Pronunciation:

SOE-dee-um tet-ra-DEK-ul SUL-fate

Brand Names:

• Sotradecol

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Sclerosing Agent

Uses of This Medicine:

Sodium tetradecyl sulfate injection is used to treat small varicose veins of the lower legs. It is a type of medicine called a sclerosing agent.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of sodium tetradecyl sulfate injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of sodium tetradecyl sulfate injection in geriatric patients.

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.

Other 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.

Other interactions—

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or
• Blood clotting problems (eg, phlebitis migrans, thrombophlebitis) or
• Blood problems (eg, dyscrasia, sepsis) or
• Blood vessel problems (eg, deep vein incompetence, huge superficial veins with connections to deeper veins, valvular vein incompetence) or
• Cancer or
• Cellulitis, acute or
• Diabetes, uncontrolled or
• Hyperthyroidism (overactive thyroid) or
• Infection, acute or
• Lung disease, acute or
• Prolonged immobilization (eg, bedridden) or
• Skin disease, acute or
• Tuberculosis or
• Varicosities caused by abdominal and pelvic tumors (unless the tumor has been removed)—Should not be used in patients with these conditions.

• Blood vessel disease (eg, peripheral arteriosclerosis, thromboangiitis obliterans or Buerger's disease)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is injected into the veins of your legs.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor or nurse right away if you have a rash, itching, hoarseness, trouble with breathing or swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may increase your risk of having blood clots in the brain, heart, blood vessels, or lungs, which may lead to stroke, heart attack, deep vein thrombosis, or pulmonary embolism. Check with your doctor right away if you have difficulty with speaking, slow speech, inability to speak, inability to move the arms, legs, or facial muscles, chest pain or discomfort, pain or discomfort in the arms, jaw, back, or neck, pain, redness, or swelling in the arm or leg, troubled breathing, or dizziness or lightheadedness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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:

Incidence not known

Anxiety

blue-green to black skin discoloration

blurred vision

chest pain or discomfort

cough

difficulty breathing or swallowing

dizziness or lightheadedness

fainting

fast heartbeat

hives, itching, skin rash

inability to speak

nausea

noisy breathing

pain or discomfort in the arms, jaw, back, or neck

pain, itching, redness, peeling, or cracking of the skin at the injection site

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

seizures

severe or sudden headache

slurred speech

temporary blindness

tightness in the chest

unusual tiredness or weakness

vomiting

weakness in the arm or leg on one side of the body, sudden and severe

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:

Incidence not known

Headache

permanent discoloration of the injected vein

red, itchy, or watery eyes

runny or stuffy nose

sneezing

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.