Ethoxysclerol
Ethoxysclerol: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Drug interactions
- 11. Analogs
- 12. Terms and conditions of storage
- 13. Terms of dispensing from pharmacies
- 14. Reviews
- 15. Price in pharmacies
Latin name: Aethoxysklerol
ATX code: C05BB02
Active ingredient: lauromacrogol 400 (lauromacrogol 400)
Producer: Kreussler Pharma (Germany)
Description and photo update: 2018-13-07
Prices in pharmacies: from 897 rubles.
Buy
Ethoxysclerol is a drug that causes sclerosis of varicose veins.
Release form and composition
Ethoxysclerol is available in the form of a solution for intravenous (IV) administration: a clear, colorless or slightly yellow-green liquid [2 ml in glass ampoules without color with a blue (or green) breaking point and colored rings (or ring): red and two blue (or blue) - for a concentration of 30 mg / ml, red and yellow (or yellow) - for a concentration of 10 mg / ml, red and two white (or gray) - for a concentration of 5 mg / ml; in a carton box 5 ampoules].
1 ampoule of solution contains:
- active substance: lauromacrogol 400 - 10 mg, 20 mg or 60 mg;
- auxiliary components: ethanol 96%, potassium hydrogen phosphate, sodium hydrogen phosphate, water for injection.
Pharmacological properties
Pharmacodynamics
Ethoxysclerol is a venosclerosing drug with a local anesthetic effect. Its therapeutic effect is due to the ability of the active substance (lauromacrogol 400, or polidocanol) to have a damaging effect on the vascular endothelium and cause protein denaturation. The required degree of damage to the endothelium is achieved by introducing a certain volume of the drug at the appropriate concentration. Applying a tight bandage immediately after administration of the solution causes compression of the vein walls, preventing excessive thrombus formation and recanalization of the originally formed parietal thrombus.
The fibrous scar, which forms during the therapy, ensures the hardening of the vein.
The local anesthetic effect of Ethoxysclerol allows sclerotherapy to be carried out without accompanying pain. This is due to a decrease in local excitability of sensory receptors and interruption of feedback through sensory nerve fibers.
Pharmacokinetics
Plasma protein binding of lauromacrogol 400 is 64%.
The volume of distribution is 24.5 liters.
T 1/2 (half-life) - approximately 4 hours.
The total clearance of the drug is 11.7 l / h, biliary - 3.14 l / h, renal - 2.43 l / h.
With repeated administrations, it is not cumulated.
During the first 12 hours, 89% of the total dose is removed from the blood.
There is no information on the penetration of lauromacrogol 400 (polidocanol) into breast milk.
Indications for use
According to the instructions, Ethoxysclerol is indicated for sclerosing varicose veins, hemorrhoids and telangiectasias.
Contraindications
- period of exacerbation of severe systemic diseases;
- individual intolerance to the components of Ethoxysclerol.
In addition, sclerotherapy of varicose veins of the lower extremities and hemorrhoids with lauromacrogol 400 solution is contraindicated in the following conditions:
- state of immobilization;
- obliterating diseases of the arteries III-IV stage according to Fontaine;
- thromboembolic diseases;
- high risk of thrombosis, including in patients with hereditary thrombophilia or with several of the following risk factors for thrombosis: hormone replacement therapy, hormonal contraception, smoking, obesity, prolonged immobilization.
An additional contraindication for sclerotherapy of hemorrhoids is acute inflammation in the anal area.
Caution should be exercised and the use of Ethoxysclerol should be started only after a careful comparison of the degree of the expected risk of possible complications and the expected benefit from therapy for the patient, if his body temperature at the time of administration of the drug is higher than 38 ° C, with obvious manifestations of allergies, bronchial asthma, severe somatic conditions.
With caution, it is necessary to carry out sclerotherapy of varicose veins of the lower extremities in the treatment for cosmetic purposes of obliterating diseases of the arteries of the II stage according to Fontaine (telangiectasia), with edema of the lower extremities that do not respond to compression methods of treatment, in the case of an inflammatory process on the skin area of the planned injection of Ethoxysclerol, with symptoms of neuropathy or microangiopathy, in patients with limited mobility (inability to be in motion for 30 minutes).
Careful medical supervision is required for sclerotherapy of hemorrhoids in patients with an established predisposition to thrombosis, chronic inflammatory bowel diseases (including Crohn's disease).
The appointment of Ethoxysclerol during pregnancy is allowed only in exceptional cases when the expected therapeutic effect for the mother outweighs the risk for the fetus.
When using the drug during lactation, breastfeeding should be discontinued within the next two or three days after the procedure.
Instructions for the use of Ethoxysclerol: method and dosage
Ethoxysclerol should not be administered intra-arterially!
The procedure should only be performed by an experienced specialist in the field of venosclerosis therapy.
The solution is administered strictly intravenously, including telangiectasia!
For injection, very thin needles, the diameter of which corresponds to insulin needles, and a syringe with a freely moving plunger are used.
The limb during the injection should be only in a horizontal or slightly raised (no more than 30–45 °) position.
Puncture the venous wall in the tangential direction and slowly inject Ethoxysclerol strictly into the lumen of the vein. After the introduction, pressing the injection site with a tampon, apply a pressure bandage. Within 0.5 hour, the patient must walk within the hospital.
Depending on the clinical indications and the diameter of the varicose veins, the following concentrations of the injected solution are used for sclerosis:
- 5 mg / ml: telangiectasia, including central veins;
- 10 mg / ml: telangiectasia of the central veins, small varicose veins, reticular varicose veins;
- 30 mg / ml: medium and large varicose veins, hemorrhoids of I and II degrees.
The maximum daily dose should not exceed 2 mg lauromacrogol 400 per 1 kg of the patient's body weight. In normal practice, maximum doses are not prescribed.
Recommended doses for sclerosis:
- telangiectasia: at a dose of 5 mg / ml - from 0.1 to 0.2 ml of solution per injection, the dose depends on the diameter of the sclerosed vein;
- telangiectasia of the central vein: the concentration depends on the diameter of the vein and can be 5 mg / ml or 10 mg / ml - from 0.1 to 0.2 ml of solution per injection;
- reticular varicose veins, small varicose veins: at a dose of 10 mg / ml - from 0.1 to 0.3 ml of solution per injection;
- medium and large varicose veins: at a dose of 30 mg / ml - the procedure should be carried out in several stages. At the first stage, you can enter no more than 0.5-1 ml of Ethoxysclerol once. Taking into account the result of the first injection and the size of the sclerosed area, then (after 7-14 days) you can do several injections in a dose of up to 2 ml each, but not more than the maximum daily dose. If a blood clot forms, it should be eliminated by making a notch and squeezing out;
- hemorrhoids: at a dose of 30 mg / ml - no more than 3 ml of solution in one course of therapy. Ethoxysclerol is injected strictly under the mucous membrane of each hemorrhoid or cranially in a dose not exceeding 1 ml. In men, special care must be taken when sclerosing a node located near the urethra and prostate gland (at "11 o'clock"). The volume of solution injected in this area should not exceed 0.5 ml. The danger of damage to the internal anal sphincter should be taken into account and measures should be taken to prevent its failure.
Sclerotherapy can be repeated after 7-14 days, depending on the size of the node (the severity of the varicose vein) and the extent.
The result of treatment largely depends on the correct application of the pressure bandage and the implementation of recommendations for the duration of its wearing. A pressure bandage is applied after hardening of telangiectasias for 2–3 days, small veins - for 5–7 days, medium and large varicose veins - for 21–35 days. After sclerosis of severe varicose veins, the use of elastic bandages or medical stockings (II – III compression class) is recommended to continue for several months.
Pressing bandages can only be removed from a high limb. Before each (even short-term) getting up, the bandage should be applied again.
Adhesive compression bandages should be used to prevent displacement of the dressing.
Side effects
- on the part of the cardiovascular system: often - hematoma, neovascularization; infrequently - phlebitis, thrombophlebitis of superficial veins; rarely - bleeding, deep vein thrombosis, with sclerotherapy of hemorrhoids - intrahemorrhoidal thrombosis; very rarely - palpitations, decrease or increase in blood pressure (BP), pulmonary embolism, vasculitis, vascular collapse, synocarotid syncope, cardiac arrest;
- from the immune system: very rarely - generalized skin rash, angioedema, bronchial asthma, anaphylactic shock;
- dermatological reactions: often - burning and hyperpigmentation of the skin area in the field of sclerotherapy, ecchymosis; infrequently - contact rash, itching, allergic dermatitis, erythema; very rarely - hypertrichosis at the injection site of Ethoxysclerol;
- from the nervous system: very rarely - headache, transient cerebrovascular accident, dizziness, migraine, loss of consciousness, local paresthesias, disorientation;
- on the part of the organ of vision: very rarely - transient visual impairment in the form of double vision, intolerance to light, "flashing midges" before the eyes, impaired vision;
- from the gastrointestinal tract: infrequently - inflammation in the perianal region with sclerotherapy of hemorrhoids; very rarely - nausea, change in taste;
- on the part of the respiratory system: very rarely - shortness of breath, cough, discomfort in the chest;
- on the part of the musculoskeletal system: rarely - pain in the limbs;
- from the reproductive system: very rarely - erectile dysfunction (with sclerotherapy of hemorrhoids);
- local reactions: often - short-term pain at the injection site, thrombosis at the injection site in the form of a local intravaricose blood clot; infrequently - edema, induration, necrosis;
- systemic reactions: very rarely - flushes of blood to the skin of the face, fever, asthenia;
- others: infrequently - nerve damage in the area of drug administration.
Overdose
Symptoms: necrosis at the injection site and adjacent tissues, especially with paravasal injections, caused by the introduction of a large volume or higher concentration of Ethoxysclerol.
Treatment: there is no specific antidote. In case of accidental intra-arterial injection, it is necessary, leaving the needle in the artery (if it has already left the vessel, it should be returned back in the same direction), inject 5-10 ml of local anesthetic without epinephrine (adrenaline), 10,000 U (unit of action) heparin. Then, having wrapped cotton wool and overlaid with ice, the ischemic limb and giving it a horizontal position, the patient should be urgently hospitalized in the vascular surgery department. In case of paravenous injection, it is necessary to inject 5 to 10 ml (depending on the concentration and amount of Ethoxysclerol administered) of saline in combination with hyaluronidase into the sclerosis area. For the relief of severe pain, it is recommended to use the introduction of an anesthetic (without epinephrine).
special instructions
Do not allow intra-arterial injection of Ethoxysclerol, this can lead to severe necrosis. In the absence of timely assistance from a specialist in vascular surgery, its dangerous consequence is forced amputation.
The appointment of Ethoxysclerol for use in the face area should be made after a thorough analysis of the clinical indications, taking into account the risk of irreversible visual impairment (blindness) against the background of changes in pressure in the arteries with intravasal injection.
In case of hardening of blood vessels in the foot and ankle area, the risk of accidental intra-arterial injection is increased, therefore it is recommended to use only the lowest dose of the solution at a concentration of 5 mg / ml for injection in these areas.
Correctly performed injection of Ethoxysclerol during sclerotherapy of hemorrhoids should not be accompanied by a sensation of pain, this is due to the absence of sensitive nerve fibers in this area. At the injection site during and after the injection, discomfort, burning sensation, pain, feeling of pressure may occur, especially in men with sclerosis of hemorrhoids in the prostate gland. As a rule, these pains are of a short-term nature, in rare cases they persist for several days.
With concomitant therapy with disulfiram or an indication in the patient's history of alcohol abuse, caution should be exercised, given the content of 5% ethanol in Ethoxysclerol solutions.
Influence on the ability to drive vehicles and complex mechanisms
Ethoxysclerol does not adversely affect the patient's psychomotor reactions and his ability to drive vehicles and mechanisms.
Application during pregnancy and lactation
There are no data on the teratogenic effects and toxicity of Ethoxysclerol during gestation, so it should not be administered to pregnant women, unless the expected benefit from therapy for the mother outweighs the potential threat to the fetus.
If it is necessary to use the drug during lactation, it is recommended to stop breastfeeding for 2-3 days after administration of the solution.
Drug interactions
The combination of Ethoxysclerol with anesthetics, including drugs for general anesthesia, can increase their effect on the cardiovascular system, increasing the risk of arterial hypotension and bradycardia.
Analogs
Ethoxysclerol analogs are Decilate, Fibro-Wayne.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C, protected from moisture.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Ethoxysclerol
Reviews of Ethoxysclerol are mostly positive. Doctors point out the high efficacy of the drug, the relative painlessness of the procedures for administering the solution, and good tolerance.
There are patient reports of the development of adverse events, including those with serious complications. Most often they are due to the individual response to the therapy.
Price for Ethoxysclerol in pharmacies
The price of Ethoxysclerol for a package containing 5 ampoules with a solution at a concentration of 5 mg / ml can be from 1303 rubles, 10 mg / ml - from 1319 rubles, 30 mg / ml - from 2127 rubles.
Ethoxysclerol: prices in online pharmacies
|
Drug name Price Pharmacy |
|
Ethoxysclerol 10 mg / ml solution for injection 2 ml 5 pcs. 897 r Buy |
|
Ethoxysclerol 5 mg / ml solution for injection 2 ml 5 pcs. 999 RUB Buy |
|
Ethoxysclerol solution for injection. 0.5% 2ml n5 1294 RUB Buy |
|
Ethoxysclerol solution for injection. 1% 2ml n5 1434 RUB Buy |
|
Ethoxysclerol 30 mg / ml solution for injection 2 ml 5 pcs. 1718 RUB Buy |
|
Ethoxysclerol solution for injection. 3% 2ml n5 2338 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
