Tugyna-500 (tranexamic acid) coated tablets 500 mg. №10

Description

Tugyna-500 (tranexamic acid) coated tablets 500 mg. №10

Composition

active substance: tranexamic acid;

1 tablet contains tranexamic acid 500 mg;

Excipients: microcrystalline cellulose, corn starch, croscarmellose sodium, stearic acid, colloidal anhydrous silica, magnesium stearate, film coating Opadry White YS-1R-7003 (titanium dioxide (E 171)), alcohol isopropyl.

Dosage form

Film-coated tablets.

Main physical and chemical properties: white or almost white capsular biconvex tablets, film-coated, with a break line on one side and engraved “500” on the other side.

Pharmacotherapeutic group

Fibrinolysis inhibitors.

ATX code B02A A02.

Pharmacological properties

Tugyna-500 is an antifibrinolytic agent. Tranexamic acid specifically inhibits the activation of profibrinolysin (plasminogen) and its conversion to fibrinolysin (plasmin). Has local and systemic hemostatic action at the bleedings connected with increase of fibrinolysis (pathology of thrombocytes, menorrhagia). Tranexamic acid also has anti-allergic and anti-inflammatory effects by inhibiting the formation of kinins and other active peptides involved in allergic and inflammatory reactions.

Indication

Tugyna-500 is indicated for bleeding or risk of bleeding with increased fibrinolysis as generalized (bleeding during prostate and postoperative surgery, hemorrhagic complications of fibrinolytic therapy) and local (uterine, nasal bleeding, post-traumatic or hepatic hemaemia, bleeding). bladder intervention, conization of the cervix, tooth extraction in patients with hemophilia). Hereditary angioneurotic edema.

Contraindication

Hypersensitivity to the drug, severe renal insufficiency, macroscopic hematuria, high risk of thrombosis, thrombophlebitis, myocardial infarction, subarachnoid hemorrhage, acute venous or arterial thrombosis; fibrinolytic conditions after coagulopathy due to depletion, except for excessive activation of the fibrinolytic system in acute severe bleeding; history of convulsions; impaired color perception.

Method of application and dose:

• Local fibrinolysis: the recommended standard dose is 15-25 mg / kg body weight (ie 2-3 tablets) 2-3 times a day.
• Post-traumatic hephaemia: 1 g to 1.5 g every 8 hours for 6-7 days.
• Menorrhagia: the recommended dose is 2 tablets (1 g), not more than 4 days. The maximum daily dose is 4 g (8 tablets). Treatment should begin at the beginning of visible bleeding and continue for the first 4 days of the menstrual cycle. Patients should be examined after three months of treatment.
• Prostatectomy: 1 g (2 tablets) 6 hours before surgery, then 1 g orally 3-4 times a day until the disappearance of macroscopic hematuria. It is not recommended to use the drug for more than two weeks.
• Conization of the cervix: from 1 g to 1.5 g (2-3 tablets) every 8 or 12 hours for up to 12 days.
• Hemophilia: The recommended dose is 25 mg / kg tranexamic acid orally every 8 hours, starting 1 day before surgery and continuing for 2 days after surgery.
• Hereditary angioneurotic edema: 2-3 tablets 2-3 times a day for several days or for a long time, depending on the course of the disease.

Children

Dosage for children depending on age is not set. Data is limited.

Overdose:

• Symptoms: nausea, vomiting, abdominal pain, orthostatic hypotension, hypotension, dizziness, headache, convulsions or increased manifestations of other adverse reactions, including the risk of thrombosis.
• Treatment: induce vomiting, gastric lavage, use activated charcoal. It is necessary to consume plenty of fluids to promote renal excretion. Symptomatic treatment and, if necessary, anticoagulant therapy are used.

Side effects:

• from the immune system: hypersensitivity reactions, including anaphylaxis;
• from the digestive system: nausea, vomiting, heartburn, diarrhea, abdominal pain, loss of appetite;
• from the skin and subcutaneous tissue: rash, itching, allergic skin reactions;
• from the nervous system: drowsiness, dizziness, convulsions;
• on the part of the visual organs: visual disturbances, color perception disorders, retinal artery occlusion, congestive retinopathy;
• from vessels: thromboembolic complications, arterial or venous thrombosis of any localization, arterial hypotension;
• from the kidneys: acute necrosis of the cortical layer of the kidneys.