Plavix

[Clopidogrel]

Indications & Dosage
INDICATIONS AND USAGE

PLAVIX (clopidogrel bisulfate) is indicated for the reduction of thrombotic 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.

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Acute Coronary Syndrome

For patients with 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.

DOSAGE AND ADMINISTRATION

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 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).

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.)

HOW SUPPLIED

PLAVIX (clopidogrel bisulfate) is available as a pink, round, biconvex, film-coated tablet 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

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
New York, NY 10016

PLAVIX® is a registered trademark of Sanofi-Synthelabo.

51-021345-02 Revised May 2002