Posted by Kate Murphy on May 8th, 2006
On March 17, 2006 the FDA approved OsmoPrep™, a tablet form of sodium phosphate for colonoscopy preparation. OsmoPrep™ is manufactured by Salix Pharmaceuticals. It is an additional option for bowel cleansing for people unable to tolerate liquid preps.
Recommended dosage is 32 tablets (48 grams of sodium phosphate) taken with at least 2 quarts of clear liquids. The prep is given in divided doses of 4 tablets with 8 ounces of clear liquid every 15 minutes. Twenty tablets are taken the night before the colonoscopy and an additional 12 pills the next day, 3 to 5 hours prior to colonoscopy. The tablets produce a large amount of watery diarrhea which removes all stool from the colon so that the its walls can be examined for polyps, colorectal cancer, or other abnormalities.
It is critical that patients drink the recommended amount of clear liquids.
Randomized clinical trials conducted by Salix, which will be published later this year, compared the 32 tablet OsmoPrep™ regimen to a kit of 2 liters of HalfLytely™ and Bisacodyl tablets. In the trials a significantly greater percentage of patients who used OsmoPrep™ recorded a mean bowel cleansing score of “excellent” compared to the HalfLytely™ kit users.
Similar oral sodium phosphate preparations, such as Fleet’s Phospho-soda™ (21 patients) and Visicol™ tablets (1 patient) have been implicated in acute phosphate nephropathy, a rare kidney failure. None had used OsmoPrep™.
The OsmoPrep™ manufacturers warn against use of the bowel cleansing prep with patients who have kidney or cardiac conditions or possible bowel obstruction.
Considerable caution should be advised before OsmoPrep Tablets are used in patients with severe renal insufficiency, congestive heart failure, ascites, unstable angina, gastric retention, ileus, acute obstruction or pseudo-obstruction of the bowel, severe chronic constipation, bowel perforation, acute colitis, toxic megacolon, gastric bypass or stapling surgery, or hypomotility syndrome. Use with caution in patients with impaired renal function, patients with a history of acute phosphate nephropathy, known or suspected electrolyte disturbances (such as dehydration), or people taking drugs that affect electrolyte levels. Patients with electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia should have their electrolytes corrected before treatment with OsmoPrep Tablets.
More information about the new prep is available on Medscape.
colonoscopy preparation