Drug Information for Clindamycin Phosphate and Benzoyl Peroxide (Mylan Pharmaceuticals Inc.): WARNINGS

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  • ORALLY AND PARENTERALLY ADMINISTERED CLINDAMYCIN HAS BEENASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENTDEATH. USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN RESULTSIN ABSORPTION OF THE ANTIBIOTIC FROM THE SKIN SURFACE. DIARRHEA,BLOODY DIARRHEA, AND COLITIS (INCLUDING PSEUDOMEMBRANOUSCOLITIS) HAVE BEEN REPORTED WITH THE USE OF TOPICAL ANDSYSTEMIC CLINDAMYCIN. STUDIES INDICATE A TOXIN(S) PRODUCED BYCLOSTRIDIA IS ONE PRIMARY CAUSE OF ANTIBIOTIC- ASSOCIATED COLITIS.THE COLITIS IS USUALLY CHARACTERIZED BY SEVERE PERSISTENTDIARRHEA AND SEVERE ABDOMINAL CRAMPS AND MAY BE ASSOCIATEDWITH THE PASSAGE OF BLOOD AND MUCUS. ENDOSCOPIC EXAMINATION MAY REVEAL PSEUDOMEMBRANOUS COLITIS. STOOL CULTUREFOR Clostridium Difficile AND STOOL ASSAY FOR C. difficile TOXIN MAYBE HELPFUL DIAGNOSTICALLY. WHEN SIGNIFICANT DIARRHEA OCCURS,THE DRUG SHOULD BE DISCONTINUED. LARGE BOWEL ENDOSCOPYSHOULD BE CONSIDERED TO ESTABLISH A DEFINITIVE DIAGNOSIS INCASES OF SEVERE DIARRHEA. ANTIPERISTALTIC AGENTS SUCH AS OPIATESAND DIPHENOXYLATE WITH ATROPINE MAY PROLONG AND/ORWORSEN THE CONDITION. DIARRHEA, COLITIS, AND PSEUDOMEMBRANOUSCOLITIS HAVE BEEN OBSERVED TO BEGIN UP TO SEVERAL WEEKSFOLLOWING CESSATION OF ORAL AND PARENTERAL THERAPY WITHCLINDAMYCIN.

    Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.

  • Drug Information Provided by National Library of Medicine (NLM).
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