Adult Dosing

Reduction of blood loss from coronary artery bypass graft surgery

High dose regimen (Regimen A)

• Four dosing stages in regimen: Test dose, loading dose, pump-priming dose and continuous IV infusion dose
• Test dose: 10,000 units (1.4 mg) IV at least 10 minutes before loading dose
• Loading dose: 2 million units (280 mg) slow IV over 20–30 min after anesthesia induction but prior to sternotomy. In patients with known prior exposure. give loading dose just prior to cannulation
• Pump prime dose: 2 million units (280 mg) IV
• Continuous dose: 500,000 U/h (70 mg/h) IV

Low dose regimen (Regimen B)

• Four dosing stages in regimen: Test dose, loading dose, pump-priming dose and continuous IV infusion dose
• Test dose: 10,000 units (1.4 mg) IV at least 10 minutes before loading dose
• Loading dose: 1 million units (280 mg) slow IV over 20–30 min after anesthesia induction but prior to sternotomy. In patients with known prior exposure. give loading dose just prior to cannulation
• Pump prime dose: 1 million units (140 mg) IV
• Continuous dose: 250,000 U/hr (35 mg/hr) IV

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Prevention of bleeding associated with Coronary Artery Bypass Graft Surgery

• Hypersensitivity to any of the ingredients of the product
• Known or suspected aprotinin exposure in past 12 months

• Trasylol administration may cause fatal anaphylactic/anaphylactoid reactions. Fatal reactions may occur with any component of regimen, including first test dose or subsequent doses even when test dose tolerated. Risk increases with re-exposure within 12 months. Obtain history of prior aprotinin exposure. Weigh treatment benefit in CABG vs. anaphylaxis risk associated with 2nd exposure. Trasylol should be administered only in operative settings where cardiopulmonary bypass can be rapidly initiated

Renal Dose Adjustment

• Renal impairment: Reduce dose; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Anaphylactic or anaphylactoid reactions have occurred with aprotinin administration, including fatal reactions in association with initial (test) dose. Hypotenison is the most frequently reported sign of hypersensitivity reaction
• Hypersensitivity reactions increase with subsequent exposures. Carefully analyse and weigh treatment benefit in CABG vs. anaphylaxis risk associated with 2nd exposure
• Aprotinin may increase risk of renal dysfunction and may increase need for dialysis in the perioperative period. Patients with pre-existing renal impairment and those receiving aminoglycosides are at increased risk

Cautions: Use cautiously in

• Renal impairment
• Concurrent nephrotoxic agents
• Hx of fibrin sealants exposure
• Hypersensitivity to any drug/agent
• Thromboembolic disorder

Pregnancy Category:B

Breastfeeding: Safety unknown.

• CV: Atrial fibrillation, hypotension, hypertension, arrhythmias, MI, atrial flutter, ventricular extrasystoles, tachycardia, heart failure, pericarditis, peripheral edema, thrombosis
• GI: Nausea, constipation, vomiting, diarrhea, abnormal LFTs
• HEMA: Anemia
• METABOLIC: Creatinine phosphokinase increased
• CNS: Confusion, insomnia, stroke, coma, encephalopathy
• RESP: Pleural effusion, atelectasis, dyspnea, pneumothorax, asthma, hypoxia
• DERM: Rash
• GU: Urinary retention, kidney function abnormalities, nephrotoxicity, renal tubular necrosis, UTI
• MISC: Anaphylaxis, hypersensitivity reactions, fever, infection, chest pain, asthenia

• Protease inhibitor; Inhibits plasmin and inflammatory cytokinase. Attenuates fibrinolysis, thrombin generation
• Metabolized by kidney
• Renally excreted
• Half Life: 150 minutes

US Trade Name(s)

• Trasylol [Discontinued]

US Availability

Trasylol

• INJ: 10,000 U/mL (1.4 mg/mL) [100, 200 mL vials]

Canadian Trade Name(s)

• Trasylol

Canadian Availability

Trasylol

• INJ: 10,000 U/mL (1.4 mg/mL) [50, 200 mL vials]

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Radiologic

Radiopharmaceuticals, Diagnostic