Medication Monitor



Generic Name (Trade Name—Company)
Notes
July 17, 2012

Sodium picosulfate, magnesium oxide, citric acid

(Prepopik—Ferring Pharmaceuticals)
New colonoscopy prep approved

Uses:

Bowel preparation

FDA announced the approval of a new colon cleansing prep that contains sodium picosulfate, magnesium oxide, and citric acid for adult patients preparing for colonoscopy. This new prep consists of two packets of powder, each of which should be dissolved in cold water and taken at separate times. It can be taken as a split-dose regimen, with one powder pack taken the night before colonoscopy and the other the morning of the colonoscopy, or as a day-before regimen, with one powder pack taken in the afternoon and the other the evening before the procedure.

Approval was based on data from two clinical studies with approxiamtely 1,200 adult patients scheduled to have a colonoscopy. Patients were randomly assigned to take the split-dose regimen, the day-before regimen, or a control preparation consisting of a polyethylene glycol plus electrolytes (PEG+E) solution and two 5-mg bisacodyl tablets administered entirely the day before colonoscopy. In both studies, the new preparation was as effective as the control preparation in cleansing the colon. In the study in which the split-dose regimen was used, it was superior to the control preparation in cleansing the colon. The most common adverse effects reported in adult patients using this new preparation were nausea, headache, and vomiting.

FDA noted that as a condition of approval, Ferring Pharmaceuticals must conduct studies to determine if the drug can be used safely and effectively in children.