VISICOL is indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. These virtually tasteless tablets may be taken with any clear liquid. A study by the Mayo Clinic indicated that the taste of liquid bowel preparations is a leading deterrent to patients consenting to colonoscopy.1
Important Safety Information about VISICOL
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).
VISICOL®
(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.
VISICOL is not to be used in patients with congestive heart failure, ascites, unstable angina pectoris, gastric retention,
ileus or acute obstruction or pseudo-obstruction, severe chronic constipation, bowel perforation, acute colitis, toxic
megacolon, or hypomotility syndrome. Use with caution in patients with impaired renal function, pre-existing electrolyte
disturbances, or people taking drugs that affect electrolyte levels. VISICOL is contraindicated in patients with a known
allergy or hypersensitivity to sodium phosphate salts or any of its ingredients. In clinical trials, the most commonly
observed (≥1%) adverse reactions occurring with use of VISICOL were generally transient and self-limited and included
nausea, vomiting, abdominal bloating, abdominal pain, dizziness and headache.
Consult with your physician to see if this product is right for you.
Complete Prescribing Information for VISICOL, including BOXED WARNING
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 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 for OSMOPREP including BOXED WARNING.
Reference: 1. Harewood GC, Wiersema MJ, Melton LJ 3rd. A prospective, controlled assessment of factors influencing acceptance of screening colonoscopy. Am J Gastroenterol. 2002;97:3186-3194.
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