prasugrel 10 mg
1 INDICATIONS AND USAGE Prasugrel tablet 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 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 tablet is 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 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 )].
lupin pharmaceuticals, inc.
OVAL ORANGE LU B72
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lupin pharmaceuticals, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Prasugrel tablets, USP are available as modified capsule shaped film-coated tablets in the following strengths, colors, debossing, and presentations: Features Strengths 5 mg 10 mg Tablet color yellow beige Tablet debossing "LU" "LU" Tablet debossing "B71" "B72" Presentations and NDC Codes Bottles of 30 68180-795-06 68180-796-06 Bottles of 90 68180-795-09 68180-796-09 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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