D-Tramix 500 mg

Generic Name:
Tranexamic Acid

Composition:
Each D-Tramix Capsule contains Tranexamic Acid BP 500 mg.

Pharmacology:
Tranexamic Acid is an antifibrinolytic agent used to treat serious bleeding. It acts as a competitive inhibitor of plasminogen activation and binds strongly to both strong and weak receptor sites of plasminogen.

Indications:
Tranexamic Acid is indicated for prophylaxis and treatment of pre- and post-operative haemorrhage or risk of haemorrhage in the following conditions:

• Prostatectomy and bladder surgery
• Menorrhagia
• Epistaxis
• Conization of the cervix
• Management of dental extraction in patients with coagulopathies
• Ulcerative colitis
• Haematuria
• Gastrointestinal haemorrhage
• General fibrinolysis as in prostatic and pancreatic cancer
• Cyclic heavy menstrual bleeding
• Haemorrhage associated with disseminated intravascular coagulation with predominant activation of the fibrinolytic system
• Melasma

Dosage & Administration:
Recommended dosage of Tranexamic Acid Capsule:

Adults:
• Usual dose: 500–1000 mg three times daily.
• For prophylaxis: 0.5–1 g orally daily.
• For haemorrhagic manifestations: Oral dose may be increased to 1–3 g daily in divided doses.

Children:
• For prophylaxis: 5–10 mg/kg body weight daily in divided doses.
• For therapeutic purposes: Oral doses may be increased to 10–20 mg/kg.

Dosage should be determined according to the patient's condition and as directed by a registered physician.

Contraindications:
Tranexamic Acid is contraindicated in:

• Patients with a history of thromboembolic disease such as deep vein thrombosis, pulmonary embolism and cerebral thrombosis
• Subarachnoid haemorrhage
• Hypersensitivity to Tranexamic Acid or any of the ingredients

Warning & Precaution:
• The dose of Tranexamic Acid should be reduced in patients with renal insufficiency because of the risk of accumulation.

Side Effects:
The insert states that there is no known case of side effect of Tranexamic Acid capsule and injection. Reported symptoms may include:

• Nausea
• Vomiting
• Diarrhoea
• Dizziness
• Disturbed colour vision

Drug Interactions:
• Co-administration with penicillin-type antibiotics should be approached with caution.
• Thrombolytic drugs such as Streptokinase and Urokinase may antagonise the antifibrinolytic action of Tranexamic Acid.
• The potential for thrombus formation may be increased with concomitant administration of estrogen-containing drugs such as oral contraceptives.
• Direct admixture of Tranexamic Acid with whole blood should be avoided during transfusion.

Use in Pregnancy & Lactation:
• Pregnancy Category B.
• Reproduction studies in mice, rats and rabbits did not reveal evidence of impaired fertility or adverse effects on the fetus.
• There are no adequate and well-controlled studies in pregnant women.
• Tranexamic Acid is present in breast milk at approximately one-hundredth of the corresponding serum concentration.
• Caution should be exercised when administered to a nursing woman.

Overdose:
No specific information is available on the treatment of overdose.

Storage:
• Store below 30°C.
• Protect from light and moisture.
• Store in a dry and cool place.
• Keep out of reach of children.

Packing:
Each box contains 30 capsules in Alu-PVC blister pack.

Dosage Form:
Capsule