CLOPIDOGREL- clopidogrel bisulfate tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Գնել հիմա

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Bryant Ranch Prepack

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

- Clopidogrel tablets are 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 tablets should be administered in conjunction with aspirin. - Clopidogrel tablets are 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 tablets 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 tablets are indicated to reduce the rate of MI and stroke. Clopidogrel tablets  are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Clopidogrel tablets

Ապրանքի ամփոփագիր:

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. NDC: 71335-0080-1: 90 Tablets in a BOTTLE NDC: 71335-0080-2: 30 Tablets in a BOTTLE NDC: 71335-0080-3: 60 Tablets in a BOTTLE NDC: 71335-0080-4: 20 Tablets in a BOTTLE NDC: 71335-0080-5: 10 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Preserve in well-closed containers. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

                                Bryant Ranch Prepack
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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 a prescription medicine used to treat people
who have any of the 
                                
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Ապրանքի հատկությունները

                                CLOPIDOGREL- CLOPIDOGREL BISULFATE TABLET, FILM COATED
BRYANT RANCH PREPACK
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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 BISULFATE 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 P2Y INHIBITOR IN PATIENTS IDENTIFIED AS CYP2C19
POOR METABOLIZERS. (5.1)
INDICATIONS AND USAGE
Clopidogrel tablets 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 have been shown to reduce
the rate of myocardial infarction (MI)
and stroke. (1.1)
– For patients with ST-elevation myocardial infarction (STEMI),
clopidogrel tablets have been shown to
reduce the rate of MI and stroke. (1.1)
Recent MI, recent stroke, or established peripheral arterial disease.
Clopidogrel tablets have been
shown to reduce the rate of MI and stroke. (1.2)
DOSAGE AND ADMINISTRATION
Acute coronary syndrome (2.1)
– Initiate clopidogrel tablets with a single 300 mg oral loading
dose and then continue at 75 mg once
daily.
– Initiating clopidogrel tablets 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 (3)
CONTRAINDICATIONS
Active pathological bleeding, such as peptic ulcer or intracrani
                                
                                Կարդացեք ամբողջական փաստաթուղթը
                                
                            

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