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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  08/15/2018
 
Trade Name:  Prepopik for oral solution
 
Generic Name or Proper Name (*):  sodium picosulfate, magnesium oxide, and anhydrous citric acid
 
Indications Studied:  Cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years and older
 
Label Changes Summary:  *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.
 
PREA(P):  P
 
Sponsor:  Ferring Pharmaceuticals Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Osmotic laxative
 
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