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Cephalexin is a promising oral treatment for neonatal pathogens, including Enterobacterales and methicillin-susceptible Staphylococcus aureus (MSSA). However, maturational changes in gastrointestinal absorption and kidney function during early infancy complicate extrapolation of dosing from older populations. We evaluated cephalexin pharmacokinetics and simulated dosing strategies to achieve pharmacodynamic targets in infants \u226460\u00a0days old.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This prospective, single-center study enrolled infants 0-60\u00a0days receiving cephalexin either as part of routine clinical care or as a single 25\u00a0mg\/kg study dose. Plasma concentrations were analyzed using non-linear mixed-effects modeling. Simulations assessed the probability of target attainment for free time above minimum inhibitory concentration (MIC) (fT\u2009&amp;gt;\u2009MIC) for \u2265 50% and\u2009\u2265\u200970% of the dosing interval across MICs 1-16\u00a0mg\/L, assuming 10% protein binding. We also simulated the cumulative fractional response using typical MIC distributions for Enterobacterales and MSSA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The analysis included 144 samples from 33 infants with median post-natal age 31\u00a0days (range 9-56) and median gestational age 37\u00a0weeks (range 29-41). A one-compartment model with first-order absorption and lag time best described the data. Weight influenced apparent volume of distribution and apparent clearance. Additionally, we identified a maturational effect on absorption rate using post-natal age and on apparent clearance using post-menstrual age. For Enterobacterales, 25\u00a0mg\/kg\/dose every 6\u00a0h achieved &amp;gt;90% cumulative fractional response for a 50% fT\u2009&amp;gt;\u2009MIC target. For MSSA, 25\u00a0mg\/kg\/dose every 8\u00a0h was sufficient. Higher or more frequent dosing was required to meet the more stringent 70% fT\u2009&amp;gt;\u2009MIC target.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Oral cephalexin can achieve necessary pharmacodynamic targets in infants 7-60\u00a0days old. These findings support the use of model-informed dosing strategies to guide safe and effective oral antibiotic use in early infancy, including for IV-to-oral transition.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jpids\/piaf088","type":"journal-article","created":{"date-parts":[[2025,9,25]],"date-time":"2025-09-25T11:20:45Z","timestamp":1758799245000},"source":"Crossref","is-referenced-by-count":1,"title":["Oral Cephalexin Population Pharmacokinetics and Target Attainment Analysis in Infants 7-60\u00a0Days Old"],"prefix":"10.1093","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5486-0522","authenticated-orcid":false,"given":"Andrew S","family":"Haynes","sequence":"first","affiliation":[{"name":"Children\u2019s Hospital Colorado, Department of Pediatrics, Section of Pediatric Infectious Diseases , Aurora, CO ,","place":["United States"]},{"name":"University of Colorado Anschutz Medical Campus, School of Medicine , Aurora, CO ,","place":["United 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Medicine , Durham, NC ,","place":["United States"]},{"name":"Duke Clinical Research Institute , Durham, NC ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5830-3491","authenticated-orcid":false,"given":"Kevin","family":"Messacar","sequence":"additional","affiliation":[{"name":"Children\u2019s Hospital Colorado, Department of Pediatrics, Section of Pediatric Infectious Diseases , Aurora, CO ,","place":["United States"]},{"name":"University of Colorado Anschutz Medical Campus, School of Medicine , Aurora, CO ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7737-8499","authenticated-orcid":false,"given":"Sonya","family":"Tang Girdwood","sequence":"additional","affiliation":[{"name":"Cincinnati Children\u2019s Hospital Medical Center, Divisions of Hospital Medicine and Translational and Clinical Pharmacology , Cincinnati, OH ,","place":["United States"]},{"name":"University of Cincinnati College of Medicine, Department of Pediatrics , Cincinnati, OH ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles A","family":"Peloquin","sequence":"additional","affiliation":[{"name":"University of Florida, College of Pharmacy, Infectious Disease Pharmacokinetics Laboratory , Gainesville, FL ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Douglas N","family":"Fish","sequence":"additional","affiliation":[{"name":"University of Colorado Anschutz Medical Campus, Skaggs School of Pharmacy and Pharmaceutical Sciences , Department of Pharmaceutical Sciences, Aurora, CO ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Anderson","sequence":"additional","affiliation":[{"name":"University of Colorado Anschutz Medical Campus, Skaggs School of Pharmacy and Pharmaceutical Sciences 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