CLOPIDOGREL BISULFATE tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

ScieGen Pharmaceuticals Inc

INN (इंटरनेशनल नाम):

Clopidogrel bisulfate

रचना:

Clopidogrel 75 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

• Clopidogrel is indicated to reduce the rate of myocardial infarction (MI) and stroke in 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 should be administered in conjunction with aspirin. • Clopidogrel is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel should be administered in conjunction with aspirin. In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel is indicated to reduce the rate of MI and stroke. Clopidogrel is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Clopidogrel is contraindicated in patients with hypersensitivity (e.

उत्पाद समीक्षा:

Clopidogrel tablets, USP 75 mg are available as pink colored, round shaped, biconvex, film coated tablets de-bossed on one side with SG and 124 on other side. Tablets are provided as follows:  Clopidogrel tablets, USP 300 mg are available as pink colored, modified oval shaped, film coated tablets de-bossed on one side with SG and 121 on other side. Tablets are provided as follows: Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

ScieGen Pharmaceuticals Inc
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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.
1. Clopidogrel tablets may not work as well in people who:
1.
have certain genetic factors that affect how the body breaks down
clopidogrel.Your doctor
may do genetic tests to make sure clopidogrel tablets are right for
you.
2.
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.
2. Clopidogrel tablets can cause bleeding which can be serious and can
sometimes lead to
death.Clopidogrel is a blood thinner medicine that lowers the chance
of blood clots forming in
your body. While you take clopidogrel tablets:
1.
you may bruise and bleed more easily
2.
you are more likely to have nose bleeds
3.
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 it 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 following:
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उत्पाद विशेषताएं

CLOPIDOGREL BISULFATE- CLOPIDOGREL BISULFATE TABLET, FILM COATED
SCIEGEN PHARMACEUTICALS INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOPIDOGREL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CLOPIDOGREL TABLETS.
CLOPIDOGREL 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 CLOPIDOGREL 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)
INDICATIONS AND USAGE
Clopidogrel is 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 has been shown to reduce the rate of
myocardial infarction (MI) and
stroke. ( 1.1)
For patients with ST-elevation myocardial infarction (STEMI),
clopidogrel has been shown to reduce
the rate of MI and stroke. ( 1.1)
Recent MI, recent stroke, or established peripheral arterial disease.
Clopidogrel has been shown to
reduce the rate of MI and stroke. ( 1.2)
DOSAGE AND ADMINISTRATION
Acute coronary syndrome ( 2.1)
Initiate clopidogrel with a single 300-mg oral loading dose and then
continue at 75 mg once daily.
Initiate clopidogrel without a loading dose will delay establishment
of an antiplatelet effect by several
days.
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 clopid