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普拉格雷FDA-label.pdf

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普拉格雷FDA-label.pdf

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HIGHLIGHTS OF PRESCRIBING INFORMATIOardiovascular event rates following acute coronary syndrome • Hypersensitivity to clopidogrel or any component of the product ()
(ACS) or percutaneous coronary intervention (PCI) than patients with
normal CYP2C19 function. () -----------------------WARNINGS AND PRECAUTIONS------------------------
• Tests are available to identify a patient's CYP2C19 genotype and can • Reduced effectiveness in impaired CYP2C19 function: Avoid concomitant
be used as an aid in determining therapeutic strategy. () use with drugs that are strong or moderate CYP2C19 inhibitors (.,
• Consider alternative treatment or treatment strategies in patients omeprazole). ()
identified as CYP2C19 poor metabolizers. (, ) • Bleeding: Plavix increases risk of bleeding. Discontinue 5 days prior to
elective surgery. ()
----------------------------RECENT MAJOR CHANGES-------------------------- • Discontinuation of Plavix: Premature discontinuation increases risk of
Boxed Warning 03/2010 cardiovascular events. ()
Dosage and Administration (, ) 08/2010 • Recent transient ischemic attack or stroke: Combination use of Plavix and
Warnings and Precautions (, , ) 08/2010 aspirin in these patients was not shown to be more effective than Plavix
alone, but was shown to increase major bleeding. ()
----------------------------INDICA