Sodium Picosulfate

Serious arrhythmias have occurred rarely with the use of ionic osmotic laxative products; use caution in patients at increased risk for arrhythmias (eg, recent MI, unstable angina, cardiomyopathy, history of prolonged QT, HF, uncontrolled arrhythmias); consider baseline and postcolonoscopy ECGs in patients at increased risk for arrhythmias.

May cause fluid and electrolyte disturbances, particularly in patients at increased risk (eg, renal impairment, concomitant medications that alter electrolyte balance). Any preexisting electrolyte abnormalities should be corrected prior to use and patients should be adequately hydrated before, during, and after use. Consider evaluating for and treating postcolonoscopy electrolyte abnormalities in patients who develop significant vomiting, dehydration, or orthostatic hypotension.

Osmotic laxatives may produce colonic mucosal aphthous ulcerations, including cases of ischemic colitis. Use caution when interpreting colonoscopy results in patients with inflammatory bowel disease.

Seizures associated with electrolyte abnormalities (eg, hyponatremia, hypokalemia, hypocalcemia, hypomagnesemia) and low serum osmolality have occurred; use with caution in patients with underlying electrolyte disturbances and in patients at increased risk for seizures (eg, concomitant medications that lower seizure threshold, withdrawal from alcohol or benzodiazepines). Disease-related concerns:

Observe semiconscious patients with impaired gag reflex or those who are otherwise prone to regurgitation or aspiration during administration.

Use with caution in patients with renal impairment and/or in patients taking medications that may adversely affect renal function (eg, diuretics, NSAIDs, ACE inhibitors, ARBs); adequate hydration is particularly important in these patients. Patients with impaired renal function who develop severe vomiting should be closely monitored including measurement of electrolytes. Use is contraindicated in severe renal impairment (CrCl • Ulcerative colitis: Use with caution in patients with severe active ulcerative colitis. If obstruction or perforation is suspected, diagnostic studies should be performed to rule out conditions prior to therapy initiation. Concurrent drug therapy issues:

Sodium picosulfate requires the presence of colonic bacteria for the conversion to the active metabolite; prior or concomitant administration of antibiotics may reduce the efficacy of sodium picosulfate.

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Oral medications administered ≤1 hour prior to the start of the bowel preparation regimen may not be absorbed. Chlorpromazine, digoxin, fluoroquinolones, iron, penicillamine, and tetracycline should be administered at least 2 hours before and 6 hours after administration of magnesium oxide to avoid chelation with magnesium. Other warnings/precautions:

Evaluate patients with symptoms of bowel obstruction/perforation (nausea, vomiting, abdominal pain or distension) prior to use. Each Prepopik packet must be diluted with water prior to use; inadvertent administration of undiluted solution may increase the risk of nausea, vomiting, and fluid/electrolyte abnormalities.