The tablet prep for confidence in clear visibility of the entire colon

The tablet prep for confidence in clear visibility of the entire colon

Osmoprep - sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP Osmoprep - sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP

OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) tablets are indicated for the cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

OSMOPREP tablets are easy to take and are virtually tasteless. That’s why those who have taken OSMOPREP in the past prefer it over other forms of colon prep. In fact, 95% of  patients would choose OSMOPREP as their preparation again.1

In a clinical trial,2 OSMOPREP demonstrated highly effective colon cleansing-an important first step for a successful colonoscopy. It is designed to be taken with clear liquids such as water, ginger ale, apple juice, lemonade, or sports drinks (no purple or red liquids). OSMOPREP was well-tolerated in a clinical trial, with 97% of participants being "fully compliant" with the OSMOPREP regimen (n=816).3 Do not take OSMOPREP if you have had a kidney biopsy that shows you have kidney problems because of too much phosphate, a blockage of your intestines, had stomach surgery involving stapling or bypass, a hole or opening in your intestines, significant irritation of the bowels such as toxic megacolon or toxic colitis, or you are allergic to sodium phosphate salts or any of the ingredients in OSMOPREP.

OSMOPREP provides clarity to help visualize the entire colonic mucosa for abnormalities.

Indication for OSMOPREP

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.

Important Safety Information about OSMOPREP

WARNINGS

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).

Do not take OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) if you have had a kidney biopsy that shows you have kidney problems because of too much phosphate, a blockage of your intestines, had stomach surgery involving stapling or bypass, a hole or opening in your intestines, significant irritation of the bowels such as toxic megacolon or toxic colitis, or you are allergic to sodium phosphate salts or any of the ingredients in OSMOPREP.

Rare, but serious kidney problems can happen in people who take medicines made with sodium phosphate, including OSMOPREP, to clean the colon before colonoscopy. These kidney problems can sometimes lead to kidney failure or the need for dialysis. These problems occur within a few days, but may develop several months after taking OSMOPREP.

Conditions that can make you more at risk for having serious kidney problems with OSMOPREP include: the loss of too much body fluid (dehydration), slow moving bowels, bowels blocked with stool (constipation), severe stomach pain or bloating, any disease that causes bowel inflammation (colitis), kidney disease or kidney problems, heart failure, and the use of water pills or non?steroidal anti?inflammatory drugs (NSAIDS). Your age may also affect your risk for having kidney problems with OSMOPREP. Talk to your doctor before you start to take OSMOPREP.

If you have a history of seizures or are at risk for seizures due to certain medications (such as tricyclic antidepressants), are undergoing withdrawal from alcohol or benzodiazepines, or if you have hyponatremia, you should talk to your doctor before you take OSMOPREP.

If you have been told you are at high risk for developing an arrhythmias or irregular heartbeat, you should tell your doctor.

It is important to drink sufficient liquids before, during, and after use of OSMOPREP.

If you have had an inflammatory bowel disease diagnosis or a blockage/opening of your intestines, tell your doctor before taking OSMOPREP.

If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking OSMOPREP.

In clinical trials, the most common side effects occurring in at least 3% of adult patients taking OSMOPREP were bloating, abdominal (stomach) pain, nausea, and vomiting.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for OSMOPREP, including BOXED WARNING.

Indication for OSMOPREP

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.

Important Safety Information about OSMOPREP

WARNINGS

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).

OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are contraindicated in patients with a biopsy-proven acute phosphate nephropathy, gastrointestinal (GI) obstruction, gastric bypass or stapling surgery, bowel perforation, toxic colitis, toxic megacolon, and known allergy or hypersensitivity to sodium phosphate salts or any component of OSMOPREP.

Renal impairment may occur with OSMOPREP. Assess renal function before treatment and during therapy. Use OSMOPREP with caution in patients with impaired renal function (creatinine clearance less than 30mL/minute), patients with a history of acute phosphate nephropathy, known or suspected electrolyte disturbances (such as dehydration), or people taking concomitant medications that may affect electrolyte levels (such as diuretics). Patients with electrolyte abnormalities (such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia) should have their electrolytes corrected before treatment with OSMOPREP Tablets.

Seizures due to electrolyte abnormalities can occur. OSMOPREP should be used with caution in patients with a history of seizures or at higher risk of seizure [e.g. patients using concomitant medications that lower the seizure threshold (such as tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia].

Use caution in patients with higher risk of arrhythmias (e.g., patients with a history of cardiomyopathy, prolonged QT, uncontrolled arrhythmias, or recent myocardial infarction).

Advise patients to hydrate adequately before, during, and after the use of OSMOPREP.

Use OSMOPREP with caution in patients with history of Inflammatory Bowel Disease. In patients with suspected GI obstruction or perforation, rule out the diagnosis before administration of OSMOPREP.

Animal reproduction studies have not been performed. OSMOPREP should only be given to a pregnant woman if clearly needed.

In clinical trials, the most commonly reported adverse reactions (reporting frequency >3%) were abdominal bloating, abdominal pain, nausea, and vomiting.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for OSMOPREP, including BOXED WARNING.

References: 1. 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.  2. OSMOPREP [prescribing information]. Raleigh, NC: Salix Pharmaceuticals, Inc; 2012. 3. Data on file. Salix Pharmaceuticals, Inc.

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