SODIUM TETRADECYL SULFATE

SOLUTION DILUTIONS

DESCRIPTION:  Sodium tetradecyl sulfate is an anionic surfactant which occurs as a white, waxy solid.  C14 H29 NaSO4  (7-Ethyl-2-methyl-4-hendecanol sulfate sodium salt ) M.W. 316.44

The original trade name was sodium tetradecyl sulfate (Sodium Tetradecyl Sulfate Injection) is a sterile nonpyrogenic solution for intravenous use as a sclerosing agent. Each ml contains sodium tetradecyl sulfate 10 mg or 30 mg, benzyl alcohol 0.02 ml and dibasic sodium phosphate, anhydrous 0.72 mg in Water for Injection.  pH 7.9; monobasic sodium phosphate and/or sodium hydroxide added, if needed, for pH adjustment.

CLINICAL PHARMACOLOGY: a mild sclerosing agent. Intravenous injection causes intima inflammation and thrombus formation. This usually occludes the injected vein. Subsequent formation of fibrous tissue results in partial or complete vein obliteration.

INDICATIONS AND USES: 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.

DOSAGE AND ADMINISTRATION: For intravenous use only. Do not use if precipitated or discolored. The strength of solution required depends on the size and degree of varicosity. In general, the 1% solution will be found most useful with the 3% solution preferred for larger varicosities. The dosage should be kept small, using 0.5 to 2 ml (preferably 1 ml maximum) for each injection, and the maximum single treatment should not exceed 10 ml.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED: 3% 15ml vial is the most common.  Other strengths and sizes are available - please ask.

STORAGE: Store at controlled room temperature 15°-30°C (59°-86°F).

ANIMAL TOXICOLOGY : The intravenous LD 50 of sodium Tetradecyl sulfate in mice was reported to be 90 ± 5 mg/kg.  In the rat, the acute intravenous LD 50 of sodium Tetradecyl sulfate was estimated to be between 72 mg/kg and 108 mg/kg.

Purified sodium tetradecyl sulfate was found to have an LD 50 of 2 g/kg when administered orally by stomach tube as a 25% aqueous solution to rats. In rats given 0.15 g/kg in drinking water for 30 days, no appreciable toxicity was seen, although some growth inhibition was discernible.

WARNINGS: Since severe adverse local effects, including tissue necrosis, may occur following extravasation, sodium tetradecyl sulfate (Sodium Tetradecyl Sulfate Injection), should be administered only by a physician familiar with proper injection technique. Extreme care in needle placement and using the minimal effective volume at each injection site are, therefore, important.

Allergic reactions, including anaphylaxis, have been reported that led to death. Therefore, as a precaution against anaphylactic shock, it is recommended that 0.5 ml of sodium tetradecyl sulfate 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. In extreme emergencies, 0.25 ml of 1:1000 Epinephrine Injection (0.25 mg) intravenously should be used and side reactions controlled with antihistamines.

PRECAUTIONS: The drug should only be administered by physicians who are familiar with an acceptable injection technique. Because of the danger of thrombosis extension into the deep venous system, thorough pre-injection 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. In particular, deep venous patency must be determined by angiography and/or the Perthes test before sclerotherapy is undertaken.

Venous sclerotherapy should not be undertaken if tests, such as the Trendelenberg and Perthes, and angiography show significant valvular or deep venous incompetence. The physician should bear in mind that injection necrosis is likely to result from extravascular injection of sclerosing agents.

Extreme caution must be exercised in the presence of underlying arterial disease such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger's Disease).

Embolism may occur as long as four weeks after injection of sodium tetradecyl sulfate. The incidence of recurrence is low if the patient wears elastic stockings.

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 sodium tetradecyl sulfate.

Heparin should not be included in the same syringe since the two are incompatible.

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 nonmutagenic in this system. However, no long-term animal carcinogenicity studies with sodium tetradecyl sulfate have been performed.

PREGNANCY: Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with sodium tetradecyl sulfate. It is also not known whether sodium tetradecyl sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium tetradecyl sulfate should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS: 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  administered to a nursing woman.

PEDIATRIC USE : Safety and effectiveness in pediatric patients have not been established.

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.

Four deaths have been reported with the use of sodium tetradecyl sulfate. One death has been reported in a patient who received sodium tetradecyl sulfate 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 sodium tetradecyl sulfate. One of the patients reported a medical history of asthma, a contraindication to the administration of sodium tetradecyl sulfate.

CONTRAINDICATIONS: Contraindicated in previous hypersensitivity reactions to the drug; in acute superficial thrombophlebitis; significant 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 respiratory or skin diseases.

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Sodium Tetradecyl Sulfate (STDS) is a sterile aqueous solution of sodium tetradecyl sulfate, buffered to pH 7.4 to 8.0 with di-sodium hydrogen phosphate and potassium di-hydrogen phosphate. It also contains benzyl alcohol.

SOLUTION DILUTIONS

USE: This solution is for intravenous use as a sclerosant in the treatment of varicose veins of the leg by compression sclerotherapy. The action of the sodium tetradecyl sulfate in this technique is considered to be that of irritation to the intima of the vein wall, so that on compression of the vein, fibrosis takes place and the vein is permanently occluded by the development of fibrosis in the wall of the compressed vein. The strength selected depends on the size of the vein being treated (large superficial varicose veins at 3%; small varicose veins and larger venules at 1%; minor venules and spider veins – venous flares – at 0.5% or 0.2%)

NOT RECOMMENDED FOR USE IN CHILDREN

DOSAGE AND ADMINISTRATION:

3%     0.5 – 1ml at each of 4 sites (maximum 4ml) per treatment session. The dose is injected into the lumen of an isolated segment of emptied superficial vein, followed by immediate continuous compression.
1%     0.25 – 1ml at each of 10 sites (maximum 10ml) per treatment session. The dose is injected into the lumen of an isolated segment of emptied superficial vein, followed by immediate continuous compression.
0.5%   0.25 – 1ml at each of 10 sites (maximum 10ml) per treatment session. The dose is injected into the lumen of an isolated segment of emptied superficial vein, followed by immediate continuous compression.
0.2%   0.1 – 1ml at each of 10 sites (maximum 10ml) per treatment session. The dose is injected into the lumen of an isolated segment of emptied superficial vein, followed by immediate continuous compression.

SIDE EFFECTS

* Local pain or burning.

* Skin pigmentation.

* Tissue necrosis and ulceration may occur with extravasation.

* Paraesthesia and anesthesia may occur if an injection effects a cutaneous nerve.

* Superficial thrombophlebitis.

* Deep vein thrombosis and pulmonary embolism are very rare.

* Inadvertent intra-arterial injection is very rare but may lead to gangrene.

     Most cases have involved the posterior tibial artery above

     the medial malleolus.

* Allergic reactions are rare, presenting as local or generalized rash, urticaria, nausea or vomiting, asthma, vascular collapse.

* Anaphylactic shock, which may potentially be fatal, is extremely rare.

PRECAUTIONS

1. STDS should only be administered by practitioners familiar with an acceptable injection technique.
2. A history of allergy should be taken from all patients prior to treatment. Where special caution is indicated a test dose of 0.25 to 0.5 ml should be given up to 24 hours before any further therapy.
3. Extreme caution in use is required in patients with arterial disease such as peripheral atherosclerosis or thromboangiitis.
4. Special care is required when injecting above and posterior to the medial malleolus where the posterior tibial artery may be at risk.
5. Do not use with heparin in the same syringe.
6. Safety for use in pregnancy has not been established.
7. It is not known whether sodium tetradecyl sulfate is excreted in human milk. Caution should be exercised when used in nursing mothers.

STORAGE: Store below 25 degrees C – away from direct sunlight. The in-use period of each prescription is for a single session of therapy and for the use in the treatment of a single patient whose name appears on the prescription label. Unused vial contents should be discarded immediately afterwards.

NOTE: This preparation is NOT available from The Comnpounder pharmacy. The above material is for information only. SOLUTION DILUTIONS