Sodium tetradecyl sulfate (STS), an anionic surfactant and detergent, is used as a sclerosing agent.1, 2, 3, 7
Sodium tetradecyl sulfate is used as a sclerosing agent for the treatment of small, uncomplicated varicose veins in the lower extremities.1, 2, 3, 4, 7, 8, 14, 20 The drug should only be used for varicose veins that show simple dilation with competent valves;1 sclerotherapy should not be used in patients with clinically important valvular or deep vein incompetence.1 The benefit-to-risk ratio should be considered in selected patients who are great surgical risks.1 (See Cautions.)
Depending on vein size and severity of symptoms or disability (e.g., cosmetic concern only without symptoms, minor discomfort, leg pain, leg fatigue, venous incompetence), varicose veins in the lower extremity are treated using conservative therapy (e.g., observation, compression or support stockings), sclerotherapy (e.g., polidocanol, sodium tetradecyl sulfate), phlebectomy, endovenous thermal ablation (laser or radiofrequency), or conventional surgery involving saphenous ligation and stripping.2, 3, 4, 5, 6, 7, 8 Uncomplicated, superficial spider or thread veins (telangiectasia) or reticular veins generally are treated with sclerotherapy if they are amenable to nonsurgical interventions.3, 7, 8
Sclerosing agents can be classified into 3 categories based on their mechanisms of destruction of the endothelium (i.e., detergents, osmotic agents, or chemical irritants).2, 3, 7 Detergent sclerosing agents approved by the US Food and Drug Administration (FDA) and used most frequently in the treatment of small, uncomplicated varicose veins in the lower extremity are polidocanol and sodium tetradecyl sulfate.2, 3, 4, 7 When used for sclerotherapy of small varicose veins, evidence to date indicates that these 2 drugs are associated with similar outcomes.3, 8
In a multicenter, randomized, double-blind, placebo- and comparator-controlled trial (EASI study), a total of 338 patients with spider or reticular varicose veins were treated with polidocanol (0.5% solution for spider veins, 1% solution for reticular veins), sodium tetradecyl sulfate (1% solution), or placebo (0.9% isotonic saline solution).15, 20 Patients were predominately female, ranging from 18-70 years of age.15 All patients received an IV injection in the first treatment session; repeat injections were given 3 and 6 weeks later if the previous injection was evaluated as unsuccessful (defined as 1, 2, or 3 on a 5-point rating scale; 1 = worse than before, 2 = same as before, 3 = moderate improvement, 4 = good improvement, 5 = complete treatment success).15 Final assessments were done at 12 and 26 weeks after the last injection.15
The primary effectiveness end point was improvement of veins based on comparison of digital images taken of the selected treatment area at baseline (prior to injection) and at 12 weeks after treatment; improvement was rated by a blinded panel using the 5-point rating scale.15 The secondary efficacy criterion was the rate of treatment success, defined as a score of 4 or 5 on the 5-point rating scale.15
Improvement of veins 12 and 26 weeks after the last injection was the same with polidocanol and sodium tetradecyl sulfate (mean scores of 4.5 at both assessments); both drugs were more effective than placebo (mean scores of 2.2 at both assessments).15, 20 Treatment success rates of 95 and 92% were reported 12 weeks after the last injection with polidocanol and sodium tetradecyl sulfate, respectively, compared with 8% after placebo injection; at 26 weeks, the rates were 95 and 91% with polidocanol and sodium tetradecyl sulfate, respectively, compared with 6% after placebo injection.15
Sodium tetradecyl sulfate has been used for endoscopic sclerotherapy in the treatment of esophageal varices† bleeding,9, 16, 17, 18, 19 and is designated an orphan drug by the US Food and Drug Administration (FDA) for this use.21
Sodium tetradecyl sulfate is administered only by IV injection.1 Extravasation should be avoided.1 (See Administration Precautions under Cautions: Warnings/Precautions.)
Sodium tetradecyl sulfate is commercially available as a 1 or 3% solution in vials (containing a total of 20 or 60 mg, respectively, in each 2-mL vial).1 Although the drug has been administered as an endovenous foam or microfoam,2, 7, 8, 11, 12, 13 these preparations are not commercially available in the US and extemporaneous preparation of sodium tetradecyl sulfate foam is not approved by the US Food and Drug Administration (FDA).
Unopened vials of sodium tetradecyl sulfate solution should be stored at 20-25°C.1
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.1 Sodium tetradecyl sulfate solutions that have precipitated or are discolored should not be used.1
Sodium tetradecyl sulfate is incompatible with heparin;1 therefore, the 2 drugs should not be mixed in the same syringe.1
Sodium tetradecyl sulfate should be administered by health-care personnel experienced in venous anatomy and familiar with the proper injection technique for sclerotherapy.1 (See Administration Precautions under Cautions: Warnings/Precautions.) Specialized references should be consulted for the specific injection technique and procedures for sclerotherapy.2
Because of the risk of anaphylactic shock (see Sensitivity Reactions under Cautions: Warnings/Precautions), an initial test dose of 0.5 mL of sodium tetradecyl sulfate solution should be injected into a varicosity and the patient observed for several hours before a second or larger dose is administered.1
Adequate posttreatment compression should be applied.1 (See Thrombotic Complications under Cautions: Warnings/Precautions.)
When used as a sclerosing agent, the concentration of sodium tetradecyl sulfate solution and injection volume depend on the size and degree of varicosity.1, 2 Low concentrations of sodium tetradecyl sulfate solution should be used for small diameter veins (e.g., telangiectasia).2 The 1% solution usually is used;1 the 3% solution is preferred for larger varicosities.1
For the treatment of small, uncomplicated varicose veins in the lower extremity, 5-20 mg of the 1% sodium tetradecyl sulfate solution (0.5-2 mL, preferably no more than 1 mL) or 15-60 mg of the 3% sodium tetradecyl sulfate solution (0.5-2 mL, preferably no more than 1 mL) is recommended by the manufacturer for each injection site.1 A maximum of 2 mL should be used for each injection site1 and a maximum of 10 mL should be used for each treatment session.1
No special population dosage recommendations.1
Sodium tetradecyl sulfate is contraindicated in patients with a history of hypersensitivity reactions to the drug1 or history of allergic conditions.1 (See Sensitivity Reactions under Cautions: Warnings/Precautions.)
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, or varicosities caused by abdominal and pelvic tumors (unless the tumor has been removed).1
The drug also is contraindicated in bedridden patients or patients with acute cellulitis, acute infections, or uncontrolled systemic diseases (e.g., diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias, acute respiratory disease, skin disease).1
Severe allergic reactions (e.g., anaphylactic shock), including some fatalities, have been reported following sodium tetradecyl sulfate treatment.1, 10 One reported fatality occurred in a patient with a history of asthma, which is a contraindication to use of sodium tetradecyl sulfate.1 (See Cautions: Contraindications.)
Other allergic reactions, including hives, asthma, and hayfever, also have been reported in patients treated with sodium tetradecyl sulfate.1
Clinicians should consider the possibility of an anaphylactic reaction when administering sodium tetradecyl sulfate and should be prepared to appropriately treat such reactions.1 Emergency resuscitation equipment should be immediately available.1
Because of the risk of anaphylactic shock, an initial volume of 0.5 mL of sodium tetradecyl sulfate solution should be injected into a varicosity and the patient observed for several hours before a second or larger dose is administered.1
Sodium tetradecyl sulfate should be administered only by health-care personnel who are experienced in venous anatomy and the diagnosis and treatment of conditions affecting the venous system and who are familiar with proper injection techniques for sclerotherapy.1
Extreme care should be taken when placing the IV needle in the target vein,1 and the smallest effective volume of sodium tetradecyl sulfate solution should be used at each injection site.1
Extravasation should be avoided since it may cause severe adverse local effects, including sloughing and tissue necrosis.1
Deep vein thrombosis and pulmonary embolism have developed following sclerotherapy of superficial varicosities.1 Embolism may occur as long as 4 weeks after sodium tetradecyl sulfate treatment.1
Because of the danger of thrombosis extension into the deep venous system, a thorough evaluation for valvular competency should be carried out prior to administration of sodium tetradecyl sulfate and only small amounts (maximum 2 mL) of sodium tetradecyl sulfate solution should be injected slowly into the varicosity.1
Deep venous patency must be determined using noninvasive testing (e.g., duplex ultrasound).1 Venous sclerotherapy should not be undertaken if tests such as Trendelenberg and Perthes, and angiography show clinically important valvular or deep venous incompetence.1
Patients should receive posttreatment follow-up of sufficient duration to assess for the development of deep vein thrombosis.1
Adequate posttreatment compression may decrease the incidence of deep vein thrombosis.1
Sodium tetradecyl sulfate must be used with extreme caution in patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger's Disease).1
Category C.1 (See Users Guide)
There are no adequate and well-controlled studies using sodium tetradecyl sulfate in pregnant women;1 the drug should be used during pregnancy only if clearly needed and if the benefits outweigh the risks.1
It is not known whether sodium tetradecyl sulfate is distributed into human milk.1 Because many drugs are distributed into milk, sodium tetradecyl sulfate should be used with caution in nursing woman.1
Safety and efficacy of sodium tetradecyl sulfate have not been established in pediatric patients.1
Adverse effects reported in patients treated with sodium tetradecyl sulfate include injection site reactions (pain, urticaria, ulceration),1 discoloration along the path of a sclerosed vein segment (may be permanent), allergic reactions, and mild systemic reactions (headache, nausea, vomiting).1
No well-controlled drug interaction studies have been performed using sodium tetradecyl sulfate in patients receiving antiovulatory agents.1 One fatality occurred in a patient who was receiving an antiovulatory agent at the time sodium tetradecyl sulfate treatment was administered.1 Other fatalities (e.g., fatal pulmonary embolism) have been reported in patients who were not taking oral contraceptives.1
Clinicians must evaluate the patient and use clinical judgment prior to initiating sodium tetradecyl sulfate treatment in patients receiving antiovulatory agents.1
Sodium tetradecyl sulfate (STS) is an anionic surfactant and detergent used as a sclerosing agent.1, 2, 3, 7 The drug is commercially available in the US as a sterile, nonpyrogenic 1 or 3% solution.1 Each mL contains 10 mg (1%) or 30 mg (3%) of sodium tetradecyl sulfate with benzyl alcohol (0.02 mL) and dibasic sodium phosphate anhydrous in water for injection.1 The solution has a pH of 7.9;1 monobasic sodium phosphate and/or sodium hydroxide are added for pH adjustment.1
Following IV injection, sodium tetradecyl sulfate causes inflammation of the intima and thrombus formation, which usually occludes the target vein.1 Subsequent formation of fibrous tissue results in partial or complete vein obliteration;1 the effect on the vein may or may not be permanent.1
Because of the risk of thrombosis, a thorough evaluation for valvular competency is necessary prior to sodium tetradecyl sulfate treatment.1
Advise patient that adequate posttreatment compression may decrease the incidence of deep vein thrombosis.1
Importance of posttreatment follow-up of sufficient duration to assess for development of deep vein thrombosis.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Additional Information
Overview® (see Users Guide). For additional information on this drug until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for IV use only | 1% | ||
3% | Sotradecol® | Angiodynamics |
1. AngioDynamics Inc. Tetradecyl hydrogen sulfate (ester) injection solution prescribing information. Queensbury, NY; 2008 Mar.
2. Gloviczki P, Comerota AJ, Dalsing MC et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg . 2011; 53(5 Suppl):2S-48S. [PubMed 21536172]
3. Schwartz L, Maxwell H. Sclerotherapy for lower limb telangiectasias. Cochrane Database Syst Rev . 2011; :CD008826. [PubMed 22161437]
4. Campbell B. Varicose veins and their management. BMJ . 2006; 333:287-92. [PubMed 16888305][PubMedCentral]
5. Leopardi D, Hoggan BL, Fitridge RA et al. Systematic review of treatments for varicose veins. Ann Vasc Surg . 2009; 23:264-76. [PubMed 19059756]
6. Subramonia S, Lees TA. The treatment of varicose veins. Ann R Coll Surg Engl . 2007; 89:96-100. [PubMed 17346396][PubMedCentral]
7. Worthington-Kirsch RL. Injection sclerotherapy. Semin Intervent Radiol . 2005; 22:209-17. [PubMed 21326695][PubMedCentral]
8. Tisi PV, Beverley C, Rees A. Injection sclerotherapy for varicose veins. Cochrane Database Syst Rev . 2006; :CD001732. [PubMed 17054141]
9. Ravi M, Kate V, Ananthakrishnan N. Prospective randomized comparison of sodium tetradecyl sulphate & polidocanol for oesophageal variceal sclerotherapy. Indian J Med Res . 2001; 113:228-33. [PubMed 11816957]
10. Brzoza Z, Kasperska-Zajac A, Rogala E et al. Anaphylactoid reaction after the use of sodium tetradecyl sulfate: a case report. Angiology . 2007 Oct-Nov; 58:644-6.
11. Rao J, Wildemore JK, Goldman MP. Double-blind prospective comparative trial between foamed and liquid polidocanol and sodium tetradecyl sulfate in the treatment of varicose and telangiectatic leg veins. Dermatol Surg . 2005; 31:631-5; discussion 635. [PubMed 15996411]
12. Chen CH, Chiu CS, Yang CH. Ultrasound-guided foam sclerotherapy for treating incompetent great saphenous veins--results of 5 years of analysis and morphologic evolvement study. Dermatol Surg . 2012; 38:851-7. [PubMed 22540961]
13. Kakkos SK, Bountouroglou DG, Azzam M et al. Effectiveness and safety of ultrasound-guided foam sclerotherapy for recurrent varicose veins: immediate results. J Endovasc Ther . 2006; 13:357-64. [PubMed 16784324]
14. Goldman MP. Treatment of varicose and telangiectatic leg veins: double-blind prospective comparative trial between aethoxyskerol and sotradecol. Dermatol Surg . 2002; 28:52-5. [PubMed 11991271]
15. Merz Aesthetics, Inc. Asclera® (polidocanol) injection for intravenous use prescribing information. Franksville, WI; 2010 Mar.
16. Chawla YK, Dilawari JB, Dhiman RK et al. Sclerotherapy in noncirrhotic portal fibrosis. Dig Dis Sci . 1997; 42:1449-53. [PubMed 9246045]
17. Waked I, Korula J. Analysis of long-term endoscopic surveillance during follow-up after variceal sclerotherapy from a 13-year experience. Am J Med . 1997; 102:192-9. [PubMed 9217570]
18. Bhargava DK, Singh B, Dogra R et al. Prospective randomized comparison of sodium tetradecyl sulfate and polidocanol as variceal sclerosing agents. Am J Gastroenterol . 1992; 87:182-6. [PubMed 1734694]
19. Benjamin SB. Sclerotherapy for esophageal varices. DICP . 1990; 24(11 Suppl):S47-50. [PubMed 2270696]
20. Rabe E, Schliephake D, Otto J et al. Sclerotherapy of telangiectases and reticular veins: a double-blind, randomized, comparative clinical trial of polidocanol, sodium tetradecyl sulphate and isotonic saline (EASI study). Phlebology . 2010; 25:124-31. [PubMed 20483861]
21. Food and Drug Administration. FDA Application: Search Orphan Drug Designations and Approvals. Rockville, MD. From FDA website. Accessed 2013 Feb 6. [Web]