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P: 877-845-6371Antifibrinolytic Agent. For Intravenous Injection. INDICATIONS AND USAGE Tranexamic acid injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Tranexamic acid injection is contraindicated:
- In patients with acquired defective color vision, since this prohibits measuring one endpoint that should be followed as a measure of toxicity.
- In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients.
- In patients with active intravascular clotting.
- In patients with hypersensitivity to tranexamic acid or any of the ingredients.
The dose of tranexamic acid injection should be reduced in patients with renal insufficiency because of the risk of accumulation. Ureteral obstruction due to clot formation in patients with upper urinary tract bleeding has been reported in patients treated with tranexamic acid injection. Venous and arterial thrombosis or thromboembolism has been reported in patients treated with tranexamic acid injection. In addition, cases of central retinal artery and central retinal vein obstruction have been reported. Patients with a previous history of thromboembolic disease may be at increased risk for venous or arterial thrombosis. Tranexamic acid injection should not be administered concomitantly with Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased. Patients with disseminated intravascular coagulation (DIC), who require treatment with tranexamic acid, must be under strict supervision of a physician experienced in treating this disorder. Tranexamic acid may cause dizziness, and therefore may influence the ability to drive or use machines. Pregnancy and Labor and Delivery
There are no adequate and well-controlled studies in pregnant women. However, tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration. Nursing Mothers
Tranexamic acid is present in the mother’s milk. Caution should be exercised when tranexamic acid injection is administered to a nursing woman. Pediatric Use
The drug has had limited use in pediatric patients, principally in connection with tooth extraction. Geriatric Use
Dose selection in elderly patients should be cautious. ADVERSE REACTIONS Gastrointestinal disturbances may occur. Allergic dermatitis, giddiness, and hypotension have been reported occasionally. Hypotension has been observed when intravenous injection is too rapid. Worldwide Post-Marketing Reports: Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction) have been rarely reported in patients receiving tranexamic acid for indications other than hemorrhage prevention in patients with hemophilia. Convulsion, chromatopsia, and visual impairment have also been reported. However, due to the spontaneous nature of the reporting of medical events and the lack of controls, the actual incidence and causal relationship of drug and event cannot be determined. Anaphylaxis or anaphylactoid reactions have been reported that are suggestive of a causal relationship. Overdosage
Cases of overdosage of tranexamic acid injection have been reported. Based on these reports, symptoms of overdosage may be gastrointestinal, hypotensive, thromboembolic, neurologic, myoclonus and rash. For additional Safety Information, please see Full Prescribing Information. You are encouraged to report Adverse Drug Events (ADEs) to American Regent Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/MedWatch or calling 1-800-FDA-1088.