Kapron® tablets

Composition:

Each tablet contains: 500 mg Tranexamic.

Indications And Usage:

Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis as occurs in the following conditions: Prostatectomy and bladder surgery Menorrhagia Epistaxis Conisation of the cervix Traumatic hyphaema Hereditary angioneurotic oedema Management of dental extraction in haemophiliacs.

Contraindications:

Hypersensitivity to tranexamic acid or any of the other ingredients Severe renal impairment because of risk of accumulation Active thromboembolic disease. History of venous or arterial thrombosis Fibrinolytic conditions following consumption coagulopathy History of convulsions.

Dosage & Administration:

Posology and method of administration Route of administration: Oral. 1. Local fibrinolysis: The recommended standard dosage is 15-25 mg/kg bodyweight (i.e. 2-3 tablets) two to three times daily. For the indications listed below the following doses may be used: 1a. Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk patients should commence pre- or post-operatively with Kapron® Injection; thereafter 2 tablets three to four times daily until macroscopic haematuria is no longer present. 1b. Menorrhagia: Recommended dosage is 2 tablets 3 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 (8 tablets) should not be exceeded. Treatment with Kapron® should not be initiated until menstrual bleeding has started. 1c. Epistaxis: Where recurrent bleeding is anticipated oral therapy (2 tablets three times daily) should be administered for 7 days. 1d. Conisation of the cervix: 3 tablets three times daily. 1e. Traumatic hyphaema: 2-3 tablets three times daily. The dose is based on 25 mg/kg three times a day. 2. Hereditary angioneurotic oedema: Some patients are aware of the onset of the illness; suitable treatment for these patients is intermittently 2-3 tablets two to three times daily for some days. Other patients are treated continuously at this dosage. 3. Haemophilia: In the management of dental extractions 2-3 tablets every eight hours. The dose is based on 25 mg/kg. Renal insufficiency: 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 (Ìmol/l) Dose tranexamic acid 20-249 15 mg/kg body weight twice daily 250-500 15 mg/kg body weight/day Children's dosage: 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. Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure .

Drug Interactions:

Interaction with other medicinal products and other forms of interaction Kapron® will counteract the thrombolytic effect of fibrinolytic preparations.

How Supplied:

Strips of 10 tablets in packs of 2 strips .

Precautions:

Special warnings and precautions for use In case of haematuria of renal origin (especially in haemophilia), there is a risk of mechanical anuria due to formation of a ureteral clot. In the long-term treatment of patients with hereditary angioneurotic oedema, regular eye examinations (e.g. visual acuity, slit lamp, intraocular pressure, visual fields) and liver function tests should be performed. Patients with irregular menstrual bleeding should not use Kapron® until the cause of irregular bleeding has been established. If menstrual bleeding is not adequately reduced by Kapron®, an alternative treatment should be considered. Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis. Patients with a previous thromboembolic event and a family history of thromboembolic disease (patients with thrombophilia) should use Kapron® only if there is a strong medical indication and under strict medical supervision. The blood levels are increased in patients with renal insufficiency. Therefore a dose reduction is recommended . The use of tranexamic acid in cases of increased fibrinolysis due to disseminated intravascular coagulation is not recommended. Patients who experience visual disturbance should be withdrawn from treatment. Clinical experience with Kapron® in menorrhagic children under 15 years of age is not available. Interaction with other medicinal products and other forms of interaction Kapron® will counteract the thrombolytic effect of fibrinolytic preparations.
Effects on ability to drive and use machines: None known.

Pregnancy & Lactation:

Pregnancy and lactation Pregnancy Although there is no evidence from animal studies of a teratogenic effect, the usual caution with use of drugs in pregnancy should be observed. Tranexamic acid crosses the placenta. Lactation 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 Immune system disorders Very rare: Hypersensitivity reactions including anaphylaxis Eye disorders Rare: Colour vision disturbances, retinal/artery occlusion Vascular disorders Rare: Thromboembolic events Very rare: Arterial or venous thrombosis at any sites Gastro-intestinal disorders Very rare: Digestive effects such as nausea, vomiting and diarrhoea, may occur but disappear when the dosage is reduced. Skin and subcutaneous tissue disorders Rare: Allergic skin reactions.