Trombovar (Sodium Tetradecyl Sulfate)

TROMBOVAR® Therapex Sodium Tetradecyl Sulfate Sclerosing Agent

Indications And Clinical Uses:

Sclerosing treatment of varicose veins in the legs, using compression sclerotherapy.

Contra-Indications:

Incompetency of collateral deep veins in the legs; incompetency of the valves of the greater and lesser saphenous veins before ligation of those veins; thrombophlebitis, tuberculosis and hyperthyroidism, acute infections, prolonged recumbency; cardiac insufficiency, diabetes, arterial disease, varicosities caused by pelvic neoplasia, pregnancy. Hypersensitivity to sodium tetradecyl sulfate.

Warnings in Clinical States:

Because of the danger of extension of thrombosis into the deep venous system, thorough pre-injection evaluation for valvular competency should be carried out. In particular, deep venous potency must be determined by angiography, Perthes test or Doppler test before sclerotherapy is undertaken. A complication of sloughing may occur if product is injected outside the vein. Allergic reactions have been reported, therefore, as a precaution, it is recommended that an injection of 0.5 mL of the 1% solution into a varicosity be followed by observance of the patient for a few hours before a second injection is administered. The possibility of an anaphylactic reaction should always be kept in mind and the physician should be prepared to treat it appropriately. In extreme emergency, 0.25 mL of a 1:1 000 solution of epinephrine (0.25 mg) i.v. should be used and side effects controlled with antihistamines.

An injection outside the vein may cause severe necrosis. A consequence of intra-arterial injection may be amputation of the limb. Injections must be carried out exclusively by an experienced physician, having thorough knowledge of the sclerotherapy technique.

Adverse Reactions:

Allergic reactions to the product are rare: In case of side effects such as pruritus of the face and extremities, redness of the conjunctiva, shortness of breath or irritating cough within minutes of injection, appropriate treatment must be carried out immediately. Hyperpigmentation at the injection site may occur, but disappears spontaneously in most cases.

Dosage And Administration:

Dosage and concentration of the solution depend on the size of the veins to sclerose. Doses at site of injection and total dose given per visit must be increased progressively from one visit to the next according to the size of the vein segment to sclerose while taking into account variable individual sensitivity to the sclerosing agent. Normal dosage varies from 0.5 to 2 mL (max) per injection, in sites situated between 6 and 12 cm from each other. Several separate injections can be made in either leg, but do not exceed a total of 10 mL of 3% solution/week.

In the treatment of superficial s.c. varicose veins, great care must be taken. In this case, only the 1% solution should be used and is most effective when used as a froth prepared by vigorously shaking the syringe. It is important to use a syringe that is transparent to be able to check the venous return to avoid extravasation.

Availability And Storage:

Each 2 mL ampul contains: sodium tetradecyl sulfate 1% or 3% with benzyl alcohol 2% as preservative in a buffered solution. Packages of 10.

TROMBOVAR® Therapex Sodium Tetradecyl Sulfate Sclerosing Agent