These highlights do not include all the information needed to use EVOCLIN Foam safely and effectively. See full prescribing information for EVOCLIN Foam.
EVOCLIN ® (clindamycin phosphate) Foam, 1%
For Topical Use
Initial U.S. Approval: 1970
INDICATIONS AND USAGE
EVOCLIN Foam is a lincosamide product indicated for acne vulgaris in patients 12 years and older. (1)
DOSAGE AND ADMINISTRATION
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For topical use only; not for oral, ophthalmic, or intravaginal use. (2)
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Apply EVOCLIN Foam once daily to affected areas. (2)
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Flammable; avoid fire, flame and/or smoking during and immediately following application. (2)
DOSAGE FORMS AND STRENGTHS
Foam containing 1% clindamycin as clindamycin phosphate. (3)
CONTRAINDICATIONS
EVOCLIN Foam is contraindicated in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis (including pseudomembranous colitis). (4)
WARNINGS AND PRECAUTIONS
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Colitis: Clindamycin can cause severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of clindamycin. EVOCLIN Foam should be discontinued if significant diarrhea occurs. (5.1)
ADVERSE REACTIONS
The most common adverse reactions (>1%) are headache and application site reactions including burning, pruritus, and dryness. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Prestium Pharma, Inc. at 1-866-897-5002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 8/2014
