Ethoxysclerol 3% injection solution is used for the following indications:
medium and large varicose veins (in the form of a solution and foam); hemorrhoids of the 1st and 2nd degree (in the form of a solution).
Composition
The active substance is lauromacrogol 400 (2 ml of solution for injection contains lauromacrogol 400 - 60 mg).
Excipients: ethanol 96%; sodium hydrogen phosphate, dihydrate; potassium dihydrogen phosphate; water for injections.
Contraindication
In the treatment of varicose veins, the drug is contraindicated in the following cases:
absolute contraindications to the use of the drug: known hypersensitivity to Lauromacrogol 400 or other components of the drug; acute severe systemic diseases (especially incurable); bedridden; obliterating endarteritis III and IV degrees; thromboembolic disease; high risk of thrombosis (for example, with hereditary thrombophilia or in the presence of multiple risk factors, such as hormone replacement therapy, use of hormonal contraceptives, obesity, smoking, all diseases and conditions that are accompanied by restriction of free movement); absolute contraindications to the use of the drug in foam form (additionally): symptomatic "open oval window" in history; relative contraindications to the use of the drug: febrile conditions; bronchial asthma or known predisposition to allergies; general weakness of the body; obliterating endarteritis II degree; leg edema (which is not corrected by the compression method); inflammatory skin diseases at the injection site; symptoms of microangiopathy or neuropathy; limited mobility in the patient; relative contraindications to the use of the drug in the form of foam (additionally): asymptomatic "open oval window" in the anamnesis; mental, neurological or visual symptoms.
In the treatment of hemorrhoids, the drug is contraindicated in the following cases:
Absolute contraindications to the use of the drug in case of hemorrhoids: known hypersensitivity to Lauromacrogol 400 or other components of the drug; acute severe systemic diseases (especially incurable); acute inflammation in the anal area; relative contraindications to the use of the drug in case of hemorrhoids: febrile conditions; bronchial asthma or known predisposition to allergies; general weakness of the body; chronic inflammatory bowel diseases (e.g. Crohn's disease); known hypercoagulability.
Method of application
The concentration of the drug is selected depending on the diameter of the vein and the individual condition of the patient.
It is necessary to use the minimum possible concentration of the drug.
The dose of Lauromacrogol 400 should not exceed 2 mg/kg of body weight per day.
For example, a patient weighing 70 kg can receive a maximum dose of 140 mg (except for dosage in case of hemorrhoids).
140 mg of Lauromacrogol 400 contains 4.6 ml of solution for injection.
If desired, the drug can be administered in the form of foam.
When using the drug in the form of foam, the dose should not exceed 10 ml of foam per session and per day, regardless of the patient's body weight.
Large varicose veins need to be treated in several sessions.
For patients with varicose veins prone to hypersensitivity reactions, only one injection is used during the first treatment session. Depending on the results of the treatment and the size of the obliteration zone, several injections can be made during the next treatment session, without exceeding the maximum dose.
Sclerotherapy of medium varicose veins: depending on the size of the varicose veins, at the first application, 0.5-1 ml of the solution for injection "Ethoxysclerol 3%" is prescribed as an intravascular solution. Depending on the course and size of the varicose veins, up to 2 ml of the solution is administered in subsequent sessions, not exceeding the maximum daily dose.
The solution for injection "Ethoxysclerol 3%" in the form of a foam (for example, for the treatment of large and small subcutaneous veins) is administered up to 4 ml per injection (maximum - 6 ml for the treatment of large subcutaneous veins). In this case, the maximum daily dose should not be exceeded.
Sclerotherapy of large varicose veins: at the first application, 1 ml of the solution for injection "Ethoxysclerol 3%" is prescribed in the form of a solution. Depending on the course and size of the varicose veins, several injections (2-3) of up to 2 ml are prescribed in subsequent sessions. In this case, the maximum daily dose should not be exceeded.
The solution for injection "Ethoxysclerol 3%" in the form of foam (for example, for the treatment of large and small subcutaneous veins) is administered in an amount of up to 4 ml per injection (maximum - 6 ml for the treatment of large subcutaneous veins). In this case, the maximum daily dose should not be exceeded.
Hemorrhoids: during one treatment session, the dose of 3 ml of the solution for injection "Ethoxysclerol 3%" should not be exceeded. Depending on the course of the disease, up to 1 ml of the solution is injected for each node by injection directly under the mucous membrane. The exception is 11-hour nodes in men, when a maximum of 0.5 ml is injected.
Medium and large varicose veins. Regardless of the method of venipuncture (a patient who is standing - only with a cannula, a patient who is sitting - with a ready-made syringe for injection), sclerotherapy is performed when the leg is in a horizontal position or slightly raised at an angle of 30-45 °. All injections are performed only intravenously. The introduction of the drug in the form of foam by direct injection into invisible truncal veins, perforating veins and varicose veins in the inguinal area or popliteal fossa should be carried out using ultrasound (preferably in duplex mode). In sclerotherapy of other invisible varicose veins, the use of ultrasound is also recommended for puncture and injection. Depending on the level and degree of varicose veins, several courses of therapy may be required. Thrombi, which can sometimes form, are removed using a puncture-incision and extrusion.
Compression therapy after injection of the drug in the form of a solution. After injection of the drug in the form of a solution, the injection site should be firmly pressed with a gauze pad and a tight elastic compression bandage should be applied. The patient should walk for at least 30 minutes immediately after injection of the drug, preferably within the hospital.
Compression therapy after foam injection After foam injection, the patient's leg should be immobilized for 2-5 minutes. Valsalva maneuvers and muscle activation of the patient should be avoided. Immediate bandaging should also be avoided. The compression band should be applied after approximately 10 minutes for the treatment of large and small saphenous veins and after approximately 5 minutes for the treatment of collateral varicose veins, recurrent varicose veins, or perforating veins.
Duration of compression therapy. The bandage should be worn for 5-7 days. Patients with extensive varicose veins are recommended to use compression therapy with short-stretch bandages for several months. To avoid slipping of the bandage, especially on the thigh, it is recommended to apply a non-slip bandage made of porous synthetic material under the compression bandage. The success of sclerotherapy depends on subsequent proper compression treatment.
Sclerotherapy of hemorrhoids. The drug is injected under the mucous membrane directly into the hemorrhoidal node or the upper part of the hemorrhoidal node in the tributary area. With special care, sclerotherapy should be performed in the area of the internal anal sphincter due to the risk of damage and subsequent incontinence. Obliteration of nodes of medium and large sizes is carried out only intravenously, preventing air embolism. When treating 11-hour nodes in men, a maximum of 0.5 ml of ethoxysclerol 3% solution for injection is administered due to the proximity to the urethra and prostate gland. The number of repeated courses of treatment is determined depending on the degree of hemorrhoids.
Application features
Pregnant women
There are insufficient data on the use of the drug in pregnant women. In animal studies, the drug showed reproductive toxicity, but did not have a teratogenic effect. The drug should be used in pregnant women only if the potential benefit outweighs the risk to the fetus.
It is not known whether Lauromacrogol 400 passes into breast milk.
If sclerotherapy is necessary, breastfeeding should be discontinued for 2-3 days.
Children
The drug is not used in children.
Drivers
There were no reports of negative effects on the ability to drive vehicles and operate other mechanisms.
Overdose
First aid measures and antidotes
Anaphylactic reactions are rare but can be potentially life-threatening. Countermeasures should always be available for sclerotherapy.
Treatment of local intoxication after incorrect use of a drug for the treatment of varicose veins of the legs:
Intraarterial injection:
Leave the cannula in the insertion site if the cannula has already been removed, move the puncture. Inject 5-10 ml of local anesthetic without the addition of adrenaline. Inject heparin 10,000 IU. The ischemic leg should be wrapped in cotton wool and lowered down. Hospitalize the patient in the vascular surgery department.
Paravenous injection: depending on the dose and concentration of the drug administered Paravenously, 5-10 ml of 0.9% sodium chloride solution is injected, if possible - together with hyaluronidase; in case of acute pain, a local anesthetic is injected (without adrenaline).
Side effects
Sclerotherapy of varicose veins
From the vascular system: often (≥ 1% to <10%) - the appearance of vessels in the area of sclerosing, hematoma.
Skin and subcutaneous tissue disorders: common (≥ 1% to < 10%) - skin discoloration (hyperpigmentation, ecchymoses).
Sclerotherapy for hemorrhoids
In the treatment of hemorrhoids, local adverse reactions such as a feeling of heat, pain, discomfort, and a feeling of pressure have been observed before and after the injection, especially in the 11 o'clock nodes in men (in the prostate area). Such reactions are short-term and rarely last 2-3 days. Sclerosis of hemorrhoids is not painful if the correct technique is chosen and there are no sensitive nerve fibers in the injection area.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 3 years.
