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The prescribing information for Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid; Ferring) has been updated to include use in pediatric patients ≥9 years old for cleansing of the colon as a preparation for colonoscopy. Previously, the treatment had only been approved for adult use.
Clenpiq is a combination of sodium picosulfate, a stimulant laxative, and magnesium oxide and anhydrous citric acid, which form magnesium citrate, an osmotic laxative. Both the split-dose (preferred) and day-before (alternative method) dosage regimens are approved for pediatric patients.
The use of Clenpiq in this age group was supported by evidence from trials evaluating another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid in adults and a single, dose-ranging, controlled trial in 78 pediatric patients 9 to 16 years of age. Results of the trial showed the safety profile in this pediatric population was similar to that seen in adults.
The most common adverse reactions observed in the trial included nausea, vomiting, and abdominal pain. In addition, 3 patients were found to have abnormally low glucose levels (40 to 47mg/dL). The updated labeling states that pediatric patients should be monitored for possible hypoglycemia as Clenpiq has no caloric substrate.
In the pediatric trial, approximately 20% of patients administered another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid had orthostatic changes (changes in blood pressure and/or heart rate) compared with 7% of those who received the comparator polyethylene glycol (PEG); these changes occurred up to 5 days after colonoscopy.
Clenpiq is available as a carton containing 2 bottles, each holding 160mL of ready-to-drink cranberry-flavored solution. Two doses of Clenpiq are required for a complete preparation for colonoscopy. An 8oz cup for measuring fluids for hydration is also included.
For more information visit fda.gov.
