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warnings and cautions
5 WARNINGS AND PRECAUTIONS Neurologic ( 5.1 ) Gastrointestinal ( 5.2 ) Renal Insufficiency ( 5.3 ) Allergic Reaction ( 5.4 ) 5.1 Neurologic There have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. The seizure cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients. 5.2 Gastrointestinal Use with caution in patient with severe ulcerative colitis, ileus or gastric retention. Observe patients with impaired gag reflex and patients prone to regurgitation or aspiration during administration of HalfLytely solution. If GI obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration. There have been reports of ischemic colitis in patients with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit. If patients develop severe abdominal pain or rectal bleeding, patients should be evaluated as soon as possible. 5.3 Renal Insufficiency Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes (sodium, potassium, calcium, BUN and creatinine). 5.4 Allergic Reaction Hives and skin rashes have been reported with PEG-3350 based products which are suggestive of an allergic reaction.
6 ADVERSE REACTIONS Most common adverse reactions (< 3%) are abdominal pain/cramping, 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 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. In a clinical study of HalfLytely and (10 mg vs. 20 mg) Bisacodyl Tablets Bowel Prep Kit multicentered, controlled clinical trials, abdominal pain/cramping, nausea, vomiting and headache were the most common adverse reactions (< 3%) after the administration of HalfLytely and (10 mg or 20 mg) Bisacodyl Tablets Bowel Prep Kit. Less than 1% of patients exposed to HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit reported vomiting and abdominal pain/cramping. The data in Table 1 reflects exposure in 222 patients to HalfLytely and 10 mg bisacodyl tablets vs. 223 patients exposed to HalfLytely and 20 mg bisacodyl tablets. The HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit population was 20-85 years of age, 46% male, 54% female, 10% African American, 85% Caucasian, 8% Hispanic requiring a colonoscopy. The demographics of the comparator group were similar. Table 1: Adverse Reactions Observed in at Least 1% of Patients HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit (N=222) HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit (N=223) Abdominal pain/cramping 1% 2% Nausea 1% 2% Vomiting 1% 2% Headache 2% 1% Table 2 displays patient diary ratings of their symptoms associated with HalfLytely and Bisacodyl Tablets Bowel Prep Kits (10 mg bisacodyl vs. 20 mg bisacodyl tablets) in the controlled trial. Table 2: Percentage of Patients Reporting in their Diaries “bothersome” to “severely distressing” Symptoms in Controlled Clinical HalfLytely and Bisacodyl Tablets Bowel Prep Kit Trial 1 1 Patients were specifically asked about the occurrence of the following symptoms: nausea, abdominal cramping, fullness, vomiting, and overall discomfort. Half Lytely and 10 mg Bisacodyl Tablets Bowel Prep Kit (N=222) HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit (N=223) Nausea 13% 21% Abdominal cramping 7% 14% Abdominal fullness 11% 13% Vomiting 5% 8% Overall Discomfort 14% 20% 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of HalfLytely and Bisacodyl Tablets Bowel Prep Kit. 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. Allergic Reactions: Cases of urticaria, rhinorrhea, dermatitis and anaphylactic reactions have been reported with PEG-based products which may represent allergic reactions. Gastrointestinal: There are isolated reports of serious post-marketing events following the administration of PEG-based products in patients over 60 years of age. These adverse reactions include upper GI bleeding from a Mallory-Weiss tear, esophageal perforation, asystole, and acute pulmonary edema after vomiting and aspirating the PEG-based solution. In addition, during administration of 4 liters of PEG-3350 colon cleansing preparation the following serious adverse reactions were seen: two deaths in end stage renal failure patients who developed diarrhea, vomiting and dysnatremia. Ischemic colitis has been reported with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit for colon preparation prior to colonoscopy. However, a causal relationship between these ischemic colitis cases and the use of HalfLytely and Bisacodyl Tablets Bowel Prep Kit has not been established. Neurologic: There have been reports of generalized tonic-clonic seizures associated with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. Cases of dizziness and syncope have been reported [see Warnings and Precautions ( 5.1 ) ].