Trilyte (Polyethylene Glycol 3350) - Summary

TRILYTE SUMMARY

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.

TriLyte™ with flavor packs is indicated for bowel cleansing prior to colonoscopy.

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NEWS HIGHLIGHTS

Published Studies Related to Trilyte (Polyethylene Glycol 3350)

A Randomized, Double-Blind, Placebo-Controlled Trial of Polyethylene Glycol Effects on Fasting and Postprandial Rectal Sensitivity and Symptoms in Hypersensitive Constipation-Predominant Irritable Bowel Syndrome. [2009.07.03]
Objective: To assess the effect of polyethylene glycol 3350 (PEG) on fasting and postprandial (PP) perception of rectal distension and symptoms in hypersensitive constipation-predominant irritable bowel syndrome (IBS-C)...

Differences in taste between two polyethylene glycol preparations. [2007.12]
BACKGROUND AND AIMS: Polyethylene glycol preparations (PEG) are increasingly used for chronic constipation in both adults and children. There are some suggestions that PEG 4000 with orange flavour (Forlax) tastes better than PEG 3350 which contains salt (Movicolon). Poor taste is an important factor for non-compliance and is one of the leading causes of therapy failure. The aim of the study was to compare the taste of two commonly used PEG preparations, PEG 4000 and PEG 3350... CONCLUSION: PEG 4000 tastes better than PEG 3350. This may have implications for patient compliance and effectiveness of treatment in patients with chronic constipation.

Polyethylene glycol 3350 plus electrolytes for chronic constipation in children: a double blind, placebo controlled, crossover study. [2007.11]
OBJECTIVES: To assess the efficacy and safety of polyethylene glycol 3350 plus electrolytes (PEG+E) for the treatment of chronic constipation in children... CONCLUSIONS: PEG+E is significantly more effective than placebo, and appears to be safe and well tolerated in the treatment of chronic constipation in children.

A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. [2007.07]
OBJECTIVES: Polyethylene glycol (PEG) 3350 (MiraLAX) is currently approved for the short-term treatment of occasional constipation. This study was designed to compare the safety and efficacy of PEG laxative versus placebo over a 6-month treatment period in patients with chronic constipation... CONCLUSIONS: PEG laxative is safe and effective for use in patients with chronic constipation for 6 months.

A Randomized, Multicenter, Placebo-Controlled Trial of Polyethylene Glycol Laxative for Chronic Treatment of Chronic Constipation. [2007.03.31]
OBJECTIVES: Polyethylene glycol (PEG) 3350 (MiraLAX) is currently approved for the short-term treatment of occasional constipation. This study was designed to compare the safety and efficacy of PEG laxative versus placebo over a 6-month treatment period in patients with chronic constipation... CONCLUSIONS: PEG laxative is safe and effective for use in patients with chronic constipation for 6 months.

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Clinical Trials Related to Trilyte (Polyethylene Glycol 3350)

Efficacy of Lubiprostone in Combination With Standard PEG Preparation [Recruiting]
A large population-based study has shown diabetes to be an independent risk factor for colon cancer compared to the general population. Thus, the completion of an adequately prepped colonoscopy is requisite in providing diabetics with adequate colon cancer screening.

Recent data has shown that diabetic patients have poorer response to bowel cleansing compared to non-diabetics (with a standard PEG prep, only 62% of diabetic patients had their colonoscopy preps rated as good or better vs. 97% of normal patients, p<0. 001). This may be due to the fact that a majority of diabetic patients report constipation as a common gastrointestinal complaint.

We postulate that lubiprostone (Amitiza), in combination with PEG, will have additional efficacy over standard PEG preparation, and provide optimal safe and effective colonic cleansing for diabetics.

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