22 Nov 2011

Cyklokapron Tablets (Tranexamic acid - menorrhagia) - United Kingdom

Updated: 22 Nov 2011

Cyklokapron Tablets

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

Cyklokapron Tablets Description, Presentation and Dosage

Cyklokapron Tablets Description

Cyklokapron Tablets Drug Class Description

Antifibrinolytics.

Cyklokapron Tablets Drug Description

Each tablet contains Tranexamic acid 500 mg as the active ingredient.

Cyklokapron Tablets Generic Name

Tranexamic acid - menorrhagia

Cyklokapron Tablets Presentation

Cyklokapron Tablets Presentation

Film-coated tablets. White, oblong tablets, 8x18 mm, engraved CY with an arc above and below the lettering, for oral use.

Cyklokapron Tablets Manufacturer

Meda Pharmaceuticals

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Cyklokapron Tablets Dosage

Cyklokapron Tablets Adult Dosage

 

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 Cyklokapron 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 Cyklokapron should not be initiated until menstrual bleeding has started.

1cEpistaxis: 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 (μmol/l) Dose tranexamic acid
120-249 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

 

Cyklokapron Tablets Child Dosage

 

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 Cyklokapron 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 Cyklokapron should not be initiated until menstrual bleeding has started.

1cEpistaxis: 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 (μmol/l) Dose tranexamic acid
120-249 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

 

Cyklokapron Tablets Elderly Dosage

 

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 Cyklokapron 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 Cyklokapron should not be initiated until menstrual bleeding has started.

1cEpistaxis: 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 (μmol/l) Dose tranexamic acid
120-249 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

 

Cyklokapron Tablets Precautions, Reactions and Contraindications

Cyklokapron Tablets Special Precautions

Cyklokapron Tablets Special Precautions

 

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 Cyklokapron until the cause of irregular bleeding has been established. If menstrual bleeding is not adequately reduced by Cyklokapron, 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 Cyklokapron 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 Cyklokapron in menorrhagic children under 15 years of age is not available.

 

 

 

Cyklokapron Tablets Adverse Reactions

Cyklokapron Tablets Adverse Reactions

 

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (GREATER-THAN OR EQUAL TO (8805)1/l0), common (GREATER-THAN OR EQUAL TO (8805)1/100 and <1/10), uncommon (GREATER-THAN OR EQUAL TO (8805)1/1000 and <1/100), rare (GREATER-THAN OR EQUAL TO (8805) 1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data).

 

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

 

Cyklokapron Tablets Contraindications

Cyklokapron Tablets 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

 

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