Renal Dose Adjustment (Based on CrCl)
- <30 mL/min: Use with caution; dose adjustments not defined
Hepatic Dose Adjustment
- Hepatic impairment: Dose adjustments not defined
See Supplemental Patient Information
- Use of sodium phosphate products prior to colonoscopy for colon cleansing has been associated with fatalities due to significant fluid shifts, severe electrolyte abnormalities, and cardiac arrhythmias; patients with renal insufficiency, bowel perforation, and those who misused or overdosed sodium phosphate products are highly susceptible for such fatalities. Hence, it is necessary to adequately hydrate patients before, during, and after the use of this drug
- Perform baseline and post-colonoscopy lab tests (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/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. On development of vomiting and/or signs of dehydration, consider measuring post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN)
- Patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy are susceptible for development of rare, but serious acute phosphate nephropathy, acute renal failure, or nephrocalcinosis. Permanent impairment of renal function have been reported in certain patients, while some patients required long-term dialysis [US Black Box Warning]. The onset of such events may occur within days or might be delayed up to several months after the ingestion of sodium phosphate products. Patients with increased age, hypovolemia, increased bowel transit time (bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (diuretics, ACE inhibitors, ARBs blockers, and possibly NSAIDs) are highly susceptible for development of acute phosphate nephropathy [US Black Box Warning]
- Undertake measures for correcting electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia before initiating treatment with sodium phosphate products
- Rare cases of generalized tonic-clonic seizures and/or loss of consciousness have been reported with the use of this product in patients with no prior history of seizures. Hyponatremia, hypokalemia, hypocalcemia, hypomagnesemia, and low serum osmolality are the risk factors associated with development of seizures. Appropriate measures for correcting fluid and electrolyte abnormalities should be undertaken
- Rare, but serious cases of arrhythmias have been reported with the use of this product. QT prolongation may be associated with electrolyte imbalances, such as hypokalemia and hypocalcemia. Consider pre-dose and post-colonoscopy ECGs in patients with high risk of serious, cardiac arrhythmias
- Excessive fluid loss, hypovolemia, and dehydration may occur with inadequate fluid intake, as with any effective purgative. Inadequate oral fluid intake, vomiting, and/or use of diuretics may exacerbate dehydration from purgation. Advise patients to avoid additional laxatives or purgatives, particularly additional sodium phosphate-containing products
- Patients with a history of swallowing difficulties or anatomic narrowing of the esophagus may have difficulty swallowing sodium phosphate tablets; undigested or partially digested tablets may be seen in the stool or during colonoscopy
- Therapy may induce colonic mucosal aphthous ulcerations. Patients with known or suspected inflammatory bowel disease are highly susceptible for such findings
Cautions: Use cautiously in
- Severe renal insufficiency (CrCl <30 mL/min)
- Impaired renal function
- CHF
- Unstable angina
- High risk of arrhythmias
- History of cardiomyopathy
- Prolonged QT
- History of uncontrolled arrhythmias
- Recent history of MI
- Cardiac surgery
- Esophageal stricture
- Concomitant use with drugs known to prolong the QT interval
- Gastric retention
- Bulimia nervosa
- Ileus
- Acute bowel obstruction
- Pseudo-obstruction of the bowel
- Severe chronic constipation
- Bowel perforation
- Acute colitis
- Toxic megacolon
- Gastric bypass or stapling surgery
- Hypomotility syndrome
- Inflammatory bowel disease
- History of seizures
- High risk of seizure
- Co-administration with medications that lower seizure threshold (such as tricyclic antidepressants)
- Patients withdrawing from alcohol or benzodiazepines
- Patients with known or suspected hyponatremia
- History of acute phosphate nephropathy
- Known or suspected electrolyte disturbances (such as dehydration)
- Concurrent use of medications that may affect electrolyte levels (such as diuretics)
- Ascites
- Patients >55 yrs
Supplemental Patient Information
- Instruct patients to drink 8 ounces of clear liquids with each dose
- Advise patients to avoid any additional laxative or purgative agents, particularly those containing sodium phosphate
Pregnancy Category:C
Breastfeeding: Safety unknown. Phosphate is a normal constituent of breastmilk. It may not be necessary to suspend breastfeeding after the use of oral sodium phosphate solutions given once or twice for bowel evacuation before a procedure, but if there is concern, suspension of nursing for 24 hrs after a dose should result in negligible increase in phosphate ingestion by the infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 8 Sept 2011).
Pricing data from www.DrugStore.com in U.S.A.
- Visicol 1.102-0.398 GM TABS [Bottle] (SALIX PHARMACEUTICALS)
INC. gm = $40
gm = $120 - OsmoPrep 1.102-0.398 GM TABS [Bottle] (SALIX PHARMACEUTICALS)
INC. gm = $100
gm = $300
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
18 yrs of age
