WARNINGS
No additional ingredients, e.g. flavorings, should be added to the solution. HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients with severe ulcerative colitis. Do NOT chew or crush the bisacodyl delayed release tablets.
PRECAUTIONS
General: Patients with impaired gag reflex and patients prone to regurgitation or aspiration should be observed during the administration of the solution. If a patient experiences severe bloating, distention or abdominal pain, administration of the solution should be slowed or temporarily discontinued until the symptoms abate. If gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of HalfLytely and Bisacodyl Tablets Bowel Prep Kit.
Patients should avoid consumption of large quantities of water during or after preparation or colonoscopy. Patients with impaired water handling (renal insufficiency or patients taking diuretics) that experience severe vomiting or nausea should be closely monitored including measurement of electrolytes. Information for patients: HalfLytely and Bisacodyl Tablets Bowel Prep Kit produces a watery stool which cleanses the bowel before examination. Prepare the solution according to the instructions on the kit. For best results, no solid food or milk (clear liquids only) should be consumed on the day of the preparation. No antacids should be taken within one hour of taking the bisacodyl delayed release tablets.
Adults swallow all four bisacodyl delayed release tablets with water (do NOT chew or crush). The first bowel movement should occur in approximately 1-6 hours after taking the bisacodyl delayed release tablets. Wait for a bowel movement (or maximum of 6 hours) then drink the solution, 1 (8 oz) glass every 10 minutes (approximately 8 glasses). Drink ALL of the solution. Rapid drinking of each portion is better than drinking small amounts continuously. A watery bowel movement should occur in approximately 1 hour after drinking the solution. You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occurs, stop drinking the solution temporarily or drink each portion at longer intervals until these symptoms disappear. Drug Interactions: Oral medication administered within one hour of the start of administration of the solution may be flushed from the gastrointestinal tract and not absorbed. Do not take the bisacodyl delayed release tablets within one hour of taking an antacid.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of HalfLytely and Bisacodyl Tablets Bowel Prep Kit. Studies to evaluate its potential for impairment of fertility or its mutagenic potential have not been performed. Pregnancy: Category C. Animal reproduction studies have not been conducted with HalfLytely and Bisacodyl Tablets Bowel Prep Kit. It is also not known whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed. Nursing Mothers: It is not known whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit is excreted in human milk, caution should be exercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients has not been established. Geriatric Use: There is no evidence for special consideration when administered to elderly patients. Of the total number of subjects in clinical studies (n=186), 28 percent were aged 65 or older, while 9.1 percent were over 75. No overall differences in safety or effectiveness were observed.
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