Lauromacrogol 400


Generic Medicine Info
Indications and Dosage
Intravenous
Sclerotherapy of varicose vein
Adult: Dose and concentration selection is based on type and size of varicose vein (varices) being treated. Telangieactasias (spider veins): 0.1-0.2 mL per inj of 0.25% or 0.5% solution. Central veins of telangiectasias: 0.1-0.2 mL per inj of 0.25%, 0.5% or 1% solution. Reticular and small varices: 0.1-0.3 mL per inj of 1% solution. Administer solution for these types of varices by inserting the needle tangentially into the vein and inject slowly. Collateral varices: Up to 4-6 mL per inj of 1% microfoam. Perforating varices: Up to 2-4 mL per inj of 1% microfoam. Medium-sized varices: Up to 2 mL per inj of 2% or 3% solution. Perforating or tributary varices: Up to 2 mL per inj of 2% microfoam. Large varices: Up to 2 mL per inj of 3% solution. Small saphenous veins: Up to 4 mL per inj of 2% or 3% microfoam. Great saphenous veins (GSV): Up to 6 mL per inj of 2% or 3% microfoam. Alternatively for GSV and accessory saphenous veins: Up to 5 mL per inj of 1% microfoam up to 15 mL per session. Give microfoam via direct inj into varicosities or single cannula into the lumen of the target vein. Inject with ultrasound guidance. All inj may be repeated as necessary. Max: As solution: 2 mg/kg daily; As microfoam: 10 mL per session and day, regardless of concentration and patient’s body weight. After inj site is covered, apply compression stockings or bandage immediately (for solution) and after 5-10 minutes (for microfoam). Maintain compression for 2-3 days (spider veins), 3-7 days (central veins of spider veins, reticular and small veins), 2 weeks (GSV and accessory saphenous veins), 4-6 weeks (medium-sized veins) and longer for extensive varicosities. Allow the patient to walk for at least 15-30 minutes while being monitored. Dose recommendations, duration of compression maintenance, and administration methods may vary based on type, size and extent of varices being treated, among individual products or between countries (refer to local product-specific guidelines).
Reconstitution
As solution for microfoam inj: Draw 2 mL of sclerosant solution into the 1st syringe (without a rubber plunger). Fix the 2nd syringe (with a rubber plunger) to a 0.2 micrometer sterile filter and draw 8 mL of sterile air. Preparation of the microfoam may be done using the Tessari and Dual Syringe System (DSS) techniques. Refer to individual product-specific information for the detailed steps of preparation per technique.
Contraindications
Hypersensitivity. Acute thromboembolic disease, immobility (e.g. bed-ridden patients), arterial disease (e.g. atherosclerotic peripheral vascular disease), high risk of thrombosis (e.g. known hereditary thrombophilia, use of hormone replacement therapy or hormonal contraceptives, obesity, smoking, extended periods of immobility), severe arterial occlusive disease (Fontaine stages III and IV), significant deep vein incompetence, acute superficial thrombophlebitis, huge superficial veins with wide open communications to deeper veins, acute cellulitis, phlebitis migrans, varicosities caused by abdominal and pelvic tumours (unless the tumour has been removed); known strong predisposition to allergies, acute infections, uncontrolled systemic diseases (e.g. diabetes mellitus, toxic hyperthyroidism, TB, asthma, neoplasm, sepsis, blood dyscrasias, acute respiratory or skin diseases); known symptomatic right-to-left shunt (specific to microfoam sclerotherapy).
Special Precautions
Patients with asymptomatic but known patent foramen ovale (specific to microfoam sclerotherapy), visual or neurological symptoms (e.g. migraine) after previous microfoam sclerotherapy; fever, arterial occlusive disease (Fontaine stage II) particularly for telangiectasias, leg oedema resistant to compression, inflammatory skin disease in the area of treatment, symptoms of microangiopathy or neuropathy, reduced mobility, underlying arterial disease (e.g. peripheral arteriosclerosis, thromboangiitis obliterans), history of DVT or pulmonary embolism, recent (within 3 months) major surgery or prolonged hospitalisation. Do not use IV solution foamed with room air. Not intended to be administered intra-arterially due to risk of severe necrosis, ischaemia or gangrene. Avoid extravasation. Renal and hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Significant: TIA, stroke, venous thrombosis, pulmonary embolism; tissue ischaemia or necrosis (if extravasation occurs).
Cardiac disorders: Palpitations.
General disorders and administration site conditions: Inj site haematoma, pain, irritation, discolouration, pruritus or warmth; fever, flushing.
Immune system disorders: Rarely, angioedema.
Nervous system disorders: Rarely, migraine, dizziness, local paresthesia, loss of consciousness.
Respiratory, thoracic and mediastinal disorders: Rarely, asthma, dyspnoea.
Skin and subcutaneous tissue disorders: Skin hyperpigmentation, ecchymosis, contact urticaria, allergic dermatitis, hypertrichosis in the area of sclerotherapy.
Vascular disorders: Neovascularisation. Rarely, vasovagal syncope, circulatory collapse, vasculitis.
Potentially Fatal: Rarely, severe allergic reactions (e.g. anaphylactic shock), stress cardiomyopathy, cardiac arrest.
Monitoring Parameters
Monitor for signs of anaphylactic or allergic reaction for at least 10-20 minutes post inj and signs of DVT or pulmonary embolism.
Drug Interactions
CV effects of other anaesthetics may be increased when used together with lauromacrogol 400.
Action
Description: Lauromacrogol 400 is a sclerosing agent that locally damages the endothelium of blood vessels in a concentration- and volume-dependent manner. This causes the formation of a thrombus at the site of damage which then leads to venous occlusion. The occluded vein is then replaced by connective fibrous tissue.
Synonyms: polidocanol, laureth-9.
Pharmacokinetics:
Distribution: Volume of distribution: 35-82 L (1% microfoam).
Excretion: Elimination half-life: Approx 90 minutes (solution); 102-153 minutes (1% microfoam).
Chemical Structure

Chemical Structure Image
Lauromacrogol 400

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 24750, 2-(Dodecyloxy)ethanol. https://pubchem.ncbi.nlm.nih.gov/compound/2-_Dodecyloxy_ethanol. Accessed Aug. 25, 2021.

Storage
Solution for inj: Store between 15-30°C. Microfoam (1%) in pressurised canister: Store below 30°C. Do not refrigerate or freeze. Do not shake. Once activated, store in an upright position and a well-ventilated place; use within 30 days. Keep away from heat and combustible materials.
MIMS Class
Phlebitis & Varicose Preparations
ATC Classification
C05BB02 - polidocanol ; Belongs to the class of sclerosing agent used as local injection in antivaricose therapy.
References
Aethoxysklerol 1% (Chemische Fabrik Kreussler & Co GmbH). MIMS Thailand. http://www.mims.com/thailand. Accessed 14/07/2021.

Aethoxysklerol 10 mg/mL Solution for Injection (Ferndale Pharmaceuticals Ltd). MHRA. https://products.mhra.gov.uk. Accessed 15/06/2021.

Anon. Lauromacrogol 400 (Polidocanol). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 15/06/2021.

Anon. Polidocanol. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 15/06/2021.

Asclera (Merz North America, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 15/06/2021.

Buckingham R (ed). Lauromacrogol 400. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/06/2021.

Varithena (Biocompatibles, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 15/06/2021.

Disclaimer: This information is independently developed by MIMS based on Lauromacrogol 400 from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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