API

Tranexamic Acid (500mg)

Drug classification

Antifibrinolytic agent; synthetic lysine analog.

Dosage form

Melano-TX OD Tablet SR is an oral, sustained-release tablet formulation.

API strength per dosage

Dose

Tranexamic acid dosing varies by indication. For adults, typical oral doses range from 500 mg to 1,500 mg 2–3 times daily. Dose adjustment may be needed in renal impairment; use with caution in hepatic impairment. Safety and dosing in children depend on indication and weight. Always follow specific product labeling and clinical guidelines.

Mechanism of action

Tranexamic acid inhibits fibrinolysis by reversibly binding to lysine sites on plasminogen, blocking its activation to plasmin. This prevents plasmin from degrading fibrin clots, thereby stabilizing clots and reducing bleeding. It does not affect platelet count or coagulation parameters directly.

Indications

Treatment of Bleeding

Side effects

Musculoskeletal bone muscle or joint pain Joint pain Headache Back pain Vomiting Nausea Abdominal pain Fatigue Diarrhea Hypotension low blood pressure Sinus disorder Nasal discomfort Muscle cramp Migraine Anemia low number of red blood cells Allergic dermatitis Lightheadedness Thromboembolism

Pregnancy category

Tranexamic acid should be used during pregnancy only if clearly needed; limited human data, animal studies show no teratogenicity, but caution is advised.

Precautions

History of thromboembolic disease, active intravascular clotting, renal impairment, visual disturbances, subarachnoid hemorrhage, concurrent hormonal contraceptives, hematuria of renal origin, monitor renal function, monitor for thrombotic events, monitor vision changes, use caution in elderly, assess for hypersensitivity reactions.

Contraindications

Active intravascular clotting, history of thromboembolic disease, subarachnoid hemorrhage, acquired defective color vision, hypersensitivity to tranexamic acid or excipients.