Dosage Overview

TRILYTE, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see Dosage and Administration (2.2), Warnings and Precautions (5.8)]. The 4 liter reconstituted TRILYTE solution contains: 420 grams of polyethylene glycol (PEG) 3350, 5.72 grams of sodium bicarbonate, 11.2 grams of sodium chloride, and 1.4 grams of potassium chloride. TRILYTE may be used with or without one of the supplied flavor packs.

Administration Instructions Prior to Dosage

On the day prior to the colonoscopy, instruct patients to:

a)

Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast.

b)

If adding a TRILYTE flavor pack, pour the contents of the 3.22 gram flavor powder (i.e., cherry or lemon-lime) into the container prior to reconstitution. No additional flavorings should be added. Discard unused flavor packs. The TRILYTE flavor packs are for use only in combination with the contents of the accompanying 4 liter container.

c)

Early in the evening prior to colonoscopy, fill the supplied container containing the TRILYTE powder (and if applicable, a flavor powder) with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters.

d)

After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours.

Dosage

The following is the recommended dose of reconstituted TRILYTE solution for adults and pediatric patients ≥ 6 months. Instruct patients they may consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration.

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Adults: Instruct patients to drink a total of up to 4 liters at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. For NGT, rate is 20 to 30 mL per minute (1.2 to 1.8 liters per hour).

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Pediatric Patients ≥ 6 Months: Pediatric patients should drink 25 mL/kg/hour until the stool is watery, clear, and free of solid matter. If pediatric patients are unable to drink the reconstituted TRILYTE solution, the solution may be given by nasogastric tube (NGT). NGT administration is at the rate of 25 mL/kg/hour.

The first bowel movements should occur approximately one hour after the start of TRILYTE administration. Continue drinking until the watery stool is clear and free of solid matter.