SUPREP Bowel Prep

SUPREP BOWEL PREP- sodium sulfate, potassium sulfate and magnesium sulfate, unspecified form solution, concentrate
Braintree Laboratories, Inc.

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage and Adminstration Overview

Administration of two bottles of SUPREP Bowel Prep Kit and additional water is required for a complete preparation for colonoscopy. One bottle of SUPREP Bowel Prep Kit is equivalent to one dose. SUPREP Bowel Prep Kit is supplied in two dosage strengths [see Dosage Forms and Strengths ( 3)] . The recommended dosage is:

Adults: Two 6-ounce doses [see Dosage and Administration ( 2.3)] .
Pediatric patients 12 years of age and older: Two 4.5-ounce doses [see Dosage and Administration ( 2.4)] .

2.2 Important Preparation and Administration Instructions

  • Correct fluid and electrolyte abnormalities before treatment with SUPREP Bowel Prep Kit [see Warnings and Precautions ( 5.1)]
  • Must dilute SUPREP Bowel Prep Kit in water before ingestion.
  • Must consume additional water after each dose of SUPREP Bowel Prep Kit.
  • On the day before colonoscopy, consume only a light breakfast or clear liquids (e.g., water, strained fruit juice without pulp, lemonade, plain coffee or tea, chicken broth, gelatin dessert without fruit). On the day of the colonoscopy only consume clear liquids up to two hours prior to colonoscopy.
  • Do not eat solid food or drink milk or eat or drink anything colored red or purple.
  • Do not drink alcohol.
  • Do not take other laxatives while taking SUPREP Bowel Prep Kit.
  • Do not take oral medications within one hour of starting each dose of SUPREP Bowel Prep Kit.
  • If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of SUPREP Bowel Kit [see Drug Interactions ( 7.2)] .
  • Stop consumption of all fluids at least 2 hours prior to the colonoscopy.

2.3 Recommended Dosage and Administration for Adults

The recommended Split-Dose (two-day) regimen for adults consists of two 6-ounce doses of SUPREP Bowel Prep Kit: the first dose during the evening prior to colonoscopy and the second dose the next day, during the morning of the colonoscopy.

Each dose consists of one bottle of SUPREP Bowel Prep Kit with additional water. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts. The following are recommended dosage and administration instructions for adults:

Dose 1 – On the Day Prior to Colonoscopy:

  • May consume a light breakfast, or only clear liquids (no solid food).
  • In the evening before the procedure, pour the contents of one bottle of SUPREP Bowel Prep Kit into the mixing container provided.
  • Add cool drinking water to the 16-ounce fill line on the container, mix, and drink the entire amount.
  • Drink two additional containers filled with water to the 16-ounce fill line over the next hour.

Dose 2 — Day of Colonoscopy:

  • Continue to consume only clear liquids.
  • In the morning (10 to 12 hours after the evening dose) on the day of the procedure, pour the contents of the second bottle of SUPREP Bowel Prep Kit into the mixing container provided.
  • Add cool drinking water to the 16-ounce fill line on the container, mix, and drink the entire amount.
  • Drink two additional containers filled with water to the 16-ounce fill line over the next hour.
  • Complete all solution of SUPREP Bowel Prep Kit and required water at least two hours prior to colonoscopy.

2.4 Recommended Dosage and Administration for Pediatric Patients 12 Years of Age and Older

The recommended Split-Dose (two-day) regimen for pediatric patients 12 years of age and older consists of two 4.5-ounce doses of SUPREP Bowel Prep Kit: the first dose during the evening prior to colonoscopy and the second dose the next day, during the morning of the colonoscopy.

Each dose consists of one bottle of SUPREP Bowel Prep Kit with additional water. The total volume of liquid required for colon cleansing (using two bottles) is 2.25 quarts. The following are recommended dosage and administration instructions for pediatric patients 12 years of age and older and/or their caregivers:

Dose 1 – On the Day Prior to Colonoscopy:

• May consume a light breakfast, or only clear liquids (no solid food).
• In the evening before the procedure, pour the contents of one bottle of SUPREP Bowel Prep Kit into the mixing container provided.
• Add cool drinking water to the 12-ounce fill line on the container, mix, and drink the entire amount.
• Drink two additional containers filled with water to the 12-ounce fill line over the next hour.

Dose 2 – Day of Colonoscopy:

• Continue to consume only clear liquids.
• In the morning (10 to 12 hours after the evening dose) on the day of the procedure, pour the contents of the second bottle of SUPREP Bowel Prep Kit into the mixing container provided.
• Add cool drinking water to the 12-ounce fill line on the container, mix, and drink the entire amount.
• Drink two additional containers filled with water to the 12-ounce fill line over the next hour. • Complete all solution of SUPREP Bowel Prep Kit solution and required water at least two hours prior to colonoscopy.

3 DOSAGE FORMS AND STRENGTHS

  • SUPREP Bowel Prep Kit (for adults): Two bottles each containing 6 ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate as a clear to slightly hazy liquid.
  • SUPREP Bowel Prep Kit (for pediatric patients 12 years of age and older): Two bottles each containing 4.5 ounces of an oral solution of 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate as a clear to slightly hazy liquid.

When diluted as directed, the solution is clear and colorless.

4 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

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. 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. Correct fluid and electrolyte abnormalities before treatment with SUPREP Bowel Prep Kit. Use SUPREP Bowel Prep Kit with caution in 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 renal impairment [see Drug Interactions ( 7.1)] .

SUPREP Bowel Prep Kit can cause temporary elevations in uric acid [see Adverse Reactions ( 6.1)] . Uric acid fluctuations in patients with gout may precipitate an acute flare. The potential for uric acid elevation should be considered before administering SUPREP Bowel Prep Kit to patients with gout or other disorders of uric acid metabolism.

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