Label Changes for:
Maxipime (cefepime hydrochloride) for Injection
September 2012
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
WARNINGS
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, stupor, and coma), myoclonus, seizures, and nonconvulsive status epilepticus (see ADVERSE REACTIONS: Postmarketing Experience). Most cases occurred ......
ADVERSE REACTIONS
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......
