Label Changes for:

Maxipime (cefepime hydrochloride, USP) for Injection

March 2013

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)

 

 

March 2013

WARNINGS

Neurotoxicity
  • non-convulsive status epilepticus

PRECAUTIONS

Information for Patients
  • Before therapy with MAXIPIME is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to cefepime, cephalosporins, penicillins, or other drugs. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to MAXIPIME occurs, discontinue the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency 15 measures including oxygen, corticosteroids, intravenous fluids, intravenous antihistamines, pressor amines, and airway management, as clinically Indicated.
  • Patients should be instructed to inform their healthcare provider at once of any neurological signs and symptoms, including ….non-convulsive status epilepticus

ADVERSE REACTIONS

Clinical Trials
  • Erythema and anemia
Postmarketing Experience
  • non-convulsive status epilepticus

 

 

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......

 

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