Aethoxysklerol

Aethoxysklerol

lauromacrogol 400

Manufacturer:

Chemische Fabrik Kreussler

Distributor:

Berlin Pharm
Full Prescribing Info
Contents
Lauromacrogol 400 (polidocanol).
Description
Aethoxysklerol 1% contains 20 mg lauromacrogol 400 (polidocanol).
It is a solution for intravenous injection, used for the obliteration of varicose veins.
Excipients/Inactive Ingredients: Ethanol 96%, potassium dihydrogen phosphate, disodium phosphate dihydrate (Ph. Eur.), water for injections.
Indications/Uses
Different concentrations of Aethoxysklerol are required, depending on the size of the varicose veins (varices) to be obliterated (sclerosed).
Aethoxysklerol 1% is used as a liquid for sclerotherapy of central veins of spider veins, web-like varicose veins (reticular varices) and small varicose veins (varices) and as a foam for sclerotherapy of small varicose veins.
When several concentrations are listed as treatment, the vein diameter and the patient's individual situation should be considered. In case of doubt, the lower concentration should be chosen.
Dosage/Direction for Use
Generally, the dose of 2 mg lauromacrogol 400 (polidocanol) per kg body weight and day should not be exceeded (for a patient weighing 70 kg, this means a daily dose of up to 14 ml Aethoxysklerol 1%).
Aethoxysklerol may be used for foam sclerotherapy. The physician has access to more detailed information in the Summary of Product Characteristics for healthcare professionals. When administering as standardised sclerosing foam, the total dose of 10 ml foam per session and day - irrespective of body weight - should not be exceeded.
In the initial treatment, patients prone to hypersensitivity reactions should be given no more than one injection. Depending on the response, several injections may be given in subsequent treatment sessions, provided that the maximum dose is not exceeded.
Depending on the size of the area to be sclerosed, 0.1-0.3 mL Aethoxysklerol 1% is given as a liquid into the veins (intravascularly).
When using Aethoxysklerol as sclerosing foam, e.g. for the treatment of collateral varices, up to 4 ml (maximum 6 ml) is injected per injection. For veins connecting to the deep vein system, up to 2 ml (maximum 4 ml) is injected per injection. The total daily dose must not be exceeded. (See Table 1.)

Click on icon to see table/diagram/image

Method of Administration: Usually, the injections should only be carried out in a leg placed horizontally or elevated to approximately 30-45° above the horizontal.
Injections of Aethoxysklerol 1% must be given into the blood vessel (intravascularly).
Extra fine needles (eg, insulin needles) and smooth-moving syringes are used. Using the narrowest puncture angle possible, the needle is inserted until its tip is securely located within the blood vessel.
When performing foam sclerotherapy, ultrasound imaging (preferably with duplex) should be used to monitor direct puncture and injection into non-visible main (truncal) veins, veins connecting to the deep vein system (perforating veins) and varicose veins (varices) located in the groin or hollow of the knee. When treating other non-visible varicose veins (varices), guidance of the puncture and injection by means of ultrasound is recommended.
When using sclerosing foam, the needle must be no smaller than 25G.
Compression treatment after injection of liquid Aethoxysklerol:
Once the injection site has been covered, a tight compression bandage or compression stocking must be applied. Thereafter, the patient should walk for 30 minutes, preferably within reach of the practice.
Compression treatment after injection of Aethoxysklerol sclerosing foam:
Once the injection site has been covered, the patient's leg is immobilised for 2-5 minutes. Valsalva's manoeuvre and muscle activation should be avoided in the patient, as should immediate compression in the injection site area. Compression is applied after approximately 10 minutes when treating the great and small saphenous vein (vena saphena magna/vena saphena parva) and after approximately 5 minutes when treating collateral varicose veins, recurrent varicose veins (occurring again after previous varicose vein treatment) or veins connecting to the deep vein system.
Compression should be applied for 5-7 days. For extensive varicose veins, prolonged compression treatment with short-traction bandages is recommended.
To ensure that the bandage does not slip, especially on the thigh and conical limbs, it is recommended that a form bandage support is applied under the actual compression bandage.
The success of sclerotherapy is largely dependent on thorough and careful follow-up compression treatment.
Frequency and duration of use: Depending on the extent of the varicose veins, several courses of repeated treatment may be required.
If more is used than recommended:
An overdose can cause local tissue destruction, particularly if injected into the surrounding tissue.
If patient forgets to use Aethoxysklerol 1%:
Not applicable.
Other questions:
If patient has any further questions on the use of this product, ask the doctor or pharmacist.
Overdosage
An overdose can cause local tissue destruction, particularly if injected into the surrounding tissue.
Contraindications
Do not use Aethoxysklerol 1% in patients with known allergy to lauromacrogol 400 (polidocanol) or any of the other ingredients of Aethoxysklerol; in patients with acute severe disease (especially if untreated); in bedridden patients or patients who are unable to walk; in patients with severe, arterial blood flow problems (arterial occlusive disease Fontaine stage III and IV); in patients with a blood vessel blockage due to a local or detached blood clot (thromboembolic diseases); in patients at high risk of blood vessel blockage (thrombosis), e.g. patients born with a tendency for blood clots or with several risk factors, such as the use of hormonal contraceptives (e.g. the Pill) or hormone replacement therapy, being overweight, smoking, extended periods of immobility, etc.
Also applicable to foam sclerotherapy: in patients with symptoms caused by a known hole in the atrial septum of the heart (known symptomatic patent foramen ovale).
Special Precautions
Take special care with Aethoxysklerol 1% if the following conditions or disease are present: feverish states; attacks of breathlessness (bronchial asthma) or marked predisposition to allergies; very poor general state of health, spider veins: arterial blood flow problems (occlusive disease Fontaine stage II); swollen legs with accumulation of watery fluid (leg oedema), if this cannot be influenced by compression; inflammatory skin disease in the treatment area; symptoms of a blockage in the small blood vessels and capillaries e.g. due to diabetes (microangiopathy) or sensory impairment (neuropathy); reduced mobility.
Also applicable to foam sclerotherapy: a known hole in the atrial septum of the heart, even if this causes no signs of disease/is not accompanied by any symptoms (known asymptomatic patent foramen ovale); history of impaired eyesight, mood disorders or nerve dysfunction (visual, psychiatric or neurological symptoms) after previous foam sclerotherapy.
Sclerosants must never be injected into an artery (intra-arterially) because this can cause extensive tissue death (necrosis), which may require amputation. A vascular surgeon must be called in immediately if any such incidents occur.
For all sclerosants, there must be a strict indication for use in the facial area, as pressure reversal in the arteries may occur in this region, which may lead to permanent visual impairment (blindness).
In certain body regions, such as in the foot or ankle region, the risk of inadvertent injection into an artery may be increased. In such areas, only small amounts should be used with particular care during treatment.
The recommended mean volume of sclerosing foam per session is 2 to 8 mL; the maximum volume of sclerosing foam per session (for one or more injections) is 10 mL.
When treating dysfunctional truncal (main) veins, the foam injection is given at a minimum distance of 8 to 10 cm from the sapheno-femoral junction. If ultrasound monitoring reveals a large amount of foam in the deep vein system, muscle activation should be performed by the patients, e.g. bending and stretching the foot at the ankle joint.
Important warnings about some of the ingredients of Aethoxysklerol 1%: Aethoxysklerol 1% contains 5% (v/v) alcohol. To be taken into account in patients with a history of alcohol dependence.
Aethoxysklerol 1% contains potassium, but less than 1 mmol (39 mg) per ampoule, i.e. essentially 'potassium­ free'.
Aethoxysklerol 1% contains sodium, but less than 1 mmol (23 mg) per ampoule, i.e. essentially 'sodium-free'.
Effects on the Ability to Drive and Using Machines: There are no known negative effects of Aethoxysklerol on the ability to drive and use machines.
Use In Pregnancy & Lactation
Use in Pregnancy: If the patient is pregnant, the attending doctor must not administer Aethoxysklerol 1% unless it is absolutely necessary, as there is not enough experience with the use of Aethoxysklerol 1% in pregnant women. Studies in animals did not produce any evidence of harmful effects on the embryo or foetus.
Use in Lactation: If sclerotherapy is required during breast-feeding, it is advisable to suspend breast-feeding for 2-3 days, as studies on the passage of lauromacrogol 400 (polidocanol) into breast milk have not been performed in humans.
Side Effects
Local adverse reactions (e.g. tissue destruction), especially of the skin and underlying tissue (and, in rare cases, of the nerves) have been observed when obliterating (sclerosing) varicose veins. These occurred after inadvertent injection into the surrounding tissue. The risk increases with increasing Aethoxysklerol concentrations and amounts. Otherwise, the following adverse reactions have been observed with varying frequency: see Table 2.

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Very common: Not applicable.
Common:
Occurrence of blood vessels in the area of sclerotisation that were not visible prior to treatment (neovascularisation), bruising (haematoma).
Discolouration of the skin (hyperpigmentation), bleeding into the skin (ecchymosis).
Pain at the injection site (short-term), blood clot formation (thrombosis) at the injection site (local blood clot formation within the blood vessel).
Uncommon: Superficial inflammation of the vein (superficial thrombophlebitis), vein inflammation (phlebitis); allergic inflammation of the skin (allergic dermatitis), hives (urticaria), skin reactions, reddening (erythema); local tissue destruction (necrosis), tissue hardening (induration), swelling; nerve injury.
Rare: Deep vein thrombosis (possibly due to the underlying disease); pain in one limb.
Very rare: Allergic shock (anaphylactic shock; symptoms include sudden breathing difficulties, dizziness, drop in blood pressure), angioedema (symptoms are sudden swelling especially in the face, e.g. of the eyelids, lips or larynx), generalised hives (urticaria), asthma (asthma attack); stroke (apoplectic stroke), headache, migraine (rare with the sclerosing foam), local sensory disturbances (paraesthesia), loss of consciousness, confusion, dizziness, worsening eyesight (transient visual disturbances (rare with the sclerosing foam)), cardiac arrest, palpitations; lung embolism, cardiovascular problems (vasovagal syncope), circulatory collapse, inflammation of the blood vessel wall (vasculitis); breathing problems (dyspnoea), chest discomfort (sensation of pressure in the chest), cough, altered taste, nausea increased body hair (hypertrichosis) in the area of sclerotisation, fever; hot flushes, feeling weak (asthenia), feeling unwell changes in blood pressure (abnormal blood pressure).
Measures to treat side effects: Allergic shock (anaphylactic reaction) is very rare but potentially life-threatening. The attending physician should be prepared for emergency measures and have a suitable emergency kit at his/her disposal.
Unknown side effects: If patient notice any side effects not mentioned in this section, please tell the physician or pharmacist.
Drug Interactions
Please tell the doctor or pharmacist if patient is taking or using, or have recently taken or used, any other medicines, including medicines obtained without a prescription.
The effect of the following medicines or groups of medicines may be influenced if used at the same time as treatment with Aethoxysklerol 1%.
The active substance lauromacrogol 400 (polidocanol) is also a local painkiller (local anaesthetic). Therefore, when given at the same time as other anaesthetics, there is a risk of enhancing the effect of the anaesthetics on the cardiovascular system.
Storage
Special Precautions for Storage: No special precautions are required.
Shelf-Life after first opening: This medicinal product is intended for single use. Discard any remaining amount.
ATC Classification
C05BB02 - polidocanol ; Belongs to the class of sclerosing agent used as local injection in antivaricose therapy.
Presentation/Packing
Inj (amp) 1% (clear solution) x 2 mL x 5's. 3% x 2 mL x 5's.
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