Kapron® ampoules

Composition:

Each 5 ml ampoule contains: 500 mg Tranexamic

Indications And Usage:

Therapeutic indications Local fibrinolysis For short term use in prophylaxis and treatment in patients at high risk of per - and post-operative haemorrhage following:

a) prostatectomy

b) conisation of the cervix

c) surgical procedures and dental extractions in haemophiliacs

General fibrinolysis a) haemorrhagic complications in association with thrombolytic therapy. b) Haemorrhage associated with disseminated intravascular coagulation with predominant activation of the fibrinolytic system.

Contraindications:

History of venous or arterial thrombosis • History of convulsions • Intrathecal and intraventricular injection, intracerebral application (risk of cerebral oedema and convulsions)

Dosage & Administration:

Posology and method of administration
Route of administration: by slow intravenous injection. Local fibrinolysis: the recommended standard dose is 5-10ml (500-1000mg) by slow intravenous injection (1 ml/min), three times daily. Following an initial intravenous injection, subsequent treatment may proceed by intravenous infusion. Following addition to a suitable diluent , Kapron® may be administered at a rate of 25-50 mg/kg body wt/day. Children: In children, for current approved indications, the dosage is in the region of 20 mg/kg/day. However, data on efficacy, posology and safety for these indications are limited. Injectable solution: The efficacy, posology and safety of Tranexamic acid in children undergoing cardiac surgery have not been fully established. Currently available data are limited. Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure. General fibrinolysis 1. In disseminated intravascular coagulation with predominant activation of the fibrinolytic system, usually a single dose of 10ml (1g) is sufficient to control bleeding. 2 Neutralisation of thrombolytic therapy; 10mg/kg body wt by slow intravenous injection.

How Supplied:

Packs of 6 ampoules

Precautions:

Special warnings and precautions for use The indications and method of administration indicated above should be followed strictly: • Intravenous injections should be given very slowly • Tranexamic acid should not be administered by the intramuscular route. • Due to the risk of cerebral oedema and convulsions, intrathecal or intraventricular injection and intracerebral application are contra-indicated. In patients with a history of convulsion, tranexamic acid should not be administered. • In case of haematuria of renal origin, there is a risk of mechanical anuria due to formation of a ureteral clot. • In patients with renal insufficiency, because of the risk of accumulation. The dose should be reduced according to the following table:

Serum Creatinine	I.V Dose	Dose Frequency
120-250 mcmol	10mg /kg	twice daily

 

Serum Creatinine	I.V Dose	Dose Frequency
>500 mcmol	5mg /kg	Evry 24 th hour

 

Serum Creatinine	I.V Dose	Dose Frequency
250-500 mcmol	10mg /kg	Evry 24 th hour

 

In massive haematuria from the upper urinary tract (especially in haemophilia) since, in a few cases, ureteric obstruction has been reported. • In patients with disseminated intravascular coagulation (DIC) treatment must be restricted to those in whom there is predominant activation of the fibrinolytic system with acute severe bleeding. Characteristically, the haematological profile approximates to the following: reduced euglobulin clot lysis time; prolonged prothrombin time; reduced plasma levels of fibrinogen, factors V and VIII, plasmin gen and alpha-2 macroglobulin; normal plasma levels of P and P complex; i.e. factors II (prothrombin), VIII and X; increased plasma levels of fibrinogen degradation products; a normal platelet count. The foregoing presumes that the underlying disease state does not of itself modify the various elements in this profile. In such acute cases a single dose of 1g tranexamic acid is frequently sufficient to control bleeding. The fibrinolytic activity in the blood will be reduced for about 4 hours if renal function is normal. Anticoagulation with heparin should be instigated in order to prevent further fibrin deposition. Administration of Kapron® in DIC should be considered only when appropriate haematological laboratory facilities and expertise are available. Kapron® must not be administered in DIC with predominant activation of the coagulation system. • Before use of TXA, risk factors of thromboembolic disease should be investigated. • Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis. Interaction with other medicinal products and other forms of interaction: The solution for injection may be mixed with the following solutions: isotonic sodium chloride; isotonic glucose; 20% fructose; 10% invertose; dextran 40; dextran 70; ringer's solution. Kapron® solution for injection may be mixed with Heparin. Effects on ability to drive and use machines:
None known

Pregnancy & Lactation:

Pregnancy and lactation: Although there is no evidence from animal studies of a teratogenic effect, the usual caution with the use of drugs in pregnancy should be observed. Tranexamic acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

Adverse Effects:

Undesirable effects Very rare adverse events have been reported : • Gastro-intestinal disorders: digestive effects such as nausea, vomiting and diarrhoea. • Cardio-vascular disorders : • malaise with hypotension, with or without loss of consciousness (generally following a too fast intravenous injection, exceptionally after oral administration) • arterial or venous thrombosis at any sites • Nervous system disorders: dizziness; convulsions, particularly in case of misuse • General disorders: hypersensitivity reactions including anaphylaxi.s