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
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
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.
Please see complete Prescribing Information for OSMOPREP, including BOXED WARNING.
References: 1. OSMOPREP [prescribing information]. Raleigh, NC: Salix Pharmaceuticals, Inc; 2012.
2. Data on file. Salix Pharmaceuticals, Inc.
The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.