Etamzilat: instructions for use and what it is needed for, price, reviews, analogues. Etamzilat: instructions for use Etamzilat injections instructions for use made in Belarus

Instructions for use:

Etamsylate is a drug that increases the formation of mucopolysaccharides in capillary walls and increases the stability of microvessels. The drug improves capillary permeability in a pathological process, and also normalizes microcirculation and has a hemostatic effect. The hemostatic effect of Etamsylate is due to the activation of thromboplastin formation. The drug enhances the formation of blood coagulation factor III and improves platelet adhesion. Etamsylate has no effect on PTI, does not have hypercoagulable properties, and does not contribute to thrombus formation. The high effectiveness of the drug ensures positive reviews of Etamzilate from doctors.

Indications for use of Etamzilat

According to the instructions for Etamzilat, this drug is used for:

• prevention and stopping of capillary bleeding against the background of diabetic angiopathy;
• surgical interventions in otolaryngological practice (tonsillectomy, ear microsurgery and others);
• ophthalmological operations (cataract removal, keratoplasty, antiglaucomatous operations);
• dental operations (removal of granulomas, cysts, tooth extraction);
• urological operations (prostatectomy);
• other surgical, including gynecological, interventions, especially on heavily vascularized organs and tissues;
• emergency situations with pulmonary and intestinal bleeding;
• hemorrhagic diathesis.

Contraindications to the use of Etamzilat

According to the instructions for Etamzilat, the drug is contraindicated in:

• bleeding due to the use of anticoagulants;
• with extreme caution - in the presence of thrombosis, embolism in the anamnesis.

Directions for use, dosage

Etamsylate is intended for intramuscular, intravenous, retrobulbar, subconjunctival, and oral use.

The hemostatic effect of the drug Etamzilat develops 5-15 minutes after intravenous use. The maximum effect is achieved after 1-2 hours. The effect of the drug lasts more than 4 hours. The effect of intramuscular use of Etamzilat develops later. When taken orally, maximum effectiveness is achieved after three hours.

For prophylactic purposes, the drug is administered intravenously or intramuscularly an hour before surgery, dosage – 2-4 ml (0.25-0.5 g of active substance). It is also possible to take it orally three hours before surgery (2-3 tablets). If necessary, Etamzilat can be administered intravenously during surgery. To prevent postoperative bleeding, administer 4-6 ml per day (or 6-8 tablets).

In case of bleeding for therapeutic purposes, immediately administer 2-4 ml of the drug, then 2 ml every four to six hours, or 2 tablets. Drip use of Etamzilat is possible; for this purpose, the drug is diluted in conventional infusion solutions. This drug should not be mixed with others in the same syringe.

When treating dysfunctional uterine bleeding, Etamzilat is prescribed 0.5 g orally or 0.25 g parenterally every six hours, the duration of therapy is about 10 days.

When treating hemorrhagic diathesis, the drug is prescribed in courses at a dosage of 1.5 g per day orally for two weeks. In severe clinical situations, treatment begins parenterally (0.25-0.5 g twice a day), then switches to oral administration.

For diabetic microangiopathies, Etamzilat is prescribed in a dosage of 1-2 tablets per day for two to three months.

Dosage for retrobulbar and subconjunctival use – 1 ml.

Side effect

The following side effects have been registered with the use of Etamzilat: heaviness in the epigastrium, heartburn, dizziness, headache, facial flushing, decreased SBP, allergic reactions, paresthesia of the lower extremities.

Use of Etamzilate during pregnancy

According to strict indications, it is possible to use Etamzilate during pregnancy, in cases where the expected benefit to the mother’s body is significantly higher than the potential risks to the fetus. No negative effects on the fetus were detected when Etamzilat was prescribed during pregnancy.

A modern pharmaceutical product designed to significantly enhance the formation of mucopolysaccharides in the capillary walls, which helps to increase their resistance to negative influences - the drug “Etamzilat”. The instructions for use indicate that the medication also has a hemostatic effect due to the activation of thromboplastin formation. Why is Etamzilat prescribed?

What is the release form

• as an ampoule solution (injections) for parenteral administration into the human body - packaged in 2 ml transparent glass ampoules, a consumer pack can contain 5 pieces or 10 pieces;
• as biconvex round tablets with a whitish tint - packed in protective blisters of 10 pcs. in pharmaceutical packages, a total of 50 pcs. or 100 pcs.

The optimal dose, frequency of administration and variant of administration into the human body are determined by a specialist exclusively on an individual basis.

Compound

Based on the attached instructions for use, the active substance of the drug “Etamzilat” is the substance of the same name - in a volume of 25 mg in the form of a solution or 250 mg in tablets.

Sodium sulfate and anhydrous sodium sulfate, as well as disodium salt of ethylenediaminetetraacetic acid and double distilled water are auxiliary components for the ampoule solution.

Calcium hydrogen phosphate dihydrate and sodium metabisulfate, as well as potato starch and povidone, in combination with calcium stearate are excipients for tablets.

Pharmacological effects

The high hemostatic properties are due precisely to the presence of the active substance Etamzilate in the composition of the drug. The instructions for use indicate that the mechanism of its effect on the human body is due to:

• the formation of mucopolysaccharides in the walls of the smallest capillaries;
• increasing the resistance of vascular structures to injury;
• normalization of capillary wall permeability;
• significant improvement in microcirculation;
• activation of thromboplastin formation – against the background of increased secretion of the 3rd blood coagulation factor;
• correction of platelet blood cell adhesion.

Moreover, the drug does not have hypercoagulable properties at all, so there is no risk of blood clots forming in the lumen of the vessels. Excretion from the body is carried out unchanged through the kidneys and urine.

Injections, tablets "Etamzilat": what does the medicine help with?

Experts recommend the antihemostatic agent for use in pathologies accompanied by capillary bleeding. As a rule, the drug “Etamzilat” shows high effectiveness in the following cases:

• stopping or preventing bleeding from capillary structures in diagnosed diabetic angiopathy;
• various operational actions on ENT structures;
• microsurgical actions in ophthalmology;
• surgical excision of pathological foci in dentistry;
• urological interventions;
• the need for surgical actions in the obstetrics and gynecology field;
• emergency bleeding – pulmonary, hemorrhagic.

The optimal regimen for using the medication will be determined by a specialist based on the severity of the diagnosed condition, the person’s age and the location of the bleeding.

The drug "Etamzilat": instructions for use

The variety of forms of medication produced by the manufacturer determines various options for its administration into the human body:

• parenterally – intramuscularly or intravenously;
• retrobulbar;
• subconjunctival;
• orally.

So, for prophylactic purposes - before an upcoming surgical intervention, the drug should be administered an hour before surgery parenterally, or orally 3 hours. Depending on individual needs, intravenous administration is acceptable directly during surgery.

Optimal doses and frequency of administration and administration of “Etamzilat”:

• in order to prevent postoperative bleeding - 4–6 ml/day, or 6–8 tablets;
• if bleeding has already occurred - 2-4 ml, then 2 ml every 4-6 hours, or 2 pieces;
• for uterine dysfunctional bleeding - 0.5 mg orally, or 0.25 mg parenterally every 6 hours;
• for hemorrhagic forms of diathesis - courses of 1.5 g/day orally for about 10–14 days;
• for diabetic microangiopathies – 1–2 pcs. per day for 2–3 months;
• in dental and ENT practice - retrobulbar 1 ml.

Each clinical case requiring the use of the drug is considered by a specialist individually to select the optimal pharmacotherapy regimen.

Contraindications

The manufacturer, in the detailed instructions attached to the pharmaceutical packaging, indicates that the drug “Etamzilat” is absolutely not allowed for use in people whose bleeding was provoked by pharmacotherapy with anticoagulants.

Particular caution is recommended if a person has a history of indicating the presence of episodes of thromboembolism or thrombosis. In this case, the specialist will take action to select another drug with a similar mechanism of pharmacological action.

Adverse events

Based on practice, specialists recorded the following side effects while taking the medication:

• heaviness in the epigastrium;
• dyspeptic disorders;
• persistent dizziness;
• cephalgia;
• hyperthermia of the integument;
• hypotension;
• various allergic conditions;
• paresthesia.

After stopping the medication, the person’s well-being improved.

Analogues of the drug "Etamzilat"

A complete analogue in composition is the drug “Ditsinon”.

Price and holiday conditions

The average price of “Etamzilat” injections (Moscow) is 35 rubles. You can buy medicine in Minsk for 1 – 2 bel. rubles The price in Kyiv is 25 - 65 hryvnia, in Kazakhstan - 500 tenge. Dispensed by prescription.

Content

The hemostatic drug Etamzilat is used for the prevention and treatment of bleeding in surgery, gynecology, and other medical fields. Prescribed to women with menstrual irregularities, 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 the 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 does not have a vasoconstrictor effect and does not promote thrombus formation.

Composition and release form

The drug Etamzilat is available in two dosage forms - tablets for oral administration and a solution for intramuscular or intravenous injection. White, convex tablets contain 250 mg of the main active ingredient (sodium etamsylate) and auxiliary components (sodium hydrogen phosphate dihydrate, sodium metabisulfite, povidone, potato starch, calcium stearate). Packaged in blisters of 50 or 100 pieces.

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

Pharmacodynamics and pharmacokinetics

The active component of the drug, sodium etamsylate, 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.

When administered intravenously or intramuscularly, the 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 surgical interventions or in emergency cases and diseases with concomitant 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 treatment regimens:

• 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;
• in 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. If bleeding occurs or there is a threat of miscarriage at a later date, it is 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 the same syringe with other medications. With parallel therapy with the pharmaceutical group of dextrans, when administering the drug at a dosage of 10 mg/kg one hour before taking them, a decrease in the antiplatelet effect is possible; administration after does not have a pronounced hemostatic effect. Combined use with aminocaproic acid, menadione sodium bisulfite is acceptable.

Side effects and overdose

A course of treatment using Etamzilat is in most cases well tolerated if the treatment regimen and daily dosage are followed. 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;
• decreased intracranial pressure;
• facial skin hyperemia;
• headache and dizziness;
• arterial hypertension;
• decreased systolic blood pressure;
• paresthesia of the 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 are listed in the instructions for use:

• 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 stored out of the reach of children, in a dark place, at a temperature not exceeding 25°C. Shelf life is two years from the date indicated on the package.

Analogues

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 of all forms of release.

Composition and release form of the drug

Injection in the form of a colorless or slightly colored, transparent liquid.

Excipients: sodium metabisulfate - 0.42 mg, sodium hydroxide solution 1M - up to pH 6.3, water for injection - up to 1 ml.

2 ml - glass syringes (1) - contour cell packaging (1) - cardboard packs.

pharmachologic effect

Antihemorrhagic agent. Normalizes the permeability of the vascular wall, improves microcirculation. The action is apparently associated with an activating effect on the formation of thromboplastin. Does not affect prothrombin time, does not have hypercoagulable properties and does not contribute to the formation of blood clots.

The onset of action is 5-15 minutes after intravenous injection, the maximum effect is 1-2 hours after administration. Duration of action - 4-6 hours.

Pharmacokinetics

About 72% of the administered dose is excreted unchanged in the urine during the first 24 hours. T1/2 after IV administration is about 2 hours.

Penetrates the placental barrier and is excreted in breast milk.

Indications

Prevention and treatment of capillary diseases in diabetic angiopathy, during surgical interventions in otolaryngological practice, ophthalmology, dentistry, urology, surgery and gynecology; emergency cases with intestinal and pulmonary bleeding, with hemorrhagic diathesis.

Contraindications

Thrombosis, thromboembolism, hypersensitivity to etamsylate.

Etamsylate cannot be used as the only remedy if the patient has hemorrhages caused by.

Dosage

When taken orally - 250-500 mg 3-4 times/day, intramuscularly or intravenously - 125-250 mg 3-4 times/day. If necessary, a single dose for oral administration can be increased to 750 mg, for parenteral administration to 375 mg.

Children - 10-15 mg/kg/day, frequency of use - 3 times/day in equal doses.

For external use, a sterile swab impregnated with ethamsylate (in the form of an injection solution) is applied to the wound.

Etamzilat

Pharmgroup

Cardiovascular drugs

Compound

Active substance: etamsylate - 125.0 mg.

Excipients: sodium disulfite (sodium metabisulfite) - 2.5 mg, sodium sulfite anhydrous - 1.0 mg, disodium edetate dihydrate (disodium salt of ethylenediaminetetraacetic acid) - 0.5 mg, water for injection - up to 1 ml.

pharmachologic effect

Hemostatic agent. It also has angioprotective and proaggregant effects. Stimulates the formation of platelets and their release from the bone marrow. The hemostatic effect, caused by the activation of thromboplastin formation at the site of damage to small vessels and the decrease in the formation of prostacyclin PgI2 in the vascular endothelium, promotes increased adhesion and aggregation of platelets, which ultimately leads to stopping or reducing bleeding. Increases the rate of formation of the primary thrombus and enhances its retraction, has virtually no effect on the concentration of fibrinogen and prothrombin time. Doses of more than 2 - 10 mg/kg do not lead to a greater effect. With repeated administrations, thrombus formation increases. Possessing antihyaluronidase activity and stabilizing ascorbic acid, it prevents the destruction and promotes the formation of mucopolysaccharides with high molecular weight in the capillary wall, increases the resistance of capillaries, reduces their fragility, and normalizes permeability in pathological processes. Reduces fluid leakage and diapedesis of blood cells from the vascular bed, improves microcirculation. Does not have a vasoconstrictor effect. Restores pathologically altered bleeding time. It does not affect the normal parameters of the hemostatic system. The hemostatic effect with intravenous administration of etamsylate occurs after 5 - 15 minutes, the maximum effect appears after 1 - 2 hours. The effect lasts for 4 - 6 hours, then gradually weakens over 24 hours; When administered intramuscularly, the effect occurs within 30 to 60 minutes.

Pharmacokinetics

The drug is well absorbed when administered intramuscularly and weakly binds to plasma proteins and blood cells. Therapeutic concentration in the blood is 0.05 - 0.02 mg/ml. Etamsylate is evenly distributed in various organs and tissues (depending on the degree of their blood supply).

The drug is excreted from the body mainly by the kidneys (unchanged), in small quantities with bile. The half-life of the drug after intravenous administration is 1.9 hours, after intramuscular administration - 2.1 hours. 5 minutes after intravenous administration, 20-30% of the administered drug is excreted by the kidneys, completely after 4 hours.

Indications for use

Prevention and control of bleeding: parenchymal and capillary bleeding (including traumatic, in surgery during operations on highly vascularized organs and tissues, during surgical interventions in dental, urological, ophthalmological, otolaryngological practice, intestinal, renal, pulmonary bleeding, metro- and menorrhagia with fibroids, etc.), secondary bleeding against the background of thrombocytopenia and thrombocytopathy, hypocoagulation, hematuria, intracranial hemorrhage (including in newborns and premature infants), nosebleeds against the background of arterial hypertension, bleeding caused by taking medications, hemorrhagic diathesis (in including Werlhof disease, von Willebrand-Jurgens disease, thrombocytopathy), diabetic microangiopathy (hemorrhagic diabetic retinopathy, repeated retinal hemorrhage, hemophthalmos).

Contraindications

Hypersensitivity to any ingredient of the drug, acute porphyria, hemoblastosis in children, thrombosis, thromboembolism.

Carefully

In case of bleeding due to an overdose of anticoagulants, pregnancy.

Use during pregnancy and lactation

The safety of Etamzilate during pregnancy has not been established. Etamsylate should be used during pregnancy only if the potential benefit to the mother outweighs the possible risk to the fetus. During the mother's treatment, breastfeeding should be stopped.

special instructions

Caution is required in patients who have ever experienced thrombosis or thromboembolism. The drug is ineffective in patients with a low platelet count. For hemorrhagic complications associated with an overdose of anticoagulants, it is recommended to use specific antidotes. The use of Etamzilat in patients with impaired blood coagulation system parameters is possible, but it should be supplemented by the administration of drugs that eliminate the identified deficiency or defect of coagulation system factors.

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Directions for use and doses

Intravenous, intramuscular, in ophthalmology - subconjunctival and retrobulbar.

Etamsylate can be administered intravenously in a 5% glucose solution or in an isotonic sodium chloride solution.

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

Children: if necessary, during surgery it is administered intravenously at the rate of 8 - 10 mg/kg body weight.

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

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

For diabetic microangiopathy, the drug is administered intramuscularly in a single dose 0.25 - 0.5 g three times a day for 10 - 14 days.

In ophthalmology, the drug is administered subconjunctivally or retrobulbarly - in a dose 0.125 g (1 ml of 125 mg/ml solution).

The injection solution can be used topically (a sterile swab is soaked and applied to the wound.

Side effect

Heartburn, heaviness in the epigastric region, headache, flushing of the facial skin, decreased blood pressure (mainly systolic), paresthesia of the lower extremities.

Interaction with other drugs

Etamzilat should not be mixed with other medications. Administration of the drug at a dose of 10 mg/kg body weight 1 hour before the administration of dextran solutions with an average molecular weight of 30,000 - 40,000 prevents the antiaggregation effect of the latter; administration of Etamsylate after dextran solutions does not have a hemostatic effect. A combination of ethamsylate with aminocaproic acid and menadione sodium bisulfite is possible.

Release form