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Label Changes for:

Invanz (ertapenem) for Injection

March 2012

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)

 

March 2012

ADVERSE REACTIONS

Postmarketing Experience
  • muscular weakness, gait disturbance, and coordination abnormal

 

 

May 2010 

ADVERSE REACTIONS

Post-Marketing Experience
  • Skin and Subcutaneous Tissue Disorders: Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome)

 

October 2009 

WARNINGS

Seizure Potential
  • Case reports in the literature have shown that co-administration of carbapenems, including ertapenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. The concomitant use of ertapenem and valproic acid/divalproex sodium is generally not recommended.

PRECAUTIONS

Information for Patients
  • Patients should be counseled to inform their physician if they are taking valproic acid or divalproex sodium. Valproic acid concentrations in the blood may drop below the therapeutic range upon coadministration with Invanz. If treatment with Invanz is necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed.

 

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