OsmoPrep (Rx only) – It's a Pill. Not a Liquid.
The latest advancement in colonoscopy preparation is OsmoPrep (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) – The Tablet Prep. Approved by the FDA in March 2006 for cleansing the colon in preparation for colonoscopy in adults, OsmoPrep is unique among bowel preps. OsmoPrep consists of a series of pills instead of a liquid prep and is taken with the clear liquid of your choice. It tastes like the liquid you choose to take it with – not like an unpleasant liquid bowel prep.
Most colon cancer is preventable or treatable if caught in its earliest stages. However, less than half of Americans who should be getting screened for colon cancer actually undergo a colonoscopy or screening by another method.1 The greatest barrier for most individuals is the bowel prep itself.2 OsmoPrep is a tolerable tablet alternative to traditional liquid bowel preps. In clinical trials, 95% of OsmoPrep users indicated that they would choose to take it again.3
Salix Pharmaceuticals is pleased to provide you with a patient-friendly Web site dedicated to OsmoPrep, www.TabletPrep.com.
We invite you to visit the site to learn more about The Tablet Prep, colon cancer, colonoscopy and other screening methods, and take advantage of the research resources offered. OsmoPrep is not for everyone, so we encourage you to discuss colonoscopy and all of your prep options with your healthcare provider.
www.TabletPrep.com
Read the OsmoPrep Medication Guide.
Additional safety information: www.warninginfoforosmoprepandvisicol.com.
References: 1. Centers for Disease Control and Prevention. Cancercolorectal cancer screening rates. Available at: http://www.cdc.gov/cancer/colorectal/statistics/screening_rates.htm. Accessed April 12, 2007. 2. Harewood GC, Wiersema MJ, Melton LJ III. A prospective, controlled assessment of factors influencing acceptance of screening colonoscopy. Am J Gastroenterol. 2002;97:3186-3194. 3. 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;101:2594-2604.
Important Safety Information about OsmoPrep
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 accompanying brief summary of 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.
For complete Prescribing Information, please click here.
For product information, adverse event reports, and product complaint reports please call:
Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: