CLOPIDOGREL BISULFATE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Torrent Pharmaceuticals Limited

INN (International ime):

CLOPIDOGREL BISULFATE

Sastav:

CLOPIDOGREL 75 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

- 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 are c

Proizvod sažetak:

Clopidogrel tablets, USP 75mg are available as light pink colored, round, beveled edge, biconvex film coated tablets printed "41" with black ink on one side and plain on the other side. Tablets are provided as follows:                         Bottles of 30                                      NDC 13668-141-30                         Bottles of 90                                      NDC 13668-141-90                         Bottles of 100                                    NDC 13668-141-01                         Bottles of 500                                    NDC 13668-141-05                         Bottles of 1000                                  NDC 13668-141-10                         Bottles of 3100                                  NDC 13668-141-44 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].

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

Torrent Pharmaceuticals Limited
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MEDICATION GUIDE
Clopidogrel (kloe PID oh grel) Tablets, USP
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 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 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 prescription medicine used to treat people who
have any of th

Svojstava lijeka

CLOPIDOGREL BISULFATE- CLOPIDOGREL BISULFATE TABLET
TORRENT PHARMACEUTICALS LIMITED
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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 BISULFATEDEPENDS 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 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