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:

Camber Pharmaceuticals, Inc.

INN (International Name):

CLOPIDOGREL BISULFATE

Composition:

CLOPIDOGREL 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

•Clopidogrel is 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 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. 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. Clopidogrel is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Clopidogrel is contraindicated in patients with hypersensitivity (e.g.,

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 31722-901-30  Bottles of 30 tablets          NDC 31722-901-90  Bottles of 90  tablets          NDC 31722-901-01  Bottles of 100  tablets          NDC 31722-901-05  Bottles of 500 tablets          NDC 31722-901-10  Bottles of 1000 tablets                  Clopidogrel tablets, USP 300 mg are available as pink colored, modified oval shaped, film coated tablets de-bossed on one side with SG and 121 on other side. Tablets are provided as follows:          NDC 31722-902-30  Bottles of 30 tablets           NDC 31722-902-90  Bottles of 90  tablets          NDC 31722-902-01  Bottles of 100 tablets          NDC 31722-902-05  Bottles of 500 tablets 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

CLOPIDOGREL - CLOPIDOGREL TABLET, FILM COATED
Camber Pharmaceuticals, Inc.
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MEDICATION GUIDE
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 u

Summary of Product characteristics

CLOPIDOGREL - CLOPIDOGREL TABLET, FILM COATED
CAMBER 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:
· 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.
•Recent MI, recent stroke, or established peripheral arterial
disease: 75 mg once daily orally without a loading