Plavix Product Information

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Plavix® (clopidogrel hydrogen sulphate). Indication: Prevention of vascular ischaemia associated with atherothrombotic events in patients with a history of symptomatic atherosclerotic disease. Dosage: 75mg daily. In non-ST-elevation Acute Coronary Syndromes, 300mg stat then 75mg daily (with aspirin). Contraindications: Hypersensitivity to clopidogrel or any excipients; severe liver impairment; active bleeding; breast-feeding. Precautions: Pregnancy Category B1; perform blood cell counts/other tests promptly if clinically indicated; patients at risk of bleeding from trauma, surgery or other pathological conditions, intraocular and/or GI lesions; moderate hepatic disease; severe renal impairment. In patients with recent transient ischaemic attack or stroke who are at high risk of recurrent ischaemic events, the combination of aspirin and clopidogrel has been shown to increase major bleeding*. Adverse Reactions: Bleeding including serious and/or fatal bleeding (very rare); diarrhoea; rash; pruritis; purpura; hypersensitivity reactions; TTP (very rare); blood dyscrasias (uncommon); acute liver failure* (very rare); serum sickness*; toxic epidermal necrolysis*; stomatitis*; interstitial pneumonitis*; others. Interactions: Aspirin, NSAIDs, heparin, GPIIb/IIIa inhibitors, thrombolytics, warfarin, drugs metabolised by P450 2C9 including phenytoin, tamoxifen, tolbutamide, fluvastatin. Presentation: 75mg tablets. PBS dispensed price: Plavix 75mg $84.13. Full prescribing information available upon request from Sanofi-Synthelabo Australia Pty Limited, a member of sanofi-aventis Group, A.B.N. 24 057 960 255, Talavera Corporate Centre, Building D, 12-24 Talavera Road, Macquarie Park NSW 2113. Plavix is a registered trademark of Sanofi-Synthelabo. * Please note changes in PI.