Indication and Important Safety Information
CLINDAGEL (clindamycin phosphate) gel, 1% is indicated for topical application in the treatment of acne. In view of the potential for diarrhea, bloody diarrhea, and pseudomembranous colitis, the physician should consider whether other agents are more appropriate.
Important Safety Information
- CLINDAGEL is contraindicated in patients with a history of hypersensitivity to clindamycin or lincomycin, or a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
- Orally and parenterally administered clindamycin has been associated with severe colitis (beginning up to several weeks following cessation of treatment), which may result in patient death.
- Diarrhea, bloody diarrhea, and pseudomembranous colitis have been reported with topical clindamycin. Discontinuation is recommended if diarrhea develops.
- CLINDAGEL should be used with caution in atopic individuals and in patients receiving neuromuscular blocking agents.
- CLINDAGEL should be used during pregnancy only if clearly needed.
- Orally and parenterally administered clindamycin has been reported in breast milk; because of the risk of adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, depending on the importance of the drug to the mother.
- The safety and effectiveness in children under 12 have not been established.
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.
References: 1. US Food and Drug Administration. Approved Drug Products With Therapeutic Equivalence Evaluations. 35th ed. Silver Spring, MD: US Food and Drug Administration; 2015. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf. Updated September 8, 2015. 2. Clindagel Topical Gel [package insert]. Cumberland, RI: Onset Dermatologics. 3. Data on File.
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