PLAVIX- clopidogrel bisulfate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (clopidogrel - UNII:A74586SNO7)

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

CLOPIDOGREL BISULFATE

Composition:

clopidogrel 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 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. 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 ischemi

Product summary:

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. 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. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 25° C (77° F); excursions permitted to 15°–30° C (59°–86° F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

PLAVIX - CLOPIDOGREL BISULFATE TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PLAVIX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PLAVIX.
PLAVIX (CLOPIDOGREL BISULFATE) TABLETS
INITIAL U.S. APPROVAL: 1997
WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
EFFECTIVENESS OF PLAVIX DEPENDS ON ACTIVATION TO AN ACTIVE METABOLITE
BY THE CYTOCHROME P450 (CYP)
SYSTEM, PRINCIPALLY CYP2C19. (5.1)
POOR METABOLIZERS TREATED WITH PLAVIX AT RECOMMENDED DOSES EXHIBIT
HIGHER CARDIOVASCULAR EVENT
RATES FOLLOWING ACUTE CORONARY SYNDROME (ACS) OR PERCUTANEOUS CORONARY
INTERVENTION (PCI) THAN
PATIENTS WITH NORMAL CYP2C19 FUNCTION. (12.5)
TESTS ARE AVAILABLE TO IDENTIFY A PATIENT'S CYP2C19 GENOTYPE AND CAN
BE USED AS AN AID IN DETERMINING
THERAPEUTIC STRATEGY. (12.5)
CONSIDER ALTERNATIVE TREATMENT OR TREATMENT STRATEGIES IN PATIENTS
IDENTIFIED AS CYP2C19 POOR
METABOLIZERS. (2.3, 5.1)
RECENT MAJOR CHANGES
Boxed Warning
03/2010
Dosage and Administration (2.3)
03/2010
Warnings and Precautions (5.1, 5.2, 5.3) 03/2010
INDICATIONS AND USAGE
Plavix is a P2Y platelet inhibitor indicated for:
Acute coronary syndrome
-
-
Recent myocardial infarction (MI), recent stroke, or established
peripheral arterial disease. Plavix has been shown to
reduce the combined endpoint of new ischemic stroke (fatal or not),
new MI (fatal or not), and other vascular death.
(1.2)
DOSAGE AND ADMINISTRATION
Acute coronary syndrome (2.1)
-
-
Recent MI, recent stroke, or established peripheral arterial disease:
75 mg once daily (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg, 300 mg (3)
12
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