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Intravenous Dilution Guidelines

Tirofiban (Aggrastat ®)

[ Usual Diluents ] [ Standard Dilution ] [ Storage and Stability ]
DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS
PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  

Drug UPDATES:   [Drug information  /  PDF]  
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)
 

Usual Diluents top of page

N/A

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate] top of page



DOSAGE FORMS AND STRENGTHS

Injection: 5 mg/100mL (50 mcg/mL) in 100 mL bag
Injection: 12.5 mg/250mL (50 mcg/mL) in 250 mL bag
Injection: 5 mg/100mL (50 mcg/mL) in 100 mL vial
Injection: 3.75 mg/15mL (250 mcg/mL) in 15 mL bolus vial


Stability data:

Drug Stability
Refrigerated
Stability
Room Temp.
Reconstituted
Vial/Powder
Notes P-Insert
Updated
Aggrastat - Tirofiban   Store AGGRASTAT at controlled room temperature, 25°C (77°F) with excursions permitted between 15-30°C (59-86°F) [see USP]. Do not freeze. Protect from light during storage. Solution Discard any unused portion left in the bag.

FOR INTRAVENOUS USE ONLY
9/2016

WARNINGS  top of page

See warnings and precautions below.


DESCRIPTION  top of page

Description:
AGGRASTAT contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation.

Tirofiban hydrochloride monohydrate is chemically described as N(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate.

CLINICAL PHARMACOLOGY: top of page

Mechanism of Action:
AGGRASTAT is a reversible antagonist of fibrinogen binding to the GP IIb/IIIa receptor, the major platelet surface receptor involved in platelet aggregation. When administered intravenously, AGGRASTAT inhibits ex vivo platelet aggregation in a dose- and concentration-dependent manner.

When given according to the PRISM-PLUS regimen of 0.4 mcg/kg/min over 30 minutes followed by a 0.1 mcg/kg/min maintenance infusion, >90% inhibition of platelet aggregation is attained by the end of the 30-minute infusion. When given according to the recommended regimen of 25 mcg/kg followed by a 0.15 mcg/kg/min maintenance infusion, >90% inhibition of platelet aggregation is attained within 10 minutes. Platelet aggregation inhibition is reversible following cessation of the infusion of AGGRASTAT.

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE:
AGGRASTAT is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).

USE IN SPECIFIC POPULATIONS
Renal Insufficiency: Reduce the dose in patients with severe renal insufficiency.

CONTRAINDICATIONS top of page

Contraindications:
Known hypersensitivity to any component of AGGRASTAT.
History of thrombocytopenia with prior exposure to AGGRASTAT.
Active internal bleeding, or history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month.

PRECAUTIONS top of page

WARNINGS AND PRECAUTIONS:
  1.  AGGRASTAT can cause serious bleeding. If bleeding cannot be controlled discontinue AGGRASTAT.
  2. Thrombocytopenia: Discontinue AGGRASTAT and heparin.

ADVERSE REACTIONS top of page

ADVERSE REACTIONS:
  • Bleeding is the most commonly reported adverse reaction. (6.1)

    To report SUSPECTED ADVERSE REACTIONS, contact Medicure at 1-800-509-0544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
    DRUG INTERACTIONS

    Coadministration of fibrinolytics, anticoagulants and antiplatelet agents, increases the risk of bleeding.
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

DOSAGE AND ADMINISTRATION  top of page

DOSAGE AND ADMINISTRATION:

2.1 Recommended Dosage

The recommended dosage is 25 mcg/kg administered intravenously within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours.

2.2 Administration

For intravenous use only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Do not use plastic INTRAVIA bags in series connections; such use can result in air embolism by drawing air from the first bag if it is empty of solution.

To open the INTRAVIA bag, first tear off its foil overpouch. The plastic may be somewhat opaque because of moisture absorption during sterilization; the opacity will diminish gradually. Check for leaks by squeezing the inner bag firmly; if any leaks are found or sterility is suspect then the solution should be discarded. Do not use unless the solution is clear and the seal is intact.

Administration Instructions

Withdraw the bolus dose of AGGRASTAT from the 15 mL premixed bolus vial into a syringe. Alternatively, the bolus dose of AGGRASTAT may be administered from the 100 mL premixed vial or from the premixed bags. Do not dilute. Administer the bolus dose within 5 minutes via a syringe or IV pump.
Immediately following the bolus dose administration, administer the maintenance infusion from the 100 mL premixed vial or bags via an IV pump.
Discard any unused portion left in the vial or bag.

The recommended bolus volume using the 15 mL premixed bolus vial can be calculated using the following equation:

Bolus volume (mL) = [25 mcg/kg x body weight (kg)] / 250 mcg/mL

The recommended bolus volume using the 100 mL premixed vial or premixed bags can be calculated using the following equation:

Bolus volume (mL) = [25 mcg/kg x body weight (kg)] / 50 mcg/mL

The recommended infusion rate for patients with CrCl (Creatinine Clearance) >60 mL/min using the 100 mL premixed vial or premixed bags can be calculated using the following equation:

Infusion rate for CrCl > 60 mL/min (mL/hr) = [0.15 mcg/kg/min x body weight (kg) x 60 min/hr] / 50 mcg/mL


Drug Compatibilities
AGGRASTAT can be administered in the same intravenous line as heparin, atropine sulfate, dobutamine, dopamine, epinephrine hydrochloride (HCl), famotidine injection, furosemide, lidocaine, midazolam HCl, morphine sulfate, nitroglycerin, potassium chloride, and propranolol HCl. Do not administer AGGRASTAT through the same IV line as diazepam. Do not add other drugs or remove solution directly from the INTRAVIA bag with a syringe.

2.3 Dose Adjustment for Renal Impairment

The recommended dosage in patients with CrCl </=60 mL/min is 25 mcg/kg intravenously within 5 minutes and then 0.075 mcg/kg/min, for up to 18 hours.

The recommended infusion rate for patients with CrCl </=60 mL/min using the 100 mL premixed vial or premixed bags can be calculated using the following equation:

Infusion rate for CrCl </= 60 mL/min (mL/hr) = [0.075 mcg/kg/min x body weight (kg) x 60 min/hr] / 50 mcg/mL

HOW SUPPLIED  top of page

DOSAGE FORMS AND STRENGTHS:

Injection: 5 mg/100mL (50 mcg/mL) in 100 mL bag
Injection: 12.5 mg/250mL (50 mcg/mL) in 250 mL bag
Injection: 5 mg/100mL (50 mcg/mL) in 100 mL vial
Injection: 3.75 mg/15mL (250 mcg/mL) in 15 mL bolus vial

Storage and Stability top of page


AGGRASTAT is supplied as a clear, non-preserved, colorless, isosmotic, sterile premixed solution with sodium chloride for tonicity adjustment.

Store AGGRASTAT at controlled room temperature, 25°C (77°F) with excursions permitted between 15-30°C (59-86°F) [see USP]. Do not freeze. Protect from light during storage.



Disclaimer
The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.  PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.
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