Bristol-myers Squibb/sanofi Pharmaceuticals Partnership

Bristol-myers Squibb/sanofi Pharmaceuticals Partnership Drugs

• Plavix
  

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  Plavix

  

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  2.1 Acute Coronary Syndrome

  Plavix can be administered with or without food [see Clinical Pharmacology (12.3)].

  For patients with non-ST-elevation ACS (UA/NSTEMI), initiate Plavix with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75–325 mg once daily) and continue in combination with Plavix [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of Plavix is 75 mg once daily orally, administered in combination with aspirin (75–325 mg once daily), with or without thrombolytics. Plavix may be initiated with or without a loading dose [see Clinical Studies (14.1)].

  2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease

  The recommended daily dose of Plavix is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].

  2.3 CYP2C19 Poor Metabolizers

  CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.

  2.4 Use with Proton Pump Inhibitors (PPI)

  Avoid using omeprazole or esomeprazole with Plavix. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of Plavix. When concomitant administration of a PPI is required, consider using another acid-reducing agent with minimal or no CYP2C19 inhibitory effect on the formation of clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

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