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Label Changes for:

Doribax (Doripenem) For Injection

April 2013

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013

 

ADVERSE REACTIONS

Adverse Reactions from Clinical Trials
  • In a Phase 1 study of healthy subjects receiving doripenem doses greater than the approved dose of 500 mg every 8 hours for 10 to 14 days, the incidence of rash was higher than that observed in subjects who received 500 mg every 8 hours. The rash resolved within 10 days after doripenem administration was discontinued.
 
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