Polidocanol is a sclerosing agent used for the treatment of uncomplicated spider veins and uncomplicated reticular veins, all less than 3 mm in diameter, in the lower extremity.
- Brand Names
- Asclera, Varithena
- Generic Name
- DrugBank Accession Number
Polidocanol is a sclerosing agent indicated to treat uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. It is marketed under the brand names Asclera and Varithena. The formula for Polidocanol has the structural formula C12H25(OCH2CH2)nOH, a mean extent of polymerization (n) of approximately 9 and a mean molecular weight of approximately 600.
- Small Molecule
- Average: 582.8073
- Chemical Formula
- Laureth 9
- Macrogol 9 lauryl ether
- Nonaethylene glycol monododecyl ether
- Nonaethylene glycol monolauryl ether
- PEG-9 lauryl ether
- Polyethylene glycol 450 lauryl ether
- Polyoxyl 9 lauryl ether
- External IDs
Polidocanol is a sclerosing agent indicated to treat uncomplicated spider veins and uncomplicated reticular veins in the lower extremity.Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.
- Associated Conditions
- Contraindications & Blackbox Warnings
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Polidocanol has a concentration and volume dependent damaging effect on the blood vessel endothelium.
- Mechanism of action
When administered, polidocanol locally damages blood vessel endothelium. Following the endothelial damage, platelets aggregate at the site and attach to the venous wall eventually resulting in a dense network of platelets, cellular debris, and fibrin that occludes the vessel. Eventually the vessel is replaced by connective fibrous tissue.
When given intravenously, the maximum blood concentrations were reached in 15 mins.
- Volume of distribution
When given intravenously, the volume of distribution was 35-82L.
- Protein binding
Plasma protein binding was not measured.
Metabolism was not measured.
- Route of elimination
Route of elimination was not indicated.
The half-life is approximately 1.5 h.
Sytemic clearance was 0.2-0.4 L/min.
- Adverse Effects
- Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.
Most adverse reactions are related to the intravenous administration such as local irritation, pain, and hematoma. Extravasation can also be an issue.
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
- 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 Antihemophilic factor (recombinant), PEGylated The therapeutic efficacy of Antihemophilic factor (recombinant), PEGylated can be decreased when used in combination with Polidocanol. Certolizumab pegol The therapeutic efficacy of Certolizumab pegol can be decreased when used in combination with Polidocanol. Damoctocog alfa pegol The therapeutic efficacy of Damoctocog alfa pegol can be decreased when used in combination with Polidocanol. Elapegademase The therapeutic efficacy of Elapegademase can be decreased when used in combination with Polidocanol. Lipegfilgrastim The therapeutic efficacy of Lipegfilgrastim can be decreased when used in combination with Polidocanol. Methoxy polyethylene glycol-epoetin beta The therapeutic efficacy of Methoxy polyethylene glycol-epoetin beta can be decreased when used in combination with Polidocanol. Nonacog beta pegol The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Polidocanol. Pegademase The therapeutic efficacy of Polidocanol can be decreased when used in combination with Pegademase. Pegaptanib The therapeutic efficacy of Polidocanol can be decreased when used in combination with Pegaptanib. Pegaspargase The therapeutic efficacy of Polidocanol can be decreased when used in combination with Pegaspargase.Identify potential medication risksEasily compare up to 40 drugs with our drug interaction checker.Get severity rating, description, and management advice.Learn more
- Food Interactions
- No interactions found.
- 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.
- International/Other Brands
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Asclera Injection, solution 0.01000 g/1mL Intravenous Merz North America, Inc 2010-06-01 2022-08-31 Asclera Injection, solution 0.01000 g/1mL Intravenous Methapharm, Inc 2010-06-01 Not applicable Asclera Injection, solution 0.00500 g/1mL Intravenous Merz North America, Inc 2010-06-01 2022-08-31 Asclera Injection, solution 0.00500 g/1mL Intravenous Methapharm, Inc 2010-06-01 Not applicable Varithena Kit 10 mg/1mL Intravenous Biocompatibles, Inc. 2013-11-25 Not applicable Varithena Kit 10 mg/1mL Intravenous Biocompatibles, Inc. 2017-12-22 Not applicable Varithena Kit 1.3 mg / mL Intravenous Provensis Ltd 2016-11-30 Not applicable Varithena Kit 10 mg/1mL Intravenous Biocompatibles, Inc. 2014-07-10 Not applicable Varithena Kit 10 mg/1mL Intravenous Biocompatibles, Inc. 2014-07-10 2017-01-09 Varithena Kit 10 mg/1mL Intravenous Biocompatibles, Inc. 2017-12-22 Not applicable
- Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Dentinox - Gel Zahnungshilfe Polidocanol (3.2 mg/g) + Chamomile (150 mg/g) + Lidocaine hydrochloride (3.4 mg/g) Gel Buccal Orifarm Healthcare A/s 1998-12-18 Not applicable DENTINOX 3.4 MG/G + 3.2 MG/G + 150 MG/G JEL, 10 G Polidocanol (3.2 mg/g) + Chamaemelum nobile flower (150 mg/g) + Lidocaine hydrochloride (3.4 mg/g) Gel Oral ABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. 2020-08-14 Not applicable DENTINOX 3.4 MG/G + 3.2 MG/G + 150 MG/G JEL, 20 G Polidocanol (3.2 mg/g) + Chamaemelum nobile flower (150 mg/g) + Lidocaine hydrochloride (3.4 mg/g) Gel Oral ABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. 2020-08-14 Not applicable KORTOS 27 MG/ 5 MG SUPOZITUAR, 10 ADET Polidocanol (5 mg) + Hydrocortisone acetate (27 mg) Suppository Rectal EXELTIS İLAÇ SAN. VE TİC. A.Ş. 2020-08-14 Not applicable Optiderm - Creme Polidocanol (3 g) + Urea (5 g) Cream Topical Almirall Hermal Gmb H 1998-02-11 Not applicable Optiderm Fett - Creme Polidocanol (3 g) + Urea (5 g) Cream Topical Almirall Hermal Gmb H 2000-08-02 Not applicable SOLCOSERYL ADHEZIV DIS PATI, 5 G Polidocanol (10 mf) + Solcoseryl (2 mg) Patch Oral MEDA PHARMA İLAÇ SAN. VE TİC. LTD. ŞTİ. 2020-08-14 Not applicable SOLCOSERYL DENTAL ADHESIVE PASTE Polidocanol (10 mg/g) + Solcoseryl (2.125 mg/g) Paste Dental A. MENARINI SINGAPORE PTE. LTD. 2020-09-08 Not applicable คอลโลแม็ค Polidocanol (2 G/100G) + Lactic acid (5 G/100G) + Salicylic acid (20 G/100G) Solution Topical บริษัท แอสมีโก้ (ประเทศไทย) จำกัด 2006-12-29 Not applicable
- ATC Codes
- C05BB02 — Polidocanol
- Drug Categories
- Antivaricose Therapy
- Cardiovascular Agents
- Compounds used in a research, industrial, or household setting
- Ethylene Glycols
- Household Products
- Macromolecular Substances
- Pegylated agents
- Pharmaceutical Preparations
- Pharmaceutical Solutions
- Polyethylene Glycols
- Sclerosing Activity
- Sclerosing Agents for Local Injection
- Sclerosing Solutions
- Surface-Active Agents
- Vascular Sclerosing Activity
- Chemical TaxonomyProvided by Classyfire
- This compound belongs to the class of organic compounds known as polyethylene glycols. These are oligomers or polymers of ethylene oxide, with the general formula (C2H4O)n (with n>=3).
- Organic compounds
- Super Class
- Organic oxygen compounds
- Organooxygen compounds
- Sub Class
- Direct Parent
- Polyethylene glycols
- Alternative Parents
- Primary alcohols / Hydrocarbon derivatives
- Alcohol / Aliphatic acyclic compound / Hydrocarbon derivative / Polyethylene glycol / Primary alcohol
- Molecular Framework
- Aliphatic acyclic compounds
- External Descriptors
- hydroxypolyether (CHEBI:46859)
- Affected organisms
- Humans and other mammals
- CAS number
- InChI Key
- IUPAC Name
- General References
- Peterson JD, Goldman MP, Weiss RA, Duffy DM, Fabi SG, Weiss MA, Guiha I: Treatment of reticular and telangiectatic leg veins: double-blind, prospective comparative trial of polidocanol and hypertonic saline. Dermatol Surg. 2012 Aug;38(8):1322-30. doi: 10.1111/j.1524-4725.2012.02422.x. Epub 2012 May 23. [Article]
- Weiss RA, Voigts R, Howell DJ: Absence of concentration congruity in six compounded polidocanol samples obtained for leg sclerotherapy. Dermatol Surg. 2011 Jun;37(6):812-5. doi: 10.1111/j.1524-4725.2011.01906..x. [Article]
- Link [Link]
- PDB Entries
- 3dm8 / 5k9d
- FDA label
- Download (86.7 KB)
- Download (567 KB)
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Treatment Chronic Achilles Tendinopathy 1 4 Completed Treatment Telangiectasias / Varicosities of the great saphenous vein 1 4 Completed Treatment Varicosities of the great saphenous vein 2 4 Not Yet Recruiting Other Varicosities of the great saphenous vein 1 4 Unknown Status Treatment Cystic tumour of the ganglia 1 4 Withdrawn Treatment Reflux / Ulcers, Leg / Varicose Ulcers / Varicose veins of legs / Varicosities of the great saphenous vein / Venous Leg Ulcer (VLU) / Venous Reflux / Venous Ulcers 1 3 Completed Treatment Great Saphenous Vein Incompetence / Visible Varicosities 1 3 Completed Treatment Varicosities of the great saphenous vein 2 2 Completed Treatment Hemorrhoids Second Degree 1 2 Completed Treatment Hemorrhoids, Internal 1
- Not Available
- Not Available
- Dosage Forms
Form Route Strength Injection, solution Intravenous Injection, solution Parenteral Solution Parenteral 10 mg/1ml Solution Parenteral 30 mg/1ml Injection, solution Intravenous 0.00500 g/1mL Injection, solution Intravenous 0.01000 g/1mL Injection, solution Gel Buccal Gel Oral Solution Parenteral 0.1 g Solution Intravenous 0.3 g Solution Parenteral 0.3 g Suppository Rectal Solution Topical Cream Topical Ointment Topical Patch Oral Paste Dental Kit Intravenous 1.3 mg / mL Kit Intravenous 10 mg/1mL Injection Intravenous 10 mg/ml Injection Intravenous 3 %
- Not Available
Patent Number Pediatric Extension Approved Expires (estimated) Region US7814943 No 2010-10-19 2027-11-19 US7842282 No 2010-11-30 2020-05-26 US7604185 No 2009-10-20 2020-05-26 US7357336 No 2008-04-15 2020-05-26 US7025290 No 2006-04-11 2020-05-26 US6572873 No 2003-06-03 2020-05-26 US7731986 No 2010-06-08 2024-11-17 USRE40640 No 2009-02-17 2016-10-14 US8734833 No 2014-05-27 2020-05-26 US8122917 No 2012-02-28 2024-09-09 US6942165 No 2005-09-13 2020-05-26 US8323677 No 2012-12-04 2020-05-26 US6846412 No 2005-01-25 2022-07-19 US7842283 No 2010-11-30 2020-05-26 US9480652 No 2016-11-01 2032-05-12
- Experimental Properties
Property Value Source melting point (°C) 33-36 °C Not Available boiling point (°C) 615.857 °C at 760 mmHg Not Available water solubility miscible http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_113.pdf logP 3.94 # http://www.chemicalize.org/structure/#!mol=polidocanol
- Predicted Properties
Property Value Source Water Solubility 0.000403 mg/mL ALOGPS logP 3.15 ALOGPS logP 3.94 ChemAxon logS -6.2 ALOGPS pKa (Strongest Acidic) 15.12 ChemAxon pKa (Strongest Basic) -2.7 ChemAxon Physiological Charge 0 ChemAxon Hydrogen Acceptor Count 10 ChemAxon Hydrogen Donor Count 1 ChemAxon Polar Surface Area 103.3 Å2 ChemAxon Rotatable Bond Count 37 ChemAxon Refractivity 158.33 m3·mol-1 ChemAxon Polarizability 74.51 Å3 ChemAxon Number of Rings 0 ChemAxon Bioavailability 0 ChemAxon Rule of Five No ChemAxon Ghose Filter No ChemAxon Veber's Rule No ChemAxon MDDR-like Rule No ChemAxon
- Predicted ADMET Features
- Not Available
- Mass Spec (NIST)
- Download (10.2 KB)
Spectrum Spectrum Type Splash Key Predicted MS/MS Spectrum - 10V, Positive (Annotated) Predicted LC-MS/MS Not Available Predicted MS/MS Spectrum - 20V, Positive (Annotated) Predicted LC-MS/MS Not Available Predicted MS/MS Spectrum - 40V, Positive (Annotated) Predicted LC-MS/MS Not Available Predicted MS/MS Spectrum - 10V, Negative (Annotated) Predicted LC-MS/MS Not Available Predicted MS/MS Spectrum - 20V, Negative (Annotated) Predicted LC-MS/MS Not Available Predicted MS/MS Spectrum - 40V, Negative (Annotated) Predicted LC-MS/MS Not Available
Drug created at September 14, 2010 16:21 / Updated at September 29, 2022 07:52