INDICATION AND IMPORTANT SAFETY INFORMATION
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 significant 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.
- 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 benefit justifies 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 artificial 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.
REFERENCE: 1. ONEXTON [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC. 2. Pariser DM, Rich P, Cook-Bolden FE, Korotzer A. An aqueous gel fixed 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.
ONEXTON is a trademark of Ortho Dermatologics' affiliated entities. © All Rights Reserved. ONX.0014.USA.18