What is the dosing for Amoxicillin-Clavulanate (Amoxy-Clav) in pediatric patients?

Amoxicillin-Clavulanate Dosing in Pediatric Patients

For pediatric patients aged 3 months and older, amoxicillin-clavulanate should be dosed at 45 mg/kg/day (based on amoxicillin component) divided twice daily for mild-moderate infections, and 90 mg/kg/day divided twice daily for severe infections, with a maximum of 2 g per dose. 1

Age-Based Dosing Recommendations

Neonates and Infants <12 weeks (<3 months)

• 30 mg/kg/day of amoxicillin component divided every 12 hours 2
• Use 125 mg/5 mL oral suspension for this age group 2

Infants and Children 12 weeks (3 months) and Older

• Mild/moderate infections: 25 mg/kg/day divided every 12 hours (or 20 mg/kg/day divided every 8 hours) 2
• Severe infections, otitis media, sinusitis, lower respiratory tract infections: 45 mg/kg/day divided every 12 hours (or 40 mg/kg/day divided every 8 hours) 2
• For patients with risk factors for resistant organisms: 90 mg/kg/day of amoxicillin with 6.4 mg/kg/day of clavulanate in 2 divided doses 1

Children Weighing ≥40 kg

• Should be dosed according to adult recommendations 2
• The 250 mg/125 mg tablets should not be used until the child weighs at least 40 kg due to different amoxicillin-to-clavulanate ratios 2

Risk Factors for Resistant Organisms

Higher dosing (90 mg/kg/day) is recommended for patients with:

• Age younger than 2 years 1
• Attendance at childcare 1
• Recent antimicrobial treatment (within previous 30 days) 1
• Moderate to severe illness 1
• Areas with high prevalence of nonsusceptible S. pneumoniae (>10%) 1

Formulation Considerations

• The 12-hour regimen is recommended as it is associated with significantly less diarrhea 2
• The pediatric formulation provides a 14:1 ratio of amoxicillin to clavulanate in an oral suspension 1
• For children who cannot tolerate oral medication, a single 50 mg/kg dose of ceftriaxone can be given intravenously or intramuscularly 1

Duration of Therapy

• Treatment should continue for a minimum of 48-72 hours beyond the time that the patient becomes asymptomatic 3
• For streptococcal infections, at least 10 days of treatment is recommended to prevent acute rheumatic fever 3
• For acute otitis media, 10 days of therapy is recommended 2

Special Considerations

Renal Impairment

• Patients with impaired renal function generally do not require dose reduction unless impairment is severe 2
• For severe impairment (GFR <30 mL/min), avoid the 875 mg/125 mg dose 2

Administration

• To minimize gastrointestinal intolerance, amoxicillin-clavulanate should be taken at the start of a meal 2, 3
• Shake oral suspension well before using 3

Common Pitfalls and Caveats

1. Dosing confusion: The twice-daily regimen is preferred over three times daily due to better compliance and fewer gastrointestinal side effects 4

2. Formulation differences: Different formulations have different amoxicillin-to-clavulanate ratios. The 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet are not interchangeable 2

3. Weight-based dosing: Always calculate dose based on body weight rather than age for more accurate dosing 5

4. Prescription clarity: Include on the prescription: daily dose, number of divided doses, duration of therapy, indication, and child's weight 5

5. Storage of suspension: After reconstitution, any unused portion must be discarded after 14 days. Refrigeration is preferable but not required 3

By following these evidence-based dosing recommendations, clinicians can optimize treatment outcomes while minimizing adverse effects in pediatric patients requiring amoxicillin-clavulanate therapy.