- Advise patients to be well hydrated before, during, and after the use of this preparation. If significant vomiting or signs of dehydration are observed after taking this preparation, consider monitoring electrolytes, creatinine, and BUN after colonoscopy
- Marked fluid and electrolyte disturbances may lead to serious adverse events such as seizures, cardiac arrhythmias, and renal impairment
- Advise patients with electrolyte abnormalities to have them corrected before treatment with this preparation. Exercise caution in patients with conditions or who are using medications which increase the risk for fluid and electrolyte disturbances
- Temporary elevation in uric acid has been associated with this product. Uric acid fluctuations in gout patients may precipitate an acute flare
- Rare events of serious arrhythmias have been reported with the use of ionic osmotic laxatives used for bowel preparation. Use cautiously and consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias
- Cases of generalized tonic-clonic seizures and/or loss of consciousness have been reported with the use of bowel preparation products in patients with no prior history of seizures. The seizures were associated with electrolyte abnormalities (e.g., hypokalemia, hyponatremia, hypomagnesemia, and hypocalcemia) and low serum osmolality. Correction of fluid and electrolyte abnormalities resolves neurologic abnormalities
- Osmotic laxative products may produce colonic mucosal aphthous ulcerations; cases of serious ischemic colitis requiring hospitalization have been reported. Concomitant administration of stimulant laxatives may increase these risks
- Use cautiously in patients with renal impairment or in those taking concomitant medications that may affect renal function. Consider monitoring baseline and post-colonoscopy electrolytes, creatinine, and BUN in these patients
- Before administering ionic osmotic laxatives, perform appropriate diagnostic studies to rule out gastrointestinal obstruction or perforation
- Recommended dilution of each bottle with water to a final volume of 16 oz and ingestion of additional water, as direct ingestion of the undiluted solution may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances
Cautions: Use cautiously in
- Electrolyte disturbances
- Known or suspected hyponatremia
- Severe ulcerative colitis
- GI perforation
- PKU (phenylalanine-containing forms)
- G6PD deficiency
- Elderly patients
Pregnancy Category:C
Breastfeeding: As per manufacturer's data, it is unknown whether this combination drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised while administering this drug to nursing women.
