CLOPIDOGREL BISULFATE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Sun Pharmaceutical Industries, Inc.

INN (International namn):

CLOPIDOGREL BISULFATE

Sammansättning:

CLOPIDOGREL 75 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

- 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 a

Produktsammanfattning:

Clopidogrel tablets, USP 75 mg are available as pink, round, biconvex, film-coated tablets imprinted with “894” on one side and plain on the other side. Tablets are provided as follows: Bottles of 30 with Child Resistant Cap……………NDC 47335-894-83 Bottles of 90 with Child Resistant Cap……………NDC 47335-894-81 Bottles of 90………NDC 47335-894-19 Bottles of 500……. NDC 47335-894-13 Bottles of 1000.. NDC 47335-894-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers as defined in USP.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
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:
•
have certain genetic factors that affect how the body breaks down
clopidogrel. 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 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 are clopidogrel tablets?
C

Produktens egenskaper

CLOPIDOGREL BISULFATE - CLOPIDOGREL BISULFATE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, 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)
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 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
Film-coated tablets: 75 mg (3)
CONTRAINDICATIONS
Active pathological bleeding, such as pe