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 ...
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
RECENT MAJOR CHANGES
Dosage and Administration 11/2012
INDICATIONS AND USAGE
SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults (1)
DOSAGE AND ADMINISTRATION
Dilute the solution prior to use. See FULL PRESCRIBING INFORMATION for complete dosing and administration instructions (2)
Split Dose (2-Day) Regimen
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Evening before colonoscopy: dilute one bottle with water to a total volume of 16 ounces (up to the fill line) and drink the entire amount.
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Drink 32 ounces of water over the next hour.
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Next morning: repeat both steps using the second bottle.
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Complete preparation at least 2 hours before colonoscopy or as directed by physician.
DOSAGE FORMS AND STRENGTHS
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Two 6 ounce bottles of oral solution, each containing sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, and magnesium sulfate 1.6 grams. (3)
CONTRAINDICATIONS
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Gastrointestinal obstruction (4, 5.6)
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Bowel perforation (4, 5.6)
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Gastric retention (4)
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Ileus (4)
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Toxic colitis or toxic megacolon (4)
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Known allergies to components of the kit (4, 11)
WARNINGS AND PRECAUTIONS
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Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment – assess concurrent medications and consider testing in some patients (5.1, 5.2, 5.3)
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Patients with renal insufficiency – use caution, ensure adequate hydration and consider testing (5.4)
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Suspected GI obstruction or perforation – rule out the diagnosis before administration (4, 5.6)
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Patients at risk for aspiration – observe during administration (5.7)
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Not for direct ingestion – dilute and take with additional water (5.8)
ADVERSE REACTIONS
Most common adverse reactions (≥3%) are: overall discomfort, abdominal fullness, nausea, abdominal cramping, and vomiting (6)
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.
DRUG INTERACTIONS
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Some drugs increase risks due to fluid and electrolyte changes (7.1)
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Oral medication taken within 1 hour of start of each dose might not be absorbed properly (7.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 11/2012
FULL PRESCRIBING INFORMATION: CONTENTS*
Table of Contents
1 INDICATIONS AND USAGE
SUPREP Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults.
SUPREP Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults.
2 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 ...
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 ounces 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:
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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.
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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 ounce fill line, and drink the entire amount.
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Drink two additional containers filled to the 16 ounce line with water over the next hour.
Day of colonoscopy:
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Have only clear liquids until after the colonoscopy. Avoid red and purple liquids, milk, and alcoholic beverages.
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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 ounce fill line, and drink the entire amount.
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Drink two additional containers filled to the 16 ounce line with water over the next hour.
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Complete all SUPREP Bowel Prep Kit and required water at least two hours prior to colonoscopy or as directed by physician.
3 DOSAGE FORMS AND STRENGTHS
Two 6 ounce bottles of oral solution. Each 6 ounce bottle contains: sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams.
Two 6 ounce bottles of oral solution.
Each 6 ounce bottle contains: sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams.
4 CONTRAINDICATIONS
Gastrointestinal obstruction Bowel perforation Gastric retention Ileus Toxic colitis or toxic megacolon Known allergies to components of the kit [see ...
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Gastrointestinal obstruction
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Bowel perforation
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Gastric retention
-
Ileus
-
Toxic colitis or toxic megacolon
-
Known allergies to components of the kit [see Description (11)]
5 WARNINGS AND PRECAUTIONS
5.1 Serious Fluid and Serum Chemistry Abnormalities Advise all patients to hydrate adequately before, during, and after the use of SUPREP Bowel Prep Kit. I
