Tranexamic acid is an antifibrinolytic agent that inhibits tissue activators responsible for converting plasminogen into plasmin
Each film-coated tablet contains:
• Tranexamic Acid BP – 500 mg
• Excipients – q.s.
• Colour: Titanium Dioxide BP
Tranexamic acid is an antifibrinolytic agent that inhibits tissue activators responsible for converting plasminogen into plasmin. At higher concentrations, it acts as a non-competitive inhibitor of plasmin. Its inhibitory effect on plasminogen activation by urokinase is 6–100 times greater, and by streptokinase 6–40 times greater, than that of aminocaproic acid. Tranexamic acid has approximately ten times the antifibrinolytic activity of aminocaproic acid.
Tranexamic acid is used for short-term treatment and prevention of bleeding associated with increased fibrinolysis or fibrinogenolysis. Local fibrinolysis may occur in the following conditions:
• Prostatectomy and bladder surgery
• Menorrhagia (heavy menstrual bleeding)
• Epistaxis (nosebleeds)
• Cervical conization
• Traumatic hyphema
• Management of tooth extraction in patients with hemophilia
• Hereditary angioedema
Dosage and Administration:
Adults
Local fibrinolysis:
The recommended standard dose is 15–25 mg/kg body weight (equivalent to 2–3 tablets) two to three times daily.
a. Prostatectomy:
For high-risk patients, prevention and treatment of bleeding should begin pre- or post-operatively with injectable therapy, followed by 2 tablets three to four times daily until macroscopic hematuria resolves.
b. Menorrhagia:
Recommended dose: 2 tablets three times daily. Treatment duration should be determined individually but should not exceed 4 days. In cases of very heavy bleeding, the dose may be increased. The total daily dose should not exceed 4 g (8 tablets). Treatment should not begin before menstrual bleeding starts.
c. Epistaxis:
For recurrent nosebleeds, oral therapy with 2 tablets three times daily for 7 days is recommended.
d. Cervical Conization:
3 tablets three times daily.
e. Traumatic Hyphema:
2–3 tablets three times daily (equivalent to 25 mg/kg three times daily).
For tooth extraction, 2–3 tablets every 8 hours (equivalent to 25 mg/kg).
Hereditary Angioedema:
Patients experiencing prodromal symptoms may take 2–3 tablets two to three times daily for several days as needed. Other patients may require continuous treatment at the same dosage.
Route of Administration:
For oral use.
• Hypersensitivity to tranexamic acid or any excipient
• Severe renal impairment due to the risk of accumulation
• Active thromboembolic disease
• History of venous or arterial thrombosis
• Fibrinolytic conditions following coagulopathy
• History of seizures
Pregnancy:
Although animal studies have not demonstrated teratogenic effects, caution should be exercised during pregnancy. Tranexamic acid crosses the placenta.
Breastfeeding:
Tranexamic acid passes into breast milk at approximately 1% of the maternal serum concentration. An antifibrinolytic effect in infants is considered unlikely.
Overdose:
Signs and Symptoms:
Nausea, vomiting, orthostatic symptoms and/or hypotension, dizziness, headache, and seizures.
Treatment:
Induce vomiting, perform gastric lavage, administer activated charcoal, and encourage adequate fluid intake to increase renal elimination. Patients predisposed to thrombosis may be at increased risk; anticoagulant therapy should be considered where appropriate.
Store below 30°C in a dry place protected from light and moisture.
Keep out of the reach of children.
