Single-dose pharmacokinetics and safety of ziprasidone in children and adolescents.
Single-dose pharmacokinetics and safety of ziprasidone in children and adolescents.
复制标题
儿童和青少年齐拉西酮的单剂量药代动力学和安全性。
DOI：
10.1097/01.chi.0000215347.93902.3e
复制
发表时间：
2006
影响因子：
13.3
通讯作者：
Patel,NickC
中科院分区：
文献类型：
--
作者：
Sallee,FloydR;Miceli,JeffreyJ;Tensfeldt,Thomas;Robarge,Lisa;Wilner,Keith;Patel,NickC
OBJECTIVEThe purpose of this study was to provide single-dose pharmacokinetic, safety, and tolerability data for ziprasidone in youths with tic disorder, for comparison to adult studies to discern whether ziprasidone pediatric dosing could be modeled from adult data.METHODA single-dose, open-label study of ziprasidone was conducted in youths (ages 7-16 years) with Tourette's disorder or chronic tic disorder. Dosing of ziprasidone oral suspension (40 mg/mL) was weight adjusted: >60 kg, 20 mg (group 1, n = 8); 31 to 60 kg, 10 mg (group 2, n = 8); and 16 to 30 kg, 5 mg (group 3, n = 8). Patients were assessed for serum ziprasidone concentration, safety, tolerability, and electrocardiogram pre- and postdose.RESULTSTwenty-four patients were evaluated for safety and tolerability, and 23 were evaluated for pharmacokinetics. Regression analysis of AUC0-∞and Cmaxvalues versus weight-normalized dose showed linear, dose-related changes in ziprasidone exposure. Ziprasidone was well tolerated with frequent, although transient, somnolence. No clinically significant change from baseline was observed in Bazett's or Fridericia's corrected QTcinterval, and change in QTcinterval was not related to serum ziprasidone concentration.CONCLUSIONSOral ziprasidone exhibited linear pharmacokinetics and dose-related exposure in youths with Tourette's disorder or chronic tic disorder, which are comparable to adult data. A single dose of ziprasidone was well tolerated without clinically significant effects on electrocardiograms collected around the time of maximum serum concentration.
