Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (CLOPIDOGREL - UNII:A74586SNO7)
NuCare Pharmaceuticals,Inc.
CLOPIDOGREL BISULFATE
CLOPIDOGREL 75 mg
ORAL
PRESCRIPTION DRUG
• • Clopidogrel is indicated to reduce the rate of myocardial infarction and stroke (MI) 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 should be administered in conjunction with aspirin. • Clopidogrel is 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 should be administered in conjunction with aspirin. In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel is indicated to reduce the rate of MI and stroke. Clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Clopidogrel tablets are contraindicated in patients with hyper
Clopidogrel Tablets USP, 75 mg are available as pink colored, circular, biconvex, film-coated tablets debossed with L 11 on one side and plain on other side. Tablets are provided as follows: NDC 68071-4031-03 Bottles of 30 Store at 20° to 25°C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
NuCare Pharmaceuticals,Inc. ---------- . Revised: 8/2017 Document Id: 55dbd02e-8de2-6b8f-e054-00144ff88e88 34391-3 Set id: 55dbd02e-8de1-6b8f-e054-00144ff88e88 Version: 1 Effective Time: 20170803 NuCare Pharmaceuticals,Inc. Прочитајте комплетан документ
CLOPIDOGREL- CLOPIDOGREL TABLET NUCARE PHARMACEUTICALS,INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CLOPIDOGREL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOPIDOGREL TABLETS. CLOPIDOGREL TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _ • EFFECTIVENESS OF CLOPIDOGREL DEPENDS ON CONVERSION TO AN ACTIVE METABOLITE BY THE CYTOCHROME P450 (CYP) SYSTEM, PRINCIPALLY CYP2C19. ( 5.1, 12.3) • TESTS ARE AVAILABLE TO IDENTIFY PATIENTS WHO ARE CYP2C19 POOR METABOLIZERS. ( 12.5) • CONSIDER USE OF ANOTHER PLATELET P2Y12 INHIBITOR IN PATIENTS IDENTIFIED AS CYP2C19 POOR METABOLIZERS. ( 5.1) RECENT MAJOR CHANGES Boxed Warning 09/2016 Indications and Usage ( 1.1, 1.2) 09/2016 Dosage and Administration ( 2.1, 2.2) 09/2016 Warnings and Precautions ( 5.1, 5.2, 5.3) 09/2016 INDICATIONS AND USAGE Clopidogrel is a P2Y 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 reduce the rate of myocardial infarction (MI) and stroke. ( 1.1) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.1) • Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.2) DOSAGE AND ADMINISTRATION • Acute coronary syndrome ( 2.1) - Initiate clopidogrel with a single 300-mg oral loading dose and then continue at 75 mg once daily - Initiating clopidogrel without a loading dose will delay establishment of an antiplatelet effect by several days • Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily orally without a loading dose ( 2.2) DOS Прочитајте комплетан документ