Cefixime Dosing for Children
The recommended dose of cefixime for pediatric patients 6 months or older is 8 mg/kg/day, which can be administered as a single daily dose or divided into 4 mg/kg every 12 hours, with a maximum daily dose of 400 mg. 1
Standard Dosing Regimen
The FDA-approved dosing for children is straightforward and weight-based 1:
- 8 mg/kg/day administered either:
- As a single daily dose, OR
- Divided as 4 mg/kg every 12 hours 1
- Maximum dose: 400 mg daily (for children >45 kg or >12 years, use adult dosing) 1
Age Restrictions
- Minimum age: 6 months or older 1
- Children weighing more than 45 kg or older than 12 years should receive the standard adult dose of 400 mg daily 1
Formulation-Specific Considerations
Critical caveat: Cefixime suspension is available in two concentrations (100 mg/5 mL and 200 mg/5 mL), so all orders specifying milliliters must include the concentration to prevent dosing errors 1. The FDA provides weight-based dosing tables to guide appropriate volume administration for each concentration 1.
Special Indication: Otitis Media
For otitis media specifically, the suspension formulation must be used rather than tablets or capsules, as clinical trials demonstrated the suspension achieves higher peak blood levels at equivalent doses 1. This is a common pitfall—do not substitute tablet/capsule formulations when treating otitis media in children 1.
Duration of Therapy
For infections caused by Streptococcus pyogenes (such as pharyngitis), cefixime must be administered for at least 10 days to ensure eradication and prevent rheumatic fever 1.
Clinical Evidence Supporting Dosing
The 8 mg/kg/day regimen has demonstrated comparable efficacy to standard comparators 2:
- In pediatric otitis media trials, cefixime 8 mg/kg daily (given once daily or divided twice daily) showed similar effectiveness to cefaclor 20-40 mg/kg daily and amoxicillin 40 mg/kg daily 2
- Post-marketing surveillance of 9,568 patients confirmed high efficacy (98% cure/improvement rate) and low adverse event rates (1.92% in children) using the 8 mg/kg dosing 3
Renal Impairment Adjustments
While the FDA label provides detailed renal dosing adjustments for adults, no specific pediatric renal dosing adjustments are provided in the prescribing information 1. In such cases, consultation with pediatric nephrology or infectious disease specialists is warranted.
Administration
Cefixime may be administered without regard to food 1. After reconstitution, the suspension remains stable for 14 days at room temperature or refrigerated; shake well before each use and discard unused portions after 14 days 1.