CLOPIDOGREL- clopidogrel bisulfate tablet, film coated
Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
Ulotka dla pacjenta
(PIL)
25-09-2020
Charakterystyka produktu
(SPC)
25-09-2020
Składnik aktywny:
CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (CLOPIDOGREL - UNII:A74586SNO7)
Dostępny od:
Clinical Solutions Wholesale
INN (International Nazwa):
CLOPIDOGREL BISULFATE
Skład:
CLOPIDOGREL 75 mg
Droga podania:
ORAL
Typ recepty:
PRESCRIPTION DRUG
Wskazania:
- 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, 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. - 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 percutaneous coronary intervention is unknown. The optimal duration of clopidogrel tablets, USP therapy in ACS is unknown. For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel tablets, U
Podsumowanie produktu:
Clopidogrel Tablets USP, 75 mg are pink colored, round, biconvex, beveled edge, film-coated tablets debossed with ‘E’ on one side and ‘34’ on the other side. Bottles of 30 NDC 65862-357-30 Bottles of 90 NDC 65862-357-90 Bottles of 100 NDC 65862-357-01 Bottles of 500 NDC 65862-357-05 Bottles of 1000 NDC 65862-357-99 10 x 10 Unit-dose Tablets NDC 65862-357-10
Status autoryzacji:
Abbreviated New Drug Application
Ulotka dla pacjenta
CLOPIDOGREL- CLOPIDOGREL BISULFATE TABLET, FILM COATED
Clinical Solutions Wholesale
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MEDICATION GUIDE
Clopidogrel Tablets, USP
(Kloe pid’ oh grel)
Read this Medication Guide before you start taking clopidogrel tablets
and each time you get a refill.
There may be new information. This Medication Guide does not take the
place of talking with your
doctor about your medical condition or your treatment.
What is the most important information I should know about clopidogrel
tablets?
1. Clopidogrel tablets may not work as well in people who:
•
have certain genetic factors that affect how the body breaks down
clopidogrel tablets. Your doctor
may do genetic tests to make sure clopidogrel tablets are right for
you.
•
take certain medicines, especially omeprazole (Prilosec ®) or
esomeprazole (Nexium ®). Your
doctor may change the medicine you take for stomach acid problems
while you take clopidogrel
tablets.
2. Clopidogrel tablets can cause bleeding which can be serious and can
sometimes lead to death.
Clopidogrel tablets are a blood thinner medicine that lowers the
chance of blood clots forming in your
body. While you take clopidogrel tablets:
•
you may bruise and bleed more easily
•
you are more likely to have nose bleeds
•
it will take longer for any bleeding to stop
Call your doctor right away if you have any of these signs or symptoms
of bleeding:
•
unexpected bleeding or bleeding that lasts a long time
•
blood in your urine (pink, red or brown urine)
•
red or black stools (looks like tar)
•
bruises that happen without a known cause or get larger
•
cough up blood or blood clots
•
vomit blood or your vomit looks like coffee grounds
Do not stop taking clopidogrel tablets without talking to the doctor
who prescribes them for you. People
who stop taking clopidogrel tablets too soon have a higher risk of
having a heart attack or dying. If you
must stop clopidogrel tablets because of bleeding, your risk of a
heart attack may be higher.
What are clopidogrel tablets?
Clopidogrel tablets are
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Charakterystyka produktu
CLOPIDOGREL- CLOPIDOGREL BISULFATE TABLET, FILM COATED
CLINICAL SOLUTIONS WHOLESALE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOPIDOGREL BISULFATE SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR CLOPIDOGREL TABLETS, USP.
CLOPIDOGREL TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
Effectiveness of clopidogrel bisulfate depends on activation to an
active metabolite by the cytochrome P450
(CYP) system, principally CYP2C19. (5.1)
Poor metabolizers treated with clopidogrel bisulfate 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 been shown to
reduce the combined endpoint of new ischemic stroke, new MI, and othe
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