Label Changes for:

Primaxin I.M. (imipenem and cilastatin for injectable suspension)

May 2008

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


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008

 

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

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Seizure Potential

PRECAUTIONS

  • Drug Interactions
    • A clinically significant reduction in serum valproic acid concentration has been reported in patients receiving
      carbapenem antibiotics and may result in loss of seizure control...

WARNINGS

Seizures and other CNS adverse experiences, such as myoclonic activity, have been reported during treatment with Primaxin I.M.

Carbapenems, including imipenem, may reduce serum valproic acid concentrations to subtherapeutic levels, resulting in loss of seizure control. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations drop below the therapeutic range or a seizure occurs.

Label approved 05/08/2008 is not available on Drugs@FDA

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