Source: Υπουργείο Υγείας (CY) Revision Year: 2015 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Pharmacotherapeutic group: Antihemorrhagics, Antifibrinolytics, Aminoacids
ATC code: B02AA02
Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the activation of plasminogen to plasmin. At much higher concentrations it is a non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen activation by urokinase has been reported to be 6-100 times and be streptokinase 6-40 times greater than that of aminocaproic acid. The anti-fibrinolytic activity of tranexamic acid is approximately ten times greater than that of aminocaproic acid.
Peak plasma tranexamic acid concentration is obtained immediately after intravenous administration administration (500mg). Then concentration decreases until the 6th hour. Elimination half-life is about 3 hours.
Tranexamic acid administered parenterally is distributed in a two compartment model. Tranexamic acid is delivered in the cell compartment and the cerebrospinal fluid with delay. The distribution volume is about 33% of the body mass.
Tranexamic acid crosses the placenta and may reach one hundredth of the serum peak concentration in the milk of lactating women.
Tranexamic acid is excreted in urine as unchanged compound. 90% of the administered dose is excreted by the kidney in the twelve first hours after administration (glomerular excretion without tubular reabsorption).
Following oral administration, 1.13% and 39% of the administered dose were recovered after 3 and 24 hours respectively.
Plasma concentrations are increased in patients with renal insufficiency.
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
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