prasugrel tablet film coated
1 INDICATIONS AND USAGE PRASUGREL tablets is 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 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 tablet is indicated to reduce the rate of thrombotic cardiovascular (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 tablet has 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 )] .
panacea biotec ltd.
ROUND ORANGE P 10
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
PRASUGREL tablet is available as round, biconvex, film- coated, non-scored tablets in the following strengths, colors, imprints, and presentations: Features Strengths 5 mg 10 mg Tablet color yellow beige Tablet imprint 5 10 Tablet imprint P P Presentations and NDC Codes Bottles of 30 43817-239-01 43817-240-01 16.2 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]. 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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