CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER

Pharmacokinetic parameters for cefepime in healthy adult male volunteers (n=9) following single 30-minute IV infusions of cefepime 500 mg, 1 g, and 2 g are summarized in Table 5. 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) re...

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 7 describes the characteristics of the evaluable patient population.

Table 7Demographics of Evaluable Patients (First Episodes Only) Cefepime Ceftazidime Total n=164 n=153 ANC = absolute neutrophil count; SBP = s...

The following adverse reactions are discussed in other sections of the labeling: 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 dose (2 g every 8 hours...

Patients with known immediate hypersensitivity reactions to cefepime or other cephalosporins, penicillins or other beta-lactam antibacterial drugs. ( 4 ) 4.1 Hypersensitivity to Cefepime or the Cephalosporin Class of Antibacterials, Penicillins, or Other Beta-lactam Antibacterials Cefepime for Injection and Dextrose Injection is contraindicated in patients who have shown immediate hypersensitivity...

Hypersensitivity reactions : Cross-hypersensitivity may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction 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 and Dextrose Injection occurs, discontinue the drug. ( 5.2 ) Clostridio ides difficile- associated diarrhea (CDAD): Evaluate if diarrhea occurs. ( 5.3 ) 5....

7 DRUG INTERACTIONS Aminoglycosides: Increased potential of nephrotoxicity and ototoxicity. ( 7.2 ) Diuretics: Nephrotoxicity has been reported with concomitant administration of cephalosporins with potent diuretics such as furosemide. Monitor renal function. ( 7.3 ) 7.1 Drug/Laboratory Test Interactions The administration of Cefepime for Injection and Dextrose Injection may result in a false-posi...