Suprep bowel prep kit

What is Suprep bowel prep kit?

• SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate, magnesium sulfate solution, concentrate) is an osmotic laxative used for cleansing of the colon in preparation for colonoscopy.

What are the uses of this medicine?

• SUPREP Bowel Prep Kit is a prescription medicine used by adults and children 12 years of age and older to clean the colon before a colonoscopy.
• SUPREP Bowel Prep Kit cleans your colon by causing you to have diarrhea.
• Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.

How does this medicine work?

• Sulfate salts provide sulfate anions, which are poorly absorbed.
• The osmotic effect of unabsorbed sulfate anions and the associated cations causes water to be retained within the gastrointestinal tract.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a blockage in your intestine (bowel obstruction)
• an opening in the wall of your stomach or intestine (bowel perforation)
• a very dilated intestine (toxic megacolon)
• problems with the emptying of food and fluid from your stomach (gastric retention)
• an allergy to any of the ingredients in SUPREP Bowel Prep Kit.

What drug interactions can this medicine cause?

• Use caution when prescribing SUPREP Bowel Prep Kit to patients taking medications that increase the risk of fluid and electrolyte disturbances.
• Administer oral medications at least one hour before starting each dose of SUPREP Bowel Prep Kit.
• Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of SUPREP Bowel Prep Kit to avoid chelation with magnesium.
• Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking SUPRPEP Bowel Prep Kit.

Is this medicine FDA approved?

• Initial U.S. Approval: 08/2010

How should this medicine be used?

Recommended dosage:

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

Recommended SUPREP Bowel Prep Kit dosage is:

• Adults: Two 6-ounce doses.
• Pediatric Patients 12 Years of Age and Older: Two 4.5-ounce doses.

Administration:

• Take SUPREP Bowel Prep Kit exactly as your healthcare provider tells you to take it.
• Each bottle of SUPREP Bowel Prep Kit must be mixed with water (diluted) before drinking.
• It is important for you to drink the additional prescribed amount of water listed in the Instructions for Use to prevent fluid loss(dehydration).
• One bottle of SUPREP Bowel Prep Kit is equal to one dose.
• Two doses of SUPREP Bowel Prep Kit are required for complete colonoscopy preparation.
• All people taking SUPREP Bowel Prep Kit should follow these general instructions starting 1 day before your colonoscopy:
• eat only a light breakfast or clear liquids (for example: water, strained fruit juice without pulp, lemonade, plain coffee or tea, chicken broth, gelatin dessert without fruit) on the day before your procedure.
• only drink clear liquids the rest of the day and the next day until 2 hours before your colonoscopy. Stop drinking all fluids at least 2 hours before your colonoscopy.
• after taking SUPREP Bowel Prep Kit if you have any bloating or feeling like your stomach is upset, wait to take your second dose until your stomach feels better.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As SUPREP Bowel Prep Kit (for adults)
• SUPREP Bowel Prep Kit (for pediatric patients 12 years of age and older)

This medicine is available in fallowing brand namesː

• SUPREP

What side effects can this medication cause?

The most common side effects of this medicine include: The most common side effects of SUPREP Bowel Prep Kit in adults include:

• overall discomfort
• stomach bloating
• stomach pain
• nausea
• vomiting

The most common side effects of SUPREP Bowel Prep Kit in children 12 to 16 years of age include:

• nausea
• stomach pain
• stomach bloating
• vomiting

SUPREP Bowel Prep Kit can cause serious side effects, including:

• dehydration
• abnormal heartbeats that can cause death
• seizures
• kidney problems

What special precautions should I follow?

• 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). 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. Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after each use.
• There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Consider pre-dose and post-colonoscopy ECGs in patients at increased risk.
• There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold.
• Use SUPREP Bowel Prep Kit with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). Use caution, ensure adequate hydration and consider laboratory testing.
• Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization.
• If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering SUPREP Bowel Prep Kit. Use with caution in patients with severe active ulcerative colitis.
• Patients with impaired gag reflex or other swallowing abnormalities are at risk for regurgitation or aspiration of SUPREP Bowel Prep Kit solution. Use with caution in these patients.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• electrolyte disturbances
• dehydration
• hypovolemia

Management of overdosage:

• Monitor for fluid and electrolyte disturbances and treat symptomatically.

Can this medicine be used in pregnancy?

• There are no available data on SUPREP Bowel Prep Kit use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of SUPREP Bowel Prep Kit (two 4.5-ounce doses) have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 12 years of age and older.
• The safety and effectiveness of SUPREP Bowel Prep Kit in pediatric patients less than 12 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredients: sodium sulfate, potassium sulfate and magnesium sulfate.
• Inactive ingredients: citric acid, USP, flavoring ingredients, malic acid, FCC, sodium benzoate, NF, sucralose, purified water, USP.

Who manufactures and distributes this medicine?

• Distributed by Braintree Laboratories, Inc.

60 Columbian Street West Braintree, USA

What should I know about storage and disposal of this medication?

• Store SUPREP Bowel Prep Kit at room temperature, between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Suprep bowel prep kit
• FDA Suprep bowel prep kit

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