Cefepime Safety in Pediatric Patients
Cefepime is safe and effective for pediatric patients aged 2 months and older, with established dosing guidelines and safety profiles for various infections. 1
Safety Profile and FDA Approval
- Cefepime is FDA-approved for pediatric patients from 2 months up to 16 years of age for treating uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, pneumonia, and as empiric therapy for febrile neutropenic patients 1
- Safety and effectiveness in pediatric patients below 2 months of age have not been established 1
- There are insufficient clinical data to support cefepime use in pediatric patients under 2 months or for treatment of serious infections where the suspected or proven pathogen is Haemophilus influenzae type b 1
Dosing Guidelines for Pediatric Patients
- For complicated intra-abdominal infections: 100 mg/kg/day administered every 12 hours 2
- For empiric therapy in culture-negative endocarditis with prosthetic valve (early, ≤1 year): 150 mg/kg/day IV in 3 equally divided doses for 6 weeks 2
- For treatment of gram-negative enteric bacilli infections: 100-150 mg/kg/day IV divided every 8 hours up to 2-4 g daily 2
Clinical Evidence Supporting Safety
- A European randomized controlled study of 300 pediatric cases with pyelonephritis found cefepime (50 mg/kg every 8 hours) to be equally safe and efficacious as ceftazidime, with drug-related adverse events occurring in only 9% of cefepime patients 3
- Pharmacokinetic studies in infants and children with normal renal function support a dosing strategy of 50 mg/kg every 12 hours for patients ≥2 months of age for infections caused by pathogens with MICs ≤8 mg/liter 4
- Clinical trials in children with lower respiratory tract infections demonstrated that cefepime (50 mg/kg/dose every 8-12 hours) produced satisfactory clinical response in 88-100% of patients with few treatment-related adverse events 5
Special Considerations and Precautions
- Renal function monitoring is essential as cefepime is primarily excreted by the kidneys, and dose adjustments are necessary in patients with impaired renal function 1
- A recent (2022) population pharmacokinetic study in critically ill children recommends:
- For patients with renal failure: 100 mg/kg/day q12h over 30 minutes
- For patients with normal or augmented renal clearance: 100 mg/kg/day as continuous infusion 6
- Serious adverse events, including encephalopathy, myoclonus, and seizures, have occurred in patients with renal impairment given unadjusted doses of cefepime 1
Pregnancy and Lactation
- While not directly relevant to pediatric patients, cefepime has not been associated with adverse developmental outcomes in animal studies at doses comparable to human therapeutic doses 1
- Cefepime is present in human milk at low concentrations (0.5 mcg/mL), with an estimated infant exposure of approximately 0.5 mg per day from 1000 mL of human milk 1
Conclusion
Cefepime is a well-established, broad-spectrum fourth-generation cephalosporin with documented safety and efficacy in pediatric patients 2 months and older. Its use should be guided by the specific infection being treated, the patient's renal function, and local antimicrobial resistance patterns. Close monitoring is recommended, particularly in patients with renal impairment.