What is the recommended dose of Cefaclor (Cephalosporin antibiotic) for children?

Cefaclor Dosing for Pediatric Patients

For children, administer cefaclor at 20 mg/kg/day divided every 8 hours for mild infections, or 40 mg/kg/day divided every 8 hours (maximum 1 g/day) for more serious infections including otitis media and infections caused by less susceptible organisms. 1

Standard Dosing Regimen

Mild to Moderate Infections

• The FDA-approved dose is 20 mg/kg/day divided into three doses given every 8 hours 1
• For a 9 kg child, this translates to 2.5 mL (half teaspoon) of the 125 mg/5 mL suspension three times daily 1
• For an 18 kg child, this translates to 5 mL (one teaspoon) of the 125 mg/5 mL suspension three times daily, or 2.5 mL of the 250 mg/5 mL suspension three times daily 1

Serious Infections and Otitis Media

• For otitis media, lower respiratory tract infections, and infections caused by less susceptible organisms, increase the dose to 40 mg/kg/day divided every 8 hours, with a maximum daily dose of 1 g 1
• For a 9 kg child with otitis media, administer 5 mL (one teaspoon) of the 125 mg/5 mL suspension three times daily, or 2.5 mL of the 250 mg/5 mL suspension three times daily 1
• For an 18 kg child with otitis media, administer 5 mL (one teaspoon) of the 250 mg/5 mL suspension three times daily 1

Alternative Twice-Daily Dosing

• For otitis media and pharyngitis specifically, the total daily dose may be divided and administered every 12 hours instead of every 8 hours 1
• This twice-daily regimen improves adherence while maintaining efficacy 1
• For an 18 kg child with pharyngitis at 20 mg/kg/day, administer 2.5 mL (half teaspoon) of the 375 mg/5 mL suspension twice daily 1
• For a 9 kg child with otitis media at 40 mg/kg/day, administer 2.5 mL (half teaspoon) of the 375 mg/5 mL suspension twice daily 1
• For an 18 kg child with otitis media at 40 mg/kg/day, administer 5 mL (one teaspoon) of the 375 mg/5 mL suspension twice daily 1

Clinical Evidence Supporting Dosing

• Clinical studies demonstrate that cefaclor at 20-40 mg/kg/day in three divided doses achieves a 97% bacteriologic cure rate in pediatric otitis media, with excellent coverage against Streptococcus pneumoniae and Haemophilus influenzae 2
• The 40 mg/kg/day dose is particularly important for otitis media, as lower doses may be inadequate for this indication 3
• Cefaclor demonstrates superior bacteriologic effectiveness compared to penicillin V for streptococcal pharyngitis, with only 3.4% bacteriologic failure rates versus 19.6% with penicillin 4

Duration of Therapy

• For β-hemolytic streptococcal infections (pharyngitis), administer cefaclor for at least 10 days to prevent rheumatic fever 1
• For otitis media and other infections, duration typically ranges from 7-10 days based on clinical response 2

Important Clinical Considerations

• Cefaclor may be administered in the presence of impaired renal function without dosage adjustment in most cases 1
• The medication is well tolerated, with mostly mild gastrointestinal adverse effects occurring in few patients 3
• Food delays absorption but does not significantly reduce bioavailability; however, administration on an empty stomach optimizes absorption 3
• The 40 mg/kg/day dose provides adequate coverage against β-lactamase-producing H. influenzae strains resistant to ampicillin 3