Cefepime injection for treating serious bacterial infections

Cefepime for injection is an antibacterial medication used intravenously or intramuscularly to treat a variety of serious bacterial infections. It is a cephalosporin antibiotic approved for moderate to severe infections caused by susceptible bacteria, including pneumonia, urinary tract infections, skin infections, and complicated intra-abdominal infections in adults. It is also used as empiric therapy in febrile neutropenic patients.

Cefepime for injection is indicated to treat infections caused by susceptible bacteria, including:

• Moderate to severe pneumonia, including cases with concurrent bacteremia, caused by Streptococcus pneumoniae, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
• Empiric monotherapy for febrile neutropenic patients, except in high-risk cases where monotherapy may be insufficient.
• Uncomplicated and complicated urinary tract infections (including pyelonephritis). For severe infections caused by Escherichia coli or Klebsiella pneumoniae. For mild to moderate infections caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, including associated bacteremia.
• Uncomplicated skin and skin structure infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes.
• Complicated intra-abdominal infections in adults, used in combination with metronidazole, caused by susceptible isolates of Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.

Use of cefepime should be reserved for infections proven or strongly suspected to be bacterial to reduce drug resistance.

Cefepime hydrochloride

Cefepime is a cephalosporin antibiotic that kills susceptible bacteria by interfering with their cell wall synthesis, which leads to bacterial cell death. It works against a broad spectrum of gram-positive and gram-negative bacteria, making it useful for various serious infections.

Adults with normal kidney function (CrCL > 60 mL/min):

Notes: For Pseudomonas aeruginosa, use 2 g IV every 8 hours. Intramuscular administration is limited to mild to moderate uncomplicated or complicated UTIs due to E. coli.

Pediatric patients (2 months to 16 years) with CrCL > 60 mL/min:

• 50 mg/kg per dose every 12 hours for uncomplicated and complicated UTIs, skin infections, and pneumonia.
• For moderate to severe pneumonia due to Pseudomonas aeruginosa, 50 mg/kg every 8 hours.
• For febrile neutropenic patients, 50 mg/kg every 8 hours.
• Do not exceed recommended adult doses.

Dosage adjustments for renal impairment (adults):

Reduce doses or extend dosing intervals based on creatinine clearance values. For example:

• CrCL 30-60 mL/min: 500 mg to 2 g every 24 hours (depending on infection severity)
• CrCL 11-29 mL/min: 250 to 2 g every 24 hours
• CrCL

For patients on hemodialysis, administer cefepime after dialysis, typically 1 g on day 1 followed by 500 mg every 24 hours, except febrile neutropenia which requires 1 g every 24 hours.

In pediatric patients with renal impairment, adjust dosing proportionally to adult recommendations due to similar pharmacokinetics.

Administration:

• Intravenous doses should be infused over approximately 30 minutes.
• For intramuscular injection, reconstitute with appropriate diluents as specified.
• Inspect solutions for particulate matter before administration; discard if present.

Cefepime for injection is contraindicated in patients with known allergy to cefepime or other cephalosporin antibiotics.

Important precautions and warnings:

• Use cefepime only for bacterial infections that are proven or strongly suspected to be caused by susceptible bacteria to reduce development of drug resistance.
• Carefully monitor patients with renal impairment and adjust dosing accordingly, as cefepime is primarily eliminated by the kidneys.
• In febrile neutropenic patients at high risk for severe infection (history of bone marrow transplantation, hypotension, hematologic malignancy, or severe/prolonged neutropenia), monotherapy with cefepime may not be sufficient; monitor closely.
• Inspect reconstituted solutions visually for particulate matter before administration and discard if detected.

Common side effects:

• Local injection site reactions such as pain or inflammation
• Gastrointestinal symptoms like nausea or diarrhea may occur

Serious side effects (require immediate medical attention):

• Signs of allergic reaction (rash, itching, swelling, severe dizziness, difficulty breathing)
• Seizures, especially in patients with renal impairment or high doses
• Clostridioides difficile–associated diarrhea
• Neurotoxicity symptoms (confusion, hallucinations) especially in renal impairment

Drug interactions to consider:

• Cefepime should not be mixed with ampicillin solutions at concentrations above 40 mg/mL due to incompatibility.
• Do not combine cefepime with metronidazole, vancomycin, gentamicin, tobramycin, netilmicin sulfate, or aminophylline in the same solution because of potential interactions; administer separately if needed.

Pregnancy and lactation:

Limited data are available on cefepime use in pregnancy. Use only if clearly needed according to healthcare provider.

Lactation: Cefepime is excreted in breast milk; evaluate risks and benefits before use during breastfeeding.

In case of overdose, signs may include neurotoxicity such as seizures due to accumulation. Management involves discontinuation and supportive care, with attention to renal function.

• Store cefepime powder vials at controlled room temperature (20°C to 25°C / 68°F to 77°F).
• After reconstitution, solutions are stable for 24 hours at room temperature or 7 days in refrigerated conditions (2°C to 8°C / 36°F to 46°F) depending on the diluent used.