BETHESDA, MD 17 Jul 2012—FDA today announced the approval of a new bowel-cleansing preparation for colonoscopy procedures in adults.
Prepopik, made by Ferring Pharmaceuticals of Parsippany, New Jersey, contains the stimulant laxative sodium picosulfate in combination with magnesium oxide and anhydrous citric acid, according to the product's labeling (PDF). A second laxative, magnesium citrate, forms when the magnesium oxide and citric acid are in solution.
The product will be available in the United States in October, according to Ferring's Prepopik website.
Each carton of Prepopik will contain two 16.1-g packets, each having 10 mg of sodium picosulfate, 3.5 g of magnesium oxide, 12 g of anhydrous citric acid, and excipients including potassium hydrogen carbonate, sodium saccharin, and flavoring ingredients, according to the product's labeling. The cartons should be stored at controlled room temperature.
The contents of each packet should be added to 5 oz of cold water immediately before use. Two packets are needed to complete a full preparative regimen.
According to Ferring, Prepopik is the lowest-volume bowel-cleansing preparation approved for use in the United States.
The preferred regimen is one 5-oz dose taken the evening before the colonoscopy followed by five 8-oz glasses of clear liquids taken within five hours after drinking the drug solution. The second dose should be taken approximately five hours before the procedure, followed by three 8-oz glasses of clear liquids.
The alternative regimen consists of one 5-oz dose taken in the afternoon or evening before the procedure followed by five 8-oz glasses of clear liquids taken within five hours after drinking the solution. The second dose should be taken approximately six hours later that evening, followed by three 8-oz glasses of clear liquids.
In clinical trials of Prepopik, the most frequently reported adverse events in patients who used the drug were nausea, headache, and vomiting.
Prepopik is contraindicated in patients with a creatinine clearance of <30 mL/min, gastrointestinal obstruction, ileus, bowel perforation, toxic colitis, toxic megacolon, gastric retention, or an allergy to any ingredient in the product.
The product should be used with caution in patients with conditions or medication use that increase the risk for fluid and electrolyte disturbances, seizure, arrhythmias, or QT-interval prolongation.
As with other bowel-cleansing preparations for colonoscopy procedures, Prepopik has a medication guide for patients.