TRANEXAMIC ACID Tranexamic acid containing medicinal products Ref.[7892] Active ingredients: Tranexamic acid

Posology

Adults

Unless otherwise prescribed, the following doses are recommended:

1. Standard treatment of local fibrinolysis: 0.5 g (1 ampule of 5 ml) to 1 g (1 ampule of 10 ml or 2 ampules of 5 ml) tranexamic acid by slow intravenous injection (= 1 ml/minute) two to three times daily
2. Standard treatment of general fibrinolysis: 1 g (1 ampule of 10 ml or 2 ampules of 5 ml) tranexamic acid by slow intravenous injection (= 1 ml/minute) every 6 to 8 hours, equivalent to 15 mg/kg BW

Renal impairment

In renal insufficiency leading to a risk of accumulation, the use of tranexamic acid is contraindicated in patient with severe renal impairment (see section 4.3). For patient with mild to moderate renal impairment, the dosage of tranexamic acid should be reduced according to the serum creatinine level:

Hepatic impairment

No dose adjustment is required in patient with hepatic impairment.

Paediatric Population

In children from 1 year, for current approved indications as described in section 4.1, the dosage is in the region of 20 mg/kg/day. However, data on efficacy, posology and safety for these indications are limited.

The efficacy, posology and safety of tranexamic acid in children undergoing cardiac surgery have not been fully established. Currently available data are limited and are described in section 5.1.

Elderly

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

Method of administration

The administration is strictly limited to slow intravenous injection.

No case of overdose has been reported.

Signs and symptoms may include dizziness, headache, hypotension, and convulsions. It has been shown that convulsions tend to occur at higher frequency with increasing dose.

Management of overdose should be supportive.