clopidogrel bisulfate clopidogrel tablet film coated
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.
mylan pharmaceuticals inc.
ROUND WHITE M C27
M C27 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Clopidogrel Tablets, USP are available containing 97.875 mg of clopidogrel bisulfate, USP equivalent to 75 mg of clopidogrel base or 391.5 mg of clopidogrel bisulfate, USP equivalent to 300 mg of clopidogrel base. The 75 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and C27 on the other side. They are available as follows: NDC 0378-3627-77 bottles of 90 tablets NDC 0378-3627-05 bottles of 500 tablets The 300 mg tablets are white, film-coated, oval, unscored tablets debossed with M C28 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3628-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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