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
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.
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.
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
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.
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
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
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
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.
The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical
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