AETHOXYSKLEROL

What it is

Aethoxysklerol is a sterile solution of lauromacrogol 400 available in four strengths: 0.5%, 1%, 2%, and 3%, buffered to pH 6.5–8.0. The 0.5% strength contains 10 mg lauromacrogol 400 in a 2 mL ampoule; the 1% contains 20 mg in 2 mL; the 2% contains 40 mg in 2 mL; and the 3% contains 60 mg in 2 mL. It is a solution for injection presented as a clear, colourless to very faintly greenish yellow solution.

Approved indications

— Treatment of varicose veins (up to 6 mm diameter) of the lower limbs by compression sclerotherapy.

Dosing overview

The dosage and selection of Aethoxysklerol concentration depends on the size of the varices to be sclerosed. The maximum dosage is 2 mg/kg body weight per day. Sclerotherapy is followed by compression bandaging of the limb. Once the injection sites have been covered, a firm compression bandage or elastic stocking should be applied, and the patient should walk, preferably under observation, for at least 30 minutes.

Key safety warnings

Aethoxysklerol should only be administered by physicians experienced in injection sclerotherapy. Aethoxysklerol must never be injected intra-arterially because this can cause severe necrosis that may necessitate amputation; a vascular surgeon must be called in immediately if any such incidents occur. Anaphylactic reactions are very rare but potentially life-threatening situations, and the attending doctor should be prepared for emergency measures and have a suitable emergency kit available. If anaphylactic reaction occurs, the injection should be stopped immediately and standard emergency procedure should be followed including the administration of oxygen, adrenaline and intravenous steroids; airway management including intubation should not be delayed if upper airway obstruction is progressive. All Aethoxysklerol preparations contain 5% (v/v) ethanol and should be considered in cases of patients with former alcoholism.

Contraindications

Sclerotherapy of varices of the lower limbs is contraindicated in patients with known hypersensitivity to lauromacrogol 400 or any of the excipients. Contraindications include immobility (bed-ridden patients and patients unable to walk), arterial disease such as severe arteriosclerotic peripheral vascular disease, and thromboembolic diseases and high risk of thrombosis. Other contraindications include acute superficial thrombophlebitis; significant valvular or deep vein incompetence; huge superficial veins with wide open communications to deeper veins; acute cellulitis; phlebitis migrans; known strong predisposition to allergies; acute infections; varicosities caused by abdominal and pelvic tumours unless the tumour has been removed; and uncontrolled systemic disease such as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias, and acute respiratory or skin diseases. Severe arterial occlusive disease (Fontaine stages III and IV) and known symptomatic right-to-left shunt are also contraindications.

Regulatory history

Aethoxysklerol was first registered on the Australian Register of Therapeutic Goods on 27 July 2001, with all four strength variants (0.5%, 1%, 2%, and 3%) registered simultaneously under licence category RE.