API

Drug classification

Dosage form

Film-Coated Tablet

API strength per dosage

Each film coated tablets contains Tranexamic …

Dose

Adults: 1-1.5 g orally three times daily for heavy menstrual bleeding. Pediatrics: 25 mg/kg orally three times daily for heavy menstrual bleeding. Adjust dose for renal impairment; contraindicated in patients with active thromboembolic disease, history of thrombosis, or consuming combination hormonal contraceptives with a history of thrombosis.

Mechanism of action

Tranexamic acid inhibits plasminogen activation by binding to plasminogen's lysine-binding sites, preventing its conversion to plasmin. This action reduces fibrinolysis, stabilizing blood clots and reducing bleeding.

Indications

Menorrhagia, hereditary angioedema, prophylaxis and treatment of hemorrhage associated with excessive fibrinolysis, dental procedures in patients with coagulopathies, trauma-induced bleeding, postpartum hemorrhage, epistaxis.

Side effects

Nausea, vomiting, diarrhea, orthostatic hypotension, thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism), visual disturbances, dizziness, headache, myalgia, nasal and sinus symptoms, anemia, skin reactions.

Pregnancy category

Precautions

Renal impairment, history of thromboembolic disease, concurrent use of thrombogenic agents, subarachnoid hemorrhage, visual disturbances, disseminated intravascular coagulation without concomitant treatment of the underlying disorder, active intravascular clotting, hypersensitivity to tranexamic acid, pregnancy (unless clearly necessary), lactation.

Contraindications

Active thromboembolic disease, history of thrombosis or thromboembolism, severe renal impairment, subarachnoid hemorrhage, hypersensitivity to tranexamic acid, concurrent use of factor IX complex concentrates or anti-inhibitor coagulant concentrates.