CLOPIDOGREL tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Wockhardt USA LLC.

INN (Medzinárodný Name):

CLOPIDOGREL BISULFATE

Zloženie:

CLOPIDOGREL 75 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

- Clopidogrel tablet, USP 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. Plavix should be administered in conjunction with aspirin. - Clopidogrel tablet, USP 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. Plavix 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 tablet, USP 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. Clopid

Prehľad produktov:

Clopidogrel tablets USP,75 mg are available as pink, round, biconvex, film-coated tablets debossed with "W 314" on one side and plain on other. Tablets are provided as follows: NDC 64679-314-01, bottle of 30 tablets NDC 64679-314-02, bottle of 90 tablets NDC 64679-314-03, bottle of 500 tablets NDC 64679-314-04, unit dose packages of 100 tablets Clopidogrel tablets USP, 300 mg are available as pink, modified capsule shaped, biconvex, film-coated tablets debossed with "W 315" on one side and plain on other. Tablets are provided as follows: NDC 64679-315-01, bottle of 30 tablets NDC 64679-315-02, bottle of 90 tablets NDC 64679-315-03, bottle of 500 tablets NDC 64679-315-04, unit dose packages of 100 tablets Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Wockhardt USA LLC.
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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 tablet is 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 tablet is 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 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 is Clopidogrel Tablet?
Clopidogrel tablet is a prescription medicine used to treat people who
have any of the following:
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Súhrn charakteristických

CLOPIDOGREL- CLOPIDOGREL TABLET, FILM COATED
WOCKHARDT USA LLC.
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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 tablets, USP has been shown to reduce the rate
of myocardial infarction (MI) and stroke. (1.1)
– For patients with ST-elevation myocardial infarction (STEMI),
clopidogrel tablets, USP has been shown to reduce the
rate of MI and stroke. (1.1)
Recent MI, recent stroke, or established peripheral arterial disease.
Clopidogrel tablet, USP has been shown to reduce
the rate of MI and stroke. (1.2)
DOSAGE AND ADMINISTRATION
Acute coronary syndrome (2.1)
– Initiate clopidogrel tablet, USP with a single 300-mg oral loading
dose and then continue at 75 mg once daily.
– Initiating clopidogrel tablet, USP 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
hemor