Sodium Tetradecyl Sulfate

Medically reviewed by Drugs.com. Last updated on July 12, 2020.

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Pronunciation

(SOW dee um tetra DEK il SUL fate)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as sulfate:

Sotradecol: 1% (2 mL); 3% (2 mL) [contains benzyl alcohol]

Generic: 3% (2 mL)

Brand Names: U.S.

• Sotradecol

Pharmacologic Category

• Sclerosing Agent

Pharmacology

Acts by irritation of the vein intimal endothelium and causes thrombosis formation leading to occlusion of the injected vein

Use: Labeled Indications

Varicose veins: Treatment of small, uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves.

Contraindications

Hypersensitivity to sodium tetradecyl sulfate or any component of the formulation; acute superficial thrombophlebitis; valvular or deep vein incompetence; phlebitis migrans; acute cellulitis; acute infections; allergic conditions; bedridden patients; patients with uncontrolled systemic disease such as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias, and acute respiratory or skin diseases; huge superficial veins with wide open communications to deeper veins; allergic conditions; varicosities caused by abdominal and pelvic tumors (unless tumor has been removed)

Canadian labeling: Additional contraindications (not in US labeling): Recent superficial or deep thrombophlebitis (6 months to 2 years); potential underlying arterial disease; renal or cardiac insufficiencies accompanied by venous stasis and dilatation; angina pectoris; hyperthyroidism

Dosing: Adult

Sclerosing agent: IV: Note: The strength of solution required depends on size and degree of varicosity; in general, the 1% solution is used most often, with the 3% solution being reserved for larger varicosities.

Test dose: 0.5 mL followed by several hours of observation is recommended before larger doses are administered.

Usual dose: 0.5 to 2 mL (preferred maximum: 1 mL) in each vein; maximum dose: 10 mL per treatment session of the 3% solution (Dietzek 2007)

The following concentrations have been recommended upon size of affected vein (Dietzek 2007):

Vessel diameter <1 mm: 0.1% to 0.3% concentration

Vessel diameter 1 to 3 mm: 0.5% to 1% concentration

Vessel diameter 4 to 6 mm: 1% to 2% concentration

Branch varicosities: 2% to 3% concentration

Dosing: Geriatric

Refer to adult dosing.

Administration

For IV injection only

Storage

Store at controlled room temperature.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

<1%, postmarketing, and/or case reports: Anaphylactic shock, anaphylaxis, asthma, cardiac insufficiency, cerebrovascular accident, headache, hypersensitivity reaction, myocardial infarction, nausea, seasonal allergic rhinitis, transient ischemic attacks, urticaria, vomiting

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis: Observe for hypersensitivity/anaphylactic reaction; emergency resuscitation equipment should be available.

• Arterial embolism: Stroke, transient ischemic attack, myocardial infarction, and impaired cardiac function have been reported with use. May be caused by air embolism when using sodium tetradecyl sulfate foamed with room air or thromboembolism. Avoid using sodium tetradecyl sulfate foamed with room air; safety and efficacy has not been established.

• Thromboembolism: Deep vein thrombosis (DVT) and pulmonary embolism (PE) have occurred following treatment.

Disease-related concerns:

• Arteriosclerosis: Use with caution in patients with peripheral arteriosclerosis.

• Thromboangiitis obliterans: Use with caution in patients with thromboangiitis obliterans.

Other warnings/precautions:

• Appropriate use: Valvular and venous competency should be evaluated prior to use.

• Extravasation: Avoid extravasation.

Monitoring Parameters

Monitor for DVT or PE (up to 4 weeks after injection); allergic reactions; pain, urticarial, matting, and pigmentation changes

Pregnancy Risk Factor

C

Pregnancy Considerations

Reproduction studies have not been conducted.

Patient Education

What is this drug used for?

• It is used to treat varicose veins.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

• Nausea

• Vomiting

• Injection site skin discoloration

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight

• Severe injection site pain, burning, swelling, or irritation

• Blood clots like numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; fast heartbeat; or coughing up blood

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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