Sodium Tetradecyl Sulfate

Indications

INDICATIONS AND USAGE 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.

Dosage and administration (summary)

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 mL to 2 mL (preferably 1 mL maximum) for each injection, and the maximum single treatment should not exceed 10 mL.

Contraindications

CONTRAINDICATIONS Sotradecol (sodium tetradecyl sulfate injection) is contraindicated in previous hypersensitivity reactions to the drug; in acute superficial thrombophlebitis; valvular or deep vein incompetence; huge superficial veins with wide open communications to deeper veins; phlebitis migrans; acute cellulitis; allergic conditions; acute infections; varicosities caused by abdominal and pelvic tumors unless the tumor has been removed; bedridden patients.

Warnings and precautions

WARNINGS Sotradecol (sodium tetradecyl sulfate injection) should only be administered by a healthcare professional experienced in venous anatomy and the diagnosis and treatment of conditions affecting the venous system and familiar with proper injection technique. Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, extreme care in intravenous needle placement and using the minimal effective volume at each injection site are important. Emergency resuscitation equipment should be immediately available.

Pregnancy

PREGNANCY Teratogenic Effects – Pregnancy Category C. Animal reproduction studies have not been conducted with Sotradecol. It is also not known whether Sotradecol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Storage and supply

STORAGE Store at 20° to 25°C (68° to 77°F).

Source: Tetradecyl Hydrogen Sulfate (Ester) (Sotradecol) — US FDA prescribing information, 2021-08-17, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.