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 Pharmaceuticals Inc.

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 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 contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see Adverse Reactions (6.2)] . 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 was observed when clopidogrel was administered to pregnant rats and rabbits during organogenesis at doses corresponding to 65 and 78

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 0378-3627-77 bottles of 90 tablets NDC 0378-3627-05 bottles of 500 tablets 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 0378-3628-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLOPIDOGREL BISULFATE- CLOPIDOGREL TABLET, FILM COATED
Mylan 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 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 lower 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 presc

Summary of Product characteristics

CLOPIDOGREL BISULFATE- CLOPIDOGREL TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
----------
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 a P2Y platelet inhibitor indicated for:
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg, 300 mg (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
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)
12
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)
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 loa