CLOPIDOGREL tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Viona Pharmaceuticals Inc

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

Clopidogrel tablets, USP equivalent to 75 mg of clopidogrel are pink-colored, biconvex, round-shaped, film-coated tablets debossed with '379' on one side and plain on the other side and are supplied as follows: NDC 72578-012-06 in bottle of 30 tablets NDC 72578-012-16 in bottle of 90 tablets NDC 72578-012-05 in bottle of 500 tablets NDC 72578-012-10 in bottle of 1,000 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].             Dispense in a tight container.

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

Viona Pharmaceuticals Inc
----------
Medication Guide
Clopidogrel Bisulfate (kloe pid' oh grel bye sul' fate) 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 stop
taking clopidogrel too soon have a higher risk of 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 problems
•
poor circulation in their legs (periphe

Vara einkenni

CLOPIDOGREL - CLOPIDOGREL TABLET, FILM COATED
VIONA PHARMACEUTICALS INC
----------
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 USE
CLOPIDOGREL TABLETS.
CLOPIDOGREL TABLETS, USP 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 TABLETS 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 tablet 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]), Plavix has been shown to reduce the rate of
myocardial infarction (MI) and stroke.
(1.1)
- For patients with ST-elevation myocardial infarction (STEMI), Plavix
has been shown to reduce the rate of
MI and stroke. (1.1)
Recent MI, recent stroke, or established peripheral arterial disease.
Clopidogrel has been shown to
reduce the rate of MI and stroke. (1.2)
DOSAGE AND ADMINISTRATION
Acute coronary syndrome (2.1)
- Initiate clopidogrel with a single 300 mg oral loading dose and then
continue at 75 mg once daily
-Initiating clopidogrel 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 intracranial
hemorrhage (4.1)
Hypersensitivity to clopidogrel or any compon