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Antifibrinolytic (Haemostatic) Pregnancy: SPC §4.6, verbatim (abridged only by omitting the animal-study cross-references): 'Women of childbearing potential have to use effective contraception during treatment (see sections 4.4 and 4.5).' 'Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or foetal outcomes. There are cases of foetal structural abnormalities that resulted in death of the newborn following administration of tranexamic acid to the mother during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear. ... Tranexamic acid passes through the placenta. The concentration in cord blood after an intravenous injection of 10 mg/kg to pregnant women is about 30 mg/L, as high as in the maternal blood. There were 13 clinical studies that described foetal and/or neonatal functional issues such as low Apgar score, neonatal sepsis, cephalohematoma and 9 clinical studies that discussed alterations to growth including low birth weight and preterm birth at 22-36 weeks of gestation in foetuses and infants exposed to tranexamic acid in-utero. For decisions regarding the use of tranexamic acid during pregnancy, the potential risk of tranexamic acid administration on the foetus should always be considered along with the mother's clinical need for tranexamic acid; an accurate risk-benefit evaluation should drive the treating physician's decision.' BREAST-FEEDING (§4.6): 'Published literature reports the presence of tranexamic acid in human milk. There are limited data on the effects of tranexamic acid on the breast-fed child or the effects on milk production ... Due to limited data, no final assessment can be established on the use of tranexamic acid during breast-feeding.' FERTILITY (§4.6): 'There are no clinical data on the effects of tranexamic acid on fertility.'

Tranexamic Acid (Surgical / Trauma Haemorrhage)

Brand names: Cyklokapron, Exacyl

Tranexamic acid is an antifibrinolytic used in surgery and major trauma to prevent and treat haemorrhage, given intravenously in trauma and theatre and also orally for bleeding such as menorrhagia.

Adult dose

Dose: Standard treatment of local fibrinolysis: 0.5 g (1 ampoule of 5 mL) to 1 g (1 ampoule of 10 mL or 2 ampoules of 5 mL) by slow intravenous injection or infusion (= 1 mL/minute), two to three times daily. Standard treatment of general fibrinolysis: 1 g by slow intravenous injection or infusion (= 1 mL/minute) every 6 to 8 hours, equivalent to 15 mg/kg body weight
Route: Intravenous only — slow intravenous injection or infusion at a maximum of 1 mL per minute; must not be given intramuscularly, intrathecally, epidurally, intraventricularly or intracerebrally
Frequency: Local fibrinolysis: two to three times daily. General fibrinolysis: every 6 to 8 hours
SCOPE — READ FIRST: the source is the IV Cyklokapron SPC, and what it doses is 'local fibrinolysis' and 'general fibrinolysis'. It contains NO trauma (CRASH-2) protocol, NO at-incision-and-repeat surgical regimen and no trauma total-dose ceiling — so the surgical-haemorrhage and CRASH-2 regimens shown elsewhere on this page are NOT supported by this source and must be re-sourced from the trial or guideline literature (their figures are not repeated here, because the point of this rebuild is to retire un-resourced dose numbers). SPC §4.1 (indications) was not fetched, so the exact licensed indications behind 'local' and 'general' fibrinolysis cannot be quoted here. || VERBATIM SPC §4.2: 'Adults Unless otherwise prescribed, the following doses are recommended: 1. Standard treatment of local fibrinolysis: 0.5 g (1 ampoule of 5 mL) to 1 g (1 ampoule of 10 mL or 2 ampoules of 5 mL) tranexamic acid by slow intravenous injection or infusion (= 1 mL/minute) two to three times daily 2. Standard treatment of general fibrinolysis: 1 g (1 ampoule of 10 mL or 2 ampoules of 5 mL) tranexamic acid by slow intravenous injection or infusion (= 1 mL/minute) every 6 to 8 hours, equivalent to 15 mg/kg body weight (BW)' || ROUTE — SAFETY (SPC §4.2, verbatim, capitals in the original): 'The administration is strictly limited to slow intravenous injection or infusion (see section 6.6) of maximum 1 mL per minute. TRANEXAMIC ACID SHOULD ONLY BE ADMINISTERED INTRAVENOUSLY and should not be administered intrathecally or epidural (see sections 4.3 and 4.4). IN ORDER TO REDUCE THE RISK OF FATAL MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION OF TRANEXAMIC ACID, IT IS STRONGLY RECOMMENDED TO LABEL THE SYRINGES CONTAINING TRANEXAMIC ACID.' SPC §4.4 adds: 'Tranexamic acid must not be administered by the intramuscular route' and 'Serious adverse reactions including fatal events have been reported when tranexamic acid was inadvertently administered intrathecally. These events have included severe back, gluteal and lower limb pain, myoclonus and generalised seizures, and cardiac arrhythmias.' || MAXIMUM: the SPC states NO absolute daily ceiling for the IV regimens above, so none is published — do not infer one by multiplying the 6- to 8-hourly dose. || ELDERLY (§4.2, verbatim): 'No reduction in dosage is necessary unless there is evidence of renal failure.' || US CROSS-CHECK — A DIFFERENT INDICATION, NOT THE DOSE ABOVE: the US label doses only haemophilia patients around tooth extraction — 'The recommended dose of tranexamic acid injection is 10 mg/kg actual body weight intravenously administered as a single-dose, immediately before tooth extractions', then 'for 2 to 8 days at a dose of 10 mg/kg actual body weight 3 to 4 times daily, intravenously', with 'Infuse no more than 1 mL/minute to avoid hypotension.' Do not transfer those figures to surgical or trauma haemorrhage.

Paediatric dose

Dose: 20 mg/kg/day
Route: Intravenous only — slow intravenous injection or infusion at a maximum of 1 mL per minute
Frequency: Total daily dose in children from 1 year — the SPC does not state how the 20 mg/kg/day is divided
Concentration: 100 mg/ml
SPC §4.2, verbatim: 'Paediatric population In children from 1 year, for current approved indications as described in section 4.1, the dosage is in the region of 20 mg/kg/day. However, data on efficacy, posology and safety for these indications are limited. The efficacy, posology and safety of tranexamic acid in children undergoing cardiac surgery have not been fully established. Currently available data are limited and are described in section 5.1.' SCOPE AND CAUTIONS: this is a TOTAL DAILY dose (mg/kg/day), NOT a per-dose figure — the SPC does not state how it is divided, does not state a paediatric maximum, and gives no dosing below 1 year. Section 4.1 (indications) was not retrieved in this bundle, so the 'current approved indications' this daily dose attaches to cannot be listed from the source. The 100 mg/mL concentration is the strength of the source product (Cyklokapron 100 mg/mL solution for injection/infusion). Verify any under-18 dose against a children's formulary before prescribing. US cross-check §8.4: 'There are limited data concerning the use of tranexamic acid injection in pediatric patients with hemophilia who are undergoing tooth extraction. The limited data suggest that there are no significant pharmacokinetic differences between adults and pediatric patients.' The bundle's WHO entry is reference-only and directs paediatric dosing to the WHO Model Formulary for Children, which was not fetched.

Dose adjustments

Renal

SPC §4.2, verbatim: 'For patients with renal impairment, the dosage of tranexamic acid should be reduced according to the serum creatinine level: Serum creatinine 120 to 249 micromol/L (1.35 to 2.82 mg/dL) — 10 mg/kg BW every 12 hours; 250 to 500 micromol/L (2.82 to 5.65 mg/dL) — 10 mg/kg BW every 24 hours; > 500 micromol/L (> 5.65 mg/dL) — 5 mg/kg BW every 24 hours.' (Note the SPC's mg/dL band boundaries are printed as 1.35 to 2.82 and 2.82 to 5.65 — they overlap at 2.82 in the source.) Elderly (§4.2, verbatim): 'No reduction in dosage is necessary unless there is evidence of renal failure.'

Hepatic

SPC §4.2, verbatim: 'Hepatic impairment No dose adjustment is required in patient with hepatic impairment.'

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Paediatric weight-based calculator

SPC §4.2, verbatim: 'Paediatric population In children from 1 year, for current approved indications as described in section 4.1, the dosage is in the region of 20 mg/kg/day. However, data on efficacy, posology and safety for these indications are limited. The efficacy, posology and safety of tranexamic acid in children undergoing cardiac surgery have not been fully established. Currently available data are limited and are described in section 5.1.' SCOPE AND CAUTIONS: this is a TOTAL DAILY dose (mg/kg/day), NOT a per-dose figure — the SPC does not state how it is divided, does not state a paediatric maximum, and gives no dosing below 1 year. Section 4.1 (indications) was not retrieved in this bundle, so the 'current approved indications' this daily dose attaches to cannot be listed from the source. The 100 mg/mL concentration is the strength of the source product (Cyklokapron 100 mg/mL solution for injection/infusion). Verify any under-18 dose against a children's formulary before prescribing. US cross-check §8.4: 'There are limited data concerning the use of tranexamic acid injection in pediatric patients with hemophilia who are undergoing tooth extraction. The limited data suggest that there are no significant pharmacokinetic differences between adults and pediatric patients.' The bundle's WHO entry is reference-only and directs paediatric dosing to the WHO Model Formulary for Children, which was not fetched.

Verify in a children's formulary

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (SPC §4.3)
  • Acute venous or arterial thrombosis (SPC §4.3, see §4.4)
  • Fibrinolytic conditions following consumption coagulopathy except in those with predominant activation of the fibrinolytic system with acute severe bleeding (SPC §4.3, see §4.4)
  • History of convulsions (SPC §4.3)
  • Intrathecal, epidural, intraventricular injection and intracerebral application — risk of cerebral oedema and convulsions and death (SPC §4.3)
  • Not a UK contraindication but a US-label contraindication (cross-check, tranexamic acid injection): 'In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients.'
  • Not a UK contraindication but a US-label contraindication (cross-check): 'In patients with active intravascular clotting'

Side effects

  • Common (≥1/100 to <1/10), SPC §4.8: diarrhoea; vomiting; nausea
  • Uncommon (≥1/1,000 to <1/100): dermatitis allergic
  • Frequency not known: hypersensitivity reactions including anaphylaxis
  • Frequency not known: convulsions, particularly in case of misuse (SPC §4.8, see §4.3 and §4.4)
  • Frequency not known: visual disturbances including impaired colour vision
  • Frequency not known: malaise with hypotension, with or without loss of consciousness — SPC §4.8: 'generally following a too fast intravenous injection, exceptionally after oral administration'
  • Frequency not known: arterial or venous thrombosis at any sites
  • US label §6 (cross-check): 'Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events.' Post-marketing: 'Hypotension has been reported when intravenous injection is too rapid' and thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery/vein obstruction) — this US section was truncated at the source-fetch limit

Monitoring

  • Correct route — SPC §4.4: 'Care should be exercised to ensure the correct route of administration of Cyklokapron ... Syringes containing Cyklokapron should be clearly labelled with the intravenous route of administration.'
  • Infusion rate — SPC §4.4: 'Intravenous injections or infusions should be given very slowly (max. 1 mL per minute)'
  • Visual disturbances — SPC §4.4: 'Attention should be paid to possible visual disturbances including visual impairment, vision blurred, impaired colour vision and if necessary, the treatment should be discontinued. With continuous long-term use of tranexamic acid, regular ophthalmologic examinations (eye examinations including visual acuity, colour vision, fundus, visual field etc.) are indicated.'
  • Haematuria — SPC §4.4: 'In case of haematuria from the upper urinary tract, there is a risk for urinary obstruction at the lower levels of the tract ... Therefore, close monitoring is recommended for those patients with haematuria or risk of haematuria from the upper urinary tract.'
  • Thromboembolic risk — SPC §4.4: 'Before use of tranexamic acid, risk factors of thromboembolic disease should be considered.'
  • Seizures — SPC §4.4: 'Cases of convulsions have been reported in association with tranexamic acid treatment. In coronary artery bypass graft (CABG) surgery, most of these cases were reported following intravenous (IV.) injection of tranexamic acid in high doses. With the use of the recommended lower doses of tranexamic acid, the incidence of post-operative seizures was the same as that in untreated patients.'
  • US label §5 (cross-check): 'Risk of Thrombosis with Concomitant Use of Factor IX: Avoid concomitant use'; 'FOR INTRAVENOUS USE ONLY'; 'Seizures: Inadvertent injection into neuraxial system may result in seizures'; 'Visual Disturbances: Visual or ocular adverse effects may occur. Discontinue use if visual or ocular symptoms occur'; 'Dizziness: Advise patients not to drive if dizziness occurs'
  • US label §7.1 (cross-check): 'Avoid concomitant use of tranexamic acid injection with medical products that are prothrombotic' — including Factor IX Complex concentrates, Anti-inhibitor Coagulant concentrates, and hormonal contraceptives
  • US label §8.5 (cross-check, older patients): 'This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function ... care should be taken in dose selection, and it may be useful to monitor renal function'
  • This list may be incomplete — check the full SPC.

Clinical monograph

How it works

It binds the lysine sites on plasminogen, blocking its conversion to plasmin and thereby inhibiting fibrinolysis, which stabilises formed clots and reduces bleeding.

Prescribing in practice

  • In significant traumatic or surgical haemorrhage early administration improves outcome, so give it promptly and ideally within the first hours of injury, after which benefit declines.
  • Use cautiously where there is active thromboembolic disease, a strong thrombotic tendency, or disseminated intravascular coagulation, and reduce exposure in renal impairment as it is renally cleared.
  • Rapid intravenous injection can cause hypotension, so administer the infusion slowly.

Monitoring

Monitor bleeding control, haemodynamic status and renal function, remaining alert for any clinical signs of thromboembolism.

Counselling the patient

  • Report calf swelling or pain, chest pain, or breathlessness, which may signal a clot.
  • Visual changes are rare but should be reported, particularly with longer oral courses.

Evidence & guidelines

The CRASH-2 and WOMAN trials and UK major-haemorrhage protocols support early tranexamic acid in trauma and surgical bleeding.

Reference: CRASH-2 trial (Lancet 2010); WOMAN Trial (Lancet 2017); NICE Trauma Haemorrhage Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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