Polyethylene glycol-electrolyte solution (PEG-ES)

Polyethylene glycol-electrolyte solution (PEG-ES)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

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Overview

Polyethylene glycol-electrolyte solution (PEG-ES) is a laxative that is FDA approved for the {{{indicationType}}} of bowel cleansing prior to colonoscopy. Common adverse reactions include abdominal bloating, abdominal fullness, and nausea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Colonoscopy - Preparation of bowel

• Dosing Information

• 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.

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

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Polyethylene glycol-electrolyte solution (PEG-ES) in adult patients.

Non–Guideline-Supported Use

Fecal impaction

• Dosing Information

• 1 liter of PEG to be taken orally in two 500 milliliter portions within 4 to 6 hours.

Operative procedure on large intestine, Colorectal - Preparation of bowel for procedure

• Dosing Information

• 1000 mL every 45 to 75 minutes.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Colonoscopy - Preparation of bowel

• Dosing Information

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Polyethylene glycol-electrolyte solution (PEG-ES) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Polyethylene glycol-electrolyte solution (PEG-ES) in pediatric patients.

Contraindications

• TRILYTE with flavor packs is contraindicated in patients known to be hypersensitive to any of the components. TRILYTE with flavor packs is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.

Warnings

• The flavor packs are for use with the accompanying 4 liter bottle. No additional ingredients, e.g., flavorings, should be added to the solution. TRILYTE with flavor packs should be used with caution in patients with severe ulcerative colitis. Use of TRILYTE with flavor packs 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

• Patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration should be observed during the administration of TRILYTE with flavor packs, 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 TRILYTE with flavor packs.

Adverse Reactions

Clinical Trials Experience

• Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of TRILYTE with flavor packs. 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.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Polyethylene glycol-electrolyte solution (PEG-ES) in the drug label.

Drug Interactions

• Oral medication administered within one hour of the start of administration of TRILYTE with flavor packs may be flushed from the gastrointestinal tract and not absorbed.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category C

• Animal reproduction studies have not been conducted with TRILYTE with flavor packs. It is also not known whether TRILYTE with flavor packs can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. TRILYTE with flavor packs should be given to a pregnant woman only if clearly needed.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Polyethylene glycol-electrolyte solution (PEG-ES) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Polyethylene glycol-electrolyte solution (PEG-ES) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Polyethylene glycol-electrolyte solution (PEG-ES) with respect to nursing mothers.

Pediatric Use

• Safety and effectiveness of TRILYTE with flavor packs in pediatric patients aged 6 months and older are supported by evidence from adequate and well-controlled clinical trials of a similar product in adults with additional safety and efficacy data from published studies of similar formulations.

Geriatic Use

There is no FDA guidance on the use of Polyethylene glycol-electrolyte solution (PEG-ES) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Polyethylene glycol-electrolyte solution (PEG-ES) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Polyethylene glycol-electrolyte solution (PEG-ES) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Polyethylene glycol-electrolyte solution (PEG-ES) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Polyethylene glycol-electrolyte solution (PEG-ES) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Polyethylene glycol-electrolyte solution (PEG-ES) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Polyethylene glycol-electrolyte solution (PEG-ES) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Nasogastric

Monitoring

There is limited information regarding Monitoring of Polyethylene glycol-electrolyte solution (PEG-ES) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Polyethylene glycol-electrolyte solution (PEG-ES) in the drug label.

Overdosage

Chronic Overdose

There is limited information regarding Chronic Overdose of Polyethylene glycol-electrolyte solution (PEG-ES) in the drug label.

Pharmacology

There is limited information regarding Polyethylene glycol-electrolyte solution (PEG-ES) Pharmacology in the drug label.

Mechanism of Action

• TRILYTE with flavor packs 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.

Structure

• TRILYTE is 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. Flavor packs, each containing 3.22 g of flavoring ingredients, are attached to the 4 liter bottle. See individual flavor packs for complete listing of ingredients. When dissolved in water to a volume of 4 liters, TRILYTE with flavor packs (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is an isosmotic solution, for oral administration, having a pleasant mineral water taste. One flavor pack can be added before reconstitution to flavor the solution. TRILYTE with flavor packs is administered orally or via nasogastric tube as a gastrointestinal lavage. This preparation can be used without the addition of a flavor pack.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Polyethylene glycol-electrolyte solution (PEG-ES) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Polyethylene glycol-electrolyte solution (PEG-ES) in the drug label.

Nonclinical Toxicology

• Carcinogenic and reproductive studies with animals have not been performed.

Clinical Studies

There is limited information regarding Clinical Studies of Polyethylene glycol-electrolyte solution (PEG-ES) in the drug label.

How Supplied

• TRILYTE with flavor packs (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is supplied in a 4 liter bottle with an attached package containing flavor packs. This preparation is supplied in powdered form (white to off-white powder) for oral administration as a solution following reconstitution. Each 4 liter bottle contains polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g. Each flavor pack contains 3.22 g of flavoring ingredients. 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.

• Store in sealed container at 25°C (77°F); excursions permitted between 15° - 30° C (59° - 86°F). When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion.

Storage

There is limited information regarding Polyethylene glycol-electrolyte solution (PEG-ES) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

• TRILYTE with flavor packs produces a watery stool which cleanses the bowel prior to 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 TRILYTE with flavor packs.

• 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. 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. Rapid drinking of each portion is better than drinking small amounts continuously. The first bowel movement should occur approximately one hour after the start of TRILYTE with flavor packs administration. You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occurs, stop drinking temporarily or drink each portion at longer intervals until these symptoms disappear.

• Use of TRILYTE with flavor packs 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 with Alcohol

• Alcohol-Polyethylene glycol-electrolyte solution (PEG-ES) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• TRILYTE®

Look-Alike Drug Names

There is limited information regarding Polyethylene glycol-electrolyte solution (PEG-ES) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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