Pediatric Augmentin Dosing for Acute Otitis Media in a 49-lb Child
For a 49-lb (22.2-kg) child with acute otitis media, prescribe high-dose amoxicillin-clavulanate at 90 mg/kg/day of the amoxicillin component, which equals 2,000 mg total daily dose, administered as 1,000 mg (approximately 12.5 mL of the 400 mg/5 mL suspension) every 12 hours for 10 days. 1, 2
Dosing Calculation and Formulation Selection
Weight-based calculation: 22.2 kg × 90 mg/kg/day = 1,998 mg/day (rounded to 2,000 mg), divided into two doses of 1,000 mg each given every 12 hours. 1, 2
Use the 400 mg/5 mL (ES-600) suspension formulation, which provides the optimal 14:1 ratio of amoxicillin to clavulanate (90 mg/kg amoxicillin with 6.4 mg/kg clavulanate). 1, 3
This formulation causes significantly less diarrhea (17–26%) compared to older 7:1 ratio formulations while maintaining superior efficacy against resistant pathogens. 1, 4, 3
Rationale for High-Dose Therapy
High-dose amoxicillin-clavulanate achieves middle-ear fluid concentrations that overcome penicillin-resistant Streptococcus pneumoniae (MIC up to 2–4 mg/L) and eradicate β-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis. 1, 2, 5
The American Academy of Pediatrics recommends high-dose therapy as first-line for children with acute otitis media who have risk factors including age <2 years, daycare attendance, recent antibiotic use within 30 days, or geographic areas with high pneumococcal resistance (>10%). 1, 2
Clinical efficacy is 90–92% against penicillin-resistant S. pneumoniae, with bacteriologic eradication rates of 96% by days 4–6 of therapy. 1, 2
Treatment Duration and Monitoring
Treat for 10 days, as recommended by the American Academy of Pediatrics for children under 6 years with acute otitis media. 1, 2, 6
Clinical improvement should occur within 48–72 hours; if no improvement or worsening occurs, reassess the diagnosis and consider treatment failure. 1, 2
If treatment fails after 48–72 hours, switch to intramuscular or intravenous ceftriaxone 50 mg/kg for three days. 2
Practical Administration Details
Administer doses every 12 hours (e.g., 8 AM and 8 PM) to maintain therapeutic middle-ear fluid concentrations throughout the dosing interval. 1, 7
The twice-daily regimen is associated with significantly less diarrhea than three-times-daily dosing and has comparable clinical efficacy. 6, 7
Common adverse effects include diarrhea (17–26%), diaper dermatitis (21–33%), nausea, vomiting, and rash, but these are generally mild and do not require discontinuation. 1, 4
Critical Pitfalls to Avoid
Do not substitute two 250 mg/125 mg tablets for one 500 mg/125 mg tablet, as they contain different amounts of clavulanate and are not equivalent. 6
Verify the suspension concentration before dispensing (125/31,250/62, or 400/57 mg per 5 mL) to avoid dosing errors. 1, 6
Do not use standard-dose amoxicillin-clavulanate (45 mg/kg/day) for acute otitis media, as it leads to treatment failure with resistant organisms and promotes antimicrobial resistance. 1
The 400 mg/5 mL (ES-600) formulation is specifically designed for children ≥3 months and should not be used in neonates or infants <3 months without specialist consultation. 1, 6