当前位置:药药网 / 数据中心 / 儿科研究特征电子表格
Prepopik for oral solution
通用名称
sodium picosulfate/magnesium oxide/anhydrous citric acid
儿科标签批准日期
2018/8/15 0:00:00
特定指示/秒
Cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years and older
标签更改摘要
- Safety and effectiveness have been established in pediatric patients 9 years and older.
- Use in this age group is supported by evidence from adequate and well-controlled trials of Prepopik in adults and a single, dose-ranging, controlled trial in 78 pediatric patients 9 to 16 years of age.
- Safety and effectiveness of Prepopik in pediatric patients less than 9 years of age have not been established.
- The safety profile in this pediatric population was similar to that seen in adults.
- Monitor for possible hypoglycemia in pediatric patients, as Prepopik has no caloric substrate.
- Information on adverse reactions, and clinical trial.
- Postmarketing study.
研究设计
Single-Blind,Parallel Group,Active Control