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 (Ref).
The following concentrations have been recommended based upon size of affected vein (Ref):
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.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided the in manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Postmarketing:
Cardiovascular: Acute myocardial infarction, cardiac insufficiency, cardiomyopathy (takotsubo) (Potter 2010)
Gastrointestinal: Nausea, vomiting
Hypersensitivity: Hypersensitivity reaction (including anaphylactic shock, anaphylaxis)
Local: Local pain (Schwartz 2011), local skin discoloration (bruising and ecchymoses) (Schwartz 2011), local skin hyperpigmentation (Schwartz 2011), local swelling (Schwartz 2011)
Nervous system: Cerebrovascular accident, headache, transient ischemic attacks
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
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.
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)
Yes
Solution (Sodium Tetradecyl Sulfate Intravenous)
3% (per mL): $46.20
Solution (Sotradecol Intravenous)
1% (per mL): $46.88
3% (per mL): $46.88
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous, as sulfate:
Tromboject: 1% (2 mL); 3% (2 mL, 5 mL)
IV: For IV injection only. Administer Tromboject [Canadian product] with a 0.22 micrometer pore size and 25 or 33 mm diameter polyethersulfone in-line filter.
Varicose veins: Treatment of small, uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves.
None known.
There are no known significant interactions.
Reproduction studies have not been conducted.
It is not known if sodium tetradecyl sulfate is excreted in breast milk. The manufacturer recommends that caution be exercised when administering sodium tetradecyl sulfate to nursing women.
Monitor for DVT or PE (up to 4 weeks after injection); allergic reactions; pain, urticarial, matting, and pigmentation changes
Acts by irritation of the vein intimal endothelium and causes thrombosis formation leading to occlusion of the injected vein
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