How Supplied:
1% (10 mg/mL) 2 mL vials in packages of 5; 3% (30 mg/mL) 2 mL vials in packages of 5
Indications and Usage:
Sotradecol 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.
Shelf Life:
Refrigeration not required.
Duration:
N/A
Side Effects and Contraindications:
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, hayfever, 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. (See WARNINGS section in full Prescribing Information.) One death has been reported in a patient who received Sotradecol who had also 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.
Company:
AngioDynamics, Inc.
800-772-6446
www.angiodynamics.com
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