Etamsylate injection. Contraindications and adverse reactions. Contraindications and side effects

solution for injection 125 mg/ml: 2 ml amp. 10 pieces.
Reg. No.: 1108/96/02/06/07/09/12 dated 03/26/2012 - Valid

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

2 ml - ampoules (10) - 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.


pharmachologic effect

Etamsylate is a means to prevent and stop bleeding. It affects the first stage of the hemostasis mechanism (the interaction between the endothelium and platelets). Etamsylate increases platelet adhesiveness, normalizes the resistance of capillary walls, thus reducing their permeability, inhibits the biosynthesis of prostaglandins, which cause platelet disaggregation, vasodilation and increased capillary permeability. As a result, bleeding time is significantly reduced and blood loss is reduced.

Pharmacokinetics

After intravenous administration of the drug, the hemostatic effect is observed after 5-15 minutes, the maximum is achieved within 1 hour. The drug is effective for 4-6 hours, after which the effect gradually disappears. After intravenous administration of ethamsylate at a dose of 500 mg, the most high level in blood plasma is reached after 10 minutes and is 50 mcg/ml.

Approximately 72% of the administered dose is excreted unchanged in the urine during the first 24 hours. T1/2 of etamsylate from blood plasma is approximately 2 hours. Etamsylate penetrates the placental barrier and is excreted into breast milk.

Indications for use

Capillary bleeding of various etiologies, especially if bleeding is caused by endothelial damage:

  • prevention and treatment of bleeding during and after surgical operations in otolaryngology, gynecology, obstetrics, urology, dentistry, ophthalmology and plastic surgery;
  • prevention and treatment of capillary bleeding of various etiologies and localization: hematuria, metrorrhagia, primary hypermenorrhea, hypermenorrhea in women with intrauterine contraception, nose bleed, bleeding gums;
  • neonatology: prevention of periventricular bleeding in premature infants.

Dosage regimen

The drug is used intravenously (slowly) or intramuscularly. The optimal daily dose for adults is 10-20 mg/kg body weight of ethamsylate, which is administered in 3-4 doses. In most cases, the contents of 1-2 ampoules are administered 3-4 times a day. Daily dose for children is half the dose for adults.

Before surgical intervention the contents of 1-2 ampoules are administered intravenously or intramuscularly. During the operation, the contents of 1-2 ampoules are administered intravenously; this dose can be repeated. After surgery, the contents of 1-2 ampoules are administered every 6 hours until the risk of bleeding disappears.

In neonatology, Etamzilat is administered intramuscularly or intravenously at a dose of 12.5 mg/kg body weight (0.1 ml = 12.5 mg). Treatment should begin within the first 2 hours after birth. The drug is administered every 6 hours for 4 days up to a total dose of 200 mg/kg.

Etamsylate can be applied topically (skin graft, tooth extraction) using a sterile gauze pad moistened with the drug.

Side effect

From the nervous system: rarely - headache, dizziness, facial flushing, paresthesia of the lower extremities.

From the outside of cardio-vascular system: very rarely - thromboembolism, arterial hypotension.

From the outside digestive tract: nausea, vomiting, epigastric pain, diarrhea.

From the outside immune system: rarely - allergic reactions, increased body temperature, skin rashes, anaphylactic shock, a case of angioedema is described.

From the outside respiratory system: bronchospasm.

From the outside endocrine system: very rarely - acute porphyria.

From the outside musculoskeletal system: rarely - back pain.

From the skin: itching, urticaria.

Others: decreased tissue perfusion, which recovers on its own after some time.

All side effects weak and transient.

Children treated with etamsylate to prevent bleeding in acute lymphatic and myeloid leukemia were more likely to have severe leukopenia.

special instructions

Use with caution in patients who have previously had thrombosis or thromboembolism, as well as hemorrhages caused by anticoagulant agents.

For hemorrhagic complications associated with an overdose of anticoagulants, it is necessary to use specific antidotes.

The drug is not effective if the platelet count is low.

Before starting treatment, other causes of bleeding should be excluded.

Treatment with Etamsylate in patients with impaired blood coagulation system parameters must be supplemented with administration medicines, eliminating the identified deficiency or defect of factors of the blood coagulation system.

Do not use the drug if the color of the injection solution changes.

Children

The drug is contraindicated in children with hemoblastosis (lymphatic and myeloid leukemia, osteosarcoma).

The ability to influence the reaction rate when driving a vehicle or working with other mechanisms

During treatment with Etamzilat, care must be taken when driving vehicles or operating other machinery, as dizziness may occur.

Drug interactions

If Etamsylate is mixed with saline solution, it must be applied immediately.

Taking it before administration of rheopolyglucin prevents the antiaggregation effect of the latter; taking it after administration of rheopolyglucin does not have a hemostatic effect. The combination with aminocaproic acid and vikasol is acceptable.

The contents of the ampoule should not be mixed with other drugs in the same syringe. Etamsylate solution is not compatible with sodium bicarbonate solution and sodium lactate powder.

Various bleedings are actually not as rare as they might seem at first glance. During surgery or dental procedures we may be exposed to this danger. There is a fairly large selection of hemostatic drugs. "Etamzilat" is in demand among buyers. Therefore, it is worth dwelling on it in more detail.

Description

"Etamzilat" is an effective medicine. It increases the formation of mucopolysaccharides (binding substances) on the walls of capillaries, and also helps strengthen blood vessels.

The active substance in this medicine is ethamsylate.

The product is available in the form of tablets or ampoules. The tablets are packaged in packs of 50 or 100 pieces. One tablet contains 250 mg of etamsylate. The ampoule contains clear liquid. One package contains 5 or 10 ampoules of 2 ml each.

pharmachologic effect

"Etamzilat" is prescribed not only to stop, but also to prevent bleeding. It affects the first stage of interaction between platelets and endothelium. The medicine strengthens the walls of capillaries and reduces their permeability, while increasing the ability of platelets to “stick” to the walls of damaged vessels.

“Etamzilat” slows down the production of substances that prevent platelets from joining each other in the area of ​​damage, and also make the walls of blood vessels thinner. This stops the bleeding.

Pharmacokinetics

The medicine normalizes the rate of blood clotting, makes capillary walls more elastic and resilient, and improves blood microcirculation even in very small vessels.

At the same time, “Etamzilat” does not contribute to the formation of blood clots.

The product begins to act 5 to 10 minutes after administration and retains its properties for four to six hours.

Dosage

As a rule, doctors prescribe Etamzilat in tablets, 1-2 pieces 3-4 times a day.

Sometimes injections of this drug are prescribed intravenously or intramuscularly at 0.125–0.25 grams 3–4 times a day.

You can also apply tampons soaked in this solution to the affected area.

"Etamzilat" is also used in veterinary medicine. In this case, the calculation should be made according to the following scheme: 0.1 ml per 1 kg of animal weight.

Indications

"Etamzilat" is prescribed in the following cases:

  • For various types of bleeding.
  • During menstruation.
  • During surgical interventions.
  • In gynecology, ophthalmology, dentistry, plastic medicine.
  • During uterine bleeding.
  • For injuries.
  • For frequent nosebleeds.
  • When all human blood vessels are affected during complications of diabetes mellitus.
  • When bleeding of the skin or individual organs occurs.

Side effects

As practice shows, this medicine can cause the following undesirable effects:

  • Heartburn.
  • Pain in the stomach area.
  • Demotion blood pressure.
  • Headache.
  • Dizziness.
  • Allergic reactions.
  • Bronchospasm.

But it is worth noting that all these phenomena are mild and pass quickly.

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Contraindications

It is forbidden to take “Etamzilat” in the following cases:

  • Individual intolerance.
  • Thrombosis.
  • Increased blood clotting.
  • Thromboembolism.

special instructions

You should not use Etamzilat as the only medicine if you have bleeding caused by substances that prevent the blood from clotting.

Patients diagnosed with thrombosis should be cautious when prescribing this medication.

"Etamzilat" is more of an additional remedy.

When administering the drug intravenously or intramuscularly, there should be no other drugs in the ampoule.

Use in childhood

Taking "Etamzilat" in childhood allowed.

The dose should be calculated as follows: 10–15 mg of medication per kilogram of the child’s weight per day. Daily norm should be evenly divided into 3 doses.

Interaction

"Etamzilat" is incompatible with taking other medications. This is especially true for ampoules.

Use during pregnancy

"Etamzilat" is not prescribed during pregnancy.

Overdose

The medicine is absorbed quite well and does not cause poisoning.

Storage conditions

“Etamzilat” should be protected from direct sun rays and moisture. The medicine should not be available to children. Storage temperature – no higher than 25 degrees.

The hemostatic drug Etamzilat is used for the prevention and treatment of bleeding in surgery, gynecology, and other medical fields. Prescribed to women for disorders menstrual cycle, to reduce heavy blood loss during menstruation. The prescription of the drug and the selection of its dosage form, regardless of the diagnosis and symptoms, must be made by the attending physician.

Instructions for use of Etamzilat

The hemostatic (hemostatic) agent Etamzilat is characterized by angioprotective, proaggregant actions. The drug stimulates an increase in the rate of platelet development and their release from bone marrow. Used to stop and prevent capillary and parenchymal bleeding, diapedetic hemorrhages, in surgery, gynecology, ophthalmological, dental, urological and otolaryngological practice during surgical interventions.

The hemostatic effect of the drug Etamzilat is due to the formation of thromboplastin at the site of vessel damage and a decrease in the formation of prostacyclin in the walls of blood vessels, which leads to stopping or reducing bleeding. The antihyaluronidase activity of the main component prevents the destruction of mucopolysaccharides of the capillary walls, increases their resistance and reduces fragility. Taking the drug has no effect vasoconstrictor effect, does not contribute to thrombus formation.

Composition and release form

The drug Etamzilat is available in two dosage forms– tablets for oral administration and solution for intramuscular or intravenous injections. Pills white convex shape contain 250 mg of the main active substance(sodium ethamsylate) and auxiliary components (sodium hydrogen phosphate dihydrate, sodium metabisulfite, povidone, potato starch, calcium stearate). Packaged in blisters of 50 or 100 pieces.

Solution for injection Etamzilat is a transparent, colorless or slightly colored yellow liquid. Packaged in ampoules of 2 ml, 1, 2 or 10 ampoules per package. Contents of active and auxiliary components solution:

Pharmacodynamics and pharmacokinetics

Active ingredient The drug – sodium ethamsylate – promotes the formation of mucopolysaccharides and thromboplastin, providing the hemostatic activity of the drug. Taking the medicine helps to normalize the rate of blood clotting, increase the elasticity and stability of capillary walls, reduce their permeability, and improve microcirculation processes. In this case, the prothrombin time (blood clotting time) does not change, normal platelet adhesion (gluing rate) is restored, and the hypercoagulable effect does not appear.

With intravenous or intramuscular injection therapeutic effect begins after 10 minutes, the maximum effect occurs after 2 hours with a duration of action of 4 to 6 hours. When taken orally, the rate of onset of positive dynamics is lower, while hemostatic indicators are better. Regardless of the route of administration, about 72% of the dose taken is excreted in the bile and excreted in the urine within 24 hours after administration.

Indications for use

The drug is used for the treatment or prevention of capillary bleeding during surgery or in case of emergency and diseases with accompanying symptoms(risk of bleeding). Indications for use are:

  • diabetic angiopathy;
  • hemorrhagic diabetic retinopathy;
  • hemorrhagic diathesis;
  • von Willebrand-Jurgens syndrome;
  • hemorrhagic vasculitis;
  • diapedesis;
  • hematuria;
  • polymenorrhea (menstruation with heavy blood loss, menstrual irregularities).
  • surgical interventions in otorhinolaryngology (tonsillectomy, microsurgical operations on the ear);
  • ophthalmological operations (antiglaucoma operations, retinal operations);
  • dental operations (removal of cysts, granulomas, tooth extraction);
  • urological operations;
  • gynecological practice (for operations on abundantly blood-supplied tissues)
  • for acute intestinal or pulmonary bleeding.

Directions for use and dosage

The duration of treatment with the drug Etamzilat, the regimen and form of administration, the volume of a single and daily dose are determined by the attending physician depending on the diagnosis and symptoms. The dosage recommended by the instructions for use is:

  • when taken orally: 250-500 mg 3-4 times a day (a single single dose for oral administration is increased to 750 mg for appropriate indications);
  • intramuscularly or intravenously: 125-250 mg, 3-4 injections per day;
  • for parenteral administration: up to 375 mg;
  • in childhood: 10-15 mg/kg per day, 3 injections per day, in equal doses.

Oral administration of the drug is prescribed for the treatment and prevention of bleeding in diabetic microangiopathies and diathesis. Etamsylate for heavy periods and for the treatment of cycle disorders is also recommended for oral administration. Possible schemes treatment:

  • Metro- and menorrhagia during menstruation and treatment of dysfunctional uterine bleeding - 0.5 g once every 6 hours, course of treatment - 5-12 days. Prophylactically - 1 tablet 4 times a day on bleeding days, and during the two following days of the cycle.
  • Diabetic angiopathy– 1-2 tablets 2-3 times a day, duration of treatment is 2-3 months.
  • Prevention of the risk of postoperative bleeding - 6-8 tablets per day with an even distribution of doses at each dose within 24 hours.

Etamsylate in ampoules

Etamzilat injections are used to prevent bleeding before and after surgery for appropriate indications (2-4 ml intramuscularly or intravenously, one hour before surgery). If there is a risk of postoperative bleeding, 4-6 ml per day is prescribed. Possible application schemes:

  • hemorrhagic diathesis – 1.5 g, one injection per day, course duration 5-14 days;
  • in ophthalmology – 0.125 g (1 ml of solution) subconjunctivally or retrobulbarly;
  • V veterinary practice– 0.1 ml per kilogram of animal weight 2 times a day.

Etamsylate during pregnancy

During pregnancy, Etamzilat is prescribed with caution. Use during the first trimester is not recommended. When bloody discharge or the threat of miscarriage for more later used in combination with Progesterone with constant monitoring of blood clotting. The prescription must be made by the doctor leading the pregnancy; self-medication can lead to negative consequences for the health of the mother or fetus.

Drug interactions

It is unacceptable to mix Etamzilat solution in one syringe with others medicines. During parallel therapy with pharmaceutical group dextrans, when administered at a dosage of 10 mg/kg one hour before taking them, the antiplatelet effect may be reduced; administration after does not have a pronounced hemostatic effect. Acceptable joint use with aminocaproic acid, menadione sodium bisulfite.

Side effects and overdose

The course of treatment using Etamzilat is in most cases well tolerated if the treatment regimen is followed, daily dosage. There have been no cases of overdose; for complicated bleeding caused by an overdose of anticoagulants, the use of specific antidotes is indicated. Possible side effects of taking the drug:

  • feeling of discomfort or burning in the chest area;
  • heartburn;
  • stomach pain;
  • anemia;
  • decline intracranial pressure;
  • facial skin hyperemia;
  • headache and dizziness;
  • arterial hypertension;
  • decreased systolic blood pressure;
  • paresthesia skin(numbness, tingling sensation) of the lower extremities.

Contraindications

The use of the drug Etamzilat is not indicated for diseases and conditions with concomitant increased thrombus formation. Contraindications for use in the instructions for use include:

  • thromboembolism;
  • thrombosis;
  • hemorrhage while taking anticoagulants;
  • increased blood clotting;
  • acute porphyria;
  • bronchial asthma;
  • hemoblastosis in children;
  • hypersensitivity to the components of the drug.

Terms of sale and storage

Etamzilat is available in pharmacies on prescription. The product must be kept out of the reach of children. dark place, at a temperature not higher than 25°C. Shelf life is two years from the date indicated on the package.

Analogs

The only registered complete structural analogue of the drug Etamsylate is Dicynone. If side effects occur or individual intolerance is identified, the attending physician will replace it with one of the following medications:

  • Dicynone;
  • Vikasol;
  • Ezelin;
  • Methylergobrevin;
  • Tachocomb;
  • Impedil;
  • Gordoks;
  • Tranexam;
  • Altodor.

Etamzilat price

You can buy the drug Etamzilat in a pharmacy or on specialized online resources and arrange for home delivery. average cost all forms of release.

Etamsylate: instructions for use

Compound

active ingredient: etamsylate;

1 ml of solution contains ethamsylate 125 mg;

excipients: sodium metabisulfite (E 223), sodium sulfite anhydrous (E 221), disodium edetate, water for injection.

Description

transparent, colorless or slightly yellowish liquid.

pharmachologic effect

Etamsylate is a means to prevent and stop bleeding. It affects the first stage of the hemostasis mechanism (the interaction between the endothelium and platelets). Etamsylate increases platelet adhesiveness, normalizes the resistance of capillary walls, thus reducing their permeability, inhibits the biosynthesis of prostaglandins, which cause platelet disaggregation, vasodilation and increased capillary permeability. As a result, bleeding time is significantly reduced and blood loss is reduced.

Pharmacokinetics

After intravenous administration The hemostatic effect of the drug is observed after 5-15 minutes, the maximum is achieved within 1 hour. The drug is effective for 4-6 hours, after which the effect gradually disappears. After intravenous administration of etamsylate at a dose of 500 mg, the highest plasma level is reached after 10 minutes and is 50 mcg/ml.

Approximately 72% of the administered dose is excreted unchanged in the urine within the first 24 hours. The half-life of ethamsylate from blood plasma is approximately 2 hours. Etamsylate crosses the placental barrier and is excreted into breast milk.

Indications for use

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

Prevention and treatment of bleeding during and after surgical operations in otolaryngology, gynecology, obstetrics, urology, dentistry, ophthalmology and plastic surgery;

Prevention and treatment of capillary bleeding of various etiologies and localization: hematuria, metrorrhagia, primary hypermenorrhea, hypermenorrhea in women with intrauterine contraceptives, nosebleeds, bleeding gums;

Neonatology: prevention of periventricular bleeding in premature infants.

Contraindications

Increased sensitivity to etamsylate or to any other component of the drug; hypersensitivity to sodium sulfite. Bronchial asthma, acute porphyria, increased blood clotting, hemorrhages caused by anticoagulant drugs, hemoblastosis (lymphatic and myeloid leukemia, osteosarcoma) in children.

Treatment can begin after eliminating the presence fibrous formations uterus.

Pregnancy and lactation


Directions for use and doses

The drug is administered intravenously (slowly) or intramuscularly. The optimal daily dose for adults is 10-20 mg/kg body weight of ethamsylate, which is administered in 3-4 doses. In most cases, the contents of 1-2 ampoules are administered 3-4 times a day. The daily dose for children is half the dose for adults.

Before surgery, the contents of 1-2 ampoules are administered intravenously or intramuscularly. During the operation, the contents of 1-2 ampoules are administered intravenously; this dose can be repeated. After surgery, the contents of 1-2 ampoules are administered every 6 hours until the risk of bleeding disappears.

In neonatology, Etamzilat is administered intramuscularly or intravenously at a dose of 12.5 mg/kg body weight (0.1 ml = 12.5 mg). Treatment should begin within the first 2 hours after birth. The drug is administered every 6 hours for 4 days up to a total dose of 200 mg/kg.


Self-medication can be harmful to your health.
You should consult your doctor and read the instructions before use.

Etamsylate (Etamsylate, Etamzilat).

Active substance:

Pharmachologic effect:

Etamsylate is a means to stop bleeding and prevent bleeding. It affects the first stage of the hemostasis mechanism (the interaction between platelets and endothelium). Etamsylate normalizes the stability of capillary walls, thus reducing their permeability, increases platelet adhesiveness, inhibits the biosynthesis of prostaglandins, which cause platelet disaggregation, increased permeability and vasodilation of capillaries. As a result, bleeding becomes significantly less and blood loss is reduced.

Indications for use:

Etamsylate is used for the prevention and control of hemorrhages in internal and superficial capillaries of various etiologies, especially if the bleeding is caused by damage to the endothelium:

For the prevention and treatment of bleeding during and after surgical operations in gynecology, obstetrics, otolaryngology, urology, ophthalmology, dentistry and plastic surgery;

For the prevention and treatment of capillary bleeding various localizations and origin: metrorrhagia, hematuria, primary hypermenorrhea, nosebleeds, bleeding gums, hypermenorrhea in women with intrauterine contraceptives.

Mode of application:

Apply internally. Take tablets during meals or after meals 3-4 times a day. The daily dose is 1-2 tablets. IN severe cases take 3-4 times a day, the dose is 3 tablets.

For menorrhagia, starting from the 5th day from the expected start of menstruation until the 5th day of the next menstrual cycle, take 3-4 tablets per day.

After surgery, until the risk of bleeding disappears, take 1-2 tablets every 6 hours.

The daily dose for children corresponds to half the dose for adults.

Side effects:

Nervous system: rarely - headache, dizziness, flushing of the face, paresthesia in the legs.

The endocrine system is very in rare cases may react with acute porphyria. Back pain is rare.

All side effects are mild and transient.

Severe leukopenia was often observed in children taking Etamsylate to prevent bleeding in acute lymphatic and myeloid leukemia.

Contraindications:

Hypersensitivity to etamsylate or to any component of the drug. Acute porphyria, thrombosis, thromboembolism, increased coagulability blood. Pregnancy or breastfeeding. Hemoblastoses (osteosarcoma, myeloid and lymphatic leukemia) in children. It is necessary to exclude the presence of fibrous formations of the uterus and only then can treatment begin.

Pregnancy:

The safety of using the drug during pregnancy has not been established. Contraindicated.

Interaction with other drugs: Taking rheopolyglucin during administration prevents the latter's antiaggregation; taking it after administration of rheopolyglucin does not have a hemostatic effect. Acceptable communication with aminocaproic acid, vikasol.

Overdose:

There are no data on overdose of ethamsylate.

Release form:

Pills. There is 1 blister in a pack. There are 10 or 50 tablets in a blister;

Storage conditions:

To protect the drug from moisture and exposure to light, store in its original packaging. No other conditions are necessary. Keep away from children!

Compound:

1 tablet contains ethamsylate 250 mg;

excipients: calcium hydrogen phosphate dihydrate, sodium metabisulfite (E 223), potato starch, povidone, calcium stearate.

Additionally: The drug is used for children over 6 years of age. Do not prescribe to children with hemoblastosis.

In patients with previously recorded thrombosis or thromboembolism, use with caution. The drug is ineffective when reduced quantity platelets.

Treatment of patients with impaired parameters of the blood coagulation system with Etamzilat must be supplemented with the introduction of drugs that eliminate the detected deficiency or defect in the factors of the blood coagulation system. Caution is required when working with vehicles or mechanisms, as dizziness is possible.

Manufacturer:

Lugansk, Ukraine. PJSC "Lugansk Chemical and Pharmaceutical Plant".

Attention! To make information easier to understand, this instruction on the use of the drug Etamzilat is translated and presented in free form on the basis official instructions By medical use drug. Before use, read the leaflet included directly with the medication.



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