What is the recommended dose of cefixime (cephalosporin antibiotic) for pediatric patients?

Recommended Dosage for Cefixime in Pediatric Patients

The recommended dose of cefixime for pediatric patients 6 months 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

Dosing Guidelines

• For pediatric patients 6 months or older, the FDA-approved dosage is 8 mg/kg/day of the suspension, which can be given as a single daily dose or divided into two doses 1
• Cefixime is available in two different concentrations for oral suspension: 100 mg/5 mL and 200 mg/5 mL 1
• For children weighing more than 45 kg or older than 12 years, the adult dose of 400 mg daily should be used 1
• In the treatment of infections due to Streptococcus pyogenes, cefixime should be administered for at least 10 days 1

Weight-Based Dosing

The FDA provides specific weight-based dosing recommendations:

• 5 to 7.5 kg: 50 mg/day (2.5 mL of 100 mg/5 mL suspension) 1
• 7.6 to 10 kg: 80 mg/day (4 mL of 100 mg/5 mL or 2 mL of 200 mg/5 mL suspension) 1
• 10.1 to 12.5 kg: 100 mg/day (5 mL of 100 mg/5 mL or 2.5 mL of 200 mg/5 mL suspension) 1
• 12.6 to 20.5 kg: 150 mg/day (7.5 mL of 100 mg/5 mL or 4 mL of 200 mg/5 mL suspension) 1
• 20.6 to 28 kg: 200 mg/day (10 mL of 100 mg/5 mL or 5 mL of 200 mg/5 mL suspension) 1
• 28.1 to 33 kg: 250 mg/day (12.5 mL of 100 mg/5 mL or 6 mL of 200 mg/5 mL suspension) 1
• 33.1 to 40 kg: 300 mg/day (15 mL of 100 mg/5 mL or 7.5 mL of 200 mg/5 mL suspension) 1
• 40.1 to 45 kg: 350 mg/day (17.5 mL of 100 mg/5 mL or 9 mL of 200 mg/5 mL suspension) 1
• 45.1 kg or greater: 400 mg/day (20 mL of 100 mg/5 mL or 10 mL of 200 mg/5 mL suspension) 1

Special Considerations

• For otitis media, the suspension formulation should be used rather than tablets or capsules, as clinical trials demonstrated that the suspension results in higher peak blood levels 1
• For patients with renal impairment, dose adjustments are necessary:
  • Creatinine clearance 60 mL/min or greater: normal dose 1
  • Creatinine clearance 21-59 mL/min: 13 mL of 100 mg/5 mL or 6.5 mL of 200 mg/5 mL suspension per day 1
  • Creatinine clearance 20 mL/min or less: 8.6 mL of 100 mg/5 mL or 4.4 mL of 200 mg/5 mL suspension per day 1

Clinical Evidence Supporting Efficacy

• Clinical studies have demonstrated the efficacy of cefixime at 8 mg/kg/day in treating various pediatric infections, including respiratory tract infections and urinary tract infections 2
• In a multicenter trial, cefixime administered at 8 mg/kg once daily for 10-14 days showed a high efficacy rate for bacterial pharyngitis and cystitis, with clinical failure occurring in only 1.8% of patients 2
• Another study found that oral cefixime at 8 mg/kg/day for 10 days was as effective as initial parenteral therapy followed by oral cefixime in treating urinary tract infections in children 3

Important Considerations

• After reconstitution, the suspension may be kept for 14 days either at room temperature or under refrigeration without significant loss of potency 1
• The suspension should be shaken well before using 1
• Common adverse effects include diarrhea or loose stools, occurring in approximately 16% of pediatric patients, but these are generally mild and rarely require discontinuation of the medication 2