FDA

Suprep Bowel Prep Kit

Approved 5 Aug 2010OralSolution

Indications

SUPREP Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult and pediatric patients 12 years of age and older. ( 1 )

Contraindications

SUPREP Bowel Prep Kit is contraindicated in the following conditions: Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6 )] Bowel perforation [see Warnings and Precaution ( 5.6 )] Toxic colitis or toxic megacolon Gastric retention Hypersensitivity to any of the ingredients in SUPREP Bowel Prep Kit [see Warnings and Precautions ( 5.8 ) and Description ( 11 )] Gastrointestinal obstruction or ileus ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Hypersensitivity to any ingredient ( 4 , 5.8 )

Warnings and precautions

Risk of fluid and electrolyte abnormalities : Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after each use. ( 5.1 , 7.1 ) Cardiac arrhythmias : Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. ( 5.2 ) Seizures : Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold.

( 5.3 , 7.1 ) Patients with renal impairment or taking concomitant medications that affect renal function : Use caution, ensure adequate hydration and consider laboratory testing. ( 5.4 , 7.1 ) Suspected GI obstruction or perforation : Rule out the diagnosis before administration. ( 4 , 5.6 ) Patients at risk for aspiration : Observe during administration. ( 5.7 ) Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur.

( 5.8 )

5.1Serious Fluid and Serum Chemistry Abnormalities

Advise all patients to hydrate adequately before, during, and after the use of SUPREP Bowel Prep Kit. If a patient develops significant vomiting or signs of dehydration after taking SUPREP Bowel Prep Kit, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment.

At a glance

Brand name: Suprep Bowel Prep Kit
Active substance: magnesium sulfate
Route: Oral
Dosage form: Solution
Applicant: Azurity
Status: Prescription
FDA approval: 5 Aug 2010
Application: NDA022372-001

Indications

Contraindications

Warnings and precautions

( 5.8 )

5.1Serious Fluid and Serum Chemistry Abnormalities

Adverse reactions

Most common adverse reactions are: Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting. ( 6.1 ) Pediatric Patients (>10%): nausea, abdominal pain, abdominal bloating and vomiting. ( 6.1 ) 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 . The following important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Serum Chemistry Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] Use in Patients with Risk of Renal Injury [see Warnings and Precautions ( 5.4 )] Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions ( 5.5 )] Patients with Significant Gastrointestinal Disease [see Warnings and Precautions ( 5.6 )] Aspiration [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )]

6.1Clinical Trials 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. Adults The safety of SUPREP Bowel Prep Kit was evaluated in a multi-center, randomized, active controlled trial in 379 adult patients undergoing colonoscopy [see Clinical Studies ( 14 )] .

Most Common Adverse Reactions Table 1 shows the most common adverse reactions reported in at least 2% of patients receiving SUPREP Bowel Prep Kit or the control (a bowel prep containing polyethylene glycol and electrolytes (PEG + E)) administered in split-dose (2-day) regimens. Table 1: Common Adverse Reactions* in Adult Patients Undergoing Colonoscopy in a Randomized, Active Controlled Trial Symptom Split-Dose (2-Day) Regimen SUPREP Bowel Prep Kit % 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 * reported in at least 2% of patients Laboratory Abnormalities Table 2 shows the most common laboratory abnormalities (at least 10% in either treatment group and more than 2% difference between groups) for 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: Adult Patients with Normal Baseline Serum Chemistry with A Shift to an Abnormal Value While on the Split-Dose (2-Day) Regimen 1 Day of Colonoscopy N (%) 2 Day 30 N (%) 2 Bicarbonate (low) SUPREP 20 (13) 7 (4) PEG + Electrolytes 24 (15) 4 (3) Bilirubin, total (high) SUPREP 14 (9) 0 (0) PEG + Electrolytes 20 (12) 3 (2) BUN (high) SUPREP 2 (2) 14 (11) PEG + Electrolytes 4 (3) 19 (15) Calcium (high) SUPREP 16 (10) 8 (5) PEG + Electrolytes 6 (4) 6 (4) Chloride (high) SUPREP 4 (2) 6 (4) PEG + Electrolytes 20 (12) 6 (4) Osmolality (high) SUPREP 8 (6) NA PEG + Electrolytes 19 (13) NA Uric acid (high) SUPREP 27 (24) 13 (12) PEG + Electrolytes 12 (10) 20 (17) 1 The study was not designed to support comparative claims for the laboratory abnormalities reported in this table. 2 Percent (n/N) of patients where N=number of patients with normal baseline who had abnormal values at the timepoint(s) of interest.

Less Common Adverse Reactions AV Block (1 case) and CK increase. Adverse Reactions with Unapproved Use In another study of 408 adult patients, higher rates of the following adverse reactions and laboratory abnormalities were reported in patients treated with SUPREP Bowel Prep Kit as an evening-only (1-day) regimen compared to the split-dose (2-day) regimen. overall discomfort, abdominal distention, nausea, and vomiting total bilirubin (high), BUN (high), creatinine (high), osmolality (high), potassium (high) and uric acid (high) Administration of SUPREP Bowel Prep Kit in an evening-only (1-day) dosing regimen is not recommended.

Pediatrics 12 Years to 16 Years of Age The safety of SUPREP Bowel Prep Kit was evaluated in a single dose-ranging clinical trial of 89 pediatric patients aged 12 years to 16 years [see Clinical Studies ( 14 )] . In 26 pediatric patients who received SUPREP Bowel Prep Kit (two 4.5-ounce doses), the most common adverse reactions (> 10%) were nausea, abdominal pain, abdominal bloating, and vomiting.

6.2Postmarketing Experience

The following adverse reactions have been identified during post-approval use of SUPREP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity: anaphylaxis, angioedema, dyspnea, rash, pruritus, urticaria [see Warning and Precautions ( 5.8 )]

Suprep Bowel Prep Kit

Indications

Contraindications

Warnings and precautions

5.1Serious Fluid and Serum Chemistry Abnormalities

At a glance

Two medicines in one question?

Suprep Bowel Prep Kit

Indications

Contraindications

Warnings and precautions

5.1Serious Fluid and Serum Chemistry Abnormalities

At a glance

Two medicines in one question?

5.2Cardiac Arrhythmias

5.3Seizures

5.4Use in Patients with Risk of Renal Injury Use

5.5Colonic Mucosal Ulcerations and Ischemic Colitis

5.6Use in Patients with Significant Gastrointestinal Disease

5.7Aspiration Patients

5.8Hypersensitivity Reactions

Interactions

7.1Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities

7.2Potential for Reduced Drug Absorption

7.3Stimulant Laxatives

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information