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Trilyte (Polyethylene Glycol 3350) - Indications and Dosage


INDICATIONS AND USAGE: TRILYTE with flavor packs is indicated for bowel cleansing prior to colonoscopy.

DOSAGE AND ADMINISTRATION: 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 Administration: Adults: 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 Solution: This preparation can be used with or without the flavor packs. The pharmacist should dispense the bottle and the attached flavor packs to the patient.

  1. To add flavor, tear open one flavor pack at the indicated marking and pour contents into the bottle BEFORE reconstitution. Discard unused flavor packs.
  2. SHAKE WELL to incorporate flavoring into the powder.
  3. 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.

HOW SUPPLIED: TRILYTE with flavor packs (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is supplied in a 4 liter bottle with an attached package containing flavor packs. This preparation is supplied in powdered form (white to off-white powder) for oral administration as a solution following reconstitution. Each 4 liter bottle contains polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g. Each flavor pack contains 3.22 g of flavoring ingredients. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

TRILYTE with flavor packs           4 liter           NDC 51525-6831-4

Rx Only

STORAGE: Store in sealed container at 25°C (77°F); excursions permitted between 15° - 30° C (59° - 86°F). When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion.

Manufactured by Kremers Urban Pharmaceuticals Inc., Seymour, IN 47274

for Wallace Pharmaceuticals Inc., Somerset, NJ 08873-4120
For Medical Inquiries, call toll-free 1-888-317-1527

TRILYTE is a registered trademark of Alaven Pharmaceutical LLC.

WALLACE AND THE “W” logo are trademarks of Wallace Pharmaceuticals Inc.

IN_6831-0 Rev 09/11

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