Quatam Warnings

Hypersensitivity reactions: As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with cefepime must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefepime, beta-lactams or other medicinal products. In 10% of the cases there is cross-reactivity between hypersensitivity to penicillin and cephalosporins.
Cefepime should be administered with caution to patients with a history of asthma or allergic diathesis. The patient must be carefully monitored during the first administration. If an allergic reaction occurs, treatment must be discontinued immediately. Adequate emergency measures must be initiated.
Renal impairment: In patients with impaired renal function, (creatinine clearance = 50 ml/min) or other conditions that may compromise renal function, the dosage of cefepime should be adjusted to compensate for the slower rate of renal elimination. Because high and prolonged serum antibiotic concentrations can occur from usual dosages in patients with renal insufficiency or other conditions that may compromise renal function, the maintenance dosage should be reduced when cefepime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organisms.
During postmarketing surveillance, the following serious adverse events have been reported: reversible encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures (including nonconvulsive status epilepticus), and/or renal failure. Most cases occurred in patients with renal impairment who received doses of cefepime that exceeded recommendations.
In general, symptoms of neurotoxicity resolved after discontinuation of cefepime and/or after hemodialysis, however, some cases included a fatal outcome. Renal function should be monitored carefully if drugs with nephrotoxic potential, such as aminoglycosides and potent diuretics are administered with cefepime.