Aprotinin: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Intravenous
Prophylaxis of perioperative blood loss in patients undergoing coronary artery bypass graft

Adult: Administer 10,000 KIU test dose 10 minutes before surgery. Loading dose: 1,000,000-2,000,000 KIU via slow IV inj or infusion over 20-30 minutes after induction of anaesthesia, followed by 250,000-500,000 KIU/hour via continuous infusion until end of the operation. An additional dose of 1,000,000-2,000,000 KIU is added to the pump prime of the heart-lung machine. Max: 7,000,000 KIU. Max rate: 5-10 mL/min.

Incompatibility

Incompatible with corticosteroids, heparin, tetracyclines and nutrient solutions containing amino acids or fat emulsions.

Contraindications

Hypersensitivity. Positive aprotinin-specific IgG antibody test. Suspected previous exposure to aprotinin including fibrin sealant in the last 12 months.

Special Precautions

Renal impairment. Pregnancy and lactation.

Adverse Reactions

Significant: Hypersensitivity.
Cardiac disorders: Myocardial ischaemia, coronary occlusion/thrombosis, MI, pericardial effusion, atrial fibrillation.
Gastrointestinal disorders: Nausea, constipation, vomiting, diarrhoea.
General disorders and administration site conditions: Fever.
Renal and urinary disorders: Oliguria, acute renal failure, renal tubular necrosis.
Vascular disorders: Thrombosis, hypotension. Rarely, arterial thrombosis.
Potentially Fatal: Anaphylactic reactions.

Monitoring Parameters

Monitor activated clotting time (ACT), fixed heparin dosing or heparin titration.

Drug Interactions

Dose-dependent inhibition on the effects of thrombolytic agents (e.g. streptokinase, urokinase, alteplase). Increased risk of renal dysfunction with aminoglycosides.

Lab Interference

Prolongs activated clotting time (ACT) in celite surface activation method in the presence of heparin.

Action

Description:
Mechanism of Action: Aprotinin, a haemostatic, acts as an inhibitor of proteolytic enzymes including chymotrypsin, kallikrein, plasmin, and trypsin. It also inhibits the contact phase activation of coagulation which both initiates coagulation and promotes fibrinolysis.
Pharmacokinetics:
Metabolism: Metabolised to shorter peptides or amino acids by lysosomal activity in the kidney.
Excretion: Via urine as inactive degradation products. Terminal elimination half-life: Approx 5-10 hours.

Storage

Store below 25°C. Protect from light. Do not freeze.

MIMS Class

Haemostatics

ATC Classification

B02AB01 - aprotinin ; Belongs to the class of proteinase inhibitor antifibrinolytics. Used in the treatment of hemorrhage.

References

Aprotinin 10,000 KIU/mL Injection BP (Nordic Group b.v.). MHRA. https://products.mhra.gov.uk/. Accessed 01/07/2020.

Aprotinin. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com/. Accessed 01/07/2020.

Buckingham R (ed). Aprotinin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/07/2020.

Trasylol (Bayer Pharmaceuticals Corporation). U.S. FDA. https://www.fda.gov/. Accessed 01/07/2020.

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