More information about the use of OsmoPrep Tablets is available in the current edition of MPR.

For your reference, please see the following full Prescribing Information, including the Boxed Warning, for OsmoPrep Tablets.

Sincerely,

Grace L. McBride
Editorial Director,
MPR Custom Programs

REFERENCES
1. OsmoPrep Tablets [package insert]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2009.
2. Rex DK, Schwartz H, Goldstein M, et al. Safety and colon-cleansing efficacy of a new residue-free formulation of sodium phosphate tablets. Am J Gastroenterol. 2006;101(11):2594-2604.
3. Data on file, Salix Pharmaceuticals, Inc.
4. Wruble L, DeMicco M, Medoff J, et al. Residue-free sodium phosphate tablets (OsmoPrep) versus Visicol for colon cleansing; a randomized, investigator-blinded trial. Gastrointest Endosc. 2007;65(4):660-670.

Important Safety Information

There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis. While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]).

It is important to use the dose and dosing regimen as recommended (PM/AM split dose).

Please see enclosed full Prescribing Information for OsmoPrep, including BOXED WARNINGS.

OsmoPrep® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. Considerable caution should be advised before OsmoPrep is used in patients with severe renal insufficiency, congestive heart failure, ascites, unstable angina, gastric retention, ileus, severe chronic constipation, bowel perforation, toxic megacolon, gastric bypass or stapling surgery, or hypomotility syndrome. Use with caution in patients with impaired renal function, patients with a history of seizures or at higher risk of seizure, patients with higher risk of cardiac arrhythmias, 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.

OsmoPrep is contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients, and in patients with biopsy-proven acute phosphate nephropathy. In clinical trials, the most commonly reported adverse reactions (reporting frequency >3%) were abdominal bloating, nausea, abdominal pain, and vomiting. It is recommended that patients receiving OsmoPrep be advised to adequately hydrate before, during, and after the use of OsmoPrep.