CLOPIDOGREL tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

NuCare Pharmaceuticals,Inc.

Designació comuna internacional (DCI):

CLOPIDOGREL BISULFATE

Composición:

CLOPIDOGREL 75 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

- 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 (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

Resumen del producto:

Clopidogrel tablets USP are available as follows: 75 mg – light-pink to pink, film-coated, capsule shaped tablets debossed with “TV” on one side and “7314” on the other side, in bottles of 30, 90, and 500. NDC 68071-4138-3 Bottles of 30 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

NuCare 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. Clopidogrel tablets may not work as well in people who:
1.
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.
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. 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:
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:
1.
unexpected bleeding or bleeding that lasts a long time
2.
blood in your urine (pink, red or brown urine)
3.
red or black stools (looks like tar)
4.
bruises that happen without a known cause or get larger
5.
cough up blood or blood clots
6.
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

Fitxa tècnica

CLOPIDOGREL- CLOPIDOGREL TABLET, FILM COATED
NUCARE 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)
RECENT MAJOR CHANGES
Boxed Warning
9/2016
Indications and Usage ( 1.1, 1.2)
9/2016
Dosage and Administration ( 2.1, 2.2)
9/2016
Warnings and Precautions ( 5.1, 5.2, 5.3)
9/2016
INDICATIONS AND USAGE
Clopidogrel tablets are a P2Y
platelet inhibitor indicated for:
1. Acute coronary syndrome
2. 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)
3. For patients with ST-elevation myocardial infarction (STEMI),
clopidogrel tablets have been shown to
reduce the rate of MI and stroke. ( 1.1)
4. 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
1. Acute coronary syndrome ( 2.1)
2. Initiate clopidogrel tablets with a single 300-mg oral loading dose
and then continue at 75 mg once
daily.
3. Initiating clopidogrel tablets without a loading dose will delay
establishment of an antiplatelet effect by
several days.
4. Recent MI, recent stroke, or established peripheral arterial
disease: 75 mg