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Sotradecol Side Effects, and Drug Interactions - Sodium Tetradecyl

Sotradecol Side Effects, and Drug Interactions - Sodium Tetradecyl

SIDE EFFECTS

Local reactions consisting of pain, urticaria or ulceration may occur at the site of injection. A permanent discoloration, usually small and hardly noticeable but which may be objectionable from a cosmetic viewpoint, 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, hayfever and anaphylactic shock have been reported. Mild systemic reactions that have been reported include headache, nausea and vomiting. (See WARNINGS .)

Four deaths have been reported with the use of Sotradecol®. One death has been reported in a patient who received Sotradecol® 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. Two cases of anaphylactic shock leading to death have been reported in patients who received Sotradecol®. One of the patients reported a medical history of asthma, a contraindication to the administration of Sotradecol®.

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 Sotradecol®. (See

SIDE EFFECTS

.)

Heparin should not be included in the same syringe as Sotradecol®, since the two are incompatible.

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