{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T03:25:13Z","timestamp":1787023513311,"version":"build-2736575974"},"reference-count":0,"publisher":"Esmon Publicidad, SA","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Investig Allergol Clin Immunol"],"published-print":{"date-parts":[[2025,7,22]]},"abstract":"<jats:p>Background: Bilastine is a second-generation antihistamine for the symptomatic treatment of allergic rhinoconjunctivitis (ARC) and urticaria\nin adults, adolescents, and children. The pharmacokinetics and safety of oral bilastine 10 mg\/d in children aged 2 to 5 years were evaluated.\nMethods: This was a multicenter, open-label clinical trial in children aged 2 to 5 years with seasonal or perennial ARC or urticaria treated\nonce daily with bilastine 10 mg orodispersible tablets. The safety evaluation included treatment-emergent adverse events (TEAEs), vital\nsigns, and physical examination. Pharmacokinetic data were pooled with data from a prior pediatric study, and pharmacokinetic modeling\nwas performed to assess consistency.\nResults: A total of 37 children with ARC (81.1%), urticaria (8.1%), or both (10.8%) were included in the study, with a mean (SD) age\nof 3.7 (1.2) years. The highest plasma concentrations of bilastine were observed 1 hour after administration (634.91 ng\/mL). Eight patients\n(21.6%) experienced 1 TEAE each, none of which was severe. Body weight and age were not covariates of variation in either systemic\nclearance or the volume of distribution in children aged 2 to 5 years and did not affect the pharmacokinetic parameters of bilastine.\nConclusions: The pharmacokinetics of bilastine was linear and consistent with data from a previous trial, suggesting that a 10-mg dose\nmay be used in children (2 to &lt;12 years). No dose adjustments are deemed necessary. Oral once-daily bilastine 10 mg presented a good\nsafety profile in children aged 2 to 5.<\/jats:p>","DOI":"10.18176\/jiaci.1003","type":"journal-article","created":{"date-parts":[[2024,5,9]],"date-time":"2024-05-09T04:50:08Z","timestamp":1715230208000},"page":"267-275","source":"Crossref","is-referenced-by-count":5,"title":["Pharmacokinetics and Safety of Bilastine 10 mg\/d in Children Aged 2 to 5 Years With Allergic Rhinoconjunctivitis or Urticaria: A Phase 3 Clinical Trial"],"prefix":"10.18176","volume":"35","author":[{"name":"BILA-4021\/PED Research Group","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B","family":"Majorek-Olechowska","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T","family":"Slomskis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L","family":"Zollerov\u00e1","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I","family":"Mart\u00edn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C","family":"S\u00e1nchez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I","family":"Gilaberte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P","family":"Arranz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"7491","published-online":{"date-parts":[[2025,7,29]]},"container-title":["Journal of Investigational Allergology and Clinical Immunology"],"original-title":["English"],"deposited":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T11:06:56Z","timestamp":1753787216000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.jiaci.org\/summary\/vol35-issue4-num3100"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,22]]},"references-count":0,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2025,7,29]]},"published-print":{"date-parts":[[2025,7,22]]}},"URL":"https:\/\/doi.org\/10.18176\/jiaci.1003","relation":{},"ISSN":["1018-9068"],"issn-type":[{"value":"1018-9068","type":"print"}],"subject":[],"published":{"date-parts":[[2025,7,22]]}}}