GoLYTELY

A white powder in a 4 liter jug for reconstitution, containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride. When dissolved in water to a volume of 4 liters, GoLYTELY for Oral Solution is an isosmotic solution having a mildly salty taste. GoLYTELY for Oral Solution is administered orally or via nasogastric tube as a gastrointestinal lavage.

GoLYTELY for Oral Solution induces a diarrhea which rapidly cleanses the bowel, usually within four hours. The osmotic activity of polyethylene glycol 3350 and the electrolyte concentration result in virtually no net absorption or excretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid or electrolyte balance.

GoLYTELY for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination.

GoLYTELY for Oral Solution is contraindicated in patients known to be hypersensitive to any of the components. GoLYTELY for Oral Solution is contraindicated in patients with gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon or ileus.

No additional ingredients, e.g. flavorings, should be added to the solution. GoLYTELY for Oral Solution should be used with caution in patients with severe ulcerative colitis.

Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of GoLYTELY for Oral Solution. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions.

Published literature contains isolated reports of serious adverse reactions following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG.

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.

In powdered form, for oral administration as a solution following reconstitution.

GoLYTELY for Oral Solution is available in a disposable jug in powdered form containing:

Store in sealed container at 59°-86°F. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL

GoLYTELY for Oral Solution

Rx Only

NDC 54868-0054-0

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL