Nulytely, cherry flavor, lemon-lime flavor, and orange flavor nulytely for oral solution

Description

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, 2.97 g potassium chloride. When dissolved in water to a volume of 4 liters, GoLYTELY (PEG-3350 and electrolytes for oral solution) is an isosmotic solution having a mildly salty taste. GoLYTELY is administered orally or via nasogastric tube as a gastrointestinal lavage.

NuLYTELY

A white powder for reconstitution containing 420 g polyethylene glycol 3350, 5.72 g sodium bicarbonate, 11.2 g sodium chloride, 1.48 g potassium chloride. When dissolved in water to a volume of 4 liters, NuLYTELY (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is an isosmotic solution having a pleasant mineral water taste. NuLYTELY is administered orally or via nasogastric tube as a gastrointestinal lavage.

Clinical Pharmacology

GoLYTELY and NuLYTELY induce 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.

Indications and Usage

GoLYTELY

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

NuLYTELY

NuLYTELY is indicated for bowel cleansing prior to colonoscopy.

Contraindications

GoLYTELY and NuLYTELY are contraindicated in patients known to be hypersensitive to any of the components. GoLYTELY and NuLYTELY are contraindicated in patients with gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon or ileus.

Warnings

GoLYTELY

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

NuLYTELY

No additional ingredients, e.g. flavorings, should be added to the solution. NuLYTELY should be used with caution in patients with severe ulcerative colitis. Use of NuLYTELY in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in 1 child and hypokalemia has been reported in 3 children.

Precautions

General:   Patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration should be observed during the administration of GoLYTELY or NuLYTELY, especially if it is administered via nasogastric tube. If a patient experiences severe bloating, distention or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate. If gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of GoLYTELY or NuLYTELY.

Information for Patients:   GoLYTELY and NuLYTELY produce a watery stool which cleanses the bowel before examination. Prepare the solution according to the instructions on the bottle. It is more palatable if chilled. For best results, no solid food should be consumed during the 3 to 4 hour period before drinking the solution, but in no case should solid foods be eaten within 2 hours of taking GoLYTELY or NuLYTELY.

GoLYTELY:   Drink 240 mL (8 oz.) every 10 minutes. Rapid drinking of each portion is better than drinking small amounts continuously.

NuLYTELY:   Adults drink 240 mL (8 oz.) every 10 minutes. Continue drinking until the watery stool is clear and free of solid matter. This usually requires at least 3 liters and it is best to drink all of the solution. Any unused portion should be discarded. Pediatric patients (aged 6 months or greater) drink 25 mL/kg/hour. Continue drinking until the watery stool is clear and free of solid matter. Any unused portion should be discarded. Use of NuLYTELY in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in 1 child and hypokalemia has been reported in 3 children.

The first bowel movement should occur approximately one hour after the start of GoLYTELY or NuLYTELY administration. You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occur, stop drinking temporarily or drink each portion at longer intervals until these symptoms disappear.

Drug Interactions

Oral medication administered within one hour of the start of administration of GoLYTELY or NuLYTELY may be flushed from the gastrointestinal tract and not absorbed.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Carcinogenic and reproductive studies with animals have not been performed.

Pregnancy:   Category C. Animal reproduction studies have not been conducted with GoLYTELY and NuLYTELY. It is also not known whether GoLYTELY and NuLYTELY can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GoLYTELY and NuLYTELY should be given to a pregnant woman only if clearly needed.

Pediatric Use:

GoLYTELY

Safety and effectiveness in children have not been established.

NuLYTELY

Safety and effectiveness of NuLYTELY in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of NuLYTELY in adults with additional safety and efficacy data from published studies of similar formulations.

Adverse Reactions

Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of GoLYTELY or NuLYTELY. 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" infiltrate on chest X-ray after vomiting and aspirating PEG.

Dosage and Administration

GoLYTELY

The recommended dose for adults is 4 liters of GoLYTELY 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 administration, but in no case should solid food be given for at least two hours before the solution is given.

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

NuLYTELY

NuLYTELY is usually administered orally, but may be given via nasogastric tube to patients who are unwilling or unable to drink the solution. Ideally, the patient should fast for approximately three or four hours prior to NuLYTELY administration, but in no case should solid food be given for at least two hours before the solution is given.

Oral administration:

Adults:   At a rate of 240 mL (8 oz.) every 10 minutes, until the rectal effluent is clear or 4 liters are consumed.

Pediatric Patients (aged 6 months or greater):   At a rate of 25 mL/kg/hour, until the rectal effluent is clear.

Rapid drinking of each portion is preferred to drinking small amounts continuously.

Nasogastric tube administration:

Adults:   At a rate of 20-30 mL per minute (1.2-1.8 liters per hour).

Pediatric Patients (aged 6 months or greater):    At a rate of 25 mL/kg/hour, until the rectal effluent is clear.

The first bowel movement should occur approximately one hour after the start of NuLYTELY administration. Ingestion of 4 liters of NuLYTELY solution prior to gastrointestinal examination produces satisfactory preparation in over 95% of patients.

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 NuLYTELY on the evening before the examination.

Preparation of the solution:

GoLYTELY solution is prepared by filling the container to the 4 liter mark with water and shaking vigorously several times to insure 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.

NuLYTELY solution is prepared by filling the container to the 4 liter mark with water and shaking vigorously several times to insure that the ingredients are dissolved. Dissolution is facilitated by using lukewarm water. The solution is more palatable if chilled before administration. However, chilled solution is not recommended for infants. The reconstituted solution should be refrigerated and used within 48 hours. Discard any unused portion.

How Supplied

GoLYTELY

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, anhydrous sodium sulfate 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 60g/L, sodium sulfate 5.68 g/L, sodium bicarbonate 1.68 g/L, sodium chloride 1.46 g/L and potassium chloride 0.745 g/L.

Pineapple Flavor GoLYTELY is available in a disposable jug in powdered form containing: 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 3.0 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.

NuLYTELY

NuLYTELY, Cherry NuLYTELY, Lemon-Lime NuLYTELY and Orange NuLYTELY are available in a disposable jug, in powdered form, for oral administration as a solution following reconstitution.

Each jug contains:

NuLYTELY: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

Cherry NuLYTELY: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

Lemon-Lime NuLYTELY: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

Orange NuLYTELY: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

STORAGE:   Store in sealed container at 25°C. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion.

GoLYTELY
NDC 52268-100-01
GoLYTELY 1 Gallon Packet
NDC 52268-700-01
Pineapple Flavor GoLYTELY
NDC 52268-101-01
NuLYTELY
NDC 52268-300-01
Cherry Flavor NuLYTELY
NDC 52268-301-01
Lemon-Lime Flavor NuLYTELY
NDC 52268-302-01
Orange Flavor NuLYTELY
NDC 52268-303-01

Rx only

Distributed by Braintree Laboratories, Inc., Braintree, MA 02185

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.
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