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WARNINGS: The flavor packs are for use with the accompanying 4 liter bottle. No additional ingredients, e.g., flavorings, should be added to the solution. TRILYTE with flavor packs should be used with caution in patients with severe ulcerative colitis. Use of TRILYTE with flavor packs in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in 1 child and hypokalemia has been reported in 3 children.
PRECAUTIONS: General: Patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration should be observed during the administration of TRILYTE with flavor packs, especially if it is administered via nasogastric tube. If a patient experiences severe bloating, distention or abdominal pain, administration 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 TRILYTE with flavor packs.
Information For Patients: TRILYTE with flavor packs produces a watery stool which cleanses the bowel prior to examination. Prepare the solution according to the instructions on the bottle. It is more palatable if chilled. For best results, no solid food should be consumed during the 3 to 4 hour period before drinking the solution, but in no case should solid foods be eaten within 2 hours of taking TRILYTE with flavor packs.
Adults drink 240 mL (8 oz.) every 10 minutes. Continue drinking until the watery stool is clear and free of solid matter. This usually requires at least 3 liters. Any unused portion should be discarded. Pediatric patients (aged 6 months or greater) drink 25 mL/kg/hour. Continue drinking until the watery stool is clear and free of solid matter. Any unused portion should be discarded. Rapid drinking of each portion is better than drinking small amounts continuously. The first bowel movement should occur approximately one hour after the start of TRILYTE with flavor packs administration. You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occurs, stop drinking temporarily or drink each portion at longer intervals until these symptoms disappear.
Use of TRILYTE with flavor packs in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in 1 child and hypokalemia has been reported in 3 children.
Drug Interactions: Oral medication administered within one hour of the start of administration of TRILYTE with flavor packs may be flushed from the gastrointestinal tract and not absorbed.
Carcinogenesis, Mutagenesis, Impairment Of Fertility: Carcinogenic and reproductive studies with animals have not been performed.
Pregnancy: Category C. Animal reproduction studies have not been conducted with TRILYTE with flavor packs. It is also not known whether TRILYTE with flavor packs can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. TRILYTE with flavor packs should be given to a pregnant woman only if clearly needed.
Pediatric Use: Safety and effectiveness of TRILYTE with flavor packs in pediatric patients aged 6 months and older are supported by evidence from adequate and well-controlled clinical trials of a similar product in adults with additional safety and efficacy data from published studies of similar formulations.
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