Capsule: Should not be used in patients with active intravenous clotting because of the risk of thrombosis. Patients with a predisposition to thrombosis are also at risk if given anti-fibrinolytic therapy.
Haemorrhage due to disseminated intravenous coagulation should therefore not be treated with anti-fibrinolytic compounds unless the condition is predominantly due to disturbances in fibrinolytic mechanisms; tranexamic acid has been used when the latter conditions are met, but with careful monitoring and anti-coagulant cover.
Injection: Patients with irregular menstrual bleeding should not use Tranexamic acid until the cause of the irregularity has been established. If menstrual bleeding is not adequately reduced by Tranexamic acid, an alternative treatment should be considered.
Patients with a high risk of thrombosis (a previous thromboembolic event and a family history of thromboembolic disease) should use Tranexamic acid only if there is a strong medical indication and under strict medical supervision.
Patients with disseminated intravascular coagulation (DIC), who require treatment with Tranexamic acid, must be under the strict supervision of a physician experienced in treating this disorder.
The blood levels are increased in patients with renal insufficiency. Therefore a dose reduction is recommended, see Dosage & Administration. In haematuria from the upper urinary tract blood clots can, in a few cases, lead to ureteric Obstruction.
In the long-term treatment of patients, regular eye examination should be performed. The preparation should not be used in patients with acquired defective colour vision. If a colour vision disorder should occur during the course of treatment, the drug should be discontinued.
No retinal changes have been reported or established in eye examination performed on patient treated with Tranexamic acid over periods ranging from several weeks to months. For patients who are to receive continual treatment with Tranexamic acid for several weeks and ophthalmological examination is advised (including visual acuity, colour vision, eyegrounds, field of vision etc.) if possible before commencing treatment and at regular intervals during treatment.
Injection: Use in Pregnancy: Tranexamic acid crosses the placenta. Clinical experience of use in pregnant women is limited. Usual caution with the use of drugs in pregnancy should be observed.
Use in Lactation: Tranexamic acid passes into breast milk to a concentration of approximately 100 of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.