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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.
Results: Successful healing was seen in 58 of 70 patients (83%) after 1 or more injections with polidocanol. In 12 patients (17%), definitive curettage was performed after previous sclerotherapy, which was considered failure of primary sclerotherapy treatment. Trends toward increased risk for >3 treatments or treatment failure included age younger than 5, epiphyseal plate involvement, and lower leg lesions. The only complication was anaphylaxis in 1 patient shortly after injection of polidocanol/contrast agent and ropivacaine, with full recovery after short resuscitation.
Conclusions: Our results show that percutaneous sclerotherapy with polidocanol has high efficacy in the treatment of primary ABC, with a low complication rate. Our only complication may have been an immediate allergic reaction to polidocanol/contrast agent or ropivacaine. Trends toward increased risk for treatment failure were age younger than 5, epiphyseal plate involvement, and lower leg lesions.
The available data from case reports on use of polidocanol-containing products, including ASCLERA, in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Although none of these risks have been identified, there is minimal benefit in treating uncomplicated spider veins and reticular veins in the lower extremity during pregnancy and lower extremity varicosities that develop during pregnancy as they may spontaneously regress postpartum. The animal reproduction studies were conducted in a manner to achieve systemic exposure, while the intended clinical use is local exposure at the injection site with minimal to no systemic exposure; therefore, these data are not relevant to the intended clinical use (see Data).
There are no data on the presence of polidocanol in human milk, the effects on the breastfed infant, or the effects on milk production. A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk up to 8 hours after ASCLERA administration in order to minimize exposure to a breastfed infant.
The active ingredient, polidocanol is a non-ionic detergent, consisting of two components, a polar hydrophilic (dodecyl alcohol) and an apolar hydrophobic (polyethylene oxide) chain. Polidocanol has the following structural formula:
Polidocanol is a sclerosing agent that locally damages the endothelium of blood vessels. When injected intravenously, polidocanol induces endothelial damage. Platelets then aggregate at the site of damage and attach to the venous wall. Eventually, a dense network of platelets, cellular debris, and fibrin occludes the vessel. Finally, the occluded vein is replaced with connective fibrous tissue.
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Varithena (polidocanol injectable foam) is 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.
The use of Varithena is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease. Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately. Varithena can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis. Physicians administering Varithena must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administration of Varithena.
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All health care professionals will now be able to purchase Asclera directly from Merz. This includes specialties such as vascular surgery, interventional radiology, general surgery, plastic surgery, cardiology, vein clinics and vein centers, as well as hospitals. Prescribing information is available online at asclera.com.
The company advised that customers can purchase Asclera directly from Merz by calling 844-4MY-MERZ (844-469-6379). Merz will maintain Asclera part numbers and continue to honor current product list prices. Privately held Merz North America is headquartered in Raleigh, North Carolina. More information is available online at www.merzusa.com.
Question When performing sclerotherapy, are there differences between 0.2% polidocanol diluted in 70% hypertonic glucose (HG) and 75% HG alone to treat reticular veins in the lower limbs
Findings We found that the combination of 0.2% polidocanol diluted in 70% glucose was superior to 75% HG alone in sclerotherapy of reticular veins, with no statistical difference for complications.
Objective To compare the efficacy and safety of 2 sclerosants used to treat reticular veins: 0.2% polidocanol diluted in 70% hypertonic glucose (HG) (group 1) vs 75% HG alone (group 2).
Conclusions and Relevance Sclerotherapy with 0.2% polidocanol diluted in 70% HG was superior to 75% HG alone in sclerosing reticular veins, with no statistical difference for complications. Pigmentation occurred in both groups, with no statistical difference between them. No serious adverse events occurred in either group.
Fig. 1. (a) Clusters of translucent to haemorrhagic papulovesicles along the left inguinal fold prior to treatment with polidocanol sclerotherapy. (b) Significant improvement with few residual papulovesicles following 2 sessions of polidocanol sclerotherapy.
Resource links provided by the National Library of Medicine MedlinePlus related topics: Hemorrhoids Drug Information available for: Polidocanol U.S. FDA Resources Arms and Interventions Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Arm Intervention/treatment Experimental: Polidocanol 3% FoamPatients enrolled in the study, according to the inclusion and exclusion criteria, will undergo sclerotherapy performed with polidocanol foam (Atossisclerol 3%, Chemische Fabrik Kreussler & Co. GmbH, Wiesbaden, Germany). Drug: Polidocanol foam (Atossisclerol 3%)The procedure will be performed in the Sims position or lithotomy position. A modified Blonde-Blanchard technique will be adopted, with the tangential injection of polidocanol foam into the submucosa of the apex of each hemorrhoidal pile, without exceeding three piles, and using a self-lighting open-ended anoscope and a 20-G needle in order to reduce bleeding Outcome Measures Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Primary Outcome Measures : Success Rate 1 [ Time Frame: 12 months follow-up ]To establish the success rate after one sclerotherapy session, in terms of complete resolution of bleeding episodes one week after the injection
Aneurysmal bone cyst is a rare tumour-like lesion which develops during growth. Our aim was to determine the efficacy of the administration of percutaneous intralesional 3% polidocanol (hydroxypolyaethoxydodecan) as sclerotherapy.
Percutaneous sclerotherapy with polidocanol is a safe alternative to conventional surgery for the treatment of an aneurysmal bone cyst. It can be used at surgically-inaccessible sites and treatment can be performed on an out-patient basis.
In recent years percutaneous sclerotherapy has emerged as an excellent method of treatment for aneurysmal bone cyst, and obviates the potential functional disabilities such as joint stiffness and shortening which are commonly seen with other methods of treatment. We report our experience using a novel method of sclerotherapy using 3% polidocanol (hydroxypolyaethoxydodecan (Samarth Life-sciences Pvt. Ltd., Solan, India); available in 2 ml ampoules; 1 ml = 30 mg of polidocanol) and describe the clinical and radiological results.
Treatment was undertaken under general anaesthesia for patients less than 15 years of age and using 2% xylocaine local anaesthetic with sedation in older patients. Polidoc
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