Minimum Age for Augmentin ES-600
Augmentin ES-600 (amoxicillin-clavulanate 600 mg/42.9 mg per 5 mL) is approved for use in pediatric patients 3 months of age and older. 1
FDA-Approved Age Indication
The FDA drug label explicitly states: "Safety and efficacy of AUGMENTIN ES-600 Powder for Oral Suspension in infants younger than 3 months have not been established" 1. This formulation has demonstrated safety and efficacy specifically for:
- Acute otitis media in infants and children 3 months to 12 years 1
- Acute bacterial sinusitis in pediatric patients 3 months to 12 years 1
Dosing for Eligible Patients
For pediatric patients ≥3 months of age, the recommended dose is 90 mg/kg/day (based on amoxicillin component) divided every 12 hours for 10 days 1. The suspension should be administered at the start of a meal to minimize gastrointestinal intolerance and enhance clavulanate absorption 1.
Clinical Context from Guidelines
While the FDA label establishes 3 months as the minimum age, pediatric pneumonia guidelines 2, 3 recommend amoxicillin-clavulanate for β-lactamase-producing organisms at doses of 45 mg/kg/day in 3 doses or 90 mg/kg/day in 2 doses for children with community-acquired infections. The ES-600 formulation specifically provides the higher-dose regimen (90 mg/kg/day) needed for resistant organisms.
Important Caveats
- Do not substitute other Augmentin suspensions for ES-600, as they contain different amounts of clavulanic acid and are not interchangeable 1
- ES-600 contains 42.9 mg clavulanic acid per 5 mL, compared to 28.5 mg/5 mL (200 mg formulation) or 57 mg/5 mL (400 mg formulation) 1
- Infants <3 months: No safety or efficacy data exist for this age group with ES-600 1