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Trasylol (Aprotinin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Trasylol® is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.

DOSAGE AND ADMINISTRATION

Trasylol® given prophylactically in both Regimen A and Regimen B (half Regimen A) to patients undergoing CABG surgery significantly reduced the donor blood transfusion requirement relative to placebo treatment. In low risk patients there is no difference in efficacy between regimen A and B. Therefore, the dosage used (A vs. B) is at the discretion of the practitioner.

Trasylol® is supplied as a solution containing 10,000 KIU/mL, which is equal to 1.4 mg/mL. All intravenous doses of Trasylol® should be administered through a central line. DO NOT ADMINISTER ANY OTHER DRUG USING THE SAME LINE. Both regimens include a 1 mL initial (test) dose, a loading dose, a dose to be added while recirculating the priming fluid of the cardiopulmonary bypass circuit (“pump prime” dose), and a constant infusion dose. To avoid physical incompatibility of Trasylol® and heparin when adding to the pump prime solution, each agent must be added during recirculation of the pump prime to assure adequate dilution prior to admixture with the other component. Regimens A and B, both incorporating a 1 mL initial (test) dose, are described in the table below:

INITIAL (TEST)
DOSE
LOADING
DOSE
“PUMP PRIME”
DOSE
CONSTANT
INFUSION DOSE
TRASYLOL®
REGIMEN A
1 mL
(1.4 mg, or
10,000 KIU)
200 mL
(280 mg, or
2.0 million KIU)
200 mL
280 mg, or
2.0 million KIU)
50 mL/hr
(70 mg/hr, or
500,000 KIU/hr)
TRASYLOL®
REGIMEN B
1 mL
(1.4 mg, or
10,000 KIU)
100 mL
(140 mg, or
1.0 million KIU)
100 mL
(140 mg, or
1.0 million KIU)
25 mL/hr
(35 mg/hr, or
250,000 KIU/hr)

The 1 ml initial (test) dose should be administered intravenously at least 10 minutes before the loading dose. With the patient in a supine position, the loading dose is given slowly over 20-30 minutes, after induction of anesthesia but prior to sternotomy. In patients with known previous exposure to Trasylol®, the loading dose should be given just prior to cannulation. When the loading dose is complete, it is followed by the constant infusion dose, which is continued until surgery is complete and the patient leaves the operating room. The “pump prime” dose is added to the recirculating priming fluid of the cardiopulmonary bypass circuit, by replacement of an aliquot of the priming fluid, prior to the institution of cardiopulmonary bypass. Total doses of more than 7 million KIU have not been studied in controlled trials.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Discard any unused portion.

Renal and Hepatic Impairment:

Trasylol® administration is associated with a risk for renal dysfunction (see WARNINGS: Renal Dysfunction). Changes in aprotinin pharmacokinetics with age or impaired renal function are not great enough to require any dose adjustment. Pharmacokinetic data from patients with pre-existing hepatic disease treated with Trasylol® are not available.

HOW SUPPLIED

HOW SUPPLIED
Size StrengthNDC
100 mL vials1,000,000 KIU0026-8196-36
200 mL vials2,000,000 KIU0026-8197-63

STORAGE

Trasylol® should be stored between 2° and 25°C (36° - 77°F).
Protect from freezing.

Bayer Pharmaceuticals Corporation
400 Morgan Lane
West Haven, CT 06516
Made in Germany
©2006 Bayer Pharmaceuticals Corporation
Printed in USA
12/06

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