Polidocanol

Polidocanol is a prescription medication used for the treatment of varicose veins. 

• Polidocanol is available under the following different brand names: Asclera, Varithena

Common side effects of Polidocanol include:

• Mild numbness or tingling,
• Mild headache,
• Dizziness,
• Increased hair growth on the treated leg, and
• Mild pain or warmth, mild itching, or slight bruising where an injection was given.

Serious side effects of Polidocanol include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Severe pain, burning, or other irritation in the leg,
• Discoloration or skin changes at the injection site,
• Sudden severe headache,
• Confusion,
• Problems with vision, speech, or balance,
• Pain, swelling, warmth, or redness in one or both legs,
• Severe numbness,
• Pounding heartbeats,
• Fluttering in the chest, and
• Lightheadedness

Rare side effects of Polidocanol include:

• None

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Intravenous injection (Asclera)

• 0.5% (2 mL ampule)
• 1% (2 mL ampule)

Injectable foam (Varithena)

• 1.3 mg/mL (delivers 1% polidocanol solution)

Varicose Veins

Adult dosage

Asclera

• Spider veins (varicose veins below 1 mm in diameter): Use 0.5% solution
• Reticular veins (varicose veins 1-3 mm in diameter): Use 1% solution
• Inject 0.1-0.3 mL Intravenous into each varicose vein; not to exceed the cumulative dose of 10 mL per treatment session.

Varithena

• Use up to 5 mL per IV injection; not to exceed 15 mL/session; repeat treatment may be necessary if the size and extent of the veins to be treated require more than 15 mL of Varithena; separate treatment sessions by a minimum of 5 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Polidocanol has no noted severe interactions with any other drugs.
• Polidocanol has no noted serious interactions with any other drugs.
• Polidocanol has no noted moderate interactions with any other drugs.
• Polidocanol has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to product or components
• Acute thromboembolic disease

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Polidocanol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Polidocanol?”

Cautions

• Severe allergic reactions reported; administer in a facility with the ability to treat anaphylaxis; observe the patient for at least 10 min after injection.
• IV use only, do not inject intra-arterially; inadvertent intra-arterial injection or extravasation may cause severe necrosis, ischemia, or gangrene; consult a vascular surgeon immediately if this occurs.
• Stroke, TIA, MI, and impaired cardiac function were reported in close temporal relationship with polidocanol administration; these events may be caused by air embolism when using the product foamed with room air (high nitrogen concentration) or thromboembolism
• Follow administration instructions closely and monitor for signs of venous thrombosis after treatment; patients with reduced mobility, a history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk of for developing thrombosis (see Administration for posttreatment compression instructions)

Pregnancy and Lactation

• There are no adequate and well-controlled studies on pregnant women.
• Few published case reports with the use of polidocanol-containing products, in pregnant women, have not identified any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes; although no risks were identified, there is minimal benefit in treating lower extremity varicosities during pregnancy and lower extremity varicosities that develop during pregnancy as they may spontaneously regress postpartum.
• Polidocanol was reported to have an embryonical effect in rabbits when given in doses approximately equal (based on body surface area) to the human dose; this effect may have been secondary to maternal toxicity
• Developmental reproductive toxicity testing was performed in rats and rabbits with IV administration
• Lactation
  • There are no data on the presence of polidocanol in human milk, its effects on the breastfed infant, or milk production; a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk up to 8 hours after administration to minimize exposure to a breastfed infant