polidocanol - Generic Medications

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: C 12 H 25 (OCH 2 CH 2 ) n 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 (1.2 mg), potassium dihydrogen phosphate (0.43 mg). chemical structure

VARITHENA injectable foam contains the sclerosant, polidocanol. It is intended for intravenous use only. Chemically, polidocanol is polyoxyl lauryl ether. The structural formula is represented below: Polidocanol has the molecular formula CH 3 (CH 2 ) 11 (OCH 2 CH 2 ) n OH and a molecular weight of 582.9 when the average ethylene glycol moieties is nine (n=9). Polidocanol is a white to almost white, waxy, hygroscopic solid that is soluble in water and alcohol and melts at temperatures above 20°C. VARITHENA is a sterile, injectable foam of an aqueous polidocanol solution (1%) containing the following inactive ingredients: alcohol (4.2% w/w, purity 96% v/v) disodium hydrogen phosphate dihydrate (0.24% w/w), and potassium dihydrogen phosphate (0.085% w/w) with a pH of 6.0-7.5. The injectable foam is generated after activation of the polidocanol canister with oxygen from a second aluminum canister, resulting in a final gas mixture of oxygen:carbon dioxide in a ratio of 65:35 with low (<0.8%) nitrogen content. At the time of use, VARITHENA is generated as an injectable foam of controlled density and bubble size. The foam is then transferred to a syringe through the VARITHENA transfer unit. The injectable foam has a liquid to gas ratio of approximately 1:7 by volume. The median bubble diameter is less than 100 µm and no bubbles are greater than 500 µm. polidocanol Structural Formula