Valid Ghana · FDA Ghana

TRANEXAMIC ACID TABLETS 500MG

TRANEXAMIC ACID

FDA/GD.223-110203 500MG

What it does

Tranexamic acid is a medicine that helps reduce excessive bleeding.

Commonly used for: heavy menstrual bleeding (menorrhagia), bleeding after surgery, bleeding disorders

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/GD.223-110203
Registration date
2022-11-25
Expiry date
2027-02-11
Status
Valid
Active ingredient
TRANEXAMIC ACID
Dosage form
-
Strength
500MG
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Vega Biotics
Country of origin
INDIA
Manufacturer location
Unnamed Road, Madhav Nagar, Akota, Vadodara, Gujarat 390007, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:03 · updated 2026-09-25 04:00:03

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Tranexamic acid is a medicine that helps reduce excessive bleeding.

What it treats

  • heavy menstrual bleeding (menorrhagia)
  • bleeding after surgery
  • bleeding disorders

How it works

It helps the blood to clot more effectively, which reduces bleeding.

Who it's for

This medicine is for people who experience heavy bleeding due to various medical conditions.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: tranexamic

Tranexamic acid is a synthetic derivative of the amino acid lysine, primarily used as an antifibrinolytic agent. It works by inhibiting the activation of plasminogen to plasmin, which reduces the breakdown of fibrin and stabilizes blood clots, making it effective in conditions where bleeding is a concern. It is commonly used in surgeries, trauma, and certain bleeding disorders.

Indications

  • Heavy menstrual bleeding (menorrhagia)
  • Surgical procedures to reduce blood loss
  • Trauma-related bleeding
  • Hereditary angioedema
  • Dental procedures in patients with bleeding disorders

Dosage

Children: Refer to the BNF for Children for specific dosing guidelines based on age, weight, and indication.

Adults: Refer to the BNF for specific dosing guidelines based on indication and patient condition.

Mechanism of action

Tranexamic acid competitively inhibits the lysine binding sites on plasminogen, preventing its conversion to plasmin. This inhibition decreases fibrinolysis, leading to increased clot stability and reduced bleeding.

Pharmacodynamics

The primary pharmacodynamic effect of tranexamic acid is its ability to reduce bleeding by stabilizing fibrin clots. The drug exhibits a dose-dependent effect on clotting, with higher doses leading to a more pronounced antifibrinolytic effect. Tranexamic acid does not significantly affect platelet function or coagulation factors.

Pharmacokinetics

Tranexamic acid is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 1 to 3 hours. It has a bioavailability of approximately 30% to 50%. The drug is primarily excreted unchanged in the urine, with a half-life of approximately 2 hours. It does not undergo significant metabolism in the liver, which is beneficial in patients with hepatic impairment.

Contra-indications

  • Active venous thromboembolism
  • History of thromboembolic disorders
  • Severe renal impairment
  • Hypersensitivity to tranexamic acid or any excipients

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Dizziness
  • Headache
  • Visual disturbances
  • Thrombosis
  • Hypotension
  • Allergic reactions

Interactions

  • Anticoagulants (increased risk of thrombosis)
  • Hormonal contraceptives (increased risk of thrombosis)
  • Fibrinolytics (increased risk of bleeding)

Precautions

  • Monitor for signs of thrombosis during treatment
  • Use with caution in patients with a history of seizures
  • Caution in patients with renal impairment
  • Assess the risk of bleeding before use

Pregnancy

Tranexamic acid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Tranexamic acid is excreted in breast milk; caution should be exercised when administered to nursing mothers.

Storage

Store at room temperature, away from moisture and direct sunlight. Keep out of reach of children.

Formulations

  • Tablets
  • Injection solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.