Sodium Tetradecyl Sulfate

INDICATIONS & 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 & 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 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.

ADVERSE REACTIONS 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. (See WARNINGS section.) 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. (See WARNINGS section.) At least six deaths have been reported with the use of sodium tetradecyl sulfate injection. Four cases of anaphylactic shock leading to death have been reported in patients who received sodium tetradecyl sulfate injection. One of these four patients reported a history of asthma, a contraindication to the administration of sodium tetradecyl sulfate injection. (See WARNINGS section.) One death has been reported in a patient who received sodium tetradecyl sulfate injection and who had been receiving an antiovulatory agent. Another death (fatal pulmonary embolism) has been reported in a 36-year-old female treated with sodium tetradecyl acetate and who was not taking oral contraceptives. Cerebrovascular accident, myocardial infarction To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800 FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS 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 sodium tetradecyl sulfate injection. (See ADVERSE REACTIONS section.) Heparin should not be included in the same syringe as sodium tetradecyl sulfate injection, since the two are incompatible.

DESCRIPTION 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. STRUCTURE

HOW SUPPLIED Sotradecol® (sodium tetradecyl sulfate injection) NDC 67457-162-02 carton containing 5 x 2 mL multiple-dose vials with 1% 20 mg/2 mL (10 mg/mL) NDC 67457-163-02 carton containing 5 x 2 mL multiple-dose vials with 3% 60 mg/2 mL (30 mg/mL)