title: Pharmacokinetics of Loratadine in Pediatric Subjects.
abstract: The pharmacokinetics of loratadine, a new nonsedating antihistamine, was studied in 14 pediatric volunteers between the ages of 8 to 12 years. In an open-label design, one volunteer (with body weight less than 30 kg) received 5 mg of loratadine syrup and 13 volunteers (with body weights greater than 30 kg) received 10 mg of loratadine syrup. Blood samples were collected up to 72 h after dosing. Plasma concentrations of loratadine and its metabolite, descarboethoxyloratadine, were determined by a specific and sensitive gas-liquid chromatographic method. Following a 10-mg dose as a syrup, plasma concentrations of loratadine and descarboethoxyloratadine could be determined up to 8 and 48 h, respectively. The maximum concentration (C(max)) of loratadine and descarboethoxyloratadine were approximately 4 ng ml(minus sign1) each. However, the AUC of the metabolite was about six times that of loratadine. The elimination phase half-life of descarboethoxyloratadine averaged about 13.8 hr. The pharmacokinetics of loratadine in pediatric subjects was similar to that in healthy adult volunteers.
authors.affiliation: Department of Drug Metabolism and Pharmacokinetics and Department of Clinical Pharmacology, Schering-Plough Research Institute, Kenilworth, USA.
authors.forename: Chin-Chung
authors.initials: CC
authors.lastname: Lin
authors.forename: Elaine
authors.initials: E
authors.lastname: Radwanski
authors.forename: Melton
authors.initials: M
authors.lastname: Affrime
authors.forename: Mitchell
authors.initials: M
authors.lastname: Cayen