CEFEPIME HYDROCHLORIDE

Pharmacokinetic parameters for cefepime in healthy adult male volunteers (n=9) following single 30-minute infusions (IV) of cefepime 500 mg, 1 g, and 2 g are summarized in Table 7. Elimination of cefepime is principally via renal excretion with an average (±SD) half-life of 2 (±0.3) hours and total body clearance of 120 (±8) mL/min in healthy volunteers. Cefepime pharmacokinetics are linear over the range 250 mg to 2 g. There is no evidence of accumulation in healthy adult male volunteers (n=7) ...

14.1 Febrile Neutropenic Patients The safety and efficacy of empiric cefepime monotherapy of febrile neutropenic patients have been assessed in two multicenter, randomized trials comparing cefepime monotherapy (at a dose of 2 g intravenously every 8 hours) to ceftazidime monotherapy (at a dose of 2 g intravenously every 8 hours). These studies comprised 317 evaluable patients. Table 10 describes the characteristics of the evaluable patient population.

Table 10Demographics of Evaluable Patients (First Episodes Only) Cefepime Ceftazidime Total 164 153 Median age (yr) 56 (range, 18 to 82) 55 (r...

The following adverse reactions are discussed in the Warnings and Precautions section and below: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 ) ] Neurotoxicity [see Warnings and Precautions ( 5.2) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.3 ) ] The most common adverse reactions (incidence ≥ 1%) were local reactions, positive Coombs' test, decreased phosphorous, increased ALT and AST, increased PT and PTT and rash. ( 6.1 ) At the highest...

Cefepime for injection is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibacterial drugs, penicillins or other beta-lactam antibacterial drugs. Patients with known immediate hypersensitivity reactions to cefepime or other cephalosporins, penicillins or other beta-lactam antibacterial drugs. ( 4 )

Hypersensitivity Reactions: Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefepime for Injection occurs, discontinue the drug. ( 5.1 ) Neurotoxicity: May occur especially in patients with renal impairment administered unadjusted doses. If neurotoxicity associated with cefepime for injection therapy occurs, discontinue the drug. ( 5.2 ) Clostridioides difficile Associated Diarrhea (C...

7 DRUG INTERACTIONS Aminoglycosides: increased potential of nephrotoxicity and ototoxicity. Monitor renal function. ( 7.2 ) Diuretics: nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide. Monitor renal function. ( 7.3 ) 7.1 Drug/Laboratory Test Interactions The administration of cefepime may result in a false-positi...