polidocanol

Action and Spectrum

Actions and Spectrum: 

polidocanol is a local anesthetic and sclerosing agent that is used in the treatment of varicose veins and spider veins. It is a detergent-like compound that acts by disrupting the cell membranes of endothelial cells, causing them to undergo necrosis and eventually leading to the formation of a fibrous clot within the treated vein. 

polidocanol works by decreasing the surface tension of the liquid lining the inside of the vein, causing it to collapse and close off. The body then naturally reabsorbs the closed vein over time. 

polidocanol is effective in treating both small and large varicose veins, as well as spider veins. It is typically administered through injection directly into the affected vein. 

polidocanol is also used as a local anesthetic for various surgical and medical procedures. It acts by blocking the nerve impulses that transmit pain signals, providing local pain relief. 

Drug Interaction

Adverse Reaction

Frequency defined 

>10% 

Asclera 

Injection site discoloration (38%)  

Injection site irritation (41%)  

Injection site hematoma (42%)  

Injection site warmth (16%)  

Injection site pruritus (19%)  

Injection site pain (24%) 

Varithena 

Infusion site thrombosis (16.1%) 

Pain in extremity (16.8%)  

Injection site pain/tenderness (10.7%)  

Limb discomfort (12.1%)  

Contusion/injection site hematoma (15.4%) 

1-10% 

Asclera 

Injection site thrombosis (6%) 

Neovascularization (8%) 

Varithena 

Superficial thrombophlebitis (5.4%)  

Deep vein thrombosis (4.7%)  

Venous thrombosis limb (8.1%) 

Black Box Warning

Contraindication / Caution

Contraindication/Caution: 

Contraindication 

polidocanol is contraindicated in patients with a known hypersensitivity to the medication or any of its components. It should also not be used in patients with acute thromboembolic disease, such as deep vein thrombosis, or in patients with active local or systemic infection. Additionally, polidocanol should not be used in pregnant or breastfeeding women, as its effects on the fetus or infant are not known. Patients with significant medical conditions, such as severe heart or lung disease, should be evaluated by a healthcare provider before undergoing polidocanol treatment. 

Caution 

• Allergic reactions: While rare, patients may experience allergic reactions to polidocanol. Signs of an allergic reaction include breathing difficulty, hives and swelling of the face, tongue, lips or throat. If an allergic reaction is suspected, treatment should be stopped immediately, and medical attention should be sought. 
• Coagulation disorders: Patients with a history of bleeding disorders or those taking anticoagulants should be evaluated by a healthcare provider before undergoing polidocanol treatment. polidocanol can cause blood clots and may increase the risk of bleeding in patients with coagulation disorders. 
• Infection: polidocanol should not be administered to patients with active local or systemic infections. Infection at the injection site may occur and should be treated appropriately if it does occur. 
• Pregnancy and breastfeeding: The safety of polidocanol use during pregnancy or while breastfeeding is not known. Women who are pregnant or breastfeeding have to consult with their physician before undergoing treatment. 
• Children and elderly patients: The safety and efficacy of polidocanol have not been established in children or elderly patients. Use in these populations should be evaluated on an individual basis by a healthcare provider. 
• Concurrent use with other medications: Patients should inform their healthcare provider of any medications they are taking before undergoing polidocanol treatment. The safety and efficacy of polidocanol in combination with other medications have not been established. 

Pregnancy / Lactation

Pregnancy consideration:  

US FDA pregnancy category: C 

Lactation:   

Excreted into human milk is Not known.   

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies do not show risk to the fetus in the first/later trimester.        
• Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women        
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.       
• Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.        
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.        
• Category N: There is no data available for the drug under this category 

Pharmacology

Pharmacology: 

polidocanol is a local sclerosing agent that is generally used to treat spider veins and varicose veins. It works by damaging the inner lining of the affected vein, leads to collapse and eventually be reabsorbed into the body. This helps to reduce the varicose veins appearance and relieve associated symptoms such as pain, swelling, and discomfort. 

Pharmacodynamics: 

polidocanol is a member of the family of alcohol-based sclerosing agents, which work by causing endothelial damage in the vein, leading to inflammation and eventually fibrosis. The exact mechanism of action of polidocanol is unknown, but it is thought to cause disruption of the endothelial cell membrane, leading to intracellular calcium influx, cellular swelling, and ultimately cell death. 

Pharmacokinetics: 

Absorption 

polidocanol is administered directly into the affected vein as an injectable solution. The rate, extent of absorption depend on the site of injection, the volume injected, and the injection technique. Following injection, polidocanol is rapidly absorbed into the bloodstream and distributed throughout the body. 

Distribution 

polidocanol is distributed throughout the body after absorption and is primarily metabolized in the liver. The drug does not appear to accumulate in any specific tissue or organ, and it does not bind to plasma proteins. 

Metabolism 

polidocanol is metabolized in the liver via oxidation and ester hydrolysis. The primary metabolites of polidocanol are ethanol and a variety of fatty acid esters, which are eliminated in the urine. 

Elimination and Excretion 

The elimination half-life of polidocanol is short, approximately 2-3 minutes, and the drug is rapidly eliminated from the body via renal excretion. 

Adminstartion

Administration: 

Intravenous administration 

polidocanol is typically administered through injection directly into the affected vein. The injection is usually given with a small needle, and the amount of polidocanol injected depends on size of the vein being treated. The healthcare provider may use ultrasound guidance to ensure the injection is given into the correct location. 

The patient may be instructed to wear compression stockings or bandages after the injection to help compress the treated vein and promote healing. Patients are advised to avoid strenuous exercise or activities for a period of time after the injection. 

polidocanol injections are usually given as an outpatient procedure and can be performed in a doctor’s office or clinic setting. The injection may cause some discomfort or pain, and patients may experience bruising, redness, itching, or swelling at the injection site. Patients should discuss any concerns they have about the injection procedure with their healthcare provider.

Patient Information Leaflet

Patient information leaflet 

Generic Name: polidocanol 

Pronounced: [pol-ee-doe-KAY-nol] 

Why do we use polidocanol? 

polidocanol is primarily used as a sclerosing agent to treat varicose veins and spider veins. It works by damaging the inner lining of the affected vein, leads to collapse and eventually be reabsorbed into the body. This helps to reduce the varicose veins appearance and relieve associated symptoms such as pain, swelling, and discomfort. 

polidocanol is also used in other medical procedures, such as foam sclerotherapy and endovenous laser treatment (EVLT), to treat varicose veins and other vein-related conditions. In foam sclerotherapy, polidocanol is mixed with air or another gas to create a foam that is injected into the affected vein. In EVLT, a laser is used to heat the vein and polidocanol is then injected to help close the vein. 

In addition to its use in treating varicose veins, polidocanol is sometimes used off-label for other conditions such as hemorrhoids, lymphedema, and chronic venous insufficiency. However, the safety and efficacy of polidocanol for these conditions have not been established by the FDA.