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Aggrastat

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Aggrastat

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OVERDOSE

In clinical trials, inadvertent overdosage with AGGRASTAT occurred in doses up to 5 times and 2 times the recommended dose for bolus administration and loading infusion, respectively. Inadvertent overdosage occurred in doses up to 9.8 times the 0.15 mcg/kg/min maintenance infusion rate.

The most frequently reported manifestation of overdosage was bleeding, primarily minor mucocutaneous bleeding events and minor bleeding at the sites of cardiac catheterization (see PRECAUTIONS, Bleeding Precautions).

Overdosage of AGGRASTAT should be treated by assessment of the patient's clinical condition and cessation or adjustment of the drug infusion as appropriate.

AGGRASTAT can be removed by hemodialysis.

CONTRAINDICATIONS

AGGRASTAT is contraindicated in patients with:

  • known hypersensitivity to any component of the product
  • active internal bleeding or a history of bleeding diathesis within the previous 30 days
  • a history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm
  • a history of thrombocytopenia following prior exposure to AGGRASTAT
  • history of stroke within 30 days or any history of hemorrhagic stroke
  • major surgical procedure or severe physical trauma within the previous month
  • history, symptoms, or findings suggestive of aortic dissection
  • severe hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg)
  • concomitant use of another parenteral GP IIb/IIIa inhibitor
  • acute pericarditis

Last reviewed on RxList: 6/13/2012
This monograph has been modified to include the generic and brand name in many instances.

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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