Polidocanol

Polidocanol is a Sclerosing Agent in the Drug for Multiple Sclerosis class.

The maximum blood concentrations (Cmax) were reached in 15 mins. The volume of distribution of Polidocanol is 35-82L. The half-life of Polidocanol is approximately 1.5 h.

Polidocanol shows side effects like Bleeding, Severe pain, burning, or irritation in legs, Discoloration of the skin, Severe headache, Itching, etc.

Polidocanol is available in the form of Injectable solution and injectable foam.

Polidocanol is available in India, the US, Australia, China, Japan, Canada, Spain and New Zealand.

Polidocanol belongs to the Drug for Multiple Sclerosis class and acts as a Sclerosing agent.

Polidocanol acts by irritation of the vein intimal endothelium and causes thrombosis formation leading to occlusion of the injected vein.

The Onset of action of Polidocanol is not clinically established.

The Time to peak plasma concentration of Polidocanol is approximately 15 mins.

Polidocanol is available in the form of Injectable solution and injectable foam.

Polidocanol injectable solution is given via intravenous route and foam is Administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into the varicosities within 75 seconds of extraction from canister.

Polidocanol is used for the treatment of uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the legs. In this condition, the veins become large, twisted and swollen when the vein valves do not work properly. Polidocanol is not recommended for use in patients less than 18 years of age.

Polidocanol is a Sclerosing Agent in the Drug for Multiple Sclerosis class.

Polidocanol acts by irritating the vein intimal endothelium and causes thrombosis formation, leading to occlusion of the injected vein.

Polidocanol is approved for use in the following clinical indications

Polidocanol (Injectable foam) is indicated for treating incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Polidocanol improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

• Varicose veins

Intravenous route:

Reticular veins (1 to 3 mm diameter): 0.1 to 0.3 mL of 1% solution per injection (maximum: 10 mL per session); may repeat in 7 to 14 days.

Spider veins (≤1 mm diameter): 0.1 to 0.3 mL of 0.5% solution per injection (maximum: 10 mL per session); may repeat in 7 to 14 days.

Injectable foam: Great saphenous veins and accessory saphenous veins: Up to 5 mL of 1% solution per injection (maximum: 5 mL per injection; 15 mL per session); may repeat in ≥5 days.

Polidocanol is available in various strengths, such as 0.5% and 1%.

Polidocanol is available in the form of Injectable solution and injectable foam.

Polidocanol is contraindicated in patients with

• Polidocanol is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases.

• Anaphylaxis/hypersensitivity reaction

Severe allergic reactions, including anaphylaxis and fatal anaphylactoid reactions have been reported with polidocanol. More frequent with larger volumes (>3 mL); therefore, dose should be minimized. Observe 10 to 20 minutes following injection to monitor for hypersensitivity/anaphylactic reaction; emergency resuscitation equipment should be available.

• Arterial embolism

Stroke, TIA, MI, and impaired cardiac function have been reported with IV solution. It may be caused by air embolism when using polidocanol IV solution foamed with room air or thromboembolism. Avoid using polidocanol IV solution foamed with room air; safety and efficacy have not been established.

• Thromboembolism

Thrombosis and subsequent pulmonary embolism or other thrombotic events can occur. Use with caution in patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, recent (≤3 months of age) major surgery, or prolonged hospitalization; increased risk for thrombosis.

• Extravasation

Polidocanol has to be administered very carefully to avoid extravasation, as this can cause severe tissue necrosis.

It is not known whether polidocanol is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for severe adverse reactions in nursing infants, avoid administering them to a nursing woman.

Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus. There are no adequate and well-controlled studies in humans, but potential benefits may warrant drug use in pregnant women despite potential risks.

Common

Hematoma at the injection site, irritation at the injection site, local discolouration, pain at the injection site, local pruritus, a warm sensation at the injection site, and Venous thrombosis at the injection site.

Rare

Allergic dermatitis, anaphylactic shock, angioedema, asthma, cerebrovascular accident, circulatory shock, confusion, deep vein thrombosis, dizziness, dyspnea, fever, flushing, hypertrichosis, loss of consciousness, migraine, neurologic injury, palpitations, paresthesia, pulmonary embolism, skin hyperpigmentation, tissue necrosis at injection site, urticaria, vasculitis, vasodepressor syncope.

No drug-drug interactions have been studied with Polidocanol.

The common side effects of Polidocanol include the following:

Common side effects

Bleeding, Severe pain, burning, or irritation in legs. Discolouration of the skin, Severe headache, Itching, Swelling, warmth, or redness in one or both legs, Numbness, Dizziness, Swelling and redness at the injection site, and Trouble breathing.

• Pregnancy

Pregnancy Category C

Polidocanol has been shown to have an embryocidal effect in rabbits when given in doses approximately equal (based on body surface area) to the human dose. This effect may have been secondary to maternal toxicity. There are no adequate and well-controlled studies in pregnant women. Polidocanol should not be used during pregnancy.

• Nursing Mothers

It is not known whether polidocanol is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for severe adverse reactions in nursing infants, avoid administering them to a nursing woman.

• Pediatric Use

The safety and effectiveness of Polidocanol in pediatric patients have not been established.

• Geriatric Use

Clinical studies of Polidocanol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

• Pharmacodynamic

Polidocanol has a concentration and volume-dependent damaging effect on the blood vessel endothelium.

• Pharmacokinetics

Absorption

The maximum blood concentrations (Cmax) were reached in 15 minutes.

Distribution

The volume of distribution of Polidocanol is 35-82L.

Metabolism and Excretion

The half-life of Polidocanol is approximately 1.5 h.

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021201s002lbl.pdf
• https://go.drugbank.com/drugs/DB06811
• https://www.uptodate.com/contents/polidocanol-drug-information?search=polidocanol&source=panel_search_result&selectedTitle=1~24&usage_type=panel&kp_tab=drug_general&display_rank=1
• https://www.drugs.com/cdi/polidocanol.html