drug-information.ru

|Sodium Tetradecyl Sulfate

Sodium Tetradecyl Sulfate

Trade Names:
Sotradecol
- Injection 10 mg/mL
- Injection 30 mg/mL

Mechanism of Action

Pharmacology

Causes venous intima inflammation and thrombus formation, which occludes the injected vein and subsequently forms fibrous tissue that results in partial or complete vein obliteration.

Indications and Usage

Treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves.

Unlabeled Uses

Bleeding esophageal varices.

Contraindications

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 tumor has been removed; bedridden patients; uncontrolled systemic diseases such as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias, acute respiratory or skin disease; hypersensitivity to any component of the product.

Dosage and Administration

IV Dose varies with size and degree of varicosity. In general, 1% solution is most useful, and the 3% solution is preferred for larger varicosities.

Storage/Stability

Store vials at controlled room temperature (68° to 77°F).

Drug Interactions

None well documented.

Heparin should not be included in the same syringe.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache.

Dermatologic

Permanent discoloration along path of sclerosed vein.

GI

Nausea; vomiting.

Local

Pain; sloughing and necrosis of tissue following extravasation; ulceration at injection site; urticaria.

Miscellaneous

Allergic reactions including anaphylactic shock, asthma, hay fever, and hives.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Special Risk Patients

Use with extreme caution in the presence of underlying arterial disease (eg, marked peripheral arteriosclerosis, thromboangiitis obliterans).

Deep vein thrombosis and pulmonary embolism

May occur.

Thrombosis extension

The risk of thrombosis extension into the deep venous system exists.

Patient Information

• Explain name, dose, action, and potential side effects of drug.
• Advise patient or caregiver that medication will be prepared and administered by health care professionals in a medical setting.
• Instruct patient to notify health care provider immediately if any of the following occur: hives, persistent pain, ulceration, or skin sloughing at injection site; pain, swelling, and/or redness of leg in which sodium tetradecyl was injected; sudden or unexplained shortness of breath and/or chest pain.
• Advise patient that a permanent discoloring may develop along the path of the sclerosed vein segment.
• Advise women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
• Advise patient that follow-up visits and examinations may be necessary to monitor response to therapy and to keep appointments