POLIDOCANOL

Description
Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205098s005lbledt.pdfhttps://www.ncbi.nlm.nih.gov/pubmed/22137964
Curator's Comment:: description was created based on several sources, including https://www.ncbi.nlm.nih.gov/pubmed/64441 | https://www.ncbi.nlm.nih.gov/pubmed/64442

Dodecyl Ethyleneglycol Monoether (lauryl ethoxylate) is a nonionic compound, that used as environmentally friendly non-Ionic surfactant with marked antibacterial activity. Dodecyl Ethyleneglycol Monoether is effective permeation enhancer, both for the passive process as well as for samples subjected to iontophoresis.

CNS Activity

Originator

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
Target ID: lipid cell membrane Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205098s005lbledt.pdf	Binding Agent 996

Conditions

Condition	Modality	Highest Phase	Product
Unknown 2502
Spider veins 2 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf	Curative	Approved 8043	ASCLERA Approved Use Asclera® (polidocanol) is indicated to sclerose 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. Asclera has not been studied in varicose veins more than 3 mm in diameter. Asclera (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 has not been studied in larger varicose veins > 3 mm in diameter. (1) Launch Date 1.26990719E12
Reticular veins 2 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf http://www.jvascsurg.org/article/S0741-5214%2804%2901277-7/fulltext?refuid=S1876-4983%2808%2900007-6&refissn=1876-4983&mobileUi=0#sec4.7	Curative	Approved 8043	ASCLERA Approved Use Asclera® (polidocanol) is indicated to sclerose 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. Asclera has not been studied in varicose veins more than 3 mm in diameter. Asclera (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 has not been studied in larger varicose veins > 3 mm in diameter. (1) Launch Date 1.26990719E12
Incompetent saphenous veins 2 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205098s005lbledt.pdf	Primary	Approved 8043	Varithena Approved Use Varithena™ (polidocanol injectable foam) is a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena™ improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. Launch Date 1.33894085E12
Visible varicosity of the great saphenous vein system 2 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205098s005lbledt.pdf	Primary	Approved 8043	Varithena Approved Use Varithena™ (polidocanol injectable foam) is a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena™ improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. Launch Date 1.33894085E12

PubMed

Title	Date	PubMed
Local therapeutic injection in bleeding peptic ulcer: a comparison of adrenaline to adrenaline plus a sclerosing agent.	2002 Jul	12432836
[Local sclerosing treatment with etoxiesclerol in ORL disease: Rendu-Osler disease, granuloma, angioma...].	2002 Nov	12584880
Specific accumulation and growth inhibitory effects of hybrid liposomes to hepatoma cells in vitro.	2002 Nov 18	12392725
The effects of water-soluble cyclodextrins on the histological integrity of the rat nasal mucosa.	2002 Oct 10	12270606
A new therapeutic approach for treatment of hydatid cysts of the spleen.	2002 Sep	12353852
Evaluation of bioadhesive properties of excipients containing lipophilic adjuvants.	2003	15058109
The efficacy of polidocanol in pleurodesis in rats.	2003	12928847
Long term results of compression sclerotherapy.	2003	12839217
Pretreatment with a water-based surfactant formulation affects transdermal iontophoretic delivery of R-apomorphine in vitro.	2003 Apr	12739775
Venous lake of the lip treated with a sclerosing agent: report of two cases.	2003 Apr	12656828
An unusual complication of facial sclerotherapy.	2003 Apr	12656827
Endoscopic obliteration of a recurrent tracheoesophageal fistula with enbucrilate and polidocanol in a child.	2003 Apr	12582778
The multidrug resistance protein ABCC1 drug-binding domains show selective sensitivity to mild detergents.	2003 Apr 18	12684054
Solubilization of adenylyl cyclase from human myometrium in a alphas-coupled form.	2003 Aug	14748538
Endoscopic sclerotherapy compared with no specific treatment for the primary prevention of bleeding from esophageal varices. A randomized controlled multicentre trial [ISRCTN03215899].	2003 Aug 15	12919638
Evaluation of the efficacy of polidocanol in the form of foam compared with liquid form in sclerotherapy of the greater saphenous vein: initial results.	2003 Dec	14725657
Influence of nonionic surfactants on the chromatographic behaviour of proteins in hydrophobic interaction chromatography.	2003 Dec	14648612
[The place of endoscopic treatment in hemorrhagic ulcers].	2003 Feb 8	12610466
Short- and medium-term clinical efficacy of three endoscopic therapies for achalasia: a single-blinded prospective study.	2003 Jan	12760727
Purification and characterization of catalytic domains of gelatinase A with or without fibronectin insert for high-throughput inhibitor screening.	2003 Jan	12509986
[Endoscopic therapy for esophageal and gastric varices].	2003 Jan 10	12652704
[Favorable results with duplex-guided compression sclerotherapy for varices of the small saphenous vein; a retrospective study].	2003 Jan 18	12577772
[Sclerotherapy of female varicocele].	2003 Jan-Feb	12828000
Membrane cholesterol regulates LFA-1 function and lipid raft heterogeneity.	2003 Jul 1	12637320
Phlebography: why it is important to study radiological imaging of spermatic veins.	2003 Mar	12741350
From clinical evidence to everyday practice: implementing findings from a cost-effectiveness analysis for endoscopic injection therapy for upper-gastrointestinal bleeding.	2003 Mar	12610325
Treatment of venous malformations with sclerosant in microfoam form.	2003 Nov	14623700
Clinical evaluation of combined endoscopic variceal ligation and sclerotherapy of gastric varices in liver cirrhosis.	2003 Nov	14606017
Sclerotherapy treatment of telangiectasias and varicose veins.	2003 Sep	14614695
Sclerosing therapy in chronic Achilles tendon insertional pain-results of a pilot study.	2003 Sep	12925869
Investigation of the phase behavior and an evaporation study of systems of lavender oil, water, Laureth 4, and Tween 80.	2003 Sep-Oct	14605685
Comparison of argon plasma coagulation and paravariceal injection sclerotherapy with 1% polidocanol in mucosa-fibrosing therapy for esophageal varices.	2004	15168254
[Sclerotherapy of small pelvis varicosis].	2004	15163996
[Sclerosing treatment of vascular malformations].	2004	15148517
Comparison and sequential study of long pulsed Nd:YAG 1,064 nm laser and sclerotherapy in leg telangiectasias treatment.	2004	15022257
The time-dependent distribution of phosphorylated intermediates in native sarcoplasmic reticulum Ca2+-ATPase from skeletal muscle is not compatible with a linear kinetic model.	2004 Apr 13	15065885
Detergents profoundly affect inhibitor potencies against both cyclo-oxygenase isoforms.	2004 Feb 1	14510637
Effect of cutaneously applied nonionic surfactants and local anesthetic bases on thermal sensations.	2004 Jan	14964422
Treatment of subcutaneous dialysate leak with polidocanol: case report.	2004 Jan-Feb	15104351
Argon plasma coagulation versus injection sclerotherapy in peptic ulcer hemorrhage--a prospective, controlled study.	2004 Jan-Feb	15011856
A randomized study of the safety of outpatient care for patients with bleeding peptic ulcer treated by endoscopic injection.	2004 Jul	15229419
Chronic tendon pain--implications for treatment: an update.	2004 Jul	15216906
Effect of membrane perturbants on the activity and phase distribution of inositol phosphorylceramide synthase; development of a novel assay.	2004 Jul 6	15222759
Ultrasound-guided injection of polidocanol microfoam in the management of venous leg ulcers.	2004 Jun	15210456
Single-blind, randomized study comparing chromated glycerin, polidocanol solution, and polidocanol foam for treatment of telangiectatic leg veins.	2004 Mar	15008862
Nitric oxide transfer from the NO-donor S-nitroso-N-acetylpenicillamine to monomers and dimers of water-soluble iron-porphyrins.	2004 Mar	14987846
Efficacy of endoscopic clipping for actively bleeding peptic ulcer: comparison with polidocanol injection therapy.	2004 Mar-Apr	15086170
[An elderly case of acute myelocytic leukemia complicated with bleeding gastric angiodysplasia, successfully treated with topical endoscopic polidocanol injection].	2004 May	15237754
Perforans varicosis: treatment of the incompetent perforating vein is important.	2004 May	15099319
Efficacy of sclerotherapy in varicose veins-- prospective, blinded, placebo-controlled study.	2004 May	15099314

Patents

Sample Use Guides

In Vivo Use Guide

Varithena (Polidocanol): Up to 5 mL per injection and no more than 15 mL per session Asclera (Polidocanol): 0.1 to 0.3 mL per injection and no more than 10 mL per session.

Route of Administration: Intravenous

In Vitro Use Guide

Human great saphenous vein in vitro model. Median endothelial cell loss with 3% polidocanol was 63.5% (62.2–82.8) at 5 min. of polidocanol exposure and 85.9% (83.8–92.5) at 15 min.

Name

Type

Language

POLIDOCANOL

Common Name

English

LAUROMACROGOL 450

Common Name

English

LAUROMACROGOL [JAN]

Common Name

English

LAUROMACROGOL 400

Official Name

English

LAURETH 9 [USAN]

Common Name

English

AETHOXY-SKLEROL

Common Name

English

POLYETHYLENE GLYCOL 450 LAURYL ETHER

Common Name

English

10XBIO

Common Name

English

NONAETHYLENE GLYCOL MONODODECYL ETHER

Common Name

English

PEG-9 LAURYL ETHER

Common Name

English

10XB-101

Common Name

English

MARLIPAL 24/90

Brand Name

English

VARITHENA

Brand Name

English

LAUROMACROGOL 400 [MART.]

Common Name

English

LAURETH-9 [INCI]

Common Name

English

NIKKOL BL-9EX

Brand Name

English

POLIDOCANOL [VANDF]

Common Name

English

POLYOXYL 9 LAURYL ETHER [USP-RS]

Common Name

English

LAURETH 9

Official Name

English

POLIDOCANOL [MI]

Common Name

English

POLYETHYLENE GLYCOL MONOLAURYL ETHER (N=9)

Common Name

English

POLYOXYL 9 LAURYL ETHER

Common Name

English

LAUROMACROGOL 400 [INN]

Common Name

English

MACROGOL 9 LAURYL ETHER

Common Name

English

POLIDOCANOL [WHO-DD]

Common Name

English

POLIDOCANOL [ORANGE BOOK]

Common Name

English

POLIDOCANOL [JAN]

Common Name

English

NONAOXYETHYLENE MONODODECYL ETHER

Common Name

English

LAUROMACROGOL 400 [EP MONOGRAPH]

Common Name

English

LAURETH-9

Official Name

English

Classification Tree Code System Code

NDF-RT

N0000175814