What is the recommended dose of Augmentin (amoxicillin/clavulanate) for pediatric patients?

Pediatric Augmentin Dosing

For most pediatric infections, use high-dose amoxicillin-clavulanate at 90 mg/kg/day of the amoxicillin component with 6.4 mg/kg/day of clavulanate, divided into 2 doses (maximum 4000 mg/day), which provides the 14:1 ratio formulation that optimizes efficacy against resistant organisms while minimizing gastrointestinal side effects. 1

Standard Dosing Algorithm

High-Dose Regimen (Preferred for Most Infections)

• 90 mg/kg/day of amoxicillin with 6.4 mg/kg/day of clavulanate in 2 divided doses 1
• This achieves the 14:1 ratio that provides adequate middle ear fluid concentrations to overcome penicillin-resistant S. pneumoniae 1
• Maximum single dose: 2 grams per dose regardless of weight 1
• Maximum daily dose: 4000 mg/day 2

Standard-Dose Regimen (Limited Use)

• 45 mg/kg/day in 3 doses OR 90 mg/kg/day in 2 doses for β-lactamase producing organisms 1
• This older regimen is now primarily reserved for mild infections without risk factors 1

Specific Indications for High-Dose Therapy

High-dose amoxicillin-clavulanate (90/6.4 mg/kg/day) is indicated for children with ANY of these risk factors: 1

• Age <2 years 1
• Daycare attendance 1
• Recent antibiotic use (within past 30 days) 1
• Incomplete Haemophilus influenzae type b vaccination (less than 3 injections) 1
• Geographic area with high prevalence of penicillin-resistant S. pneumoniae (>10%) 1
• Moderate to severe illness 1
• Bilateral acute otitis media in children 6-23 months 1
• Concurrent purulent acute otitis media 1

Age-Based Oral Suspension Dosing (Alternative Approach)

For standard infections when high-dose therapy is NOT indicated: 1

• <1 year (1-12 months): 2.5 ml three times daily of 125/31 suspension 1
• 1-6 years: 5 ml three times daily of 125/31 suspension 1, 3
• 7-12 years: 5 ml three times daily of 250/62 suspension 1
• 12-18 years: 1 tablet (250/125) three times daily 1

However, this age-based approach provides substantially lower doses than the weight-based high-dose regimen and should NOT be used for respiratory infections, otitis media, or when resistant organisms are suspected. 1

Intravenous Dosing

• 30 mg/kg three times daily IV for all pediatric ages with severe infections 1

Treatment Duration

• 10 days for most pediatric infections including acute otitis media, bacterial pneumonia, and acute bacterial rhinosinusitis 1, 2
• 7 days after patient becomes free of signs and symptoms (alternative recommendation) 1
• Minimum 48-72 hours beyond symptom resolution 2

Clinical Monitoring

• Clinical improvement expected within 48-72 hours 1, 3
• If no improvement or worsening after 72 hours: reevaluate diagnosis, consider atypical pathogens, evaluate for complications, or switch antibiotics 1
• Fever typically resolves within 24-48 hours for pneumococcal infections 2

Critical Dosing Considerations

Why High-Dose Matters

• Using standard doses when high-dose therapy is indicated leads to treatment failure with resistant organisms 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 14:1 ratio formulation causes less diarrhea than other amoxicillin-clavulanate preparations while maintaining efficacy 1

Pharmacokinetic Advantages

• Serum levels of amoxicillin increase linearly with dose 1
• The difference in adverse effects between lower and higher doses is generally negligible 1
• The high-dose formulation achieved 76-95% clinical response rates and eradicated penicillin-resistant S. pneumoniae with MICs of 2-4 mg/L 1

Common Adverse Effects

• Diarrhea: Most common (7.2% with twice-daily dosing vs 10.7% with three-times-daily) 4
• Nausea and vomiting 1
• Rash and urticaria 1, 3
• Diaper dermatitis: 51% vs 35% placebo in children <2 years 1

The 14:1 ratio formulation significantly reduces diarrhea compared to older formulations while maintaining equivalent efficacy 1, 4

Common Pitfalls to Avoid

• Verify suspension concentration (125/31 vs 250/62) before calculating volume to avoid dosing errors 1
• Do NOT use subtherapeutic doses as they fail to achieve adequate tissue concentrations and promote antimicrobial resistance 1
• Do NOT prescribe for viral URTIs as the vast majority are viral and do not benefit from antibiotics 1
• Do NOT give 875 mg dose to patients with GFR <30 mL/min 5

Renal Dosing Adjustments

For children ≥3 months and >40 kg with renal impairment: 5

• GFR 10-30 mL/min: 500 mg or 250 mg every 12 hours 5
• GFR <10 mL/min: 500 mg or 250 mg every 24 hours 5
• Hemodialysis: 500 mg or 250 mg every 24 hours, with additional dose during and at end of dialysis 5

For children <3 months: Due to incompletely developed renal function, maximum dose is 30 mg/kg/day divided every 12 hours 5

Preparation Instructions

After reconstitution: 5

• Shake well before each use 5
• Refrigeration preferable but not required 5
• Discard unused portion after 14 days 5
• Administer at start of meals to minimize gastrointestinal intolerance 5