Tranexamic Acid

Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. • Local fibrinolysis occurs in the following conditions: Prostatectomy Menorrhagia Epistaxis Conisation of the cervix Traumatic hyphaema Management of dental extraction in haemophiliacs • Hereditary angioneurotic oedema

1 Pediatrics Based on the data submitted and reviewed by Health Canada, the safety and efficacy of tranexamic acid in pediatric patients has been established for use in hereditary angioneurotic oedema and increased local fibrinolysis when the diagnosis is indicative of hyperfibrinolysis.

Specific data is available for surgical patients undergoing cardiac and orthopedic surgeries. Therefore, Health Canada has authorized Tranexamic Acid Tablets in these indications for pediatric use. For menorrhagia (hypermenorrhea), limited data are available to Health Canada.

Clinical experience with tranexamic acid in menorrhagic (hypermenorrhea) children under 18 years of age is not available. Therefore, Health Canada has not authorized Tranexamic Acid Tablets for this indication for pediatric use. 2 Geriatrics Clinical studies of tranexamic acid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

1 INDICATIONS AND USAGE Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

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