通用名称

sodium picosulfate/magnesium oxide/anhydrous citric acid

儿科标签批准日期

2019/8/8 0:00:00

特定指示/秒

Cleansing of the colon as a preparation for colonoscopy to pediatric patients 9 years and older

标签更改摘要

- Safety and effectiveness have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 9 years and older. - Use in this age group is supported by evidence from adequate and well-controlled trials in adults and a single, dose-ranging, controlled trial in 78 pediatric patients 9 to 16 years of age all of which evaluated another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid. - The safety profile in this pediatric population was similar to that seen in adults. - Monitor for possible hypoglycemia in pediatric patients, as Clenpiq has no caloric substrate. - Safety and effectiveness in pediatric patients less than 9 years have not been established. - Information on dosing, adverse reactions, PK parameters, and clinical trial. - Postmarketing study.

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立法类型

PREA Only

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