RiteMED Cefepime Special Precautions

Careful inquiry should be made concerning previous immediate hypersensitivity to cephalosporins, penicillins, or other drugs before initiating therapy with cefepime. If cefepime is given to penicillin-sensitive patients, caution should be exercised since cross-hypersensitivity among beta-lactam antibiotics has been clearly documented. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted.
Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, IV fluids and IV antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.
Clostridium difficile-associated diarrhea (CDAD) and colitis have been reported with the use of nearly all antibacterial agents, including cefepime, and may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.
Since high or prolonged serum cefepime concentrations can occur if usual dosage is used in patients with renal impairment or other conditions that may compromise renal function, the maintenance dosage of cefepime should be decreased in patients with renal impairment (i.e., creatinine clearance 60 mL/minute or less). Continued dosage should be determined by the degree of renal impairment, severity of infection and susceptibility of the causative organisms.
Serious adverse events, including life-threatening or fatal encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, and seizures and/or renal failure, have been reported in patients receiving cefepime during postmarketing surveillance. Most cases occurred in patients with renal impairment who received dosage adjusted for renal impairment. In most patients, symptoms of neurotoxicity were reversible and resolved after discontinuance of cefepime and/or after hemodialysis.
If seizures associated with cefepime therapy occur, the drug should be discontinued.
Antimicrobial monotherapy may not be appropriate in patients at high risk of severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying malignancy, or with severe or prolonged neutropenia). Insufficient data exist to support the efficacy of cefepime monotherapy in such patients.
Cephalosporins may be associated with a fall in prothrombin activity. Patients who are at risk are those with renal or hepatic impairment or poor nutritional state as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous Vitamin K administered as indicated.
Prescribing cefepime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increased the risk of development of drug-resistant bacteria.
As with other antibacterial agents, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.
Renal Impairment: The dose of cefepime in patients with impaired renal function should be adjusted to compensate for the slower rate of renal elimination [see Dosage & Administration].
Hepatic Impairment: The PK of cefepime is unaltered in patients with hepatic impairment who received a single 1 g dose. The PK of cefepime does not change to a clinically significant degree in cystic fibrosis patients. It is not necessary to alter the dosage of cefepime in these patient groups.
Use in Children: The safety and efficacy of cefepime have been established in children 2 months up to 16 years old.
However, there are insufficient clinical data to support the use of cefepime in patients under 2 months old or for the treatment of serious infections in pediatric patients of any age where the suspected or proven pathogen is Haemophilus influenzae type b (Hib).
An alternative agent with demonstrated clinical efficacy should be used in patients with meningeal seeding from a distant infection site or when meningitis is suspected or documented.
Use in Elderly: Elderly patients are more likely to have decreased renal function, therefore, care should be taken in dose selection and renal function should be monitored.
Serious adverse events occur in elderly patients with renal insufficiency given unadjusted doses of cefepime including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, seizures and/or renal failure.