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Sotradecol

Generic Name: Sodium Tetradecyl Sulfate
Class: Sclerosing Agents
Chemical Name: 7-ethyl-2-methyl-4-hendecanol sulfate sodium salt
Molecular Formula: C14H29NaSO4
CAS Number: 139-88-8

Introduction

Sclerosing agent; anionic surfactant and detergent.1 2 3 7

Uses for Sotradecol

Sclerotherapy

Treatment of small, uncomplicated varicose veins of the lower extremity.1 2 3 4 7 8 14 20 Use only for veins showing simple dilation with competent valves;1 do not use in patients with clinically important valvular or deep vein incompetence.1 Consider benefit-to-risk ratio in selected patients who are great surgical risks.1 (See Cautions.)

Treatment of bleeding esophageal varices;9 16 17 18 19 designated an orphan drug by FDA for this use.21

Sotradecol Dosage and Administration

Administration

IV Administration

Administer only by IV injection.1 Avoid extravasation.1 (See Administration Precautions under Cautions.)

Commercially available as 1 or 3% solution in vials (containing a total of 20 or 60 mg, respectively, in each 2-mL vial).1 Has been administered as an endovenous foam or microfoam;2 7 8 11 12 13 these preparations not commercially available in US and extemporaneous preparation of sodium tetradecyl sulfate foam not approved by FDA.

Should be administered by health-care personnel experienced in venous anatomy and familiar with proper injection technique for sclerotherapy.1 Consult specialized references for specific injection technique and procedures for sclerotherapy.2

Because of risk of anaphylactic shock (see Sensitivity Reactions under Cautions), inject initial test dose of 0.5 mL of sodium tetradecyl sulfate solution into a varicosity and observe patient for several hours before administering a second or larger dose.1

Use adequate posttreatment compression.1 (See Thrombotic Complications under Cautions.)

Dosage

Adults

Sclerotherapy
Uncomplicated Varicose Veins in Lower Extremity
IV

Concentration of sodium tetradecyl sulfate solution and injection volume to be used depend on type and size of varicose veins.1 2 Use low concentrations for small diameter veins (e.g., telangiectasia).2 Generally use 1% solution;1 3% solution preferred for larger varicosities.1

5–20 mg of the 1% sodium tetradecyl sulfate solution (0.5–2 mL, preferably ≤2) or 15–60 mg of the 3% sodium tetradecyl sulfate solution (0.5–2 mL, preferably ≤2) recommended by manufacturer for each injection site.1 Do not exceed 2 mL per injection site or 10 mL per treatment session.1

Prescribing Limits

Adults

Sclerotherapy
Uncomplicated Varicose Veins in Lower Extremity
IV

Maximum 2 mL of 1 or 3% solution (20 or 60 mg, respectively) per injection site; maximum 10 mL per treatment session.1

Special Populations

No special population dosage recommendations.1

Cautions for Sotradecol

Contraindications

  • History of hypersensitivity reactions to sodium tetradecyl sulfate1 or history of allergic reactions.1 (See Sensitivity Reactions under Cautions.)

  • 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 tumor has been removed).1

  • 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

Warnings/Precautions

Sensitivity Reactions

Severe allergic reactions (e.g., anaphylactic shock), including some fatalities, reported.1 10 One reported fatality occurred in patient with history of asthma.1 (See Contraindications under Cautions.)

Other allergic reactions, including hives, asthma, and hay fever, also reported.1

Consider possibility of anaphylactic reaction; be prepared to appropriately treat such reactions.1 Have emergency resuscitation equipment immediately available.1

Because of risk of anaphylactic shock, inject an initial volume of 0.5 mL into a varicosity and observe patient for several hours before administering second or larger dose.1

Administration Precautions

Should be administered only by health-care personnel experienced in venous anatomy and diagnosis and treatment of conditions affecting the venous system and who are familiar with proper injection techniques for sclerotherapy.1

Use extreme care when placing IV needle into target vein; use smallest effective volume of solution at each injection site.1

Avoid extravasation since it may cause severe adverse local effects, including sloughing and tissue necrosis.1

Thrombotic Complications

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 danger of thrombosis extension into the deep venous system, perform thorough preinjection evaluation for valvular competency and only inject small amount (maximum 2 mL) of sodium tetradecyl sulfate solution slowly into the varicosity.1

Determine deep venous patency using noninvasive testing (e.g., duplex ultrasound).1 Do not undertake venous sclerotherapy if tests such as Trendelenburg and Perthes, and angiography indicate significant valvular or deep venous incompetence.1

Posttreatment follow-up of sufficient duration is necessary to assess for development of deep vein thrombosis.1

Adequate posttreatment compression may decrease incidence of deep vein thrombosis.1

Use with extreme caution in patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger Disease).1

Specific Populations

Pregnancy

Category C.1

Use during pregnancy only if clearly needed and if benefits outweigh risks.1

Lactation

Not known whether distributed into human milk;1 use with caution in nursing woman.1

Pediatric Use

Safety and efficacy not established.1

Common Adverse Effects

Injection site reactions (pain, urticaria, ulceration),1 discoloration along path of sclerosed vein segment (may be permanent), allergic reactions, mild systemic reactions (headache, nausea, vomiting).1

Interactions for Sotradecol

Specific Drugs

Drug

Interaction

Comments

Estrogens/Progestins

No well-controlled interaction studies in patients receiving antiovulatory agents;1 fatality reported in patient receiving an antiovulatory agent at the time of sodium tetradecyl sulfate treatment1

Evaluate and use clinical judgment prior to sodium tetradecyl sulfate treatment in patients receiving antiovulatory agents1

Sotradecol Pharmacokinetics

Stability

Storage

Parenteral

Solution for IV Injection

20-25°C.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

For information on systemic interactions resulting from concomitant use, see Interactions.

Drug Compatibility

Syringe Compatibility1

Incompatible

Heparin

Actions

  • An anionic surfactant and detergent used as a sclerosing agent.1 2 3 7 Commercially available in the US as a sterile, nonpyrogenic 1 or 3% solution.1

  • Following IV injection, causes inflammation of intima and thrombus formation which usually occludes the target vein.1 Subsequent formation of fibrous tissue results in partial or complete vein obliteration;1 effect on vein may or may not be permanent.1

Advice to Patients

  • 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.)

Preparations

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.

Sodium Tetradecyl Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV use only

1%

Sotradecol

Angiodynamics

3%

Sotradecol

Angiodynamics

AHFS DI Essentials. © Copyright, 2016, American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814. Review Date: September 06, 2016.

References

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]

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]

7. Worthington-Kirsch RL. Injection sclerotherapy. Semin Intervent Radiol. 2005; 22:209-17. [PubMed 21326695]

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.

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