CLOPIDOGREL BISULFATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

INN (International Name):

CLOPIDOGREL BISULFATE

Composition:

CLOPIDOGREL 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel bisulfate tablets is 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 contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see Adverse Reactions ( 6.2)] . Risk Summary Available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage [see Data] .There are risks to the pregnant woman and fetus associated with myocardial infarction and stroke [see Clinical Considerations]. No evidence of fetotoxicity

Product summary:

Clopidogrel tablets, USP 75mg are available as light pink colored, round, beveled edge, biconvex film coated tablets printed "41" with black ink on one side and plain on the other side. Tablets are provided as follows: Cartons of 100 Tablets (1 tablets each blister pack x 10), NDC 0904-6294-61 Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLOPIDOGREL BISULFATE- CLOPIDOGREL BISULFATE TABLET
Major Pharmaceuticals
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SPL MEDGUIDE
Medication Guide
Clopidogrel (kloe PID oh grel) Tablets, USP
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 tabletsmay 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 tabletscan cause bleeding which can be serious and can
sometimes lead to death. Clopidogrel
tablets are 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 prescrip

Summary of Product characteristics

CLOPIDOGREL BISULFATE- CLOPIDOGREL BISULFATE TABLET
MAJOR PHARMACEUTICALS
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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.
•
•
•
INDICATIONS AND USAGE
Clopidogrel tablets are 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
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Bleeding, including life-threatening and fatal bleeding, is the most
commonly reported adverse reaction. (
6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TORRENT PHARMA INC. AT
1-800-912-9561
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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SEE 17 FOR PATIENT COUNSELING