1、 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 POORMETABOLIZER
2、SSee 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 fol
3、lowing acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) than patients with normal CYP2C19 function. (12.5) Tests are available to identify a patients CYP2C19 genotype and can be used as an aid in determining therapeutic strategy. (12.5) Consider alternative treatment or trea
4、tment strategies in patients identified as CYP2C19 poor metabolizers. (2.3, 5.1) -INDICATIONS AND USAGE- Plavix 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),
5、 Plavix 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 (STEM
6、I), Plavix 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. Plavix has been shown
7、to reduce the combined endpoint of new ischemic stroke, new MI, and other vascular death. (1.2) -DOSAGE AND ADMINISTRATION- Acute coronary syndrome (2.1) - UA/NSTEMI: 300 mg loading dose followed by 75 mg once daily, in combination with aspirin (75-325 mg once daily) - STEMI: 75 mg once daily, in co
8、mbination with aspirin (75-325 mg once daily), with or without a loading dose 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- Active pathological bleeding, such as peptic ulcer or
9、 intracranial hemorrhage (4.1) Hypersensitivity to clopidogrel or any component of the product (4.2) -WARNINGS AND PRECAUTIONS- CYP2C19 inhibitors: Avoid concomitant use of omeprazole or esomeprazole. (5.1) Bleeding: Plavix increases risk of bleeding. Discontinue 5 days prior to elective surgery. (5
10、.2) Premature discontinuation increases risk of cardiovascular events. (5.3) Recent transient ischemic attack or stroke: Combination use of Plavix and aspirin is not more effective than Plavix alone, but increases major bleeding. (5.4) Thrombotic thrombocytopenic purpura (TTP) has been reported. (5.
11、5) Cross-reactivity among thienopyridines has been reported. (5.6) -ADVERSE REACTIONS- Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership
12、 at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. -DRUG INTERACTIONS- Nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs): Increases risk of bleeding. (7.2,7.3,7.4) -USE IN SPECIFIC POPULATION
13、S- Nursing mothers: Discontinue drug or nursing. (8.3) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 7/2015 1 Reference ID: 3792973 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS 1 INDICATIONS AND USAGE 1.1 Acute Coronary Syn
14、drome (ACS)1.2 Recent MI, Recent Stroke, or Established Peripheral ArterialDisease2 DOSAGE AND ADMINISTRATION 2.1 Acute Coronary Syndrome2.2 Recent MI, Recent Stroke, or Established Peripheral ArterialDisease2.3 CYP2C19 Poor Metabolizers2.4 Use with Proton Pump Inhibitors (PPI)3 DOSAGE FORMS AND STR
15、ENGTHS4 CONTRAINDICATIONS4.1 Active Bleeding4.2 Hypersensitivity5 WARNINGS AND PRECAUTIONS 5.1 Diminished Antiplatelet Activity Due to Impaired CYP2C19Function5.2 General Risk of Bleeding5.3 Discontinuation of Plavix5.4 Patients with Recent Transient Ischemic Attack (TIA) orStroke5.5 Thrombotic Thro
16、mbocytopenic Purpura (TTP)5.6 Cross-Reactivity among Thienopyridines6 ADVERSE REACTIONS 6.1 Clinical Studies Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 CYP2C19 Inhibitors7.2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)7.3 Warfarin (CYP2C9 Substrates)* Sections or subsections om
17、itted from the full prescribing information are not listed. 7.4 SSRIs and SNRIs8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action12.2
18、Pharmacodynamics12.3 Pharmacokinetics12.5 Pharmacogenomics13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES 14.1 Acute Coronary Syndrome14.2 Recent Myocardial Infarction, Recent Stroke, or EstablishedPeripheral Arterial Disease14.3 Lack of Establi
19、shed Benefit of Plavix plus Aspirin in Patientswith Multiple Risk Factors or Established Vascular Disease16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 17.1 Benefits and Risks17.2 Bleeding17.3 Other Signs and Symptoms Requiring Medical Attention17.4 Invasive Procedures17.5 Concomitant Medications2 Reference ID: 3792973
