DescriptionSources: https://www.ncbi.nlm.nih.gov/pubmed/22137964http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205098s005lbledt.pdfCurator's Comment: description was created based on several sources, including
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf
http://www.drugbank.ca/drugs/DB06811
Sources: https://www.ncbi.nlm.nih.gov/pubmed/22137964http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205098s005lbledt.pdf
Curator's Comment: description was created based on several sources, including
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf
http://www.drugbank.ca/drugs/DB06811
Polidocanol is a non-ionic surfactant sclerosing agent indicated to treat uncomplicated spider veins and uncomplicated reticular veins in the lower extremity. Polidocanol also is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee. 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. Adverse reactions include pain in extremity, infusion site thrombosis, contusion/injection site hematoma, limb discomfort and some others.
Originator
Curator's Comment: Polidocanol was synthesized by German chemical/pharmaceutical company BASF and introduced in 1936 as a local and topical anesthetic under the tradename Sch 600. Additional resources: http://www.lovelylegs.com/treatments/sclerotherapy/history/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2787977/
Approval Year
Targets
| Primary Target | Pharmacology | Condition | Potency |
|---|---|---|---|
Target ID: lipid cell membrane |
Conditions
| Condition | Modality | Targets | Highest Phase | Product |
|---|---|---|---|---|
| Curative | ASCLERA Approved UseAsclera® (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 Date2010 |
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| Curative | ASCLERA Approved UseAsclera® (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 Date2010 |
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| Primary | Varithena Approved UseVarithena™ (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 Date2012 |
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| Primary | Varithena Approved UseVarithena™ (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 Date2012 |
PubMed
| Title | Date | PubMed |
|---|---|---|
| Effect of membrane perturbants on the activity and phase distribution of inositol phosphorylceramide synthase; development of a novel assay. | 2004-07-06 |
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| A randomized study of the safety of outpatient care for patients with bleeding peptic ulcer treated by endoscopic injection. | 2004-07 |
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| Chronic tendon pain--implications for treatment: an update. | 2004-07 |
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| Ultrasound-guided injection of polidocanol microfoam in the management of venous leg ulcers. | 2004-06 |
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| [An elderly case of acute myelocytic leukemia complicated with bleeding gastric angiodysplasia, successfully treated with topical endoscopic polidocanol injection]. | 2004-05 |
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| Perforans varicosis: treatment of the incompetent perforating vein is important. | 2004-05 |
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| Efficacy of sclerotherapy in varicose veins-- prospective, blinded, placebo-controlled study. | 2004-05 |
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| Treatment of subcutaneous dialysate leak with polidocanol: case report. | 2004-04-24 |
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| Efficacy of endoscopic clipping for actively bleeding peptic ulcer: comparison with polidocanol injection therapy. | 2004-04-17 |
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| The time-dependent distribution of phosphorylated intermediates in native sarcoplasmic reticulum Ca2+-ATPase from skeletal muscle is not compatible with a linear kinetic model. | 2004-04-13 |
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| Argon plasma coagulation versus injection sclerotherapy in peptic ulcer hemorrhage--a prospective, controlled study. | 2004-03-12 |
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| Single-blind, randomized study comparing chromated glycerin, polidocanol solution, and polidocanol foam for treatment of telangiectatic leg veins. | 2004-03 |
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| Nitric oxide transfer from the NO-donor S-nitroso-N-acetylpenicillamine to monomers and dimers of water-soluble iron-porphyrins. | 2004-03 |
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| Detergents profoundly affect inhibitor potencies against both cyclo-oxygenase isoforms. | 2004-02-01 |
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| Effect of cutaneously applied nonionic surfactants and local anesthetic bases on thermal sensations. | 2004-01 |
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| Comparison of argon plasma coagulation and paravariceal injection sclerotherapy with 1% polidocanol in mucosa-fibrosing therapy for esophageal varices. | 2004 |
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| [Sclerotherapy of small pelvis varicosis]. | 2004 |
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| [Sclerosing treatment of vascular malformations]. | 2004 |
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| Comparison and sequential study of long pulsed Nd:YAG 1,064 nm laser and sclerotherapy in leg telangiectasias treatment. | 2004 |
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| Evaluation of the efficacy of polidocanol in the form of foam compared with liquid form in sclerotherapy of the greater saphenous vein: initial results. | 2003-12 |
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| Influence of nonionic surfactants on the chromatographic behaviour of proteins in hydrophobic interaction chromatography. | 2003-12 |
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| Treatment of venous malformations with sclerosant in microfoam form. | 2003-11 |
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| Clinical evaluation of combined endoscopic variceal ligation and sclerotherapy of gastric varices in liver cirrhosis. | 2003-11 |
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| Percutaneous sclerotherapy for venous malformations using polidocanol under fluoroscopy. | 2003-10 |
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| Injection of polidocanol foam (PF) in varicose veins as a trigger for attacks of migraine with visual aura. | 2003-10 |
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| A therapeutic alternative in the treatment of epididymal cysts: percutaneous sclerotherapy. | 2003-09-02 |
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| Sclerotherapy treatment of telangiectasias and varicose veins. | 2003-09 |
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| Severe pruritus in a patient with urticaria pigmentosa treated with topical 5% urea and 3% polidocanol cream. | 2003-09 |
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| Is vasculo-neural ingrowth the cause of pain in chronic Achilles tendinosis? An investigation using ultrasonography and colour Doppler, immunohistochemistry, and diagnostic injections. | 2003-09 |
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| Sclerosing therapy in chronic Achilles tendon insertional pain-results of a pilot study. | 2003-09 |
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| Endoscopic sclerotherapy compared with no specific treatment for the primary prevention of bleeding from esophageal varices. A randomized controlled multicentre trial [ISRCTN03215899]. | 2003-08-15 |
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| Solubilization of adenylyl cyclase from human myometrium in a alphas-coupled form. | 2003-08 |
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| Membrane cholesterol regulates LFA-1 function and lipid raft heterogeneity. | 2003-07-01 |
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| [Sclerotherapy of female varicocele]. | 2003-06-28 |
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| Investigation of the phase behavior and an evaporation study of systems of lavender oil, water, Laureth 4, and Tween 80. | 2003-06-16 |
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| [Effect of surfactants on the in vitro and in vivo properties of amphotericin B liposome]. | 2003-06 |
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| The multidrug resistance protein ABCC1 drug-binding domains show selective sensitivity to mild detergents. | 2003-04-18 |
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| Pretreatment with a water-based surfactant formulation affects transdermal iontophoretic delivery of R-apomorphine in vitro. | 2003-04 |
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| Venous lake of the lip treated with a sclerosing agent: report of two cases. | 2003-04 |
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| An unusual complication of facial sclerotherapy. | 2003-04 |
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| Phlebography: why it is important to study radiological imaging of spermatic veins. | 2003-03 |
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| From clinical evidence to everyday practice: implementing findings from a cost-effectiveness analysis for endoscopic injection therapy for upper-gastrointestinal bleeding. | 2003-03 |
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| [The place of endoscopic treatment in hemorrhagic ulcers]. | 2003-02-08 |
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| [Endoscopic therapy for esophageal and gastric varices]. | 2003-01-10 |
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| Short- and medium-term clinical efficacy of three endoscopic therapies for achalasia: a single-blinded prospective study. | 2003-01 |
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| Evaluation of bioadhesive properties of excipients containing lipophilic adjuvants. | 2003 |
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| The efficacy of polidocanol in pleurodesis in rats. | 2003 |
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| Long term results of compression sclerotherapy. | 2003 |
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| [Local sclerosing treatment with etoxiesclerol in ORL disease: Rendu-Osler disease, granuloma, angioma...]. | 2002-11 |
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| The effect of surfactants upon mammalian cells in vitro. | 1976-10 |
Sample Use Guides
In Vivo Use Guide
Curator's Comment: Varithena (Polidocanol): Repeat treatment may be necessary if the size and extent of the veins to be treated require more than 15 mL of Varithena. Separate treatment sessions by a minimum of 5 days. (http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205098s005lbledt.pdf)
Asclera (Polidocanol): Repeat treatments may be necessary if the extent of the varicose veins requires more than 10 ml. These treatments should be separated by 1 to 2 weeks. (http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf)
Unknown
Route of Administration:
Topical
Rat peritoneal mast cells were used for activity evaluation. The mast cells were incubated for 3 hr at 37°C with a range of concentrations of Dodecyl Ethyleneglycol Monoether (from 0.001 to 10.0 mM). The cell density was generally about 1 x 10^5 cells/assay tube. After incubation with the surfactants, the cells were centrifuged and the separated supematant solution and cell pellet were assayed for histamine
| Substance Class |
Polymer
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N0000175814
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464614
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CHEMBL2108373
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DB06811
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SUB77418
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ACTIVE MOIETY |
| Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
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| MOL_WEIGHT:CALCULATED | CHEMICAL |
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