Tranexam solution for intravenous administration 50 mg/ml ampoule 5 ml N10

Tranexam®

Tranexamic acid solution is administered intravenously very slowly; tranexamic acid cannot be administered intramuscularly.

Convulsions

Cases of seizures have been described that have been associated with the use of tranexamic acid. In patients undergoing coronary artery bypass surgery, seizures, in most cases, developed when tranexamic acid was used in high doses. When using the drug in recommended doses, the frequency of seizures after

surgery was the same as in patients who did not receive tranexamic acid.

Visual impairment

When using tranexamic acid, visual impairment may develop, including impaired color perception. Before starting and during long-term treatment with tranexamic acid, it is necessary to conduct an examination by an ophthalmologist (visual acuity, color vision, fundus). If visual impairment occurs during treatment, discontinuation of the drug is necessary.

Hematuria

Tranexamic acid preparations should be used with caution in hematuria caused by diseases of the renal parenchyma, since intravascular fibrin deposition is often observed in these conditions, which can aggravate renal damage. In addition, in cases of massive bleeding of any etiology from the upper urinary tract, antifibrinolytic therapy increases the risk of blood clots in the renal pelvis and/or ureter and, accordingly, secondary mechanical obstruction of the urinary tract and the development of anuria.

Thromboembolic events

Before using tranexamic acid, possible risk factors for thromboembolic events should be taken into account. In patients with a history of thromboembolic disease or in patients with an increased incidence of thromboembolic events in the family history (patients at high risk of thrombophilia), tranexamic acid injection should only be prescribed for strict medical indications after consultation with a hemostasis specialist. The use of the drug in such patients should be carried out under close medical supervision.

Tranexamic acid should be used with caution in patients receiving oral contraceptives due to the increased risk of thrombosis.

The effectiveness and safety of tranexamic acid preparations in the treatment of menorrhagia in patients under 16 years of age have not been established.

Disseminated intravascular coagulation syndrome (DIC syndrome)

The use of tranexamic acid in patients with DIC is contraindicated in most cases. Tranexamic acid can be prescribed to such patients only if the patient has symptoms of predominant activation of the fibrinolytic system with acute severe bleeding. In such acute cases, a single dose of tranexamic acid 1 g is often sufficient to stop bleeding. The prescription of tranexamic acid for disseminated intravascular coagulation should be made only if appropriate laboratory data are available and after evaluation of these data by a specialist.

Due to the lack of adequate clinical studies, the simultaneous use of tranexamic acid preparations with anticoagulants should be carried out under the careful supervision of a specialist experienced in the treatment of blood clotting disorders.

Tranexam solution for intravenous administration 50 mg/ml ampoule 5 ml N10

Intravenous drip or stream slowly, injection rate 1 ml/min (50 mg/min). Rapid intravenous administration should be avoided!

Adult patients:

• Menorrhagia and metrorrhagia, gastrointestinal bleeding:
  500 mg (2 ampoules of 5 ml) 2-3 times a day from the moment the bleeding develops until it stops.
• Treatment of bleeding after surgical interventions on the prostate gland and urinary tract:
  1000 mg (4 ampoules of 5 ml) 3 times a day from the moment the bleeding develops until it stops.
• Prevention and treatment of bleeding during surgical interventions in the nasal cavity, mouth and pharynx:
  10-15 mg/kg body weight every 6-8 hours until bleeding stops.
• Prevention and treatment of bleeding during thoracic, abdominal and other major surgical interventions:
  15 mg/kg body weight every 6-8 hours until bleeding stops.
• Prevention and treatment of bleeding during cardiac surgery:
  loading dose of 15 mg/kg after induction of anesthesia before surgery, then intravenous infusion at a rate of 4.5 mg/kg/hour throughout the operation, it is recommended to administer tranexamic acid at a dose of 0.6 mg /kg into the heart-lung machine.
• Treatment of obstetric and gynecological bleeding (including bleeding during gynecological surgical interventions):
  15 mg/kg body weight every 6-8 hours from the development of bleeding until it stops.
• Treatment of bleeding caused by the use of fibrinolytic drugs:
  10 mg/kg body weight every 6-8 hours from the development of bleeding until it stops.

If long-term (more than 48 hours) hemostatic therapy is necessary, the use of tranexamic acid preparations in tablet dosage form is recommended.

Children over 1 year old

Experience with the use of tranexamic acid in children is limited. The recommended dose of the drug for the treatment of bleeding caused by local and generalized fibrinolysis is 20 mg/kg/day.

Use of the drug in special groups of patients

Renal dysfunction

In patients with mild to moderate impairment of renal excretory function, adjustment of the dose and frequency of tranexamic acid administration is necessary:

Liver dysfunction

In patients with impaired liver function, no dose adjustment is required.

Elderly age

In elderly patients in the absence of renal failure, no dose adjustment is required.

Contraindications and side effects

Tablets and injection solution should not be used if you have an individual intolerance to the active substance or auxiliary components. There is also an absolute contraindication for use in the case of diagnosed subarachnoid bleeding.

Tranexam is used with caution in the presence of thrombosis or an increased risk of its development, as well as in thrombohemorrhagic complications, in the case of renal failure, impaired color discrimination and hematuria.

During a course of therapy using Tranexam tablets and injections, the following side effects are possible:

• allergic manifestations;
• dizziness;
• weakness;
• increased drowsiness;
• tachycardia;
• dyspepsia;
• decreased blood pressure;
• chest pain;
• violation of color discrimination;
• thrombosis;
• thromboembolism, etc.

Indications for the use of Tranexam tablets and solution

The drug is prescribed for bleeding or increased risk of bleeding. They can be associated with various factors, so there are quite a few indications for the use of Tranexam tablets:

• bleeding during pregnancy;
• uterine;
• nasal;
• internal bleeding in the gastrointestinal tract;
• dental;
• stomatitis;
• laryngitis;
• pharyngitis;
• tonsillitis;
• hematuria;
• hereditary angioedema;
• allergic diseases (including rash, skin irritation, urticaria, allergic dermatitis, eczema).

Solutions for intravenous administration are indicated for use against the background of the following pathologies:

• risks of bleeding due to fibrinolysis of various nature;
• consequences of bladder surgery;
• consequences of operations in the presence of systemic inflammation (peritonitis, sepsis, gestosis, shock conditions and others).

Composition, release form

"Tranexam" is a drug with anti-inflammatory, antiallergic and hemostatic effects. Contains tranexamic acid (active ingredient) and additional components, including calcium stearate, talc, silicon dioxide and others.

"Tranexam" is produced in the form of tablets and solutions for intravenous injection. Tablets are sold in packs of 10, 10, 30 and 50 pieces. Ampoules with a volume of 50 ml each are packaged in 5 or 10 pieces.

The drug is released only with a prescription. Store under standard conditions (temperature no higher than 30 degrees). The shelf life of the injection solution and tablets is the same and is 3 years from the date of production.

Tranexam tablets: special instructions

Regardless of the diagnosis and age of the patient, before starting a course of therapy, an appointment with an ophthalmologist is indicated, who must conduct standard examinations:

• color perception;
• determination of visual acuity;
• fundus examination.

Tranexam is often used to treat heavy bleeding during menstruation. Moreover, in these cases, doctors prescribe the drug only in tablets. You need to take 3-4 pieces one at a time. per day for no more than 4 days.

Also, tablets are used to stop uterine bleeding of various natures. But only a doctor can prescribe an appointment - self-medication in this case is excluded.

During pregnancy and lactation, the drug can be prescribed only in the presence of bleeding. The active ingredient passes freely into breast milk, so the product can only be used in a limited dosage of up to 500 mg per day. In this case, the duration of the course is no more than 7 days.

Attention!

Drinking alcohol during the course of therapy is excluded.

TRANEXAMIC ACID

special instructions

Before starting and during treatment with tranexamic acid, it is necessary to consult an ophthalmologist (determining visual acuity, color vision, condition of the fundus).
If visual impairment occurs during treatment with tranexamic acid, the drug should be discontinued. Tranexamic acid preparations should be used with caution in hematuria caused by diseases of the renal parenchyma, since intravascular fibrin deposition is often observed in these conditions, which can aggravate renal damage. In addition, in cases of massive bleeding of any etiology from the upper urinary tract, antifibrinolytic therapy increases the risk of blood clots in the renal pelvis and (or) ureter and, accordingly, the risk of secondary mechanical obstruction of the urinary tract and the development of anuria.

Although clinical studies have not revealed a significant increase in the incidence of thrombosis, the risk of thrombotic complications cannot be completely excluded. Cases of the development of venous and arterial thrombosis and thromboembolism in patients receiving tranexamic acid have been described. In addition, cases of occlusion of the central retinal artery and central retinal vein have been reported. Several patients developed intracranial thrombosis during treatment with tranexamic acid. Accordingly, in patients with a high risk of developing thrombosis (history of thromboembolic complications, cases of thromboembolism in relatives, verified diagnosis of thrombophilia), tranexamic acid should be used only if absolutely necessary and under strict medical supervision. Before using tranexamic acid, an examination should be performed to identify risk factors for thromboembolic complications.

The presence of blood in cavities, such as the pleural cavity, joint cavities and urinary tract (including the renal pelvis and bladder) can lead to the formation of an “insoluble clot” in them due to extravascular coagulation, and such a clot can be resistant to physiological fibrinolysis. Patients with irregular menstrual bleeding should not be prescribed tranexamic acid until the cause of dysmenorrhea is determined. If the amount of menstrual bleeding is inadequately reduced during treatment with tranexamic acid, alternative treatment should be considered.

The effectiveness and safety of tranexamic acid preparations in the treatment of menorrhagia in patients under 16 years of age have not been established.

Particular caution should be exercised if tranexamic acid is used in women concomitantly taking combined oral contraceptives due to the increased risk of thrombosis (see section "Interaction with other medicinal products").

In patients with DIC who require treatment with tranexamic acid, therapy should be carried out under the close supervision of a physician experienced in treating this disease.

Due to the lack of adequate clinical studies, the simultaneous use of tranexamic acid with anticoagulants should be under the close supervision of a specialist experienced in the treatment of blood clotting disorders.

TRANEXAM solution for injection. IV 100 mg/ml amp. 5 ml No. 10

special instructions

Tranexamic acid solution is administered intravenously very slowly; tranexamic acid cannot be administered intramuscularly.
Convulsions

Cases of seizures have been described that have been associated with the use of tranexamic acid. In patients undergoing coronary artery bypass surgery, seizures, in most cases, developed when tranexamic acid was used in high doses. When using the drug in recommended doses, the frequency of seizures after

surgery was the same as in patients who did not receive tranexamic acid.

Visual impairment

When using tranexamic acid, visual impairment may develop, including impaired color perception. Before starting and during long-term treatment with tranexamic acid, it is necessary to conduct an examination by an ophthalmologist (visual acuity, color vision, fundus). If visual impairment occurs during treatment, discontinuation of the drug is necessary.

Hematuria

Tranexamic acid preparations should be used with caution in hematuria caused by diseases of the renal parenchyma, since intravascular fibrin deposition is often observed in these conditions, which can aggravate renal damage. In addition, in cases of massive bleeding of any etiology from the upper urinary tract, antifibrinolytic therapy increases the risk of blood clots in the renal pelvis and/or ureter and, accordingly, secondary mechanical obstruction of the urinary tract and the development of anuria.

Thromboembolic events

Before using tranexamic acid, possible risk factors for thromboembolic events should be taken into account. In patients with a history of thromboembolic disease or in patients with an increased incidence of thromboembolic events in the family history (patients at high risk of thrombophilia), tranexamic acid injection should only be prescribed for strict medical indications after consultation with a hemostasis specialist. The use of the drug in such patients should be carried out under close medical supervision.

Tranexamic acid should be used with caution in patients receiving oral contraceptives due to the increased risk of thrombosis.

The effectiveness and safety of tranexamic acid preparations in the treatment of menorrhagia in patients under 16 years of age have not been established.

Disseminated intravascular coagulation syndrome (DIC syndrome)

The use of tranexamic acid in patients with DIC is contraindicated in most cases. Tranexamic acid can be prescribed to such patients only if the patient has symptoms of predominant activation of the fibrinolytic system with acute severe bleeding. In such acute cases, a single dose of tranexamic acid 1 g is often sufficient to stop bleeding. The prescription of tranexamic acid for disseminated intravascular coagulation should be made only if appropriate laboratory data are available and after evaluation of these data by a specialist.

Due to the lack of adequate clinical studies, the simultaneous use of tranexamic acid preparations with anticoagulants should be carried out under the careful supervision of a specialist experienced in the treatment of blood clotting disorders.