Sotradecol® (sodium tetradecyl sulfate injection) is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit-to-risk ratio should be considered in selected patients who are great surgical risks.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if precipitated or discolored.

Sotradecol® (sodium tetradecyl sulfate injection) is for intravenous use only. The strength of solution required depends on the size and degree of varicosity. In general, the 1% solution will be found most useful with the 3% solution preferred for larger varicosities. The dosage should be kept small, using 0.5 to 2 mL (preferably 1 mL maximum) for each injection, and the maximum single treatment should not exceed 10 mL.

Sotradecol® (sodium tetradecyl sulfate injection)

1% (10 mg/mL) - 2 mL vials; in packages of 5 (NDC 65974-162-02)
3% (30 mg/mL) - 2 mL vials; in packages of 5 (NDC 65974-163-02)

Storage

Store at 20°C to 25°C (68°F to 77°F) (See USP Controlled Room Temperature).

Manufactured for: Angiodynamics, Inc. Queensbury, NewYork12804. Tel: 1-800-772-6446. Manufactured by: Bioniche Teo, Inverin, Co. Galway, Ireland. Sotradecol is a registered trademark used by Bioniche under license from a third party. Issued: October 2006. Revised: December 2006. FDA rev date: 11/12/2004

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