COLYTE SUMMARY
colyte® with flavor packs is a colon lavage preparation provided as water-soluble components for solution. In solution this preparation with one flavor pack added delivers the following, in grams per liter.
colyte® with flavor packs is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.
PEDIATRIC USE
Safety and effectiveness in pediatric patients have not been established.
GERIATRIC USE
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.
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NEWS HIGHLIGHTS
Published Studies Related to Colyte (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)...
SodiumPhosphate (NaP) versus polyethylene glycol-electrolyte lavage solution (PEG-ELS) tolerability: a prospective randomized study in patients with gynecological malignancy. [2008]
PURPOSE: The aim of the study was to evaluate patient tolerability and compliance to two bowel cleansing agents (PEG-ELS and NaP) as well as to compare the cost effectiveness... CONCLUSION: NaP was rated superior to PEG-ELS in terms of patient tolerability, compliance, completion of the regimen and cost effectiveness and should be the first-choice treatment.
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.
Clinical Trials Related to Colyte (Polyethylene Glycol 3350)
Amitiza® Plus GoLYTELY® Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation [Recruiting]
The primary objective is to compare the effectiveness and tolerance of Amitiza®
(lubiprostone) plus GoLYTELY® (polyethylene glycol-electrolyte solution) versus placebo and
GoLYTELY ® (polyethylene glycol-electrolyte solution) as a bowel cleansing preparation for
colonoscopy.
HalfLytely Bowel Prep System for Colonoscopy [Completed]
The purpose of the this study was to compare the safety and efficacy of HalfLytely (2L
NULYTELY + 20mg bisacodyl) to NULYTELY for preparation prior to colonoscopy.
Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy [Completed]
The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by
the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the
prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and
size of polyps detected on examination.
A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population [Completed]
This randomized, parallel, multi-center, single-blind study is designed to compare the safety
and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy
for a routinely accepted indication.
A Comparison of the Efficacy and Safety of HalfLytely Vs Visicol Prior To Colonoscopy. [Completed]
The objective of this study is to determine the efficacy and safety of HalfLytely as compared
to Visicol as bowel preparations before colonoscopic examination.
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