Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Tranexamic acid

Generic name
Tranexamic acid
Brand name
ATC Code
B02AA02

Pharmacokinetics in children

No information

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Mucous membrane bleeding with a blood clotting disorder
  • Oral
    • 0 years up to 18 years and < 40 kg
      • 25 - 50 mg/kg/day in 3 - 4 doses.
      • Duration of treatment:

        7-10 days

      • The intravenous liquid can also be administered orally.

    • 0 years up to 18 years and ≥ 40 kg
      • 3 - 4 g/day in 3 - 4 doses.
      • Duration of treatment:

        7-10 days

  • Intravenous
    • 0 years up to 18 years
      • 25 mg/kg/day in 3 - 4 doses.
      • Duration of treatment:

        7-10 days
Massive bleeding in case of trauma
  • Intravenous
    • 1 month up to 18 years
      • Initial dose: 15 mg/kg/dose, bolus in 10 minutes. Max: 1 g/dose.
      • Maintenance dose: in continued massive bleeding 2 mg/kg/hour, continuous infusion over 8 hours or until bleeding stops.
    • Term neonate
      • Initial dose: 15 mg/kg/dose, bolus in 10 minutes. Max: 1 g/dose.
      • Maintenance dose: 2 mg/kg/hour, continuous infusion over 8 hours or until bleeding stops.

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Renal impaiment in children > 3 months

Oral

  • GFR ≥ 50: no dosage adjustment is needed
  • GFR 30-50: 100% of normal reversal dose, interval between 2 doses: 12 hours.
  • GFR 10-30: 100% of normal reversal dose, interval between 2 doses: 24 hours.
  • GFR <10: general advice is not given.

Intravenous

  • GFR ≥ 50: no dosage adjustment is needed
  • GFR 30-50: 67% of normal reversal dose, interval between 2 doses: 12 hours.
  • GFR 10-30: 67% of normal reversal dose, interval between 2 doses: 24 hours.
  • GFR <10: general advice is not given.
Clinical consequences

With impaired renal function, the half-life of tranexamic acid may be prolonged. This increases the risk of adverse reactions.

Clinical Effects:
Possible symptoms of overdose include nausea, diarrhea, dizziness, headache, hypotension, and myopathy.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Abdominal pain and diarrhoea. These side effects are dose-dependent.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

Haematuria

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Adjust the dose in renal insufficiency.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Nederlandse Vereniging van Hemofiliebehandelaars (NVHB)., Richtlijn Diagnostiek en Behandeling van Hemofilie, 2020
  3. NVK, Werkboek kinderhematologie, www.hematologienederland.nl, 23 sept 2012
  4. MMI, Online GL, Cyklokapron®, Filmtbl., Accessed June 7, 2018.
  5. MEDA, SmPC Cyklokapron 500mg Filmtabletten (6376142.00.00), 07/2016
  6. Pfizer, SmPC Cyklokapron 500mg/5ml_1000mg/10ml Injektionslösung (6376165.00.00), 06/2016
  7. Carino, SmPC Tranexamsäure 100mg/ml Injektionslösung (88847.00.00), 08/2014
  8. Turner, NM. Leroy, P., Advanced Paediatric Life Support, de Nederlandse editie, 2017, 5e editie
  9. NKFK Workinggroup Acute Kidney Impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021
  10. Beno S,et al, Tranexamic acid in pediatric trauma: why not?, Crit Care, 2014, Jul 2;18(4):, 313.
  11. Beno S,et al, Tranexamic acid in pediatric trauma: why not?, Crit Care, 2014, Jul 2;18(4):, 313.

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Changes

Changes