Drugs List

Therapeutic Indications

Uses

Epistaxis
Haemorrhage - after dental extraction in haemophilia
Hereditary angioneurotic oedema
Local fibrinolysis: short-term treatment
Menorrhagia
Prevention of local fibrinolysis

Contraindications

Neonates
Disseminated intravascular coagulation without reactive major fibrinolysis
History of seizures
Severe renal impairment
Thromboembolic disorder

Precautions and Warnings

Family history of thromboembolic disorder
Undiagnosed irregular menstrual bleeding
Breastfeeding
Haematuria
History of thromboembolic disorder
Pregnancy
Renal impairment

Use in menorrhagia before onset of bleeding is not recommended
No clinical experience in menorrhagic children (less than 15 years)
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Some products may have a pharmacy only legal classification
Monitor hepatic function in patients with hereditary angioneurotic oedema
Regular eye examinations in patients with hereditary angioneurotic oedema
Discontinue if disturbance of colour vision occurs

In the long term treatment of patients with hereditary angioneurotic oedema, regular eye examinations and liver function tests should be performed. Eye examinations should include visual acuity, slit lamp, intraocular pressure and visual fields.

If menstrual bleeding is not adequately reduced by tranexamic acid, 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.

When being sold to the public as a 'P' medicine
The following patient groups should consult their doctor prior to initiating treatment:
Women over the age of 45;
Patients with diabetes;
Obese patients;
Patients with polycystic ovary syndrome or a history of endometrial cancer in a first degree relative;
Patients receiving unopposed oestrogen or tamoxifen;
Patients should consult doctor if menstrual bleeding is not reduced after three menstrual cycles.

Pregnancy and Lactation

Pregnancy

Tranexamic acid should be used with caution in pregnancy.

There is no evidence of teratogenicity in animal studies and no adverse effects to the foetus or newborn have been reported following the use of tranexamic acid in pregnancy in either humans or animals. Tranexamic acid crosses the human placenta, however its lack of effect on plasminogen activator activity in the vascular wall versus the drug effects in the peripheral circulation, the foetus and newborn may be protected from potential thromboembolic effects (Briggs, 2011). Schaefer (2007) suggests that there are no specific indications for use of tranexamic acid during pregnancy and that inadvertent use of the drug during the first trimester does not require termination or invasive diagnostic procedures.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Tranexamic acid should be used with caution during breastfeeding.

Tranexamic acid is also contraindicated in neonates. Tranexamic acid passes into the breast milk in small amounts to a concentration of approximately one hundredth of the concentration in the maternal blood. The amount absorbed by a nursing infant has not be determined and any resultant effects are unknown (Briggs, 2011). An antifibrinolytic effect in the infant is unlikely. Because amounts in the breast milk appear to be low and the drug has a half life of about 2 hours, waiting for 3 to 4 hours after a dose before nursing again is thought to minimise the infants dosage.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic skin reactions
Anaphylaxis
Arterial thrombosis
Convulsions
Diarrhoea
Dizziness
Hypersensitivity reactions
Hypotension
Impaired consciousness
Macular degeneration of colour vision
Malaise
Nausea
Retinal artery occlusion
Thromboembolic complications
Venous thrombosis
Visual disturbances
Vomiting

Presentation

Oral formulations of tranexamic acid.

Drugs List

Therapeutic Indications

Uses

Epistaxis
Haemorrhage - after dental extraction in haemophilia
Hereditary angioneurotic oedema
Local fibrinolysis: short-term treatment
Menorrhagia
Prevention of local fibrinolysis

Dosage

Adults

Children

Patients with Renal Impairment

Contraindications

Neonates
Disseminated intravascular coagulation without reactive major fibrinolysis
History of seizures
Severe renal impairment
Thromboembolic disorder

Precautions and Warnings

Family history of thromboembolic disorder
Undiagnosed irregular menstrual bleeding
Breastfeeding
Haematuria
History of thromboembolic disorder
Pregnancy
Renal impairment

Use in menorrhagia before onset of bleeding is not recommended
No clinical experience in menorrhagic children (less than 15 years)
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Some products may have a pharmacy only legal classification
Monitor hepatic function in patients with hereditary angioneurotic oedema
Regular eye examinations in patients with hereditary angioneurotic oedema
Discontinue if disturbance of colour vision occurs

In the long term treatment of patients with hereditary angioneurotic oedema, regular eye examinations and liver function tests should be performed. Eye examinations should include visual acuity, slit lamp, intraocular pressure and visual fields.

If menstrual bleeding is not adequately reduced by tranexamic acid, 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.

When being sold to the public as a 'P' medicine
The following patient groups should consult their doctor prior to initiating treatment:
Women over the age of 45;
Patients with diabetes;
Obese patients;
Patients with polycystic ovary syndrome or a history of endometrial cancer in a first degree relative;
Patients receiving unopposed oestrogen or tamoxifen;
Patients should consult doctor if menstrual bleeding is not reduced after three menstrual cycles.

Pregnancy and Lactation

Pregnancy

Tranexamic acid should be used with caution in pregnancy.

There is no evidence of teratogenicity in animal studies and no adverse effects to the foetus or newborn have been reported following the use of tranexamic acid in pregnancy in either humans or animals. Tranexamic acid crosses the human placenta, however its lack of effect on plasminogen activator activity in the vascular wall versus the drug effects in the peripheral circulation, the foetus and newborn may be protected from potential thromboembolic effects (Briggs, 2011). Schaefer (2007) suggests that there are no specific indications for use of tranexamic acid during pregnancy and that inadvertent use of the drug during the first trimester does not require termination or invasive diagnostic procedures.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Tranexamic acid should be used with caution during breastfeeding.

Tranexamic acid is also contraindicated in neonates. Tranexamic acid passes into the breast milk in small amounts to a concentration of approximately one hundredth of the concentration in the maternal blood. The amount absorbed by a nursing infant has not be determined and any resultant effects are unknown (Briggs, 2011). An antifibrinolytic effect in the infant is unlikely. Because amounts in the breast milk appear to be low and the drug has a half life of about 2 hours, waiting for 3 to 4 hours after a dose before nursing again is thought to minimise the infants dosage.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic skin reactions
Anaphylaxis
Arterial thrombosis
Convulsions
Diarrhoea
Dizziness
Hypersensitivity reactions
Hypotension
Impaired consciousness
Macular degeneration of colour vision
Malaise
Nausea
Retinal artery occlusion
Thromboembolic complications
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: April 2015

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press Accessed on 16 April 2015.

Summary of Product characteristics: Boots Cyklo-f heavy period relief 500mg tablets. The Boots Company Plc. Revised March 2014.

Summary of Product Characteristics: Cyklokapron tablets. Meda Pharmaceuticals. Revised February 2014.
Summary of Product characteristics: Cyklo-f 500mg film coated tablets. Meda Pharmaceuticals. Revised March 2014.

Summary of Product characteristics: Menstralite 500mg tablets. Sovereign Medical. Revised December 2014.

Summary of Product characteristics: Tranexamic acid 500mg tablets. Sandoz Ltd. Revised November 2014.

The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 04 September 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Tranexamic acid. Last revised: 11 November, 2014.
Last accessed: 16 April, 2015.