merely enough Asclera Generic Name: Polidocanol Class: Sclerosing Agents Chemical Name: Polyethylene glycol monododecyl ether (average polymer, n = 9; nonaethylene glycol monododecyl ether) CAS Number: 9002-92-0 Overview Side Effects Dosage Professional Pregnancy More User Reviews Support Group Q & A Pricing & Coupons Introduction Sclerosing agent; nonionic detergent. 1 2 Uses for Asclera Sclerotherapy Treatment of uncomplicated spider veins (varicose veins 1 mm in diameter) in lower extremity. 1 14 Treatment of uncomplicated reticular veins (varicose veins 1 3 mm in diameter) in lower extremity. 1 14 Not studied in varicose veins >3 mm in diameter. 1 Slideshow Cancer Prevention: Live Longer With These Simple Steps Asclera Dosage and Administration Administration IV Administration Administer only by IV injection. 1 Avoid extravasation. 1 (See Administration Precautions under Cautions.) Commercially available as 0.5 or 1% solution in single-use ampuls (containing a total of 10 or 20 mg, respectively, in each 2-mL ampul). 1 Has been administered as an endovenous foam or microfoam; 2 3 6 8 9 11 12 13 these preparations not commercially available in US and extemporaneous preparation of polidocanol foam not approved by FDA. Administration Procedure Use a syringe (glass or plastic) with a fine needle (typically, 26- or 30-gauge). 1 Insert needle tangentially into target vein and inject solution slowly while needle is still in vein. 1 To prevent vein rupture, only apply gentle pressure during injection. 1 After removing needle from target vein and covering injection site, apply compression in the form of a stocking or bandage. 1 After treatment session, have patient walk for 15 20 minutes and observe patient to detect any anaphylactic or allergic reaction. 1 (See Sensitivity Reactions under Cautions.) Advise patient to maintain compression (stocking or bandage) for 2 3 days after treatment of spider veins or 5 7 days after treatment of reticular veins. 1 For extensive varicosities, longer compression treatment with compression bandages or gradient compression stocking of a higher compression class is recommended. 1 If small intravaricose blood clots (thrombi) develop, they may be removed by stab incision and thrombus expression (microthrombectomy). 1 Dosage Adults Sclerotherapy Uncomplicated Varicose Veins in Lower Extremity IV Concentration of polidocanol solution (0.5 or 1%) and injection volume depend on type and size of varicose veins. 1 2 After polidocanol treatment, compression is necessary to reduce risk of deep vein thrombosis. 1 (See IV Administration under Dosage and Administration.) Spider veins (varicose veins 1 mm in diameter): 0.1 0.3 mL (0.5 1.5 mg) of 0.5% solution for each injection. 1 Do not exceed 10 mL (50 mg) per treatment session. 1 Reticular veins (varicose veins 1 3 mm in diameter): 0.1 0.3 mL (1 3 mg) of 1% solution for each injection. 1 Do not exceed 10 mL (100 mg) per treatment session. 1 Repeat treatments may be necessary if extent of varicose veins requires >10 mL of solution. 1 Separate treatment sessions by 1 2 weeks. 1 Prescribing Limits Adults Sclerotherapy Uncomplicated Varicose Veins in Lower Extremity IV Maximum 0.3 mL of 0.5 or 1% solution (1.5 or 3 mg, respectively) per injection site; maximum 10 mL per treatment session. 1 Cautions for Asclera Contraindications Known allergy (anaphylaxis) to polidocanol. 1 (See Sensitivity Reactions under Cautions.) Acute thromboembolic diseases. 1 Warnings/Precautions Sensitivity Reactions Severe allergic reactions (e.g., anaphylactic reactions), including some fatalities, reported. 1 Severe reactions more frequent with larger volumes (>3 mL). 1 Use minimal required dose. 1 Postmarketing reports of allergic dermatitis, angioedema, generalized urticaria, and asthma. 1 Observe patient for 15 20 minutes after polidocanol treatment session in case an anaphylactic or allergic reaction occurs. 1 Clinicians should be prepared to provide appropriate treatment of anaphylaxis. 1 Administration Precautions Extravasation may result in severe adverse local effects, including tissue necrosis. 1 Carefully place IV needle into target vein; 1 use smallest effective volume of solution at each injection site. 1 Overdosage may result in higher incidence of localized reactions such as necrosis. 1 After polidocanol treatment session, apply compression to treatment area with a stocking or bandage and have patient walk for 15 20 minutes. 1 (See IV Administration under Dosage and Administration.) Supervise patient during this period in case an anaphylactic or allergic reaction occurs. 1 (See Sensitivity Reactions under Cautions.) Accidental Intra-arterial Injection Accidental intra-arterial injection may cause severe necrosis, ischemia, or gangrene. 1 Immediately consult vascular surgeon if occurs. 1 Inadvertent Perivascular Injection Inadvertent perivascular injection can cause pain. 1 If pain is severe, a local anesthetic (without adrenaline) may be injected. 1 Specific Populations Pregnancy Category C. 1 Do not use during pregnancy. 1 Labor and Delivery Effects on labor and delivery unknown. 1 Lactation Not known whether distributed into human milk. 1 Potential for serious adverse reactions in nursing infants; avoid use in nursing women. 1 Pediatric Use Safety and efficacy not established in pediatric patients. 1 Geriatric Use Insufficient experience in patients 65 years to determine whether geriatric patients respond differently than younger adults. 1 Common Adverse Effects Injection site reactions including hematoma, irritation, discoloration, pain, pruritus, warmth, neovascularization, thrombosis. 1 Interactions for Asclera No drug interaction studies. 1 Asclera Pharmacokinetics Absorption Onset Rapid onset and offset of local sclerosing effect. 10 Plasma Concentrations Following IV injection of 4.5 18 mg in 4 adults, low systemic plasma concentrations were observed. 1 10 Peak concentrations occurred 5 minutes after IV injection. 10 Elimination Metabolism Not known. 10 Elimination Route Not known. 10 Half-life Mean apparent terminal half-life is 1.5 hours. 1 10 Stability Storage Parenteral Solution for IV Injection 15 30 C. 1 Use immediately after opening ampul; does not contain a preservative. 1 Actions A nonionic detergent consisting of 2 components: a polar hydrophilic (dodecyl alcohol) chain and an apolar hydrophobic (polyethylene oxide) chain. 1 Used as a sclerosing agent. 1 Has a concentration- and volume-dependent damaging effect on blood vessel endothelium. 1 Following IV injection, induces local endothelial damage in target vein. 1 Platelets then aggregate at site of damage and attach to the venous wall; eventually, a dense network of platelets, cellular debris, and fibrin occludes the vessel. 1 Finally, the occluded vein is replaced with connective fibrous tissue. 1 Effect on the vein is permanent. 10 Advice to Patients Advise patients that compression will be applied in the form of a stocking or bandage immediately after polidocanol treatment to reduce the risk of deep vein thrombosis. 1 Importance of walking for 15 20 minutes immediately after polidocanol treatment and then daily for next few days. 1 Importance of wearing compression stockings or support hose on the treated legs continuously for 2 3 days after treatment of spider veins or for 5 7 days after treatment of reticular veins. 1 After this initial period, importance of wearing compression stockings or support hose during daytime for an additional 2 3 weeks. 1 Depending on area treated, compression stockings or support hose should be thigh or knee high to provide adequate coverage. 1 Advise patients to avoid heavy exercise, sunbathing, long plane flights, and hot baths or sauna for 2 3 days after polidocanol treatment. 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses. 1 Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 1 Importance of informing patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Polidocanol Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral Injection, for IV use 0.5% Asclera Merz 1% Asclera Merz AHFS DI Essentials. Copyright 2017, Selected Revisions May 28, 2013. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Merz Aesthetics, Inc. Asclera (polidocanol) injection for intravenous use prescribing information. Franksville, WI; 2010 Mar. 2. Gloviczki P, Comerota AJ, Dalsing MC et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg . 2011; 53(5 Suppl):2S-48S. [PubMed 21536172] 3. Schwartz L, Maxwell H. Sclerotherapy for lower limb telangiectasias. Cochrane Database Syst Rev . 2011; :CD008826. [PubMed 22161437] 4. Campbell B. Varicose veins and their management. BMJ . 2006; 333:287-92. [PubMed 16888305] 5. Leopardi D, Hoggan BL, Fitridge RA et al. Systematic review of treatments for varicose veins. Ann Vasc Surg . 2009; 23:264-76. [PubMed 19059756] 6. Subramonia S, Lees TA. The treatment of varicose veins. Ann R Coll Surg Engl . 2007; 89:96-100. [PubMed 17346396] 7. Worthington-Kirsch RL. Injection sclerotherapy. Semin Intervent Radiol . 2005; 22:209-17. [PubMed 21326695] 8. Tisi PV, Beverley C, Rees A. Injection sclerotherapy for varicose veins. Cochrane Database Syst Rev . 2006; :CD001732. [PubMed 17054141] 9. US National Institutes of Health. Polidocanol clinical trials. From National Library of Medicine website. Accessed 2012 Nov 2. 10. Center for Drug Evaluation and Research. Application number: 21-201s000 (polidocanol): Clinical pharmacology and biopharmaceutics review(s). From FDA Website. Accessed 2012 Nov 2. 11. Alòs J, Carreño P, López JA et al. Efficacy and safety of sclerotherapy using polidocanol foam: a controlled clinical trial. Eur J Vasc Endovasc Surg . 2006; 31:101-7. [PubMed 16226901] 12. Uncu H. Sclerotherapy: a study comparing polidocanol in foam and liquid form. Phlebology . 2010; 25:44-9. [PubMed 20118346] 13. Eckmann DM. Polidocanol for endovenous microfoam sclerosant therapy. Expert Opin Investig Drugs . 2009; 18:1919-27. [PubMed 19912070] 14. Rabe E, Schliephake D, Otto J et al. Sclerotherapy of telangiectases and reticular veins: a double-blind, randomized, comparative clinical trial of polidocanol, sodium tetradecyl sulphate and isotonic saline (EASI study). Phlebology . 2010; 25:124-31. [PubMed 20483861] Next Pregnancy Warnings Print this page Add to My Med List More about Asclera (polidocanol) Side Effects During Pregnancy Dosage Information Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: sclerosing agents Consumer resources Asclera Asclera polidocanol Professional resources Asclera (FDA) Polidocanol (AHFS Monograph) Other brands: Varithena Related treatment guides Varicose Veins} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Sclerosing agents Related Drugs Varicose Veins polidocanol , Sotradecol , Varithena , More... Asclera Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } Best Microwave
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