Tranexam pills 500 mg 10 pcs.

Composition

Composition per tablet: Active ingredient: tranexamic acid 500.0 mg. Excipients (core): microcrystalline cellulose, hyprolose, sodium carboxymethyl starch, talc, colloidal silicon dioxide, calcium stearate. Excipients (shell): hypromellose, titanium dioxide, talc, macrogol.

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 in bleeding associated with increased fibrinolysis (platelet pathology, menorrhagia). Tranexamic acid also has an anti-allergic and anti-inflammatory effect by suppressing the formation of kinins and other active peptides involved in allergic and inflammatory reactions.

Active ingredients

Tranexamic Acid

Indications

Short-term treatment of bleeding associated with increased fibrinolysis in the following pathological conditions: Prostatectomy; surgical interventions on the bladder; Menorrhagia; Nosebleeds; 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.

Use during pregnancy and lactation

In preclinical studies, tranexamic acid did not have a teratogenic effect. Adequate and strictly controlled studies of the efficacy and safety of tranexamic acid preparations in pregnant women have not been conducted. Tranexamic acid passes through the placenta and can be found in umbilical cord blood in concentrations close to maternal. Since studies of reproductive function in animals do not always predict reactions in humans, tranexamic acid should only be used during pregnancy if absolutely necessary. Tranexamic acid penetrates 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 children is unlikely. However, caution should be exercised when using tranexamic acid in nursing mothers.

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 the anamnesis (deep vein thrombosis of the legs, pulmonary embolism, intracranial vascular thrombosis, etc. ) if simultaneous therapy with anticoagulants is not possible; Fibrinolysis due to consumption coagulopathies (hypocoagulation stage of disseminated intravascular coagulation syndrome [DIC-syndrome]); Convulsions in the anamnesis; Acquired color vision impairment; Subarachnoid hemorrhage (due to the risk of brain edema, ischemia and cerebral infarction); Children under 3 years of age (solid dosage form).

Side effects

the incidence of adverse drug reactions identified in accordance with the who classification: very often (>1/10), often (>1/100, ≤1/10), infrequently (>1/1000, ≤1/100), rare (>1/10000, ≤1/1000), very rare (less than 1/10000), frequency unknown (cannot be installed according to the available data). Disorders of the gastrointestinal tract: often — nausea, vomiting, diarrhea (symptoms disappear when the dose is reduced). Skin and subcutaneous tissue disorders: rarely – allergic skin reactions, including allergic dermatitis. Visual disturbances: rarely-visual disturbances, including color perception disorders, retinal vascular thrombosis. 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 localization; 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 the aorto-coronary shunt, 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).

Interaction

When combined with hemostatic drugs and hemocoagulase, thrombosis may be activated.

How to take, course of administration and dosage

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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 of 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 the macrohematuria 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 the end of menorrhagia, but not more than 4 days. With profuse bleeding, the dose of the drug can be increased, while the total daily dose should not exceed 4000 mg. Treatment with tranexamic acid should not be started before menstrual bleeding occurs. In clinical trials, 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 the operation of conization of the cervix: 1500 mg 3 times a day for 12 days after the operation.
• 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 of body weight 2 hours before tooth extraction, and then 1000-1500 mg 3 times a day for 6-8 days. Blood clotting factors VIII or IX should be administered simultaneously.
• For hereditary angioedema: 1000-1500 mg 2-3 times a day. If the patient can anticipate an exacerbation of the disease, the drug can be taken intermittently, depending on the presence of prodromal symptoms. In all other cases, the drug should be taken constantly.
• Bleeding during pregnancy: 250-500 mg 3-4 times a day until the bleeding stops completely. The average duration of treatment is 7 days.

Use of the drug in special groups of patients

Impaired renal function

In patients with mild to moderate renal excretory function impairment, the dose and frequency of tranexamic acid administration should be adjusted:

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Impaired liver function

No dose adjustment is required in patients with hepatic impairment.

Advanced age

In elderly patients with no renal insufficiency, no dose adjustment is required.

Children’s age

Data on the efficacy and safety of tranexamic acid preparations in children are limited.

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

Actions when skipping the next dose

If you miss one dose, you must take the next dose of the drug at the set time. Do not take a double dose of the drug after skipping the next dose.

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Overdose

Data on overdose of the drug are not provided.

Description

Hemostatic agent

Description

Oblong biconvex tablets covered with a white film coating. On a cross-section, the core is white or white with a creamy or grayish tinge of color.

Functional features

Absorption with oral doses in the range of 0.5-2 g – 30-50%. The time of onset of the maximum concentration with oral administration of 0.5,1 and 2 g is 3 hours, the maximum concentration is 5,8 and 15 mcg/ml, respectively. Plasma protein binding (profibrinolysin) is less than 3%. It is distributed relatively evenly in the tissues (except for the cerebrospinal fluid, where the concentration is 1/10 of the plasma); it penetrates through the placental barrier, into breast milk (about 1% of the concentration in the mother’s 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 is maintained for 17 hours, in plasma-up to 7-8 hours. A small part is metabolized. The area curve under the 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 were identified: N-acetylated and deaminated derivatives. With impaired renal function, there is a risk of accumulation of tranexamic acid.

Complete set

Film-coated tablets 500 mg.10 tablets in a contour cell package made of polyvinyl chloride film and aluminum foil printed varnished.1,2,3,5 contour cell packages together with the instructions for use are placed in a pack of cardboard.

Special instructions

In patients with hereditary angioedema, consultation with an ophthalmologist is necessary before starting treatment (determination of visual acuity, color vision, fundus condition). During treatment, regular ophthalmological examination is necessary (including assessment of visual acuity and color perception, examination of the fundus with a slit lamp, measurement of intraocular pressure, assessment of visual fields). If visual disturbances occur during treatment with tranexamic acid, the drug should be discontinued. In patients with hereditary angioedema who have been receiving tranexamic acid preparations for a long time, regular laboratory monitoring of liver function is necessary. Tranexamic acid preparations should be used with caution in hematuria caused by diseases of the renal parenchyma, since in these conditions intravascular deposition of fibrin is often observed, which can aggravate kidney 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. Although clinical studies have not shown a significant increase in the incidence of thrombosis, the risk of thrombotic complications cannot be completely excluded. Cases of venous and arterial thrombosis and thromboembolism have been described in patients treated with tranexamic acid. 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 (a history of thromboembolic complications, cases of thromboembolism in relatives, a 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 (incl. in the renal pelvis and in the bladder) can lead to the formation of an “insoluble clot” in them due to extravascular coagulation, which can be resistant to physiological fibrinolysis. Patients with irregular menstrual bleeding should not be prescribed tranexamic acid until the cause of dysmenorrhea is established. If the volume of menstrual bleeding is not adequately reduced during treatment with tranexamic acid, alternative treatment should be considered. There are insufficient data on the efficacy and safety of tranexamic acid in the treatment of menorrhagia in patients under 15 years of age, so the drug should be used with caution. Tranexamic acid should be used with caution in women who are taking combined oral contraceptives at the same time, due to the increased risk of thrombosis (See the section “Interaction with other medications”). In patients with DIC who require treatment with tranexamic acid, therapy should be carried out under the close supervision of a doctor who has experience in the treatment of this disease. Due to the lack of adequate clinical studies, the concomitant use of tranexamic acid with anticoagulants should be carried out under the careful supervision of a specialist with experience in the treatment of blood clotting disorders. If there is a visual impairment while taking tranexamic acid, you should stop taking the drug and consult a doctor.

Form of production

Film-coated tablets

Storage conditions

At a temperature not exceeding 30 °C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Tranexamic Acid

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Weight

Weight: 20 g.