Clindamycin

CLINICAL STUDIES In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used CLINDAGEL (clindamycin phosphate topical gel, 1%) once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, CLINDAGEL applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table: Lesions CLINDAGEL QD N=162 Vehicle Gel QD N=82 Inflammatory 51% 40% P<0.05 Noninflammatory 25% 12% Total 38% 27% There was a trend in the investigator’s global assessment of the results, which favored CLINDAGEL QD over the vehicle QD.

ADVERSE REACTIONS In the one well-controlled clinical study comparing CLINDAGEL and its vehicle, the incidence of skin and appendages adverse events occurring in ≥1% of the patients in either group is presented in the following table: Number (%) of Patients Body System/Adverse Event CLINDAGEL QD N=168 Vehicle Gel QD N=84 Skin and Appendages Disorders Dermatitis 0 (0.0) 1 (1.2) Dermatitis contact 0 (0.0) 1 (1.2) Dermatitis fungal 0 (0.0) 1 (1.2) Folliculitis 0 (0.0) 1 (1.2) Photosensitivity reaction 0 (0.0) 1 (1.2) Pruritus 1 (0.6) 1 (1.2) Rash erythematous 0 (0.0) 0 (0.0) Skin dry 0 (0.0) 0 (0.0) Peeling 1 (0.6) 0 (0.0) Orally and parenterally administered clindamycin has been associated with severe colitis, which may end fatally.

WARNINGS 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. Studies indicate a toxin(s) produced by Clostridia is one primary cause of 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. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for Clostridium difficile and stool assay for C. CONTRAINDICATIONS CLINDAGEL is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.