Etamsylate injections for uterine bleeding. Etamsilat: instructions for use

Etamsylate refers to hemostatic agents. It is prescribed to stop bleeding. It is used widely enough, the drug is used after the extraction of teeth, tonsils, cataracts, and micro surgical operations on the ears, prostatectomy, etc.

Description and composition

Etamsylate in the form of a solution is a colorless transparent or slightly colored liquid.

As active substance in 1 ml it contains 125 mg of etamsylate. In addition to it, the drug contains sodium disulfite, Trilon B, water for injection.

The tablets are white, a creamy and pinkish tint is allowed, they have a bevel and risk. As an active substance, 1 tablet contains 250 mg of etamsylate. In addition to it, they include the following additional ingredients:

• E 341;
• E 572;
• potato starch;
• sodium metabisulfite;
• povidone.

Pharmacological group

Etamsylate is used to prevent and stop bleeding. It disrupts the interaction of endothelium and platelets, increases the adhesiveness of the latter, reduces the permeability of the capillary walls and the duration of bleeding, as a result, blood loss decreases.

After intravenous administration, the hemostatic effect occurs after 5-15 minutes and lasts up to 4-6 hours. Active substance crosses the placenta and is excreted in breast milk.

After intravenous administration of the drug, its maximum concentration is reached after 10 minutes. After oral administration, the drug is rapidly adsorbed from the gastrointestinal tract, the maximum concentration in this case is observed 4 hours after taking the tablets.

Most of the drug is excreted in the urine during the first day unchanged. After intravenous administration, the half-life is 2 hours, after oral administration - 8 hours.

Indications for use

for adults

Etamsylate is prescribed for the treatment and prevention of capillary bleeding of various nature, including:

• with diabetic microangiopathy;
• during and after surgical treatment eye, gynecological and urological diseases, as well as in ENT practice, dentistry, plastic surgery;
• with the appearance of blood in the urine, heavy menstruation, including in women with an intrauterine device, bleeding from the nose and gums;
• with hemorrhages in the brain in newborns and premature babies.

for children

Etamsylate should not be prescribed to children if hemoblastosis is diagnosed: osteosarcoma, lymphatic and myeloid leukemia. In other cases, the drug is prescribed according to indications.

Etamsilate is contraindicated during childbearing and breastfeeding. After transferring the infant to an adapted mixture, the drug can be prescribed according to indications.

Contraindications

Etamsilate should not be prescribed if the patient is found to have:

• intolerance to the composition of the drug and sodium sulfite;
• acute porphyria;
• bleeding caused by taking anticoagulants;
• bronchial asthma;
• increased blood clotting;
• thrombosis and thromboembolism;
• fibrous formations of the uterus.

Applications and doses

for adults

The treatment regimen with Etamsilat is selected individually. The optimal daily dosage can vary from 10 to 20 mg per kg of body weight, it should be divided by 3-4 times. Usually it is 250-500 mg 3-4 times a day. In exceptional cases, a single dosage can be increased to 750 mg, the frequency of administration is 3-4 times a day.

With prolonged and heavy monthly bleeding, the drug is prescribed in a daily dosage of 750-1000 mg 5 days before the expected menstruation until the 5th day of the next monthly cycle.

After surgical intervention the medication is prescribed in a single dosage of 0.25-0.5 g every 6 hours until the likelihood of bleeding disappears.

for children

For children, Etamsilat is prescribed in a daily dosage of 10-15 mg per kg of body weight. It should be divided by 3-4 times. In neonatology, the drug is administered intramuscularly and intravenously (slowly), therapy is prescribed within the first 2 hours after birth.

for pregnant women and during lactation

After transferring the child to artificial feeding, Etamsilat is discharged as usual.

Side effects

During therapy, the following undesirable effects may occur:

• sensitivity disorder lower limbs (numbness, crawling sensations);
• headaches, vertigo, flushing of the head;
• thromboembolism, pressure reduction;
• nausea, diarrhea, epigastric pain;
• bronchospasm;
• back pain;
• temperature increase;
• allergy, which can manifest itself as Quincke's edema, anaphylaxis, rash;
• acute porphyria;
• a decrease in tissue perfusion (it normalizes on its own after a while).

All of these effects are not pronounced and passing.

Children who were treated with the drug to prevent blood loss in acute lymphatic and myeloid leukemia were more likely to have severe leukopenia.

Interaction with other medicinal products

Pharmaceutical solution Etamsilat is not compatible with other medicines. Therefore, it is unacceptable to mix the contents of the ampoule with any drugs in one syringe. When Etamizilat is prescribed before the introduction of rheopolyglucin, it suppresses the antiaggregatory effect of the latter, the use after rheopolyglucin does not have a hemostatic effect.

The interaction of Etamsilat tablets with other drugs has not been noted.

special instructions

Treatment should be carried out with caution if a person has a history of thrombosis and thromboembolism.

Etamsylate is not effective in patients with a reduced platelet count. It is important to rule out other causes of bleeding before starting therapy.

In injections, the drug can only be used by a medical institution.

If the patient has a bleeding disorder, but Etamzilat can only be used in combination with medications that eliminate this defect.

If the color of the injection solution has changed during storage, then it cannot be injected.

During the period of treatment, care must be taken when driving a car, as the use of a medication can provoke dizziness.

Overdose

There are no data on drug overdose.

Storage conditions

The drug, regardless of the form of release, should be stored in a place where it will not be accessible to children, at a temperature not exceeding 25 degrees. The shelf life of tablets and injections is 36 months. Etamsilat is a prescription drug, so self-medication is prohibited.

Analogs

Etamsilat analogs include the following medicines:

1. - this is swiss drug, available in tablets and injections. Injections can be given into a vein or muscle. It differs from Etamsilat in the composition of the indifferent component, it has a longer shelf life (5 years) and it can be used during pregnancy if the benefit to the woman outweighs the possible threat to the fetus.
2. refers to hemostatic agents, which is a synthetic analogue of the vitamin. It is produced in injections and tablets, can be used in children from birth and women in the position according to indications.
3. Nettle leaves are hemostatic vegetable origin... In the pharmacy, it can be found in bulk and in filter bags, the latter are more convenient to use. It can be used as a styptic from the age of 12. A contraindication to its use is individual intolerance, child bearing and natural feeding.
4. Shepherd's purse herb has a hemostatic effect. It is recommended to use it for heavy menstrual bleeding from 12 years of age. Plants can be drunk with caution during lactation. It is prohibited during pregnancy.

Price

The cost of Etamsilat is 111 rubles on average. Prices range from 24 to 135 rubles.

solution for injection 125 mg / ml: 2 ml amp. 10 pieces.
Reg. No: 16/01/1602 dated 05/22/2014 - Current

Injection colorless or slightly colored, transparent.

Excipients: sodium metabisulfite, sodium sulfite anhydrous, disodium edetate, water d / i.

2 ml - ampoules (5) - inserts (2) - cardboard packs.

Description medicinal product ETAMZILATE created in 2013 on the basis of instructions posted on the official website of the Ministry of Health of the Republic of Belarus. Updated date: 14.05.2019

pharmachologic effect

Etamsylate is hemostatic drug... The hemostatic effect is based on enhancing the interaction between the endothelium and platelets. Increases platelet adhesion, stabilizes capillary walls, thus reducing their permeability, inhibits the synthesis of prostaglandins, which cause platelet disaggregation, vasodilation and increased capillary permeability, which shortens bleeding time and reduces blood loss. Increases the rate of formation of a primary thrombus and enhances its retraction, practically does not affect the level of fibrinogen and prothrombin time.

Restores pathologically altered bleeding time. It does not affect the normal parameters of the hemostasis system.

Hemostatic effect with intravenous administration Etamsylate occurs in 5-15 minutes, the maximum effect is in 1-2 hours, the effect lasts for 4-6 hours. When administered intramuscularly, the hemostatic effect occurs in 30-60 minutes.

Pharmacokinetics

The drug is well absorbed by intramuscular injection, weakly binds to plasma proteins and blood corpuscles. Etamsylate is evenly distributed in various organs and tissues (depending on the degree of their blood supply).

T 1/2 of the drug after intravenous administration is 1.9 hours; after i / m administration - 2.1 h. 5 min after i / v administration by the kidneys, 20-30% of the administered drug is excreted, completely excreted after 4 hours. The effective concentration in the blood is 0.05-0.02 mg / ml. The drug is excreted from the body mainly in the urine, in small quantities in the bile.

Indications for use

Capillary bleeding of various etiologies, especially if the bleeding is caused by damage to the endothelium:

• prevention and control of bleeding during and after surgery on well-vascularized tissues in otolaryngology, gynecology, obstetrics, urology, dentistry, ophthalmology and plastic surgery;
• prevention and treatment of capillary bleeding of various etiology and localization: hematuria, metrorrhagia, primary menorrhagia, menorrhagia in women with intrauterine contraceptives, nosebleeds, bleeding gums.

Dosage regimen

Etamsylate is administered intravenously, intramuscularly, in ophthalmology, subconjunctivally and retrobulbar. Etamsylate can be injected intravenously in a 5% glucose solution or in 0.9% sodium chloride solution.

Adults: for prophylactic purposes during surgical interventions, the drug is administered intravenously or intramuscularly 1 hour before the operation - at a dose of 0.25-0.5 g (2-4 ml of a solution of 125 mg / ml), if necessary during the operation - at a dose of 0.25- 0.5 g (2-4 ml of a solution of 125 mg / ml), with the danger of postoperative bleeding - 0.5-0.75 g (4-6 ml of a solution of 125 mg / ml) during the day.

Children: if necessary intraoperatively Etamsylate is administered intravenously at the rate of 8-10 mg / kg of body weight.

To stop bleeding, Etamsylate is administered intravenously or intramuscularly 0.25-0.5 g (2-4 ml of a solution of 125 mg / ml), then every 4-6 hours, 0.25 g (2 ml of a solution of 125 mg / ml) for 5 -10 days.

In the treatment of metro-menorrhagia, Etamsilat is prescribed in a single dose of 0.25 g (2 ml of a solution of 125 mg / ml) intravenously or intramuscularly every 6-8 hours for 5-10 days.

In diabetic myacroangiopathy, Etamsylate is administered intramuscularly for 10-14 days in a single dose of 0.25-0.5 g three times / day.

In ophthalmology, Etamsylate is administered subconjunctivally or retrobulbar - at a dose of 0.125 g (1 ml of a solution of 125 mg / ml).

Application during pregnancy and lactation

The safety of the drug during pregnancy has not been established. Etamsylate should be used during pregnancy only if the potential benefit to the mother exceeds possible risk for the fetus. Should stop breast-feeding during the treatment of the mother with the drug Etamsilat.

Etamsilat

International non-proprietary name

Etamsilat

Dosage form

Solution for injection 12.5%, 2 ml

Composition

One ampoule contains

active substance - etamsylate - 250.0 mg,

excipients: sodium metabisulfite, sodium sulfite anhydrous, water for injection.

Description

Transparent, colorless or slightly colored liquid.

Pharmacotherapeutic group

Hemostatics. Vitamin K and other hemostatics. Other systemic hemostatics. Etamsilat.

ATX code B02BX01

Pharmacological properties

Pharmacokinetics

After intravenous administration of 500 mg of etamsylate, the maximum plasma concentration is reached after 10 minutes; the plasma half-life is approximately 1.9 hours. About 85% of the dose taken is excreted in the urine within the first 24 hours.

The degree of binding to blood plasma proteins is approximately 95%. The plasma half-life is approximately 3.7 hours. About 72% of the dose taken is excreted unchanged within the first 24 hours in the urine. Etamsylate crosses the placental barrier. Maternal and umbilical cord blood contain similar concentrations of ethamsylate. It is not known whether etamsylate passes into breast milk.

Pharmokokinetics in patients with hepatic and renal failure not studied.

Pharmacodynamics

Etamsylate is a synthetic hemostatic and angioprotective drug used as a primary hemostatic agent, which is due to an increase in the interaction between the endothelium and platelets, which promotes adhesion and aggregation of platelets, and ultimately leads to stopping or reducing bleeding. The hemostatic effect of etamsylate develops when administered intravenously after 5-15 minutes, the maximum effect occurs after 1-2 hours, the effect lasts 4-6 hours or more. When intramuscular injection the effect is somewhat slower. When taken orally, the maximum effect is noted after 3 hours. Etamsylate stimulates the formation of platelets and their release from the bone marrow, accelerates the formation of tissue thromboplastin, increases the rate of formation of a primary thrombus at the site of injury and enhances its retraction. Etamsylate enhances the formation of mucopolysaccharides with a high molecular weight in the capillary wall, increases capillary resistance, normalizes their permeability in pathological processes and improves microcirculation. Against the background of treatment with Etamsilat, pathologically altered hemostasis parameters are restored. Etamsylate does not have a vasoconstrictor effect, does not affect fibrinolysis and does not alter plasma coagulation factors.

Indications for use

Prevention and arrest of capillary and parenchymal bleeding of various etiology and localization in otorhinolaryngology, microsurgery, ophthalmology, dentistry, urology, surgery and gynecology.

Hematuria

Intracranial hemorrhage (including in newborns and premature babies)

Nosebleeds on the background of arterial hypertension

Medication-related bleeding

Hemorrhagic diathesis (including Werlhof, Willebrand-Jurgens disease, thrombocytopathy)

Method of administration and dosage

Adults

Before surgery: 1-2 ampoules (250 - 500 mg) intravenously or intramuscularly 1 hour before surgery.

During the operation (if necessary): 1-2 ampoules (250 - 500 mg) intravenously.

After operation (prophylactically): if there is a risk of bleeding, 1-2 ampoules (250-500 mg) should be administered prophylactically after the operation intravenously or intramuscularly every 4-6 hours.

Emergency cases, according to the severity of the case: 1-2 ampoules intravenously or intramuscularly every 4-6 hours for as long as there is a risk of bleeding.

Local treatment: moisten the tampon with the contents of the ampoule and apply it to the bleeding site, or the tooth socket after tooth extraction. If necessary, the application of a tampon soaked in the contents of the ampoule can be repeated, or combined with oral or parenteral administration of the drug.

Children: the daily dose is 10-15 mg / kg of body weight, divided into 3-4 doses.

Neonatology: Etamsylate should be given intramuscularly or intravenously at 10 mg / kg body weight (0.1 ml \u003d 12.5 mg), within 2 hours after birth, and then every 6 hours for 4 days.

Special populations:

The use of the drug in the form of a solution for injection in patients with hepatic or renal insufficiency should be carried out under the strict supervision of a physician.

Side effects

Adverse reactions are listed by MedDRA by organ class and frequency as follows:

Very often (≥ 1/10)

Often (≥ 1/100,<1/10)

Uncommon (≥ 1/1000,<1/100)

Rarely (≥ 1/10000 to<1/1000)

Rarely (<1/10000), не известно (из имеющихся данных не могут быть оценены)

From the digestive system

Often

Nausea, abdominal pain, abdominal discomfort, diarrhea

On the part of the skin and subcutaneous tissue

Often

Skin rash

From the nervous system

Often

Headache, vascular disorders

Rarely

Thromboembolism, hypotension

On the part of the blood and lymphatic system

Rarely

- agranulocytosis, neutropenia, thrombocytopenia

From the musculoskeletal system

Seldom

Arthralgia

From the immune system

Rarely

Allergic reactions (anaphylactic shock, life-threatening asthma attacks)

Often

Asthenia

Rarely

Fever

These side effects are usually reversible and disappear after treatment.

In case of adverse skin reactions or fever, you must discontinue treatment and inform your doctor as these may be the first signs of hypersensitivity.

Contraindications

Hypersensitivity to any component of the drug

Acute porphyria

Bronchial asthma

Hemoblastosis in children (lymphoblastic and myeloblastic leukemia, osteosarcoma)

Thrombosis, thromboembolism

Drug interactions

Introduction at a dose of 10 mg / kg body weight 1 hour before the administration of dextrans (average molecular weight 30-40 thousand Da) prevents their antiplatelet effect. The introduction of Etamsylate after the introduction of dextrans does not have a hemostatic effect.

A combination with aminocaproic acid and sodium menadione with bisulfite is possible.

Pharmaceutical incompatible (in the same syringe) with other drugs.

If it is necessary to simultaneously administer with dextran, the ethamsylate solution should be administered first.

According to studies, when administered intravenously, ethamsylate can affect blood creatinine, lactate, triglycerides, uric acid and cholesterol, determined by the enzymatic method, for up to 12 hours. During treatment with Etamsilat, it is recommended to take samples (for example, blood) before the first administration of the drug in order to minimize the effect on laboratory results.

special instructions

Caution is required (despite the absence of thrombus induction) when prescribing Etamsilat to patients with a history of thrombosis or thromboembolism.

For hemorrhagic complications associated with an overdose of anticoagulants, it is recommended to use specific antidotes. The use of Etamsilat in patients with impaired indicators of the blood coagulation system is possible, but it should be supplemented by the administration of drugs that eliminate the identified deficiency or defect of the coagulation system factors.

Before starting treatment, it must be borne in mind that the drug is ineffective in patients with thrombocytopenia.

Since parenteral administration of the drug Etamsylate can cause a decrease in blood pressure, careful monitoring should be exercised over patients suffering from changes in blood pressure or hypotension.

Etamsylate contains sulfites, which is why caution is also required when administering it to patients with allergies.

In case of an allergic reaction, treatment with the drug should be stopped immediately.

Pregnancy and lactation.

Use during pregnancy is possible only in cases where the potential benefit of therapy to the mother outweighs the possible risk to the fetus. If it is necessary to prescribe the drug during lactation, the question of stopping breastfeeding should be resolved.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

There is no data on the effect of the drug on the ability to drive transport and other mechanisms that require concentration.

Overdose

Overdose cases have not been identified. In case of overdose, treatment is symptomatic.

Release form and packaging

2.0 ml of the drug is poured into neutral glass ampoules or sterile syringe-filled ampoules, or imported.

Each ampoule is labeled with a label made of label or writing paper, or the text is applied directly to the ampoule with gravure ink for glass products.

5 ampoules are packed in a blister from a film

polyvinyl chloride and aluminum foil

2 or 10 contour packs, together with the approved instructions for medical use in the state and Russian languages, are placed in a cardboard box. An ampoule scarifier is placed in each pack. When packing ampoules with notches, rings and dots, scarifiers are not inserted.

It is allowed to place contour cell packages (without enclosing in a carton box) in cardboard boxes. Each box, according to the number of packages, contains instructions for medical use in the state and Russian languages.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Storage period

Do not use after the expiration date.

Terms of dispensing from pharmacies

On prescription

Manufacturer

JSC "Khimfarm", Kazakhstan,

shymkent, st. Rashidova, 81

Marketing Authorization Holder

JSC "Khimfarm", Kazakhstan

The address of the organization that accepts claims from consumers on the quality of products (goods) on the territory of the Republic of Kazakhstan

JSC "Khimfarm", Kazakhstan

shymkent st. Rashidova, 81

Fax number +7 7252 (561342)

Name, address of the organization in the territory of the Republic of Kazakhstan responsible for post-registration supervision of the safety of the medicinal product

JSC "Khimfarm", Republic of Kazakhstan, Shymkent, st. Rashidova, 81,

Phone number +7 7252 (561342)

Fax number +7 7252 (561342)

E-mail address [email protected]

Etamsylate is a modern effective hemostatic (hemostatic) agent. The drug ensures blood coagulation in small vessels and has a pronounced angioprotective effect.

Etamsilat: release form and composition

The active active ingredient of the drug is ethamsylate (INN). The compound is 2,5-dihydroxybenzenesulfonic acid in combination with diethylamine. The drug Etamsylate is available in the form for parenteral (intravenous or intramuscular). Each ampoule contains 2 ml of injection solution, which corresponds to 0.25 g of dry matter (12.5% \u200b\u200bsolution). Etamsylate in ampoules is supplied in packs of 10. This anticoagulant and microcirculation corrector is also produced in tablet form for oral administration. Each tablet contains 250 mg of active ingredient. They are packaged in dark glass containers of 50 or 100 pieces. Etamzilat's analogs are, Ezelin, Cyclonamin, and Aglumin.

Indications for use

An anticoagulant is prescribed both for prophylactic purposes and for stopping parenchymal and capillary bleeding of various origins. Indications for the appointment of Etamzilat are:

• diabetic (including retinopathy);
• hemorrhagic diathesis;
• hemorrhagic vasculitis;
• surgical interventions on various organs;
• preoperative period;
• postoperative period;
• intracranial hemorrhage;
• intestinal bleeding (for emergency indications);
• pulmonary bleeding (for emergency indications);
• meno- and metrorrhagia (dysfunctional uterine bleeding);
• hematuria; ... secondary bleeding (with trombocytopenia and thrombocytopathy);
• increased bleeding of the gums.

Method of administration and dosage

The solution can, depending on the indications, be administered intramuscularly or intravenously, and in ophthalmology - subconjunctivally or behind the eyeball (retrobulbar). The tablets are taken orally. With intravenous injection, the hemostatic effect develops within 5-15 minutes after injection. The greatest effect is observed after 1-2 hours (depending on individual characteristics), and the duration of action is from 4 to 6 hours.

After intramuscular injection, the drug begins to act somewhat later. The maximum effect from taking the pills is recorded after 3 hours.

In the preoperative period, in order to prevent capillary bleeding during surgery, the patient is injected parenterally with 2-4 ml of solution (1 hour before surgery). In tablets (2-3 pieces) Etamsilat should be given to the patient 3 hours before the start of the operation. According to indications, 1-2 ampoules can be additionally administered directly during the intervention.

In the postoperative period, to prevent bleeding, the patient is administered from 4 to 8 ml of injection solution per day or 6-8 tablets per day (2 per dose) are given, observing approximately the same time intervals. If bleeding already occurs, the drug is administered intravenously or intramuscularly in a dose of 2 to 4 ml. Additionally, appoint 2 ml at 4-6 hour intervals. Alternatively, oral pills may be prescribed (2 tablets every 4-6 hours).

Capillary pathologies that develop against the background of diabetes mellitus require a long course of treatment. The angioprotector is prescribed to patients 1-2 tablets 3 times a day for 2-3 months. Alternatively, intramuscular injections of 2 ml are carried out 2 times a day; in this case, the duration of the course is reduced to 1.5-2 weeks.

Course therapy for hemorrhagic diathesis involves daily intake of 1.5 g of anticoagulant (divided into 3 equal doses). The duration of treatment can range from 5 days to 2 weeks, depending on the severity of the pathological process.

The most severe clinical cases require the appointment of 0.25-0.5 g 1-2 times a day for 3-8 days. Then the patient is shown taking maintenance doses of the drug in tablet form.

The course reception of Etamzilat in gynecology is indicated for metrorrhagia and menorrhagia. Initially, the patient needs to take 0.5 g of the drug (or inject parenterally 0.25 g) for 5-10 days every 6 hours. Then the woman will need a maintenance dose of 0.25 g 4 times a day directly during bleeding (the last 2 cycles). Parenterally 0.25 g is administered 2 times a day. The solution for injection can be impregnated with a sterile swab, which is applied to the wound surface.

Etamsilat: contraindications

Contraindications to the appointment of this hemostatic agent are:

• individual hypersensitivity to etamsylate;
• bleeding that began against the background of the introduction of anticoagulants;
• thromboembolism.

special instructions

Special care should be taken when prescribing Etamsilat to patients with a history of thrombosis and embolism.

Etamsylate: mechanism of action

The active component of hemostatic is able to stimulate the synthesis of platelets and accelerate their entry from the bone marrow into the bloodstream. It also increases the biosynthesis of mucopolysaccharides of significant molecular weight in the capillary walls. Under the action of a unique angioprotector, the movement of blood in the capillaries improves, strengthens the walls of blood vessels and normalizes their permeability, previously impaired due to certain diseases. Etamsylate is capable of stopping blood, since the active ingredient directly affects the process of thromboplastin formation. The pharmacological agent activates the synthesis of coagulation factor III and stabilizes the rate of platelet adhesion due to a decrease in the level of prostacyclin in the endothelium of the vascular walls.

It should be noted that the gepostatic-angioprotective agent does not significantly affect the prothrombin time. For him, hypercoagulant properties are also uncharacteristic. When taken or parenterally administered, the drug does not form blood clots and does not increase the degree of blood clotting. Thus, the use of Etamsilat can be considered safe from the point of view of possible complications.

When the patient receives the drug in the form of injections, the half-life is on average 2 hours. The active component practically does not bind with plasma proteins. Almost ¾ of the active substance is excreted unchanged by the kidneys during the first day. Etamsylate is able to bypass the hematoplacental barrier, and during lactation is found in breast milk.

Etamsylate: side effects

Most patients tolerate the drug well. In rare cases, the following side effects may occur:

• feeling of heaviness "in the stomach";
• transient and insignificant drop in "upper" (systolic) blood pressure;
• redness (hyperemia) of the skin of the facial area;
• heartburn;
• headache;
• dizziness;
• violation of sensitivity (paresthesia) of the legs;
• allergic reactions.

Interaction with other medications

Etamsilate in the form of a solution for injection should not be mixed in one syringe with any other pharmacological agents! The effect of the parallel administration of antiplatelet agents from the dextran group is reduced to zero.

Interaction of etamsylate with alcohol

This anticoagulant cannot be combined with ethanol. During the course of treatment, you must refuse to take alcohol-containing liquids.

Etamsylate during pregnancy and lactation

According to indications, a hemostatic drug can be prescribed to pregnant and lactating women.

Etamsilat: instructions for use for children

Hemostatic can be administered to children. The dosage is determined by the attending physician at the rate of 10-15 mg per 1 kg of body weight per day (divided into 3 doses and administered at regular intervals). The drug is indicated for intracranial hemorrhage in newborns (including premature babies).

Storage conditions and shelf life

All dosage forms of the angioprotective agent should be stored in a dark place at room temperature. The solution can be kept in the refrigerator. Do not freeze! Keep out of the reach of children! The shelf life for injection solution and tablets is 5 years from the date of issue.

1 ml of solution contains

active substance - etamsylate 125 mg,

excipients: sodium metabisulfite, sodium sulfite anhydrous, disodium edetate (Trilon B), water for injection.

Description

Transparent, colorless or slightly creamy liquid

Pharmacotherapeutic group

Hemostatics. Vitamin K and other hemostatics. Other systemic hemostatics. Etamsilat.

ATX code B02B X01.

Pharmacological properties

Pharmacokinetics

After intravenous (intravenous) or intramuscular (intramuscular) administration of Etamsylate in a dose of 500 mg, its concentration in blood plasma after 1 hour is 30 μg / ml. The hemostatic effect with intravenous administration of Etamsylate occurs in 5-15 minutes, the maximum effect is in 1-2 hours, the action lasts 4-6 hours. With i / m administration, the hemostatic effect occurs in 30-60 minutes. The half-life after i / v application is 1.9 hours, after i / m - 2.1 hours. 95% of the administered drug binds to plasma proteins. Etamsylate is not metabolized and is excreted unchanged from the body mainly in the urine (\u003e 80%), partially excreted in the bile and feces.

Pharmacodynamics

The drug has a hemostatic effect. The hemostatic effect is due to an increase in the interaction between the endothelium and platelets, which promotes platelet adhesion and aggregation, and, ultimately, leads to stopping or reducing bleeding. Etamsylate stimulates the formation of platelets and their release from the bone marrow, accelerates the formation of tissue thromboplastin, increases the rate of formation of a primary thrombus at the site of injury and enhances its retraction. Etamsylate enhances the formation of mucopolysaccharides with a high molecular weight in the capillary wall, increases capillary resistance, normalizes their permeability in pathological processes and improves microcirculation. Against the background of treatment with Etamsilat, pathologically altered hemostasis parameters are restored.

Indications for use

Prevention and control of bleeding during surgery:

In otorhinolaryngology (tonsillectomy, microsurgery on the ear)

Ophthalmology (keratoplasty, cataract removal, antiglaucoma

operations)

In dentistry (removal of cysts, granulomas, tooth extraction)

In urology (prostatectomy)

In surgery (operations on well-vascularized organs and tissues)

In gynecology

In traumatology

In emergency cases with pulmonary, intestinal bleeding

Metro- and menorrhagia with fibromas

Diabetic angiopathies

Hemorrhagic diathesis (including in emergency cases)

Method of administration and dosage

Etamsylate is used intravenously, intramuscularly, subconjunctivally or retrobulbar. For prophylactic purposes, the drug is administered intravenously or intramuscularly to adults 1 hour before surgery, 0.25-0.5 g (2-4 ml of a 12.5% \u200b\u200bsolution). If necessary, during the operation, it is administered intravenously in a dose of 2-4 ml of a 12.5% \u200b\u200bsolution. If there is a danger of postoperative bleeding, 4-6 ml of a 12.5% \u200b\u200bsolution per day is administered for prophylactic purposes. For medicinal purposes, in emergency cases, Etamsilat is administered to adults intravenously or intramuscularly (2-4 ml of a 12.5% \u200b\u200bsolution), and then 2 ml every 4-6 hours. In the treatment of metrorrhagia and menorrhagia, Etamsylate is prescribed 0.25 g (2 ml of 12.5% \u200b\u200bsolution) parenterally every 6-8 hours for 5-10 days, and then 0.25 g (2 ml 12.5 % solution) parenterally 2 times a day during bleeding and 2 subsequent cycles.

In diabetic angiopathies, Etamsilat is prescribed intramuscularly (10-14 days), 2 ml 2 times a day.

Subconjunctival or retrobulbar (keratoplasty, cataract removal, glaucoma surgery, etc.), 1 ml of a 12.5% \u200b\u200bsolution is injected.

For children, including newborns, with severe hemorrhages, the drug is administered once intravenously or intramuscularly, 0.5-2 ml, taking into account body weight (10-15 mg / kg).

You can apply the injection solution topically: a sterile swab soaked in the drug is applied to the wound.

The maximum single dose for adults is 4 mg (0.5 g), the daily dose is 14 mg (1.75 g).

Side effects

Headache, dizziness

Decreased blood pressure, feeling of heaviness in the region of the heart

Facial hyperemia, paresthesia of the lower extremities

Allergic rash

Allergic reactions (skin rashes, anaphylactic shock, life-threatening asthma attacks)

Backache

Nausea, bitterness in the mouth, epigastric pain, diarrhea

Contraindications

Hypersensitivity to the drug

Hemorrhages due to anticoagulant drugs

History of thrombosis or embolism

Lactation period

Bronchial asthma

Hemoblastosis in children (lymphatic and myeloid leukemia, osteosarcoma)

Acute porphyria

Drug interactions

Etamsilat solution cannot be mixed in the same syringe with other drugs. When used together with rheopolyglucin, the effects of both drugs are completely inhibited. If necessary, intravenous drip of the drug, Etamsilat is added to a glucose solution or physiological sodium chloride solution.

special instructions

Caution is required in patients with a history of thrombosis or thromboembolism. For hemorrhagic complications associated with an overdose of anticoagulants, it is necessary to use specific antidotes. Etamsylate is prescribed only as an adjuvant and, mainly, for violations of the platelet-vascular component of hemostasis. The drug is not effective in patients with thrombocytopenia.

It is prescribed with caution to patients with cardiac arrhythmias and angina pectoris.

Etamsylate contains sulfites, which is why it is also necessary to be careful when administering it to patients with bronchial asthma and allergies.

In case of allergic reactions, treatment should be stopped immediately.

Pregnancy

The use of Etamsilat during pregnancy is possible only if the expected effect of therapy outweighs the potential risk to the fetus.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms