通用名称

lithium

儿科标签批准日期

2018/10/4 0:00:00

特定指示/秒

Monotherapy treatment of acute manic or mixed episodes of bipolar I disorder and maintenance monotherapy of bipolar I disorder in pediatric patients ages 7 to 17 years

标签更改摘要

- Safety and effectiveness for monotherapy treatment of acute manic or mixed episodes of bipolar I disorder and maintenance monotherapy of bipolar I disorder in pediatric patients ages 7 to 17 years have been established in a clinical trial of 8 weeks in duration followed by a 28-week randomized withdrawal phase. - Safety and effectiveness of lithium has not been established in pediatric patients less than 7 years of age with bipolar I disorder. - Common adverse reactions in pediatric patients 7 to 17 years included nausea/vomiting, polyuria, thyroid abnormalities, tremor, thirst/polydipsia, dizziness, rash/dermatitis, ataxia/gait disturbance, decreased appetite, and blurry vision. - Information on dosing, PK parameters and clinical trials. - Off-patent Written Request.

治疗类别

N/A

立法类型

409I(BPCA)

产品说明书链接

书号

2.0 1.0

研究年龄

7 YEARS - 17 YEARS 7 YEARS - 17 YEARS

学习类型

Efficacy,Safety

研究设计

Multicenter,Randomized,Double-Blind,Parallel Group,Placebo Control Multicenter,Randomized,Placebo Control

登记的患者

81 61

患者分析

81 61

中心的数量

11 7

国家数量

1 1

西班牙裔拉美裔/拉丁裔总计

12 3

非西班牙裔/非拉丁裔总人数

67 56

总数#种族不明

3 0

亚裔学生总数

2 0

黑人总数

26 11

白人总数

44 48

夏威夷或太平洋岛民总数

0 0

美洲印第安人/阿拉斯加本地人总数

0 0

其他种族总计

6 2

未知种族总数

N/A N/A

国家

N/A N/A