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) ] .

Mylan Pharmaceuticals Inc.

FDA Reported Adverse Reactions
`[1] drug dependence` `[2] pain` `[3] overdose` `[4] emotional distress` `[5] death` `[6] toxicity to various agents` `[7] drug withdrawal syndrome` `[8] drug ineffective` `[9] nausea` `[10] drug abuse`

4 years ago

OVAL YELLOW M PH1

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

PRASUGREL Tablets, USP are available containing

PRASUGREL hydrochloride, USP equivalent to 5 mg or 10 mg

PRASUGREL, respectively. The 5 mg tablets are yellow, film-coated, capsule shaped, unscored tablets debossed with M on one side of the tablet and PH1 on the other side. They are available as follows: NDC 0378-5185-93 bottles of 30 tablets The 10 mg tablets are brown, film-coated, capsule shaped, unscored tablets debossed with M on one side of the tablet and PH2 on the other side. They are available as follows: NDC 0378-5186-93 bottles of 30 tablets 16.2 Storage and Handling Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from moisture. Keep and dispense only in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. PHARMACIST: Dispense a Medication Guide with each prescription.

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Mylan Pharmaceuticals Inc.

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