What is the maximum dose of tranexamic acid (TXA) in pediatric patients?

Maximum Dose of Tranexamic Acid in Pediatric Patients

The maximum dose of tranexamic acid in pediatric patients is 15 mg/kg per dose for loading, followed by 2 mg/kg/hour for maintenance infusion, with no absolute maximum daily dose specified in current guidelines, though dosing should be weight-based rather than using fixed adult doses. 1, 2, 3

Standard Dosing Regimens by Clinical Indication

Trauma and Surgery

• Loading dose: 15 mg/kg IV administered over 10 minutes, followed by maintenance infusion of 2 mg/kg/hour 1, 2, 3
• This represents the most widely adopted dosing regimen in U.S. pediatric trauma centers and is recommended by the American College of Surgeons 3
• For adolescents over 12 years weighing more than 40 kg who are physiologically mature, adult dosing may be used (1 gram loading dose followed by 1 gram over 8 hours) 3

Menorrhagia in Adolescents

• Oral dosing: 30-50 mg/kg/day divided into 2-3 doses, with a maximum daily dose of 3-4 grams 1, 2
• For severe cases requiring IV treatment: 15 mg/kg loading dose followed by 2 mg/kg/hour infusion 2

Hereditary Angioedema Prophylaxis

• Maximum dose: 15-25 mg/kg two to three times daily, not exceeding 3 grams per day 1, 2

Important Dosing Considerations

Weight-Based vs. Fixed Dosing

• Always use weight-based dosing in pediatric patients rather than fixed adult doses to avoid under- or overdosing 1
• The FDA label specifies 10 mg/kg as the recommended dose for hemophilia patients undergoing tooth extraction, administered 3-4 times daily for 2-8 days post-procedure 4

Alternative Dosing Ranges in Literature

• Some experts recommend a broader range of 10-30 mg/kg loading dose followed by 5-10 mg/kg/hour maintenance based on pharmacokinetic studies 5
• A more conservative "10-10-4-4 rule" has been proposed for neonates and infants in cardiac surgery: 10 mg/kg bolus, 10 mg/kg/hour infusion, then 4 mg/kg into CPB prime with reduced 4 mg/kg/hour infusion during bypass 6

Critical Timing and Safety Parameters

Administration Timing

• TXA must be administered within 3 hours of injury in trauma cases to maximize mortality benefit 1
• Benefit decreases by approximately 10% for every 15 minutes of delay 1
• Administration beyond 3 hours may be harmful rather than beneficial 1

Renal Dose Adjustments

• For serum creatinine 1.36-2.83 mg/dL: 10 mg/kg twice daily 4
• For serum creatinine 2.83-5.66 mg/dL: 10 mg/kg once daily 4
• For serum creatinine >5.66 mg/dL: 10 mg/kg every 48 hours or 5 mg/kg every 24 hours 4

Common Pitfalls to Avoid

Route of Administration Errors

• TXA injection is for IV use ONLY - inadvertent intrathecal administration has caused seizures and cardiac arrhythmias 4
• Infuse no faster than 1 mL/minute to avoid hypotension 4

Contraindications

• Active intravascular clotting 4
• Subarachnoid hemorrhage (risk of cerebral edema and infarction) 4
• Recent thrombosis, atrial fibrillation, or known thrombophilia are relative contraindications 2

Drug Interactions

• Avoid concomitant use with pro-thrombotic agents including Factor IX concentrates, anti-inhibitor coagulant concentrates, and hormonal contraceptives 4
• Do NOT mix with penicillin-containing solutions 4

Clinical Evidence Supporting Dosing

Real-world data from pediatric combat trauma shows that TXA administration in massively transfused children (requiring ≥40 mL/kg blood products) reduced in-hospital mortality from 18.3% to 8.5%, with an odds ratio of 0.35 for death 7. Survey data indicates that 35% of U.S. trauma centers caring for pediatric patients use TXA, with 68% using the 15 mg/kg initial dose and 87% following with maintenance infusions 8.