Aprotinin
Aprotinin is a serine protease inhibitor used to reduce excessive bleeding during complex surgical procedures, particularly cardiac and liver surgery. It works by inhibiting proteolytic enzymes including plasmin and kallikrein, thereby decreasing fibrinolysis and maintaining clot stability. Due to safety concerns regarding kidney dysfunction and cardiovascular risks, its use has been significantly restricted in many countries.
Aprotinin is a protease inhibitor medication used to minimize blood loss during major surgeries by preventing excessive clot breakdown.
Key facts at a glance
- ATC
- B02AB01
- RxNorm
- 1056
- Generic
- Aprotinin
- Class
- atc-b02
- Brands
- —
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- solution
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
13 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring and uterine activity monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingavoid
not recommended during breastfeeding - drug may pass into breast milk
monitor infant for adverse effects
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderlyreduce dose and monitor closely
use with extreme caution due to increased risk of renal impairment and cardiovascular events
monitor renal function, serum creatinine, and cardiovascular status
Use with caution and monitor for adverse effects.
pediatric_age
infantsnot recommended
safety and efficacy not established in pediatric patients - avoid use
not applicable - avoid use
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
childrennot recommended
safety and efficacy not established in pediatric patients - avoid use
not applicable - avoid use
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
mildreduce dose by 25-50%
use with caution - drug is primarily eliminated by kidneys and may accumulate
monitor renal function closely, serum creatinine, and for signs of toxicity
Use with caution and monitor for adverse effects.
renal_impairment
moderateavoid or significantly reduce dose
use with extreme caution or avoid - high risk of accumulation and renal toxicity
frequent monitoring of renal function, serum creatinine, and drug levels if available
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
severecontraindicated
contraindicated in patients with severe renal impairment
not applicable - avoid use
Use of this medication in this population requires careful consideration of risks and benefits.
hepatic_impairment
mildmonitor closely
use with caution - may have altered metabolism
monitor liver function tests and for signs of bleeding
Use with caution and monitor for adverse effects.
hepatic_impairment
moderatereduce dose
use with caution - risk of accumulation and increased bleeding
monitor liver function, coagulation parameters, and for bleeding
Use with caution and monitor for adverse effects.
hepatic_impairment
severeavoid if possible
use with extreme caution or avoid in severe hepatic impairment
close monitoring of liver function, coagulation studies, and bleeding
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
Commonly prescribed since
Aprotinin was approved by FDA in 1993 for reducing blood loss in cardiac surgery
Drug class
Drug class classification for Aprotinin
Market withdrawal
Aprotinin was voluntarily withdrawn from market by manufacturer and later by FDA due to safety concerns
Primary use
Main therapeutic indication for Aprotinin
Aprotinin is primarily used to reduce perioperative blood loss and transfusion requirements in patients undergoing complex cardiac surgery (such as coronary artery bypass grafting), liver transplantation, and certain orthopedic procedures. It is considered in patients at high risk for significant bleeding.
Aprotinin is a broad-spectrum serine protease inhibitor that works by directly inhibiting proteolytic enzymes including plasmin, trypsin, chymotrypsin, and kallikrein. This action reduces fibrinolysis (the breakdown of blood clots) and decreases the inflammatory response triggered by surgery, helping to maintain hemostasis during and after operative procedures.
Due to documented safety concerns including increased risks of renal dysfunction, myocardial infarction, stroke, and mortality, aprotinin was temporarily withdrawn from the market and has since been reintroduced with restricted use in many regions. It should only be used when benefits clearly outweigh risks, typically in high-risk cardiac surgery patients. Close monitoring of renal function is essential, and it is contraindicated in patients with known hypersensitivity to aprotinin.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 20, 2026. · Read our editorial policy