Sodium tetradecyl sulfate

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# Overview
Sodium tetradecyl sulfate is a sclerosing Agent that is FDA approved for the treatment of small uncomplicated varicose veins of the lower extremities.   Common adverse reactions include Local reactions consisting of pain, urticaria or ulceration, Allergic reactions.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Indications
- 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
- 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.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sodium tetradecyl sulfate in adult patients.

### NonGuideline-Supported Use
- Esophageal varices
- Hemangioma

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Sodium tetradecyl sulfate in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sodium tetradecyl sulfate in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Sodium tetradecyl sulfate in pediatric patients.

# 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.

# 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 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.
- The development of deep vein thrombosis and pulmonary embolism have been reported following sclerotherapy treatment of superficial varicosities. Patients should have post-treatment follow-up of sufficient duration to assess for the development of deep vein thrombosis. Embolism may occur as long as four weeks after injection of sodium tetradecyl sulfate. Adequate post-treatment compression may decrease the incidence of deep vein thrombosis.

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

# Adverse Reactions

## Clinical Trials Experience
- 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.
- 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.
- 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.
- 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.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Sodium tetradecyl sulfate in the drug label.

# 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.
- Heparin should not be included in the same syringe as Sotradecol, since the two are incompatible.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
- Animal reproduction studies have not been conducted with Sotradecol. It is also not known whether Sotradecol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sotradecol should be given to a pregnant woman only if clearly needed and the benefits outweigh the risks.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sodium tetradecyl sulfate in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Sodium tetradecyl sulfate during labor and delivery.

### 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 Sotradecol is administered to a nursing woman.

### Pediatric Use
- Safety and effectiveness in pediatric patients have not been established.

### Geriatic Use
There is no FDA guidance on the use of Sodium tetradecyl sulfate with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Sodium tetradecyl sulfate with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Sodium tetradecyl sulfate with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Sodium tetradecyl sulfate in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Sodium tetradecyl sulfate in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Sodium tetradecyl sulfate in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Sodium tetradecyl sulfate in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Intravenous

### Monitoring
There is limited information regarding Monitoring of Sodium tetradecyl sulfate in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Sodium tetradecyl sulfate in the drug label.

# Overdosage
There is limited information regarding Overdose of Sodium tetradecyl sulfate in the drug label.

# Pharmacology

## Mechanism of Action
- Sotradecol (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.

## Structure
- Sodium tetradecyl sulfate is an anionic surfactant which occurs as a white, waxy solid. The structural formula is as follows:
- Sotradecol (sodium tetradecyl sulfate injection) is a sterile nonpyrogenic solution for intravenous use as a sclerosing agent.
- 1% 20 mg/2 mL (10 mg/mL): Each mL contains sodium tetradecyl sulfate 10 mg, benzyl alcohol 0.02 mL and dibasic sodium phosphate, anhydrous 4.0 mg in Water for Injection. pH 7.9; monobasic sodium phosphate and/or sodium hydroxide added, if needed, for pH adjustment.
- 3% 60 mg/2 mL (30 mg/mL): Each mL contains sodium tetradecyl sulfate 30 mg, benzyl alcohol 0.02 mL and dibasic sodium phosphate, anhydrous 9.0 mg in Water for Injection. pH 7.9; monobasic sodium phosphate and/or sodium hydroxide added, if needed, for pH adjustment.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Sodium tetradecyl sulfate in the drug label.

## Pharmacokinetics
- Sotradecol (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.

## Nonclinical Toxicology
- 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.
- The intravenous LD50 of sodium tetradecyl sulfate in mice was reported to be 90  5 mg/kg.
- In the rat, the acute intravenous LD50 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 LD50 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.

# Clinical Studies
There is limited information regarding Clinical Studies of Sodium tetradecyl sulfate in the drug label.

# How Supplied
- Sotradecol (sodium tetradecyl sulfate injection)

## Storage
- Store at 20 to 25C (68 to 77F).

# Images

## Drug Images

## Package and Label Display Panel

### PRINCIPAL DISPLAY PANEL - 10 MG/ML CARTON LABEL
Sotradecol 1%
(SODIUM TETRADECYL SULFATE INJECTION)
20 mg/2 mL
(10 mg/mL)
FOR INTRAVENOUS USE ONLY
Rx only
Distributed by:
AngioDynamics, Inc.
Queensbury, NY 12804
Manufactured by:
Mylan Institutional 
Galway, Ireland
Each mL contains: 
Sodium tetradecyl sulfate 10 mg, benzyl alcohol 0.02 mL and dibasic
sodium phosphate, anhydrous 4.0 mg in Water for Injection. pH 7.9;
monobasic sodium phosphate and/or sodium hydroxide added, if
needed, for pH adjustment.
WARNING: Do not use if precipitated.
USUAL DOSAGE: See accompanying prescribing information.
Store at 20 to 25C (68 to 77F). 
0319C102

### PRINCIPAL DISPLAY PANEL - 30 MG/ML CARTON LABEL
5 x 2 mL Vials     NDC 65974-163-02
Sotradecol 3%
(SODIUM TETRADECYL SULFATE INJECTION)
60 mg/2 mL
(30 mg/mL)
FOR INTRAVENOUS USE ONLY
Rx only
Distributed by:
AngioDynamics, Inc.
Queensbury, NY 12804
Manufactured by:
Mylan Institutional 
Galway, Ireland
Each mL contains: 
Sodium tetradecyl sulfate 30 mg, benzyl alcohol 0.02 mL and dibasic
sodium phosphate, anhydrous 9.0 mg in Water for Injection. pH 7.9;
monobasic sodium phosphate and/or sodium hydroxide added, if
needed, for pH adjustment.
WARNING: Do not use if precipitated.
USUAL DOSAGE: See accompanying prescribing information.
Store at 20 to 25C (68 to 77F). 
0320C102

### Ingredients and appearance

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Sodium tetradecyl sulfate in the drug label.

# Precautions with Alcohol
- Alcohol-Sodium tetradecyl sulfate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- SOTRADECOL

# Look-Alike Drug Names
There is limited information regarding Sodium tetradecyl sulfate Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price