PDR MEMBER LOGIN:
  • PDR Search

    Required field
  • Advertisement
  • CLASSES

    Tissue Sealing Agents

    DEA CLASS

    Rx

    DESCRIPTION

    Injectable, sclerosing agent
    Used for small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves
    Associated with severe adverse local effects, including tissue necrosis, after extravasation

    COMMON BRAND NAMES

    Sotradecol

    HOW SUPPLIED

    Sotradecol Intravenous Inj Sol: 1%, 3%

    DOSAGE & INDICATIONS

    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.[30664]

    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.

    †Indicates off-label use

    MAXIMUM DOSAGE

    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.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Injectable Administration

    Visually inspect solution for particulate matter and discoloration prior to administration whenever solution and container permit.[30664]

    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.

    STORAGE

    Sotradecol:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    Extravasation, requires an experienced clinician

    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.

    Asthma, diabetes mellitus, hematological disease, infection, neoplastic disease, pulmonary disease, sepsis, skin disease, thromboangiitis obliterans (Buerger's disease), thrombophlebitis, thyrotoxicosis, tuberculosis

    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.

    Air embolism

    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.

    Pregnancy

    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.

    Breast-feeding

    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.[30664]

    ADVERSE REACTIONS

    Severe

    tissue necrosis / Early / Incidence not known
    anaphylactic shock / Rapid / Incidence not known
    myocardial infarction / Delayed / Incidence not known
    thromboembolism / Delayed / Incidence not known
    stroke / Early / Incidence not known
    air embolism / Rapid / Incidence not known
    pulmonary embolism / Delayed / Incidence not known

    Moderate

    skin ulcer / Delayed / Incidence not known

    Mild

    urticaria / Rapid / Incidence not known
    injection site reaction / Rapid / Incidence not known
    skin discoloration / Delayed / Incidence not known
    headache / Early / Incidence not known
    vomiting / Early / Incidence not known
    nausea / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Sodium Tetradecyl Sulfate products.

    PREGNANCY AND LACTATION

    Pregnancy

    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.[30664]

    MECHANISM OF ACTION

    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.

    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.