TRANEXAMIC ACID

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 per- or post-operatively with an injectable form; 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 tranexamic acid should not be initiated until menstrual bleeding has started.

1c.

Epistaxis:

When repeated bleeding is anticipated oral therapy (2 tablets three times daily) should be administered for 7 days. 1d. Cervix Conisation: 3 tablets three times daily 1e. Traumatic Hyphaema: 2-3 tablets 3 times daily. The dose is based on 25mg/kg three times a day.

2.

Haemophilia:

In the management of dental extractions 2-3 tablets every eight hours. The dose is based on 25mg/kg. 3.

Hereditary angioneurotic oedema:

Some patients are aware of the onset of 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.

Pediatric population:

This should be calculated according to bodyweight at 25mg/kg per dose at the adult dosing frequencies. However, data on efficacy, posology and safety for these indications are limited.

Elderly:

No reduction in dosage is necessary unless there is evidence of renal failure (see guidelines below). 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( μmol/l) Oral Dose Dose Frequency 120-249 15 mg/kg body weight twice daily 250-500 15 mg/kg body weight daily Method of administration Oral

Adverse effects have been ranked under headings of frequency using the following convention: Very common (≥ 1/10) Common (≥1/100, <1/10) Uncommon (≥1/1000, <1/100) Rare (≥ 1/10,000, <1/1,000) Very rare (<1/10,000) including isolated reports Not known (cannot be estimated from the available data).

4) Skin and subcutaneous tissue disorders Rare: Allergic skin reactions.

Not known:

Fixed drug eruption Vascular disorders Rare: thromboembolic events.

Very rare:

Arterial or venous thrombosis at any sites Eye disorders Rare: colour vision disturbances, retinal/artery occlusion Renal and urinary disorders Not known: Acute renal cortical necrosis Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard).

In case of haematuria of renal origin (especially in haemophilia), there is a risk for urinary obstruction at the lower levels of the tract. If left untreated, urinary obstruction may lead to serious consequences such as renal insufficiency, urinary tract infection, hydronephrosis, and anuria.

Therefore, close monitoring is recommended for those patients with haematuria or risk of haematuria from the upper urinary tract. g. visual acuity, slit lamp, intraocular pressure, visual fields) and liver function tests should be performed.

Patients with irregular menstrual bleeding should not use Tranexamic Acid until the cause of irregular bleeding has been established. If menstrual bleeding is not adequately reduced by Tranexamic Acid, an alternative treatment should be considered.

Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis. Patients with a previous thromboembolic event and a family history of thromboembolic disease (patients with thrombophilia) should use Tranexamic Acid only if there is a strong medical indication and under strict medical supervision.

The blood levels are increased in patients with renal insufficiency. 2). The use of tranexamic acid in cases of increased fibrinolysis due to disseminated intravascular coagulation is not recommended. Patients who experience visual disturbance should be withdrawn from treatment.

Clinical experience with Tranexamic Acid in menorrhagic children under 15 years of age is not available. Cases of convulsions have been reported in association with tranexamic acid treatment. ) injection of tranexamic acid in high doses.

1 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