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:

Bryant Ranch Prepack

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
BRYANT RANCH PREPACK
----------
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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO
LOSS-OF-FUNCTION
ALLELES OF THE CYP2C19 GENE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
EFFECTIVENESS OF PLAVIX DEPENDS ON CONVERSION TO AN ACTIVE METABOLITE
BY THE CYTOCHROME P450 (CYP)
SYSTEM, PRINCIPALLY CYP2C19. (5.1, 12.3)
TESTS ARE AVAILABLE TO IDENTIFY PATIENTS WHO ARE CYP2C19 POOR
METABOLIZERS. (12.5)
CONSIDER USE OF ANOTHER PLATELET P2Y12 INHIBITOR IN PATIENTS
IDENTIFIED AS CYP2C19 POOR METABOLIZERS.
(5.1)
RECENT MAJOR CHANGES
Boxed Warning
9/2016
Indications and Usage (1.1, 1.2)
9/2016
Dosage and Administration (2.1, 2.2)
9/2016
Warnings and Precautions (5.1, 5.2, 5.3)
9/2016
INDICATIONS AND USAGE
Plavix is a P2Y platelet inhibitor indicated for:
Acute coronary syndrome
-
-
Recent MI, recent stroke, or established peripheral arterial disease.
Plavix has been shown to reduce the rate of MI and
stroke. (1.2)
DOSAGE AND ADMINISTRATION
Acute coronary syndrome (2.1)
-
-
Recent MI, recent stroke, or established peripheral arterial disease:
75 mg once daily orally without a loading dose (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
CYP2C19 inhibitors: Avoid concomitant use of omeprazole or
esomeprazole. (5.1)
Bleeding: Plavix increases risk of bleeding. (5.2)
Discontinuation: Premature discontinuation increases risk of
cardiovascular events. Discontinue 5 days prior to elective
12
For patients with non-ST-segment elevation ACS [unstable angina
(UA)/non-ST-elevation myocardial infarction