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warnings and cautions
5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment: Assess concurrent medications and consider laboratory assessments prior to and after use ( 5.1 , 5.2 , 5.3 ) Risks in patients with renal insufficiency or patients taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider testing ( 5.4 ) Mucosal ulcerations and risk of ischemic colitis: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease ( 5.5 ) Suspected GI obstruction or perforation: Rule out the diagnosis before administration ( 4 , 5.6 ) 5.1 Serious Fluid and Serum Chemistry Abnormalities Advise all patients to hydrate adequately before, during, and after the use of Suclear. If a patient develops significant vomiting or signs of dehydration after taking Suclear, perform post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse reactions including cardiac arrhythmias, seizures and renal impairment. Patients with electrolyte abnormalities should have them corrected before treatment with Suclear. Consider the risks of prescribing Suclear in patients with certain medical conditions that predispose them (or who are using medications that increase the risk of) fluid and electrolyte disturbances or that may increase the risk of seizure, arrhythmias, and renal impairment. Use of alcohol may increase the risk of dehydration. 5.2 Cardiac Arrhythmias There have been rare reports of serious arrhythmias associated with the use of osmotic laxative products for bowel preparation. Carefully consider the risks of prescribing Suclear 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 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. Consider the risks of prescribing Suclear in 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 Use in Patients with Renal Impairment Consider the risks of prescribing Suclear 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). Advise these patients of the importance of adequate hydration before and after the use of Suclear. Consider performing baseline and post-colonoscopy laboratory tests in these patients (e.g., electrolytes, creatinine, and BUN). 5.5 Colonic Mucosal Ulcerations and Ischemic Colitis Osmotic laxatives 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 Suclear 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. 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 Suclear. Patients with severe active ulcerative colitis may be at increased risk of exacerbation of their disease with Suclear. 5.7 Use in Patients at Risk of Aspiration and Regurgitation Patients with impaired gag reflex and patients prone to regurgitation or aspiration should be observed during administration of Suclear solution. 5.8 Not for Direct Ingestion Direct ingestion of the undiluted solution may increase the risk of nausea, vomiting, dehydration or other serious adverse reactions. Each bottle must be diluted with water to the recommended final volume.
6 ADVERSE REACTIONS Most common adverse reactions (≥2%) are overall discomfort, abdominal distension, abdominal pain, nausea, vomiting and headache ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Braintree Laboratories, Inc. at 1-800-874-6756 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice. In randomized, multicenter, controlled clinical trials, the effectiveness of Suclear for colon cleansing was compared with two separate preparations containing two liters of polyethylene glycol plus electrolytes (Studies 1 and 2) [see Clinical Studies ( 14 )]. Suclear and the comparator preparation were administered entirely the day before the colonoscopy in Study 1, whereas they were administered as split doses in Study 2. In addition to collection of spontaneously reported adverse reactions, patients were instructed to complete a symptom scale questionnaire that targeted expected adverse reactions (overall discomfort, stomach cramping, stomach bloating, and nausea). Patients also were asked separately to report vomiting episodes. Table 1 presents the most common adverse reactions in Study 1 and Study 2. Table 1: Adverse Reactions Observed in At Least 2% of Patients Who Received the Day-Before Regimen or Split-Dose Regimen Adverse Reaction Study 1 (Day-Before Regimen) Study 2 (Split-Dose Regimen) Suclear (N=176) n (%) Comparator 1 † (N=190) n (%) Suclear (N=186) n (%) Comparator 2 ‡ (N=185) n (%) # Include spontaneously reported adverse reactions as well as those reported in a symptom scale questionnaire. * Abdominal pain also included reports of upper abdominal pain and abdominal tenderness. † Comparator 1: PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution; and two bisacodyl 5-mg delayed-release tablets. ‡ Comparator 2: PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution. Overall discomfort # 122 (69) 108 (57) 116 (62) 121 (65) Abdominal distension # 92 (52) 85 (45) 96 (52) 112 (61) Abdominal pain #* 71 (40) 78 (41) 70 (38) 79 (43) Nausea # 74 (42) 75 (40) 86 (46) 72 (39) Vomiting # 19 (11) 15 (8) 26 (14) 13 (7) Headache 1 (1) 3 (2) 3 (2) 2 (1) Electrolyte Abnormalities Table 2 presents the incidence of new laboratory abnormalities in Study 1 and Study 2. Table 2: Shifts from Normal at Baseline to Outside the Normal Range on the Day of Colonoscopy (for n/N, n= number with the event and N= number with normal baseline value) Laboratory Parameter (direction of change) Study 1: Day-Before Regimen Study 2: Split-Dose Regimen Suclear % (n/N) Comparator 1 † % (n/N) Suclear % (n/N) Comparator 2 ‡ % (n/N) † Comparator 1: PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution; and two bisacodyl 5-mg delayed-release tablets. ‡ Comparator 2: PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution. * Anion gap was calculated using the following formula: [Sodium (mEq/L)] - [Chloride (mEq/L)] + [Bicarbonate (mEq/L)]. Normal range was defined as 12±4, and high was defined as a calculated value >16. ** eGFR was calculated using the Cockcroft-Gault formula. Anion gap (high) * 3% (5/155) 5% (8/170) 10% (17/166) 8% (12/155) Bicarbonate (low) 3% (4/156) 3% (5/167) 4% (6/170) 12% (20/161) Bilirubin, total (high) 8% (12/157) 10% (17/170) 11% (19/170) 4% (6/162) Calcium (high) 9% (12/139) 4% (5/139) 4% (6/141) 5% (7/144) Chloride (low) 1% (1/157) 0% (0/171) 1% (1/173) 0% (0/163) Creatinine (high) 2% (3/145) 3% (4/155) 1% (2/167) 1% (1/153) Creatine kinase (high) 7% (10/138) 4% (6/151) 7% (10/147) 5% (7/143) eGFR (low) ** 25% (21/84) 14% (12/88) 9% (9/101) 11% (9/85) Glucose (high) 7% (10/146) 3% (4/156) 2% (3/160) 3% (5/150) Magnesium (low) 1% (1/158) 1% (1/169) 0% (0/169) 1% (1/163) Osmolality (high) 2% (3/139) 5% (8/153) 4% (6/151) 8% (12/145) Phosphate (low) 0% (0/155) 0% (0/168) 3% (5/171) 1% (2/160) Potassium (low) 4% (5/144) 3% (4/160) 4% (6/162) 4% (7/159) Sodium (low) 0% (0/157) 0% (0/169) 1% (1/169) 1% (1/163) Uric acid (high) 6% (8/143) 7% (11/160) 4% (7/163) 3% (4/154)