TRANEXAMIC ACID

Posology Adults:

The recommended standard dose is 15-25 mg / kg body weight (which generally equates to 2 to 3 tablets), two to three times a day.

The following doses are also suggested for the listed indications:

Prostatectomy: Prophylaxis and treatment of haemorrhage in high-risk patients should commence pre or post operatively with tranexamic acid injection. Thereafter 2 tablets should be dosed three to four times a day until macroscopic haematuria is no longer present.

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.

Epistaxis: 2 tablets should be dosed three times a day for seven days where recurrent bleeding is anticipated. Conisation of the cervix: 3 tablets should be dosed three times a day. Traumatic hyphaema: 2 to 3 tablets should be dosed three times a day.

This dose should be based on a dose of 25 mg / kg body weight three times a day. Hereditary angioneurotic oedema: 2 to 3 tablets should generally be dosed two to three times a day. In some patients this dosing should be continuous, but intermittent treatment can be used where patients are aware of the onset of the illness.

Haemophilia: 2 to 3 tablets should be dosed three times a day in the management of dental extractions. Again, this dose should be based on a dose of 25 mg / kg body weight.

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/1) Dose tranexamic acid 120-249 15 mg/kg body weight/twice daily 250-500 15 mg/kg body weight/day.

Elderly:

No reduction in dosage is necessary unless there is any evidence of renal failure.

Adverse events reported are listed below by System Organ Class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data).

4) 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 coagulations 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.

This medicine contains less than 1mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1 • Severe renal impairment because of the risk of accumulation • Active thromboembolic disease • History of venous or arterial thrombosis • Fibrinolytic conditions following disseminated intravascular coagulation • History of convulsions