| HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use SUPREP Bowel Prep Kit safely and effectively. See full prescribing information for SUPREP Bowel Prep Kit
SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) Oral Solution
Initial U.S. Approval: 08/2010 [Braintree Laboratories, Inc.]
| CLINICAL PHARMACOLOGY
Mechanism of Action
| INDICATIONS AND USAGE
SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults
-Toxic colitis or toxic megacolon
-Known allergies to components of the kit
| WARNINGS AND PRECAUTIONS
Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment- assess concurrent medications and consider testing in some patients.
Patients with renal insufficiency- use caution, ensure adequate hydration and consider testing.
Suspected GI obstruction or perforation - rule out the diagnosis before administration.
Patients at risk for aspiration - observe during administration.
Not for direct ingestion - dilute and take with additional water.
| Most common adverse reactions (≥3%) are: overall discomfort, abdominal fullness, nausea, abdominal cramping, and vomiting.
To report SUSPECTED ADVERSE REACTIONS, contact Braintree Laboratories, Inc. at 1-800-874-6756 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
| DOSAGE AND ADMINISTRATION
SUPREP Bowel Prep Kit should be taken as a split-dose oral regimen.
The dose for colon cleansing requires administration of two bottles of SUPREP Bowel Prep Kit. Each bottle is administered as 16 oz of diluted SUPREP solution with an additional 1 quart of water taken orally. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts (approximately 2.8 L) taken orally prior to the colonoscopy in the following way:
Split-Dose (Two-Day) Regimen
Day of colonoscopy:
| DOSAGE FORMS AND STRENGTHS
Two 6 oz bottles of oral solution.
Each 6 oz bottle contains: sodium sulfate 17.5 g, potassium sulfate 3.13 g, magnesium sulfate 1.6 g.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here.