Cefixime Dosing in Children
For children 6 months and older, the standard cefixime dose is 8 mg/kg once daily, with a maximum of 400 mg per day, administered as oral suspension or capsules for patients who can swallow them. 1
Standard Weight-Based Dosing Algorithm
Primary Dosing Recommendation
- The FDA-approved dose is 8 mg/kg/day given as a single daily dose for children ≥6 months of age. 1
- The maximum daily dose is 400 mg regardless of weight, which is the standard adult dose. 1
- Cefixime is available as oral suspension (100 mg/5 mL or 200 mg/5 mL) for younger children and 400 mg capsules for older children who can swallow capsules. 1
Alternative Dosing Schedules
- Some clinical studies have used 8 mg/kg once daily (the FDA-approved regimen), while others have employed 4 mg/kg twice daily (divided into two doses 12 hours apart). 2, 3
- Once-daily dosing is preferred for convenience and improved adherence, and has demonstrated equivalent efficacy to twice-daily regimens in clinical trials. 3
Indication-Specific Considerations
Urinary Tract Infections
- The standard 8 mg/kg once daily achieves plasma and urinary concentrations well above the minimum inhibitory concentration for common urinary pathogens for up to 12 hours (plasma) and 24 hours (urine). 4
- For prophylaxis of recurrent UTIs, a lower dose of 2 mg/kg once daily has been studied and found effective, though this is not FDA-approved. 5
Pharyngitis and Tonsillitis
- 8 mg/kg once daily for 10 days is effective for streptococcal pharyngitis, with clinical cure rates exceeding 98% in pediatric studies. 3
Otitis Media and Respiratory Tract Infections
- The standard 8 mg/kg once daily for 7–10 days is appropriate for uncomplicated otitis media and respiratory infections caused by susceptible organisms. 2, 3
Renal Impairment Adjustments
- Dose adjustment is required when creatinine clearance is <60 mL/min. 1
- For creatinine clearance 21–60 mL/min: reduce dose to 75% of standard dose (approximately 6 mg/kg once daily or 300 mg maximum). 1
- For creatinine clearance ≤20 mL/min or patients on hemodialysis: reduce dose to 50% of standard dose (approximately 4 mg/kg once daily or 200 mg maximum). 1
Age Restrictions and Safety
- Cefixime is contraindicated in infants <6 months of age because efficacy and safety have not been established in this population. 1
- The drug is contraindicated in patients with known hypersensitivity to cefixime or other cephalosporins. 1
Pharmacokinetic Considerations
- Peak plasma concentrations occur approximately 3–4 hours after oral administration. 4
- The elimination half-life in children is approximately 3.9 hours, comparable to adults on a mg/kg basis. 4
- Approximately 15% of the dose is excreted unchanged in urine, providing high urinary concentrations for UTI treatment. 4
Common Pitfalls to Avoid
- Do not exceed 400 mg daily even in adolescents or larger children, as this is the maximum approved dose. 1
- Do not use cefixime for MRSA coverage—it has no activity against methicillin-resistant Staphylococcus aureus; use clindamycin or linezolid instead. 6
- Avoid using cefixime as monotherapy for gonococcal infections in children—CDC guidelines note that oral cephalosporins for gonococcal infections in children have not been adequately evaluated, and parenteral ceftriaxone is preferred. 7
- Monitor for Clostridium difficile-associated diarrhea, especially with prolonged use, as gastrointestinal side effects (particularly diarrhea) occur in approximately 16% of pediatric patients. 1, 3
Practical Dosing Examples
- 20 kg child: 8 mg/kg = 160 mg once daily (8 mL of 100 mg/5 mL suspension or 4 mL of 200 mg/5 mL suspension)
- 30 kg child: 8 mg/kg = 240 mg once daily (12 mL of 100 mg/5 mL suspension or 6 mL of 200 mg/5 mL suspension)
- ≥50 kg child: 400 mg once daily (maximum dose; one 400 mg capsule or 20 mL of 100 mg/5 mL suspension)