CLOPIDOGREL BISULFATE- clopidogrel bisulfate 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:

REMEDYREPACK 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 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 are

Product summary:

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, 90, 100 and 500.  Bottles of 30                           NDC 55111-196-30                        Bottles of 90                           NDC 55111-196-90                        Bottles of 100                         NDC 55111-196-01                        Bottles of 500                         NDC 55111-196-05 Preserve in well-closed containers. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

REMEDYREPACK 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:
•
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.
•
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?
Clopidogrel tablets are prescription medicine used to treat people who
have any of the following

Summary of Product characteristics

CLOPIDOGREL BISULFATE- CLOPIDOGREL BISULFATE TABLET, FILM COATED
REMEDYREPACK 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 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 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 i