Augmentin 90 mg/kg/day Can Be Started at 3 Months of Age
Augmentin (amoxicillin-clavulanate) at the high-dose regimen of 90 mg/kg/day may be initiated in children ≥3 months of age when bacterial infection is suspected or confirmed. 1
Age-Based Safety and Approval
The minimum age for initiating Augmentin is 3 months, as safety and efficacy data are robust for children at or above this age but remain limited for younger infants. 1
Pharmacokinetic studies demonstrate reliable metabolism and clearance of the clavulanate component only after the neonatal period (≥3 months), which supports this age cutoff. 1
For infants younger than 3 months with suspected serious bacterial infection, intravenous regimens (e.g., ampicillin plus gentamicin or cefotaxime) are preferred over oral Augmentin. 1
High-Dose Regimen Specifications
The high-dose formulation is defined as 90 mg/kg/day of amoxicillin with 6.4 mg/kg/day of clavulanate, administered in two divided doses. 1
This regimen provides a 14:1 ratio of amoxicillin to clavulanate in oral suspension, which causes less diarrhea than other amoxicillin-clavulanate preparations while maintaining efficacy. 1
Primary Indications in Children ≥3 Months
The high-dose regimen is indicated for acute otitis media, community-acquired pneumonia, and acute bacterial rhinosinusitis in children 3 months and older. 1
For presumed bacterial pneumonia in outpatient children under 5 years old, the American Academy of Pediatrics recommends the amoxicillin component at 90 mg/kg/day in 2 doses. 1
Risk Factors Requiring High-Dose Therapy
High-dose amoxicillin-clavulanate (90 mg/kg/day) is specifically indicated when any of the following risk factors are present: 1
- Age <2 years
- Daycare attendance
- Recent antibiotic use within the previous 30 days
- Incomplete Haemophilus influenzae type b vaccination (fewer than 3 injections)
- Geographic area with high prevalence of penicillin-resistant S. pneumoniae (>10%)
- Moderate to severe illness at presentation
Clinical Efficacy Against Resistant Pathogens
The high-dose formulation achieves middle ear fluid concentrations adequate to overcome penicillin-resistant S. pneumoniae based on acute otitis media data. 1
High-dose amoxicillin (80-90 mg/kg/day) exceeds the minimum inhibitory concentration for intermediately resistant S. pneumoniae and many highly resistant serotypes. 1
The high-dose formulation (90/6.4 mg/kg/day) eradicated penicillin-resistant S. pneumoniae with MICs of 2-4 mg/L in clinical trials, with clinical response rates of 76-95%. 1
Treatment Duration and Monitoring
The Infectious Diseases Society of America recommends treatment courses of 10 days for most pediatric infections, including acute otitis media and community-acquired pneumonia. 1
Clinical improvement should be evident within 48-72 hours after initiating therapy; if no improvement or worsening occurs, reevaluation and consideration of switching antibiotics or further investigation is recommended. 1
Common Pitfalls to Avoid
Using standard doses when high-dose therapy is indicated leads to treatment failure with resistant organisms. 1
Verify the suspension concentration (125/31 vs 250/62) before calculating volume to avoid dosing errors. 1
If oral Augmentin is deemed absolutely necessary in a critically ill 1-2 month-old infant, specialist consultation should be obtained before prescribing. 1
French pediatric guidelines explicitly limit acute otitis media recommendations to children over 3 months, reinforcing the age restriction. 1