Polidocanol
Regulatory sources consulted
Approved indications
- Sclerotherapy of uncomplicated spider veins up to 1 mm and uncomplicated reticular veins 1–3 mm in diameter in the lower extremities. It has not been studied in varicose veins larger than 3 mm.
- Spanish profile (Etoxisclerol): sclerotherapy of varicose veins and telangiectasias; concentration is selected according to varicose vein size and severity, and the lower concentration is chosen when in doubt.
Contraindications
Absolute
- Known allergy to polidocanol.
- Acute thromboembolic disease.
- Spanish profile: immobilization.
- Spanish profile: severe acute systemic disease, especially when untreated.
- Spanish profile: severe occlusive arterial disease, Fontaine stage III or IV.
- Spanish profile: high thrombosis risk, such as known inherited thrombophilia or multiple thrombotic risk factors.
- Spanish microfoam profile: known symptomatic right-to-left shunt, such as patent foramen ovale.
Clinical warnings
- Major warning · Anaphylaxis, including fatal reactions, may occur; minimize the dose, have emergency treatment available and observe after injection. — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bb1f342b-5352-4059-a0b2-e60fd652fd28
- Major warning · Venous thrombosis, pulmonary embolism and other thrombotic events may occur; follow the administration technique and monitor for thrombosis, especially with reduced mobility, thromboembolic history, recent surgery or hospitalization, or pregnancy. — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bb1f342b-5352-4059-a0b2-e60fd652fd28
- Major warning · Do not inject intra-arterially: arterial injection or extravasation may cause ischemia, necrosis or gangrene. Use the smallest effective volume and urgently consult vascular surgery after an arterial injection. — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bb1f342b-5352-4059-a0b2-e60fd652fd28
- Major warning · US profile (Asclera): avoid foam prepared with room air; its safety and effectiveness have not been established, and arterial embolism, stroke, transient ischemic attack, myocardial infarction and impaired cardiac function have been reported. — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bb1f342b-5352-4059-a0b2-e60fd652fd28
Drug interactions
- ModerateOther local anesthetics
Mechanism: Lauromacrogol 400 has local anesthetic activity and may produce additive cardiovascular effects with other anesthetics.
Recommendation: Assess the additive effect and monitor cardiovascular function when they are combined.
https://cima.aemps.es/cima/dochtml/ft/55550/FT_55550.html
Adverse events
Common (≥1%)
Injection-site hematoma · Injection-site irritation · Injection-site discoloration · Injection-site pain · Injection-site pruritus or warmth · Neovascularization
Rare but serious
Anaphylaxis or anaphylactic shock · Deep vein thrombosis or pulmonary embolism · Stroke, loss of consciousness or circulatory collapse · Injection-site necrosis or nerve injury
Pregnancy and lactation
US profile (Asclera): available case reports have not identified an associated risk, but there is minimal benefit in treating uncomplicated varicose veins during pregnancy and they may regress after delivery; during breastfeeding, interruption with pumping and discarding milk for up to 8 hours may be considered. Spanish profile (Etoxisclerol): if sclerotherapy is necessary during breastfeeding, interrupt breastfeeding for 2–3 days.
Recent literature (PubMed)
This review article provides an updated review of a relatively common pathology with various manifestations. Superficial venous diseases (SVDs) are a broad spectrum of venous vascular disease that predominantly affects the body's lower extremities. The most serious manifestation of this disease includes varicose veins, chronic venous insufficiency, stasis dermatitis, venous ulcers, superficial venous thrombosis, reticular veins, and spider telangiectasias. The anatomy, pathophysiology, and risk factors of SVD were discussed during this review. The risk factors for developing SVD were related to race, age, sex, lifestyle, and certain genetic conditions as well as comorbid deep vein thrombosis. Various classification systems were listed, focusing on the most common one-the revised Clinical-Etiology-Anatomy-Pathophysiology classification. The clinical features including history and physical examination findings elicited in SVD were outlined. Imaging modalities utilized in SVD were highlighted. Duplex ultrasound is the first line in evaluating SVD but magnetic resonance imaging and computed tomography venography, plethysmography, and conventional venography are feasible options in the event of an ambiguous venous duplex ultrasound study. Treatment options highlighted in this review ranged from conservative treatment with compression stockings, which could be primary or adjunctive to pharmacologic topical and systemic agents such as azelaic acid, diuretics, plant extracts, medical foods, nonsteroidal anti-inflammatory drugs, anticoagulants and skin substitutes for different stages of SVD. Interventional treatment modalities include thermal ablative techniques like radiofrequency ablationss, endovenous laser ablation, endovenous steam ablation, and endovenous microwave ablation as well as nonthermal strategies such as the Varithena (polidocanol microfoam) sclerotherapy, VenaSeal (cyanoacrylate) ablation, and Endovenous mechanochemical ablation. Surgical treatments are als
Skin hyperpigmentation after sclerotherapy with polidocanol-containing sclerosants is a common local side effect. Sclerotherapists should be familiar with factors that trigger hyperpigmentation after sclerotherapy with polidocanol-containing sclerosants. A systematic literature review of works reporting hyperpigmentation after sclerotherapy for telangiectasias, reticular veins, side branches and truncal varices with polidocanol-containing sclerosants was performed. Reported incidence rates, follow-up periods and potentially triggering factors were assessed and analysed. The search yielded 1687 results; of these, 27 reports met the inclusion criteria. The incidence of hyperpigmentation seemed to increase with higher concentrations of polidocanol and was more evident after sclerotherapy for epifascial veins than for intrafascial truncal veins when the polidocanol concentration was more than 0.25%. Regarding sclerotherapy for telangiectasias and reticular veins, the incidence of hyperpigmentation ranged between 2% and 25% for polidocanol 0.25% (liquid and foam), between 12.5% and 67.9% for polidocanol 0.5% (liquid and foam) and between 13% and 73% for polidocanol 1% (liquid and foam). Regarding truncal veins, the incidence ranged from 7% to 45.8% for polidocanol 1% (liquid and foam), from 16% to 17% for polidocanol 2% (foam) and from 7.4% to 32.5% for polidocanol 3% (liquid and foam). Regarding the treatment of side branches, the incidence of hyperpigmentation ranged from 5.6% to 53% for both foam and liquid sclerotherapy. Regarding the duration of hyperpigmentation, there are few data describing reticular veins and telangiectasias. Hyperpigmentation persisting for more than 6 months has been reported to have an incidence of up to 7.5%. Hyperpigmentation persisting for more than 1 year after foam polidocanol 1%-3% treatment for truncal veins has an incidence ranging from 8.1% to 17.5%. Other factors such as higher volumes and compression therapy after treatment seem to
The Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society collaborated to update the 2011 Society for Vascular Surgery/American Venous Forum clinical practice guidelines and provide new evidence-based recommendations on critical issues affecting the care of patients with varicose veins. Each recommendation is based on a recent, independent systematic review and meta-analysis of the diagnostic tests and treatments options for patients with lower extremity varicose veins. Part I of the guidelines includes evidence-based recommendations for the evaluation of patients with CEAP (Clinical Class, Etiology, Anatomy, Pathology) class 2 varicose vein using duplex ultrasound scanning and other diagnostic tests, open surgical treatment (ligation and stripping) vs endovenous ablation techniques, thermal vs nonthermal ablation of the superficial truncal veins, and management of incompetent perforating veins in CEAP class 2 disease. We have also made recommendations on the concomitant vs staged treatment of varicose tributaries using phlebectomy or liquid or foam sclerotherapy (with physician-compounded foam or commercially prepared polidocanol endovenous microfoam) for patients undergoing ablation of incompetent superficial truncal veins.
Varicose veins are enlarged and tortuous veins, affecting up to one-third of the world's population. They can be a cause of chronic venous insufficiency, which is characterised by oedema, pigmentation, eczema, lipodermatosclerosis, atrophie blanche, and healed or active venous ulcers. Injection sclerotherapy (liquid or foam) is widely used for treatment of varicose veins aiming to transform the varicose veins into a fibrous cord. However, there is limited evidence regarding its effectiveness and safety, especially in patients with more severe disease. This is the second update of the review first published in 2002. To assess the effectiveness and safety of injection sclerotherapy for the treatment of varicose veins. For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, AMED, CINAHL, and LILACS databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries, on 20 July 2021. We included all randomised controlled trials (RCTs) (including cluster-randomised trials and first phase cross-over studies) that used injection sclerotherapy for the treatment of varicose veins. Two review authors independently assessed, selected and extracted data. Disagreements were cross-checked by a third review author. We used Cochrane's Risk of bias tool to assess the risk of bias. The outcomes of interest were cosmetic appearance, complications, residual varicose veins, quality of life (QoL), persistence of symptoms, and recurrent varicose veins. We calculated risk ratios (RRs) or mean difference (MD) with 95% confidence intervals (CIs). We used the worst-case-scenario for dichotomous data imputation for intention-to-treat analyses. For continuous outcomes, we used the 'last-observation-carried-forward' for data imputation if there was balanced loss to follow-up. We assessed the certainty of the evidence using the GRADE approach. We i