Safety

KEY SAFETY PARAMETERS

HYDRATION

Associated with significant fluid shifts?

NO2-5

ELECTROLYTES

Increased likelihood of urine calcium precipitate?

Associated with clinically significant hyperphosphatemia?

NO9

NO2,3,5,10

RENAL RISK FACTORS

Acute phosphate nephropathy?

Black Box Warning for acute phosphate nephropathy?

NO2-5,9,10

NO2

AGE FACTOR

Elevated risk of acute phosphate nephropathy with advancing age?

NO2

IMPORTANT SAFETY INFORMATION

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. Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache.

Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance.

View the Full Prescribing Information and Medication Guide.

References: 1. IQVIA. National Prescription Audit Report. June 2019. 2. SUPREP Bowel Prep Kit [package insert]. Braintree, MA: Braintree Laboratories, Inc; 2017. 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. Plenvu [package insert]. Amsterdam, the Netherlands: Norgrine B.V.; 2018. 12. Clenpiq [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc; 2018. 13. 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. 14. Data on file. Braintree Laboratories, Inc. Braintree, MA.