Sotradecol

Tissue Sealing Agents

Visually inspect solution for particulate matter and discoloration prior to administration whenever solution and container permit.[30664]

Administer only by a healthcare professional experienced in venous anatomy and familiar with proper injection technique. Extreme care in intravenous needle placement and using the minimal effective volume at each injection site are important to avoid extravasation and tissue necrosis.

tissue necrosis / Early / Incidence not known
anaphylactic shock / Rapid / Incidence not known
myocardial infarction / Delayed / Incidence not known
thromboembolism / Delayed / Incidence not known
stroke / Early / Incidence not known
air embolism / Rapid / Incidence not known
pulmonary embolism / Delayed / Incidence not known

skin ulcer / Delayed / Incidence not known

urticaria / Rapid / Incidence not known
injection site reaction / Rapid / Incidence not known
skin discoloration / Delayed / Incidence not known
headache / Early / Incidence not known
vomiting / Early / Incidence not known
nausea / Early / Incidence not known

Sotradecol

Rx

Injectable, sclerosing agent
Used for small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves
Associated with severe adverse local effects, including tissue necrosis, after extravasation

0.5 to 2 mL IV depending on the size and degree of varicosity. Reserve 3% solution for large varicose veins. Usual Max: 1 mL/injection. Max: 10 mL/treatment.[30664]

0.5 to 20 mL IV directly into varix under endoscopic visualization. Sclerotherapy is commonly used as adjunctive treatment, often after medical stabilization of bleeding with octreotide. The use of emergency sclerotherapy as the first-line treatment is controversial.

†Indicates off-label use

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

There are no drug interactions associated with Sodium Tetradecyl Sulfate products.

Sodium Tetradecyl Sulfate/Sotradecol Intravenous Inj Sol: 1%, 3%

10 mL total per single treatment for varicose veins.

10 mL total per single treatment for varicose veins.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

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. Sclerosant-induced venous thrombosis may not be the principal hemostatic mechanism in variceal sclerotherapy. A key factor in the ability of sodium tetradecyl sulfate, as well as other sclerosing agents, to stop active hemorrhage and initiate hemostasis might be attributed to the esophageal and vascular smooth muscle spasm which is induced by the sclerosing agent. During active bleeding, the sclerosant injected into the esophageal varices may dissipate rapidly since the varices have a much higher blood-flow rate and no functioning valves. There is no difference in the rate of hemostasis when sclerosants are intentionally injected around the varices compared to intravascular injection, further supporting the theory that acute venous thrombosis is not the primary hemostatic mechanism. The mechanical compression effect of submucosal edema, created by the injection of sclerosing agents, may also be responsible for acute hemostasis.

Sodium tetradecyl sulfate is injected locally into varicose veins and esophageal varices.

Measurable concentrations are not expected to be present in the peripheral blood following injection at the recommended doses. The recommended quantities administered at each treatment session are not expected to result in overt systemic clinical effects.

It is not known whether sodium tetradecyl sulfate can cause fetal harm or affect reproduction capacity when administered to a pregnant woman. Animal reproduction studies have not been conducted with sodium tetradecyl sulfate. Administer sodium tetradecyl sulfate during pregnancy only if clearly needed and the benefits outweigh the risks.

It is not known if sodium tetradecyl sulfate is excreted in human milk. Because many drugs are excreted in human milk, use caution when sodium tetradecyl sulfate is administered to a breast-feeding woman.[30664]