What is the typical treatment duration with amoxicillin (amoxicillin/clavulanate) for children?

Amoxicillin/Clavulanate Treatment Duration for Children

For most pediatric bacterial upper respiratory tract infections, amoxicillin or amoxicillin-clavulanate should be prescribed for 5-7 days in children 2 years and older, with 10-day courses reserved for children under 2 years or those with severe/complicated infections. 1

Duration by Specific Infection Type

Acute Otitis Media (AOM)

• Children ≥2 years with uncomplicated AOM: 5 days 1
• Children <2 years: 10 days 2, 3
• The shorter 5-day duration is equally effective as 10 days in older children without recent AOM episodes 4
• Children who had AOM in the preceding month may benefit from 10-day treatment due to higher risk of resistant bacteria 4

Acute Bacterial Rhinosinusitis

• Standard duration: 5-8 days 1
• Alternative approach: 7-10 days, continuing until symptom-free for 7 days (typically 10-14 days total) 2
• Some cephalosporins (cefuroxime-axetil, cefpodoxime-proxetil) have demonstrated efficacy with 5-day courses 2

Community-Acquired Pneumonia

• Non-severe pneumonia: 3-5 days 5, 6
• Recent high-quality evidence demonstrates 3-day courses are non-inferior to 7-day courses for uncomplicated pneumonia 6
• European guidelines recommend 80-100 mg/kg/day in three divided doses for children under 3 years 1

Dosing Considerations

Standard Dosing

• Mild-moderate infections: 40-45 mg/kg/day divided into 2-3 doses 1, 7
• Severe infections or resistant pathogens: 90 mg/kg/day (amoxicillin component) 2, 1
• For amoxicillin-clavulanate specifically: 90 mg/6.4 mg per kg per day for high-dose regimen 2

Age-Specific Dosing

• Neonates and infants <12 weeks: 30 mg/kg/day divided every 12 hours 7
• Children ≥12 weeks: See infection-specific dosing above 7
• Children ≥40 kg: Use adult dosing 7

When to Use Longer Durations (10 Days)

The following situations warrant 10-day treatment courses:

• Age <2 years with AOM 2, 3
• Recent antibiotic exposure (within 4-6 weeks) 2
• Recent AOM episode (within preceding month) 4
• Severe symptoms at presentation 2
• Bilateral AOM in young children 2
• Immunocompromised patients 2
• Treatment failure after initial shorter course 2

Critical Clinical Pitfalls

Common Prescribing Errors

• Despite guidelines recommending 5-7 day courses, 75% of children still receive unnecessary 10-day prescriptions 8
• Do not substitute two 250 mg/125 mg tablets for one 500 mg/125 mg tablet - they contain different clavulanate ratios 7
• The 250 mg/125 mg tablet and 250 mg/62.5 mg chewable tablet are not interchangeable 7

Assessment of Treatment Response

• Evaluate response at 48-72 hours - lack of improvement indicates treatment failure 1
• If no improvement after 3-5 days on amoxicillin, switch to high-dose amoxicillin-clavulanate or alternative agent 2
• Continue treatment until patient is symptom-free for 7 days when using the longer approach 2

Adverse Effects

• Amoxicillin-clavulanate causes significantly more diarrhea (25% vs 15%) and diaper dermatitis (51% vs 35%) compared to placebo 3
• Shorter courses reduce antibiotic exposure and associated microbiome disruption 1
• Non-adherence is the strongest predictor of treatment failure, which increases with longer prescribed durations 5

High-Quality Evidence Summary

The most recent high-quality evidence strongly supports shorter durations. A 2021 factorial non-inferiority RCT (CAP-IT trial) demonstrated that 3-day amoxicillin courses were non-inferior to 7-day courses for uncomplicated pneumonia, with similar rates of treatment failure (12.5% vs 12.5%), adverse events, and antimicrobial resistance 6. Similarly, a 2011 landmark RCT in children 6-23 months with stringently-diagnosed AOM showed 10-day amoxicillin-clavulanate reduced clinical failure compared to placebo (16% vs 51%), establishing efficacy in this young age group 3.

However, a 2024 observational study across two academic health systems revealed that despite guideline recommendations, 75% of children ≥2 years still receive 10-day courses when 5-7 days would suffice 8. This represents a major stewardship opportunity to reduce unnecessary antibiotic exposure while maintaining clinical efficacy.