CLOPIDOGREL BISULFATE- clopidogrel tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

INN (International Name):

CLOPIDOGREL BISULFATE

Composition:

CLOPIDOGREL 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 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 . 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 . - 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.

Product summary:

Clopidogrel Tablets, USP are available containing 97.875 mg of clopidogrel bisulfate, USP equivalent to 75 mg of clopidogrel base or 391.5 mg of clopidogrel bisulfate, USP equivalent to 300 mg of clopidogrel base. The 75 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and C27 on the other side. They are available as follows: NDC 51079-557-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 300 mg tablets are white, film-coated, oval, unscored tablets debossed with M C28 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-558-03 – Unit dose blister packages of 30 (5 cards of 6 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Mylan Institutional 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 lower 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:
•
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?
Clopidogrel tablets are a prescription medicine used to treat people
who have any of the fo

Summary of Product characteristics

CLOPIDOGREL BISULFATE- CLOPIDOGREL TABLET, FILM COATED
MYLAN INSTITUTIONAL 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 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)
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:
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 dail