Anaxyl 500 capsule: Each capsule contains Tranexamic Acid BP 500 mg.
Anaxyl 500 IV injection: Each 5 ml ampoule contains Tranexamic Acid BP 500 mg.
Anaxyl ® is a preparation of Tranexamic acid which prevents haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Tranexamic acid produces an antifibrinolytic effect by competitively inhibiting the activation of plasminogen to plasmin, thereby preventing the breakdown of fibrin clots and stabilization of fibrin structures.
Adults: The recommended standard dose is 2-3 capsules (1-1.5 g) or 5-10 ml (0.5-1 g) by slow intravenous infusion at a rate of 1 ml /min two to three times daily. Dosage of Anaxyl ® according to indication- Prostatectomy: 5-10 ml (0.5-1 g) by slow intravenous infusion every 8 hours (the first injection being given during the operation) for the first 3 days after surgery. Thereafter 2-3 capsules(1-1.5 g) three to four times daily until macroscopic haematuria is no longer present. Menorrhagia: Orally 2-3 capsules (1-1.5 g) three to four times daily for 3 to 4 days. Anaxyl ® therapy is initiated when bleeding has become profuse. Epistaxis: Orally 3 capsules (1.5 g) three times daily for 4 to 10 days. Anaxyl ® injection may be applied topically to the nasal mucosa of patients suffering from epistaxis. This can be done by soaking a gauze strip in the solution, and then packing the nasal cavity. Haematuria: Orally 2-3 capsules (1-1.5 g) two to three times daily until macroscopic haematuria is no longer present. Conisation of the cervix: Orally 3 capsules (1.5 g) three times a day for 12 to 14 days post- operatively. Dental surgery in patients with coagulopathies: Immediately before surgery, 10mg /kg body-weight should be given intravenously. After surgery, 25mg /kg body-weight are given orally three to four times daily for 6 to 8 days. Coagulation factor concentrate might be necessary to administrate. General fibrinolysis: 10 ml (1 g) by slow intravenous injection three to four times daily. With fibrinolysis in conjunction with diagnosed, increased intravascular coagulation i.e. defibrillation syndrome, an anticoagulant such as heparin may be given with caution. Hereditary angioneurotic oedema: Orally 2-3 capsules (1-1.5 g) two to three times daily as intermittent or continuoustreatment depending on whether the patient has prodromal symptoms or not. Renal insufficiency: For patients with impaired renal function, the dose of Tranexamic Acid should be decreased as there is a chance of accumulation. For these patients the following dosages are recommended:
120-249 µmol/L: 10 mg/kg IV, 15 mg/kg oral Twice daily
250-500 µmol/L: 10 mg/kg IV, 15 mg/kg oral Once daily
>500 µmol/L: 5 mg/kg IV, 7.5 mg/kg oral Once daily (or 10 mg/kg IV, 15 mg/kg oral Once every 48 hours)
For intravenous infusion Anaxyl ® injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions and dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to Anaxyl ® injection. Anaxyl ® injection should not be mixed with blood. The drug is a synthetic amino acid and should not be mixed with solutions containing penicillin. Children: For the inhibition of fibrinolysis, hereditary angioedema By mouth: Child 1 month to 18 years 15-25 mg/kg (max. 1.5 g) two to three times daily By intravenous injection over at least 10 minutes: Child 1 month to 18 years 10 mg/kg (max. 1 g) two tothree times daily By continuous intravenous infusion: Child 1 month to 18 years 45 mg/kg over 24 hours. For the prevention of excessive bleeding after dental procedures (e.g. in hemophilia) Child 6-18 years 10 mg/kg (max. 1.5 g) by intravenous injection pre-operatively, followed by 15-25 mg/ kg (max. 1.5 g) two to three times daily by mouth for up to 8 days. For menorrhagia By mouth: Child 12-18 years the recommended dose is 1 g three to four times daily for up to 4 days; max. 4 g daily (initiate when menstruation has started).
Combined oral contraceptives, estrogens, or factor IX complex increase risk of arterial and venous thrombosis; thrombolytic agents (alteplase, streptokinase) counteract antifibrinolytic effect; tretinoin co-administration increases thromboembolic complications.
Tranexamic Acid should not be given in patients with a history or risk of thrombosis, unless at the same time it is possible to give treatment with anticoagulants. It is also contraindicated in patients with active thromboembolic disease such as deep vein thrombosis, pulmonary embolism and cerebral thrombosis and subarachnoid haemorrhage. Tranexamic Acid preparations should not be given to patients with acquired disturbances of color vision.
Common: Nausea, vomiting, diarrhea. Less Common: Giddiness, hypotension (on rapid IV injection). Rare: Color vision disturbances, thromboembolic events, allergic skin reactions.
Overdose
Symptoms: nausea, vomiting, dizziness, and headache. Treatment of overdosage: if justified, vomiting should be initiated, then gastric lavage, charcoal therapy and symptomatic treatment. Adequate diuresis should be maintained. Toxicity: 37 g of Tranexamic acid caused mild intoxication in a seventeen-year-old patient after gastric
lavage.
Category B. Crosses the placenta; use during pregnancy only if clearly needed. Lactation: Passes into breast milk at ~1% maternal serum concentration; use with caution in nursing women.
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.