Can Augmentin ES-600 Be Prescribed for an 18-Month-Old?
Yes, Augmentin ES-600 (amoxicillin/clavulanate 600 mg/42.9 mg per 5 mL) is FDA-approved and appropriate for children 3 months and older, including 18-month-olds, at a dose of 90 mg/kg/day divided every 12 hours. 1
FDA-Approved Dosing for Pediatric Patients
The FDA label explicitly states that Augmentin ES-600 is indicated for pediatric patients 3 months and older at 90 mg/kg/day (based on the amoxicillin component) divided every 12 hours for 10 days. 1
Weight-Based Dosing Table
For an 18-month-old child, determine the appropriate volume based on weight: 1
- 8 kg: 3 mL twice daily
- 12 kg: 4.5 mL twice daily
- 16 kg: 6 mL twice daily
- 20 kg: 7.5 mL twice daily
Clinical Context and Indications
Augmentin ES-600 was specifically developed to address persistent or recurrent acute otitis media in children where drug-resistant Streptococcus pneumoniae or beta-lactamase-producing organisms are suspected. 2, 3, 4
Key Clinical Scenarios for Use
- Recurrent or persistent acute otitis media after failure of standard-dose amoxicillin 2, 4
- Suspected involvement of penicillin-resistant S. pneumoniae (MIC ≤2 mg/L) 2
- Beta-lactamase-producing Haemophilus influenzae or Moraxella catarrhalis 3, 4
The high-dose formulation provides a 14:1 ratio of amoxicillin to clavulanate (compared to 4:1 or 7:1 in conventional formulations), delivering higher amoxicillin concentrations while maintaining the same daily clavulanate dose to minimize gastrointestinal side effects. 4
Administration Guidelines
Administer Augmentin ES-600 at the start of a meal to minimize gastrointestinal intolerance and enhance clavulanate absorption. 1
Important Preparation Instructions
- Reconstitute the suspension by adding approximately 2/3 of the required water, shake vigorously, then add the remainder and shake again 1
- Always shake the oral suspension well before each use 1
- Store reconstituted suspension appropriately per package insert 1
Safety and Tolerability
The twice-daily high-dose formulation (90/6.4 mg/kg/day) demonstrates similar tolerability to conventional twice-daily formulations (45/6.4 mg/kg/day), with diarrhea being the most common adverse event. 2, 5
- Diarrhea occurs less frequently with twice-daily dosing compared to three-times-daily regimens 5
- Most adverse events are mild-to-moderate and transient 5
- A large postmarketing study reported only 3.6% total adverse events with no serious events in pediatric patients 2
Critical Formulation Warning
Do NOT substitute other amoxicillin/clavulanate suspensions (200 mg/28.5 mg per 5 mL or 400 mg/57 mg per 5 mL) for Augmentin ES-600, as they contain different amounts of clavulanic acid and are not interchangeable. 1
This is a common prescribing error that can lead to either inadequate amoxicillin dosing or excessive clavulanate exposure with increased gastrointestinal side effects. 1