic evaluations for HPA axis suppression if hydrocortisone butyrate cream, 0.1% is applied to large surface areas or used under occlusion. If HPA axis suppression is noted, reduce the application frequency, discontinue use, or switch to a lower potency corticosteroid.
- 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 larger skin surface-to-body-mass ratios.
- Initiate appropriate therapy if concomitant skin infections develop.
- Discontinue use if irritation develops.
- The most commonly reported adverse events were local adverse reactions including Stinging, burning, itching, irritation, dryness, or redness.
- Tell your doctor right away if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration, acne, extreme/unwanted hair growth, “hair bumps” (folliculitis).
For additional safety and other information, including Patient Information, please see Full Prescribing Information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.