Polyethylene glycol

Identification

Summary

Polyethylene glycol is a laxative used to treat constipation and used for bowel preparation before colonoscopies and other procedures.

Brand Names
Bi-peglyte, Clearlax, Colyte, Gavilax, Gavilyte-C, Gavilyte-G, Gavilyte-H and Bisacodyl, Gavilyte-N, Gentlelax, Gialax, Glycolax, Golytely, Healthylax, Miralax, Moviprep, Nulytely, Peglyte, Pegylax, Plenvu, Purelax, Trilyte
Generic Name
Polyethylene glycol
DrugBank Accession Number
DB09287
Background

Polyethylene glycol (PEG) is a synthetic polymer produced via polymerization of ethylene oxide molecules to make joining units of ethylene glycol by an ether linkage.2,3 PEGs are water-soluble polymers that can form hydrogen bonds in a ratio of 100 water molecules per one PEG molecule.2 Molecular weights of PEGs vary by time of the polymerization process and the molecular weight represents the weighted average of the individual PEG molecules. PEGs differ in their physical and chemical properties depending on their molecular weight: PEGs are liquids when molecular weights are <1000 and the molecule turns to waxy solids with increasing molecular weights.3 The most common preparations of PEGs include PEG 3350 and PEG 400. PEGs have various applications in many fields, ranging from medical to industrial areas. PEGs have a long history of gastroenterology: PEG 3350 is a common over-the-counter osmotic laxative used to relieve occasional constipation.8 PEG 3350 is also used for cleansing of the colon in preparation for colonoscopy in adults.5

The rationale of using PEG in gastroenterology is due to the physical properties of the compound: its potent water-binding capacity, negligible intestinal absorption with increasing molecular mass, lack of significant toxicity, and limited intestinal enzymatic degradation or bacterial metabolism all make PEG a useful therapeutic agent for the treatment of occasional constipation and bowel cleansing for preparation in colonoscopy.1

Type
Small Molecule
Groups
Approved, Vet approved
Synonyms
  • Macrogol
  • Macrogol 3350
  • Macrogol 4000
  • Macrogol 6000
  • PEG
  • Polyethylene glycol 3350
  • Polyethylene glycol 4000
  • Polyethylene glycol 6000

Pharmacology

Indication

Polyethylene glycol is indicated for use as an over-the-counter osmotic laxative to relieve occasional constipation.8 When used in combination with sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride, it is used for cleansing of the colon in preparation for colonoscopy in adults.5

Pharmacology
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Associated Conditions
Associated Therapies
Contraindications & Blackbox Warnings
Contraindications
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Pharmacodynamics

The osmotic effect of PEG produces a copious watery diarrhea. The onset of action of PEG 3350 is about 1 to 2 hours after oral ingestion.5 The colonic transit of polyethylene glycol occurs in a dose-dependent manner.2 When used for bowel preparation before colonscopy, electrolytes are typically added in the oral solution to prevent dehydration and electrolyte disturbances. As an over-the-counter laxative, the OTC product does not contain any salts that can be absorbed.4 In a study involving healthy subjects, PEG 3350 had negligible effects on colonic fluid absorption or with the ability of the colonic mucosa to generate and sustain steep electrochemical gradients.3

Mechanism of action

Osmotic laxatives contain substances that are poorly absorbable and draw water into the lumen of the bowel.9 Polyethylene glycol functions is an osmotic laxative that causes increased water retention in the lumen of the colon by binding to water molecules, thereby producing loose stools.4,5

Absorption

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, the mean Cmax was 2.7 mcg/mL and the mean Tmax was 3 hours.5 Typically, polyethylene glycols with a high molecular weight are poorly absorbed from the gastrointestinal tract following oral administration.2,3

Volume of distribution

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, the mean volume of distribution was 48,481 L.5

Protein binding

There is limited information on the protein binding profile of polyethylene glycols.

Metabolism

Polyethylene glycol is a metabolically inert laxative that does not undergo intestinal enzymatic degradation or bacterial metabolism.1,4

Route of elimination

Following administration of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, up to 85% to 99% of the compound was excreted in the feces.5

Half-life

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, the mean half life was 4.1 hours.5

Clearance

There is limited information on the clearance rate of polyethylene glycols.

Adverse Effects
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Toxicity

The oral LD50 of PEG 3350 in rats is 22000 mg/kg.10

There is limited clinical information on the overdose of polyethylene glycols. Based on the pharmacological action of the compound, severe diarrhea may be suspected. Overdose of polyethylene glycols should be responded with symptomatic and supportive care.

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AcetazolamideThe risk or severity of adverse effects can be increased when Acetazolamide is combined with Polyethylene glycol.
AclidiniumThe therapeutic efficacy of Polyethylene glycol can be decreased when used in combination with Aclidinium.
AlfentanilThe therapeutic efficacy of Polyethylene glycol can be decreased when used in combination with Alfentanil.
AlloinThe risk or severity of adverse effects can be increased when Polyethylene glycol is combined with Alloin.
AlmasilateThe therapeutic efficacy of Polyethylene glycol can be decreased when used in combination with Almasilate.
Aluminium phosphateThe therapeutic efficacy of Polyethylene glycol can be decreased when used in combination with Aluminium phosphate.
Aluminum hydroxideThe therapeutic efficacy of Polyethylene glycol can be decreased when used in combination with Aluminum hydroxide.
AmantadineThe therapeutic efficacy of Polyethylene glycol can be decreased when used in combination with Amantadine.
AmilorideThe risk or severity of adverse effects can be increased when Amiloride is combined with Polyethylene glycol.
AmiodaroneThe therapeutic efficacy of Polyethylene glycol can be decreased when used in combination with Amiodarone.
Interactions
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Food Interactions
  • Avoid alcohol. Withdrawing from alcohol increases the risk of seizures, which is also caused by the drug.
  • Avoid milk and dairy products.
  • Avoid solid foods. Consume only clear liquids from the start of drug treatment until after the colonoscopy.

Products

Products
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Product Ingredients
IngredientUNIICASInChI Key
Polyoxyethylene 23 lauryl etherN72LMW566GNot AvailableNot applicable
International/Other Brands
Fortrans / GlycoLax / TriLyte
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
GialaxKit1 g/1gOralPhlight Pharma, Llc2011-10-01Not applicableUS flag
Polyethylene Glycol 3350 NF PEGyLAXPowder, for solution17 g/17gOralMartin Ekwealor Pharmaceuticals, Inc.2013-12-16Not applicableUS flag
Generic Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
GavilaxPowder, for solution17 g/17gOralDirectrx2015-01-01Not applicableUS flag
Polyethylene Glycol 3350Powder1 g/1gOralAvKARE, Inc.2013-07-052018-11-02US flag
Polyethylene Glycol 3350Powder, for solution17 g/17gOralProficient Rx LP2006-09-062021-07-31US flag
Polyethylene Glycol 3350Powder, for solution17 g/1OralNexgen Pharma, Inc.2006-09-27Not applicableUS flag
Polyethylene Glycol 3350Powder, for solution17 g/17gOralREMEDYREPACK INC.2015-03-312017-01-30US flag
Polyethylene Glycol 3350Powder, for solution17 g/17gOralPaddock Laboratories, LLC2006-05-242020-10-31US flag
Polyethylene Glycol 3350Powder, for solution17 g/17gOralGolden State Medical Supply, Inc.2013-02-082017-01-02US flag
Polyethylene Glycol 3350Powder1 g/1gOralPhysicians Total Care, Inc.2004-10-07Not applicableUS flag
Polyethylene Glycol 3350Powder, for solution17 g/17gOralBreckenridge Pharmaceutical, Inc.2006-09-062021-07-31US flag
Polyethylene Glycol 3350Powder, for solution17 g/17gOralAtlantic Biologicals Corps.2006-09-06Not applicableUS flag
Over the Counter Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Basic Care ClearlaxPowder, for solution17 g/17gOralAmazon.com Services LLC2020-06-22Not applicableUS flag
Basic Care ClearlaxPowder, for solution17 g/17gOralL. Perrigo Company2017-08-10Not applicableUS flag
Berkley and Jensen ClearlaxPowder, for solution17 g/17gOralBJWC2009-12-17Not applicableUS flag
BET-R-PrepPowder, for solution17 g/17gOralSatius Pharmaceuticals, Llc2017-11-27Not applicableUS flag
Care One ClearlaxPowder, for solution17 g/17gOralAmerican Sales Company2009-10-09Not applicableUS flag
ClarilaxPowder, for solution1 g / gOralPharmascience IncNot applicableNot applicableCanada flag
Clear LaxPowder, for solution17 g/17gOralH E B2009-10-08Not applicableUS flag
Clear LaxPowder, for solution17 g/17gOralMeijer Distribution Inc2017-07-12Not applicableUS flag
Clear LaxPowder, for solution17 g/17gOralMeijer Distribution Inc2009-10-06Not applicableUS flag
Clear LaxPowder, for solution17 g/17gOralMeijer Distribution2009-10-062013-10-19US flag
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Aquasite DpsPolyethylene glycol (.2 %) + Dextran 70 (.1 %)Solution / dropsOphthalmicCiba Vision1993-12-312000-11-08Canada flag
Bi-peglytePolyethylene glycol (59.55 g / sachet) + Bisacodyl (5 mg / tab) + Potassium chloride (0.76 g / sachet) + Sodium bicarbonate (1.69 g / sachet) + Sodium chloride (1.46 g / sachet) + Sodium sulfate (5.74 g / sachet)Kit; Powder, for solution; Tablet, delayed releaseOralPendopharm Division Of Pharmascience Inc2010-06-06Not applicableCanada flag
Clenz-LytePolyethylene glycol (236 g/4L) + Potassium chloride (2.97 g/4L) + Sodium bicarbonate (6.74 g/4L) + Sodium chloride (5.86 g/4L) + Sodium sulfate (22.74 g/4L)Powder, for solutionNasogastric; OralPaddock Laboratories, Inc.2010-06-072010-06-07US flag
ColytePolyethylene glycol (857.69 mg / g) + Potassium chloride (10.65 mg / g) + Sodium bicarbonate (24.02 mg / g) + Sodium chloride (20.87 mg / g) + Sodium sulfate (81.2 mg / g)Powder, for solutionNasogastric; OralPendopharm Division Of Pharmascience Inc1986-12-31Not applicableCanada flag
ColytePolyethylene glycol (240 g/4L) + Potassium chloride (2.98 g/4L) + Sodium bicarbonate (6.72 g/4L) + Sodium chloride (5.84 g/4L) + Sodium sulfate decahydrate (22.72 g/4L)Powder, for solutionNasogastricMEDA Pharmaceuticals2014-08-052021-09-30US flag
ColytePolyethylene glycol (227.1 g/3.785L) + Potassium chloride (2.82 g/3.785L) + Sodium bicarbonate (6.36 g/3.785L) + Sodium chloride (5.53 g/3.785L) + Sodium sulfate decahydrate (21.5 g/3.785L)Powder, for solutionNasogastric; OralAlaven Pharmaceutical2010-09-012016-05-31US flag
Colyte with flavor packsPolyethylene glycol (240 g/4L) + Potassium chloride (2.98 g/4L) + Sodium bicarbonate (6.72 g/4L) + Sodium chloride (5.84 g/4L) + Sodium sulfate decahydrate (22.72 g/4L)Powder, for solutionNasogastric; OralAlaven Pharmaceutical1999-04-072016-08-31US flag
Electropeg SolutionPolyethylene glycol (238.8 g / 277 g) + Potassium chloride (3 g / 277 g) + Sodium bicarbonate (6.7 g / 277 g) + Sodium chloride (5.8 g / 277 g) + Sodium sulfate (22.7 g / 277 g)PowderOralTechnilab Pharma Inc.1998-04-201999-09-27Canada flag
ENDOFALK TOZ İÇEREN SAŞE, 72 SAŞEPolyethylene glycol (52.5 g) + Potassium chloride (0.185 g) + Sodium bicarbonate (0.715 g) + Sodium chloride (1.4 g)PowderOralALİ RAİF İLAÇ SAN. A.Ş.2020-08-14Not applicableTurkey flag
ENDOFALK TOZ İÇEREN SAŞE, 8 SAŞEPolyethylene glycol (52.5 g) + Potassium chloride (0.185 g) + Sodium bicarbonate (0.715 g) + Sodium chloride (1.4 g)PowderOralALİ RAİF İLAÇ SAN. A.Ş.2020-08-14Not applicableTurkey flag
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
GialaxPolyethylene glycol (1 g/1g)KitOralPhlight Pharma, Llc2011-10-01Not applicableUS flag
GOLYTELY BAGIRSAK TEMIZLEME TOZU, 4 LPolyethylene glycol (236 g/4L)PowderOralAVİCENNA FARMA DIŞ TİC. VE PAZ. A.Ş.2020-08-14Not applicableTurkey flag
PCP 100 KitPolyethylene glycol (17 g/17g) + Bisacodyl (5 mg/1) + Magnesium citrate (1.745 g/29.6mL) + Metoclopramide hydrochloride (10 mg/1) + Petrolatum (0.76 g/1g)KitOralAsclemed Usa, Inc.2014-01-02Not applicableUS flag
PegPolyethylene glycol (55 g/100g) + Polyethylene glycol 400 (45 g/100g)CreamTopicalBiocellerex, Inc.2015-07-142016-01-05US flag
Polyethylene Glycol 3350 NF PEGyLAXPolyethylene glycol (17 g/17g)Powder, for solutionOralMartin Ekwealor Pharmaceuticals, Inc.2013-12-16Not applicableUS flag

Categories

ATC Codes
A06AD15 — MacrogolA06AD65 — Macrogol, combinations
Drug Categories
Classification
Not classified
Affected organisms
  • Humans and other mammals

Chemical Identifiers

UNII
3WJQ0SDW1A
CAS number
25322-68-3

References

General References
  1. Hammer HF, Hammer J, Gasche C: [Polyethylene glycol (Macrogol)--an overview of its use in diagnosis and therapy of gastrointestinal diseases]. Wien Klin Wochenschr. 2000 Jan 28;112(2):53-60. [Article]
  2. Minguez M, Lopez Higueras A, Judez J: Use of polyethylene glycol in functional constipation and fecal impaction. Rev Esp Enferm Dig. 2016 Dec;108(12):790-806. doi: 10.17235/reed.2016.4571/2016. [Article]
  3. Fordtran JS, Hofmann AF: Seventy Years of Polyethylene Glycols in Gastroenterology: The Journey of PEG 4000 and 3350 From Nonabsorbable Marker to Colonoscopy Preparation to Osmotic Laxative. Gastroenterology. 2017 Mar;152(4):675-680. doi: 10.1053/j.gastro.2017.01.027. Epub 2017 Jan 29. [Article]
  4. Portalatin M, Winstead N: Medical management of constipation. Clin Colon Rectal Surg. 2012 Mar;25(1):12-9. doi: 10.1055/s-0032-1301754. [Article]
  5. PLENVU (polyethylene glycol 3350, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) US FDA 2018 Label [Link]
  6. PegaLAX (polyethylene glycol 3350) 2017 Canadian Prescribing Information [Link]
  7. NCBI StatPearls [Internet]: Bowel Preparation [Link]
  8. DailyMed Label: GAVILAX (Polyethylene glycol 3350) powder, for solution [Link]
  9. Laxatives - StatPearls - NCBI Bookshelf [Link]
  10. Spectrum Chemical: POLYETHYLENE GLYCOL 3350 Safety Data Sheet [Link]
KEGG Drug
D03370
PubChem Substance
347910429
RxNav
1310594
ChEMBL
CHEMBL1201478
Wikipedia
Polyethylene_glycol
FDA label
Download (539 KB)
MSDS
Download (710 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedNot AvailableColonoscopy1
4CompletedBasic ScienceConstipation - Functional / Irritable Bowel Syndrome Characterized by Constipation1
4CompletedDiagnosticColon Adenomas / Colon Lesions / Colon Polyps1
4CompletedDiagnosticColonoscopy1
4CompletedDiagnosticColonoscopy Preparation1
4CompletedDiagnosticEndoscopy1
4CompletedDiagnosticPolyethylene Glycol / Sodium Phosphate1
4CompletedOtherChronic Constipation1
4CompletedOtherCleansing Quality of the Colon1
4CompletedOtherSmall Bowel Diseases1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Kit; powder, for solution; tablet, delayed releaseOral
Powder, for solutionOral1.685 g
Powder, for solutionOral100 g
SolutionOral
Powder, for solutionOral1 g / g
Powder, for solutionOral100 %
Powder, for solutionTopical17 g/1
Powder, for solutionOral64 g
Powder, for solutionOral86.85001 g
Powder, for solutionNasogastric
Powder, for suspensionOral100 g
Powder
PowderTopical17 g/17g
PowderOral
PowderOral17 g/17g
Powder, for solutionOral99.59 g
Powder, for solutionOral
KitOral1 g/1g
Powder, for solutionNasogastric; Oral
PowderOral
Powder, for solutionOral17 g / dose
Powder, for solutionOral17 g
GelNasal
Aerosol, meteredNasal
Powder, for solutionOral13.125 g
SolutionOral
Solution, concentrateOral
Injection, solution, concentrateOral
KitOral
Powder, for solutionOral105 g
Solution, concentrateOral
CreamTopical
Powder, for solutionOral100 % w/w
LiquidOral
Powder, for suspensionOral17 g/17g
PowderOral1 g/1g
Powder, for solutionOral1 g/1g
Powder, for solutionOral17 g/1
Powder, for solutionOral60 g/1L
Powder, for solutionOral17 g/1d
Powder, for solutionOral17 g/1g
Powder, for solutionOral17 g/17g
Powder, for solutionOral
Spray, meteredNasal
GelTopical
SprayNasal
Powder, for solutionOral2950 mg
Solution / dropsOphthalmic
LiquidOphthalmic
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
US7291324No2007-11-062022-10-22US flag
US7169381No2007-01-302024-09-01US flag
US7658914No2010-02-092024-09-01US flag
US9326969No2016-05-032033-09-10US flag
US9592252No2017-03-142032-08-11US flag
US9707297No2017-07-182033-09-10US flag
US8999313No2015-04-072033-09-10US flag
US10016504No2018-07-102033-09-10US flag
US10646512No2012-03-252032-03-25US flag
US10792306No2012-03-092032-03-09US flag
US10780112No2012-03-092032-03-09US flag
US10918723No2013-09-102033-09-10US flag

Properties

State
Solid
Experimental Properties
PropertyValueSource
melting point (°C)58-61MSDS
boiling point (°C)>200MSDS
Predicted Properties
Not Available
Predicted ADMET Features
Not Available

Spectra

Mass Spec (NIST)
Not Available
Spectra
Not Available

Transporters

Kind
Protein
Organism
Humans
Pharmacological action
No
Actions
Inhibitor
General Function
Xenobiotic-transporting atpase activity
Specific Function
Energy-dependent efflux pump responsible for decreased drug accumulation in multidrug-resistant cells.
Gene Name
ABCB1
Uniprot ID
P08183
Uniprot Name
Multidrug resistance protein 1
Molecular Weight
141477.255 Da
References
  1. Shen Q, Lin Y, Handa T, Doi M, Sugie M, Wakayama K, Okada N, Fujita T, Yamamoto A: Modulation of intestinal P-glycoprotein function by polyethylene glycols and their derivatives by in vitro transport and in situ absorption studies. Int J Pharm. 2006 Apr 26;313(1-2):49-56. doi: 10.1016/j.ijpharm.2006.01.020. Epub 2006 Feb 24. [Article]
  2. Wang SW, Monagle J, McNulty C, Putnam D, Chen H: Determination of P-glycoprotein inhibition by excipients and their combinations using an integrated high-throughput process. J Pharm Sci. 2004 Nov;93(11):2755-67. doi: 10.1002/jps.20183. [Article]
  3. Werle M: Natural and synthetic polymers as inhibitors of drug efflux pumps. Pharm Res. 2008 Mar;25(3):500-11. doi: 10.1007/s11095-007-9347-8. Epub 2007 Sep 26. [Article]

Drug created on October 29, 2015 18:17 / Updated on July 29, 2021 06:27