Cefaclor Dosing for Pediatric Patients
Standard Dosing Regimen
The recommended dose of oral cefaclor for children is 20 mg/kg/day divided every 8 hours for mild infections, or 40 mg/kg/day divided every 8 hours for more serious infections including otitis media, with a maximum daily dose of 1 gram. 1
Weight-Based Dosing Guidelines
- For mild infections, administer 20 mg/kg/day divided into three doses every 8 hours 1
- For more serious infections, otitis media, and infections caused by less susceptible organisms, increase to 40 mg/kg/day divided every 8 hours, not exceeding 1 g/day 1
- The FDA label provides specific examples: for a 9 kg child on the 40 mg/kg/day regimen, give 1 teaspoon (5 mL) of 125 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 option improves adherence while maintaining efficacy for these specific indications 1
Maximum Doses and Duration
- The maximum daily dose is 1 gram per day regardless of weight or severity 1
- For β-hemolytic streptococcal infections, continue treatment for at least 10 days to prevent rheumatic fever 1
- Clinical studies support 10-day courses for streptococcal pharyngitis, with cefaclor showing superior bacteriologic eradication (96.6%) compared to penicillin V (80.4%) 2
Special Populations
Infants Under 1 Month
- The FDA label does not provide specific dosing recommendations for infants younger than 1 month of age 1
- Safety and efficacy have not been established in neonates, and cefaclor should be avoided in this age group unless no alternative exists 1
Renal Impairment
- Dosage adjustment is typically not required for children with renal impairment, as cefaclor may be administered in the presence of impaired renal function 1
- However, no specific dose reduction guidelines are provided for severe renal impairment (CrCl <30 mL/min) in the pediatric population 1
Clinical Context and Positioning
- Cefaclor demonstrates particular effectiveness against β-lactamase-producing Haemophilus influenzae resistant to ampicillin, making it valuable for otitis media 3, 4
- The drug achieves therapeutic plasma levels readily in children when administered at 20-40 mg/kg/day 4
- Adverse reactions are generally mild and predominantly gastrointestinal, occurring in a minority of patients 3
Critical Dosing Considerations
- Always divide the total daily dose into three equal doses given every 8 hours for standard administration 1
- Food delays absorption but does not significantly reduce bioavailability 3
- For streptococcal pharyngitis, the 20-40 mg/kg/day range may be insufficient for optimal bacteriologic cure; consider using the higher end of the dosing range 3, 2