"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Sotradecol® (sodium tetradecyl) (sodium tetradecyl sulfate injection) should only be administered by a physician familiar with 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® (sodium tetradecyl) be injected into a varicosity, followed by observation of the patient for several hours before administration of a second or larger dose. The possibility of an anaphylactic reaction should be kept in mind, and the physician should be prepared to treat it appropriately.
Because of the danger of thrombosis extension into the deep venous system, thorough preinjection evaluation for valvular competency should be carried out and slow injections with a small amount (not over 2 mL) of the preparation should be injected into the varicosity. Deep venous patency must be determined by angiography or noninvasive testing such as duplex ultrasound. Venous sclerotherapy should not be undertaken if tests such as Trendelenberg and Perthes, and angiography show significant valvular or deep venous incompetence.
The development of deep vein thrombosis and pulmonary embolism have been reported following sclerotherapy treatment of superficial varicosities. Patients should have post-treatment follow-up of sufficient duration to assess for the development of deep vein thrombosis. Embolism may occur as long as four weeks after injection of sodium tetradecyl sulfate. Adequate post-treatment compression may decrease the incidence of deep vein thrombosis.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
When tested in the L5178YTK +/- mouse lymphoma assay, sodium tetradecyl sulfate did not induce a dose-related increase in the frequency of thymidine kinase-deficient mutants and, therefore, was judged to be non mutagenic in this system. However, no long-term animal carcinogenicity studies with sodium tetradecyl sulfate have been performed.
Teratogenic Effects - Pregnancy Category C. Animal reproduction studies have not been conducted with Sotradecol® (sodium tetradecyl) . It is also not known whether Sotradecol® (sodium tetradecyl) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sotradecol® (sodium tetradecyl) should be given to a pregnant woman only if clearly needed and the benefits outweigh the risks.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SotradecoP is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/16/2008
Additional Sotradecol Information
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