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U.S. Department of Health and Human Services

Safety

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Cefepime for Injection USP and Dextrose Injection USP in the Duplex Container, and Cefepime Injection in the GALAXY Container for Intravenous Use

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2012

 

Summary View

5 WARNINGS AND PRECAUTIONS

5.2 Use in Patients with Renal Impairment
  • In patients with creatinine clearance less than or equal to 60 mL/min, the dose of Cefepime Injection should be adjusted to compensate for the slower rate of renal elimination.......susceptibility of the causative organisms. Refer to specific recommendations for dosing adjustment [see Dosage and Administration (2.2)].
5.3 Neurotoxicity
  • During postmarketing surveillance, serious adverse reactions have been reported including life-threatening or fatal occurrences of the following: encephalopathy (disturbance of consciousness including confusion, hallucinations.....

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • Encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and nonconvulsive status epilepticus have been reported. Although most cases occurred in patients with renal impairment......
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