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Composition:


active ingredient: lauromacrogol 400 (polidocanol);


2 ml of solution for injection contains lauromacrogol 400-10 mg or 20 mg, or 60 mg;


excipients: ethanol 96%; sodium hydrophosphate, dihydrate; potassium dihydrogen phosphate; water for injection.


Dosage form. Solution for injection.


Basic physical and chemical properties: clear solution from colorless to slightly greenish-yellow in color.


Pharmacotherapeutic group.


Sclerosing agents for local administration. ATX code C05B B02.


Pharmacological properties.


Pharmacodynamics.


Lauromacrogol 400 has a sclerosing and at the same time local analgesic effect. This ensures almost painless obliteration of varicose nodes. The action is mainly aimed at the endothelium. Lauromacrogol 400 has a high affinity for damaged endothelium, while it does not affect intact areas, so the sclerosing effect occurs only in a truly varicose vein, and not just in a cylindrical moderately dilated vein. The sclerosing effect is based on irritation of the damaged vein endothelium, which causes local thrombosis. Thanks to the tight fixing bandage that is applied after the injection, the walls of the vein are compressed, and this prevents the recanalization of the resulting blood clot, and therefore the desired transformation of the blood clot into a fibrous scar cord occurs. With the correct choice of concentration and dosage, as well as the correct treatment and maintenance technique for the patient at the stage of recovery (compression treatment), lauromacrogol 400 provides reliable and long-term obliteration.


Pharmacokinetics.


As early as 12 hours after intravenous injection of lauromacrogol 400, 89% of the administered dose is removed from the blood. As a result of the study, the following indicators were established in patients with varicose veins (diameter more than 3 mm) after administration of Ethoxysclerol 3%: the final half – life is 0.94–1.27 hours, the volume of distribution is 17.9 liters, and the total clearance is 12.4 liters/hour.


Clinical characteristics.


Indications.


Sclerotherapy of vascular networks, varicose veins of the central vein branches, reticular varicose veins, small, medium and large varicose nodes; hemorrhoids of the 1st and 2nd degree.

Contraindications.


In the treatment of varicose veins, the drug is contraindicated in the following cases::


absolute contraindications for the use of the drug:


- known hypersensitivity to lauromacrogol 400 or other components of the drug;


- acute severe systemic diseases (especially incurable ones);


- bedridden;


- obliterating endarteritis of 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, the use of hormonal contraceptives, obesity, smoking, all diseases and conditions that are accompanied by restriction of free movement);


absolute contraindications for the use of the drug in the form of foam (optional):


- a history of symptomatic "open oval window" ;


relative contraindications for the use of the drug:


- febrile States;


- bronchial asthma or a known tendency to allergies;


- general weakness of the body;


- obliterating endarteritis of the second degree;


- swelling of the legs (not corrected by compression method);


- inflammatory skin diseases at the injection site;


- symptoms of microangiopathy or neuropathy;


- limited mobility in the patient;


relative contraindications for the use of the drug in the form of foam (optional):


- asymptomatic" open oval window " in the Anamnesis;


- mental, neurological symptoms or symptoms from the visual organs.


In the treatment of hemorrhoids, the drug is contraindicated in the following cases::


absolute contraindications for the use of the drug in the case of hemorrhoids:


- known hypersensitivity to lauromacrogol 400 or other components of the drug;


- acute severe systemic diseases (especially incurable ones);


- acute inflammation in the anal area;


relative contraindications for the use of the drug in the case of hemorrhoids:


- febrile States;


- bronchial asthma or a known tendency to allergies;


- general weakness of the body;


- chronic inflammatory bowel diseases (such as Crohn's disease);


- known hypercoagulation.


Interactions with other drugs and other types of interactions.


Lauromacrogol 400 is a local anesthetic. When used concomitantly with other anesthetics, there is a risk of increasing their effect on the cardiovascular system.


Application features.


The drug contains 5% (vol./ about.) alcohol, which should be taken into account in patients with a history of alcoholism.


The drug contains potassium (less than 39 mg per ampoule) and sodium (less than 23 mg per ampoule).


Sclerotherapy of varicose veins


Like all sclerosing agents, lauromacrogol 400 should never be administered intraarterially, as this can cause severe necrosis, which in turn can lead to amputation. In such cases, you should immediately consult a vascular surgeon.


For all sclerosing agents, there is a strict definition of indications for use on the face, since after an intravascular injection, blood pressure can change and cause irreversible eye damage, which can lead to blindness.


The risk of accidental intra-arterial injection at the foot or ankle site should also be considered. In case of ankle obliteration, in order to avoid an excessive obliteration reaction, only a small dose with a low concentration is given under close supervision.


The recommended total volume of foam per session is 2-8 ML, the maximum volume of foam (for one or more injections) is 10 ml.


In the treatment of truncular veins, an injection in the form of foam is administered at a minimum distance of 8-10 mm from the safeno-femoral interface. If an ultrasound examination shows a foam embolism in the deep vein system, the patient needs to perform muscle activation, for example, by bending the ankle joint back.


Hemorrhoid sclerotherapy


Hemorrhoid sclerotherapy should be performed with extreme caution due to the risk of damage to the internal anal sphincter and subsequent incontinence.


In the treatment of 11-hour nodes in men, a maximum of 0.5 ml of Ethoxysclerol is administered




Use during pregnancy or lactation.


Data on the use of the drug in pregnant women are insufficient. In animal studies, the drug showed reproductive toxicity, but did not have a teratogenic effect.


The drug should be used in pregnant women only when the potential benefit outweighs the risk to the fetus.


It is not known whether lauromacrogol 400 penetrates into breast milk.


If sclerotherapy is necessary, breast-feeding should be stopped for 2-3 days.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


There were no reports of negative effects on the ability to drive vehicles and work with other mechanisms.


Dosage and administration.


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.


Dosage (single and daily doses).


Do not exceed the dose of lauromacrogol 400 at the rate of 2 mg/kg of body weight per day.


For example, a patient with a body weight of 70 kg can use a maximum dose of 140 mg (with the exception of the dosage in the case of hemorrhoids).


140 mg of lauromacrogol 400 contains:


Ethoxysclerol 0.5% : 28 ML solution for injection;


If desired, you can enter the drug in the form of foam.


To prepare a standardized homogeneous viscous foam, see the instructions for individual systems. 


When using the drug in the form of foam, do not exceed the dose of 10 ml of foam per session and per day, regardless of the patient's body weight.


Extensive varicose veins should be treated in several sessions.


For patients with varicose veins who are prone to hypersensitivity reactions, only one injection is used at the first treatment session. Depending on the results of treatment and the size of the obliteration area, several injections can be given at the next treatment session, without exceeding the maximum dose.


Sclerotherapy of vascular networks: depending on the size of varicose nodes, the following medications are prescribed:


0.1-0.2 ml of Ethoxysclerol 0.5% intravascular.

Children.


The drug is not used in children.


Overdose.


Emergency measures and antidotes


Anaphylactic reactions


Anaphylactic reactions are rare, but they can be potentially life-threatening. In the case of sclerosing therapy, medications for countermeasures should always be prepared.


Treatment of local intoxication after inappropriate use of the drug for the treatment of varicose veins of the legs:


- intra-arterial injection


1. leave the cannula at the injection site; if the cannula has already been removed, move the puncture.


2. Enter 5-10 ml of local anesthetic without the addition of epinephrine.


3. Enter heparin 10,000 IU.


4.the ischemic leg should be wrapped in cotton wool and lowered down.


5.hospitalize the patient in the Department of vascular surgery.


- paravenous injection


Depending on the dose and concentration of the drug administered paravenically, 5-10 ml of 0.9% sodium chloride solution is administered, if possible – together with hyaluronidase. In case of acute pain, a local anesthetic is administered (without epinephrine).


Adverse reactions.


Sclerotherapy of varicose veins


The adverse reactions described below are determined based on reports on the use of lauromacrogol 400 received from around the world. In some cases, the adverse reactions were severe, but in most cases temporary. Often, such reports were spontaneous, without belonging to a certain group of patients, without any control group, and therefore it is impossible to accurately assess the frequency, as well as accurately determine the dependence of the occurrence of an adverse reaction on the effect of the drug.


Local adverse reactions (e.g. necrosis), especially of the skin and adjacent tissues (rarely nerve endings), were observed after accidental injection into surrounding tissues (paravenous injection). The risk of such reactions increases with increasing concentration and volume of Ethoxysclerol.


Adverse reactions are listed at the following frequency of occurrence (according to MedDRA): very common:


≥ 10%, often: ≥ 1% before


Immune system disorders: very rarely-anaphylactic shock, angioedema, generalized urticaria, asthma (asthmatic attacks).


From the nervous system: very rarely – impaired cerebral circulation, headache, migraine (rarely – when using the drug in the form of foam), local sensitivity disorders, loss of consciousness, confusion, dizziness, speech loss, ataxia, hemiparesis, oral hypesthesia.


From the side of the visual organs: very rarely (rarely when using the drug in the form of foam) – visual impairment.


From the heart: very rarely-cardiac arrest, stress cardiomyopathy, palpitations.


From the vascular system: often – the appearance of blood vessels at the site of sclerosis, hematoma; infrequently – superficial thrombophlebitis, phlebitis; rarely – deep vein thrombosis, possibly caused by the underlying condition; very rarely-pulmonary embolism, vasovagal loss of consciousness, collapse, vasculitis.


From the respiratory system: very rarely-difficulty breathing, a feeling of pressure in the chest, cough.


From the digestive system: very rarely – dysgeusia, nausea, vomiting.


From the skin and subcutaneous tissue: often-discoloration of the skin (hyperpigmentation, ecchymosis); infrequently – allergic dermatitis, contact urticaria, skin reaction, erythema;


very rarely – hypertrichosis in the area of sclerosis.


From the side of the muscle and connective tissue system: rarely - pain in the extremities.


General reactions: often-pain at the injection site (short – term), local (at the injection site) blood clot in the varicose node; infrequently – necrosis, compaction, swelling of tissues; very rarely-fever, hot flashes, asthenia, malaise.


Laboratory parameters: deviation from the norm of blood pressure indicators, abnormal heart rate.


Injuries, poisoning, and procedural complications: infrequently – nerve damage.


Hemorrhoid sclerotherapy


When treating hemorrhoids before and after the injection, local adverse reactions were observed, such as a feeling of heat, pain, discomfort, a feeling of pressure, especially with 11-hour nodes in men (in the prostate area). Such reactions are short-lived and can 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 site.


Adverse reactions are listed at the following frequency of occurrence (according to MedDRA): very common:


≥ 10%, often: ≥ 1% before


Immune system disorders: very rarely-anaphylactic shock, angioedema, generalized urticaria, asthma (asthmatic attacks).


Nervous system disorders: very rarely – loss of consciousness, confusion, dizziness.


From the heart: palpitations.


From the vascular system: very rarely-vasovagal loss of consciousness, collapse.


From the digestive system: infrequently – proctitis, anal itching; very rarely – nausea.


From the skin and subcutaneous tissue: infrequently – allergic dermatitis, contact urticaria, skin reaction.


From the reproductive system: very rarely – erectile dysfunction.


General reactions: often-burning sensation of the mucous membrane, pain at the injection site, discomfort, pressure sensation; infrequently – compaction; rarely – necrosis (local, less often spreads to nearby tissues), bleeding at the injection site, Thrombosis at the injection site (intrahemoroidal); very rarely – pyrexia.


Laboratory parameters: very rarely-deviations from the norm of blood pressure indicators.

Tags: Polydocanol