Source: Υπουργείο Υγείας (CY) Revision Year: 2016 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Prevention and treatment of haemorrhages due to general or local fibrinolysis in adults and children from one year.
Specific indications include:
Unless otherwise prescribed, the following doses are recommended:
Standard treatment of local fibrinolysis:
0.5 g (2 ampoules of 250mg/5 ml or 1 ampoule of 500mg/5 ml) to 1 g (4 ampoules of 250mg/5 ml or 2 ampoules of 500mg/5 ml) tranexamic acid by slow intravenous injection (= 1 ml/minute) two to three times daily
Standard treatment of general fibrinolysis:
1 g (4 ampoules of 250mg/5 ml or 2 ampoules of 500mg/5 ml) tranexamic acid by slow intravenous injection (= 1 ml/minute) every 6 to 8 hours, equivalent to 15 mg/kg BW.
In renal insufficiency leading to a risk of accumulation, the use of tranexamic acid is contraindicated in patients 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:
| Serum creatinine | Dose IV | Administration | |
|---|---|---|---|
| μmol/l | mg/10 ml | ||
| 120 to 249 | 1.35 to 2.82 | 10 mg/kg BW | Every 12 hours |
| 250 to 500 | 2.82 to 5.65 | 10 mg/kg BW | Every 24 hours |
| >500 | >5.65 | 5 mg/kg BW | Every 24 hours |
No dose adjustment is required in patients with hepatic impairment.
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.
No reduction in dosage is necessary unless there is evidence of renal failure.
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.
5 years.
After first opening: the solution for injection is for single use only. Unused solution for injection must be discarded.
This medicinal product does not require any special storage conditions.
Azeptil 250mg/5ml and 500mg/5ml solution for injection are filled into brown glass type I ampoules. 5 ampoules are placed into a PVC case. Cases and leaflet in an outer carton. Boxes of ten ampoules are available.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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