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Loxapine powder for oral inhalation was administered via a single\u2010use handheld drug device to children and adolescents (aged 10\u201317 years) with any condition warranting chronic antipsychotic use. Patients were dosed according to body weight and cohort (&lt;50 kg [n = 15], 2.5 or 5 mg; \u226550 kg [n = 15], 5 or 10 mg); the first 6 patients (cohort 1) enrolled in each weight group received the lower dose. Patients were enrolled in the higher\u2010dose group (cohort 2) after an interim pharmacokinetic and safety analysis of data from cohort 1. Blood samples were collected for 48 hours after dosing to determine the pharmacokinetic profile of loxapine and its metabolites. Safety was assessed using adverse event (AE), laboratory value, physical\/neurologic examination, vital sign, electrocardiogram, suicidality, and extrapyramidal symptom assessment. Thirty patients were enrolled and evaluable for pharmacokinetics. Loxapine plasma concentrations peaked by 2 to 5 minutes in most patients; systemic exposure increased with dose in both weight subgroups. Loxapine terminal elimination half\u2010life was \u223c13 to 17 hours. The most common AEs were sedation and dysgeusia. Sedation was severe in 1 patient in the &lt;50\u2010kg group (2.5\u2010mg dose) and 1 patient in the \u226550\u2010kg group (5\u2010mg dose). No AEs indicative of bronchospasm or other serious AEs were reported. Inhaled loxapine was rapidly absorbed and generally well tolerated in pediatric patients; no new safety signals were observed.<\/jats:p>","DOI":"10.1002\/jcph.932","type":"journal-article","created":{"date-parts":[[2017,5,16]],"date-time":"2017-05-16T12:57:00Z","timestamp":1494939420000},"page":"1244-1257","source":"Crossref","is-referenced-by-count":9,"title":["Pharmacokinetics and Safety of Single\u2010Dose Inhaled Loxapine in Children and Adolescents"],"prefix":"10.1002","volume":"57","author":[{"given":"Sally","family":"Selim","sequence":"first","affiliation":[{"name":"Clinical Development Teva Pharmaceutical Industries  Frazer PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Riesenberg","sequence":"additional","affiliation":[{"name":"Atlanta Center for Medical Research  Atlanta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Cassella","sequence":"additional","affiliation":[{"name":"Alexza Pharmaceuticals, Inc.  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