Description
Latin name
Tranexam
Release form
250 mg film-coated tablets. On 10 tablets in a blister strip packaging from a film of polyvinyl chloride and a printed aluminum foil varnished. 1, 2, 3, 5 blister packs along with instructions for use are placed in a pack of cardboard.
packaging 10 pcs
Pharmacological action
Antifibrinolytic agent. Tranexamic acid specifically inhibits the activation of profibrinolysin (plasminogen) and its conversion to fibrinolysin (plasmin). It has local and systemic hemostatic effects in case of bleeding associated with increased fibrinolysis (platelet pathology, menorrhagia).
Pharmacokinetics
Oral absorption in the range of 0.5-2 g – 30-50%. The onset time of the maximum concentration when taken orally is 0.5, 1 and 2g – 3 hours, the maximum concentration is 5, 8 and 15 μg / ml, respectively. Communication with plasma proteins (profibrinolysin) – less than 3%.
Distributed in the tissues relatively evenly (with the exception of cerebrospinal fluid, where the concentration is 1/10 of the plasma) penetrates 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 distribution volume is 9-12 liters. The antifibrinolytic concentration in various tissues lasts 17 hours, in the 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. The total renal clearance is equal to the plasma (7 l / h). It is excreted by the kidneys (the main way is glomerular filtration) – more than 95% unchanged during the first 12 hours.
2 metabolites of tranexamic acid were identified: N-acetylated and deaminated derivative. With impaired renal function, there is a risk of cumulation of tranexamic acid.
Indications
Bleeding or risk of bleeding in the background:
increased local fibrinolysis (uterine, including with von Willebrand disease and other coagulopathies, nasal, gastrointestinal bleeding, hematuria, bleeding after prostatectomy, conization of the cervix due to cancer, tooth in patients with hemorrhagic diathesis)
enhance generalized fibrinolysis (malignant neoplasms of the pancreas and prostate gland, surgery on the organs of the chest, postpartum hemorrhage, hand nasal separation of the placenta, leukemia, liver disease).
Bleeding during pregnancy.
Hereditary angioedema, allergic diseases (eczema, allergic dermatitis, urticaria, drug and toxic rash).
Inflammatory diseases (tonsillitis, pharyngitis, laryngitis, stomatitis, aphthae of the oral mucosa).
Contraindications
Hypersensitivity to the drug, subarachnoid hemorrhage.
With caution
With caution, the drug is prescribed for thrombosis (cerebral vascular thrombosis, myocardial infarction, thrombophlebitis) or a threat of their development, with thrombohemorrhagic complications (in combination with heparin and indirect anticoagulants), color vision, hematuria from the upper waterway blood clot obstruction is possible), renal failure (cumulation is possible).
Pregnancy and lactation
There have been no adequate and strictly controlled clinical trials of the safety of tranexamic acid during pregnancy, so the intended benefit and potential risk of therapy should be carefully assessed when prescribed.
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.
Side effects of
When taking the drug, nausea, vomiting, heartburn, diarrhea, rash, skin itching, decreased appetite, drowsiness, and dizziness may occur. Color disturbance may occur rarely – thrombosis, thromboembolism.
Drug Interaction
When combined with hemostatic drugs and hemocoagulase, thrombus formation can be activated.
Storage conditions
At a temperature not exceeding 30 ° C. Keep out of reach of children.
Shelf life
3 years.
Deystvuyushtee substance
Traneksamovaya Chisloth
Dosage PMA
Prescribing
Prescribing
Prescribing to nursing mothers, As prescribed by a doctor, Adult Designation as prescribed by a doctor, Pregnant as prescribed by a doctor
Obninsk CPA, Russia
