Vyvanse
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,
研究年龄
4 YEARS - 6 YEARS
4 YEARS - 5 YEARS
4 YEARS - 5 YEARS
学习类型
Safety,Tolerability
Efficacy,Safety,Tolerability
Safety,Pharmacokinetic,Tolerability
研究设计
Multicenter,Open-Label,Phase 3,Long-term
Multicenter,Randomized,Placebo,Double-Blind,Parallel Group,Phase 3
Multicenter,Open-Label,Phase 2
国家
United States
United States
United States