ndrome (NSTE-ACS).
2 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:
equation-1
The recommended bolus volume using the 100 mL premixed vial or premixed bags can be calculated using the following equation:
equation-2
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:
equation-3
Example calculation of infusion rate for 60 kg patient with CrCl >60 mL/min using the 100 mL premixed vial or premixed bags:
equation-4
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:
equation-5
3 DOSAGE FORMS AND STRENGTHS
AGGRASTAT is a clear, non-preserved, colorless, isosmotic, sterile premixed injection with sodium chloride for tonicity adjustment available in the following presentations:
Table 1 AGGRASTAT strength and packaging
Strength Volume - Packaging
50 mcg/mL 100 mL - bag
50 mcg/mL 250 mL - bag
50 mcg/mL 100 mL - vial
250 mcg/mL 15 mL - bolus vial
4 CONTRAINDICATIONS
AGGRASTAT is contraindicated in patients with:
Severe hypersensitivity reaction to AGGRASTAT (i.e., anaphylactic reac |
