clopidogrel 300 MG Oral Tablet
1 INDICATIONS AND USAGE CLOPIDOGREL is a P2Y 12 platelet inhibitor indicated for: Acute coronary syndrome - For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], CLOPIDOGREL has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. (1.1) - For patients with ST-elevation myocardial infarction (STEMI), CLOPIDOGREL has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary PCI is unknown. (1.1) Recent MI, recent stroke, or established peripheral arterial disease. CLOPIDOGREL has been shown to reduce the combined endpoint of new ischemic stroke, new MI, and other vascular death. ( 1.2 ) 1.1 Acute Coronary Syndrome (ACS) For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization, clopidogrel has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown. The optimal duration of clopidogrel therapy in ACS is unknown. 1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
Blenheim Pharmacal, Inc.
OVAL PINK SG 121
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16 HOW SUPPLIED/STORAGE AND HANDLING Clopidogrel tablets, USP 75 mg are available as pink colored, round shaped, biconvex, film coated tablets de-bossed on one side with SG and 124 on other side. Tablets are provided as follows: NDC 50228-124-30 Bottles of 30 NDC 50228-124-10 Bottles of 1000 Clopidogrel tablets, USP 300 mg are available as pink colored, modified oval shaped, film coated tablets de-bossed on one side with SG and 121 on other side. Tablets are provided as follows: NDC 50228-121-30 Bottles of 30 NDC 50228-121-05 Bottles of 500 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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