What is the recommended Augmentin (amoxicillin + clavulanic acid) dosing for a newborn (0–28 days old), including adjustments for weight and renal function?

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Augmentin Dosing for Newborns (0-28 Days)

Augmentin is NOT routinely recommended for newborns from birth, and specific neonatal dosing guidelines are not established in major pediatric infectious disease guidelines. For neonates requiring β-lactam/β-lactamase inhibitor therapy, alternative agents with established neonatal dosing are preferred.

Neonatal Antibiotic Alternatives with Established Dosing

When β-lactam/β-lactamase inhibitor coverage is needed in neonates, ampicillin-sulbactam is the preferred agent with the following dosing 1:

  • Ampicillin-sulbactam: 200 mg/kg/day of ampicillin component, divided every 6 hours 1

For specific neonatal infections requiring broad-spectrum coverage 1:

  • Necrotizing enterocolitis: Ampicillin + gentamicin + metronidazole, or ampicillin + cefotaxime + metronidazole, or meropenem 1
  • Complicated intra-abdominal infections: Ampicillin-sulbactam 200 mg/kg/day every 6 hours 1

Piperacillin-Tazobactam as Alternative

If piperacillin-tazobactam is considered 1:

  • Postmenstrual age ≤30 weeks: 100 mg/kg/dose IV every 8 hours (of piperacillin component) 1
  • Postmenstrual age >30 weeks: 80 mg/kg/dose IV every 6 hours (of piperacillin component) 1

Critical Considerations for Neonatal Dosing

Renal function is immature in neonates, requiring careful dose adjustment 1:

  • Gestational age and postnatal age significantly affect drug clearance 1
  • Cystatin C levels and renal maturation must be considered 2
  • Augmented renal clearance in critically ill neonates may require more frequent dosing 2

Why Augmentin Is Not Standard in Neonates

The amoxicillin-clavulanate combination lacks:

  • Established pharmacokinetic data in neonates <3 months 3, 4
  • FDA approval for use in newborns 5, 6
  • Guideline-based dosing recommendations for the 0-28 day age group 1

For infants ≥3 months requiring amoxicillin-clavulanate, standard dosing begins at 45 mg/kg/day divided every 12 hours for mild infections, or 90 mg/kg/day divided every 12 hours for severe infections or high-resistance areas 3, 4.

Common Pitfall to Avoid

Never extrapolate pediatric or infant dosing to neonates due to immature renal function, altered volume of distribution, and prolonged elimination half-lives in this age group 2, 7. Always consult pediatric infectious disease specialists when β-lactam/β-lactamase inhibitor therapy is considered essential in a neonate.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Amoxicillin Dosing Guidelines for Pediatric Patients

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2026

Guideline

Augmentin Dosing Guidelines for Pediatric Patients

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2026

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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