Administration of sodium phosphate products prior to colonoscopy has resulted in fatalities due to significant fluid shifts, severe electrolyte abnormalities, and cardiac arrhythmias.
These fatalities have been observed in patients with renal insufficiency, in patients with bowel perforation, and in patients who misused or overdosed sodium phosphate products.Considerable caution should be advised before Visicol® Tablets are used in patients with the following illnesses: severe renal insufficiency (creatinine clearance less than 30 mL/minute), congestive heart failure, ascites, unstable angina, acute bowel obstruction, bowel perforation, toxic megacolon, gastric retention, ileus, pseudo-obstruction of the bowel, severe chronic constipation, acute colitis, gastric bypass or stapling surgery or hypomotility syndrome.Consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in patients who may be at increased risk for serious adverse events, including those with history of renal insufficiency, history of ? or at greater risk of ? acute phosphate nephropathy, known or suspected electrolyte disorders, seizures, arrhythmias, cardiomyopathy, prolonged QT, recent history of a MI and those with known or suspected hyperphosphatemia, hypocalcemia, hypokalemia, and hypernatremia.
Also if patients develop vomiting and/or signs of dehydration then measure post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN).Renal Disease, Acute Phosphate Nephropathy, and Electrolyte DisordersThere have been rare, but serious reports of renal failure and acute phosphate nephropathy (also known as nephrocalcinosis) in patients who received oral sodium phosphate products (including oral sodium phosphate solutions and tablets) for colon cleansing prior to colonoscopy.
These cases often resulted in permanent impairment of renal function and several patients required long-term dialysis.
Patients at increased risk of acute phosphate nephropathy may include patients with the following: hypovolemia, baseline kidney disease, increased age, and patients using medicines that affect renal perfusion or function [such as diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers, and possibly nonsteroidal anti-inflammatory drugs (NSAIDs). Use Visicol® with caution in patients with impaired renal function, known or suspected electrolyte disturbances, 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 them corrected before treatment with Visicol® Tablets.SeizuresThere have been rare reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of sodium phosphate products in patients with no prior history of seizures.
The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality.
The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.
Visicol® should be used with caution in patients with a history of seizures and in patients at higher risk of seizure [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].Cardiac ArrhythmiasThere have been rare, but serious reports of arrhythmias associated with the use of sodium phosphate products.
Visicol® should be used with caution in patients with higher risk of arrhythmias (patients with a history of cardiomyopathy, patients with prolonged QT, patients with a history of uncontrolled arrhythmias, and patients with a recent history of a myocardial infarction).Pre-dose and post-colonoscopy ECGs should be considered in patients with high risk of serious, cardiac arrhythmias.