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) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8)] Most common adverse reactions are: Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials 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. Adults The safety of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution was evaluated in a multi-center, randomized, active controlled trial in 379 adult patients undergoing colonoscopy [see Clinical Studies (14) ] .
Most Common Adverse Reactions Table 1 shows the most common adverse reactions reported in at least 2% of patients receiving sodium sulfate, potassium sulfate, and magnesium sulfate oral solution or the control (a bowel prep containing polyethylene glycol and electrolytes (PEG + E)) administered in split-dose (2-day) regimens. Table 1: Common Adverse Reactions reported in at least 2% of patients in Adult Patients Undergoing Colonoscopy in a Randomized, Active Controlled Trial Split-Dose (2-Day) Regimen Symptom Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution % N=190 PEG + E product % N=189 Overall Discomfort 54 67 Abdominal Distension 40 52 Abdominal Pain 36 43 Nausea 36 33 Vomiting 8 4 Laboratory Abnormalities Table 2 shows the most common laboratory abnormalities (at least 10% in either treatment group and more than 2% difference between groups) for patients who developed new abnormalities of important electrolytes and uric acid after completing the bowel preparation with either sodium sulfate, potassium sulfate, and magnesium sulfate oral solution or PEG+E administered as a split-dose (2-day) regimen.
Table 2: Adult Patients with Normal Baseline Serum Chemistry with A Shift to an Abnormal Value While on the Split-Dose (2-Day) Regimen The study was not designed to support comparative claims for the laboratory abnormalities reported in this table. Day of Colonoscopy N (%) Percent (n/N) of patients where N=number of patients with normal baseline who had abnormal values at the time-point(s) of interest. Day 30 N (%) Bicarbonate (low) Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution 20 (13) 7(4) PEG + Electrolytes 24 (15) 4 (3) Bilirubin, total (high) Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution 14 (9) 0 (0) PEG + Electrolytes 20 (12) 3 (2) BUN (high) Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution 2 (2) 14 (11) PEG + Electrolytes 4(3) 19 (15) Calcium (high) Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution 16 (10) 8 (5) PEG + Electrolytes 6 (4) 6 (4) Chloride (high) Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution 4 (2) 6 (4) PEG + Electrolytes 20 (12) 6 (4) Osmolality (high) Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution 8 (6) NA PEG + Electrolytes 19 (13) NA Uric acid (high) Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution 27 (24) 13 (12) PEG + Electrolytes 12 (10) 20 (17) Less Common Adverse Reactions AV Block (1 case) and CK increase.
Adverse Reactions with Unapproved Use In another study of 408 adult patients, higher rates of the following adverse reactions and laboratory abnormalities were reported in patients treated with sodium sulfate, potassium sulfate, and magnesium sulfate oral solution as an evening-only (1-day) regimen compared to the split-dose (2-day) regimen. overall discomfort, abdominal distention, nausea, and vomiting total bilirubin (high), BUN (high), creatinine (high), osmolality (high), potassium (high) and uric acid (high) Administration of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution in an evening-only (1-day) dosing regimen is not recommended.
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.
6.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity : anaphylaxis, angioedema, dyspnea, rash, pruritus, urticaria [see Warning and Precautions (5.8)].
