FDA label 9985d915-fd7d-3df2-e053-2995a90a4e25

5 WARNIGNS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment– assess concurrent medications and consider testing in some patients. ( 5.1 , 5.2 , 5.3 ) Patients with renal insufficiency – use caution, ensure adequate hydration and consider testing. ( 5.4 ) Suspected GI obstruction or perforation – rule out the diagnosis before administration. ( 4 , 5.6 ) Patients at risk for aspiration – observe during administration. ( 5.7 ) 5.1 Serious Fluid and Serum Chemistry Abnormalities Advise all patients to hydrate adequately before, during, and after the use of ColPrep Kit. If a patient develops significant vomiting or signs of dehydration after taking ColPrep Kit, 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. Patients with electrolyte abnormalities should have them corrected before treatment with ColPrep Kit. In addition, use caution when prescribing ColPrep Kit for 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) ] ColPrep Kit 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 ColPrep Kit 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 ColPrep Kit 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). Pre-dose and post-colonoscopy ECGs should be considered 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 ColPrep Kit 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. 5.4 Renal Impairment Use caution when prescribing ColPrep Kit for 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). Advise these patients of the importance of adequate hydration, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients. 5.5 Colonic Mucosal Ulcerations and Ischemic Colitis Administration of 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 ColPrep Kit may increase these risks. The potential for mucosal ulcerations resulting from the bowel preparation should be considered 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 ColPrep Kit. Use with caution in patients with severe active ulcerative colitis. 5.7 Aspiration Use with caution in patients with impaired gag reflex and patients prone to regurgitation or aspiration. Such patients should be observed during administration of ColPrep Kit. 5.8 Not for Direct Ingestion Each bottle must be reconstituted followed by dilution with water to a final volume of 16 ounces and ingestion of 32 ounces of additional water as recommended is important to patient tolerance. Direct ingestion of the undiluted solution may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.

6 ADVERSE REACTIONS Most common adverse reactions (≥3%) are: overall discomfort, abdominal fullness, nausea, abdominal cramping, and vomiting. To report SUSPECTED ADVERSE REACTIONS, contact KVK-Tech, Inc. at 1-215-579-1842 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. The safety of ColPrep Kit has been established from adequate and well-controlled trials of another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) [See Clinical Studies (14) ] . Below is a display of the adverse reactions of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) in these adequate and well-controlled studies. In a multicenter, controlled clinical trial comparing another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) with a bowel prep containing polyethylene glycol and electrolytes (PEG + E) that were administered in a split-dose (2-day) regimen, the most common adverse reactions after administration of another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) were overall discomfort, abdominal distention, abdominal pain, nausea, vomiting, and headache; See Table 1, below. Less common adverse reactions occurring were atrioventricular (AV) block (1 case) and creatine kinase (CK) increase. In this study, patients receiving another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) were limited to a light breakfast followed by clear liquids; patients receiving the PEG + E bowel prep were allowed to have a normal breakfast and a light lunch, followed by clear liquids. Table 2 shows the percentages of patients who developed new abnormalities of important electrolytes and uric acid after completing the bowel preparation with either another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g)or PEG+E administered as a split-dose (2-day) regimen. There were also 408 patients who participated in a study in which another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) or PEG+E were administered in an evening-only (1-day) regimen. Higher rates of overall discomfort, abdominal distention, and nausea were observed with the evening-only (1- day) regimen compared to the split-dose (2-day) regimen for both preparations. Patients treated with another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) had increased rates of vomiting with the evening-only (1- day) regimen. An evening-only (1-day) dosing regimen was associated with higher rates of abnormal values for some electrolytes when compared to the split-dose (2-day) regimen for both preparations. For another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g), the evening only (1-day) regimen was associated with higher rates of total bilirubin (high), BUN (high), creatinine (high), osmolality (high), potassium (high) and uric acid (high) than the split dose (2-day) regimen. Administration of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g) in an evening-only (1-day) dosing regimen is not recommended. table 1 table 2