EVOCLIN® Foam is indicated for topical application in the treatment
of acne vulgaris. 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 for Prescription EVOCLIN®
Foam
EVOCLIN® (clindamycin phosphate) Foam, 1% is contraindicated in individuals
with a history of hypersensitivity to preparations containing clindamycin or lincomycin,
or a history of regional enteritis, ulcerative colitis, or antibiotic-associated
colitis.
The colitis is usually characterized by severe persistent diarrhea and severe abdominal
cramps and may be associated with the passage of blood and mucus.
Diarrhea, bloody diarrhea, and pseudomembranous colitis have been reported with
systemic and rarely with topical clindamycin. Discontinuation is recommended if
significant diarrhea develops.
EVOCLIN® Foam should be prescribed with caution in atopic individuals.
Avoid contact of EVOCLIN® Foam with eyes. If contact occurs, rinse
eyes thoroughly with water.
The most common adverse events in clinical trials were headache (3%) and application-site
reactions including burning (6%), itching (1%), and dryness (1%).
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Prescribing Information for EVOCLIN® Foam
STIEFEL and STIEFEL & Design, EVOCLIN, the foam design, VERSAFOAM, STIEFELCARE and STIEFEL CARE & Design are registered trademarks of Stiefel Laboratories, Inc.
You are encouraged to report the side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

