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Tranexamic Acid is an Anti Fibrinolytic for excessive bleeding
Each Capsule contains:
Tranexamic Acid ……………………………………………………………… 500 mg
White or almost white crystalline powder encapsulated in empty gelatin capsule size #0 with
pink opaque body and gray opaque cap.
Tranexamic acid (SYTRANEX) is an anti-fibrinolytic drug which inhibits breakdown of fibrin
clots. Its primary action is to block the binding of plasminogen and fibrinolysin to fibrin.
Tranexamic Acid (SYTRANEX) is absorbed from the gastrointestinal tract with peak plasma
concentrations occurring after about 3 hours. Bioavailability is about 30%-50%. Tranexamic
Acid (SYTRANEX) is widely distributed throughout the body and has very low protein
binding. It diffuses across the placenta and is distributed into breast milk. Tranexamic Acid
(SYTRANEX) has a plasma elimination half-life of about 2 hours. It is excreted in the urine
mainly as unchanged drug.
Treatment and prophylaxis of hemorrhage associated with excessive fibrinolysis.
DOSAGE AND MODE/ROUTE OF ADMINISTRATION:
Oral: The recommended standard dose is 1 capsule twice or thrice daily.
Or as prescribed by a physician.
• Hypersensitivity to tranexamic acid or any component of the product.
• Active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism,
• History of thrombosis or thromboembolism (e.g., retinal vein or artery occlusion) or
intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvular disease,
thrombogenic cardiac rhythm disease, hypercoagulopathy), unless at the same time it is
possible to give treatments with anticoagulants.
• Patients receiving thrombin because of increased risk of thrombosis
• Patients with acquired disturbances of color vision.
• Patients with subarachnoid hemorrhage since cerebral edema and cerebral infarction may
be caused by tranexamic acid in such cases.
WARNING AND PRECAUTIONS:
Tranexamic acid should not be used in patients with active intravascular clotting or patients
with predisposition to thrombosis because of the risk of thrombosis. It should not also be
used in patients with hemorrhage due to disseminated intravascular coagulation unless the
condition is predominantly due to disturbances of fibrinolytic mechanisms. Clots in the renal
system can lead to intrarenal obstruction, so caution is required in the treatment of patients,
with haematuria. Doses of tranexamic acid should be reduced in patients with renal
PREGNANCY AND LACTATION:
PREGNANCY CATEGORY B:
Either animal-reproduction studies have not demonstrated a fetal risk but there are no
controlled studies in pregnant women or animal-reproduction studies have shown an
adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies
in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Tranexamic acid (SYTRANEX) is present in the mother’s milk at a concentration of about
one hundredth of the corresponding serum concentration. Tranexamic Acid (SYTRANEX)
should be used during lactation only if clearly needed.
• Batroxobin: May cause thromboembolism.
• Coagulation factor agents: Coagulation may be further activated at sites with enhanced
local fibrinolysis such as the oral cavity.
• Hemocoagulase: Coadministration at high doses may cause thrombosis.
• Estrogens: Increased risk of thrombus formation.
ADVERSE DRUG EFFECTS:
Tranexamic Acid appears to be well tolerated. However, it can produce dose–related
gastrointestinal disturbances. Its use has also been associated with transient disturbance of
color vision. Hypersensitivity skin reactions have also been reported.