pharmacopeia
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/api/v1/drug/sodium-tetradecyl-sulfate

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Sclerosing Activity.

Indications

Sourced from openFDA
  • Sodium tetradecyl sulfate injection is 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.

Contraindications

Sourced from openFDA
  • Sodium tetradecyl sulfate injection is contraindicated in previous hypersensitivity reactions to the drug; 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 respiratory or skin diseases.contraindicated

Dosage & administration

Sourced from openFDA

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if precipitated or discolored. Sodium tetradecyl sulfate injection is for intravenous use only. 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 mL to 2 mL (preferably 1 mL maximum) for each injection, and the maximum single treatment should not exceed 10 mL.

Warnings & precautions

Sourced from openFDA

Sodium tetradecyl sulfate injection should only be administered by a healthcare 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 following extravasation; therefore, extreme care in intravenous needle placement and using the minimal effective volume at each injection site are important. Emergency resuscitation equipment should be immediately available. Allergic reactions, including fatal anaphylaxis, have been reported. As a precaution against anaphylactic shock, it is recommended that 0.5 mL of sodium tetradecyl sulfate injection 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. Because of the danger of thrombosis extension into the deep venous system, thorough preinjection 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. Deep venous patency must be determined by noninvasive testing such as duplex ultrasound. Venous sclerotherapy should not be undertaken if tests such as Trendelenberg and Perthes, and angiography show significant valvular or deep venous incompetence.

Adverse reactions

Sourced from openFDA

Local reactions consisting of pain, urticaria or ulceration may occur at the site of injection. A permanent discoloration may remain along the path of the sclerosed vein segment. Sloughing and necrosis of tissue may occur following extravasation of the drug. (See WARNINGS section.) Allergic reactions such as hives, asthma, hay fever and anaphylactic shock have been reported. Mild systemic reactions that have been reported include headache, nausea and vomiting. (See WARNINGS section.) At least six deaths have been reported with the use of sodium tetradecyl sulfate injection. Four cases of anaphylactic shock leading to death have been reported in patients who received sodium tetradecyl sulfate injection. One of these four patients reported a history of asthma, a contraindication to the administration of sodium tetradecyl sulfate injection. (See WARNINGS section.) One death has been reported in a patient who received sodium tetradecyl sulfate injection 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. Cerebrovascular accident, myocardial infarction To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800 FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

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

Approval history

Sourced from openFDA
  • Dec 9, 2019ANDAANDA209937Hikma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
49 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use714%
  2. 2Product Use In Unapproved Indication48.2%
  3. 3Air Embolism36.1%
  4. 4Disease Progression36.1%
  5. 5Drug Ineffective For Unapproved Indication36.1%
  6. 6Ischaemic Stroke36.1%
  7. 7Acute Myocardial Infarction24.1%
  8. 8Adverse Reaction24.1%
  9. 9Anaphylactic Reaction24.1%
  10. 10Chronic Pigmented Purpura24.1%
  11. 11Deep Vein Thrombosis24.1%
  12. 12Drug Ineffective24.1%
  13. 13Facial Paralysis24.1%
  14. 14Muscle Necrosis24.1%
  15. 15Pain24.1%

Literature

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Recent PubMed references pinned to Sodium Tetradecyl Sulfate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 18 ClinicalTrials.gov registrations naming Sodium Tetradecyl Sulfate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Sodium Tetradecyl Sulfate work?
Mechanism-of-action class: Sclerosing Activity.
What is Sodium Tetradecyl Sulfate used for?
According to FDA labeling, Sodium Tetradecyl Sulfate carries indications including: Sodium tetradecyl sulfate injection is 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Sodium Tetradecyl Sulfate?
Sodium Tetradecyl Sulfate is classified as Sclerosing agents for local injection, Sclerosing Activity, Increased Platelet Activating Factor Activity, Vascular Sclerosing Activity.
What are the brand names for Sodium Tetradecyl Sulfate?
Sodium Tetradecyl Sulfate is marketed under brand names including Sotradecol.
What are the contraindications for Sodium Tetradecyl Sulfate?
Sodium Tetradecyl Sulfate labeling lists contraindications including: Sodium tetradecyl sulfate injection is contraindicated in previous hypersensitivity reactions to the drug; 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 respiratory or skin diseases.. Always consult the full prescribing information and a clinician.
Note. Data for sodium-tetradecyl-sulfate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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