Cefixime Dosing in Pediatric Patients
The recommended dose of cefixime for pediatric patients 6 months of age or older is 8 mg/kg/day, which may be administered as a single daily dose or divided into two doses of 4 mg/kg every 12 hours. 1
Standard Dosing Regimen
- For children ≥6 months of age: The FDA-approved dose is 8 mg/kg/day of the oral suspension 1
- Administration options: This total daily dose can be given either as a single daily dose OR divided as 4 mg/kg every 12 hours 1
- Maximum dose: Children weighing more than 45 kg or older than 12 years should receive the adult dose of 400 mg daily 1
Weight-Based Dosing Table
The FDA provides specific dosing recommendations based on weight ranges 1:
- 5-7.5 kg: 50 mg/day (2.5 mL of 100 mg/5 mL suspension)
- 7.6-10 kg: 80 mg/day (4 mL of 100 mg/5 mL or 2 mL of 200 mg/5 mL)
- 10.1-12.5 kg: 100 mg/day (5 mL of 100 mg/5 mL or 2.5 mL of 200 mg/5 mL)
- 12.6-20.5 kg: 150 mg/day (7.5 mL of 100 mg/5 mL or 4 mL of 200 mg/5 mL)
- 20.6-28 kg: 200 mg/day (10 mL of 100 mg/5 mL or 5 mL of 200 mg/5 mL)
- 28.1-33 kg: 250 mg/day (12.5 mL of 100 mg/5 mL or 6 mL of 200 mg/5 mL)
- 33.1-40 kg: 300 mg/day (15 mL of 100 mg/5 mL or 7.5 mL of 200 mg/5 mL)
- 40.1-45 kg: 350 mg/day (17.5 mL of 100 mg/5 mL or 9 mL of 200 mg/5 mL)
- >45 kg: 400 mg/day (adult dose) 1
Important Clinical Considerations
Otitis Media Specific Guidance
- Otitis media must be treated with the suspension formulation, not tablets or capsules 1
- Clinical trials demonstrated that the suspension produces higher peak blood levels than tablets at equivalent doses, making it essential for adequate treatment of middle ear infections 1
Duration of Therapy
- For Streptococcus pyogenes infections (pharyngitis/tonsillitis): Administer for at least 10 days to ensure eradication and prevent rheumatic fever complications 1
- For uncomplicated gonorrhea: A single 400 mg dose is recommended for patients ≥6 months 1
Concentration Awareness
- Critical safety point: Cefixime suspension is available in two concentrations (100 mg/5 mL and 200 mg/5 mL) 1
- All prescriptions specifying milliliters must include the concentration to prevent dosing errors 1
Clinical Efficacy Data
- Clinical studies demonstrate cure or improvement rates of 96-100% in pediatric respiratory tract infections when using the 8 mg/kg/day dosing regimen 2, 3
- The twice-daily dosing schedule (4 mg/kg every 12 hours) was preferred in 54.4% of pediatric cases in large surveillance studies 2
- Adverse events occur in approximately 1.92% of children, with diarrhea being the most common but typically mild and transient 2
Age Restrictions
Cefixime is NOT approved for infants younger than 6 months of age 1. For neonates and young infants requiring third-generation cephalosporin therapy, alternative agents such as ceftazidime (100-150 mg/kg/day divided every 8-12 hours) or cefotaxime (150 mg/kg/day divided every 8 hours) should be used instead 4.