Tranexamic acid parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of tranexamic acid.
Drugs List
Therapeutic Indications
Uses
General fibrinolysis: treatment
Local fibrinolysis: short-term treatment
Prevention of local fibrinolysis
Prevention or treatment of haemorrhage due to fibrinolysis.
Indications include:
Menorrhagia and metrorrhagia
Gastrointestinal bleeding
Haemorrhagic urinary disorders
Ear, nose or throat surgery
Gynaecological surgery or disorders of obstetric origin
Thoracic, abdominal or cardiovascular surgery
Management of haemorrhage due to the administration of a fibrinolytic agent.
Unlicensed Uses
Haemorrhage following trauma
Hereditary angioedema
Dosage
Adults
Local fibrinolysis
The usual dosage is 500mg to 1g by slow intravenous injection (1ml/minute) two to three times daily.
This may be followed by 25 to 50mg/kg/day by intravenous (unlicensed).
General fibrinolysis
1g tranexamic acid by slow intravenous injection (1ml/minute) every 6 to 8 hours, equivalent to 15mg/kg body weight.
Treatment and prevention of trauma-induced haemorrhage (unlicensed)
Initial dose: 1g given over ten minutes by intravenous injection. Start within 8 hours of the trauma.
Maintenance dose: 1g given over 8 hours by continuous intravenous infusion (unlicensed).
Children
Children aged 1 year and older
The dosage is in the region of 20mg/kg/day. However, data on efficacy, posology and safety are limited.
The following alternative unlicensed dosage schedule may be suitable:
Inhibition of fibrinolysis, hereditary angioedema
By intravenous injection over at least 10 minutes
10mg/kg (maximum per dose 1g), two to three times daily.
By continuous intravenous infusion (unlicensed)
45mg/kg, dose to be given over 24 hours.
Prevention of excessive bleeding after dental procedures (e.g. in haemophilia)
By intravenous injection pre-operatively
Children aged 6 to 18 years: 10mg/kg (maximum per dose 1.5g).
Patients with Renal Impairment
The manufacturer recommends the dosage should be reduced as follows:
Serum creatinine 120 to 249micromole/L: 10mg/kg every 12 hours.
Serum creatinine 250 to 500micromole/L: 10mg/kg every 24 hours.
Serum creatinine greater than 500micromole/L: 5mg/kg every 24 hours.
The Renal Drug Handbook suggests the following doses:
Glomerular filtration rate (GFR)
GFR 20 to 50mL/minute: 10mg/kg 12 hourly.
GFR 10 to 20mL/minute: 10mg/kg 24 hourly.
GFR less than 10mL/minute: 5mg/kg 24 hourly.
Administration
For slow intravenous injection or infusion (1ml/minute) or continuous intravenous infusion (unlicensed) administration.
Contraindications
Neonates
Breastfeeding
Disseminated intravascular coagulation without reactive major fibrinolysis
First trimester of pregnancy
History of seizures
Severe renal impairment
Thromboembolic disorder
Precautions and Warnings
Children aged 1 month to 1 year
Family history of thromboembolic disorder
Females of childbearing potential
Undiagnosed irregular menstrual bleeding
Haematuria
History of thromboembolic disorder
Renal impairment
Second trimester of pregnancy
Third trimester of pregnancy
Reduce dose in patients with renal impairment
Do not mix with other drugs or substances
During prolonged therapy eye examinations are advisable
Monitor hepatic function in patients with hereditary angioneurotic oedema
Advise patient to report any blurred vision or any other eye symptoms
Discontinue if any kind of visual disturbance occurs
Female: Ensure adequate contraception during treatment
Massive haemorrhage from upper urinary tract, risk of urethral obstruction has been reported (especially in haemophilia).
Before use of tranexamic acid, risk factors for thromboembolic disease should be investigated.
Tranexamic acid should be administered with care in patients receiving oral contraceptives due to an increased risk of thrombosis.
Tranexamic acid should only be considered in patients with disseminated intravascular coagulation when appropriate haematological laboratory facilities are available.
Pregnancy and Lactation
Pregnancy
Use tranexamic acid with caution during pregnancy.
The manufacturer does not recommend using tranexamic acid during the first trimester of pregnancy, and should only be used throughout pregnancy if the expected benefit justifies the potential risk. At the time of writing there is limited published information regarding the use of tranexamic acid during pregnancy. Potential risks are unknown.
Lactation
Tranexamic acid is contraindicated during breastfeeding.
Use of tranexamic acid when breastfeeding is contraindicated by the manufacturer. Tranexamic acid is present in human breast milk. Effects on exposed infants are unknown.
Side Effects
Allergic skin reactions
Anaphylaxis
Arterial thrombosis
Convulsions
Diarrhoea
Dizziness
Hypersensitivity reactions
Hypotension
Impaired consciousness
Macular degeneration of colour vision
Malaise
Nausea
Venous thrombosis
Visual disturbances
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: August 2021
Reference Sources
Summary of Product Characteristics: Cyklokapron injection. Pharmacia Ltd. Revised March 2019.
Summary of Product Characteristics: Tranexamic acid 500mg/5ml solution for injection. Focus Pharmaceuticals Ltd. Revised June 2015.
Summary of Product Characteristics: Tranexamic acid 1g/10ml solution for injection ampoules. Bowmed Ibisqus Limited. Revised January 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 August 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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