In medicine, hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis, and hemophilia, thrombocytopenic purpura, and mishaps during thrombolytic treatment and transfusion are all treated. Prophylaxis and antihemorrhagic treatment for many types of surgeries, including pulmonary, cardiovascular, and abdominal surgery, as well as post-operative and traumatic shock. Prophylaxis and antihemorrhagic treatment for prostatic, vesical, and renal surgery in urology. Hematurias. In obstetrics, prophylaxis and treatment of postpartum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD-induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment), and cervical conization. Prophylaxis and antihemorrhagic medication after a tonsillectomy, specialty surgery in general, epistaxis. Prophylaxis and antihemorrhagic treatment after maxillofacial procedures, teeth extractions in stomatology. In oncology (as a kind of supportive therapy): To stimulate the creation of a fibrin capsule to wall off ovarian tumors and thereby prevent their progression. To produce ascites regression owing to malignancy. To minimize bleeding during surgical procedures.
This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
Adults-
- The usual dose: 500-1000 mg 3 times daily.
- For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
- For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.
Children-
- For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
- For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.
Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.
Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.
Severe renal failure, active intravascular clotting, thromboembolic disease, colour vision disorders, subarachnoid bleeding. Mild to moderate renal impairment, irregular menstrual bleeding, previous history of thromboembolic disease, haematuria. Monitor closely in disseminated intravascular coagulation. Monitor LET & eye exam regularly during long-term use. Discontinue if disturbance in colour vision occurs. Avoid IV mi rate >1 mI/minute due to risk of hypotension. Pregnancy, lactation.
Diarrhoea, nausea, vomiting, disturbances in colour vision, giddiness, hypotension (after rapid IV inj), thromboembolic events.
Tranexamic acid is categorized as pregnancy category B. No harm has been found in animal studies. Small amounts appears in breast milk if taken during lactation. If it is required for other reasons, breastfeeding may be continued. In kidney impairment, tranexamic acid is not well studied.
Store in a dry place at 15-30°C, away from light and keep out of children's reach.
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