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Aggrastat

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Aggrastat

Aggrastat

INDICATIONS

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).

DOSAGE AND ADMINISTRATION

Administer intravenously 25 mcg/kg over 3 minutes and then 0.15 mcg/kg/min (or 0.075 mcg/kg/min for patients with serum creatinine ≤ 60 mL/min), for up to 18 hours. This is not the regimen that was used in studies that established effectiveness of AGGRASTAT [see Clinical Studies].

The instructions by weight and creatinine clearance are tabulated in Table 1.

Table 1 : Dosing by Weight and CrCl

Weight (kg) First 3 min All Patients (mL) Maintenance Infusion Rate (mL/hr.)
CrCl > 60 mL/min CrCl ≤ 60 mL/min
30-37 17 6 3
38-45 21 7.5 3.75
46-54 25 9 4.5
55-62 29 10.5 5.25
63-70 33 12 6
71-79 37.5 13.5 6.75
80-87 42 15 7.5
88-95 46 16.5 8.25
96-104 50 18 9
105-112 54 19.5 9.75
113-120 58 21 10.5
121-128 62 22.5 11.25
129-137 66.5 24 12
138-145 71 25.5 12.75
146-153 75 27 13.5

Important Administration Instructions

  1. To open the container, 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. Suspend the container from its eyelet support, remove the plastic protector from the outlet port, and attach a conventional administration set.
  2. You may administer AGGRASTAT in the same intravenous line as 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.
  3. Do not add other drugs or remove solution directly from the bag with a syringe.
  4. Do not use plastic containers in series connections; such use can result in air embolism by drawing air from the first container if it is empty of solution.
  5. Discard any unused portion left in the bag.

HOW SUPPLIED

Dosage Forms And Strengths

FOR INTRAVENOUS USE ONLY

AGGRASTAT Injection Premixed 5 mg tirofiban per 100 mL (50 mcg per mL) and 12.5 mg tirofiban per 250 mL (50 mcg per mL) are clear, non-preserved, sterile solutions premixed in a vehicle made iso-osmotic with sodium chloride.

Storage And Handling

AGGRASTAT Injection Premixed 5 mg tirofiban per 100 mL (50 mcg per mL) and 12.5 mg tirofiban per 250 mL (50 mcg per mL) are clear, non-preserved, sterile solutions premixed in a vehicle made iso-osmotic with sodium chloride, and are supplied as follows:

NDC 25208-002-01, 100 mL single-dose INTRAVIA containers (PL 2408 Plastic).
NDC 25208-002-02, 250 mL single-dose INTRAVIA containers (PL 2408 Plastic).

FOR INTRAVENOUS USE ONLY

Store AGGRASTAT at 25°C (77°F) with excursions permitted between 15-30°C (59-86°F) (see USP Controlled Room Temperature). Do not freeze. Protect from light during storage.

AGGRASTAT is manufactured for: Medicure International, Inc. By: Baxter Healthcare Corporation, Deerfield, Illinois 60015 USA. Distributed by: Medicure Pharma, Inc. Somerset, NJ 08873 USA. 1-800-509-0544. Revised: Oct 2013

Last reviewed on RxList: 11/6/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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