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Sodium tetradecyl sulfate: Drug information

Sodium tetradecyl sulfate: Drug information
(For additional information see "Sodium tetradecyl sulfate: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Sotradecol
Brand Names: Canada
  • Tromboject
Pharmacologic Category
  • Sclerosing Agent
Dosing: Adult
Sclerosing agent

Sclerosing agent: IV: Note: The strength of solution required depends on size and degree of varicosity; in general, the 1% solution is used most often, with the 3% solution being reserved for larger varicosities.

Test dose: 0.5 mL followed by several hours of observation is recommended before larger doses are administered.

Usual dose: 0.5 to 2 mL (preferred maximum: 1 mL) in each vein; maximum dose: 10 mL per treatment session of the 3% solution (Ref).

The following concentrations have been recommended based upon size of affected vein (Ref):

Vessel diameter <1 mm: 0.1% to 0.3% concentration.

Vessel diameter 1 to 3 mm: 0.5% to 1% concentration.

Vessel diameter 4 to 6 mm: 1% to 2% concentration.

Branch varicosities: 2% to 3% concentration.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided the in manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Postmarketing:

Cardiovascular: Acute myocardial infarction, cardiac insufficiency, cardiomyopathy (takotsubo) (Potter 2010)

Gastrointestinal: Nausea, vomiting

Hypersensitivity: Hypersensitivity reaction (including anaphylactic shock, anaphylaxis)

Local: Local pain (Schwartz 2011), local skin discoloration (bruising and ecchymoses) (Schwartz 2011), local skin hyperpigmentation (Schwartz 2011), local swelling (Schwartz 2011)

Nervous system: Cerebrovascular accident, headache, transient ischemic attacks

Contraindications

Hypersensitivity to sodium tetradecyl sulfate or any component of the formulation; acute superficial thrombophlebitis; valvular or deep vein incompetence; phlebitis migrans; acute cellulitis; acute infections; allergic conditions; bedridden patients; patients with uncontrolled systemic disease such as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias, and acute respiratory or skin diseases; huge superficial veins with wide open communications to deeper veins; allergic conditions; varicosities caused by abdominal and pelvic tumors (unless tumor has been removed)

Canadian labeling: Additional contraindications (not in US labeling): Recent superficial or deep thrombophlebitis (6 months to 2 years); potential underlying arterial disease; renal or cardiac insufficiencies accompanied by venous stasis and dilatation; angina pectoris; hyperthyroidism

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis: Observe for hypersensitivity/anaphylactic reaction; emergency resuscitation equipment should be available.

• Arterial embolism: Stroke, transient ischemic attack, myocardial infarction, and impaired cardiac function have been reported with use. May be caused by air embolism when using sodium tetradecyl sulfate foamed with room air or thromboembolism. Avoid using sodium tetradecyl sulfate foamed with room air; safety and efficacy has not been established.

• Thromboembolism: Deep vein thrombosis (DVT) and pulmonary embolism (PE) have occurred following treatment.

Disease-related concerns:

• Arteriosclerosis: Use with caution in patients with peripheral arteriosclerosis.

• Thromboangiitis obliterans: Use with caution in patients with thromboangiitis obliterans.

Other warnings/precautions:

• Appropriate use: Valvular and venous competency should be evaluated prior to use.

• Extravasation: Avoid extravasation.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as sulfate:

Sotradecol: 1% (2 mL); 3% (2 mL) [contains benzyl alcohol]

Generic: 3% (2 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Sodium Tetradecyl Sulfate Intravenous)

3% (per mL): $46.20

Solution (Sotradecol Intravenous)

1% (per mL): $46.88

3% (per mL): $46.88

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as sulfate:

Tromboject: 1% (2 mL); 3% (2 mL, 5 mL)

Administration: Adult

IV: For IV injection only. Administer Tromboject [Canadian product] with a 0.22 micrometer pore size and 25 or 33 mm diameter polyethersulfone in-line filter.

Use: Labeled Indications

Varicose veins: Treatment of small, uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Reproduction studies have not been conducted.

Breastfeeding Considerations

It is not known if sodium tetradecyl sulfate is excreted in breast milk. The manufacturer recommends that caution be exercised when administering sodium tetradecyl sulfate to nursing women.

Monitoring Parameters

Monitor for DVT or PE (up to 4 weeks after injection); allergic reactions; pain, urticarial, matting, and pigmentation changes

Mechanism of Action

Acts by irritation of the vein intimal endothelium and causes thrombosis formation leading to occlusion of the injected vein

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AU) Australia: Fibro-vein;
  • (BG) Bulgaria: Fibrovein;
  • (CZ) Czech Republic: Fibro Vein;
  • (EE) Estonia: Fibrovein | Sotradecol;
  • (ES) Spain: Veinfibro;
  • (FR) France: Fibrovein | Trombovar;
  • (GB) United Kingdom: Fibro Vein;
  • (HK) Hong Kong: Fibrovein | Tromboject;
  • (HU) Hungary: Fibro-vein;
  • (IE) Ireland: Fibro Vein;
  • (IT) Italy: Fibro Vein | Trombovar;
  • (KR) Korea, Republic of: Fibrovein | Tromboject;
  • (KW) Kuwait: Fibro Vein;
  • (MY) Malaysia: Fibro-vein | Setrol;
  • (NO) Norway: Fibrovein;
  • (NZ) New Zealand: Fibrovein;
  • (PL) Poland: Fibro Vein;
  • (PR) Puerto Rico: Sotradecol;
  • (PT) Portugal: Fibrovein;
  • (RO) Romania: Fibrovein;
  • (RU) Russian Federation: Fibro Vein | Fibrovein;
  • (SA) Saudi Arabia: Fibrovein;
  • (SI) Slovenia: Fibrovein;
  • (TW) Taiwan: Fibro Vein | Sotradecol | Tromboject;
  • (UA) Ukraine: Fibro Vein
  1. Dietzek CL. Sclerotherapy: introduction to solutions and techniques. Perspect Vasc Surg Endovasc Ther. 2007;19(3):317-324. [PubMed 17966153]
  2. Potter B, Gobeil F, Oiknine A, Laramée P. The first case of takotsubo cardiomyopathy associated with sodium tetradecyl sulphate sclerotherapy. Can J Cardiol. 2010;26(4):146-148. doi:10.1016/s0828-282x(10)70373-1 [PubMed 20386776]
  3. Schwartz L, Maxwell H. Sclerotherapy for lower limb telangiectasias. Cochrane Database Syst Rev. 2011;2011(12):CD008826. doi:10.1002/14651858.CD008826.pub2 [PubMed 22161437]
  4. Sotradecol (sodium tetradecyl sulfate) [prescribing information]. Morgantown, WV: Mylan Institutional LLC; August 2021.
  5. Tromboject (sodium tetradecyl sulfate) [product monograph]. Montreal, Quebec, Canada: Omega Laboratories Limited; October 12, 2021.
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