Tranexam, 500 mg, film-coated tablets, 30 pcs., NIZHFARM JSC buy in Moscow at a low price

Nosological classification (ICD-10)

D68.0 Von Willebrand disease
D69.9 Hemorrhagic condition, unspecified
J02 Acute pharyngitis
J03 Acute tonsillitis [tonsillitis]
J31.2 Chronic pharyngitis
J35.0 Chronic tonsillitis
K12 Stomatitis and related lesions
K12.0 Recurrent oral aphthae
K76.9 Liver disease, unspecified
K92.2 Gastrointestinal bleeding, unspecified
L20 Atopic dermatitis
L27.0 Generalized skin rash caused by drugs and medications
L27.1 Localized skin rash caused by drugs and medications
L30.9 Dermatitis, unspecified
L50 Urticaria
N93.9 Abnormal uterine and vaginal bleeding, unspecified
O20 Bleeding in early pregnancy
O46 Antepartum haemorrhage, not elsewhere classified
O72.2 Late or secondary postpartum hemorrhage
O83.2 Childbirth with other obstetric manipulations [manual techniques]
R04.0 Nosebleed
R21 Rash and other nonspecific skin eruptions
R31 Nonspecific hematuria
R58 Bleeding, not elsewhere classified
T78.3 Angioedema
T78.4 Allergy, unspecified
T81.0 Bleeding and hematoma complicating the procedure, not elsewhere classified
Z100* CLASS XXII Surgical practice

Compound

Film-coated tablets	1 table
active substance:
tranexamic acid	250 mg
500 mg
Excipients:
core - MCC; hyprolose; sodium carboxymethyl starch; talc; colloidal silicon dioxide; calcium stearate
shell - hypromellose; titanium dioxide; talc; macrogoal

Solution for intravenous administration	1 l
active substance:
tranexamic acid	50 g
excipients: water for injection - up to 1 l

Pharmacodynamics

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 (platelet pathology, menorrhagia), as well as anti-inflammatory, anti-allergic, anti-infective and anti-tumor 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 potentiating effect on the analgesic activity of opiates.

Tranexam 500 mg 30 pcs. film-coated tablets

pharmachologic effect

Composition and release form Tranexam 500 mg 30 pcs. film-coated tablets

One tablet contains: tranexamic acid 500 mg.

Excipients (core): microcrystalline cellulose, hyprolose, sodium carboxymethyl starch, talc, colloidal silicon dioxide, calcium stearate.

Excipients (shell): hypromellose, titanium dioxide, talc, macrogol. Film-coated tablets, 500 mg. 10 tablets in a blister pack made of polyvinyl chloride film and printed varnished aluminum foil. 1, 2, 3, 5 blister packs along with instructions for use are placed in a cardboard pack.

Description of the dosage form

Film-coated tablets

Characteristic

The tablets are biconvex, film-coated, white, oblong in shape. On a cross section - white or white with a creamy or grayish tint

Directions for use and doses

Inside, regardless of food intake.

Short-term treatment of bleeding caused by increased fibrinolysis:

The recommended standard dose of tranexamic acid is 15-25 mg/kg body weight, on average 1000-1500 mg 2-3 times a day.

For prostatectomy and surgical interventions on the bladder: 1000 mg 6 hours before surgery, then 1000 mg 3-4 times a day until gross hematuria disappears. It is not recommended to use the drug for more than 2 weeks after surgery.
For menorrhagia: the recommended dose is 1000 mg 3 times a day until menorrhagia stops, but not more than 4 days. In case of profuse bleeding, the dose of the drug can be increased, but the total daily dose should not exceed 4000 mg. Treatment with tranexamic acid should not be started before menstrual bleeding occurs. In clinical studies, tranexamic acid was not used for more than three consecutive menstrual cycles.
For recurrent nosebleeds: 1000 mg 3 times a day for 7 days.
After cervical conization surgery: 1500 mg 3 times a day for 12 days after surgery.
For traumatic hyphema: 1000-1500 mg 3 times a day (target dose 25 mg/kg body weight) for 7 days.

Patients with hemophilia: the drug is prescribed orally at a dose of 25 mg/kg body weight 2 hours before tooth extraction, and then 1000-1500 mg 3 times a day for 6-8 days. Coagulation factors VIII or IX should be prescribed simultaneously.

For hereditary angioedema: 1000-1500 mg 2-3 times a day. If the patient can foresee an exacerbation of the disease, the drug can be taken intermittently depending on the presence of prodromal symptoms. In other cases, the drug should be taken continuously.

Bleeding during pregnancy: 250-500 mg 3-4 times a day until bleeding stops completely. The average duration of treatment is 7 days.

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:

Serum creatinine concentration | Glomerular filtration rate (GFR) | Tranexamic Acid Dose | Frequency of reception

120-249 µmol/l (1.36-2.82 mg/dl) | 60-89 ml/min/1.73m2 | 15 mg/kg body weight | 2 times a day

250-500 µmol/L (2.83-5.66 mg/dL) | 30-59 ml/min/1.73m2 | 15 mg/kg body weight | 1 time per day

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.

Childhood

Data regarding the effectiveness and safety of tranexamic acid in children are limited.

In children, tranexamic acid is prescribed at a rate of 25 mg/kg body weight 2-3 times a day.

What to do if you miss a dose

If you miss one dose, you must take the next dose of the drug at the prescribed time. You should not take a double dose of the drug after missing the next dose.

Pharmacodynamics

Pharmacokinetics

Absorption after oral administration of doses in the range of 0.5-2 g is 30-50%. The time to reach the maximum concentration when taken orally 0.5, 1 and 2 g is 3 hours, the maximum concentration is 5, 8 and 15 mcg/ml, respectively. Communication with plasma proteins (profibrinolysin) - less than 3%.

Distributed relatively evenly in tissues (with the exception of cerebrospinal fluid, where the concentration is 1/10 of the plasma concentration); penetrates the placental 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 liters. 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 final phase of 3 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. In case of impaired renal function, there is a risk of accumulation of tranexamic acid.

Indications for use Tranexam 500 mg 30 pcs. film-coated tablets

Short-term treatment of bleeding associated with increased fibrinolysis in the following pathological conditions:

Prostatectomy; surgical interventions on the bladder;
Menorrhagia;
Nose bleed;
Conization of the cervix;
Traumatic hyphema (hemorrhage in the anterior chamber of the eye);

Prevention and treatment of bleeding in patients with hemophilia who undergo minor surgery (including tooth extraction);

Hereditary angioedema (prevention of exacerbations of the disease).

Bleeding during pregnancy.

Contraindications

Hypersensitivity to tranexamic acid or other components of the drug;
Severe chronic renal failure (glomerular filtration rate [GFR] less than 30 mg/ml/1.73 m2) due to the risk of accumulation;
Venous or arterial thrombosis currently or in history (deep vein thrombosis of the legs, pulmonary embolism, thrombosis of intracranial vessels, etc.) if simultaneous anticoagulant therapy is impossible;
Fibrinolysis due to consumption coagulopathy (hypocoagulable stage of disseminated intravascular coagulation syndrome [DIC]);
history of seizures;
Acquired color vision impairment;
Subarachnoid hemorrhage (due to the risk of developing cerebral edema, ischemia and cerebral infarction);
Children up to 3 years of age (solid dosage form).

Application of Tranexam 500 mg 30 pcs. film-coated tablets during pregnancy and breastfeeding

In preclinical studies, tranexamic acid did not have a teratogenic effect. Adequate and strictly controlled studies of the effectiveness and safety of tranexamic acid in pregnant women have not been conducted. Tranexamic acid crosses the placenta and may be present in cord blood in concentrations close to maternal levels.

Because animal reproduction studies do not always predict reactions in humans, tranexamic acid should be used during pregnancy only when absolutely necessary.

Tranexamic acid passes into breast milk (the concentration of the drug in milk is about 1% of the concentration in the mother's blood plasma). The development of an antifibrinolytic effect in an infant is unlikely. However, caution should be exercised when using tranexamic acid in nursing mothers.

special instructions

Tranexamic acid should be used with caution in the following situations:

Hematuria caused by diseases of the renal parenchyma and bleeding from the upper urinary tract (risk of secondary mechanical obstruction of the urinary tract by a blood clot with the development of anuria) (See section "Special instructions");
Patients with a high risk of developing thrombosis (history of thromboembolic events or family history of thromboembolic diseases, verified diagnosis of thrombophilia);
Disseminated intravascular coagulation syndrome [DIC syndrome]);
Presence of blood in cavities, for example, in the pleural cavity, joint cavities and urinary tract;
Patients receiving anticoagulant therapy (experience is limited);
Simultaneous use of drugs of blood coagulation factors II, VII, IX and X in combination with [prothrombin complex] or anti-inhibitor coagulant complex (See section “Interaction with other drugs”);
Treatment of menorrhagia in patients under the age of 15 years (experience is limited);
Patients taking combined oral contraceptives (due to an increased risk of venous thromboembolic complications and arterial thrombosis) (See section "Interaction with other drugs").

Overdose

There are limited data on cases of overdose. One case of overdose has been reported (ingestion of 37 g of tranexamic acid).

Symptoms: dizziness, headache, nausea, vomiting, diarrhea, orthostatic symptoms (including dizziness when moving from a horizontal to a vertical position), orthostatic arterial hypotension. Predisposed patients have an increased risk of thrombosis.

Treatment: no known antidote. If an overdose of tranexamic acid is suspected, hospitalization is necessary. When providing assistance, induce vomiting, then perform gastric lavage. Activated carbon reduces the absorption of tranexamic acid when taken orally during the first 1-2 hours after an overdose. If the patient is unconscious or has difficulty swallowing, activated charcoal can be administered through a nasogastric tube. It is recommended to take orally or parenterally administer large amounts of fluid to enhance renal excretion, forced diuresis, and control the amount of urine excreted. In some cases, the use of anticoagulants may be justified.

Side effects Tranexam 500 mg 30 pcs. film-coated tablets

The incidence of adverse drug reactions is determined in accordance with the WHO classification: very often (more than 1/10), often (more than 1/100, ≤1/10), infrequently (more than 1/1000, ≤1/100), rarely (more than 1/10000, ≤1/1000), very rare (less than 1/10000), frequency unknown (cannot be determined from available data).

Gastrointestinal disorders: often - nausea, vomiting, diarrhea (symptoms disappear when the dose is reduced).

Disorders of the skin and subcutaneous tissues: rarely - allergic skin reactions, including allergic dermatitis.

Disorders of the organ of vision: rarely - visual disturbances, including impaired color perception, thrombosis of retinal vessels.

Vascular disorders: rarely - thromboembolic complications, marked decrease in blood pressure (usually due to excessively rapid intravenous administration, in exceptional cases - after oral administration); very rarely - arterial and venous thrombosis of various locations; frequency unknown - acute myocardial infarction, cerebral artery thrombosis, carotid artery thrombosis, stroke, deep vein thrombosis of the legs, pulmonary embolism, renal artery thrombosis with the development of cortical necrosis and acute renal failure, occlusion of coronary artery bypass graft, thrombosis of the central artery and retinal vein .

Immune system disorders: very rarely - hypersensitivity reactions, including anaphylactic shock.

Nervous system disorders: rarely - dizziness, convulsions (usually with intravenous administration).

Drug interactions

Special clinical studies have not been conducted to study the interactions of tranexamic acid with other drugs.

Tranexamic acid prevents the development of the pharmacological effect of fibrinolytic (thrombolytic) drugs.

Combined oral contraceptives increase the risk of venous thromboembolic complications and arterial thrombosis (in particular, ischemic stroke and myocardial infarction). There is no experience with the use of tranexamic acid in women taking combined oral contraceptives. Since tranexamic acid has an antifibrinolytic effect, simultaneous use with combined oral contraceptives may lead to an additional increase in the risk of thrombotic complications.

The simultaneous use of tranexamic acid with drugs of blood coagulation factors II, VII, IX and X in combination [prothrombin complex] or anti-inhibitor coagulant complex increases the risk of thrombosis.

There may be an increased risk of thrombotic complications (in particular myocardial infarction) with simultaneous use of tranexamic acid with hydrochlorothiazide, desmopressin, ampicillin-sulbactam, ranitidine and nitroglycerin.

When combined with hemostatic drugs, activation of thrombus formation is possible.

Concomitant use of tranexamic acid with anticoagulants should be carried out under the strict supervision of a physician (experience is limited).

Pharmacokinetics

Absorption after oral administration of doses in the range of 0.5–2 g is 30–50%. Tmax when taken orally 0.5; 1 and 2 g - 3 hours, Cmax - 5; 8 and 15 μg/ml, respectively. Plasma protein binding (profibrinolysine) - less than 3%.

Distributed relatively evenly in tissues (with the exception of cerebrospinal fluid, where the concentration is 1/10 of the plasma concentration); penetrates the placental 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. Antifibrinolytic concentration in various tissues lasts 17 hours, in plasma - up to 7-8 hours.

A small part is metabolized. The AUC curve has a three-phase shape with T1/2 in the final phase - 3 hours (for solution for intravenous administration - 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. In case of impaired renal function, there is a risk of accumulation of tranexamic acid.

Tranexam 250 mg 10 pcs. film-coated tablets

pharmachologic effect

Antifibrinolytic agent.
Tranexamic acid specifically inhibits the activation of profibrinolysin (plasminogen) and its conversion to fibrinolysin (plasmin). It has a local and systemic hemostatic effect for bleeding associated with increased fibrinolysis (platelet pathology, menorrhagia). Also, tranexamic acid, by suppressing the formation of kinins and other active peptides involved in allergic and inflammatory reactions, has anti-allergic and anti-inflammatory effects. Absorption after oral administration of doses in the range of 0.5-2 g is 30-50%. The time to reach the maximum concentration when taken orally is 0.5, 1 and 2 g-3 hours, the maximum concentration is 5, 8 and 15 mcg/ml, respectively. Communication with plasma proteins (profibrinolysin) - less than 3%.

Two metabolites of tranexamic acid have been identified: N-acetylated and deaminated derivatives. In case of impaired renal function, there is a risk of accumulation of tranexamic acid.

Composition and release form Tranexam 250 mg 10 pcs. film-coated tablets

One tablet contains: tranexamic acid 250 mg.

Excipients (core): microcrystalline cellulose, hyprolose, sodium carboxymethyl starch, talc, colloidal silicon dioxide, calcium stearate.

Excipients (shell): hypromellose, titanium dioxide, talc, macrogol. Film-coated tablets, 250 mg. 10 tablets in a blister pack made of polyvinyl chloride film and printed varnished aluminum foil. 1, 2, 3, 5 blister packs along with instructions for use are placed in a cardboard pack.

Description of the dosage form

Film-coated tablets

Characteristic

The tablets are biconvex, white, film-coated. On a cross section - white or white with a creamy or grayish tint.

Directions for use and doses

Inside, regardless of food intake.

Short-term treatment of bleeding caused by increased fibrinolysis:

The recommended standard dose of tranexamic acid is 15-25 mg/kg body weight, on average 1000-1500 mg 2-3 times a day.

For prostatectomy and surgical interventions on the bladder: 1000 mg 6 hours before surgery, then 1000 mg 3-4 times a day until gross hematuria disappears. It is not recommended to use the drug for more than 2 weeks after surgery.
For menorrhagia: the recommended dose is 1000 mg 3 times a day until menorrhagia stops, but not more than 4 days. In case of profuse bleeding, the dose of the drug can be increased, but the total daily dose should not exceed 4000 mg. Treatment with tranexamic acid should not be started before menstrual bleeding occurs. In clinical studies, tranexamic acid was not used for more than three consecutive menstrual cycles.
For recurrent nosebleeds: 1000 mg 3 times a day for 7 days.
After cervical conization surgery: 1500 mg 3 times a day for 12 days after surgery.
For traumatic hyphema: 1000-1500 mg 3 times a day (target dose 25 mg/kg body weight) for 7 days.

Bleeding during pregnancy: 250-500 mg 3-4 times a day until bleeding stops completely. The average duration of treatment is 7 days.

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:

Serum creatinine concentration | Glomerular filtration rate (GFR) | Tranexamic Acid Dose | Frequency of reception

120-249 µmol/l (1.36-2.82 mg/dl) | 60-89 ml/min/1.73m2 | 15 mg/kg body weight | 2 times a day

250-500 µmol/L (2.83-5.66 mg/dL) | 30-59 ml/min/1.73m2 | 15 mg/kg body weight | 1 time per day

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.

Childhood

Data regarding the effectiveness and safety of tranexamic acid in children are limited.

In children, tranexamic acid is prescribed at a rate of 25 mg/kg body weight 2-3 times a day.

What to do if you miss a dose

If you miss one dose, you must take the next dose of the drug at the prescribed time. You should not take a double dose of the drug after missing the next dose.

Pharmacodynamics

Pharmacokinetics

Two metabolites of tranexamic acid have been identified: N-acetylated and deaminated derivatives. In case of impaired renal function, there is a risk of accumulation of tranexamic acid.

Indications for use Tranexam 250 mg 10 pcs. film-coated tablets

Short-term treatment of bleeding associated with increased fibrinolysis in the following pathological conditions:

Prostatectomy; surgical interventions on the bladder;
Menorrhagia;
Nose bleed;
Conization of the cervix;
Traumatic hyphema (hemorrhage into the anterior chamber of the eye).

Prevention and treatment of bleeding in patients with hemophilia who undergo minor surgery (including tooth extraction);

Hereditary angioedema (prevention of exacerbations of the disease).

Contraindications

Hypersensitivity to tranexamic acid or other components of the drug;
Severe chronic renal failure (glomerular filtration rate [GFR] less than 30 mg/ml/1.73 m2) due to the risk of accumulation;
Venous or arterial thrombosis currently or in history (deep vein thrombosis of the legs, pulmonary embolism, thrombosis of intracranial vessels, etc.) if simultaneous anticoagulant therapy is impossible;
Fibrinolysis due to consumption coagulopathy (hypocoagulable stage of disseminated intravascular coagulation syndrome [DIC]);
history of seizures;
Acquired color vision impairment;
Subarachnoid hemorrhage (due to the risk of developing cerebral edema, ischemia and cerebral infarction);
Children up to 3 years of age (solid dosage form).

Application of Tranexam 250 mg 10 pcs. film-coated tablets during pregnancy and breastfeeding

Because animal reproduction studies do not always predict reactions in humans, tranexamic acid should be used during pregnancy only when absolutely necessary.

special instructions

Tranexamic acid should be used with caution in the following situations:

Hematuria caused by diseases of the renal parenchyma and bleeding from the upper urinary tract (risk of secondary mechanical obstruction of the urinary tract by a blood clot with the development of anuria) (See section "Special instructions");
Patients with a high risk of developing thrombosis (history of thromboembolic events or family history of thromboembolic diseases, verified diagnosis of thrombophilia);
Disseminated intravascular coagulation syndrome [DIC syndrome]);
Presence of blood in cavities, for example, in the pleural cavity, joint cavities and urinary tract;
Patients receiving anticoagulant therapy (experience is limited);
Simultaneous use of drugs of blood coagulation factors II, VII, IX and X in combination with [prothrombin complex] or anti-inhibitor coagulant complex (See section “Interaction with other drugs”);
Treatment of menorrhagia in patients under the age of 15 years (experience is limited);
Patients taking combined oral contraceptives (due to an increased risk of venous thromboembolic complications and arterial thrombosis) (See section "Interaction with other drugs").

Overdose

There are limited data on cases of overdose. One case of overdose has been reported (ingestion of 37 g of tranexamic acid).

Side effects Tranexam 250 mg 10 pcs. film-coated tablets

Gastrointestinal disorders: often - nausea, vomiting, diarrhea (symptoms disappear when the dose is reduced).

Disorders of the skin and subcutaneous tissues: rarely - allergic skin reactions, including allergic dermatitis.

Disorders of the organ of vision: rarely - visual disturbances, including impaired color perception, thrombosis of retinal vessels.

Immune system disorders: very rarely - hypersensitivity reactions, including anaphylactic shock.

Nervous system disorders: rarely - dizziness, convulsions (usually with intravenous administration).

Drug interactions

Special clinical studies have not been conducted to study the interactions of tranexamic acid with other drugs.

Tranexamic acid prevents the development of the pharmacological effect of fibrinolytic (thrombolytic) drugs.

When combined with hemostatic drugs, activation of thrombus formation is possible.

Concomitant use of tranexamic acid with anticoagulants should be carried out under the strict supervision of a physician (experience is limited).

Indications of the drug Tranexam®

Pills

bleeding or risk of bleeding due to:

- increased local fibrinolysis (uterine, including against the background of von Willebrand disease and other coagulopathies, nasal, gastrointestinal bleeding, hematuria, bleeding after prostatectomy, conization of the cervix for carcinoma, tooth extraction in patients with hemorrhagic diathesis);

- increased generalized fibrinolysis (malignant neoplasms of the pancreas and prostate glands, operations on the chest organs, postpartum hemorrhage, manual separation of the placenta, leukemia, liver diseases);

bleeding during pregnancy;

hereditary angioedema, allergic diseases (eczema, allergic dermatitis, urticaria, drug and toxic rashes);

inflammatory diseases (tonsillitis, pharyngitis, laryngitis, stomatitis, aphthae of the oral mucosa).

Solution for intravenous administration

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 bleeding, after conization of the cervix for carcinoma, nasal, pulmonary, gastrointestinal, hematuria, bleeding after prostatectomy, tooth extraction in patients with hemorrhagic diathesis);

surgical interventions on the bladder;

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

Content

Characteristics of tranexam tablets 250 mg No. 30

Composition: Release form: Film-coated tablets 250 mg.

10 tablets in a blister pack made of polyvinyl chloride film and printed varnished aluminum foil.

1, 2, 3, 5 blister packs along with instructions for use are placed in a cardboard pack.

Film-coated tablets 500 mg.

10 tablets in a blister pack made of polyvinyl chloride film and printed varnished aluminum foil.

1, 2, 3, 5 blister packs along with instructions for use are placed in a cardboard pack.

Composition: Dosage 250 mg, one tablet contains: Active substance Tranexamic acid 250 mg.

Excipients (core): Microcrystalline cellulose, hyprolose, sodium carboxymethyl starch, talc, colloidal silicon dioxide, calcium stearate.

Excipients (shell): Hypromellose, titanium dioxide, talc, macrogol.

Dosage 500 mg, one tablet contains: Active substance Tranexamic acid 500 mg.

Excipients (core): Microcrystalline cellulose, hyprolose, sodium carboxymethyl starch, talc, colloidal silicon dioxide, calcium stearate.

Excipients (shell): Hypromellose, titanium dioxide, talc, macrogol.

Quantity per package: 30 tablets.

Pharmacological Action: Antifibrinolytic agent.

Tranexamic acid specifically inhibits the activation of profibrinolysin (plasminogen) and its conversion to fibrinolysin (plasmin).

It has a local and systemic hemostatic effect for bleeding associated with increased fibrinolysis (platelet pathology, menorrhagia).

Also, tranexamic acid, by suppressing the formation of kinins and other active peptides involved in allergic and inflammatory reactions, has anti-allergic and anti-inflammatory effects.

Indications for Use: Bleeding or risk of bleeding due to: increased local fibrinolysis (uterine, including von Willebrand disease and other coagulopathies, nasal, gastrointestinal bleeding, hematuria, bleeding after prostatectomy, conization of the cervix due to cancer, tooth extraction in patients with hemorrhagic diathesis); increased generalized fibrinolysis (malignant neoplasms of the pancreas and prostate glands, operations on the chest organs, postpartum hemorrhage, manual separation of the placenta, leukemia, liver diseases).

Bleeding during pregnancy.

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

Inflammatory diseases (tonsillitis, pharyngitis, laryngitis, stomatitis, aphthae of the oral mucosa).

Method of Application: Inside.

For local fibrinolysis, 1000-1500 mg is prescribed 2-3 times a day.

For profuse uterine bleeding, 1000-1500 mg is prescribed 3-4 times a day for 3-4 days.

For bleeding due to von Willebrand disease and other coagulopathies, 1000-1500 mg 3-4 times a day.

The duration of treatment is 3-10 days.

After cervical conization surgery, 1500 mg is prescribed 3 times a day for 12-14 days.

For nosebleeds, 1000 mg is prescribed 3 times a day for 7 days.

Patients with coagulopathies after tooth extraction are prescribed 1000-1500 mg 3-4 times a day for 6-8 days.

For bleeding during pregnancy, 250-500 mg 3-4 times a day until bleeding stops completely.

The average duration of treatment is 7 days.

For hereditary angioedema, 1000-1500 mg is prescribed 2-3 times a day continuously or intermittently, depending on the presence of prodromal symptoms.

For symptoms of allergy and inflammation, 1000-1500 mg 2-3 times a day for 3-9 days, depending on the severity of the condition.

For generalized fibrinolysis, therapy begins with parenteral (intravenous) administration of Tranexam, followed by a transition to oral administration of 1000 - 1500 mg 2-3 times a day.

In case of impairment of the excretory function of the kidneys, correction of the dosage regimen is necessary: if the concentration of creatinine in the blood is 120-250 µmol/l, 1000 mg is prescribed 2 times a day; if the creatinine concentration is 250 - 500 µmol/l, 1000 mg is prescribed once a day; if the creatinine concentration is more than 500 µmol/l, 500 mg is prescribed once a day.

Interaction: When combined with hemostatic drugs and hemocoagulase, activation of thrombus formation is possible.

Side Effects: When taking the drug, nausea, vomiting, heartburn, diarrhea, rash, itching, loss of appetite, drowsiness, and dizziness may occur.

Color vision disturbance may occur; rarely - thrombosis, thromboembolism.

Contraindications: Hypersensitivity to the drug, subarachnoid hemorrhage.

With caution With caution, the drug is prescribed for thrombosis (cerebral vascular thrombosis, myocardial infarction, thrombophlebitis) or the threat of their development, for thrombohemorrhagic complications (in combination with heparin and indirect anticoagulants), impaired color vision, hematuria from the upper urinary tract (possible obstruction of blood clot), renal failure (cumulation is possible).

Special Instructions: Before starting and during treatment, it is necessary to conduct an examination by an ophthalmologist for visual acuity, color vision, and the condition of the fundus.

Animal studies did not reveal teratogenic or embryotoxic effects.

Side effects

Pills

Nausea, vomiting, heartburn, diarrhea, rash, itching, decreased appetite, drowsiness, and dizziness may occur. Color vision disturbance may occur; rarely - thrombosis, thromboembolism.

Solution for intravenous administration

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

Directions for use and doses

Pills

Inside.

For local fibrinolysis, 1000–1500 mg is prescribed 2–3 times a day.

For profuse uterine bleeding, 1000–1500 mg is prescribed 3–4 times a day for 3–4 days.

For bleeding due to von Willebrand disease and other coagulopathies - 1000–1500 mg 3–4 times a day. The duration of treatment is 3–10 days.

After cervical conization surgery, 1500 mg is prescribed 3 times a day for 12–14 days.

For nosebleeds, 1000 mg is prescribed 3 times a day for 7 days.

Patients with coagulopathies after tooth extraction are prescribed 1000–1500 mg 3–4 times a day for 6–8 days.

For bleeding during pregnancy - 250-500 mg 3-4 times a day until bleeding stops completely. The average duration of treatment is 7 days.

For hereditary angioedema, 1000–1500 mg is prescribed 2–3 times a day continuously or intermittently, depending on the presence of prodromal symptoms.

For symptoms of allergy and inflammation - 1000–1500 mg 2–3 times a day for 3–9 days, depending on the severity of the condition.

For generalized fibrinolysis, therapy begins with parenteral (iv) administration of the drug Tranexam®, followed by switching to oral administration of 1000–1500 mg 2–3 times a day.

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, 1000 mg is prescribed 2 times a day; if the creatinine concentration is 250–500 µmol/l, 1000 mg is prescribed once a day; if the creatinine concentration is more than 500 µmol/l, 500 mg is prescribed once a day.

Solution for intravenous administration

IV (drip, stream).

For generalized fibrinolysis, a single dose of 15 mg/kg 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 - at a dose of 10-11 mg/kg 20-30 minutes before the intervention.

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

In case of impaired renal excretory function, it is necessary to adjust the dosage regimen depending on the concentration of creatinine in the blood: if the concentration of creatinine in the blood is 120–250 µmol/l, 10 mg/kg is prescribed 2 times a day; at 250–500 µmol/l - 10 mg/kg 1 time per day; at >500 µmol/kg - 5 mg/kg 1 time per day.

Tranexam, 30 pcs., 250 mg, film-coated tablets

Pills

Inside.