Country: United States
Language: English
Source: NLM (National Library of Medicine)
CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (clopidogrel - UNII:A74586SNO7)
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
CLOPIDOGREL BISULFATE
clopidogrel 75 mg
PRESCRIPTION DRUG
New Drug Application
PLAVIX - CLOPIDOGREL BISULFATE TABLET, FILM COATED LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PLAVIX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PLAVIX. PLAVIX (CLOPIDOGREL BISULFATE) TABLETS INITIAL U.S. APPROVAL: 1997 WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ EFFECTIVENESS OF PLAVIX DEPENDS ON ACTIVATION TO AN ACTIVE METABOLITE BY THE CYTOCHROME P450 (CYP) SYSTEM, PRINCIPALLY CYP2C19. (5.1) POOR METABOLIZERS TREATED WITH PLAVIX AT RECOMMENDED DOSES EXHIBIT HIGHER CARDIOVASCULAR EVENT RATES FOLLOWING ACUTE CORONARY SYNDROME (ACS) OR PERCUTANEOUS CORONARY INTERVENTION (PCI) THAN PATIENTS WITH NORMAL CYP2C19 FUNCTION. (12.5) TESTS ARE AVAILABLE TO IDENTIFY A PATIENT'S CYP2C19 GENOTYPE AND CAN BE USED AS AN AID IN DETERMINING THERAPEUTIC STRATEGY. (12.5) CONSIDER ALTERNATIVE TREATMENT OR TREATMENT STRATEGIES IN PATIENTS IDENTIFIED AS CYP2C19 POOR METABOLIZERS. (2.3, 5.1) RECENT MAJOR CHANGES Dosage and Administration (2.3, 2.4) 08/2010 Warnings and Precautions (5.1, 5.2, 5.3) 08/2010 INDICATIONS AND USAGE Plavix is a P2Y platelet inhibitor indicated for: Acute coronary syndrome - - Recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease. Plavix has been shown to reduce the combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death. (1.2) DOSAGE AND ADMINISTRATION Acute coronary syndrome (2.1) - - Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily (2.2) DOSAGE FORMS AND STRENGTHS Tablets: 75 mg, 300 mg (3) CONTRAINDICATIONS 12 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, Plavix has been Read the complete document