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:

Wockhardt Limited

INN (International Name):

CLOPIDOGREL BISULFATE

Composition:

CLOPIDOGREL 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- For 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 tablet has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablet has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown. The optimal duration of clopidogrel tablets therapy in ACS is unknown. For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel tablet has been shown to redu

Product summary:

Clopidogrel tablets USP,75 mg are available as pink, round, biconvex, film-coated tablets debossed with "W 314" on one side and plain on other. Tablets are provided as follows: NDC 64679-314-01, bottle of 30 tablets NDC 64679-314-02, bottle of 90 tablets NDC 64679-314-03, bottle of 500 tablets NDC 64679-314-04, unit dose packages of 100 tablets Clopidogrel tablets USP, 300 mg are available as pink, modified capsule shaped, biconvex, film-coated tablets debossed with "W 315" on one side and plain on other. Tablets are provided as follows: NDC 64679-315-01, bottle of 30 tablets NDC 64679-315-02, bottle of 90 tablets NDC 64679-315-04, unit dose packages of 100 tablets Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Wockhardt Limited
----------
•
have certain genetic factors that affect how the body breaks down
clopidogrel tablets. Your doctor
may do genetic tests to make sure clopidogrel tablet is 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 tablet 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, USP without talking to the
doctor who prescribes it for you. People
who are treated with a stent, and stop taking clopidogrel tablets too
soon, have a higher risk of getting a
blood clot on the stent, 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 is Clopidogrel?
Clopidogrel is a prescription medicine used to treat people who have
any of the following:
•
chest pain due to heart problems
•
poor circulation in their legs (peripheral arterial disease)
•
a heart attack
•
a stroke
Clopidogrel tablet is used alone or with aspirin to lower your chance
of having another serious problem
with your heart or blood vessels such as heart attack, stroke, or
blood clot that can lead to death.
Platelets are blood cells that help your blood clot normally.
C

Summary of Product characteristics

CLOPIDOGREL- CLOPIDOGREL TABLET, FILM COATED
WOCKHARDT LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOPIDOGREL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CLOPIDOGREL.
CLOPIDOGREL TABLETS, USP
INITIAL U.S. APPROVAL: 1997
WARNING: DIMINISHED EFFECTIVENESS IN POOR
METABOLIZERS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
EFFECTIVENESS OF CLOPIDOGREL DEPENDS ON ACTIVATION TO AN ACTIVE
METABOLITE BY THE CYTOCHROME P450
(CYP) SYSTEM, PRINCIPALLY CYP2C19. (5.1)
POOR METABOLIZERS TREATED WITH CLOPIDOGREL AT RECOMMENDED DOSES
EXHIBIT HIGHER CARDIOVASCULAR
EVENT RATES FOLLOWING ACUTE CORONARY SYNDROME (ACS) OR PERCUTANEOUS
CORONARY INTERVENTION (PCI)
THAN PATIENTS WITH NORMAL CYP2C19 FUNCTION. (12.5)
TESTS ARE AVAILABLE TO IDENTIFY A PATIENT'S CYP2C19 GENOTYPE AND CAN
BE USED AS AN AID IN DETERMINING
THERAPEUTIC STRATEGY. (12.5)
CONSIDER ALTERNATIVE TREATMENT OR TREATMENT STRATEGIES IN PATIENTS
IDENTIFIED AS CYP2C19 POOR
METABOLIZERS. (2.3, 5.1)
RECENT MAJOR CHANGES
Dosage and Administration (2.4) 12/2011
Warnings and Precautions (5.1) 12/2011
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)] including patients who are to be managed medically and those
who are to be managed with coronary
revascularization, clopidogrel tablets has been shown to decrease the
rate of a combined endpoint of cardiovascular
death, myocardial infarction (MI), or stroke as well as the rate of a
combined endpoint of cardiovascular death, MI,
stroke, or refractory ischemia. (1.1)
For patients with ST-elevation myocardial infarction (STEMI),
clopidogrel tablets has been shown to reduce the rate of
death from any cause and the rate of a combined endpoint of death,
re-infarction, or stroke. The benefit for patients who
undergo primary PCI is unknown. (1.1)
● Recent myoc