Journal of Clinical and Aesthetic Dermatology

FEB 2018

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

Issue link: http://jcadonline.epubxp.com/i/934167

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INSTANT SAVINGS FOR ELIGIBLE PATIENTS AT ORTHORXACCESS.COM TERMS AND CONDITIONS APPLY • ONEXTON Gel should not be used in combination with erythromycin-containing products because of its clindamycin component. • ONEXTON Gel should be used during pregnancy only if the potential benefi t justifi es the potential risk to the fetus. A decision should be made whether to use ONEXTON Gel while nursing, taking into account the importance of the drug to the mother. • Patients should be advised to avoid contact with the eyes or mucous membranes. • Patients should minimize exposure to natural and avoid artifi cial sunlight (tanning beds or UVA/B treatment) while using ONEXTON Gel. To minimize exposure to sunlight, protective clothing should be worn and a sunscreen with SPF 15 rating or higher should be used. To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. Please see Brief Summary of full Prescribing Information on the following page. ONEXTON is a trademark of Ortho Dermatologics' affi liated entities. © All Rights Reserved. ONX.0109.USA.17 INDICATION ONEXTON (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. IMPORTANT SAFETY INFORMATION • ONEXTON Gel is contraindicated in patients with a known hypersensitivity to clindamycin, benzoyl peroxide, any component of the formulation, or lincomycin. • ONEXTON Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. • Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. ONEXTON Gel should be discontinued if signifi cant diarrhea occurs. • Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in death. • Anaphylaxis, as well as other allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide. If a patient develops symptoms of an allergic reaction such as swelling and shortness of breath, they should be instructed to discontinue use and contact a physician immediately. • The most common local adverse reactions experienced by patients in clinical trials were mild and moderate erythema, scaling, itching, burning and stinging. References: 1. ONEXTON [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC. 2. Pariser DM, Rich P, Cook-Bolden FE, Korotzer A. An aqueous gel fi xed combination of clindamycin phosphate 1.2% and benzoyl peroxide 3.75% for the once-daily treatment of moderate to severe acne vulgaris. J Drugs Dermatol. 2014;13(9):1083-1089. LEARN MORE AT ONEXTON.COM Effi cacy and tolerability matter when it comes to treating acne. In the pivotal trial, ONEXTON GEL was shown to treat both infl ammatory and noninfl ammatory acne, and no patients discontinued due to an adverse event. 1,2 ALL ABOARD ONEXTON GEL

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