SUPREP® BOWEL PREP KIT

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IMPORTANT SAFETY INFORMATION

INDICATION

SUPREP^® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 12 years of age and older.

CONTRAINDICATIONS

Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any ingredients in SUPREP Bowel Prep Kit.

DOSAGE AND ADMINISTRATION

Each bottle must be diluted with water to a final volume of 16 ounces (Adults) and 12 ounces (Pediatric patients 12 years of age and older). Must consume additional water after each dose. Stop consumption of all fluids at least 2 hours prior to the colonoscopy.

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 medications that affect renal functions: Use caution, ensure adequate hydration and consider laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration; Patients at risk for aspiration: Observe during administration.

ADVERSE REACTIONS

Most common adverse reactions: Adults: (> 2%) are overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting; Pediatric Patients (>10%) are nausea, abdominal pain, abdominal bloating and vomiting.

DRUG INTERACTIONS

Drugs that may increase the risk of fluid and electrolyte abnormalities.

View the Full Prescribing Information and Medication Guide.

References: 1. IQVIA. National Prescription Audit Report. November 2021. 2. SUPREP Bowel Prep Kit [package insert]. Braintree, MA: Braintree Laboratories, Inc. 3. Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study evaluating the safety and efficacy of a new, reduced-volume, oral sulfate colon-cleansing preparation for colonoscopy. Am J Gastroenterol. 2009;104(9):2275-2284. 4. Rex DK, Di Palma JA, McGowan J, Cleveland M. A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy. Gastrointest Endosc. 2014;80(6):1113-1123. 5. Rex DK, Di Palma JA, McGowan J, Cleveland M. 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. 6. Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009;104(3):739-750. 7. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53. 8. Cleveland M, Zamora C, Pelham R. PEG-sports drink bowel prep: physiology of electrolyte imbalance. Poster presented at: American College of Gastroenterology Annual Meeting; October 16-21, 2015; Honolulu, Hawaii. Abstract 1482. 9. Patel V, Nicar M, Emmett M, et al. Intestinal and renal effects of low-volume phosphate and sulfate cathartic solutions designed for cleansing the colon: pathophysiological studies in five normal subjects. Am J Gastroenterol. 2009;104(4):953-965. 10. Pelham RW, Alcorn H Jr, Cleveland M. A pharmacokinetics evaluation of a new, low-volume, oral sulfate colon cleansing preparation in patients with renal or hepatic impairment and healthy volunteers. J Clin Pharmacol. 2010;50(3):350-354. 11. SUTAB^® [package insert]. Braintree, MA: Braintree Laboratories, Inc. 12. Plenvu [package insert]. Amsterdam, the Netherlands: Norgrine B.V. 13. Clenpiq [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc. 14. 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. 15. Data on file. Braintree Laboratories, Inc. Braintree, MA.