CLOPIDOGREL tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

DIRECT RX

INN (Rahvusvaheline Nimetus):

CLOPIDOGREL BISULFATE

Koostis:

CLOPIDOGREL 75 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

1.1 Acute Coronary Syndrome (ACS) - 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. 1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease For patients with a history of recent my

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

DIRECT RX
----------
SPL MEDGUIDE SECTION
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 a prescription medicine used to treat people
who have any of the followi

Toote omadused

CLOPIDOGREL- CLOPIDOGREL TABLET, FILM COATED
DIRECT RX
----------
CLOPIDOGREL
BOXED WARNING SECTION
WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS
The effectiveness of clopidogrel bisulfate is dependent on its
activation to an active
metabolite by the cytochrome P450 (CYP) system, principally CYP2C19
[see
Warnings and Precautions (5.1)]. Clopidogrel bisulfate at recommended
doses
forms less of that metabolite and has a smaller effect on platelet
function in
patients who are CYP2C19 poor metabolizers. Poor metabolizers with
acute
coronary syndrome or undergoing percutaneous coronary intervention
treated
with clopidogrel bisulfate at recommended doses exhibit higher
cardiovascular
event rates than do patients with normal CYP2C19 function. Tests are
available to
identify a patient's CYP2C19 genotype; these tests can be used as an
aid in
determining therapeutic strategy [see Clinical Pharmacology (12.5)].
Consider
alternative treatment or treatment strategies in patients identified
as CYP2C19 poor
metabolizers [see Dosage and Administration (2.3)].
INDICATIONS & USAGE SECTION
1.1 Acute Coronary Syndrome (ACS)
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.
1.2 Recent MI, Recent Stroke, or Establishe