Asclera

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• For intravenous use only.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Do not use if particulate matter is seen or if the contents of the vial are discolored or if the vial is damaged in any way.
• For spider veins (varicose veins ≤1 mm in diameter), use Asclera 0.5%.
• For reticular veins (varicose veins 1 to 3 mm in diameter), use Asclera 1%.
• Use 0.1 to 0.3 mL per injection and no more than 10 mL per session.
• Use a syringe (glass or plastic) with a fine needle (typically, 26- or 30-gauge).
• Insert the needle tangentially into the vein and inject the solution slowly while the needle is still in the vein.
• Apply only gentle pressure during injection to prevent vein rupture.
• After the needle has been removed and the injection site has been covered, apply compression in the form of a stocking or bandage.
• After the treatment session, encourage the patient to walk for 15 to 20 minutes.
• Keep the patient under observation to detect any anaphylactic or allergic reaction [see Warnings and Precautions (5.3) ] .
• Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins.
• For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended.
• Post-treatment compression is necessary to reduce the risk of deep vein thrombosis.
• Repeat treatments may be necessary if the extent of the varicose veins requires more than 10 mL.
• These treatments should be separated by 1 to 2 weeks.
• Small intravaricose thrombi that develop may be removed by microthrombectomy.
• For intravenous use only.
• Solution strength and the volume injected depend on the size and extent of the varicose veins.
• Extensive varicosities may require multiple treatment sessions.
• ( 2 ) Spider veins (varicose veins ≤1 mm in diameter): Use Asclera 0.5%.
• ( 2 ) Reticular veins (varicose veins 1 to 3 mm in diameter): Use Asclera 1%.
• ( 2 ) Use 0.1 to 0.3 mL for each injection into each varicose vein.
• The maximum recommended volume per treatment session is 10 mL.
• ( 2 )

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and effectiveness of Asclera in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies of Asclera did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The most common adverse reactions occurring at least 3% more frequently than on placebo are mild local reactions at the site of injection.
• ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Methapharm at 1-866-701-4636 or medinfo@methapharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Study Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• In 5 controlled randomized clinical trials, Asclera has been administered to 401 patients with small or very small varicose veins (reticular and spider veins) and compared with another sclerosing agent and with placebo.
• Patients were 18 to 70 years old.
• The patient population was predominately female and consisted of Caucasian and Asian patients.
• Table 1 shows adverse events more common with Asclera or sodium tetradecyl sulfate (STS) 1% than with placebo by at least 3% in the placebo-controlled EASI study [see Clinical Studies (14) ] .
• All of these were injection site reactions and most were mild.
• Table 1:
• Adverse Reactions in EASI-study ASCLERA (180 patients) STS 1% (105 patients) Placebo (53 patients) Injection site haematoma 42% 65% 19% Injection site irritation 41% 73% 30% Injection site discoloration 38% 74% 4% Injection site pain 24% 31% 9% Injection site pruritus 19% 27% 4% Injection site warmth 16% 21% 6% Neovascularisation 8% 20% 4% Injection site thrombosis 6% 1% 0% Ultrasound examinations at one week (±3 days) and 12 weeks (±2 weeks) after treatment did not reveal deep vein thrombosis in any treatment group.
• 6.2 Post-marketing Safety Experience The following adverse reactions have been reported during use of polidocanol in world-wide experience.
• Because these reactions are reported voluntarily from a population of uncertain size and without a control group, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
• Immune system disorders:
• Anaphylactic shock, angioedema, urticaria generalized, asthma Nervous system disorders:
• Cerebrovascular accident, migraine, paresthesia (local), loss of consciousness, confusional state, dizziness Cardiac disorders:
• Cardiac arrest, palpitations Vascular disorders:
• Deep vein thrombosis, pulmonary embolism, syncope vasovagal, circulatory collapse, vasculitis Respiratory, thoracic and mediastinal disorders:
• Dyspnea Skin and subcutaneous tissue disorders :
• Skin hyperpigmentation, dermatitis allergic, hypertrichosis (in the area of sclerotherapy) General disorders and injection site conditions :
• Injection site necrosis, pyrexia, hot flush Injury, poisoning and procedural complications :
• Nerve injury

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to wear compression stockings or support hose on the treated legs continuously for 2 to 3 days and for 2 to 3 weeks during the daytime.
• Compression stockings or support hose should be thigh or knee high depending upon the area treated in order to provide adequate coverage.
• Advise the patient to walk for 15 to 20 minutes immediately after the procedure and daily for the next few days.
• For two to three days following treatment, advise the patient to
• avoid heavy exercise, sunbathing, long plane flights, and hot baths or sauna.
• Distributed by: Methapharm, Inc.
• Boca Raton, FL 33433 Tel:
• 1-833-766-8346 www.asclera.com Manufactured by:
• Chemische Fabrik Kreussler & Co.
• GmbH 65203 Wiesbaden GERMANY Asclera is a registered trademark of Chemische Fabrik Kreussler & Co.
• GmbH, 65203 Wiesbaden, GERMANY

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Asclera (polidocanol) is an injection for intravenous use and is available as follows:
• 0.5% [10 mg/2 mL (5 mg/mL)] solution in 2 mL single-dose glass ampule
• 1% [20 mg/2 mL (10 mg/mL)] solution in 2 mL single-dose glass ampule 0.5% and 1% solution in 2 mL glass ampules. ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Asclera (polidocanol) injection is a colorless to faintly greenish-yellow solution supplied in single-dose, sterile, preservative free ampules in the following packages:
• NDC 67850-140-05 Five 0.5 % ampules [10 mg/2 mL (5 mg/mL)] NDC 67850-141-05 Five 1 % ampules [20 mg/2 mL (10 mg/mL)] Each ampule is intended for immediate use in a single patient.
• Each unopened ampule is stable up to three years.
• Store at 15°C to 30°C;
• (59°F to 86°F).

Quoted from the official label, section “How Supplied”.

How to store it

Store at 15°C to 30°C; (59°F to 86°F).

Quoted from the official label, section “Storage and Handling”.

What is in it

• Asclera is a sterile, nonpyrogenic, and colorless to faintly greenish-yellow solution of polidocanol for intravenous use as a sclerosing agent.
• The active ingredient, polidocanol is a non-ionic detergent, consisting of two components, a polar hydrophilic (dodecyl alcohol) and an apolar hydrophobic (polyethylene oxide) chain.
• Polidocanol has the following structural formula:
• C 12 H 25 (OCH 2 CH 2 ) n OH Polyethylene glycol monododecyl ether Mean extent of polymerization (n) :
• Approximately 9 Mean molecular weight :
• Approximately 600 Each mL contains 5 mg (0.5%) or 10 mg (1.0%) polidocanol in water for injection with 5% (v/v) ethanol at pH 6.5-8.0; disodium hydrogen phosphate dihydrate (1.2 mg), potassium dihydrogen phosphate (0.43 mg). chemical structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Polidocanol