FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
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.
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
TRILYTE with flavor packs is indicated for bowel cleansing prior to colonoscopy.
History
There is currently no drug history available for this drug.
Other Information
TRILYTE is a white powder for reconstitution containing 420 g polyethylene glycol 3350, 5.72 g sodium bicarbonate, 11.2 g sodium chloride, 1.48 g potassium chloride. Flavor packs, each containing 3.22 g of flavoring ingredients, are attached to the 4 liter bottle. See individual flavor packs for complete listing of ingredients. When dissolved in water to a volume of 4 liters, TRILYTE with flavor packs (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is an isosmotic solution, for oral administration, having a pleasant mineral water taste. One flavor pack can be added before reconstitution to flavor the solution. TRILYTE with flavor packs is administered orally or via nasogastric tube as a gastrointestinal lavage. This preparation can be used without the addition of a flavor pack.
Sources
Trilyte Manufacturers
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Alaven Pharmaceutical Llc
Trilyte | Alaven Pharmaceutical Llc
TRILYTE with flavor packs is usually administered orally, but may be given via nasogastric tube to patients who are unwilling or unable to drink the solution. Ideally, the patient should fast for approximately three or four hours prior to TRILYTE with flavor packs administration, but in no case should solid food be given for at least two hours before the solution is given.
Oral AdministrationAdults: At a rate of 240 mL (8 oz.) every 10 minutes, until the rectal effluent is clear or 4 liters are consumed. Pediatric Patients (aged 6 months or greater): At a rate of 25 mL/kg/hour, until the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. Nasogastric Tube Administration: Adults: At a rate of 20-30 mL per minute (1.2-1.8 liters per hour). Pediatric Patients (aged 6 months or greater): At a rate of 25 mL/kg/hour, until the rectal effluent is clear.
The first bowel movement should occur approximately one hour after the start of TRILYTE with flavor packs administration. Ingestion of 4 liters of TRILYTE with flavor packs solution prior to gastrointestinal examination produces satisfactory preparation in over 95% of patients.
Various regimens have been used. One method is to schedule patients for examination in midmorning or later, allowing the patients three hours for drinking and an additional one hour period for complete bowel evacuation. Another method is to administer TRILYTE with flavor packs on the evening before the examination.
Preparation of the SolutionThis preparation can be used with or without the flavor packs. The pharmacist should dispense the bottle and the attached flavor packs to the patient.
To add flavor, tear open one flavor pack at the indicated marking and pour contents into the bottle BEFORE reconstitution. Discard unused flavor packs. SHAKE WELL to incorporate flavoring into the powder. Add tap water to FILL line marked 4 liters. Replace cap tightly and SHAKE WELL until all ingredients have dissolved. No additional ingredients, e.g., flavorings, should be added to the solution.Note: If not using a flavor pack, omit steps one and two above.
Dissolution is facilitated by using lukewarm water. The solution is more palatable if chilled before administration. However, chilled solution is not recommended for infants. The reconstituted solution should be refrigerated and used with 48 hours. Discard any unused portion.
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