Sodium tetradecyl sulfate is an injectable sclerosing agent indicated for 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. Sodium tetradecyl sulfate should only be administered by a health care professional experienced in 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 after extravasation.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Injectable Administration
-Visually inspect solution for particulate matter and discoloration prior to administration whenever solution and container permit.
Intravenous Administration
-Administer only by a healthcare professional experienced in venous anatomy and familiar with proper injection technique. Extreme care in intravenous needle placement and using the minimal effective volume at each injection site are important to avoid extravasation and tissue necrosis.
An injection site reaction consisting of pain, urticaria, or ulceration (skin ulcer) may occur with sodium tetradecyl sulfate. Sloughing and tissue necrosis may result from extravasation. Permanent skin discoloration may remain along the path of the sclerosed vein segment.
Allergic reactions, including hives, asthma, hay fever, and anaphylactic shock, have been reported with sodium tetradecyl sulfate. At least 6 deaths have been reported with sodium tetradecyl sulfate use; 4 deaths were due to anaphylactic shock. A single patient reported a history of asthma, which is a contraindication to use.
Mild systemic reactions including headache, nausea, and vomiting have been reported with sodium tetradecyl sulfate use.
Cerebrovascular accident and myocardial infarction have been reported with sodium tetradecyl sulfate use. Stroke, transient ischemic attack, myocardial infarction, and impaired cardiac function have been reported in close temporal relationship with sodium tetradecyl sulfate administration and may be caused by air embolism when using the intravenous solution product foamed with room air. Fatal pulmonary embolism was reported in a 36-year-old female treated with sodium tetradecyl acetate and who was not taking oral contraceptives. Death was also reported in a patient who was receiving a concomitant antiovulatory agent. Thromboembolism can occur up to 4 weeks after injection. Adequate post-treatment compression may reduce the incidence of deep vein thrombosis.
Sodium tetradecyl sulfate is contraindicated in patients with a previous hypersensitivity reaction to the drug or allergic conditions. Emergency resuscitation equipment should be immediately available. As a precaution against anaphylactic shock, inject 0.5 mL sodium tetradecyl sulfate into a varicosity and observe the patient for several hours before administration of a second or larger dose. Sodium tetradecyl sulfate administration requires an experienced clinician familiar with proper injection technique, venous anatomy, and the diagnosis and treatment of conditions affecting the venous system. Using the minimum effective volume at each injection site and careful needle placement is extremely important to avoid severe adverse local reactions, including tissue necrosis, due to extravasation.
Sodium tetradecyl sulfate is contraindicated in patients with acute superficial thrombophlebitis; valvular or deep vein incompetence; huge superficial veins with wide-open communications to deeper veins; phlebitis migrans; acute cellulitis; acute infection such as tuberculosis or sepsis; varicosities caused by abdominal and pelvic tumors unless the tumor has been removed; those who are bedridden; and those with uncontrolled diabetes mellitus, thyrotoxicosis, neoplastic disease, blood dyscrasias (hematological disease), acute pulmonary disease (e.g., asthma), or acute skin disease. Because of the danger of thrombosis extension into the deep venous system, perform a thorough pretreatment evaluation for valvular competency, and inject a small amount (2 mL or less) of the preparation slowly into the varicosity. Determine deep venous patency by noninvasive testing such as duplex ultrasound. Do not perform venous sclerotherapy if tests, such as the Trendelenburg and Perthes, and angiography show significant valvular or deep venous incompetence. Use sodium tetradecyl sulfate with extreme caution in patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger's Disease). Embolism can occur up to 4 weeks after treatment with sodium tetradecyl sulfate. Adequate post-treatment compression may reduce the incidence of deep vein thrombosis.
Avoid use of sodium tetradecyl sulfate foamed with room air. Stroke, transient ischemic attack, myocardial infarction, and impaired cardiac function have been reported in close temporal relationship with sodium tetradecyl sulfate administration. Such events may be caused by air embolism when using the product foamed with room air (high nitrogen concentration) or thromboembolism.
It is not known whether sodium tetradecyl sulfate can cause fetal harm or affect reproduction capacity when administered to a pregnant woman. Animal reproduction studies have not been conducted with sodium tetradecyl sulfate. Administer sodium tetradecyl sulfate during pregnancy only if clearly needed and the benefits outweigh the risks.
It is not known if sodium tetradecyl sulfate is excreted in human milk. Because many drugs are excreted in human milk, use caution when sodium tetradecyl sulfate is administered to a breast-feeding woman.
For the treatment of varicose veins:
Intravenous dosage (1% or 3% solution):
Adults: 0.5 to 2 mL IV depending on the size and degree of varicosity. Reserve 3% solution for large varicose veins. Usual Max: 1 mL/injection. Max: 10 mL/treatment.
For the treatment of upper GI bleeding* (variceal bleeding*) related to esophageal varices*:
NOTE: Sodium tetradecyl sulfate has been designated as an orphan drug by the FDA for the treatment of GI bleeding due to esophageal varices.
Intravenous dosage (1% or 3% solution):
Adults: 0.5 to 20 mL IV directly into varix under endoscopic visualization. Sclerotherapy is commonly used as adjunctive treatment, often after medical stabilization of bleeding with octreotide. The use of emergency sclerotherapy as the first-line treatment is controversial.
Maximum Dosage Limits:
-Adults
10 mL total per single treatment for varicose veins.
-Geriatric
10 mL total per single treatment for varicose veins.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Sodium Tetradecyl Sulfate products.
Sodium tetradecyl sulfate injection is a 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 that may or may not be permanent. Sclerosant-induced venous thrombosis may not be the principal hemostatic mechanism in variceal sclerotherapy. A key factor in the ability of sodium tetradecyl sulfate, as well as other sclerosing agents, to stop active hemorrhage and initiate hemostasis might be attributed to the esophageal and vascular smooth muscle spasm which is induced by the sclerosing agent. During active bleeding, the sclerosant injected into the esophageal varices may dissipate rapidly since the varices have a much higher blood-flow rate and no functioning valves. There is no difference in the rate of hemostasis when sclerosants are intentionally injected around the varices compared to intravascular injection, further supporting the theory that acute venous thrombosis is not the primary hemostatic mechanism. The mechanical compression effect of submucosal edema, created by the injection of sclerosing agents, may also be responsible for acute hemostasis.
Pharmacokinetics:
Sodium tetradecyl sulfate is injected locally into varicose veins and esophageal varices.
-Route-Specific Pharmacokinetics
Intravenous Route
Measurable concentrations are not expected to be present in the peripheral blood following injection at the recommended doses. The recommended quantities administered at each treatment session are not expected to result in overt systemic clinical effects.