Golytely

The recommended dose for adults is 4 liters of GoLYTELY for Oral Solution solution prior to gastrointestinal examination, as ingestion of this dose produces a satisfactory preparation in over 95% of patients. Ideally, the patient should fast for approximately three or four hours prior to GoLYTELY for Oral Solution administration, but in no case should solid food be given for at least two hours before the solution is given.

GoLYTELY for Oral Solution is usually administered orally, but may be given via nasogastric tube to patients who are unwilling or unable to drink the solution. Oral administration is 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. Nasogastric tube administration is at the rate of 20-30 mL per minute (1.2-1.8 liters per hour). The first bowel movement should occur approximately one hour after the start of GoLYTELY for Oral Solution administration.

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 GoLYTELY for Oral Solution on the evening before the examination, particularly if the patient is to have a barium enema.

Preparation of the solution: GoLYTELY for Oral Solution solution is prepared by filling the container to the 4 liter mark with water and shaking vigorously several times to ensure that the ingredients are dissolved. Dissolution is facilitated by using lukewarm water. The solution is more palatable if chilled before administration. The reconstituted solution should be refrigerated and used within 48 hours. Discard any unused portion.

2.1 Dosage Overview

GoLYTELY, 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 GoLYTELY solution contains: 236 grams of polyethylene glycol (PEG) 3350, 22.74 grams sodium sulfate (anhydrous), 6.74 grams of sodium bicarbonate, 5.86 grams of sodium chloride, and 2.97 grams of potassium chloride. GoLYTELY is also available with pineapple flavor.

2.2 Administration Instructions Prior to Dosage

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

Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast. Early in the evening prior to colonoscopy, fill the supplied container containing the GoLYTELY 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. 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 GoLYTELY solution for adults. 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).

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