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Polidocanol (Intravenous route)

Pronunciation:

pol-ee-doe-KAY-nol

Brand Names:

  • Varithena

Dosage Forms:

  • Solution
  • Foam

Classifications:

Therapeutic—

Sclerosing Agent

Uses of This Medicine:

Polidocanol injection is used to treat small varicose veins of the lower legs. This medicine is also used to treat incompetent great saphenous veins, accessory saphenous veins, and visible varicose veins above and below the knees. 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 polidocanol injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of polidocanol injection in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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:

  • Blood clots or
  • Blood clotting disorders, acute—Should not be used in patients with these conditions.
  • Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism), history of or
  • Major surgery, recent (within 3 months) or
  • Prolonged immobilization—May increase risk for blood clotting problems.
  • Blood vessel disease (eg, peripheral arteriosclerosis, thromboangiitis obliterans)—May increase risk for tissue ischemia.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

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. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor or nurse right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Wear compression stockings or support hose on the treated legs continuously for 2 to 3 days or for 5 to 7 days, and for 2 to 3 weeks during daytime. This would help prevent formation of blood clots.

It is recommended for you to walk for 10 to 20 minutes immediately after the treatment and daily for the next few days, unless your doctor tells you otherwise.

This medicine may cause a permanent depression (necrosis) under the skin at the injection site. Contact your doctor right away if you notice any of these side effects at the injection site: depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or sloughing (peeling) of the skin.

Avoid heavy exercise, sunbathing, long plane flights, and hot baths or sauna for 2 to 3 days after receiving this medicine.

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:

More common
Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
collection of blood under the skin of the injection site
deep, dark purple bruise at the injection site
Incidence not known
Anxiety
blue-green to black skin discoloration
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain
cough
darkening of the skin
difficult or labored breathing
difficulty with swallowing
dizziness or lightheadedness
fainting
fast, irregular, pounding, or racing heartbeat or pulse
fever
inability to speak
increased hair growth in the treatment area
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of consciousness
nerve injury
no blood pressure or pulse
noisy breathing
pain, redness, or sloughing of the skin at the injection site
pain, redness, or swelling in the arm or leg
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
seizures
severe or sudden headache
shortness of breath
skin rash
slurred speech
sores, welting, or blisters
stopping of the heart
sudden shortness of breath or troubled breathing
temporary blindness
tightness in the chest
unconsciousness
unusual tiredness or weakness
weakness in the arm or leg on one side of the body, sudden and severe
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:

Incidence not known
Confusion
feeling of warmth
redness of the face, neck, arms, and occasionally, upper chest
sudden sweating

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.


Last Updated: 4/4/2014

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