Sodium Sulfate Anhydrous, Potassium Sulfate, And Magnesium Sulfate

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 , 5.6 ) Patients at risk for aspiration: Observe during administration. ( 5.7 ) Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. (5.8) 5.1 Serious Fluid and Serum Chemistry Abnormalities Advise all patients to hydrate adequately before, during, and after the use of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. If a patient develops significant vomiting or signs of dehydration after taking sodium sulfate, potassium sulfate, and magnesium sulfate oral solution 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 sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. Use sodium sulfate, potassium sulfate, and magnesium sulfate oral solution 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) ] . Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution 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 sodium sulfate, potassium sulfate, and magnesium sulfate oral solution to patients with gout or other disorders of uric acid metabolism. 5.2 Cardiac Arrhythmias There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing sodium sulfate, potassium sulfate, and magnesium sulfate oral solution for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. 5.3 Seizures 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. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Use caution when prescribing sodium sulfate, potassium sulfate, and magnesium sulfate oral solution for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see Drug Interactions (7.1) ] . 5.4 Use in Patients with Risk of Renal Injury Use sodium sulfate, potassium sulfate, and magnesium sulfate oral solution 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) [see Drug Interactions (7.1) ] . These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration with sodium sulfate, potassium sulfate, and magnesium sulfate oral solution and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Use in Specific Populations (8.6) ] . 5.5 Colonic Mucosal Ulcerations and Ischemic Colitis Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and sodium sulfate, potassium sulfate, and magnesium sulfate oral solution may increase these risks [see Drug Interactions (7.3) ] . Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD). 5.6 Use in Patients with Significant Gastrointestinal Disease If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering sodium sulfate, potassium sulfate, and magnesium sulfate oral solution [see Contraindications (4) ] . Use with caution in patients with severe active ulcerative colitis. 5.7 Aspiration Patients with impaired gag reflex or other swallowing abnormalities are at risk for regurgitation or aspiration of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. Observe these patients during administration of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. Use with caution in these patients. 5.8 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, angioedema, dyspnea, rash, pruritus and urticaria have been reported with sodium sulfate, potassium sulfate, and magnesium sulfate oral solution [see Adverse Reactions (6.2)] . Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.