clopidogrel 75 MG Oral Tablet
1. INDICATIONS AND USAGE Clopidogrel tablets are 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 tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. ( 1.1 ) Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. ( 1.2 ) 1.1 Acute Coronary Syndrome (ACS) Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in 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 tablets should be administered in conjunction with aspirin. Clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel tablets should be administered in conjunction with aspirin. 1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel tablets are indicated to reduce the rate of MI and stroke.
Accord Healthcare Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Clopidogrel tablets USP 75 mg are available as pink colored, round, biconvex, film coated tablets debossed with "CI" on one side and plain on other side. Tablets are provided as follows: NDC 16729-218-10 Bottles of 30 count comes in child-resistant package NDC 16729-218-15 Bottles of 90 count comes in child-resistant package NDC 16729-218-16 Bottles of 500 count comes in child-resistant package NDC 16729-218-46 Blisters of 100 count Clopidogrel tablets USP 300 mg are available as pink colored, oval, biconvex, beveled edged, film coated tablets debossed with "CL" on one side and plain on other side. Tablets are provided as follows: NDC 16729-219-75 Blisters of 30 count NDC 16729-219-46 Blisters of 100 count Store at 25° C (77° F); excursions permitted to 15°C to 30° C (59°F to 86° F) [see USP Controlled Room Temperature].
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