Product Information
Registration Status: ActiveVARITHENA POLIDOCANOL INJECTABLE FOAM 10MG/ML is approved to be sold in Singapore with effective from 2018-02-15. It is marketed by TRANSMEDIC PTE LTD, with the registration number of SIN15433P.
This product contains Polidocanol 10mg/ml in the form of INJECTION. It is approved for INTRAVENOUS use.
This product is manufactured by Biocompatibles UK Limited (including sterilization) in UNITED KINGDOM.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Polidocanol is a sclerosing agent indicated to treat 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. It is marketed under the brand names Asclera and Varithena. The formula for Polidocanol has the structural formula C12H25(OCH2CH2)nOH, a mean extent of polymerization (n) of approximately 9 and a mean molecular weight of approximately 600.
Indication
Polidocanol is a sclerosing agent indicated to treat uncomplicated spider veins and uncomplicated reticular veins in the lower extremity.
Mechanism of Action
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.
Pharmacokinetics
- Absorption
- When given intravenously, the maximum blood concentrations were reached in 15 mins.
- Distribution
- When given intravenously, the volume of distribution was 35-82L.
- Metabolism
- Metabolism was not measured.
- Elimination
Clearance
Sytemic clearance was 0.2-0.4 L/min.
Toxicity
Most adverse reactions are related to the intravenous administration such as local irritation, pain, and hematoma. Extravasation can also be an issue.
Active Ingredient/Synonyms
Aethoxy-sklerol | Laureth 9 | Laureth-9 | Macrogol 9 lauryl ether | Nonaethylene glycol monododecyl ether | Nonaethylene glycol monolauryl ether | PEG-9 lauryl ether | Polydocanol | Polyethylene glycol 450 lauryl ether | Polyoxyl 9 lauryl ether | Polidocanol |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.