SUPREP BOWEL PREP®

Navigation

(description)

Clinical pharmacology

Indications and usage

Contraindications

Precautions

Adverse reactions

Dosage and administration

How supplied

Reference

(description)

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

CLINICAL PHARMACOLOGY

Mechanism of Action
Sulfate salts provide sulfate anions, which are poorly absorbed. The osmotic effect of unabsorbed sulfate anions and the associated cations causes water to be retained within the gastrointestinal tract.

Pharmacodynamics
The osmotic effect of the unabsorbed ions, when ingested with a large volume of water, produces a copious watery diarrhea.

Indications and usage

INDICATIONS AND USAGE
SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults

Contraindications

CONTRAINDICATIONS
-Gastrointestinal obstruction
-Bowel perforation
-Gastric retention
-Ileus
-Toxic colitis or toxic megacolon
-Known allergies to components of the kit

Precautions

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.

Adverse reactions

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

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 prior to colonoscopy:

A light breakfast may be consumed, or have only clear liquids on the day before colonoscopy. Avoid red and purple liquids, milk, and alcoholic beverages.
Early in the evening prior to colonoscopy: pour the contents of one bottle of SUPREP Bowel Prep Kit into the mixing container provided. Fill the container with water to the 16 oz fill line, and drink the entire amount.
Drink two additional containers filled to the 16 oz line with water over the next hour.

Day of colonoscopy:

Have only clear liquids until after the colonoscopy. Avoid red and purple liquids, milk, and alcoholic beverages.
The morning of colonoscopy (10 to 12 hours after the evening dose): pour the contents of the second bottle of SUPREP Bowel Prep Kit into the mixing container provided. Fill the container with water to the 16 oz fill line, and drink the entire amount.
Drink two additional containers filled to the 16 oz line with water over the next hour.
Complete all SUPREP Bowel Prep Kit and required water at least one hour prior to colonoscopy.

How supplied

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.

Reference

Package Insert data:

Reference(s)

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.