Sodium tetradecyl sulfate: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->{{RB}}  
|authorTag=<!--Overview-->{{RB}}
|genericName=Sodium tetradecyl sulfate
|genericName=Sodium tetradecyl sulfate
|aOrAn=a
|aOrAn=a
|drugClass=sclerosing Agent
|drugClass=sclerosing Agent
|indicationType=treatment
|indicationType=treatment
|indication=small uncomplicated varicose veins of the lower extremities
|indication=small uncomplicated [[varicose veins]] of the lower extremities
|adverseReactions=Local reactions consisting of pain, urticaria or ulceration, Allergic reactions  
|adverseReactions=Local reactions consisting of [[pain]], [[urticaria]] or [[ulceration]], [[Allergic reactions]]


<!--Black Box Warning-->
<!--Black Box Warning-->
Line 18: Line 18:
<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult=====Indications====
|fdaLIADAdult=====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.
* 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====
====Dosage====
* Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if precipitated or discolored.
* 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.
* 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.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


Line 40: Line 40:


<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|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-->
<!--Warnings-->
|warnings=* Description
|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====
====Precautions====


* Description
=====GENERAL=====
* 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-->
<!--Adverse Reactions-->


<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=* [[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.  


=====Body as a Whole=====
* [[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=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.




=====Cardiovascular=====


<!--Drug Interactions-->
|drugInteractions=* 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-->
|FDAPregCat=C
|useInPregnancyFDA=* 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.
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


=====Digestive=====
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=* 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.
|useInPed=* Safety and effectiveness in pediatric patients have not been established.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.


<!--Administration and Monitoring-->
|administration=* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.






=====Endocrine=====
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


<!--Overdosage-->
|overdose=There is limited information regarding <i>Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->


<!--Drug box 2-->
|drugBox={{Drugbox2
| Verifiedfields = changed
| Watchedfields = changed
| verifiedrevid = 459450489
| IUPAC_name = Sodium 7-ethyl-2-methyl-4-undecanyl sulfate
| image = Sodium Tetra Wiki Str.png


=====Hematologic and Lymphatic=====
<!--Clinical data-->
| tradename =
| Drugs.com = {{drugs.com|CDI|sodium_tetradecyl_sulfate}}
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_US = <!-- A / B            / C / D / X -->
| pregnancy_category =
| legal_AU = <!-- Unscheduled / S2 / S3 / S4 / S5 / S6 / S7 / S8 / S9 -->
| legal_CA = <!--            / Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_UK = <!-- GSL        / P      / POM / CD / Class A, B, C -->
| legal_US = <!-- OTC                  / Rx-only  / Schedule I, II, III, IV, V -->
| legal_status = Prescription only medicine
| routes_of_administration = Intravenous injection


<!--Pharmacokinetic data-->
| bioavailability = 
| protein_bound = 
| metabolism = 
| elimination_half-life = 
| excretion = 


<!--Identifiers-->
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 
| ATC_prefix = C05
| ATC_suffix = BB04
| PubChem = 14492
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = 
| UNII_Ref = {{fdacite|changed|FDA}}
| UNII = Q1SUG5KBD6
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 1200354
|  ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = 8440


<!--Chemical data-->
| C=14 | H=29 | Na=1 | O=4 | S=1
| molecular_weight = 316.43243 g/mol
|  smiles = CCCCC(CC)CCC(CC(C)C)OS(=O)(=O)[O-].[Na+]
|  InChI = 1/C14H30O4S.Na/c1-5-7-8-13(6-2)9-10-14(11-12(3)4)18-19(15,16)17;/h12-14H,5-11H2,1-4H3,(H,15,16,17);/q;+1/p-1
|  InChIKey = FVEFRICMTUKAML-REWHXWOFAZ
|  StdInChI_Ref = {{stdinchicite|changed|chemspider}}
| StdInChI = 1S/C14H30O4S.Na/c1-5-7-8-13(6-2)9-10-14(11-12(3)4)18-19(15,16)17;/h12-14H,5-11H2,1-4H3,(H,15,16,17);/q;+1/p-1
|  StdInChIKey_Ref = {{stdinchicite|changed|chemspider}}
| StdInChIKey = FVEFRICMTUKAML-UHFFFAOYSA-M
| synonyms = 7-Ethyl-2-methyl-4-hendecanol sulfate sodium salt
}}


=====Metabolic and Nutritional=====




<!--Mechanism of Action-->
|mechAction=* 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-->
|structure=* Sodium tetradecyl sulfate is an anionic surfactant which occurs as a white, waxy solid. The structural formula is as follows:


=====Musculoskeletal=====
: [[File:Sodium Tetra Str.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


* 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.


=====Neurologic=====
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


<!--Pharmacokinetics-->
|PK=* 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-->
|nonClinToxic======CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY=====
* 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.


=====ANIMAL TOXICOLOGY=====
* The intravenous LD50 of sodium tetradecyl sulfate in mice was reported to be 90 ± 5 mg/kg.


=====Respiratory=====
* In the rat, the acute intravenous LD50 of sodium tetradecyl sulfate was estimated to be between 72 mg/kg and 108 mg/kg.
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====


* 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-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


<!--How Supplied-->
|howSupplied=* Sotradecol (sodium tetradecyl sulfate injection)


=====Metabolic and Nutritional=====
: 1% 20 mg/2 mL (10 mg/mL) - 2 mL vials; in packages of 5 (NDC 65974-162-02)


: 3% 60 mg/2 mL (30 mg/mL) - 2 mL vials; in packages of 5 (NDC 65974-163-02)
|storage=* Store at 20° to 25°C (68° to 77°F).
|packLabel=====PRINCIPAL DISPLAY PANEL - 10 MG/ML CARTON LABEL====
5 x 2 mL Vials    NDC 65974-162-02




=====Musculoskeletal=====
Sotradecol® 1%


(SODIUM TETRADECYL SULFATE INJECTION)


20 mg/2 mL
(10 mg/mL)


=====Neurologic=====
FOR INTRAVENOUS USE ONLY


Rx only


Distributed by:
AngioDynamics, Inc.
Queensbury, NY 12804


=====Respiratory=====
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.


=====Skin and Hypersensitivy Reactions=====
USUAL DOSAGE: See accompanying prescribing information.


Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]


0319C102


=====Special Senses=====
: [[File:Sodium Tetra PDP 1.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


====PRINCIPAL DISPLAY PANEL - 30 MG/ML CARTON LABEL====
5 x 2 mL Vials    NDC 65974-163-02


Sotradecol® 3%


=====Urogenital=====
(SODIUM TETRADECYL SULFATE INJECTION)


60 mg/2 mL
(30 mg/mL)


FOR INTRAVENOUS USE ONLY


=====Miscellaneous=====
Rx only


Distributed by:
AngioDynamics, Inc.
Queensbury, NY 12804


Manufactured by:
Mylan Institutional
Galway, Ireland


<!--Drug Interactions-->
Each mL contains:  
|drugInteractions=* Drug
Sodium tetradecyl sulfate 30 mg, benzyl alcohol 0.02 mL and dibasic
:* Description
sodium phosphate, anhydrous 9.0 mg in Water for Injection. pH 7.9;
 
monobasic sodium phosphate and/or sodium hydroxide added, if
<!--Use in Specific Populations-->
needed, for pH adjustment.
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
WARNING: Do not use if precipitated.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.


<!--Administration and Monitoring-->
USUAL DOSAGE: See accompanying prescribing information.
|administration=* Oral


* Intravenous
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Description
0320C102


<!--IV Compatibility-->
: [[File:Sodium Tetra PDP 2.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


<!--Overdosage-->
====Ingredients and appearance====
|overdose====Acute Overdose===


====Signs and Symptoms====
: [[File:Sodium Tetra Ing and App.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


* Description
<!--Patient Counseling Information-->
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*
 
<!--Structure-->
|structure=*
 
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
 
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
<!--How Supplied-->
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


Line 251: Line 292:


<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
|brandNames=* SOTRADECOL®<ref>{{Cite web | title = Sodium tetradecyl sulfate | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4749ba52-52d4-431b-8e86-14dcbeec7220}}</ref>


<!--Look-Alike Drug Names-->
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
{{PillImage
|fileName=No image.jpg
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
}}
<!--Pill Image-->
<!--Pill Image-->

Latest revision as of 17:10, 20 August 2015

Sodium tetradecyl sulfate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

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.

Non–Guideline-Supported Use

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.

Non–Guideline-Supported Use

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

Contraindications

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

GENERAL

Adverse Reactions

Clinical Trials Experience

  • 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

Template:Px
Sodium tetradecyl sulfate
Systematic (IUPAC) name
Sodium 7-ethyl-2-methyl-4-undecanyl sulfate
Identifiers
CAS number ?
ATC code C05BB04
PubChem 14492
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 316.43243 g/mol
SMILES eMolecules & PubChem
Synonyms 7-Ethyl-2-methyl-4-hendecanol sulfate sodium salt
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status

Prescription only medicine

Routes Intravenous injection

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:
This image is provided by the National Library of Medicine.
  • 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

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
  • 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.
ANIMAL TOXICOLOGY
  • 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)
1% 20 mg/2 mL (10 mg/mL) - 2 mL vials; in packages of 5 (NDC 65974-162-02)
3% 60 mg/2 mL (30 mg/mL) - 2 mL vials; in packages of 5 (NDC 65974-163-02)

Storage

  • Store at 20° to 25°C (68° to 77°F).

Images

Drug Images

{{#ask: Page Name::Sodium tetradecyl sulfate |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL - 10 MG/ML CARTON LABEL

5 x 2 mL Vials     NDC 65974-162-02


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 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

0319C102

This image is provided by the National Library of Medicine.

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 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

0320C102

This image is provided by the National Library of Medicine.

Ingredients and appearance

This image is provided by the National Library of Medicine.

{{#ask: Label Page::Sodium tetradecyl sulfate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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®[4]

Look-Alike Drug Names

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

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Iwase H, Kusugami K (1997). "Symposium on endoscopic hemostasis in gastric diseases. 2. Choice of endoscopic therapy for esophagogastric varices: aiming for safer and more effective therapy". Intern Med. 36 (2): 128–9. PMID 9099596.
  2. ↑ Anavi Y, Har-El G, Mintz S (1988). "The treatment of facial haemangioma by percutaneous injections of sodium tetradecyl sulfate". J Laryngol Otol. 102 (1): 87–90. PMID 3343573.
  3. ↑ Woods JE (1987). "Extended use of sodium tetradecyl sulfate in treatment of hemangiomas and other related conditions". Plast Reconstr Surg. 79 (4): 542–9. PMID 3823245.
  4. ↑ "Sodium tetradecyl sulfate".
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