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:

NuCare Pharmaceuticals,Inc.

INN (International Name):

CLOPIDOGREL BISULFATE

Composition:

CLOPIDOGREL 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.1 Acute Coronary Syndrome (ACS) - Clopidogrel is indicated to reduce the rate of myocardial infarction and stroke (MI) 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 should be administered in conjunction with aspirin. - Clopidogrel 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. Clopdiogrel should be administered in conjunction with aspirin. 1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopdigorel is indicated to reduce the rate of MI and stroke. 4.1 Active Bleeding Clopidogrel is contraindicated in patients with active pathological bleeding

Product summary:

Clopidogrel tablets, USP 75 mg are available as pink colored, round shaped, biconvex, film coated tablets de-bossed on one side with SG and 124 on other side. Tablets are provided as follows: NDC 68071-4057-9 Bottles of 90 Store at 25° C (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

NuCare Pharmaceuticals,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. 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 is 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 a prescription medicine used to treat people
who have any of the following

Summary of Product characteristics

CLOPIDOGREL BISULFATE- CLOPIDOGREL BISULFATE TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOPIDOGREL TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOPIDOGREL TABLETS,
USP.
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)
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 is a P2Y
platelet inhibitor indicated for: (1)
Acute coronary syndrome
For patients with non-ST-segment elevation ACS [unstable angina
(UA)/non-ST-elevation myocardial infarction
(NSTEMI)], Clopidogrel has been shown to reduce the rate of myocardial
infarction (MI) and stroke. (1.1)
For patients with ST-elevation myocardial infarction (STEMI),
Clopidogrel 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
Initiate Clopidogrel without a loading dose will delay establishment
of an antiplatelet effect by several days
(2)
Recent MI, recent stroke, or established peripheral arterial disease:
75 mg once daily orally without a loading dose (