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IMPORTANT SAFETY INFORMATION

INDICATION
SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

DOSAGE AND ADMINISTRATION
A low residue breakfast may be consumed. After breakfast, only clear liquids may be consumed until after the colonoscopy. Administration of two doses of SUTAB (24 tablets) are required for a complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose. Water must be consumed with each dose of SUTAB and additional water must be consumed after each dose. Complete all SUTAB tablets and required water at least 2 hours before colonoscopy.

CONTRAINDICATIONS
Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention.

WARNINGS AND PRECAUTIONS
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. Suspected GI obstruction or perforation: Rule out the diagnosis before administration.

ADVERSE REACTIONS
Most common gastrointestinal adverse reactions are nausea, abdominal distension, vomiting, and upper abdominal pain.

DRUG INTERACTIONS
Drugs that increase risk of fluid and electrolyte imbalance.

View the Full Prescribing Information and Medication Guide.

References: 1. SUTAB® [package insert]. Braintree, MA: Braintree Laboratories, Inc; 2020. 2. Di Palma JA, Bhandari R, Cleveland M, et al. A safety and efficacy comparison of a new sulfate-based tablet bowel preparation versus a PEG and ascorbate comparator in adult subjects undergoing colonoscopy. Am J Gastroenterol. Published online November 6, 2020. doi: 10.14309/ajg.0000000000001020. 3. Rex DK, Johnson DA, Anderson JC, et al; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009;104(3):739-750. 4. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53. 5. Data on file. Braintree Laboratories, Inc. Braintree, MA. 6. SUPREP Bowel Prep Kit [package insert]. Braintree, MA: Braintree Laboratories, Inc; 2020. 7. Plenvu [package insert]. Bridgewater, NJ: Bausch Health LLC; 2019. 8. Clenpiq [package insert]. Parsippany, NJ: Ferring Pharmaceuticals, Inc; 2019. 9. Rex DK, Di Palma JA, Rodriguez R, et al. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010;72(2):328-336. 10. Matro R, Daskalakis C, Negoianu D, et al. Randomised clinical trial: polyethylene glycol 3350 with sports drink vs. polyethylene glycol with electrolyte solution as purgatives for colonoscopy – the incidence of hyponatraemia. Aliment Pharmacol Ther. 2014;40(6):610-619.