Important Safety Information
Indication: Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris. Adverse Events: In the pivotal study, the most commonly reported adverse reactions (1%) in patients treated with Epiduo Forte Gel were skin irritation, eczema, atopic dermatitis and skin burning sensation. Warnings/Precautions: Patients using Epiduo Forte Gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of Epiduo Forte Gel and may necessitate discontinuation. When applying Epiduo Forte Gel, care should be taken to avoid the eyes, lips and mucous membranes.
1. According to data from Symphony Health Solutions, Pharmaceutical Audit Suite, Retail Audit, March 2018. 2. Epiduo® Forte Gel Clinical Study Report (SPR 105061). Data on file. Galderma laboratories, L.P. 3. Tan J, Bourdes V, Bissonnette R, et al. Prospective study of pathogenesis of atrophic acne scars and role of macular erythema. J Drugs Dermatol. 2017;16(6):567-573. 4. Tan J, Sewon K, Leyden J. Prevalence and risk factors of acne scarring among patients consulting dermatologists in the United States. J Drugs Dermatol. 2017;16(2):97-102. 5. Alexis AF, Cook-Bolden FE, York JP. Adapalene/benzoyl peroxide gel in 0.3%/2.5%: a safe and effective acne therapy in all skin prototypes. J Drugs Dermatol. 2017;16(6):574-581. 6. Leyden J, Stein-Gold L, Weiss J. Why topical retinoids are mainstay of therapy for acne. Dermatol Ther. 2017;7(3):293–304. 7. Leyden JJ. Topical treatment of acne vulgaris: retinoids and cutaneous irritation. J Am Acad Dermatol. 998;38(4):S1–S4. 8. Thielitz A, Sidou F, Gollnick H. Control of microcomedone formation throughout a maintenance treatment with adapalene gel, 0.1%. J Eur Acad Dermatol Venereol. 2007;21(6):747-753. 9. Tucker R, Walton S. The role of benzoyl peroxide in the management of acne vulgaris. Pharm J. 2007;279:48-53. 10. Mills OH, Jr, Kligman AM, Pochi P, Comite H. Comparing 2.5%, 5%, and 10% benzoyl peroxide on inflammatory acne vulgaris. Int J Dermatol. 1986;25(10):664-667. 11. Data on file, Galderma Laboratories, L.P. 12. Epiduo® Forte Gel Clinical Study Report (SRE 18240). Data on file. Galderma Laboratories, L.P. 13. Data on File: RD.03.SPR.105061, September 2017.
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