Sotradecol

Sotradecol is a prescription medication used to treat varicose veins.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Sotradecol is part of the drug class:

• Sclerosing agents for local injection

Get emergency medical help if you have any of these signs of an allergic reaction: hives; sneezing, runny nose, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pain or swelling in one or both legs;

• chest pain, sudden cough, wheezing, rapid breathing, fast heart rate; or

• pain, itching, peeling, skin sores, or skin changes where the medicine was injected.

Common side effects may include:

• mild headache;

• nausea, vomiting; or

• discolored skin along the treated vein (may be permanent).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sclerosing agent; anionic surfactant and detergent.1 2 3 7

Specific Drugs

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% 20 mg/2 mL (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% 60 mg/2 mL (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.

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.

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.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sotradecol is administered to a nursing woman.

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 mL 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)

NDC 67457-162-02
carton containing 5, 2 mL vials with 1% 20 mg/2 mL (10 mg/mL)

NDC 67457-163-02
carton containing 5, 2 mL vials with 3% 60 mg/2 mL (30 mg/mL)

Applies to sodium tetradecyl sulfate: injectable solution

Local

Local side effects have included pain and urticaria or ulceration at the injection site. A permanent discoloration along the path of the sclerosed vein segment has also been reported.[Ref]

Hypersensitivity

Four cases of anaphylactic shock leading to death have been reported in patients receiving sodium tetradecyl sulfate (the active ingredient contained in Sotradecol) Of these four patients, one had a history of asthma.[Ref]

Hypersensitivity side effects have included hives, asthma, hayfever, and anaphylactic shock.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.[Ref]

General

General side effects have included headache.[Ref]

Some side effects of Sotradecol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.