Amoun Pharmaceuticals Co.

Product Data

Each tablet contains: 500 mg Tranexamic.
Indications And Usage:
Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis as occurs in the following conditions: Prostatectomy and bladder surgery Menorrhagia Epistaxis Conisation of the cervix Traumatic hyphaema Hereditary angioneurotic oedema Management of dental extraction in haemophiliacs.
Hypersensitivity to tranexamic acid or any of the other ingredients Severe renal impairment because of risk of accumulation Active thromboembolic disease. History of venous or arterial thrombosis Fibrinolytic conditions following consumption coagulopathy History of convulsions.
Dosage & Administration:
Posology and method of administration Route of administration: Oral. 1. Local fibrinolysis: The recommended standard dosage is 15-25 mg/kg bodyweight (i.e. 2-3 tablets) two to three times daily. For the indications listed below the following doses may be used: 1a. Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk patients should commence pre- or post-operatively with Kapron® Injection; thereafter 2 tablets three to four times daily until macroscopic haematuria is no longer present. 1b. Menorrhagia: Recommended dosage is 2 tablets 3 times daily as long as needed for up to 4 days. If very heavy menstrual bleeding, dosage may be increased. A total dose of 4g daily (8 tablets) should not be exceeded. Treatment with Kapron® should not be initiated until menstrual bleeding has started. 1c. Epistaxis: Where recurrent bleeding is anticipated oral therapy (2 tablets three times daily) should be administered for 7 days. 1d. Conisation of the cervix: 3 tablets three times daily. 1e. Traumatic hyphaema: 2-3 tablets three times daily. The dose is based on 25 mg/kg three times a day. 2. Hereditary angioneurotic oedema: Some patients are aware of the onset of the illness; suitable treatment for these patients is intermittently 2-3 tablets two to three times daily for some days. Other patients are treated continuously at this dosage. 3. Haemophilia: In the management of dental extractions 2-3 tablets every eight hours. The dose is based on 25 mg/kg. Renal insufficiency: By extrapolation from clearance data relating to the intravenous dosage form, the following reduction in the oral dosage is recommended for patients with mild to moderate renal insufficiency. Serum Creatinine (Ìmol/l) Dose tranexamic acid 20-249 15 mg/kg body weight twice daily 250-500 15 mg/kg body weight/day Children's dosage: This should be calculated according to body weight at 25 mg/kg per dose. However, data on efficacy, posology and safety for these indications are limited. Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure .