Label Changes for:

Coly-Mycin M Parenteral Solution (colistimethate sodium, USP)

March 2013

Changes have been made to the WARNINGS sections of the safety label.

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

 

March 2013

WARNINGS

  • Maximum daily dose calculated from colistin base activity should not exceed 5 mg/kg/day with normal renal function.
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