Label Changes for:
Cefepime for Injection USP and Dextrose Injection USP in the Duplex ContainerCefepime Injection in the GALAXY Container for intravenous use
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2012
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)].
- 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......