NULYTELY Powder for oral solution Ref.[50755] Active ingredients: Macrogol Potassium chloride Sodium bicarbonate Sodium chloride

2.1 Dosage Overview

• NuLYTELY, 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)].
• Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7)].
• The 4-liter reconstituted NuLYTELY solution contains: 420 grams of polyethylene glycol (PEG) 3350, 5.72 grams of sodium bicarbonate, 11.2 grams of sodium chloride, 1.4 grams of potassium chloride and 2 grams of flavor ingredients.

2.2 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) Early in the evening prior to colonoscopy, fill the supplied container containing the NuLYTELY 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.

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

2.3 Dosage

The following is the recommended dose of reconstituted NuLYTELY 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.

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 20-30 mL per minute (1.2 – 1.8 liters per hour).

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 NuLYTELY solution, the solution may be given by nasogastric (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 NuLYTELY administration. Continue drinking until the watery stool is clear and free of solid matter.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion.

Keep out of reach of children.

Lemon-Lime Flavor NuLYTELY NDC 52268-302-01