Dosage Forms
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)
Pharmacology
Mechanism of Action
Acts by irritation of the vein intimal endothelium and causes thrombosis formation leading to occlusion of the injected vein
Use: Labeled Indications
Varicose veins: Treatment of small, uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves.
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
Dosage and Administration
Dosing: Adult
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 (Dietzek 2007)
The following concentrations have been recommended upon size of affected vein (Dietzek 2007):
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: Geriatric
Refer to adult dosing.
Administration
For IV injection only
Storage
Store at controlled room temperature.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
<1%, postmarketing, and/or case reports: Anaphylactic shock, anaphylaxis, asthma, cardiac insufficiency, cerebrovascular accident, headache, hypersensitivity reaction, myocardial infarction, nausea, seasonal allergic rhinitis, transient ischemic attacks, urticaria, vomiting
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.
Monitoring Parameters
Monitor for DVT or PE (up to 4 weeks after injection); allergic reactions; pain, urticarial, matting, and pigmentation changes
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
Reproduction studies have not been conducted.
Patient Education
What is this drug used for?
- It is used to treat varicose veins.
Frequently reported side effects of this drug
- Headache
- Nausea
- Vomiting
- Injection site skin discoloration
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Severe cerebrovascular disease like change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or vision changes
- Severe injection site pain, burning, swelling, or irritation
- Blood clots like numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; fast heartbeat; or coughing up blood
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
