FDA Approves Cefepime for Injection and Dextrose Injection (cefepime) for Moderate to Severe Pneumonia and Other Infections
The FDA has approved Cefepime for Injection and Dextrose Injection, a cephalosporin antibacterial, for intravenous use in treating several moderate to severe infections caused by susceptible bacteria. This approval provides a specific formulation in a duplex container for patients requiring the entire 1 or 2 gram dose.
The indicated infections include pneumonia (moderate to severe), empiric therapy for febrile neutropenic patients, uncomplicated and complicated urinary tract infections, uncomplicated skin and skin structure infections, and complicated intra-abdominal infections (used with metronidazole). For clinicians, this represents an established antibiotic agent in a ready-to-use format for hospitalized patients meeting the specific dosing requirements.
The label emphasizes using the drug only for infections proven or strongly suspected to be bacterial to reduce drug-resistant bacteria development. It is administered intravenously over approximately 30 minutes.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
Cefepime for Injection and Dextrose Injection is a cephalosporin antibacterial indicated for treating infections caused by susceptible strains of designated microorganisms. Indications include: 1) Moderate to severe pneumonia caused by Streptococcus pneumoniae (including cases with concurrent bacteremia), Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species. For P. aeruginosa, the recommended dose is 2 g IV every 8 hours. 2) Empiric monotherapy for febrile neutropenic patients, though monotherapy may not be appropriate for patients at high risk for severe infection (e.g., recent bone marrow transplant, hypotension, underlying hematologic malignancy, severe/prolonged neutropenia). 3) Uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae when severe, or by E. coli, K. pneumoniae, or Proteus mirabilis when mild to moderate. 4) Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible only) or Streptococcus pyogenes. 5) Complicated intra-abdominal infections (used with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or Bacteroides fragilis. The drug should be used only for infections proven or strongly suspected to be bacterial.
For intravenous use only, administered over approximately 30 minutes. This formulation should be used only in adult and pediatric patients who require the entire 1 or 2 gram dose and not any fraction thereof. For adult patients with creatinine clearance (CrCL) >60 mL/min: Moderate to severe pneumonia: 1 or 2 g IV every 8-12 hours for 10 days (use 2 g every 8 hours for P. aeruginosa). Empiric therapy for febrile neutropenia: 2 g IV every 8 hours for 7 days or until resolution of neutropenia. Mild to moderate uncomplicated/complicated UTI: 0.5 or 1 g IV every 12 hours for 7-10 days. Severe uncomplicated/complicated UTI: 2 g IV every 12 hours for 10 days. Moderate to severe uncomplicated skin infections: 2 g IV every 12 hours for 10 days. Complicated intra-abdominal infections (with metronidazole): 2 g IV every 8-12 hours for 7-10 days. For pediatric patients (2 months to 16 years) with CrCl >60 mL/min: usual recommended dosage is 50 mg/kg per dose every 12 hours (every 8 hours for febrile neutropenia). Dose adjustment is required for patients with CrCl ≤60 mL/min.
Trial data not available in label.
Not reported in label.
To reduce the development of drug-resistant bacteria and maintain effectiveness, Cefepime for Injection and Dextrose Injection should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection.
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