Registration number: LSR-001709/07-060812
Tradename: Tranexam®
International (nonproprietary) name: Tranexamic acid

Dosage form. Solution for intravenous administration
Compound. Active substance: tranexamic acid - 50.00 g
Excipients - water for injection - up to 1000 ml.

Description. Transparent or almost transparent, colorless or light brown solution.

Pharmacotherapeutic group. Hemostatic agent.

ATX code. B02AA02

Pharmacological properties.

Tranexamic acid is an antifibrinolytic agent that specifically inhibits the activation of profibrinolysin (plasminogen) and its conversion to fibrinolysin (plasmin). It has local and systemic hemostatic effects in bleeding associated with increased fibrinolysis, as well as anti-inflammatory, antiallergic, anti-infective and antitumor effects due to the suppression of the formation of kinins and other active peptides involved in allergic and inflammatory reactions. The experiment confirmed the intrinsic analgesic activity of tranexamic acid, as well as the super-total potentiating effect on the analgesic activity of opiates.

Pharmacokinetics.

Distributed relatively evenly in tissues (with the exception of cerebrospinal fluid, where the concentration is 1/10 of the plasma concentration); penetrates the placental and blood-brain barrier into breast milk (about 1% of the concentration in maternal plasma). It is found in seminal fluid, where it reduces fibrinolytic activity, but does not affect sperm migration. The initial volume of distribution is 9-12 l. Communication with plasma proteins (profibrinolysin) - less than 3%. In the blood, about 3% is associated with protein (plasminogen).
The concentration in the cerebrospinal fluid is 1/10 of the plasma concentration. Total renal clearance is equal to plasma clearance.
Antifibrinolytic concentration in various tissues lasts 17 hours, in plasma - up to 7-8 hours.
A small part is metabolized. The concentration-time curve has a three-phase shape with a half-life in the terminal phase of 2 hours. Total renal clearance is equal to plasma (7 l/h).
Excreted by the kidneys (the main route is glomerular filtration) - more than 95% unchanged during the first 12 hours. Two metabolites of tranexamic acid have been identified: N-acetylated and deaminated derivatives. If renal function is impaired, there is a risk of accumulation of tranexamic acid.

Indications for use

Bleeding or the risk of bleeding against the background of increased fibrinolysis, as generalized (bleeding during operations and in the postoperative period, postpartum hemorrhage, manual separation of the placenta, chorionic detachment, bleeding during pregnancy, malignant neoplasms pancreas and prostate glands, hemophilia, hemorrhagic complications of fibrinolytic therapy, thrombocytopenic purpura, leukemia, liver disease, previous streptokinase therapy), and local (uterine, cervical conization for carcinoma, nasal, pulmonary, gastrointestinal bleeding, hematuria, bleeding after prostatectomy, tooth extraction in patients with hemorrhagic diathesis). Surgical interventions on bladder. Surgical manipulations for systemic inflammatory reactions (sepsis, peritonitis, pancreatic necrosis, severe and moderate gestosis, shock of various etiologies and other critical conditions).

Contraindications

Hypersensitivity to the drug, subarachnoid hemorrhage.
With caution - thrombohemorrhagic complications (in combination with heparin and indirect anticoagulants), thrombosis (thrombophlebitis, deep veins, thromboembolic syndrome, myocardial infarction), color vision disorders, hematuria from the upper sections urinary tract(possible obstruction due to blood clot) renal failure(cumulation is possible).

Directions for use and doses

Intravenously (drip, stream).
For generalized fibrinolysis, a single dose of 15 mg/kg body weight is administered every 6-8 hours, the injection rate is 1 ml/min.
For local fibrinolysis, it is recommended to administer the drug at a dose of 250-500 mg 2-3 times a day.
For prostatectomy or bladder surgery, 1 g is administered during surgery, then 1 g every 8 hours for 3 days, after which they switch to oral tablet form until gross hematuria disappears.
With a high risk of bleeding, with a systemic inflammatory reaction, a dose of 10-11 mg/kg 20-30 minutes before the intervention.
Patients with coagulopathies are administered a dose of 10 mg/kg body weight before tooth extraction; after tooth extraction, oral tablet form of the drug is prescribed.
In case of impaired renal excretory function, correction of the dosage regimen is necessary: ​​if the concentration of creatinine in the blood is 120 - 250 µmol/l, 10 mg/kg is prescribed twice a day; when the creatinine concentration is 250 - 500 µmol/l, 10 mg/kg is prescribed once a day; if the creatinine concentration is more than 500 µmol/l, 5 mg/kg is prescribed once a day.

Side effects. Allergic reactions (rash, itchy skin, urticaria), dyspeptic symptoms (anorexia, nausea, vomiting, heartburn, diarrhea), dizziness, weakness, drowsiness, tachycardia, chest pain, hypotension (with rapid intravenous administration), impaired color vision, blurred vision, thrombosis or thromboembolism (the risk of development is minimal).

Special instructions. When combined with hemostatic drugs and hemocoagulase, activation of thrombus formation is possible. Before starting and during treatment, it is necessary to conduct an examination by an ophthalmologist (visual acuity, color vision, fundus).

Interaction with other drugs

Pharmaceutically incompatible with blood products, solutions containing penicillin, urokinase, hypertensive drugs (norepinephrine, deoxyepinephrine hydrochloride, metharmine bitartrate), tetracyclines, dipyridamole, diazepam. Hemostatic drugs and hemocoagulase potentiate the activation of thrombus formation.

Release form
Ampoules 50 mg/ml. 5 ml of the drug per ampoule of neutral glass, 5 ampoules per blister pack made of PVC film and aluminum foil.
1 or 2 blister packs along with instructions for use are placed in a cardboard pack.
20, 50 or 100 blister packs, respectively, with 10, 25 and 50 instructions for use are placed in cardboard boxes or in boxes made of corrugated cardboard(for hospital).

Storage conditions
At a temperature not exceeding 25° C. Keep out of the reach of children.

Best before date
3 years. Do not use after the expiration date stated on the package.

Tranexam is a drug used to stop and prevent bleeding of various etiologies.

The drug has a local and general hemostatic effect for bleeding associated with increased fibrinolysis (platelet pathology, menorrhagia). Additionally, tranexamic acid in Tranexam is characterized by effective antiallergic, anti-inflammatory, anti-infective and antitumor effects based on the inhibition of active peptides involved in inflammatory and allergic reactions.

Available in the form of tablets and solution for injection (injections), the main active substance is tranexamic acid.

Clinical and pharmacological group

The tablets have antifibrinolytic, hemostatic, antiallergic and anti-inflammatory effects.

Terms of sale from pharmacies

Can buy according to a doctor's prescription.

Price

How much does Tranexam cost in pharmacies? The average price is 270 rubles.

Composition and release form

Tranexam is available in the form of tablets and solution for injection into a vein. Tablets containing the active ingredient 250 and 500 mg are packaged in contour cells of 10 pieces, 1, 2, 3, 5 cells per package.

• Each tablet contains 250 mg or 500 mg of the active ingredient - Tranexamic acid, and the drug also includes a number of auxiliary components.

pharmachologic effect

Tranexam is a fibrinolysis inhibitor, a hemostatic drug. This drug inhibits the conversion of plasminogen to plasmin.

In bleeding caused by fibrinolysis, tranexamic acid exhibits a systemic and local hemostatic effect. In addition, it has antiallergic, anti-inflammatory, antitumor and anti-infective effects, which are based on suppressing the formation of active peptides that take part in inflammatory and allergic reactions.

The potentiating effect of tranexamic acid in relation to the analgesic activity of opiates and its own analgesic activity have been confirmed experimentally.

When taken orally, up to 50% of the drug is absorbed, the maximum concentration is reached after three hours. Binds to plasma proteins, penetrates the placental barrier, and is excreted in breast milk in a concentration of 1%. It acts for 17 hours in tissues, 7-8 hours in plasma. If kidney function is impaired, there is a risk of accumulation of the active substance. When administered intravenously, the analgesic activity of the drug was confirmed.

Indications for use

The drug is prescribed to patients for the treatment or prevention of disorders of the circulatory system, namely:

• Bleeding or the risk of its development with increased generalized fibrinolysis: manual separation of the placenta, postpartum hemorrhage, malignant tumors prostate and pancreas, liver diseases, surgical interventions on the chest organs, leukemia.
• Bleeding or the risk of its development with increased local fibrinolysis: hematuria, gastrointestinal, uterine (including von Willebrand disease and other coagulopathies) and nasal bleeding, as well as bleeding after prostatectomy, conization of the cervix in carcinoma, tooth extraction in patients with hemorrhagic diathesis.

Tranexam capsules are also used for the following diseases:

• Bleeding during pregnancy;
• Allergic diseases ( allergic dermatitis, eczema, urticaria, toxic and drug rash);
• Hereditary angioedema;
• Inflammatory diseases (aphthae of the mucous membrane oral cavity, stomatitis, pharyngitis, tonsillitis, laryngitis).

The intravenous solution is also used in the following cases:

• Bladder surgeries;
• Surgical interventions for systemic inflammatory reactions (pancreatic necrosis, sepsis, peritonitis, severe or moderate gestosis, shock of various etiologies and other critical conditions).

  Tranexam for uterine bleeding

  There are many cases where uterine bleeding caused iron deficiency, which is also a threat to human health and life. Therefore, when uterine bleeding Hemostatic tablets are prescribed, including Tranexam. Of course, this should not be done without a doctor’s prescription, since it is important to establish the causes of the disorder, which can be very different.

  Contraindications

  Absolute:

  • subarachnoid hemorrhage;
  • hypersensitivity to the components of the drug.

  Relative (Tranexam is used with caution):

  • thrombosis (myocardial infarction, thromboembolic syndrome, deep vein thrombophlebitis);
  • thrombohemorrhagic complications (in combination with indirect anticoagulants and heparin);
  • renal failure;
  • hematuria from the upper urinary tract;
  • color vision disorders.

  Prescription during pregnancy and lactation

  The drug Tranexam during pregnancy is prescribed to women according to indications, only when the benefit to the mother exceeds possible risks for the fetus. Treatment is prescribed in the minimum effective dose, while blood test results are constantly monitored.

  During clinical trials The teratogenic and embryotoxic effects of Tranexam on the fetus have not been established, but the drug easily penetrates the placental barrier.

  Use of the drug during breastfeeding Not recommended. If therapy is necessary, it is advisable to stop lactation so as not to harm the baby.

  Dosage and method of administration

  As indicated in the instructions for use, Tranexam tablets are taken:

  • For repeated nosebleeds, 1.0 g three times a day for 7 days;
  • For uterine bleeding - 1.0 g every six hours for three days;
  • After tooth extraction in patients with hemorrhagic diathesis, to prevent secondary bleeding, Tranexam tablets are prescribed at a rate of 25 mg/kg 4 times a day for a week;
  • For the treatment of hereditary angioedema, the drug is prescribed in courses or continuously at 1.0 g twice a day;
  • In the postoperative period, 1.5 g three times a day for 10–14 days.

  Tranexam for intravenous drip or jet administration is usually used to stop massive bleeding, as well as bleeding that occurs during surgery. Before tooth extraction, patients with impaired blood clotting are also administered the drug intravenously, and after extraction they are prescribed Tranexam in tablets.

  Side effects

  During treatment with the drug in ampoules and tablets, the following may appear:

  • allergies, which are manifested by rashes, itchy skin and hives;
  • thromboembolism and thrombosis;
  • loss of appetite up to anorexia, loose stools, heartburn, nausea and vomiting;
  • vertigo, drowsiness, color perception and color vision disorders.

  When prescribing the drug in ampoules, the following undesirable reactions may occur:

  • increased heart rate;
  • chest pain;
  • pressure drop.

  Overdose

  Data on drug overdose are not provided.

  special instructions

  Before starting to take Tranexam and during the treatment process, regular examinations by an ophthalmologist are recommended to diagnose visual acuity, the condition of the fundus, and color vision.

  During pregnancy, the drug is used with caution (contraindications must be taken into account). When prescribing tranexamic acid to pregnant and lactating women, it is necessary to take into account that this substance can pass through the placental barrier and enter breast milk.

  Interaction with other drugs

  When used simultaneously with hemocoagulase and hemostatic agents, thrombus formation may be activated.

  Tranexam solution is pharmaceutically incompatible with urokinase, blood products, tetracyclines, diazepam, dipyridamole, hypertensive drugs (metformin bitartrate, deoxyepinephrine hydrochloride, norepinephrine) and solutions containing penicillin.

Active substance

Tranexamic acid

Release form, composition and packaging

Solution for intravenous administration transparent or almost transparent, colorless or with a light brown tint.

Excipients: water for injection.

5 ml - glass ampoules (5) - contour cell packaging (1) - cardboard packs.
5 ml - glass ampoules (5) - contour cell packaging (2) - cardboard packs.

pharmachologic effect

Tranexamic acid is an antifibrinolytic agent that specifically inhibits the activation of profibrinolysin (plasminogen) and its conversion to fibrinolysin (plasmin). It has local and systemic hemostatic effects in bleeding associated with increased fibrinolysis, as well as anti-inflammatory, anti-infective and antitumor effects due to the suppression of the formation of kinins and other active peptides involved in allergic and inflammatory reactions. The experiment confirmed the intrinsic analgesic activity of tranexamic acid, as well as the super-total potentiating effect on the analgesic activity of opiates.

Pharmacokinetics

Distributed relatively evenly in tissues (with the exception of cerebrospinal fluid, where the concentration is 1/10 of the plasma concentration); penetrates the placental and blood-brain barrier into breast milk (about 1% of the concentration in the mother). It is found in seminal fluid, where it reduces fibrinolytic activity, but does not affect sperm migration. The initial volume of distribution is 9-12 l. Communication with plasma proteins (profibrinolysin) - less than 3%. In the blood, about 3% is associated with protein (plasminogen).

The concentration in the cerebrospinal fluid is 1/10 of the plasma concentration. Total renal clearance is equal to plasma clearance.

Antifibrinolytic concentration in various tissues lasts 17 hours, in plasma - up to 7-8 hours.

A small part is metabolized. The concentration-time curve has a three-phase shape with a half-life in the terminal phase of 2 hours. Total renal clearance is equal to plasma (7 l/h).

Excreted by the kidneys (the main route is glomerular filtration) - more than 95% unchanged during the first 12 hours. Two metabolites of tranexamic acid have been identified: N-aetylated and deaminated derivatives. In case of impaired renal function, there is a risk of accumulation of tranexamic acid.

Indications

- bleeding or the risk of bleeding against the background of increased fibrinolysis, as generalized (bleeding during operations and in the postoperative period, postpartum hemorrhage, manual separation of the placenta, chorionic detachment, bleeding during pregnancy, malignant neoplasms of the pancreas and prostate glands, hemophilia, hemorrhagic complications of fibrinolytic therapy, thrombocytopenic purpura, leukemia, liver disease, previous therapy with streptokinase), and local (uterine, cervical conization for carcinoma, nasal, pulmonary, gastrointestinal bleeding, hematuria, bleeding after prostatectomy, tooth extraction in patients with hemorrhagic diathesis);

— surgical interventions on the bladder;

— surgical manipulations for a systemic inflammatory reaction (sepsis, peritonitis, pancreatic necrosis, severe and moderate gestosis, shock of various etiologies and other critical conditions).

Contraindications

- hypersensitivity to the drug;

- subarachnoid hemorrhage.

Carefully: thrombohemorrhagic complications (in combination with indirect anticoagulants), thrombosis (deep vein thrombophlebitis, thromboembolic syndrome, myocardial infarction), color vision disorders, hematuria from the upper urinary tract (possible obstruction by a blood clot), renal failure (cumulation possible).

Dosage

Intravenously (drip, stream). For generalized fibrinolysis, a single dose of 15 mg/kg body weight is administered every 6-8 hours, the injection rate is 1 ml/min. For local fibrinolysis, it is recommended to administer the drug at a dose of 250-500 mg 2-3 times a day. For prostatectomy or bladder surgery, 1 g is administered during surgery, then 1 g every 8 hours for 3 days, after which they switch to oral tablet form until gross hematuria disappears.

With a high risk of bleeding, with a systemic inflammatory reaction, a dose of 10-11 mg/kg 20-30 minutes before the intervention.

Patients with coagulopathies are administered a dose of 10 mg/kg body weight before tooth extraction; after tooth extraction, oral tablet form of the drug is prescribed.

In case of impaired renal excretory function, correction of the dosage regimen is necessary: ​​if the concentration of creatinine in the blood is 120-250 µmol/l, 10 mg/kg is prescribed twice a day; if the creatinine concentration is 250-500 µmol/l, 10 mg/kg is prescribed once a day; if the creatinine concentration is more than 500 µmol/l, 5 mg/kg is prescribed once a day.

Side effects

Allergic reactions (rash, skin itching, urticaria), dyspeptic symptoms (anorexia, nausea, vomiting, heartburn, diarrhea), dizziness, weakness, drowsiness, tachycardia, pain in the difficult cell, hypotension (with rapid intravenous administration), impaired color vision, blurred visual perception; thrombosis or thromboembolism (the risk of development is minimal).

Tranexam is a drug that belongs to the group of fibrinolysis inhibitors. This drug has hemostatic, antiallergic, and anti-inflammatory therapeutic properties. In addition, Tranexam is characterized by the presence of an antitumor and anti-infective clinical effect. The therapeutic effect is achieved due to the ability of the drug to suppress the formation of active peptides. The medicine is used to stop bleeding or prevent its development, strengthening local fibrinolysis. In addition, the drug is used to treat allergic dermatitis, urticaria, toxic rashes and others. diseases.

1. Pharmacological action

Drug group: A drug to stop bleeding. Therapeutic effects of Tranexam:

• Blocking fibrin dissolution;
• Blocking plasminogen activation;
• Preventing the conversion of plasminogen to plasmin;
• Stopping bleeding caused by menorrhagia;
• Stopping bleeding caused by platelet pathologies;
• Suppression of formation biologically active substances causing inflammatory reactions;
• Blocking the formation of biologically active substances that cause hypersensitivity reactions;
• Anti-inflammatory effect;
• Anti-infective effect;
• Antiallergic effect;
• Antitumor effect.

Pharmacokinetics:

• able to penetrate the placental barrier;
• able to penetrate the blood-brain barrier;
• distributed evenly throughout all tissues of the body;
• reaches its maximum concentration three hours after taking it;
• The therapeutic concentration of Tranexam in tissues is maintained for 17 hours.

Excretion: kidneys.

2. indications for use

Stop bleeding

• in the postoperative period;
• when manually removing the placenta;
• for malignant pancreatic tumors;
• at ;
• during pregnancy;
• during surgical interventions;
• with zorion detachment;
• for malignant prostate tumors;
• for hemophilia;
• at various diseases liver;
• stopping uterine bleeding with local enhancement of fibrinolysin;
• preventing the occurrence of uterine bleeding;
• stopping nosebleeds with local enhancement of fibrinolysin
• preventing nosebleeds;
• stopping bleeding from organs digestive system with local enhancement of fibrinolysin;
• preventing bleeding from the digestive system;
• elimination of hematuria with local enhancement of fibrinolysin;
• preventing the occurrence of hematuria;
• stopping bleeding after tooth extraction in patients suffering from hemorrhagic diathesis;
• prevention of bleeding in patients suffering from hemorrhagic diathesis; Antiallergic agent:
• at ;
• for skin rashes caused by various medicines;
• for skin rashes caused by various toxins;
• for eczema;
• at ;
• at ;
• at ;
• at ;
• treatment of hereditary angioedema.

3. Method of application

Tranexam in tablet form:

• drug for locally enhanced fibrinolysin: up to 1.5 grams of the drug up to four times a day;
• after tooth extraction: 25 milligrams of the drug per kilogram of weight up to four times a day for one week;
• the drug after surgical interventions on the cervix: 1.5 grams of the drug three times a day for two weeks;
• for repeated nosebleeds: one gram of the drug three times a day for one week;
• for profuse bleeding from the uterus: up to 1.5 grams of the drug up to four times a day for four days;
• for hereditary angioedema: up to 1.5 grams of the drug up to three times a day on an ongoing basis, or in courses under the supervision of a specialist.

Tranexam in the form of solution for injection:

• at general increase fibrinolysin: 15 milligrams per kilogram of weight every eight hours at an administration rate of one milliliter of the drug per minute;
• for prostatectomy: one gram of the drug during surgery, then one gram of the drug every eight hours for three days, after which they switch to taking the drug in tablet form;
• for surgical interventions on the bladder: one gram of the drug during surgery, then one gram of the drug every eight hours for three days, after which they switch to taking the drug in tablet form;
• with local enhancement of fibrinolysin: up to 500 milligrams of the drug up to three times a day;
• before tooth extraction in patients suffering from bleeding disorders: 10 milligrams per kilogram of weight, then switch to the drug in tablet form (after extraction).

Features of application: Tranexam in the form of an injection solution is administered intravenously by drip or jet method.

4. Side effects

• Central and peripheral nervous system: weakness, drowsiness, headaches;
• Sense organs: visual disturbances, color perception disturbances;
• Hypersensitivity reactions to Tranexam: skin itching, skin rash;
• Digestive system: nausea, heartburn, urge to vomit, diarrhea, decreased or complete loss of appetite;
• Cardiovascular system: chest pain, thromboembolism, increased heart rate, thrombosis, decreased total blood pressure.

5. Contraindications

6. During pregnancy and lactation

Pregnant women can only use Tranexam in exceptional cases and as directed by a specialist. Nursing mothers can use Tranexam only in exceptional cases and as directed by a specialist.

7. Interaction with other drugs

The simultaneous use of Tranexam with drugs that have a hemostatic effect leads to the formation of blood clots.

8. Overdose

There is no reliable information about an overdose of Tranexam.

9. Release form

Tablets, 250 or 500 mg - 10, 20, 30 or 50 pcs. Solution for injection in ampoules, 250 mg/5 ml, ampoule - 5 or 10 pcs.

10. Storage conditions

• Inability for children to access;
• Inability to access light;
• The room humidity level is within normal limits.

Recommended storage temperature- should not be higher than 25 degrees. Recommended shelf life- within three years.

11. Composition

1 tablet:

• tranexamic acid - 250 mg;
• Excipients: microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate, talc, calcium stearate, colloidal silicon dioxide (Aerosil).

1 ml solution:

• tranexamic acid - 50 mg;
• Excipients: water.

12. Conditions for dispensing from pharmacies

The drug is dispensed according to the prescription of the attending physician.

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* Instructions for medical use of the drug Tranexam are published in free translation. THERE ARE CONTRAINDICATIONS. BEFORE USE, YOU MUST CONSULT WITH A SPECIALIST

Tranexam (tranexamic acid) is a hemostatic drug. Used to treat and prevent blood loss due to decreased blood clotting. The use of blood components and products is associated with an increased risk of developing certain complications: bacterial infection, allergies, so-called. "massive transfusion syndrome". In this regard, the issue of finding safer and more reliable blood-saving technologies is relevant. The process of hemostasis starts immediately from the moment of traumatic damage to the vessel, and ends with the formation of a hemostatic plug in the form of a platelet-fibrin mesh. The latter acts as a mechanical barrier to further blood loss. An imbalance of the hemostatic mechanism has two extremes as a consequence: excessive blood loss and increased thrombus formation. Today, doctors have a number of hemostatic agents in their arsenal. medicines- coagulants of direct and indirect action, synthetic and animal fibrinolysis inhibitors - each of which, however, has its own limitations for use. Of particular interest in terms of hemostatic and blood-saving technology is Tranexam, a drug based on tranexamic acid. It is an antifibrinolytic that suppresses the activation of the plasmin precursor proenzyme, plasminogen. The medical literature provided data that Tranexam is two orders of magnitude superior to aminocaproic acid in its antifibrinolytic activity in vitro and by an order of magnitude in vivo.

The antifibrinolytic properties of tranexamic acid were discovered in 1962 by the Japanese scientist Okamoto. Then clinical studies were conducted, which proved that pharmacotherapy with Tranexam significantly reduces the amount of blood loss and significantly reduces the need for drugs donated blood– fresh frozen plasma and erythrocyte mass. In addition, interpretation of coagulogram parameters confirmed a decrease in the severity of excess fibrinolysis. Today Tranexam is a first-line hemostatic agent with a high safety profile and is effective in the treatment and prevention of massive blood loss. Reduces the amount of bleeding after surgery by 30-40%. Reduces the need for blood transfusion by half. Does not increase the risk of thromboembolic complications. Has a systemic anti-inflammatory effect. It is more effective and safe than aminocaproic acid preparations and aprotinin. Has half a century of experience and a solid evidence base in various areas of medicine, including hematology, cardiac anesthesiology, traumatology, obstetrics and gynecology, urology, gastroenterology, oncology, otorhinolaryngology. In case of massive uterine bleeding, it has proven advantages in comparison with non-steroidal anti-inflammatory drugs and etamsylate.

Pharmacology

Antifibrinolytic agent. Inhibits the action of plasmin and plasminogen activator, has a hemostatic effect in bleeding associated with increased fibrinolysis, as well as anti-allergic and anti-inflammatory effects due to the suppression of the formation of kinins and other active peptides involved in allergic and inflammatory reactions.

Release form

White, film-coated tablets, biconvex.

Excipients: microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate, talc, calcium stearate, colloidal silicon dioxide (Aerosil).

Shell composition: hypromellose, titanium dioxide, talc, polyethylene glycol 6000.

10 pieces. - contour cellular packaging (1) - cardboard packs.
10 pieces. - contour cell packaging (2) - cardboard packs.
10 pieces. - contour cell packaging (3) - cardboard packs.
10 pieces. - contour cell packaging (5) - cardboard packs.
10 pieces. - polymer jars (1) - cardboard packs.
20 pcs. - polymer jars (1) - cardboard packs.
30 pcs. - polymer jars (1) - cardboard packs.
50 pcs. - polymer jars (1) - cardboard packs.

Dosage

Individual, depending on the clinical situation. A single dose for oral administration is 1-1.5 g, the frequency of use is 2-4 times a day, the duration of treatment is 3-15 days. A single dose for intravenous administration is 10-15 mg/kg. If repeated use is necessary, the interval between each administration should be 6-8 hours. In case of impaired renal excretory function, correction of the dosage regimen is necessary: ​​if the level of serum creatinine in the blood is 120-250 µmol/l, 15 mg/kg is prescribed orally, i.v. 10 mg/kg 2 times/day; at a serum creatinine level of 250-500 µmol/l - orally and intravenously in the same single dose, frequency - 1 time/day; if the serum creatinine level is more than 500 µmol/l - 7.5 mg/kg orally, 5 mg/kg intravenously, multiplicity - 1 time/day.

Interaction

When used simultaneously with hemostatic drugs and hemocoagulase, activation of thrombus formation is possible.

The solution should not be added to blood products or solutions containing penicillin.

Side effects

From the digestive system: loss of appetite, nausea, diarrhea, heartburn.

From the side of the central nervous system: drowsiness, impaired color vision.

Allergic reactions: incl. skin rash, itching.

Indications

Treatment and prevention of bleeding due to increased general fibrinolysis (malignant neoplasms of the pancreas, prostate; operations on the chest organs; postpartum hemorrhage, manual separation of placenta; leukemia; liver disease; complications of streptokinase therapy) and local fibrinolysis (uterine, nasal, gastrointestinal bleeding, hematuria, bleeding after prostatectomy, conization of the cervix due to carcinoma, tooth extraction in patients with hemorrhagic diathesis).

Hereditary angioedema, allergic diseases(eczema, allergic dermatitis, urticaria, drug and toxic rashes).

Inflammatory diseases of the oral cavity (stomatitis, aphthae of the mucous membrane, pharynx (tonsillitis, pharyngitis, laryngitis).

Contraindications

Hypersensitivity to tranexamic acid.

Features of application

Use during pregnancy and breastfeeding

Adequate and strictly controlled clinical trials The safety of the use of tranexamic acid during pregnancy has not been studied, therefore, when prescribing, the expected benefits and potential risks of therapy should be carefully assessed.

Use for renal impairment

In case of impaired renal excretory function, adjustment of the dosage regimen is necessary.

special instructions

It should be used with caution in combination with heparin and anticoagulants in patients with coagulation disorders and with thrombosis (cerebral vascular thrombosis, myocardial infarction, thrombophlebitis) or the threat of their development.

Before starting and during treatment, it is necessary to consult an ophthalmologist (determining visual acuity, color vision, condition of the fundus).