Age for Starting Augmentin (Amoxicillin/Clavulanate) in Pediatric Patients
Augmentin can be started at 3 months (12 weeks) of age for most pediatric infections, with special dosing considerations for infants younger than 3 months. 1
Age-Specific Dosing Guidelines
Infants Under 3 Months (Less than 12 Weeks)
- For infants less than 12 weeks of age, the maximum recommended dose is 30 mg/kg/day of the amoxicillin component divided every 12 hours due to incompletely developed renal function affecting drug elimination. 1
- The FDA label specifically addresses this age group with modified dosing to account for delayed amoxicillin elimination, though clavulanate elimination remains unaltered. 2
- Treatment duration should be at least 10 days for infections caused by Streptococcus pyogenes to prevent acute rheumatic fever, even in this youngest age group. 1
Infants 3 Months and Older
- Standard weight-based dosing can be used starting at 3 months of age, with doses ranging from 20-90 mg/kg/day of the amoxicillin component depending on infection severity and risk factors. 1
- For infants 3-12 months with acute otitis media, the age-based oral suspension dosing is 2.5 ml three times daily of the 125/31 suspension. 3
- The high-dose formulation (90 mg/kg/day amoxicillin with 6.4 mg/kg/day clavulanate in two divided doses) is particularly important for infants under 2 years, as this age group has increased risk for resistant organisms. 3
Clinical Pharmacology Supporting Early Use
- Pharmacokinetic studies demonstrate that a syrup formulation of amoxicillin/clavulanate at 25 mg/kg doses (20 mg amoxicillin + 5 mg clavulanate per kg) achieves adequate plasma concentrations in children as young as 3 years, with mean peak levels of 7.2 mg/L for amoxicillin and 2.0 mg/L for clavulanic acid. 4
- A pediatric formulation containing 100 mg amoxicillin and 12.5 mg clavulanic acid per ml has been studied in infants as young as 3 months for acute otitis media, demonstrating over 92% resolution rates. 5
- The safety and effectiveness of amoxicillin/clavulanate has been established in pediatric patients through studies in children aged 2 months to 12 years with acute otitis media. 2
Critical Considerations for Neonates and Young Infants
- There are currently no dosing recommendations for pediatric patients with impaired renal function under 3 months of age, requiring careful clinical judgment. 1
- The 30 mg/kg/day maximum for infants under 12 weeks represents a significant dose reduction compared to older children (who may receive up to 90 mg/kg/day), reflecting the immature renal clearance in this population. 1
- Amoxicillin is excreted in human milk, and use by nursing mothers may lead to sensitization of infants, requiring caution when administered to breastfeeding women with very young infants. 2
Common Pitfalls to Avoid
- Do not use the 875 mg tablet formulation or high adult doses in young children—always use weight-based pediatric dosing with appropriate suspension formulations. 1
- Verify the suspension concentration (125/31 vs 250/62 mg per 5 ml) before calculating volume to avoid dosing errors, as different concentrations require different volumes for the same dose. 3
- The twice-daily high-dose formulation (90/6.4 mg/kg/day) causes less diarrhea than three-times-daily standard formulations while maintaining equivalent efficacy, making it preferable when high-dose therapy is indicated. 3, 6