Bleeding or the risk of bleeding with increased fibrinolysis, both generalized and local, in adults and children older than 1 year. Specific indications include bleeding due to increased general or local fibrinolysis, such as: menorrhagia and metrorrhagia; Gastrointestinal bleeding; Hemorrhagic urinary tract disorders resulting from surgery on the prostate gland or as a result of surgery or procedures on the urinary tract; Otolaryngological (removal of adenoids, tonsillectomy) and dental (tooth extraction) surgery; Gynecological surgery or complications in obstetric practice; Thoracic, abdominal and other major surgical interventions, such as cardiovascular surgery; Control of hemorrhage in connection with the introduction of a fibrinolytic drug.
Composition and form of release
Active ingredients: tranexamic acid (100 mg / ml).
Tramix is produced in the form of a solution for injection.
It is an antihemorrhagic agent. It is an inhibitor of fibrinolysis. Specifically inhibits the activation of plasminogen (profibrinolysin), its transformation into plasmin (fibrinolysin). It has a systemic and local hemostatic effect in bleeding, which is associated with an increase in fibrinolysis (menorrhagia, platelet pathology). Also, tranexamic acid has an anti-allergic, anti-inflammatory effect by inhibiting the formation of kinins, other active peptides involved in reactions of this type.
Tramix is used:
- with bleeding or the risk of bleeding as a result of increased fibrinolysis, as generalized (during operations, in the postoperative period, after childbirth, manual separation of the placenta, with chorionic detachment, bleeding during pregnancy, with malignant neoplasm of the pancreas or prostate glands, with hemophilia, hemorrhagic complications of fibrinolytic therapy, with thrombocytopenic purpura, liver diseases, leukemia, after streptokinase therapy), and local bleeding (pulmonary, uterine, nasal, gastrointestinal, hematuria, after conization of the cervix for carcinoma, after prostatectomy, tooth extraction in individuals with hemorrhagic diathesis);
- with surgical intervention on the bladder;
- during surgical procedures against the background of a systemic inflammatory reaction (peritonitis, sepsis, pancreatic necrosis, preeclampsia, shock, other critical conditions).
Tramix is not used:
- if you are allergic to tranexamic acid;
- with intolerance to auxiliary components;
- with thromboembolic diseases;
- with a high risk of thrombosis, thrombophlebitis;
- with macroscopic hematuria;
- with coagulopathy due to disseminated intravascular coagulation syndrome (diffuse intravascular coagulation) without fibrinolysis activation;
- with myocardial infarction;
- with subarachnoid hemorrhage;
- with a history of seizures;
- in case of violation of color vision;
- with severe kidney failure.
Application during pregnancy and lactation
There have been no strictly controlled clinical studies of the safety of tranexamic acid during pregnancy. No teratogenic or embryotoxic effects were found.
The drug is prescribed to pregnant women if the expected health benefits to the mother outweigh the risk to the fetus.
The drug is used in childbirth and cesarean section.
The active substance passes into breast milk in small amounts. If there is a need for treatment, the question of stopping breastfeeding is decided.
Method of administration and dosage
Tramix is used intravenously (jet, drip).
The dosage regimen is selected individually depending on the clinical situation.
The standard dose for generalized fibrinolysis is 15 mg / kg every 6-8 hours intravenously slowly (the recommended rate of administration is 1 ml / minute).
The standard dose for local fibrinolysis is 0.5-1 g 2-3 times a day intravenously slowly (1 ml / minute).
With prostatectomy, bladder surgery – 1 g during surgery, then 1 g every 8 hours for three days, after which they switch to tablet forms of tranexamic acid (until gross hematuria disappears).
With the risk of bleeding against the background of a systemic inflammatory reaction – 10-11 mg / kg 20-30 minutes before surgery.
For children from one year old, the maximum dose should not exceed 20 mg / kg / day, the maximum single dose is 10 mg / kg.
Symptoms: convulsions, nausea, orthostatic symptoms, dizziness, vomiting, arterial hypotension, headache, increased manifestations of adverse reactions.
Treatment: the appointment of symptomatic therapy, forced diuresis, maintenance of the water-salt balance.
- Gastrointestinal disorders: nausea, heartburn, vomiting, diarrhea, discomfort in the intestines and stomach.
- Neurological disorders: convulsions, drowsiness, dizziness.
- Cardiovascular disorders: arterial hypotension, orthostatic hypotension, chest pain, tachycardia, thromboembolism, pulmonary embolism, deep vein thrombosis, cerebral vessels.
- Urinary disorders: acute necrosis of the renal cortex.
- Ophthalmic disorders: chromatopsia, impairment, blurred vision.
- General disorders: weakness, manifestations of hypersensitivity (including anaphylaxis, allergic dermatitis, skin rashes, itching, urticaria).
Storage conditions and periods
Store Tramix for no more than two years at temperatures up to +25 ° C.