Source: Υπουργείο Υγείας (CY) Revision Year: 2023 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:
Hereditary angioneurotic oedema
Management of dental extraction in haemophiliacs
The recommended standard dosage is 15-25mg/kg bodyweight (2-3 tablets) 2-3 times daily.
For the indications listed below the following doses may be used:
Adults
Prostatectomy:
Prophylaxis and treatment of haemorrhage in high risk patients should commence per- or post-operatively with an injectable form of tranexamic acid; thereafter 2 tablets (1 g) 3-4 times daily until macroscopic haematuria is no longer present.
Menorrhagia:
2-3 tablets (1-1.5 g) 3-4 times daily for 3-4 days. Tranexamic acid therapy should be initiated only after heavy bleeding has started.
Epistaxis:
Where recurrent bleeding is anticipated oral therapy, 2 tablets (1 g) 3 times daily should be administered for 7 days.
Conisation of the cervix:
3 tablets (1.5 g) 3 times daily.
Traumatic hyphaema:
2-3 tablets (1-1.5 g) 3 times a day. The dose is based on 25 mg/kg 3 times a day.
Hereditary angioneurotic edema:
2-3 tablets 2-3 times daily intermittently for some days, or continuously, depending on whether or not the patient has prodromal symptoms.
Haemophilia:
In the management of dental extractions, 2-3 tablets (1-1.5 g) every eight hours. The dose is based on 25mg/kg.
Upper gastrointestinal haemorrhage:
10 ml tranexamic acid injection by slow intravenous injection every 6 hours for the first 3 days, then 2-3 tablets (1-1.5 g) orally every 6 hours for a further 3-4 days.
In children, 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.
No reduction in dosage is necessary unless there is evidence of renal failure.
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 | 15 mg/kg body weight twice daily |
| 250-500 | 15 mg/kg body weight/day |
Oral.
No cases of overdosage have 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 of tranexamic acid. Initiate vomiting, then stomach lavage, and charcoal therapy. Maintain a high fluid intake to promote renal excretion.
5 years.
Store below 25°C in the original package, in order to protect from light.
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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