Sodium tetradecyl sulfate Intravenous

In the U.S.

• Sotradecol

Available Dosage Forms:

• Solution

Therapeutic Class: Sclerosing Agent

Sodium tetradecyl sulfate is a type of medicine called a sclerosing agent. It is used for the treatment of small varicose veins of the lower extremities.

sodium tetradecyl sulfate is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sodium tetradecyl sulfate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sodium tetradecyl sulfate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on sodium tetradecyl sulfate have been done only in adult patients, and there is no specific information comparing use of sodium tetradecyl sulfate in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of sodium tetradecyl sulfate in the elderly with use in other age groups.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of sodium tetradecyl sulfate. Make sure you tell your doctor if you have any other medical problems, especially:

The presence of other medical problems may affect the use of sodium tetradecyl sulfate. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergic conditions or
• Bedridden or
• Cellulitis or
• Deep vein incompetence or
• Huge superficial veins with connections to deeper veins or
• Infections or
• Phlebitis migrans or
• Respiratory diseases or
• Skin diseases or
• Thrombophlebitis or
• Valvular vein incompetence or
• Varicosities caused by abdominal and pelvic tumors (unless the tumor has been removed)—Sodium tetradecyl sulfate should not be administered.

• Asthma or
• Blood dyscrasias or
• Diabetes or
• Hyperthyroidism or
• Neoplasm or
• Sepsis or
• Tuberculosis—Sodium tetradecyl sulfate should not be administered.

• Peripheral arteriosclerosis or
• Thromboangiitis obliterans (Buerger's disease)—Extreme caution should be used; sodium tetradecyl sulfate may make these conditions worse.

Embolisms (i.e., blood clots) may occur up to 4 weeks following injection of sodium tetradecyl sulfate.

It is possible that deep vein thrombosis (i.e., blood clot in a deep vein) can develop.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Anxiety
• burning
• chest pain
• cough
• difficulty breathing
• difficulty swallowing
• dizziness or light-headedness
• fainting
• fast heartbeat
• hayfever
• hives
• itching
• nausea
• noisy breathing
• pain, redness, or swelling in arm or leg
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• raised red swellings on the skin, lips, tongue, or in the throat
• redness of skin
• skin rash
• sudden shortness of breath or troubled breathing
• tightness in chest
• unusual tiredness or weakness
• vomiting
• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache
• pain, local
• pain or redness at site of injection
• pale skin at site of injection
• peeling or sloughing of skin
• ulceration at site of injection

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Consult your pharmacist.

How to use Sodium Tetradecyl Sulfate Solution

Consult your pharmacist.