CEFEPIME

Generic Name/API: cefepime hydrochloride

Manufacturer: Apotex Corp.

Dosage Forms & Strength & Pack Size:
Cefepime for Injection, USP is a sterile powder of cefepime in single-dose vials for reconstitution, available
in the following strengths:
•0.5 gram per vial, 1 gram per vial and 2 grams per vial.

Storage:
Cefepime for Injection, USP in the dry state should be stored at 20 to 25°C (68 to 77°F)
[see USP controlled room temperature.] and protected from light.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION
Cefepime for Injection is a cephalosporin antibacterial indicated for the treatment of the following
infections caused by susceptible strains of the designated microorganisms:
Pneumonia. (1.1)
Empiric therapy for febrile neutropenic patients. (1.2)
Uncomplicated and complicated urinary tract infections (including pyelonephritis). (1.3)
Uncomplicated skin and skin structure infections. (1.4)
Complicated intra-abdominal infections (used in combination with metronidazole) in adults. (1.5)

WARNINGS AND PRECAUTIONS
• 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)
• Clostridium difficile Associated Diarrhea (CDAD):
Evaluate if diarrhea occurs. (5.3)

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