Sotradecol

Name: Sotradecol

What is the most important information i should know about sodium tetradecyl sulfate (sotradecol)?

You should not be treated with sodium tetradecyl sulfate if you are allergic to it, if you are bedridden due to serious illness, or if you have a serious blood clot or a clotting disorder, allergies, cancer, severe blood infection, or any untreated or uncontrolled disease such as diabetes, overactive thyroid, tuberculosis, asthma, a blood cell disorder, or skin disease.

Sodium tetradecyl sulfate should not be used to treat varicose veins that are caused by a tumor in your stomach or pelvis area, unless the tumor has been surgically removed.

You will be watched closely for several hours after your injection, to make sure this medication is not causing harmful effects. Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

Call your doctor at once if you have a serious side effect such as pain or swelling in one or both legs, chest pain, sudden cough, wheezing, rapid breathing, fast heart rate, or skin changes where the medicine was injected.

Side Effects of Sotradecol

Serious side effects have been reported with Sotradecol. See the "Drug Precautions" section.

Common side effects of Sotradecol include the following:

  • injection site pain
  • hives
  • injection site ulcer (sore)
  • skin necrosis (skin tissue dies)
  • severe whole-body allergic reaction
  • permanent discoloration
  • nausea
  • vomiting
  • headache

This is not a complete list of Sotradecol side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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

Precautions While Using Sotradecol

Embolisms (i.e., blood clots) may occur up to 4 weeks following injection of sodium tetradecyl sulfate.

It is possible that deep vein thrombosis (i.e., blood clot in a deep vein) can develop.

What do I need to tell my doctor BEFORE I take Sotradecol?

  • If you have an allergy to sodium tetradecyl sulfate or any other part of Sotradecol (sodium tetradecyl sulfate).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have blood clots.
  • If you have any of these health problems: Asthma or other breathing problems, blood problems, blood vessel problems, high blood sugar (diabetes), infection, skin problems, thyroid problems, tuberculosis (TB), tumors, or if you are not able to get out of bed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Sotradecol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Sotradecol) best taken?

Use Sotradecol as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into a vein.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

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. (See ADVERSE REACTIONS section.)

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

Pregnancy

Teratogenic Effects – Pregnancy Category 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.

Pediatric use

Safety and effectiveness in pediatric patients have not been established.

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.

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Manufactured by:
Mylan Institutional
Galway, Ireland

REVISED MARCH 2013
MI:SOTRIJ:R3
0521L108

®Sotradecol is a registered trademark of Mylan Pharma Group Limited

PRINCIPAL DISPLAY PANEL - 30 mg/mL Carton Label

NDC 67457-163-02

Sotradecol® 3%
(sodium tetradecyl sulfate injection)

60 mg/2 mL
(30 mg/mL)

For Intravenous Use Only

Rx only     5 x 2 mL Vials

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.]

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Manufactured by:
Mylan Institutional
Galway, Ireland

MI:163:5C:R3

Mylan.com

Sotradecol 
tetradecyl hydrogen sulfate (ester) injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67457-162
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRADECYL HYDROGEN SULFATE (ESTER) (TETRADECYL HYDROGEN SULFATE (ESTER)) TETRADECYL HYDROGEN SULFATE (ESTER) 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzyl Alcohol 0.02 mL  in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 4 mg  in 1 mL
Water  
Packaging
# Item Code Package Description
1 NDC:67457-162-02 5 VIAL, GLASS in 1 CARTON
1 NDC:67457-162-00 2 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040541 04/29/2013
Sotradecol 
tetradecyl hydrogen sulfate (ester) injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67457-163
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRADECYL HYDROGEN SULFATE (ESTER) (TETRADECYL HYDROGEN SULFATE (ESTER)) TETRADECYL HYDROGEN SULFATE (ESTER) 30 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzyl Alcohol 0.02 mL  in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 9 mg  in 1 mL
Water  
Packaging
# Item Code Package Description
1 NDC:67457-163-02 5 VIAL, GLASS in 1 CARTON
1 NDC:67457-163-00 2 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040541 04/29/2013
Labeler - Mylan Institutional LLC (790384502)
Revised: 04/2013   Mylan Institutional LLC
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