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U.S. Department of Health and Human Services

Safety

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Coly-Mycin M Parenteral (colistimethate for Injection, USP)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

 

Summary View

 

WARNINGS

  • Clostridium difficile associated disease (CDAD) has been reported with use of nearly all antibacterial agents, including Coly-Mycin M Parenteral, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile....

PRECAUTIONS

    Information for Patients

  • Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued...