|Manufacturer:||Medicure International Inc.|
¹ Registered trademark of Medicure International Inc.
© 1998 Copyright used under license.
All rights reserved. ² Bovill, E.G.; et al.: Hemorrhagic Events during Therapy with Recombinant Tissue-Type Plasminogen Activator, Heparin, and Aspirin for Acute Myocardial Infarction, Results of the Thrombolysis in Myocardial Infarction (TIMI) Phase II Trial, Annals of Internal Medicine, 115(4): 256-265, 1991.³ Registered trademark of Baxter International, Inc.
AGGRASTAT, in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy.
In this setting, AGGRASTAT has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure (for discussion of trial results and for definition of acute coronary syndrome see CLINICAL PHARMACOLOGY, Clinical Trials).AGGRASTAT has been studied in a setting, as described in Clinical Trials, that included aspirin and heparin.
Acute Coronary Syndrome
-- An episode of MYOCARDIAL ISCHEMIA that generally lasts longer than a transient anginal episode but that does not usually result in MYOCARDIAL INFARCTION.
-- NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).
-- A hypoperfusion of the BLOOD through an organ or tissue caused by a PATHOLOGIC CONSTRICTION or obstruction of its BLOOD VESSELS, or an absence of BLOOD CIRCULATION.
AGGRASTAT is contraindicated in patients with:known hypersensitivity to any component of the productactive internal bleeding or a history of bleeding diathesis within the previous 30 daysa history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysma history of thrombocytopenia following prior exposure to AGGRASTAThistory of stroke within 30 days or any history of hemorrhagic strokemajor surgical procedure or severe physical trauma within the previous monthhistory, symptoms, or findings suggestive of aortic dissectionsevere hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg)concomitant use of another parenteral GP IIb/IIIa inhibitoracute pericarditis
-- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.
-- Bleeding within the cranium.
-- Tumors that occur in the brain.
-- A benign vascular lesion characterized by the presence of a complex network of communicating arterial and venous vascular structures.
-- A subnormal level of BLOOD PLATELETS.
-- sudden neurologic impairment due to a cerebrovascular disorder, either an arterial occlusion or an intracranial hemorrhage.
-- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.
-- Inflammation of the PERICARDIUM from various origins, such as infection, neoplasm, autoimmune process, injuries, or drugs-induced. Pericarditis usually leads to PERICARDIAL EFFUSION, or CONSTRICTIVE PERICARDITIS.
Bleeding is the most common complication encountered during therapy with AGGRASTAT.
Administration of AGGRASTAT is associated with an increase in bleeding events classified as both major and minor bleeding events by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI)².
Most major bleeding associated with AGGRASTAT occurs at the arterial access site for cardiac catheterization.
Fatal bleedings have been reported (see ADVERSE REACTIONS).AGGRASTAT should be used with caution in patients with platelet count <150,000/mm3, in patients with hemorrhagic retinopathy, and in chronic hemodialysis patients.
Because AGGRASTAT inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis.
The safety of AGGRASTAT when used in combination with thrombolytic agents has not been established.
During therapy with AGGRASTAT, patients should be monitored for potential bleeding.
When bleeding cannot be controlled with pressure, infusion of AGGRASTAT and heparin should be discontinued.
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It should not to be used for self-diagnosis or treatment.