Plavix (clopidogrel bisulfate) is indicated for the reduction of atherothrombotic events as follows:

• 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.
• Acute Coronary Syndrome
  For patients with non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI) including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or CABG, Plavix has been shown to decrease the rate of a combined endpoint of cardiovascular death, MI, or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
  For patients with ST-segment elevation acute myocardial infarction, 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. This benefit is not known to pertain to patients who receive primary angioplasty.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease

The recommended daily dose of Plavix is 75 mg once daily.

Acute Coronary Syndrome

For patients with non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI), Plavix should be initiated with a single 300-mg loading dose and then continued at 75 mg once daily. Aspirin (75 mg-325 mg once daily) should be initiated and continued in combination with Plavix. In CURE, most patients with Acute Coronary Syndrome also received heparin acutely (see CLINICAL STUDIES).

For patients with ST-segment elevation acute myocardial infarction, the recommended dose of Plavix is 75 mg once daily, administered in combination with aspirin, with or without thrombolytics. Plavix may be initiated with or without a loading dose (300 mg was used in CLARITY; see CLINICAL STUDIES).

Plavix can be administered with or without food.

No dosage adjustment is necessary for elderly patients or patients with renal disease. (See CLINICAL PHARMACOLOGY: Special Populations.)

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 63653-1332-3 unit-dose packages of 100

Storage

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 October 2007. FDA Rev date: 9/20/2007

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