Medication info
Tranexamic Acid 500 mg Tablet

Tranexamic Acid 500 mg Tablet

Prescription medicationTablet경구
Ingredient · strength
Tranexamic Acid›500mg / 1 tablet
Manufacturer / importer
지엘파마(주)
Appearance
White to off-white oval tablet
Packaging
100 tablets/PTP (10 tablets/PTP*10)
Approval status
Active

MFDS item code 202107030 · Approved 2021.10.20

Summary

Main use
Improvement of bleeding tendency associated with systemic and local fibrinolysis.
Who takes it
Adults
Adult dose
As tranexamic acid, the usual adult dosage is 750 to 2000 mg per day, divided into 3 to 4 oral doses. The dosage may be adjusted according to age and symptoms.

Ingredients

Manufacturer
지엘파마(주)

Efficacy & effects

Improvement of bleeding tendency associated with systemic and local fibrinolysis.

  • Systemic fibrinolysis
  • bleeding tendency
  • leukemia
  • aplastic anemia
  • purpura
  • abnormal bleeding during surgery
  • abnormal bleeding after surgery
  • local fibrinolysis
  • abnormal bleeding
  • pulmonary hemorrhage
  • nasal bleeding
  • genital bleeding
View approved original text

This medication is used for bleeding tendencies associated with systemic fibrinolysis, such as leukemia, aplastic anemia, purpura, and abnormal bleeding occurring during or after surgery. It is also used to treat abnormal bleeding associated with local fibrinolysis that may occur in cases of pulmonary hemorrhage, nasal bleeding, genital bleeding, renal bleeding, and during or after prostate surgery. It can assist in improving various bleeding conditions.

How to take

Adult dose

As tranexamic acid, the usual adult dosage is 750 to 2000 mg per day, divided into 3 to 4 oral doses. The dosage may be adjusted according to age and symptoms.

Precautions

This medication should not be used in patients receiving thrombin or those with severe renal failure. Additionally, it should not be administered to patients with allergic reactions to this medication or its components, or those with active thromboembolic disease. Caution is advised when used in patients with thrombosis or those at risk of thromboembolism, as well as in patients who have been bedridden for long periods post-surgery or receiving pressure hemostasis, as they are at an increased risk of thrombosis. Care must be taken in renal failure patients, as drug concentrations in the blood may increase. Rarely, hypersensitivity reactions such as shock, itching, rash, and flushing may occur; if such symptoms appear, administration should be stopped immediately, and appropriate treatment should be sought. Temporary alteration in color perception may occur, and if this symptom arises, the medication should be discontinued. Massive hematuria may occur in the upper urinary tract, particularly in hemophilia patients who may be at risk of ureteral obstruction. Gastrointestinal symptoms may include loss of appetite, nausea, vomiting, diarrhea, and abdominal discomfort. Additionally, drowsiness, headache, and arterial and venous thrombosis have rarely been reported; if these symptoms occur, consultation with a physician is recommended. Patients using this medication for a prolonged period are advised to have regular eye examinations and liver function tests. Patients with irregular menstrual bleeding should refrain from using this medication until the cause of the bleeding is identified, and if menstrual bleeding does not decrease, alternative treatments should be considered. This medication may increase the formation of blood clots when used with thrombin or hemostatic drugs, thus co-administration should be avoided or done with caution. Women using hormonal contraceptives may be at increased risk for thromboembolism and are advised to consider non-hormonal contraceptive methods. During pregnancy, as it can cross the placenta, it should be used with caution; while small amounts of the drug can be excreted in breast milk during lactation, it is expected to have little impact on infants. Safety in pediatric patients under 15 years has not been fully established, so caution is necessary. Elderly patients may have decreased physical function and should use this medication with dosage adjustments and care. In cases of overdose, symptoms such as nausea, vomiting, and orthostatic hypotension may occur, requiring treatment including inducing vomiting, gastric lavage, and activated charcoal administration, with adequate fluid intake maintained. Anticoagulant treatment should also be considered if there is a risk of thrombus formation. Finally, prolonged high-dose administration in animal studies has reported retinal changes, thus caution is warranted for long-term use.

Side effects and when to seek care immediately

Serious side effects

Shock, massive hematuria in the upper urinary tract, ureteral obstruction, arterial and venous thrombosis, thromboembolism

Mild side effects

  • Itching
  • rash
  • flushing
  • temporary alteration in color perception
  • loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • abdominal discomfort
  • drowsiness
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  • headache
  • orthostatic hypotension

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. It is advisable to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature. Storing it this way helps retain the drug's efficacy and safety over time.

Appearance and packaging

Appearance

White to off-white oval tablet

Package unit

100 tablets/PTP (10 tablets/PTP*10)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.