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Asclera
Overview
What is Asclera?
Asclera is a sterile, nonpyrogenic, and colorless to faintly greenish-yellow solution of polidocanol for intravenous use as a sclerosing agent.
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:
CH(OCHCH)OH Polyethylene glycol monododecyl ether Mean extent of polymerization (n) : Approximately 9 Mean molecular weight : Approximately 600
Each mL contains 5 mg (0.5%) or 10 mg (1.0%) polidocanol in water for injection with 5% (v/v) ethanol at pH 6.5-8.0; disodium hydrogen phosphate dihydrate, potassium dihydrogen phosphate are added for pH adjustment.
What does Asclera look like?
What are the available doses of Asclera?
0.5% and 1% solution in 2 mL glass ampules. ()
What should I talk to my health care provider before I take Asclera?
How should I use Asclera?
Asclera (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.
For intravenous use only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter is seen or if the contents of the vial are discolored or if the vial is damaged in any way.
For spider veins (varicose veins ≤1 mm in diameter), use Asclera 0.5%. For reticular veins (varicose veins 1 to 3 mm in diameter), use Asclera 1%. Use 0.1 to 0.3 mL per injection and no more than 10 mL per session.
Use a syringe (glass or plastic) with a fine needle (typically, 26- or 30-gauge). Insert the needle tangentially into the vein and inject the solution slowly while the needle is still in the vein. Apply only gentle pressure during injection to prevent vein rupture. After the needle has been removed and the injection site has been covered, apply compression in the form of a stocking or bandage. After the treatment session, encourage the patient to walk for 15 to 20 minutes. Keep the patient under observation to detect any anaphylactic or allergic reaction (see ).
Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis.
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.
Small intravaricose blood clots (thrombi) that develop may be removed by stab incision and thrombus expression (microthrombectomy).
What interacts with Asclera?
Sorry No Records found
What are the warnings of Asclera?
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What are the precautions of Asclera?
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What are the side effects of Asclera?
Sorry No records found
What should I look out for while using Asclera?
Asclera is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases.
What might happen if I take too much Asclera?
Overdose may result in a higher incidence of localized reactions such as necrosis.
How should I store and handle Asclera?
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.Asclera is supplied in single-use, preservative free ampules in the following packages:NDC 46783-121-52 Five 0.5% ampules (2 mL) NDC 46783-221-52 Five 1.0% ampules (2 mL)Each ampule is intended for immediate use in a single patient. Each unopened ampule is stable up to three years.Asclera is supplied in single-use, preservative free ampules in the following packages:NDC 46783-121-52 Five 0.5% ampules (2 mL) NDC 46783-221-52 Five 1.0% ampules (2 mL)Each ampule is intended for immediate use in a single patient. Each unopened ampule is stable up to three years.Asclera is supplied in single-use, preservative free ampules in the following packages:NDC 46783-121-52 Five 0.5% ampules (2 mL) NDC 46783-221-52 Five 1.0% ampules (2 mL)Each ampule is intended for immediate use in a single patient. Each unopened ampule is stable up to three years.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The active ingredient of Asclera is polidocanol.
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.
Non-Clinical Toxicology
Asclera is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases.Potassium-sparing diuretics, angiotensin converting enzyme inhibitors (see ).
Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are more frequent with use of larger volumes (> 3 mL). The dose of polidocanol should therefore be minimized. Be prepared to treat anaphylaxis appropriately.
Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, care should be taken in intravenous needle placement and the smallest effective volume at each injection site should be used.
After the injection session is completed, apply compression with a stocking or bandage, and have the patient walk for 15-20 minutes. Keep the patient under supervision during this period to treat any anaphylactic or allergic reaction .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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