Asclera

INDICATIONS

Asclera™ (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins ≤ 1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera (polidocanol injection) has not been studied in varicose veins more than 3 mm in diameter.

DOSAGE AND ADMINISTRATION

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 (polidocanol injection) 0.5%. For reticular veins (varicose veins 1 to 3 mm in diameter), use Asclera (polidocanol injection) 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).

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 blood clots (thrombi) that develop may be removed by stab incision and thrombus expression (microthrombectomy).

HOW SUPPLIED

Dosage Forms And Strengths

Asclera (polidocanol injection) is available as a 0.5% and 1% solution in 2 mL glass ampules.

Storage And Handling

Asclera (polidocanol injection) is supplied in single-use, preservative free ampules in the following packages:

NDC XXXXX-XXX-XX Five 0.5% ampules (2 mL)
NDC XXXXX-XXX-XX Five 1.0% ampules (2 mL)

Each ampule is intended for immediate use in a single patient. Each unopened ampule is stable up to three years.

Store at 15-30°C; (59-86°F).

Distributed by: BioForm Medical, Inc. 4133 Courtney Road, Suite #10, Franksville, WI 53126. Manufactured by: Chemische Fabrik Kreussler & Co. GmbH 65203 Wiesbaden GERMANY.

Last reviewed on RxList: 4/16/2010
This monograph has been modified to include the generic and brand name in many instances.

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