Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Varithena

Descriptions


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.

This product is available in the following dosage forms:

  • Solution
  • Foam

Before Using

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.

Pediatric

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.

Geriatric

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

Pregnancy

Information about this polidocanol-intravenous-route
Pregnancy Category Explanation
All Trimesters C Animal 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.

Breastfeeding

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.

Drug Interactions

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

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

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

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

  1. 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
  2. collection of blood under the skin of the injection site
  3. deep, dark purple bruise at the injection site

Incidence not known

  1. Anxiety
  2. blue-green to black skin discoloration
  3. blurred vision
  4. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  5. chest pain
  6. cough
  7. darkening of the skin
  8. difficult or labored breathing
  9. difficulty with swallowing
  10. dizziness or lightheadedness
  11. fainting
  12. fast, irregular, pounding, or racing heartbeat or pulse
  13. fever
  14. inability to speak
  15. increased hair growth in the treatment area
  16. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  17. loss of consciousness
  18. nerve injury
  19. no blood pressure or pulse
  20. noisy breathing
  21. pain, redness, or sloughing of the skin at the injection site
  22. pain, redness, or swelling in the arm or leg
  23. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  24. seizures
  25. severe or sudden headache
  26. shortness of breath
  27. skin rash
  28. slurred speech
  29. sores, welting, or blisters
  30. stopping of the heart
  31. sudden shortness of breath or troubled breathing
  32. temporary blindness
  33. tightness in the chest
  34. unconsciousness
  35. unusual tiredness or weakness
  36. weakness in the arm or leg on one side of the body, sudden and severe
  37. 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

  1. Confusion
  2. feeling of warmth
  3. redness of the face, neck, arms, and occasionally, upper chest
  4. 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.