SUPREP Bowel Prep Kit - Prescribing Information Highlights - Colonoscopy Bowel Cleansing

Sep 27, 2026

Uploaded by Margaret

SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) is an osmotic laxative indicated for cleansing the colon prior to colonoscopy in adults. The highlights cover split-dose (two-day) preparation with dilution requirements, timing of diluted solution and additional water, and the total liquid volume needed. Contraindications include GI obstruction, perforation, gastric retention, ileus, toxic colitis/megacolon, and known component allergies. Warnings address fluid and electrolyte abnormalities, seizure and arrhythmia risk, renal impairment, aspiration risk, and the need not for direct ingestion.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages11

Reading Time28 min

AccessFree to download

INDICATIONS AND USAGE

DOSAGE AND ADMINISTRATION

Split-Dose (Two-Day) Regimen

DOSAGE FORMS AND STRENGTHS

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

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 ----------------------------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 • Evening before colonoscopy: dilute 1 bottle to 16 oz with water and drink entire amount. • Drink 32 oz water over the next hour. • Next morning: repeat both steps using the second bottle. • Complete preparation at least 1 hour before colonoscopy. ---------------------DOSAGE FORMS AND STRENGTHS---------------------- • Two 6 oz bottles of oral solution (3) -------------------------------CONTRAINDICATIONS------------------------------ • Gastrointestinal obstruction (4, 5.6) • Bowel perforation (4, 5.6) • Gastric retention (4) • Ileus (4) • Toxic colitis or toxic megacolon (4) • Known allergies to components of the kit (4, 11) -----------------------WARNINGS AND PRECAUTIONS------------------------ • 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) • Patients with renal insufficiency– use caution, ensure adequate hydration and consider testing (5.4) • Suspected GI obstruction or perforation – rule out the diagnosis before administration (4, 5.6) • Patients at risk for aspiration – observe during administration (5.7) • 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](www.fda.gov/medwatch). ------------------------------DRUG INTERACTIONS------------------------------- • Some drugs increase risks due to fluid and electrolyte changes (7.1) • 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 08/2010 | FULL PRESCRIBING INFORMATION: CONTENTS* | | 8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers | | --- | --- | --- | | 1 | INDICATIONS AND USAGE | | | 2 | DOSAGE AND ADMINISTRATION | 8.4 Pediatric Use | | 3 | DOSAGE FORMS AND STRENGTHS | 8.5 Geriatric Use | | 4 | CONTRAINDICATIONS | 11 DESCRIPTION | | 5 | WARNINGS AND PRECAUTIONS | 12 CLINICAL PHARMACOLOGY | | 6 | 5.1 Patients at Risk for Serious Fluid and Electrolyte Abnormalities 5.2 Risk of Seizures
5.3 Risk of Cardiac Arrhythmias
5.4 Risk of Renal Impairment
5.5 Risk of Colonic Mucosal Aphthous Ulcerations
5.6 Use in Patients with Significant Gastrointestinal Disease
5.7 Patients at Risk for Aspiration
5.8 Not for Direct Ingestion
ADVERSE REACTIONS | 12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION | | 7 | 6.1 Clinical Studies Experience
DRUG INTERACTIONS
7.1 Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities
7.2 Potential for Altered Dru

FAQs

What is SUPREP Bowel Prep Kit used for?

SUPREP Bowel Prep Kit is indicated for cleansing of the colon in preparation for colonoscopy in adults.

How should SUPREP be taken before colonoscopy?

Use a split-dose (two-day) oral regimen: dilute each bottle before use, drink the required diluted amount, drink additional water containers, and complete all required liquid at least 1 hour before colonoscopy.

What conditions mean a person should not use SUPREP?

Do not use it with gastrointestinal obstruction, bowel perforation, gastric retention, ileus, toxic colitis or toxic megacolon, or known allergies to kit components.

Sep 27, 2026

Uploaded by Margaret