Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate

1 INDICATIONS AND USAGE Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult patients. Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL 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 patients. ( 1 )

6 ADVERSE REACTIONS 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) ] Most common adverse reactions are: • Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting.

8.1 Pregnancy Risk Summary There are no available data on sodium sulfate, potassium sulfate and magnesium sulfate oral solution use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproductive studies have not been conducted with sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

5 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 CONTRAINDICATIONS Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 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 sodium sulfate, potassiu...