Magnesium sulfate, Potassium sulfate and Sodium sulfate

Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult Patient. "Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREPBOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information." Sodium sulfate, Potassium sulfate and Magnesium sulfate oral solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult.

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.

Preparation and Administration. • Must dilute in water prior to ingestion. • Administration of two bottles of Sodium sulfate, Potassium sulfate and Magnesium sulfate oral solution is required for a complete preparation for colonoscopy. One bottle is equivalent to one dose. • Must consume additional water after each dose. • Stop consumption of all fluids at least 2 hours before the colonoscopy. Recommended Dosage and Administration • Split-Dose (two-day) regimen consists of two doses of Sodium sulfate, potassium sulfate and magnesium sulfate oral solution first dose during the evening prior to colonoscopy and second dose the next day, during the morning of colonoscopy. • Recommended Sodium sulfate, potassium sulfate and magnesium sulfate oral solution dosage is: o Adults: Two 6-ounce doses.

Sodium sulfate, Potassium sulfate and Magnesium sulfate oral solution is contraindicated in the following conditions: • Gastrointestinal obstruction or ileus • Bowel perforation • Toxic colitis or toxic megacolon • Gastric retention • Hypersensitivity to any of the ingredients in sodium sulfate, potassium sulfate and magnesium sulfate oral solution • Gastrointestinal obstruction or ileus. • Bowel perforation. • Toxic colitis or toxic megacolon. • Gastric retention. • Hypersensitivity to any ingredient

• 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 concomitant medications that affect renal function: 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. • Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur.

The following important adverse reactions for bowel preparations are described elsewhere in the labeling: • Serious Fluid and Serum Chemistry Abnormalities • Cardiac Arrhythmias • Seizures • Use in Patients with Risk of Renal Injury • Colonic Mucosal Ulceration and Ischemic Colitis • Patients with Significant Gastrointestinal Disease • Aspiration • Hypersensitivity Reactions Most common adverse reactions are: • Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting.

Drugs that increase risk of fluid and electrolyte imbalance. Drugs That May Increase Risk of Fluid and Electrolyte Abnormalities Use caution when prescribing sodium sulfate, potassium sulfate and magnesium sulfate oral solution to patients taking medications that increase the risk of 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.

Store at 20° to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). "Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREPBOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution.