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INDICATION

SUPREP^® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 12 years of age and older.

CONTRAINDICATIONS

Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any ingredients in SUPREP Bowel Prep Kit.

DOSAGE AND ADMINISTRATION

Each bottle must be diluted with water to a final volume of 16 ounces (Adults) and 12 ounces (Pediatric patients 12 years of age and older). Must consume additional water after each dose. Stop consumption of all fluids at least 2 hours prior to the colonoscopy.

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; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Patients with renal impairment or taking medications that affect renal functions: Use caution, ensure adequate hydration and consider laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration; Patients at risk for aspiration: Observe during administration.

ADVERSE REACTIONS

Most common adverse reactions: Adults: (> 2%) are overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting; Pediatric Patients (>10%) are nausea, abdominal pain, abdominal bloating and vomiting.

DRUG INTERACTIONS

Drugs that may increase the risk of fluid and electrolyte abnormalities.