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:

Cardinal Health

INN (International Name):

clopidogrel bisulfate

Composition:

clopidogrel 75 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

PLAVIX- CLOPIDOGREL BISULFATE TABLET, FILM COATED
CARDINAL HEALTH
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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, 2.4)
08/2010
Warnings and Precautions (5.1, 5.2, 5.3) 08/2010
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)
CONTRAINDICATIONS
Active pathological bleeding, such as peptic ulcer or intracranial
hemorrhage (4.1)
Hypersensitivity to clopidogrel or any component of the product (4.2)
WARNINGS AND PRECAUTIONS
Reduced effectiveness in impaired CYP2C19 function: Avoid concomitant
use with drugs that are strong or moderate