CLOPIDOGREL tablet film coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

St Marys Medical Park Pharmacy

INN (Alþjóðlegt nafn):

CLOPIDOGREL BISULFATE

Samsetning:

CLOPIDOGREL 75 mg

Gerð lyfseðils:

PRESCRIPTION DRUG

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

CLOPIDOGREL - CLOPIDOGREL TABLET, FILM COATED
ST MARYS MEDICAL PARK PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOPIDOGREL TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOPIDOGREL TABLETS
USP.
CLOPIDOGREL TABLETS USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
EFFECTIVENESS OF CLOPIDOGREL DEPENDS ON ACTIVATION TO AN ACTIVE
METABOLITE BY THE CYTOCHROME P450
(CYP) SYSTEM, PRINCIPALLY CYP2C19. (5.1)
POOR METABOLIZERS TREATED WITH CLOPIDOGREL 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
Warnings and Precautions (5.6) 12/2013
INDICATIONS AND USAGE
Clopidogrel tablets USP are a P2Y platelet inhibitor indicated for:
Acute coronary syndrome
For patients with non-ST-segment elevation ACS [unstable angina
(UA)/non-ST-elevation myocardial infarction
(NSTEMI)], clopidogrel tablets USP have 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. (1.1)
For patients with ST-elevation myocardial infarction (STEMI),
clopidogrel tablets USP have 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 PCI is unknown. (1.1)
Recent MI, recent stroke, or established peripheral arterial disease.
Clopidogrel tablets USP have