Magnesium sulfate, Potassium chloride and Sodium sulfate

SUTAB is indicated for the cleansing of the colon as a preparation for colonoscopy in adults. SUTAB is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

The primary mode of action is osmotic action of sodium sulfate and magnesium sulfate, which induce a laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.

For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing information. Preparation and Administration. Administration of two doses (24 tablets) are required for a complete preparation for colonoscopy. SUTAB is supplied as two bottles each containing 12 tablets. Twelve tablets are equivalent to one dose. Each SUTAB bottle contains a desiccant. Remove and discard the desiccant from both bottles the evening prior to the colonoscopy. Must consume water with each dose and an additional 32 ounces of water after each dose. Do not take other laxatives. Administer oral medications at least 1 hour before starting each dose of SUTAB.

SUTAB is contraindicated in the following conditions: Gastrointestinal obstruction or ileus Gastrointestinal obstruction or ileus. Bowel perforation. Toxic colitis or toxic megacolon. Gastric retention. Hypersensitivity to any ingredient in SUTAB

Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use. Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold. Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing. Colonic Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. Suspected GI obstruction or perforation: Rule out the diagnosis before administration.

The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Electrolyte Abnormalities Cardiac Arrhythmias Seizures Patients with Risk of Renal Injury Colonic Mucosal Ulceration and Ischemic Colitis Patients with Significant Gastrointestinal Disease Hypersensitivity Reactions Risk of Gastrointestinal Complications with Ingestion of Desiccant Most common gastrointestinal adverse reactions are nausea, abdominal distension, vomiting and upper abdominal pain.

Drugs that increase risk of fluid and electrolyte imbalance Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities Use caution when prescribing SUTAB to patients taking medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities.

Storage Store at 20º to 25°C (68º to 77°F). Excursions permitted between 15º to 30°C (59º to 86°F). See USP controlled room temperature.