API

Ethamsylate (500mg)

Drug classification

Hemostatic agent; specific subclass: synthetic antihemorrhagic (capillary stabilizer).

Dosage form

Film-coated oral tablet containing 500 mg of ethamsylate.

API strength per dosage

Dose

Ethamsylate 500 mg is typically administered orally 2–3 times daily for adults; dosing in children is weight-based and should follow specialist guidance. Adjustments may be necessary in severe renal or hepatic impairment. Always consult product-specific information and prescriber instructions for individual cases. Safety and efficacy in paediatric populations require careful consideration.

Mechanism of action

Ethamsylate promotes hemostasis by enhancing capillary endothelial stability and improving platelet adhesion. It acts primarily by stimulating the synthesis of prostaglandin PGI2 (prostacyclin), which reduces capillary bleeding, and by facilitating platelet aggregation at sites of vascular injury, thereby reducing blood loss without affecting normal coagulation parameters.

Indications

Bleeding

Side effects

Skin rash Vomiting Headache Nausea Diarrhea

Pregnancy category

Ethamsylate should be used during pregnancy only if clearly needed; safety in pregnancy is not well established. Consult a healthcare professional before use.

Precautions

Hypersensitivity reactions, history of thrombosis, bleeding disorders, renal or hepatic impairment, pregnancy and lactation status, monitor for signs of thrombosis, monitor platelet count, monitor for gastrointestinal disturbances, use with caution in children, assess ongoing need for therapy regularly.

Contraindications

Hypersensitivity to ethamsylate, acute porphyria, history of thromboembolic disease, current use in patients with active intravascular clotting, known intolerance to excipients.