Delving into the Latest Updates on Polyethylene glycol 3350/Potassium chloride/Sodium bicarbonate/Sodium chloride/Sodium sulfate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

COLYTE-FLAVORED, Colyte, Colyte With Flavor Packs

+ [1]

Target-

Mechanism-

Therapeutic Areas

Other Diseases

Active Indication

Intestinal preparation

Inactive Indication-

Originator Organization

Braintree Laboratories, Inc.

Active Organization

Braintree Laboratories, Inc.

Inactive Organization

Mylan Specialty LP

Hospira, Inc.

Drug Highest PhaseApproved

First Approval Date

US (13 Jul 1984),

Intestinal preparation

Regulation-

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Structure

Molecular FormulaClNa

InChIKeyFAPWRFPIFSIZLT-UHFFFAOYSA-M

CAS Registry7647-14-5

View All Structures (5)

The aim of this randomized trial is to compare the proportion of patients achieving an adequate bowel preparation after a 1-day split-dose 4-liter PEG-based bowel preparation regimen (Golytely, Braintree Laboratory Inc, MA, USA) vs. the same regimen given on 2 consecutive days in a population identified as high risk for an inadequate bowel preparation.
2. Research Design: This study is a single-center prospective randomized study at the West Haven VAMC.
3. Methodology:
Primary endpoint: Adequate bowel preparation as defined by a Boston Bowel Preparation Scale (BBPS) score of 2 or 3 (on scale of 0-3) in all 3 colon segments (left, transverse, and right).
Secondary endpoints: Adenoma detection rate, polyp detection rate, sessile serrated polyp/adenoma detection rate, patient tolerability of preparation using the validated Mayo clinic bowel prep tolerability questionnaire, adverse events potentially related to bowel preparation
Patients scheduled for routine outpatient colonoscopy will be eligible if they are at high risk for poor bowel preparation,

Start Date01 Jan 2017

Sponsor / Collaborator-

100 Clinical Results associated with Polyethylene glycol 3350/Potassium chloride/Sodium bicarbonate/Sodium chloride/Sodium sulfate

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100 Translational Medicine associated with Polyethylene glycol 3350/Potassium chloride/Sodium bicarbonate/Sodium chloride/Sodium sulfate

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100 Patents (Medical) associated with Polyethylene glycol 3350/Potassium chloride/Sodium bicarbonate/Sodium chloride/Sodium sulfate

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109

Literatures (Medical) associated with Polyethylene glycol 3350/Potassium chloride/Sodium bicarbonate/Sodium chloride/Sodium sulfate

01 Jun 2024·Cureus

Cardiac Arrest Following GoLytely Consumption: A Potential Trigger for Hypovolemic Shock

Article

Author: Zaher, Eli A ; Patel, Parth ; Adhikari, Bibek ; Ebrahim, Mohamed A

This case report presents a rare but severe complication of polyethylene glycol (PEG) used for colonoscopic bowel preparation. A 71-year-old male developed cardiac arrest secondary to hypovolemic shock following consumption of GoLytely. Despite being hemodynamically stable prior to ingestion, the patient experienced extreme weakness, dizziness, and orthostatic hypotension post-consumption. Evaluation ruled out other causes of arrest. While serious complications from PEG are rare, this case underscores the importance of vigilance. Further investigation is warranted to elucidate the relationship between PEG use and cardiac events and to identify potential risk factors for adverse outcomes associated with bowel preparation regimens.

01 Jan 2023·Therapeutic Advances in Rare Disease

A novel case of homozygous PAX1 mutation associated with hypoparathyroidism

Author: Heidenreich, Leah ; Asumda, Faizal Z. ; Hamel, Benjamin L. ; Kumar, Seema ; DaSilva, Christiana ; Joshi, Avni

The PAX1 gene plays an important role in the development of the parathyroid glands and the thymus. Mouse knockout models of PAX1, PAX3, and PAX9 have been found to have hypoplastic or absent parathyroid glands. To our knowledge, there are no reported cases of PAX1-associated hypoparathyroidism in humans. We present a case of hypoparathyroidism in a 23-month-old boy with a homozygous pathogenic variant in the PAX1 gene ( PAX1 NM_006192.5 c.463_465del variant), predicted to cause an in-frame deletion of asparagine at position 155 (p.Asn155del) of the PAX1 protein. The hypoparathyroidism was unmasked after the patient developed significant hypocalcemia while receiving GoLYTELY (polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride) for bowel cleanout. The patient had mild and asymptomatic hypocalcemia prior to hospitalization. The patient was noted to have inappropriately normal parathyroid hormone (PTH) level at the time of documented hypocalcemia thereby suggesting a diagnosis of hypoparathyroidism. Plain language summary The first human case of hypoparathyroidism associated with a rare genetic disorder: a case report of PAX1 gene mutation The paired box ( PAX) gene family is important for embryo development. One subfamily, PAX1, is necessary for development of the spinal column, thymus (important for the immune system development), and parathyroid (helps regulate the amount of calcium in the body). We present the case of a 23-month-old boy with known PAX1 gene mutation who came in with episodes of vomiting and poor growth. His presentation was thought to be most likely related to constipation. He was started on bowel cleanout medication and intravenous fluids. However, his calcium that had been mildly low subsequently dropped to very low levels. The level of parathyroid hormone (which helps regulate calcium levels) was inappropriately normal, meaning that his body was unable to make more, and was consistent with hypoparathyroidism. He was treated with calcium supplements and vitamin D and calcium levels normalized. He continues to be on calcium and vitamin D and calcium levels have remained stable. Doctors should keep this complication in mind when treating patients with PAX1 gene mutation.

01 Mar 2022·Annals of PharmacotherapyQ4 · MEDICINE

A Galvanizing Solution: Colonoscopy Bowel Preparation as a Trigger for Supraventricular Tachycardia

Q4 · MEDICINE

Article

Author: Ramappa, Preeti ; Kajy, Marvin

Background: Polyethylene glycol (PEG)-based solutions are among the most commonly used bowel preparation regimens for colonoscopy. Although these solutions are well tolerated, rare adverse cardiac events have been reported. Objectives: We sought to identify the characteristics that may predispose patients to develop supraventricular tachycardia (SVT) after ingestion of GoLYTELY (PEG 3350 and electrolytes oral solution) in anticipation for their colonoscopy. Methods: We performed a retrospective observational cohort study of the electronic medical record of all patients who developed SVT after ingestion of GoLYTELY solution from April 2012 to March 2019 at the John D. Dingell VA Medical Center. Clinical data were obtained through review of medical records. Results: We identified 16 patients with new-onset SVT after ingestion of bowel preparation solution before undergoing the colonoscopy procedure. In all, 12 (75%) patients developed atrial fibrillation, 3 (18.8%) patients developed atrial tachycardia, and 1 patient (6.3%) developed atrial flutter. Most patients were male (93.8%), and the mean age was 69 ± 8.2 years. The commonly associated comorbidities were hypertension (87.5%), hyperlipidemia (56.3%), and diabetes (37.5%). Laboratory testing demonstrated a normal electrolyte panel and thyroid stimulating hormone level. A significant percentage of patients had dilated atria and left-ventricular hypertrophy on echocardiogram. Conclusion: Our case series suggests that there may be certain individuals who are predisposed to development of atrial arrhythmias, more so than others, after ingestion of PEG based solution for colonoscopy. We hypothesize that the combination of atrial dilation, sympathovagal discharge, and transient electrolyte shifts at the cellular level led to the development of SVTs.

100 Deals associated with Polyethylene glycol 3350/Potassium chloride/Sodium bicarbonate/Sodium chloride/Sodium sulfate

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Intestinal preparation	US	Braintree Laboratories, Inc.	13 Jul 1984

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01283152 (HELP \| PSE, CTgov)	Not Applicable	Hepatic Encephalopathy \| Fibrosis	50	Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) (Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®))	jsqrapftpf(ravsskvhoc) = rvulygfhxh qyleewjhyg (zzuwliycfe, uieyzrlcoa - nxkexjvfki) View more	-	11 Dec 2014
				Lactulose (Lactulose)	jsqrapftpf(ravsskvhoc) = ezsbzwrnng qyleewjhyg (zzuwliycfe, qiyytacrsp - nqlplnzhuh) View more
NCT00953017 (CTgov)	Phase 4	-	425	Amitiza (Lubiprostone) (Miralax Plus Amitiza)	awxtcvscig(ocomsvxhad) = mmgcwjasnu ngcupuzquu (aewnmtnuxj, pmpzioiflf - bijgzdpuqw) View more	-	30 Nov 2012
				Dulcolax (Bisacodyl) (Miralax Plus Dulcolax)	awxtcvscig(ocomsvxhad) = vvxhaxexvr ngcupuzquu (aewnmtnuxj, tuzhcwcukt - asbcqmexyb) View more