(SOTRADECOL) SODIUM TETRADECYL SULFATE 30 mg/mL
(SOTRADECOL) SODIUM TETRADECYL SULFATE · INJECTION, SOLUTION · HF Acquisition Co LLC, DBA HealthFirst
(SOTRADECOL) SODIUM TETRADECYL SULFATE is a prescription injection, solution containing (sotradecol) sodium tetradecyl sulfate at 30 mg/mL, taken intravenous. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.
Key Facts
- Brand Name
- (SOTRADECOL) SODIUM TETRADECYL SULFATE
- Generic Name
- (SOTRADECOL) SODIUM TETRADECYL SULFATE
- NDC Code (Product)
51662-1563- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- 30 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA040541
- Marketing Start
- 06/25/2021
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS & USAGE Sotradecol (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.
Dosage & Administration
DOSAGE & ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if precipitated or discolored. Sotradecol (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
WARNINGS Sotradecol (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 Sotradecol 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…
Contraindications
CONTRAINDICATIONS Sotradecol (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.
Drug Interactions
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 Sotradecol. (See ADVERSE REACTIONS section.) Heparin should not be included in the same syringe as Sotradecol, since the two are incompatible.
Adverse Reactions
ADVERSE REACTIONS 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 Sotradecol. Four cases of anaphylactic shock leading to death have been reported in patients who received Sotradecol. One of these four patients reported a history of asthma, a contraindication to the administration of Sotradecol. (See WARNINGS section.) One death has been reported in a patient who received Sotradecol 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
Frequently Asked Questions
What is (SOTRADECOL) SODIUM TETRADECYL SULFATE used for?
(SOTRADECOL) SODIUM TETRADECYL SULFATE contains (SOTRADECOL) SODIUM TETRADECYL SULFATE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is (SOTRADECOL) SODIUM TETRADECYL SULFATE a controlled substance?
(SOTRADECOL) SODIUM TETRADECYL SULFATE is not classified as a controlled substance by the DEA.
What is the generic name for (SOTRADECOL) SODIUM TETRADECYL SULFATE?
The generic name for (SOTRADECOL) SODIUM TETRADECYL SULFATE is (SOTRADECOL) SODIUM TETRADECYL SULFATE. There are no other listed brand versions of (SOTRADECOL) SODIUM TETRADECYL SULFATE.
What is the NDC code for (SOTRADECOL) SODIUM TETRADECYL SULFATE 30 mg/mL?
The NDC (National Drug Code) for (SOTRADECOL) SODIUM TETRADECYL SULFATE 30 mg/mL is 51662-1563, listed by HF Acquisition Co LLC, DBA HealthFirst.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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