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Plavix

"March 11, 2010 - The FDA has put a new "black box" warning on the anti-clotting drug Plavix, the second best-selling drug in the world.

The new label warns that normal doses of Plavix have a potentially deadly lack of effect in 2% "...

Plavix

Plavix

INDICATIONS

Acute Coronary Syndrome (ACS)

  • 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 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.
  • For patients with ST-elevation myocardial infarction (STEMI), 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 percutaneous coronary intervention is unknown.

The optimal duration of Plavix therapy in ACS is unknown.

Recent MI, Recent Stroke, Or Established Peripheral Arterial Disease

For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, Plavix has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.

DOSAGE AND ADMINISTRATION

Acute Coronary Syndrome

Plavix can be administered with or without food [see CLINICAL PHARMACOLOGY].

  • 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].
  • 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].

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].

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], an appropriate dose regimen for this patient population has not been established.

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, DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

  • 75 mg tablets: Pink, round, biconvex, film-coated tablets debossed with “75” on one side and “1171” on the other
  • 300 mg tablets: Pink, oblong, film-coated tablets debossed with “300” on one side and “1332” on the other

Storage And Handling

Plavix (clopidogrel bisulfate) 75 mg tablets are available as pink, round, biconvex, film-coated tablets debossed with “75” on one side and “1171” on the other. Tablets are provided as follows:

NDC 63653-1171-6 Bottles of 30
NDC
63653-1171-1 Bottles of 90
NDC
63653-1171-5 Bottles of 500
NDC
63653-1171-3 Blisters of 100

Plavix (clopidogrel bisulfate) 300 mg tablets are available as pink, oblong, film-coated tablets debossed with “300” on one side and “1332” on the other. Tablets are provided as follows:

NDC 63653-1332-2 Unit-dose packages of 30
NDC 63653-1332-3 Unit-dose packages of 100

Store at 25° C (77° F); excursions permitted to 15°–30° C (59°–86° F) [see USP Controlled Room Temperature].

Distributed by: Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership Bridgewater, NJ 08807. Revised December 2013

Last reviewed on RxList: 12/30/2013
This monograph has been modified to include the generic and brand name in many instances.

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