Source: Υπουργείο Υγείας (CY) Revision Year: 2015 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis may occur in the following conditions:
The recommended standard oral doses is 15-25mg/kg bodyweight (ie.1000mg-1500mg) two to three times daily.
For the indications listed below the following doses may be used:
Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk patients should commence per or post-operatively with an injectable form of tranexamic acid; thereafter 1000 mg three to four times daily until macroscopic haematuria is no longer present.
Menorrhagia: Recommended dosage is 1000mg orally three 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 should not be exceeded. Treatment with Azeptil should not be initiated until menstrual bleeding has started.
Epistaxis: Where recurrent bleeding is anticipated oral therapy, 1000 mg three times daily should be administered for 7 days.
Conisation of the cervix: 1500mg three times daily.
Traumatic hyphaema: 1000-1500mg three times daily. The dose is based on 25mg/kg three times a day.
Hereditary angioneurotic edema: Some patients are aware of the onset of the illness; suitable treatment for these patients is intermittently 1000-1500mg two to three times daily for some days. Other patients are treated continuously at this dosage.
Haemophilia: In the management of dental extractions, 1000-1500mg every eight hours. The dose is based on 25mg/kg.
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) | Dose tranexamic acid |
|---|---|
| 120-249 | 15mg/kg body weight twice daily |
| 250-500 | 15mg/kg body weight/day |
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.However, data on efficacy, posology and safety for these indications are limited.
No reduction in dosage is necessary, unless there is evidence of renal failure (see guidelines below).
Oral.
Symptoms may be nausea, vomiting, orthostatic symptoms and/or hypotension. Initiate vomiting, then gastric lavage and charcoal therapy. Maintain a high fluid intake to promote renal excretion. There is a risk of thrombosis in predisposed individuals.
Anticoagulant treatment should be considered.
5 years.
Store below 25°C in the original package.
Azeptil is packaged in combination blisters of polyvinylchloride film and aluminum foil. Blisters and leaflet are found in an outer carton.
Azeptil is available in packs of 20, or 50 capsules as well as hospital packs of 500 or 1000 capsules.
Not all pack sizes may be marketed.
No special requirements.
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