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Usual Dosing (Adults)

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.

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.

Renal Dosing

dialysis 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

Hemodialysis

dialysis Insufficient data

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.
Tirofiban

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