CLOPIDOGREL BISULFATE 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:

Physicians Total Care, Inc.

Designació comuna internacional (DCI):

Clopidogrel bisulfate

Composición:

Clopidogrel 75 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

- For 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 have been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown.  The optimal duration of clopidogrel tablet therapy in ACS is unknown. For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel tablets has been shown to

Resumen del producto:

Clopidogrel tablets USP, 75 mg are white, film coated, round, biconvex tablets debossed with “R” on one side and “196” on other side and are supplied in bottles of 30 and 90.  Bottles of 30                           NDC 54868-6336-0                       Bottles of 90                           NDC 54868-6336-1                        Preserve in well-closed containers. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Physicians Total Care, Inc.
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17.6 MEDICATION GUIDE
Medication Guide
Clopidogrel Tablets USP
Read this Medication Guide before you start taking clopidogrel 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?
1. Clopidogrel may not work as well in people who:
•
have certain genetic factors that affect how the body breaks down
clopidogrel. Your doctor may
do genetic tests to make sure clopidogrel 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.
2. Clopidogrel 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:
•
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 without talking to the doctor who
prescribes it for you. People who are
treated with a stent, and stop taking clopidogrel too soon, have a
higher risk of getting a blood clot on the
stent, having a heart attack, or dying. If you must stop clopidogrel
because of bleeding, your risk of a
heart attack may be higher.
What is clopidogrel?
Clopidogrel is a prescription medicine used to treat people who have
any of the following:
•
chest pain due to heart proble

Fitxa tècnica

CLOPIDOGREL BISULFATE - CLOPIDOGREL BISULFATE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, 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 USP
INITIAL U.S. APPROVAL: 1997
WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
EFFECTIVENESS OF CLOPIDOGREL DEPENDS ON ACTIVATION TO AN ACTIVE
METABOLITE BY THE CYTOCHROME P450
(CYP) SYSTEM, PRINCIPALLY CYP2C19. (5.1)
POOR METABOLIZERS TREATED WITH CLOPIDOGREL AT RECOMMENDED DOSES
EXHIBIT HIGHER CARDIOVASCULAR
EVENT RATES FOLLOWING ACUTE CORONARY SYNDROME (ACS) OR PERCUTANEOUS
CORONARY INTERVENTION (PCI)
THAN PATIENTS WITH NORMAL CYP2C19 FUNCTION. (12.5)
TESTS ARE AVAILABLE TO IDENTIFY A PATIENT'S CYP2C19 GENOTYPE AND CAN
BE USED AS AN AID IN DETERMINING
THERAPEUTIC STRATEGY. (12.5) CONSIDER ALTERNATIVE TREATMENT OR
TREATMENT STRATEGIES IN PATIENTS
IDENTIFIED AS CYP2C19 POOR METABOLIZERS. (2.3, 5.1)
RECENT MAJOR CHANGES
Dosage and Administration (2.4) 12/2011
Warnings and Precautions (5.1) 12/2011
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)] including patients who are to be managed medically and those
who are to be managed with coronary
revascularization, clopidogrel tablets has been shown to decrease the
rate of a combined endpoint of cardiovascular death,
myocardial infarction (MI), or stroke as well as the rate of a
combined endpoint of cardiovascular death, MI, stroke, or
refractory ischemia. (1.1)
- For patients with ST-elevation myocardial infarction (STEMI),
clopidogrel tablets has been shown to reduce the rate of
death from any cause and the rate of a combined endpoint of death,
re-infarction, or stroke. The benefit for patients