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Sodium Tetradecyl Sulfate

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]

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)

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.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided the in manufacturer's labeling.

Administration

For IV injection only

Storage

Store at controlled room temperature.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not defined.

Central nervous system: Headache

Dermatologic: Discoloration at site of injection, sloughing and tissue necrosis following extravasation

Gastrointestinal: Nausea, vomiting

Local: Pain, itching, or ulceration at injection site

Miscellaneous: Allergic reaction (including hives, asthma, hay fever); anaphylactic shock

Warnings/Precautions

Concerns related to adverse effects:

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

• 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

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, nausea, vomiting, or injection site skin discoloration. Have patient report immediately to prescriber severe injection site pain, burning, edema, or irritation or signs of blood clots (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; angina; shortness of breath; tachycardia; or coughing up blood) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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