In medicine: Prophylaxis and treatment of hemoptysis, gastrointestinal bleeding, hemorrhagic syndromes in conditions such as leukemia, cirrhosis and hemophilia, thrombocytopenic purpura, complications during thrombolytic therapy, and bleeding associated with transfusion.

In surgery: Prophylaxis and antihemorrhagic management during various surgical procedures, especially pulmonary, cardiovascular and abdominal surgeries, as well as in post-operative and traumatic shock.

In urology: Prophylaxis and treatment of bleeding in prostate, bladder and kidney surgeries; management of hematuria.

In obstetrics: Prevention and treatment of postpartum and puerperal hemorrhage, hemorrhagic metrorrhagia, functional menometrorrhagia, idiopathic or IUD-induced menorrhagia, primary hyperfibrinolysis (such as abruptio placentae and premature placental separation), and during cervical procedures.

In otorhinolaryngology: Prophylaxis and control of bleeding during tonsillectomy and other ENT surgeries; management of epistaxis.

In stomatology: Prevention and treatment of bleeding during maxillofacial surgeries and dental extractions.

In oncology (supportive therapy): To promote fibrin capsule formation around tumors, thereby limiting tumor growth; to reduce ascites related to carcinoma; and to minimize bleeding during surgical procedures.

This preparation contains tranexamic acid (trans-4-aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a potent antifibrinolytic agent, showing significantly higher activity compared to conventional hemostatics in both in vivo and in vitro conditions. Its antihemorrhagic effect is mainly due to inhibition of plasminogen activation by both exogenous activators (such as streptokinase) and endogenous activators (such as urokinase and tissue plasminogen activator). This mechanism makes tranexamic acid effective in controlling bleeding under various clinical conditions.

Tranexamic acid has very low acute toxicity and minimal chronic toxicity. It is well absorbed when taken orally, with effects observed within 15–30 minutes. It is primarily excreted through the kidneys, although at a slower rate than conventional hemostatic agents, resulting in a longer duration of action. Therefore, lower doses can be administered at longer intervals without significant reduction in antifibrinolytic activity between doses.

At therapeutic doses, tranexamic acid does not interfere with normal clotting processes, and even with prolonged use, it has not been associated with an increased risk of thrombophilia.

Adults:

• Usual dose: 500–1000 mg three times daily.
• For prophylaxis: The average recommended daily dose is 0.5–1 g orally, or 500 mg via parenteral route (intravenous or intramuscular).
• For treatment of hemorrhagic conditions: The oral dose may be increased to 1–3 g daily in divided doses. In severe or urgent cases, begin with a slow intravenous injection of one ampoule (500 mg), followed by appropriate oral doses.

Children:

• For prophylaxis: 5–10 mg/kg body weight daily, given orally in divided doses.
• For therapeutic use: Oral doses may be increased to 10–20 mg/kg. Intravenous or intramuscular treatment may be started at 10 mg/kg (0.5 mL/5 kg) via slow IV injection, followed by oral dosing as required. In certain cases (e.g., infants), diluted ampoules may be administered orally instead of capsules.

Elderly: No dosage adjustment is required unless there is evidence of renal impairment.

Tranexamic Acid is a synthetic amino acid and is incompatible with solutions containing penicillins (e.g., benzyl penicillin). Thrombolytic agents such as streptokinase and urokinase may counteract its antifibrinolytic effect. The risk of thrombus formation may increase when used together with estrogen-containing medications, such as oral contraceptives. Direct mixing of Tranexamic Acid with whole blood should be avoided during transfusion.

Known hypersensitivity to the product. Thromboembolic disorders, including arterial and venous thrombosis, intracavitary hemorrhage, and severe renal impairment.

• Tranexamic Acid is generally well tolerated; however, occasional symptoms such as fatigue, conjunctival irritation, nasal congestion, itching, skin redness, and rashes may occur.
• After oral use, gastrointestinal symptoms like nausea, diarrhea, and gastric discomfort (heartburn) may be observed.
• Rare cases of postural hypotension have been reported.
• If hypersensitivity to tranexamic acid occurs, discontinue or suspend treatment and initiate appropriate therapy.

As the drug can cross the placenta and its effects on the fetus are not fully known, Tranexamic Acid should generally be avoided during known or suspected pregnancy. Tranexamic Acid is excreted into breast milk at approximately one hundredth of the maternal blood concentration. An antifibrinolytic effect in the breastfed infant is unlikely.

• Tranexamic Acid should be used in conditions associated with hyperfibrinolysis. Prophylactic treatment should be started 24 hours before surgery and continued for 3–4 days afterward.
• Treatment of hemorrhage should be continued for at least 24 hours after bleeding has stopped.
• In cases of hematuria, especially when not associated with other bleeding disorders, the dose should be reduced to avoid clot formation in the urinary tract.
• Tranexamic Acid is contraindicated in severe renal impairment or anuria and should be used cautiously in mild to moderate renal dysfunction.
• Special caution is required in patients with cardiac or hepatic disease.

Anti-fibrinolytic drugs,Hemostatic drugs (medicines that control bleeding)

Store in a dry place at 15–30°C, protected from light. Keep out of the reach of children.