Presentation and Status in Health Basket
5 X 5 ml
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Rapid intravenous injection should be avoided.
Adults: The recommended standard dosage is 5-10 ml intravenously, at a rate of 1 ml/minute, 2-3 times daily. For the indications listed below, specific recommendations are made as follows:
General Fibrinolysis: 10 ml intravenously, 3-4 times daily.
Prostatectomy: 5-10 ml by slow I.V. injection, every 8 hours (the first dose being administered during the operation), for the first 3 days following surgery. When required, oral treatment with tranexamic acid may be followed.
Dental Surgery: Factor VIII or IX concentrates and Tranexamic Acid 10 mg/kg body weight should be administered intravenously immediately before surgery. When required, oral treatment with tranexamic acid may be followed.
Epistaxis: The drug may be applied topically to the nasal mucosa, either using a spray or by soaking a gauze strip in the solution and then packing the nasal cavity.
Children: Dosage should be calculated according to body weight, 10 mg/kg Tranexamic Acid, intravenously.
Renal impairment: In renal insufficiency leading to a risk of accumulation, the use of tranexamic acid is contra-indicated in patient with severe renal impairment. For patient with mild to moderate renal impairment, the dosage of tranexamic acid should be reduced according to the serum creatinine level: See prescribing information for full details.
Hepatic impairment: No dose adjustment is required in patient with hepatic impairment.
Paediatric Population: In children from 1 year, for current approved indications as the dosage is in the region of 20 mg/kg/day. However, data on efficacy, posology and safety for these indications are limited. The efficacy, posology and safety of tranexamic acid in children undergoing cardiac surgery have not been fully established.
Elderly: No reduction in dosage is necessary unless there is evidence of renal failure.
Method of administration: The administration is strictly limited to slow intravenous injection.
See prescribing information for full details.
General fibrinolysis. This may occur in prostatic and pancreatic carcinoma following thoracic surgery and other major operative procedures, in obstetrical complications such as abruptio placentae and post-partum hemorrhage, in connection with thrombolytic therapy, and in initial and follow-up treatment following prostatectomy and bladder surgery. Prior to, and following, dental surgery in hemophiliacs. Epistaxis.
– Hypersensitivity to the active substance or to any of the excipients.
– Acute venous or arterial thrombosis.
Fibrinolytic conditions following consumption coagulopathy except in those with predominant activation of the fibrinolytic systemwith acute severe bleeding.
– Severe renal impairment (risk of accumulation).
– History of convulsions.
– Intrathecal and intraventricular injection, intracerebral application (risk of cerebral oedema and convulsions).
The indications and method of administration indicated above should be followed strictly: Intravenous injections should be given very slowly Tranexamic acid should not be administered by the intramuscular route.
Convulsions: Cases of convulsions have been reported in association with tranexamic acid treatment. In coronary artery bypass graft (CABG) surgery, most of these cases were reported following intravenous (i.v.) injection of tranexamic acid in high doses. With the use of the recommended lower doses of TXA, the incidence of post-operative seizures was the same as that in untreated patients.
Visual disturbances: Attention should be paid to possible visual disturbances including visual impairment, vision blurred, impaired color vision and if necessary the treatment should be discontinued. With continuous long-term use of TXA solution for injection, regular ophthalmologic examinations (eye examinations including visual acuity, color vision, fundus, visual field etc.) are indicated. With pathological ophthalmic changes, particularly with diseases of the retina, the physician must decide after consulting a specialist on the necessity for the long-term use of TXA solution for injection in each individual case.
Haematuria: In case of haematuria from the upper urinary tract, there is a risk for urethral obstruction.
Thromboembolic events: Before use of TXA, risk factors of thromboembolic disease should be considered. In patients with a history of thromboembolic diseases or in those with increased incidence of thromboembolic events in their family history (patients with a high risk of thrombophilia), Tranexamic acid solution for injection should only be administered if there is a strong medical indication after consulting a physician experienced in hemostaseology and under strict medical supervision. Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis.
Disseminated intravascular coagulation: Patients with disseminated intravascular coagulation (DIC) should in most cases not be treated with tranexamic acid. If tranexamic acid is given it must be restricted to those in whom there is predominant activation of the fibrinolytic system with acute severe bleeding. Characteristically, the haematological profile approximates to the following: reduced euglobulin clot lysis time; prolonged prothrombin time; reduced plasma levels of fibrinogen, factors V and VIII, plasminogen fibrinolysin and alpha-2 macroglobulin; normal plasma levels of P and P complex; i.e. factors II (prothrombin), VIII and X; increased plasma levels of fibrinogen degradation products; a normal platelet count. The foregoing presumes that the underlying disease state does not of itself modify the various elements in this profile. In such acute cases a single dose of 1g tranexamic acid is frequently sufficient to control bleeding. Administration of Tranexamic acid in DIC should be considered only when appropriate haematological laboratory facilities and expertise are available.
Common: Diarrhea, vomiting, nausea.
See prescribing information for full details.
No interaction studies have been performed. Simultaneous treatment with anticoagulants must take place under the strict supervision of a physician experienced in this field. Medicinal products that act on haemostasis should be given with caution to patients treated with tranexamic acid. There is a theoretical risk of increased thrombus-formation potential, such as with oestrogens. Alternatively, the antifibrinolytic action of the drug may be antagonised with thrombolytic drugs.
Pregnancy and Lactation
Pregnancy: Women of childbearing potential have to use effective contraception during treatment.
There are insufficient clinical data on the use of tranexamic acid in pregnant
women. As a result, although studies in animals do not indicate teratogenic
effects, as a precaution for use, tranexamic acid is not recommended during the
first trimester of pregnancy. Limited clinical data on the use of tranexamic acid
in different clinical haemorrhagic settings during the second and third trimesters did not identify deleterious effect for the foetus. Tranexamic acid should be used throughout pregnancy only if the expected benefit justifies the potential risk.
Lactation: Tranexamic acid is excreted in human milk. Therefore, breastfeeding is not recommended.
No cases of overdosage have been reported. Signs and symptoms may include dizziness, headache, hypotension, and convulsions. It has been shown that convulsions tend to occur at higher frequency with increasing dose. Management of overdose should be supportive.
Compatibility: The drug may be mixed with electrolyte, carbohydrate, amino acid and dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added. Should not be mixed with blood and infusion solutions containing penicillin.
Storage: Store below 25°C. Store in the original packaging. Do not refrigerate or freeze.
Shelf life: 36 months. Use immediately. The mixture should be prepared the same day the solution is to be used. Discard any unused portion.