Avoid mistakes in therapy, and if PLAVIX should be temporarily interrupted, restart as soon as possible. The early cessation of clopidogrel may increase the risk of cardiovascular events.Concomitant use of Plavix and drugs that inhibit the activity of CYP2C19. Co-administration of clopidogrel with omeprazole, a proton pump inhibitor is an inhibitor of CYP2C19, reduces the pharmacological activity of Plavix if co-administration or if they are given 12 hours [see Drug Interactions (7.1)]. Consider using another agent reduces the activity of acid inhibitor of CYP2C19 less. Pantoprazole, an inhibitor of CYP2C19 poor, has less effect on the pharmacological activity of Plavix as omeprazole [see Drug Interactions (7.1) and Dosage and Administration (2.4)].
Plavix is contra-indicated in patients with active pathologic bleeding such as intracranial hemorrhage o.
In patients with recent TIA or stroke who are at high risk of recurrent ischemic events, the combination of aspirin and clopidogrel has been shown to be more effective than clopidogrel alone, but the combination has been shown to increase major bleeding.
Plavix is contra-indicated in patients with hypersensitivity (for example) to clopidogrel or any component of the product.
For patients with a history of recent myocardial infarction (MI), recent stroke or established, PLAVIX has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), a new MI (fatal or not), and other vascular death.
Bristol-Myers Squibb Company (NYSE: BMY) and Sanofi-aventis (EURONEXT: SAN, NYSE: SNY) announced that the U. S. Food and Drug Administration (FDA) has granted the company another six months of market exclusivity of Plavix (clopidogrel bisulfate). Exclusive PLAVIX in the United States is now scheduled to expire May 17, 2012.
TTP, sometimes fatal, have been reported following use of PLAVIX, sometimes after a short exposure (
Plavix is marketed by Bristol-Myers Squibb and Sanofi-Aventis and is indicated for adult patients as follows:
Including patients who need to be managed physician and those 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 as a combined endpoint rate of death cardiovascular disease, myocardial infarction, stroke, or refractory ischemia.