Tetradecyl hydrogen sulfate (ester)

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.

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) 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, such uncontrolled systemic diseases as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias and acute respiratory or skin diseases.

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. Allergic reactions, including fatal anaphylaxis, have been reported. As a precaution against anaphylactic shock, it is recommended that 0.5 mL of Sotradecol be injected into a varicosity, followed by observation of the patient for several hours before administration of a second or larger dose.

Local reactions consisting of pain, urticaria or ulceration may occur at the site of injection. A permanent discoloration may remain along the path of the sclerosed vein segment. Sloughing and necrosis of tissue may occur following extravasation of the drug. Allergic reactions such as hives, asthma, hay fever and anaphylactic shock have been reported. Mild systemic reactions that have been reported include headache, nausea and vomiting. At least six deaths have been reported with the use of Sotradecol. Four cases of anaphylactic shock leading to death have been reported in patients who received Sotradecol. One of these four patients reported a history of asthma, a contraindication to the administration of Sotradecol. One death has been reported in a patient who received Sotradecol and who had been receiving an antiovulatory agent.

No well-controlled studies have been performed on patients taking antiovulatory agents. The physician must use judgment and evaluate any patient taking antiovulatory drugs prior to initiating treatment with Sotradecol. Heparin should not be included in the same syringe as Sotradecol, since the two are incompatible.

Store at 20° to 25°C (68° to 77°F).