Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
08/08/2019
Trade Name:
Clenpiq
Generic Name or Proper Name (*):
sodium picosulfate, magnesium oxide, and anhydrous citric acid
Indications Studied:
Cleansing of the colon as a preparation for colonoscopy to pediatric patients 9 years and older
Label Changes Summary:
*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.
PREA(P):
P
Sponsor:
Ferring International
NNPS:
FALSE
-
-