Description
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. This medicine improves the symptoms and appearance of varicose veins. 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:
- Foam
- Solution
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.
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. It is given through a needle placed into one of your veins.
Precautions
It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests will be needed to check for unwanted effects.
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.
Wear compression stockings or a support hose on the treated leg(s) 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 that you walk for 10 to 20 minutes for Varithena® or 15 to 20 minutes for Asclera® 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.
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, trouble breathing, or dizziness or lightheadedness.
Avoid heavy exercise, sunbathing, long plane flights, and hot baths or saunas for 2 to 3 days for Asclera® or 1 week for Varithena® after you receive this medicine. Do not spend long periods of time being inactive (including long car rides) for 1 month after Varithena® treatment.
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
- 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
- pain, discomfort, redness, or swelling in the arm or leg
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 or tightness
- 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 genitals
- loss of consciousness
- nerve injury
- no blood pressure or pulse
- noisy breathing
- pain, redness, or sloughing of the skin at the injection site
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness, soreness, or itching skin
- seizures
- severe or sudden headache
- skin rash
- slurred speech
- sores, welts, or blisters
- stopping of the heart
- temporary blindness
- trouble breathing
- unusual tiredness or weakness
- weakness in the arm or leg on one side of the body, sudden and severe
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid
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.
DRG-20074103
