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Plavix 300mg tablets - Patient Information Leaflet PIL - eMC Unstable angina, non-ST-segment elevation MI (NSTEMI): 300 mg loading dose; initiating therapy without a loading dose will delay establishment of antiplatelet effect by several days; following the loading dose, administer 75 mg/day PO for up to 12 months; may administer beyond 12 months if used in combination with aspirin (75-100 mg/day); long-term combination therapy with aspirin, following stent placement, is individualized depending on how a patient tolerates long-term dual antiplatelet therapy (DAPT), whether they have stable coronary artery disease, and do NOT have risk factors (eg, TIA or stroke, age 300 mg PO plus aspirin 81-325 mg for 1 dose on day before carotid artery stenting (CAS), then 75 mg/day PO plus aspirin 81-325 mg/day for at least 30 days after CAS Alternative: 300-600 mg PO once, then 75 mg/day for 4 days before CAS in combination with aspirin 81-325 mg/day CYP2C19 poor metabolizers associated with diminished antiplatelet response to clopidogrel; although hher-dose regimen (600 mg loading dose followed by 150 mg once daily) in poor metabolizers increases antiplatelet response, no appropriate dosing regimen for poor metabolizers has been established in clinical outcome trials Upper respiratory tract infection (8.7%) Chest pain (8.3%) Headache (7.6%) Flulike syndrome (7.5%) Arthralgia (6%) Pain (6%) Dizziness (6%) Diarrhea (4.5%) Rash (4.2%) Rhinitis (4.2%) Depression (3.6%) Urinary tract infection (3.1%) Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura (TTP), acquired hemophilia A Eye disorders: Eye (conjunctival, ocular, retinal) bleeding Gastrointestinal disorders: Gastrointestinal and retroperitoneal hemorrhage with fatal outcome, colitis (including ulcerative or lymphocytic colitis), pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea General disorders and administration site condition: Fever, hemorrhage of operative wound Hepato-biliary disorders: Acute liver failure, hepatitis (non-infectious), abnormal liver function test Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness Musculoskeletal, connective tissue and bone disorders: Musculoskeletal bleeding, myalgia, arthralgia, arthritis Nervous system disorders: Taste disorders, fatal intracranial bleeding, headache Psychiatric disorders: Confusion, hallucinations Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, respiratory tract bleeding, eosinophilic pneumonia Renal and urinary disorders: Increased creatinine levels Skin and subcutaneous tissue disorders: Maculopapular, erythematous, or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), erythema multiforme, skin bleeding, lichen planus, generalized pruritus, acute generalized exanthematous pustulosis (AGEP) Vascular disorders: Vasculitis, hypotension Clopidogrel's antiplatelet activity is dependent on conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19 Tests are available to identify patients who are CYP2C19 poor metabolizers Consider use of another platelet P2Y12 inhibitor in patients identified as CYP2C19 poor metabolizers Use with caution in patients with bleeding or platelet disorders Premature discontinuation increases risk of cardiovascular events; discontinue 5 days prior to elective surgery that has a major risk of bleeding Use caution in patients with atrial fibrillation; assess bleeding risk carefully; snificant increase in major bleeding events reported in patients receiving clopidogrel plus aspirin instead of aspirin alone Patients allergic to aspirin who are undergoing PCI; see American Heart Association (AHA)/American College of Chest Physicians (ACCP)/American College of Cardiology (ACC) recommendations Rare but potentially fatal thrombotic thrombocytopenic purpura associated with use Risk of bleeding with potentially fatal outcome Hepatic or renal impairment Allergic cross-reactivity including rash, angioedema, or hematologic reaction among thienopyridines (eg, ticlopidine, prasugrel) reported; evaluate patient for history of hypersensitivity Use caution in patients with severe hepatic or renal impairment Use caution or avoid in patients with hypersensitivity or hematologic reactions to previous thienopyridine use, including ticlopidine and prasugrel Use caution in patients receiving either anticoagulants, including heparin and warfarin, or other platelet aggregation inhibitors; risk of bleeding increases Premature interruption of therapy may result in stent thrombosis with subsequent fatal and nonfatal myocardial infarction; duration of therapy is determined by type of stent placed May increase risk of major hemorrhage in patients with recent lacunar stroke Pregnancy: There are no adequate and well-controlled studies in pregnant women; because animal reproduction studies are not always predictive of human response, clopidogrel should be used during pregnancy only if clearly needed Lactation: Not known whether drug is excreted in human milk; because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from clopidogrel, a decision should be made whether to discontinue nursing or to discontinue drug, taking into account importance of drug to mother Metabolized in liver by hepatic CYP450 enzymes (in vitro by CYP3A4, CYP2C19 [predominantly], others) to generate active metabolite and also by esterase to generate inactive metabolite Metabolites: Thiol (active); further activation of thiol metabolite is required through hydrolysis via paraoxonase-1 (PON-1); allele variation of PON-1 may inhibit activation and increase risk for stent thrombosis The above information is provided for general informational and educational purposes only. Plavix 300mg tablets - Patient Information Leaflet PIL by SANOFI. Skip to content. HOME; MEDICINES. Plavix ® 300 mg. film-coated tablets. clopidogrel.
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Plavix 300 mg film-coated tablets Prevention of atherothrombotic events Clopidogrel is indicated in: • Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Plavix is a medicine that contains the active substance clopidogrel. It is available as pink tablets round 75 mg; oblong 300 mg. What is it used for?
PLAVIX® clopidogrel bisulfate tablets Prescribing Information Pill imprint 300 1332 has been identified as Plavix 300 mg. PLAVIX ® Prescribing Information clopidogrel bisulfate tablets Rx only. Plavix clopidogrel bisulfate 300 mg tablets are available as pink, oblong.
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