At what age can Augmentin (amoxicillin-clavulanate) be given to children?

Augmentin Can Be Given Starting at 3 Months of Age

Augmentin (amoxicillin-clavulanate) is approved for use in pediatric patients starting at 12 weeks (3 months) of age, with dosing modifications required for younger infants due to incompletely developed renal function. 1

Age-Specific Dosing Guidelines

Infants ≥12 Weeks (≥3 Months)

• Standard dosing for less severe infections: 25 mg/kg/day every 12 hours or 20 mg/kg/day every 8 hours 2
• Higher dosing for more severe infections: 45 mg/kg/day every 12 hours or 40 mg/kg/day every 8 hours 2
• High-dose formulation for resistant infections: 90 mg/kg/day of amoxicillin with 6.4 mg/kg/day of clavulanate in two divided doses 2, 3

Infants <12 Weeks (<3 Months)

• Dosing must be modified due to incompletely developed renal function that delays amoxicillin elimination (clavulanate elimination is unaltered in this age group) 1
• The FDA label specifically states that "dosing of amoxicillin and clavulanate potassium should be modified in pediatric patients aged <12 weeks (<3 months)" 1
• Clinical studies have demonstrated safety and efficacy in infants as young as 3 months, with one multicenter study including patients aged 3 months to 3 years showing 92% resolution rates 4

Clinical Evidence Supporting Early Use

Established Safety Profile

• Safety and effectiveness are well-established in pediatric patients, supported by evidence from studies in adults plus additional data from pediatric studies in children aged 2 months to 12 years with acute otitis media 1
• A large multicenter study in infants aged 3 months to 3 years demonstrated excellent efficacy (92% resolution) and tolerability with dosing of 80 mg/kg/day in divided doses 4
• Intravenous formulations have been studied in children as young as 1 year with dosing of 100-200 mg/kg/day, achieving complete cure or distinct improvement in all assessable cases 5

Formulation Development

• The original formulation (4:1 ratio) was followed by a 7:1 ratio, and the current high-dose formulation provides a 14:1 ratio of amoxicillin to clavulanate (600 mg amoxicillin per 5 mL) 3
• This high-dose formulation was specifically developed to address penicillin-resistant Streptococcus pneumoniae while maintaining the same daily dose of clavulanic acid as regular strength formulations 3, 6

Critical Prescribing Considerations

When to Use High-Dose Formulations

Consider high-dose amoxicillin-clavulanate (90 mg/kg/day) when: 2

• Recent antibiotic use within the past 30 days
• Contact with healthcare environment
• Prior antibiotic therapy failure
• High prevalence of resistant bacteria in the community
• Moderate to severe infections
• Recurrent or persistent acute otitis media 6, 7

Monitoring Requirements

• Evaluate clinical response within 48-72 hours of initiating therapy 2, 8
• If no improvement occurs within this timeframe, consider alternative diagnoses or resistant organisms 8
• For children with respiratory infections, reassess and consider alternative antibiotics if necessary 8

Common Pitfalls to Avoid

Underdosing in Resistant Infections

• In areas with high penicillin-resistant S. pneumoniae prevalence (>10%), always use high-dose formulations to achieve adequate serum concentrations 2
• The high-dose formulation can eradicate penicillin-resistant S. pneumoniae with MICs up to 2-4 mg/L 6, 7

Gastrointestinal Tolerability

• Diarrhea is generally less frequent with twice-daily dosing compared to three-times-daily treatment 6
• The high-dose formulation shows similar tolerability to conventional twice-daily formulations 6
• Most adverse events are mild gastrointestinal disturbances with a low overall incidence (3.6%) in large postmarketing studies 6

Duration of Therapy

• Typical course for respiratory infections: 7-10 days 2
• For sinusitis: 10-14 days or until symptomatically improved for 7 days 2
• Treatment courses of 10 days have been best studied, though shorter courses may be effective for milder outpatient disease 9