aprotinin (Rx)

Brand and Other Names:Trasylol
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 10,000,000 units/mL
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Regimen A

Administer test dose (10,000 KIU) IV at least 10 minutes before loading dose

Load: 2 million KIU IV over 20-30 minutes, THEN

Pump Prime (added during recirculation of priming fluid): 2 million KIU IV, THEN

500,000 KIU/hour IV continuous infusion during operation

Regimen B

Each dose half of regimen A

Administer test dose (10,000 KIU) IV at least 10 minutes before loading dose

Load: 1 million KIU IV over 20-30 minutes, THEN

Pump Prime (added during recirculation of priming fluid): 1 million KIU IV, THEN

250,000 KIU/hour IV continuous infusion during operation

Administration

Administer the loading dose after induction of anesthesia but prior to sternotomy

Administer loading dose just prior to cannulation in patients with previous exposure to aprotinin; constant infusion should be continued until surgery is complete

To avoid physical incompatibility with heparin when adding to pump prime solutionadd each agent during recirculaiton to assure adequate dilution

No safety/efficacy difference between regimens in low-risk patients

Safety & efficacy not established

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Interactions

Interaction Checker

and aprotinin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Atrial fibrillation (21%)

            Fever (15%)

            Nausea (11%)

            1-10%

            Hypotension (8%)

            Lung disorder (8%)

            Pleural effusion (7%)

            Myocardial infarction (6%)

            Tachycardia (6%)

            Infection (6%)

            Ventricular extrasystoles (6%)

            Ventricular tachycardia (5%)

            Atelectasis (5%)

            Heart failure (5%)

            Pericarditis (5%)

            peripheral edema (5%)

            Supraventricular tachycardia (4%)

            Arrhythmia (4%)

            Constipation (4%)

            Dyspnea (4%)

            Pneumothorax (4%)

            Hypertension (4%)

            Atrial arrhythmia (3%)

            Vomiting (3%)

            Uurinary retention (3%)

            Diarrhea (3%)

            LFT abnormalities (3%)

            Kidney function abnormal (3%)

            Asthenia (2%)

            Asthma (2%)

            Anemia (2%)

            Chest pain (2%)

            Creatine phosphokinase increased (2%)

            Hypoxia (2%)

            Musculoskeletal event (2%)

            Rash (2%)

            Urinary tract infection (2%)

            Frequency Not Defined

            Cardiovascular symptoms most likely sequelae of open-heart surgery

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            Warnings

            Black Box Warnings

            Aprotinin administration may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with an initial test dose as well as with any of the components of the dose regimen. Fatal reactions have also occurred in situations where the initial test dose was tolerated. The risk for anaphylactic or anaphylactoid reactions is increased among patients with prior aprotinin exposure. A history of any prior aprotinin exposure must be sought prior to administration of this agent

            The risk for a fatal reaction appears to be greater upon re-exposure within 12 months of the most recent prior aprotinin exposure. Aprotinin should be administered only in operative settings where cardiopulmonary bypass can be rapidly initiated. The benefit of aprotinin to patients undergoing primary CABG surgery should be weighed against the risk of anaphylaxis associated with any subsequent exposure to aprotinin

            Contraindications

            Hypersensitivity

            Known or suspected exposure within the last 12 months

            Cautions

            Use test dose first to determine anaphylactic reaction possibility

            Has been linked to serious kidney problems, heart failure, heart attacks & stroke

            Has been linked to increased risk of death in observational studies

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            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: Excretion in breast milk not known; use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Broad spectrum serine protease inhibitor that attenuates coagulation, fibrinolytic, and inflammatory pathways through inhibition of chemical mediators including plasmin, kallikrein, and thrombin

            Pharmacokinetics

            Half-Life: 2.5-10 hr

            Absorption: Rapid

            Excretion: Urine (25-40%)

            Distribution: Renal phagolysosomes and extracellular space

            Metabolism: Lysosomal enzymes slowly degrade aprotinin

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            Administration

            IV Incompatibilities

            Do not administer any other drug using the same line

            IV Administration

            Administer through a central line

            Follow either regimen A or B

            Both regimens include a 1 mL test dose, a loading dose, a dose to be added while recirculating the priming fluid of the cardiopulmonary bypass circuit ("pump prime" dose), & a constant infusion dose

            To avoid physical incompatibility of Trasylol and heparin when adding to pump prime solution, each agent must be added during recirculation of pump prime to assure adequate dilution prior to admixture with other component

            Storage

            Store between 2-25°C

            Protect from freezing

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.