prasugrel 5 MG Oral Tablet
1 INDICATIONS AND USAGE Prasugrel tablets are a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) (1.1) . Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI (1.1) . 1.1 Acute Coronary Syndrome Prasugrel tablets are indicated to reduce the rate of thrombotic CV events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI. Prasugrel tablets have been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies (14) ] .
Amneal Pharmaceuticals LLC
OVAL BROWN AN001
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prasugrel 10 MG Oral Tablet
Amneal Pharmaceuticals LLC
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
PRASUGREL tablets USP, 5 mg are supplied as tan colored, oval shaped, film-coated, non-scored tablets, debossed with “AN001” on one side and plain on the other side. They are available as follows: Bottles of 30 (unit-of-use): NDC 65162-001-03
PRASUGREL tablets USP, 10 mg are supplied as tan colored, oval shaped, film-coated, non-scored tablets, debossed with “AN002” on one side and plain on the other side. They are available as follows: Bottles of 30 (unit-of-use): NDC 65162-002-03 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep and dispense only in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet.
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