Clindamycin Phosphate Topical Solution is indicated in the treatment of acne vulgaris.
Important Safety Information
- Do not use clindamycin phosphate topical solution if you have hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
- Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.
- Clindamycin Phosphate Topical Solution contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water.
- In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities.
- Safety and effectiveness in pediatric patients under the age of 12 have not been established.
- In clinical trials, treatment emergent adverse dermatological reactions included burning, itching, dryness, erythema, oily skin and peeling.
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.