通用名称

lisdexamfetamine dimesylate

儿科标签批准日期

2021/7/29 0:00:00

特定指示/秒

Attention Deficit Hyperactivity Disorder in pediatric patients ages four to less than 6 years

标签更改摘要

- Safety and effectiveness have not been established in pediatric patients below the 6 years. - Safety and efficacy were evaluated in a double-blind, randomized, parallel-group, placebo-controlled, fixed-dose study in pediatric patients ages 4 to 5 years with ADHD, followed by a 1-year open-label extension study. - In these studies, patients experienced elevated rates of adverse reactions, including weight loss, decreased BMI, decreased appetite, insomnia, infections (upper respiratory and nasopharyngitis), irritability, and affect lability. - With the same VYVANSE dose, mean steady state exposure of dextroamphetamine was approximately 44% higher in pediatric patients ages 4 to 5 years compared to the pediatric patients ages 6 to 11 years. - Information on adverse reactions, and clinical trials. - Postmarketing study,

治疗类别

ADHD

立法类型

PREA + BPCA

产品说明书链接