Sotradecol is contraindicated 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 or respiratory or skin diseases.
Sotradecol should only be administered by a healthcare professional experienced in the diagnosis and treatment of conditions affecting the venous system including proper injection technique.
Allergic reactions, including anaphylaxis, have been reported; therefore, emergency equipment should be immediately available. The possibility of an anaphylactic reaction should be kept in mind, and the physician should be prepared to treat it appropriately.
A thorough pre-injection evaluation for valvular competency should be carried out and slow injections with a small amount of preparation, not over 2 mL, of the preparation should be injected into the varicosity. The development of deep vein thrombosis and pulmonary embolism have been reported following sclerotherapy treatment of superficial varicosities. No well-controlled studies have been performed on patients taking antiovulatory agents; therefore, the physician should evaluate any patient taking these drugs prior to initiating treatment with Sotradecol.
Extreme caution must be exercised in the presence of underlying arterial disease such as marked peripheral arteriosclerosis or thromboangiitis obliterans.
Adverse events seen in clinical trials include pain, urticarial or ulceration at the site of injection. A permanent discoloration may remain along the path of the sclerosed vein segment.
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