Cefixime Once-Daily Dosing in Infants
Cefixime should NOT be given to infants younger than 6 months of age, as it is not approved for this population; for infants 6 months and older, once-daily dosing is appropriate and safe. 1
Age-Based Safety Considerations
- Cefixime is contraindicated in neonates and young infants under 6 months of age - alternative third-generation cephalosporins must be used instead 1
- For infants requiring third-generation cephalosporin therapy who are younger than 6 months, use ceftazidime (100-150 mg/kg/day divided every 8-12 hours) or cefotaxime (150 mg/kg/day divided every 8 hours) 1
- This age restriction is critical because cefixime has not been studied or approved for safety and efficacy in this vulnerable population 1
Once-Daily Dosing for Eligible Infants (≥6 Months)
For infants 6 months and older, cefixime is specifically designed for once-daily administration, making it highly practical for outpatient management 1, 2
Weight-Based Dosing Algorithm
- Infants 5-7.5 kg: 50 mg once daily (2.5 mL of 100 mg/5 mL suspension) 1
- Infants 7.6-10 kg: 80 mg once daily (4 mL of 100 mg/5 mL or 2 mL of 200 mg/5 mL) 1
- Infants 10.1-12.5 kg: 100 mg once daily (5 mL of 100 mg/5 mL or 2.5 mL of 200 mg/5 mL) 1
Clinical Evidence Supporting Once-Daily Dosing
- A multicenter trial demonstrated that 8 mg/kg once daily was safe and effective in 206 pediatric patients, with an overall success rate of 98.2% for pharyngitis and cystitis 2
- The once-daily regimen showed excellent tolerability, with only 1.9% of patients discontinuing due to adverse effects (primarily mild diarrhea in 16% of cases) 2
- Another study confirmed that cefixime given twice daily at 6-12 mg/kg/day achieved a 93% cure rate across various infections, though once-daily dosing is the standard recommendation 3
- Comparative trials showed cefixime 8 mg/kg once daily was equivalent to amoxicillin three times daily for acute otitis media, with no significant differences in cure rates or recurrences 4
Common Pitfalls to Avoid
- Never use cefixime in infants under 6 months - this is the most critical error to avoid, as safety data does not exist for this age group 1
- Do not split the daily dose into multiple administrations unless specifically indicated - the pharmacokinetics support once-daily dosing 2
- Monitor for mild diarrhea (occurs in approximately 16% of patients), but this rarely requires discontinuation 2
- Ensure proper weight-based dosing rather than age-based dosing, as weight is the primary determinant of appropriate dose 1