{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,11]],"date-time":"2026-04-11T10:40:43Z","timestamp":1775904043045,"version":"3.50.1"},"reference-count":12,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2013,7,18]],"date-time":"2013-07-18T00:00:00Z","timestamp":1374105600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2013,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:label\/><jats:p>To characterize doxylamine pharmacokinetics in children. This study was conducted in 41 subjects, ages 2\u201317 years. Doxylamine succinate doses based on age\/weight ranged from 3.125 to 12.5\u2009mg. A single oral dose was administered with 2 to 4\u2009oz. of water or decaffeinated beverages \u223c2\u2009hours after a light breakfast. Plasma samples were obtained before and for 72\u2009hours after dosing and analyzed for doxylamine using HPLC MS\/MS. Pharmacokinetic parameters were estimated using non\u2010compartmental methods and relationships with age were assessed using linear regression. Over the fourfold dose range, C<jats:sub>max<\/jats:sub> was similar while AUC increased only 60%, although not statistically significant (<jats:italic>P<\/jats:italic>\u2010value\u2009=\u20090.0517). As expected due to increasing body size, CL<jats:sub>o<\/jats:sub> and V<jats:sub>z<\/jats:sub>\/F increased with age. Due to a similar increase with age for Cl<jats:sub>o<\/jats:sub> and V<jats:sub>z<\/jats:sub>\/F, no age\u2010related differences in t<jats:sub>1\/2,z<\/jats:sub> were observed (\u223c16\u2009hours). Allometric scaling indicated no maturation related changes in CL<jats:sub>o<\/jats:sub>; although V<jats:sub>z<\/jats:sub>\/F remained age\u2010dependent, the predicted range decreased \u223c70%. Overall, the single doses were well tolerated. Somnolence was the most common reported AE with no apparent differences in incidence noted with age. An age\/weight dosing nomogram utilizing a fourfold range of doses achieves similar C<jats:sub>max<\/jats:sub>, whereas AUC increases only 60%.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcph.137","type":"journal-article","created":{"date-parts":[[2013,7,19]],"date-time":"2013-07-19T09:05:06Z","timestamp":1374224706000},"page":"1177-1185","source":"Crossref","is-referenced-by-count":8,"title":["Doxylamine pharmacokinetics following single dose oral administration in children ages 2\u201317 years"],"prefix":"10.1002","volume":"53","author":[{"given":"Guhan","family":"Balan","sequence":"first","affiliation":[{"name":"The Procter &amp; Gamble Company Mason OH USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gary A.","family":"Thompson","sequence":"additional","affiliation":[{"name":"GA Thompson Consulting LLC Cincinnati OH USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roger","family":"Gibb","sequence":"additional","affiliation":[{"name":"The Procter &amp; Gamble Company Mason OH USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lijuan","family":"Li","sequence":"additional","affiliation":[{"name":"The Procter &amp; Gamble Company Mason OH USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Hull","sequence":"additional","affiliation":[{"name":"The Procter &amp; Gamble Company Mason OH USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Molly","family":"Seeck","sequence":"additional","affiliation":[{"name":"The Procter &amp; Gamble Company Mason OH USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,7,18]]},"reference":[{"issue":"1","key":"e_1_2_8_2_1","first-page":"1","article-title":"The clinical evaluation of a new histamine antagonist, decapryn","volume":"6","author":"Brown EA","year":"1948","journal-title":"Ann Allergy"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0009-9236(98)90049-2"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1552-4604.1985.tb02875.x"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1552-4604.1989.tb03323.x"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1021\/js950443e"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.3109\/00498258709044198"},{"key":"e_1_2_8_8_1","unstructured":"Code of Federal Regulations Title 21. 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