"The U.S. Food and Drug Administration today approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, known as gastroparesis.
Current tests used to diagnose gastroparesis "...
DOSAGE AND ADMINISTRATION
GoLYTELY, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see WARNINGS AND PRECAUTIONS]. The 1 gallon reconstituted GoLYTELY solution contains: 227.1 grams of polyethylene glycol (PEG) 3350, 21.5 grams sodium sulfate (anhydrous), 6.36 grams of sodium bicarbonate, 5.53 grams of sodium chloride, and 2.82 grams of potassium chloride.
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, obtain a food grade container with a volume of at least one gallon. After cutting open the packet, pour the entire contents into the container. Add lukewarm water (to facilitate dissolution) to bring the volume of solution to 1 gallon.
- The solution is clear and colorless when reconstituted to a final volume of 1 gallon.
- After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours.
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 1gallon at a rate of 240 mL (8 oz.) every 10 minutes, until 1 gallon is 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.
Dosage Forms And Strengths
For oral solution: A packet with powder for reconstitution with water to 1 gallon.
Each packet contains: polyethylene glycol 3350 227.1 g, sodium sulfate (anhydrous) 21.5 grams, sodium bicarbonate 6.36 g, sodium chloride 5.53 g, potassium chloride 2.82. When made up to 1 gallon volume with water, the solution contains PEG-3350 60 g/L, sodium sulfate 5.58 g/L sodium bicarbonate 1.68 g/L, sodium chloride 1.46 g/L, and potassium 0.745 g/L.
Storage And Handling
In powdered form, for oral administration as a solution following reconstitution.
GoLYTELY is available in a disposable jug and a packet in powdered form containing:
Disposable Jug: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. When made up to 4 liters volume with water, the solution contains PEG-3350 17.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L.
Packet: polyethylene glycol 3350 227.1 g, sodium sulfate (anhydrous) 21.5 g, sodium bicarbonate 6.36 g, sodium chloride 5.53 g, potassium chloride 2.82 g. When made up to 1 gallon volume with water, the solution contains PEG-3350 60 g/L, sodium sulfate 5.86/L, sodium bicarbonate 1.68 g/L, sodium chloride 1.46 g/L and potassium chloride 0.745g/L.
Pineapple Flavor GoLYTELY: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g, flavoring ingredients 3g. When made up to 4 liters volume with water, the solution contains PEG-3350 17.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L.
Store in sealed container at 59° to 86°F (15°C to 30°C). When reconstituted, keep solution refrigerated. Use within 48 hours, Discard unused portion.
Keep out of reach of children.
GoLYTELY NDC 52268-100-01
GoLYTELY Packet NDC 52268-700-01
Pineapple Flavor GoLYTELY NDC 52268-101-01
Distributed by Braintree Laboratories, Inc. Braintree, MA 02185. Revised: September 2013.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/4/2013
Additional GoLytely Information
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