Cefepime

Cefepime Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: pneumonia, empiric therapy for febrile neutropenic patients, uncomplicated and complicated urinary tract infections, uncomplicated skin and skin structure infections, and complicated intra-abdominal infections (used in combination with metronidazole). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime Injection and other antibacterial drugs, Cefepime Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Cefepime is an antibacterial drug.

Recommended Dosage in Adults With Creatinine Clearance (CrCL) Greater Than 60 mL/min. Site and Type of Infection (Adults) Dose (IV) Frequency Duration (Days) Moderate to Severe Pneumonia For Pseudomonas aeruginosa, use 2 g IV every 8 hours 1-2 g Every 8-12 hours 10 Empiric therapy for febrile neutropenic patients 2 g Every 8 hours 7 Or until resolution of neutropenia.

Cefepime Injection is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibacterials, penicillins or other beta-lactam antibacterial drugs. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products. • Prior immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibacterial drugs, penicillins, and other beta-lactam antibacterial drugs.

• 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 Injection occurs, discontinue the drug. • Neurotoxicity: May occur especially in patients with renal impairment administered unadjusted doses. If neurotoxicity associated with Cefepime Injection therapy occurs, discontinue the drug. • Clostridioides difficile Associated Diarrhea (CDAD): Evaluate if diarrhea occurs.

The following adverse reactions are discussed in other sections of the labeling: • Hypersensitivity reactions • Neurotoxicity • Clostridioides difficile -associated diarrhea • 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. • At the highest dose (2 g every 8 hours), incidence of adverse reactions was ≥1% for rash, diarrhea, nausea, vomiting, pruritis, fever, and headache.

• Aminoglycosides -- increased potential of nephrotoxicity and ototoxicity. • Diuretics -- nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.

Store at or below –20°C (-4°F). Thaw frozen container at room temperature 25°C (77°F) or under refrigeration 5°C (41°F). The thawed solution remains stable for 7 days under refrigeration 5°C (41°F) or 24 hours at room temperature 25°C (77°F).