{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T10:53:39Z","timestamp":1784199219930,"version":"3.55.0"},"reference-count":28,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2023,12,3]],"date-time":"2023-12-03T00:00:00Z","timestamp":1701561600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003825","name":"Magyar Tudom\u00e1nyos Akad\u00e9mia","doi-asserted-by":"publisher","award":["bo_481_21"],"award-info":[{"award-number":["bo_481_21"]}],"id":[{"id":"10.13039\/501100003825","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100005881","name":"Emberi Eroforr\u00e1sok Miniszt\u00e9riuma","doi-asserted-by":"publisher","award":["\u00daNKP\u201023\u20105\u2010SZTE\u201070"],"award-info":[{"award-number":["\u00daNKP\u201023\u20105\u2010SZTE\u201070"]}],"id":[{"id":"10.13039\/501100005881","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:p>Influenza infection may lead to serious complications in the postpartum period, therefore, oseltamivir treatment in these patients and their breastfed infants is of great importance. However, the pharmacokinetics of oseltamivir in postpartum lactating women with acute influenza infection, and the consequent infant exposure to oseltamivir are still unknown, and these data would help in assessing risk and the need for dose adjustment in breastfed infants. Six lactating women with influenza\u2010like symptoms, at a standard dose of 75\u2009mg oral oseltamivir twice daily for 5\u2009days, were recruited in this phase IV clinical study during the 2011\/2012 H1N1 pandemic seasons. Breast milk\/colostrum and venous blood samples were taken at multiple timepoints, maternal urine samples were obtained from total output within the 12\u2010hour observational period following the seventh dose of oseltamivir. Oseltamivir phosphate (OP) reached a maximum 69.5\u2009\u00b1\u200929.4\u2009ng\/mL concentration in breast milk, higher than that found in the plasma, and showed elimination within ~\u20098\u2009hours. Oseltamivir carboxylate (active metabolite of OP) showed a lower, nearly steady\u2010state concentration in breast milk during the observational period (maximum plasma concentration (<jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>)\u2009=\u200938.4\u2009\u00b1\u200912.9\u2009ng\/mL). Based on estimated daily milk consumption of exclusively breastfed infants, their calculated daily exposure is &lt;\u20090.1% of the infant dose of oseltamivir for treatment of influenza as per marketing authorization. Here, we provide the first maternal breast milk pharmacokinetic data for oral multiple\u2010dose oseltamivir in lactating patients with influenza and showed that its concentration in the breast milk is not sufficient to reach a therapeutic dose for breastfed infants.<\/jats:p>","DOI":"10.1002\/cpt.3107","type":"journal-article","created":{"date-parts":[[2023,11,17]],"date-time":"2023-11-17T11:15:57Z","timestamp":1700219757000},"page":"318-323","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["An Observational Study on the Pharmacokinetics of Oseltamivir in Lactating Influenza Patients"],"prefix":"10.1002","volume":"115","author":[{"given":"Eszter","family":"Fodor","sequence":"first","affiliation":[{"name":"Pharmahungary Group  Szeged Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3253-5398","authenticated-orcid":false,"given":"Regina N.","family":"Nagy","sequence":"additional","affiliation":[{"name":"MTA\u2010SE System Pharmacology Research Group, Department of Pharmacology and Pharmacotherapy Semmelweis University  Budapest Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andr\u00e1s","family":"N\u00f3gr\u00e1di","sequence":"additional","affiliation":[{"name":"Pharmahungary Group  Szeged Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Toovey","sequence":"additional","affiliation":[{"name":"Pegasus Research  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed A.","family":"Kamal","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals Inc  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P\u00e9ter","family":"Vad\u00e1sz","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Selye J\u00e1nos Hospital  Kom\u00e1rom Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P\u00e9ter","family":"Bencsik","sequence":"additional","affiliation":[{"name":"Pharmahungary Group  Szeged Hungary"},{"name":"Department of Pharmacology and Pharmacotherapy University of Szeged  Szeged Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anik\u00f3","family":"G\u00f6rbe","sequence":"additional","affiliation":[{"name":"Pharmahungary Group  Szeged Hungary"},{"name":"MTA\u2010SE System Pharmacology Research Group, Department of Pharmacology and Pharmacotherapy Semmelweis University  Budapest Hungary"},{"name":"Department of Pharmacology and Pharmacotherapy University of Szeged  Szeged Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P\u00e9ter","family":"Ferdinandy","sequence":"additional","affiliation":[{"name":"Pharmahungary Group  Szeged Hungary"},{"name":"MTA\u2010SE System Pharmacology Research Group, Department of Pharmacology and Pharmacotherapy Semmelweis University  Budapest Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,12,3]]},"reference":[{"key":"e_1_2_10_1_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejogrb.2021.01.005"},{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ogc.2014.08.002"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdr2.1445"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciy866"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2020.568651"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2012.06.068"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/adc.2010.182873"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clp.2004.03.019"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0032-1323585"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/crj.12953"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.phrs.2012.09.001"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jix629"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/irv.12862"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00431-010-1293-5"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofab138"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph19053018"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejim.2020.12.010"},{"key":"e_1_2_10_18_1","unstructured":"Summary of Product Characteristics of Tamiflu Hard Capsules<https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/tamiflu\u2010epar\u2010product\u2010information_en.pdf>. 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