A fixed-dose combination (FDC) of two hemostatic agents with complementary mechanisms of action. Tranexamic acid is a synthetic lysine analog antifibrinolytic, while Ethamsylate is a synthetic hemostatic agent that improves platelet adhesion and reduces capillary bleeding. This combination is widely used in India for the management and prophylaxis of bleeding from various causes, particularly in gynecological conditions like menorrhagia. It is considered a rational combination as it targets different pathways of hemostasis.
Adult: 1 tablet (Tranexamic Acid 250mg + Ethamsylate 250mg) three to four times daily. For menorrhagia: Typically started 3-4 days before expected menses and continued through heavy flow days, up to 5 days per cycle.
Note: Administer orally with or after food to minimize gastrointestinal upset. Tablets should be swallowed whole with a glass of water. For menorrhagia, therapy is usually cyclic, not continuous throughout the month.
The combination works synergistically. Tranexamic Acid competitively inhibits the activation of plasminogen to plasmin, preventing fibrinolysis and clot breakdown. Ethamsylate acts by increasing platelet adhesion by correcting impaired platelet aggregation (possibly via prostaglandin synthesis modulation) and reducing capillary permeability and fragility. This dual action stabilizes clots and prevents capillary bleeding.
Pregnancy: Category B (US FDA) for Tranexamic Acid. Ethamsylate: Animal studies show no risk, human data limited. Use only if clearly needed and potential benefit justifies potential risk to the fetus. Not recommended in first trimester unless absolutely necessary.
Driving: May cause dizziness, visual disturbances, or lethargy. Patients should not drive or operate machinery until they know how the medicine affects them.
| Hormonal Contraceptives (Combined Oral Contraceptives) | Increased risk of thromboembolic events; additive effect. | Major |
| Anticoagulants (Warfarin, NOACs like Apixaban, Rivaroxaban) | May antagonize the effect of anticoagulants, reducing INR. Caution required. | Moderate |
| Anti-fibrinolytics (Aprotinin, Aminocaproic Acid) | Additive antifibrinolytic effect, increased risk of thrombosis. | Major |
| Factor IX Complex Concentrates / Antithrombin III | Increased risk of thrombosis. | Major |
| Tretinoin (All-trans-retinoic acid) | Increased risk of thrombosis (reported with concomitant use in APL). | Moderate |
Same composition (Tranexamic Acid (250mg) + Ethamsylate (250mg)), different brands: