Ticagrelor 90 MG Oral Tablet Brilinta
1 INDICATIONS AND USAGE BRILINTA is a P2Y 12 platelet inhibitor indicated • to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1) • to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of BRILINTA was established in a population with type 2 diabetes mellitus (T2DM). (1.2) • to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3) 1.1 Acute Coronary Syndrome or a History of Myocardial Infarction BRILINTA is indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS [see Clinical Studies (14.1) ] . 1.2 Coronary Artery Disease but No Prior Stroke or Myocardial Infarction BRILINTA is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events [see Clinical Studies (14.2) ] . While use is not limited to this setting, the efficacy of BRILINTA was established in a population with type 2 diabetes mellitus (T2DM). 1.3 Acute Ischemic Stroke or Transient Ischemic Attack (TIA) BRILINTA is indicated to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA) [see Clinical Studies (14.3) ] .
AstraZeneca Pharmaceuticals LP
ROUND YELLOW 90 T
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16 HOW SUPPLIED/STORAGE AND HANDLING BRILINTA (
TICAGRELOR) 90 mg is supplied as a round, biconvex, yellow, film-coated tablet with a “90†above “T†on one side: Bottles of 60 – NDC 0186-0777-60 100 count Hospital Unit Dose – NDC 0186-0777-39 BRILINTA (
TICAGRELOR) 60 mg is supplied as a round, biconvex, pink, film-coated tablet with a “60†above “T†on one side: Bottles of 60 – NDC 0186-0776-60 Storage and Handling Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP controlled room temperature].
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