Sotradecol (Sodium Tetradecyl Sulfate) - Description and Clinical Pharmacology

DESCRIPTION

Sodium tetradecyl sulfate is an anionic surfactant which occurs as a white, waxy solid. The structural formula is as follows:  

C14H29NaSO4 7-Ethyl-2-methyl-4-hendecanol sulfate sodium salt MW 316.44

Sotradecol® (sodium tetradecyl sulfate injection) is a sterile nonpyrogenic solution for intravenous use as a sclerosing agent.

1% (10 mg/mL): Each mL contains sodium tetradecyl sulfate 10 mg, benzyl alcohol 0.02 mL and dibasic sodium phosphate, anhydrous 4.0 mg in Water for Injection. pH 7.9; monobasic sodium phosphate and/or sodium hydroxide added, if needed, for pH adjustment.

3% (30 mg/mL): Each mL contains sodium tetradecyl sulfate 30 mg, benzyl alcohol 0.02 mL and dibasic sodium phosphate, anhydrous 9.0 mg in Water for Injection. pH 7.9; monobasic sodium phosphate and/or sodium hydroxide added, if needed, for pH adjustment.

CLINICAL PHARMACOLOGY

Sotradecol® (sodium tetradecyl sulfate injection) is a sclerosing agent. Intravenous injection causes intima inflammation and thrombus formation. This usually occludes the injected vein. Subsequent formation of fibrous tissue results in partial or complete vein obliteration that may or may not be permanent.

ANIMAL TOXICOLOGY

The intravenous LD50 of sodium tetradecyl sulfate in mice was reported to be 90 ± 5 mg/kg.

In the rat, the acute intravenous LD50 of sodium tetradecyl sulfate was estimated to be between 72 mg/kg and 108 mg/kg.

Purified sodium tetradecyl sulfate was found to have an LD50 of 2 g/kg when administered orally by stomach tube as a 25% aqueous solution to rats. In rats given 0.15g/kg in drinking water for 30 days, no appreciable toxicity was seen, although some growth inhibition was discernible.

Manufactured for:                                             Manufactured by Bioniche Teo

Bioniche Pharma U.S.A. LLC.                        Inverin, Co. Galway, Ireland

Lake Forest, IL 60045