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Sotradecol

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Sotradecol

INDICATIONS

Sotradecol® (sodium tetradecyl) (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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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 (sodium tetradecyl) 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

Last reviewed on RxList: 7/16/2008
This monograph has been modified to include the generic and brand name in many instances.

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