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Sodium Tetradecyl


General


Pronunciation

(SOW dee um tetra DEK il SUL fate)


Brand Names: U.S.

  • Sotradecol

Indications


Use: Labeled Indications

Treatment of small, uncomplicated varicose veins of the lower extremities


Contraindications


Hypersensitivity to sodium tetradecyl sulfate or any component of the formulation; arterial disease, acute thrombophlebitis; valvular or deep vein incompetence, phlebitis migrans, cellulitis, acute infections; 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)


Dosing and Administration


Dosing: Adult

Sclerosing agent: IV: Test dose: 0.5 mL given several hours prior to administration of larger dose; 0.5-2 mL (preferred maximum: 1 mL) in each vein, maximum: 10 mL per treatment session; 3% solution reserved for large varices


Dosing: Geriatric

Refer to adult dosing.


Dosing: Renal Impairment

No dosage adjustment provided in manufacturer 's labeling.


Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer 's labeling.


Administration

Inject slowly.


Storage

Store at controlled room temperature.


Dosage Forms/Strengths


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]


Compatibility

Incompatible with heparin.


Drug Interactions

There are no known significant interactions.


Monitoring Parameters

Monitor for DVT or PE (up to 4 weeks after injection)


Adverse Reactions


Frequency not defined.

Central nervous system: Headache

Dermatologic: Discoloration at site of injection, sloughing and tissue necrosis following extravasation

Gastrointestinal: Nausea, vomiting

Local: Pain, itching, or ulceration at injection site

Miscellaneous: Allergic reaction (including hives, asthma, hay fever); anaphylactic shock


Warnings/Precautions


Concerns related to adverse effects:

- Anaphylaxis: Observe for hypersensitivity/anaphylactic reaction; emergency resuscitation equipment should be available.

- 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.


Pregnancy Risk Factor

C


Pregnancy Considerations

Reproduction studies have not been conducted.


Actions


Pharmacology

Acts by irritation of the vein intimal endothelium and causes thrombosis formation leading to occlusion of the injected vein


Patient and Family Education


Patient Education

- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

- Patient may experience headache, nausea, vomiting, or skin discoloration at injection site. Have patient report immediately to prescriber skin ulcers, injection site pain, or signs of blood clots (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; angina; shortness of breath; fast heartbeat; or coughing up blood) (HCAHPS).

- Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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