ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023
Oral and Intravenous Amoxicillin Dosing Recommendations in Neonates: A Pooled Population Pharmacokinetic Study.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
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Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.
- Population pharmacokinetics of imipenem in different populations for individualized dosing: a systematic review.Frontiers in pharmacology · 2025Pooled it
- Treatment of Urinary Tract Infections in Neonates and Young Infants: Evidence and Recommendations.Antibiotics (Basel, Switzerland) · 2026Review
- Population pharmacokinetic modelling of amoxicillin in human breast milk-A contribution from the ConcePTION project.British journal of clinical pharmacology · 2026Article
- Appropriateness and Abuse of Antipyretics, Anti-Inflammatory Drugs and Antibiotics in Children and Adults.Antibiotics (Basel, Switzerland) · 2026Review
- Reflections on the Theoretical Prerequisites for Initial Oral Antibiotic Treatment for Paediatric Bone and Joint Infections: A Narrative Review.Antibiotics (Basel, Switzerland) · 2026Review
- Do the redefined EUCAST susceptibility categories warrant adjustment of paediatric antibiotic dosages? Pragmatic physiologically based pharmacokinetic modelling of four commonly used agents.The Journal of antimicrobial chemotherapy · 2026Article
- Article
- Oral Cephalexin Population Pharmacokinetics and Target Attainment Analysis in Infants 7-60 Days Old.Journal of the Pediatric Infectious Diseases Society · 2025Article
- Evaluation of amoxicillin and benzylpenicillin therapy in early-onset neonatal sepsis: a pharmacometric external validation and simulation study.The Journal of antimicrobial chemotherapy · 2025Article
- A Pooled Population Pharmacokinetic Study of Oral and Intravenous Administration of Clavulanic Acid in Neonates and Infants: Targeting Effective Beta-Lactamase Inhibition.Clinical pharmacology and therapeutics · 2025Article
Corrections and comments
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Authors and funding
17 authors at 9 institutions in 3 countries.
Funding
Abstract
backgroundThere is a lack of evidence on oral amoxicillin pharmacokinetics and exposure in neonates with possible serious bacterial infection (pSBI). We aimed to describe amoxicillin disposition following oral and intravenous administration and to provide dosing recommendations for preterm and term neonates treated for pSBI.
methodsIn this pooled-population pharmacokinetic study, 3 datasets were combined for nonlinear mixed-effects modeling. In order to evaluate amoxicillin exposure following oral and intravenous administration, pharmacokinetic profiles for different dosing regimens were simulated with the developed population pharmacokinetic model. A target of 50% time of the free fraction above the minimal inhibitory concentration (MIC) with an MICECOFF of 8 mg/L (to cover gram-negative bacteria such as Escherichia coli) was used.
resultsThe cohort consisted of 261 (79 oral, 182 intravenous) neonates with a median (range) gestational age of 35.8 weeks (range, 24.9-42.4) and bodyweight of 2.6 kg (range, 0.5-5). A 1-compartment model with first-order absorption best described amoxicillin pharmacokinetics. Clearance (L/h/kg) in neonates born after 30 weeks' gestation increased with increasing postnatal age (PNA day 10, 1.25-fold; PNA day 20, 1.43-fold vs PNA day 3). Oral bioavailability was 87%. We found that a twice-daily regimen of 50 mg/kg/day is superior to a 3- or 4-times daily schedule in the first week of life for both oral and intravenous administration.
conclusionsThis pooled population pharmacokinetic description of intravenous and oral amoxicillin in neonates provides age-specific dosing recommendations. We conclude that neonates treated with oral amoxicillin in the first weeks of life reach adequate amoxicillin levels following a twice-daily dosing regimen. Oral amoxicillin therapy could therefore be an adequate, cost-effective, and more patient-friendly alternative for neonates worldwide.
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Registered trials
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