At what minimum age can Augmentin (amoxicillin‑clavulanate) be started in children?

Minimum Age for Starting Augmentin in Children

Augmentin (amoxicillin-clavulanate) can be started in children as young as 3 months of age. 1, 2

Age-Based Prescribing Guidelines

Infants 3 Months and Older

• Children ≥3 months of age are appropriate candidates for Augmentin therapy when bacterial infection is suspected or confirmed 1, 2
• The most common indications in this age group include acute otitis media, community-acquired pneumonia, and acute bacterial rhinosinusitis 1

Infants Under 3 Months

• Augmentin is NOT routinely recommended for infants younger than 3 months due to limited safety and efficacy data in this population 1
• The French guidelines specifically state that recommendations for acute otitis media only apply to children over 3 months of age 1

Standard Dosing by Age Category

Ages 3-12 Months (Under 1 Year)

• 2.5 mL of 125/31 suspension three times daily for standard infections 2
• For high-dose regimens when resistant organisms are suspected: 90 mg/kg/day of amoxicillin component divided into 2 doses 2

Ages 1-6 Years

• 5 mL of 125/31 suspension three times daily for standard infections 2
• High-dose therapy: 90 mg/kg/day in 2 divided doses (maximum 4000 mg/day) 1, 2

Ages 7-12 Years

• 5 mL of 250/62 suspension three times daily for standard infections 2
• High-dose therapy follows the same 90 mg/kg/day principle with appropriate maximum dosing 2

Clinical Context for the 3-Month Threshold

Why 3 Months Is the Cutoff

• Bacterial pathogens in acute otitis media (S. pneumoniae, H. influenzae, M. catarrhalis) become more prevalent after 3 months of age, making antibiotic therapy more relevant 1
• Pharmacokinetic and safety data supporting Augmentin use are robust for children ≥3 months but limited below this age 1, 3
• The clavulanate component's metabolism and clearance are better established in infants beyond the neonatal period 4

Special Circumstances in Young Infants

• For infants under 3 months with suspected serious bacterial infection, intravenous antibiotics (ampicillin plus gentamicin or cefotaxime) are preferred over oral Augmentin 1
• If oral therapy is absolutely necessary in a 1-2 month old infant in a critical situation, specialist consultation is strongly advised 1

Common Pitfalls to Avoid

• Do not prescribe Augmentin for viral upper respiratory infections, even in children with a history of recurrent otitis media—a placebo-controlled trial showed only 6.6% difference in preventing acute otitis media (not statistically significant), while exposing 94 children to antibiotics to prevent just 6 cases 5
• Verify the suspension concentration (125/31 vs 250/62) before calculating the volume to dispense—dosing errors are common when practitioners assume the wrong formulation 2
• Do not use standard-dose regimens when high-dose therapy is indicated (age <2 years, daycare attendance, recent antibiotic use, incomplete H. influenzae type b vaccination)—this leads to treatment failure with resistant organisms 2
• Ensure the diagnosis truly warrants antibiotics: isolated redness of the tympanic membrane without bulging or effusion is NOT an indication for Augmentin 1