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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, Suflave
- 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
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Used in combination to treat Chronic constipation Combination Product in combination with: Sodium bicarbonate (DB01390), Potassium chloride (DB00761), Sodium chloride (DB09153) ••• ••• ••••••••• ••••••••••• Treatment of Constipation ••• ••• ••••••• ••• •••••••• Used in combination for symptomatic treatment of Constipation Combination Product in combination with: Citric acid (DB04272), Potassium chloride (DB00761), Sodium chloride (DB09153), Sodium citrate (DB09154) •••••••••••• ••••••••• ••••••••••• Used in combination for symptomatic treatment of Dry eye syndrome (des) Combination Product in combination with: Propylene glycol (DB01839) •••••••••••• •••••••• • ••••• Used in combination for symptomatic treatment of Dry eyes Combination Product in combination with: Propylene glycol (DB01839) •••••••••••• •••••••• • ••••• - Associated Therapies
- Contraindications & Blackbox Warnings
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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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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.
Drug Interaction Integrate drug-drug
interactions in your softwareAcetazolamide The risk or severity of dehydration can be increased when Acetazolamide is combined with Polyethylene glycol. Aclidinium The therapeutic efficacy of Polyethylene glycol can be decreased when used in combination with Aclidinium. Alfentanil The therapeutic efficacy of Polyethylene glycol can be decreased when used in combination with Alfentanil. Alloin The risk or severity of adverse effects can be increased when Polyethylene glycol is combined with Alloin. Almasilate The therapeutic efficacy of Polyethylene glycol can be decreased when used in combination with Almasilate. - 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
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Product Ingredients
Ingredient UNII CAS InChI Key Polyoxyethylene 23 lauryl ether N72LMW566G Not Available Not applicable - International/Other Brands
- Fortrans / GlycoLax / TriLyte
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Gialax Kit 1 g/1g Oral Phlight Pharma, Llc 2011-10-01 Not applicable US 
Polyethylene Glycol 3350 NF PEGyLAX Powder, for solution 17 g/17g Oral Martin Ekwealor Pharmaceuticals, Inc. 2013-12-16 Not applicable US - Generic Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Gavilax Powder, for solution 17 g/17g Oral Directrx 2015-01-01 2023-12-31 US Polyethylene Glycol 3350 Powder, for solution 17 g/1 Oral Metrics, Inc. 2006-05-24 2009-02-28 US Polyethylene Glycol 3350 Powder, for solution 17 g/17g Oral Proficient Rx LP 2006-05-24 2020-10-31 US Polyethylene Glycol 3350 Powder, for solution 17 g/17g Oral Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 2006-09-06 2020-01-22 US Polyethylene Glycol 3350 Powder, for solution 17 g/17g Oral Cardinal Health 2006-05-24 2020-07-31 US - Over the Counter Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Basic Care Clearlax Powder, for solution 17 g/17g Oral Amazon.com Services LLC 2022-11-28 Not applicable US Basic Care Clearlax Powder, for solution 17 g/17g Oral Amazon.com Services LLC 2020-06-22 Not applicable US Basic Care Clearlax Powder, for solution 17 g/17g Oral L. Perrigo Company 2017-08-10 Not applicable US Berkley and Jensen Clearlax Powder, for solution 17 g/17g Oral BJWC 2009-12-17 Not applicable US BET-R-Prep Powder, for solution 17 g/17g Oral Satius Pharmaceuticals, Llc 2017-11-27 Not applicable US - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Aquasite Dps Polyethylene glycol (.2 %) + Dextran 70 (.1 %) Solution / drops Ophthalmic Ciba Vision 1993-12-31 2000-11-08 Canada 
Bi-peglyte Polyethylene 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 release Oral Pendopharm Division Of Pharmascience Inc 2010-06-06 Not applicable Canada Clenz-Lyte Polyethylene 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 solution Nasogastric; Oral Paddock Laboratories, Inc. 2010-06-07 2010-06-07 US Colyte Polyethylene 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 solution Nasogastric; Oral Pendopharm Division Of Pharmascience Inc 1986-12-31 Not applicable Canada Colyte Polyethylene 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 solution Nasogastric Meda Pharma S.P.A. 2014-08-05 2021-09-30 US - Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Gialax Polyethylene glycol (1 g/1g) Kit Oral Phlight Pharma, Llc 2011-10-01 Not applicable US GOLYTELY BAGIRSAK TEMIZLEME TOZU, 4 L Polyethylene glycol (236 g/4L) Powder Oral AVİCENNA FARMA DIŞ TİC. VE PAZ. A.Ş. 2016-04-19 2024-04-12 Turkey 
PCP 100 Kit Polyethylene 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) Kit Oral Asclemed Usa, Inc. 2014-01-02 Not applicable US Peg Polyethylene glycol (55 g/100g) + Polyethylene glycol 400 (45 g/100g) Cream Topical Biocellerex, Inc. 2015-07-14 2016-01-05 US Polyethylene Glycol 3350 NF PEGyLAX Polyethylene glycol (17 g/17g) Powder, for solution Oral Martin Ekwealor Pharmaceuticals, Inc. 2013-12-16 Not applicable US
Categories
- ATC Codes
- A06AD15 — Macrogol
- A06AD — Osmotically acting laxatives
- A06A — DRUGS FOR CONSTIPATION
- A06 — DRUGS FOR CONSTIPATION
- A — ALIMENTARY TRACT AND METABOLISM
- Drug Categories
- Alcohols
- Alimentary Tract and Metabolism
- Compounds used in a research, industrial, or household setting
- Drug Delivery Systems
- Drugs for Constipation
- Electrolytes
- Ethylene Glycols
- Excipients
- Gastrointestinal Agents
- Glycols
- Laxatives
- Macromolecular Substances
- Osmotic Activity
- Osmotic Laxatives
- P-glycoprotein inhibitors
- Pegylated agents
- Pharmaceutic Aids
- Pharmaceutical Preparations
- Pharmaceutical Vehicles
- Polyethylene Glycols
- Polymers
- Solvents
- Stimulation Large Intestine Fluid/Electrolyte Secretion
- Surface-Active Agents
- Classification
- Not classified
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- 3WJQ0SDW1A
- CAS number
- 25322-68-3
References
- General References
- 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]
- 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]
- 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]
- 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]
- PLENVU (polyethylene glycol 3350, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) US FDA 2018 Label [Link]
- PegaLAX (polyethylene glycol 3350) 2017 Canadian Prescribing Information [Link]
- NCBI StatPearls [Internet]: Bowel Preparation [Link]
- DailyMed Label: GAVILAX (Polyethylene glycol 3350) powder, for solution [Link]
- Laxatives - StatPearls - NCBI Bookshelf [Link]
- Spectrum Chemical: POLYETHYLENE GLYCOL 3350 Safety Data Sheet [Link]
- External Links
- KEGG Drug
- D03370
- PubChem Substance
- 347910429
- 1310594
- ChEMBL
- CHEMBL1201478
- Wikipedia
- Polyethylene_glycol
- FDA label
- Download (539 KB)
- MSDS
- Download (710 KB)
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample dataNot Available Active Not Recruiting Not Available Children, Only / Polyethylene Glycols 1 somestatus stop reason just information to hide Not Available Completed Not Available Caries 1 somestatus stop reason just information to hide Not Available Completed Not Available Colon Adenomas / Colon Cancer / Colon Cancer, Rectal Cancer / Colon Polyps 1 somestatus stop reason just information to hide Not Available Completed Not Available Colon Cancer / Colon Cleansing / Colonic Diseases 1 somestatus stop reason just information to hide Not Available Completed Not Available Colonoscopy Preparation 2 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Solution / drops Ophthalmic Powder, for solution Oral 17 g Powder, for solution Oral 8.5 g Kit; powder, for solution; tablet, delayed release Oral Powder, for solution Oral 100 g Powder, for solution Oral 4 G Solution Oral 500 MG/ML Solution Oral Powder, for solution Oral 1 g / g Powder, for solution Oral 100 % Powder, for solution Topical 17 g/1 Powder, for solution Oral 64 g Powder, for solution Oral 86.85001 g Powder, for solution Oral 8685001 g Powder, for solution Oral 17.5 G Powder, for solution Nasogastric Drug delivery system Oral 255.00 g Powder, for suspension Oral 100 g Powder 17 G Solution Intravenous Powder Topical 17 g/17g Powder Oral Powder Oral 17 g/17g Powder, for solution Oral 99.59 g Powder, for solution Oral Powder, for solution Oral 10 g Granule, for solution Oral 64 g Kit Oral 1 g/1g Powder, for solution Nasogastric; Oral Powder Oral 236 g/4L Powder Oral 17 g/dose Powder, for solution Oral 17 g / dose Gel Nasal Aerosol, metered Nasal Powder, for solution Oral 5.9 G Powder, for solution Oral 13.125 g Powder, for solution Oral 13.125 G Solution, concentrate Oral 13.9 G/25ML Injection, solution, concentrate Oral Kit Oral Kit; solution Oral Solution Oral Powder, for solution Oral 105 g Solution, concentrate Oral Powder, for solution Oral 10 G Cream Topical Powder, for solution Oral 100 % w/w Powder Oral 238.33 g Liquid Oral Kit; powder, for solution Oral Powder, for solution Oral 7.54 g Powder Oral Cream; kit; powder, for solution; tablet, coated Oral; Rectal Powder, for suspension Oral 17 g/17g Powder Oral 1 g/1g Powder, for solution Oral 1 g/1g Powder, for solution Oral 17 g/1 Powder, for solution Oral 60 g/1L Powder, for solution Oral 17 g/1d Powder, for solution Oral 17 g/1g Powder, for solution Oral 17 g/17g Powder, for solution Oral Spray, metered Nasal Gel Topical Spray Nasal Powder Oral 17.000 g Powder Oral 105.000 g Powder, for solution Oral 2950 mg Solution Ophthalmic 0.500 mg Liquid Ophthalmic - Prices
- Not Available
- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region US7291324 No 2007-11-06 2022-10-22 US US7169381 No 2007-01-30 2024-09-01 US US7658914 No 2010-02-09 2024-09-01 US US9326969 No 2016-05-03 2033-09-10 US US9592252 No 2017-03-14 2032-08-11 US US9707297 No 2017-07-18 2033-09-10 US US8999313 No 2015-04-07 2033-09-10 US US10016504 No 2018-07-10 2033-09-10 US US10646512 No 2020-05-12 2032-03-25 US US10792306 No 2020-10-06 2032-03-09 US US10780112 No 2020-09-22 2032-03-09 US US10918723 No 2021-02-16 2033-09-10 US US11529368 No 2012-03-09 2032-03-09 US
Properties
- State
- Solid
- Experimental Properties
Property Value Source melting point (°C) 58-61 MSDS boiling point (°C) >200 MSDS - Predicted Properties
- Not Available
- Predicted ADMET Features
- Not Available
Spectra
- Mass Spec (NIST)
- Not Available
- Spectra
- Not Available
- Chromatographic Properties
Collision Cross Sections (CCS)
Not Available
Transporters
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- No
- Actions
- Inhibitor
- General Function
- Translocates drugs and phospholipids across the membrane (PubMed:2897240, PubMed:35970996, PubMed:8898203, PubMed:9038218). Catalyzes the flop of phospholipids from the cytoplasmic to the exoplasmic leaflet of the apical membrane. Participates mainly to the flop of phosphatidylcholine, phosphatidylethanolamine, beta-D-glucosylceramides and sphingomyelins (PubMed:8898203). Energy-dependent efflux pump responsible for decreased drug accumulation in multidrug-resistant cells (PubMed:2897240, PubMed:35970996, PubMed:9038218)
- Specific Function
- ABC-type xenobiotic transporter activity
- Gene Name
- ABCB1
- Uniprot ID
- P08183
- Uniprot Name
- ATP-dependent translocase ABCB1
- Molecular Weight
- 141477.255 Da
References
- 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]
- 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]
- 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 at October 29, 2015 18:17 / Updated at October 14, 2024 05:53