通用名称

mixed salts of a single-entity amphetamine

儿科标签批准日期

2019/9/13 0:00:00

特定指示/秒

Attention Deficit Hyperactivity Disorder (ADHD)

标签更改摘要

- Safety and effectiveness have not been established in pediatric patients ages 12 years and younger. - Mydayis has been studied for the treatment of ADHD in pediatric patients 6 to 12 years in two placebo-controlled safety and efficacy trials. - In the first trial, pediatric patients 6 to 12 years experienced higher rates of adverse reactions in some cases compared to patients 13 years and older, including higher rates of insomnia (30% versus 8%) and appetite decreased (43% versus 22%). - Amphetamine systemic exposures in pediatric patients 6 to 12 years following a single dose were higher than those observed in adults at the same dose (72-79% higher Cmax and approximately 83% higher AUC). A second trial evaluated a lower dose than those approved for pediatric patients 13 to 17 years; efficacy was not demonstrated for the lower dose. - A safe and effective dose cannot be established in pediatric patients 12 years and younger. - Information on adverse reactions, PK parameters, and clinical trials. - Postmarketing requirement.

治疗类别

CNS Stimulants

立法类型

PREA + BPCA

产品说明书链接