Data from FDA - Curated by Marshall Pearce - Last updated 12 November 2017

Indication(s)

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 an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS Gastrointestinal obstruction Bowel perforation Gastric retention Ileus Toxic colitis or toxic megacolon Known allergies to components of the kit [see Description (11)] 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)
Adverse reactions
6 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 . 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. In a multicenter, controlled clinical trial comparing SUPREP Bowel Prep Kit with a bowel prep containing polyethylene glycol and electrolytes (PEG + E) that were administered in a split-dose (2-day) regimen, the most common adverse reactions after administration of SUPREP Bowel Prep Kit were overall discomfort, abdominal distention, abdominal pain, nausea, vomiting, and headache; see Table 1, below. Less common Adverse Reactions occurring were AV Block (1 case) and CK increase. In this study, patients receiving SUPREP Bowel Prep Kit were limited to a light breakfast followed by clear liquids; patients receiving the PEG + E bowel prep were allowed to have a normal breakfast and a light lunch, followed by clear liquids. Table 1: Treatment-Emergent Adverse Reactions Observed in at Least 2% of Patients on the Split-Dose (2-Day) Regimen Symptom Split-Dose (2-Day) Regimen SUPREP N=190 PEG + E product N=189 Overall Discomfort 54% 67% Abdominal Distension 40% 52% Abdominal Pain 36% 43% Nausea 36% 33% Vomiting 8% 4% Headache 1.1% 0.5% Table 2 shows the percentages of patients who developed new abnormalities of important electrolytes and uric acid after completing the bowel preparation with either SUPREP Bowel Prep Kit or PEG+E administered as a split-dose (2-day) regimen. Table 2: Patients with Normal Baseline Serum Chemistry with A Shift to an Abnormal Value While on the Split-Dose (2-Day) Regimen *Percent (n/N) of patients where N=number of patients with normal baseline who had abnormal values at the timepoint(s) of interest. †Patients with normal bicarbonate at baseline who developed low bicarbonate (≤ 21 mEq/L) and high anion gap (≥ 13 mEq/L) on Day of Colonoscopy or Day 30. Day of Colonoscopy n (%)* Day 30 n (%)* Anion gap (high) † SUPREP 14 (8.9) 3 (1.9) PEG + Electrolytes 12 (7.6) 2 (1.4) Bicarbonate (low) SUPREP 20 (12.7) 7 (4.4) PEG + Electrolytes 24 (15.2) 4 (2.7) Bilirubin, total (high) SUPREP 14 (8.5) 0 (0) PEG + Electrolytes 20 (11.7) 3 (1.9) BUN (high) SUPREP 2 (1.6) 14 (11.2) PEG + Electrolytes 4 (2.9) 19 (14.5) Calcium (high) SUPREP 16 (10.4) 8 (5.2) PEG + Electrolytes 6 (3.7) 6 (3.9) Chloride (high) SUPREP 4 (2.4) 6 (3.7) PEG + Electrolytes 20 (12.2) 6 (3.8) Creatinine (high) SUPREP 3 (1.9) 5 (3.2) PEG + Electrolytes 2 (1.2) 8 (5.2) Osmolality (high) SUPREP 8 (5.8) NA PEG + Electrolytes 19 (12.9) NA Osmolality (low) SUPREP 3 (2.2) NA PEG + Electrolytes 2 (1.4) NA Potassium (high) SUPREP 3 (1.8) 6 (3.7) PEG + Electrolytes 5 (2.9) 8 (4.9) Sodium (low) SUPREP 5 (3.1) 1 (0.6) PEG + Electrolytes 4 (2.3) 2 (1.2) Uric acid (high) SUPREP 27 (23.5) 13 (11.5) PEG + Electrolytes 12 (9.5) 20 (16.7) There were also 408 patients who participated in a study in which either SUPREP Bowel Prep Kit or PEG+E were administered in an evening-only (1-day) regimen. Higher rates of overall discomfort, abdominal distention, and nausea were observed with the evening-only (1-day) regimen compared to the split-dose (2-day) regimen for both preparations. Patients treated with SUPREP Bowel Prep Kit had increased rates of vomiting with the evening-only (1-day) regimen. An evening-only (1-day) dosing regimen was associated with higher rates of abnormal values for some electrolytes when compared to the split-dose (2-day) regimen for both preparations. For SUPREP Bowel Prep Kit, the evening-only (1-day) regimen was associated with higher rates of total bilirubin (high), BUN (high), creatinine (high), osmolality (high), potassium (high) and uric acid (high) than the SUPREP Bowel Prep Kit split-dose (2day) regimen. Administration of SUPREP Bowel Prep Kit in an evening-only (1-day) dosing regimen is not recommended.

Usage information

Dosing and administration
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 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: 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 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce 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 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Complete all SUPREP Bowel Prep Kit and required water at least two hours prior to colonoscopy or as directed by physician. 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 one bottle with water to a total volume of 16 ounces (up to the fill line) and drink the entire amount. Drink 32 ounces of water over the next hour. Next morning: repeat both steps using the second bottle. Complete preparation at least 2 hours before colonoscopy or as directed by physician.
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with SUPREP Bowel Prep Kit. It is also not known whether SUPREP Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SUPREP Bowel Prep Kit should be given to a pregnant woman only if clearly needed. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SUPREP Bowel Prep Kit is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Of the 375 patients who received SUPREP Bowel Prep Kit in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of SUPREP Bowel Prep Kit administered as a split-dose (2-day) regimen were observed between geriatric patients and younger patients. Geriatric patients reported more vomiting when SUPREP Bowel Prep Kit was given as a one-day preparation.
Pregnancy and lactation
8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SUPREP Bowel Prep Kit is administered to a nursing woman.

Interactions

7 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) 7.1 Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities Use caution when prescribing SUPREP Bowel Prep Kit for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [see Warnings (5)] in patients taking these concomitant medications. 7.2 Potential for Altered Drug Absorption Oral medication administered within one hour of the start of each SUPREP Bowel Prep Kit dose may be flushed from the gastrointestinal tract, and the medication may not be absorbed properly.

More information

Category Value
Authorisation number NDA022372
Agency product number 1K573LC5TV
Orphan designation No
Product NDC 52268-012
Date Last Revised 30-01-2017
Type HUMAN PRESCRIPTION DRUG
Storage and handling Storage: Store at 20° to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). See USP controlled room temperature. Keep out of reach of children. SUPREP Bowel Prep Kit NDC 52268-012-01
Marketing authorisation holder Braintree Laboratories, Inc.