CLOPIDOGREL- clopidogrel bisulphate 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:

State of Florida DOH Central Pharmacy

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 tablets USP have 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 tablets USP have 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 USP therapy in ACS is unknown. For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel tablets USP h

Product summary:

Clopidogrel tablets USP 75 mg are available as pink colored, round, biconvex, film coated tablets debossed with "CI" on one side and plain on other side. Clopidogrel tablets USP 300 mg are available as pink colored, oval, biconvex, beveled edged, film coated tablets debossed with "CL" on one side and plain on other side. They are supplied by State of Florida DOH Central Pharmacy as follows: 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

State of Florida DOH Central Pharmacy
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Medication Guide
Clopidogrel Tablets USP
Read this Medication Guide before you start taking clopidogrel tablets
USP 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 USP?
1.
Clopidogrel tablets USP may not work as well in people who:
•
have certain genetic factors that affect how the body breaks down
clopidogrel tablets USP.
Your doctor may do genetic tests to make sure clopidogrel tablets USP
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 USP.
2.
Clopidogrel tablets USP can cause bleeding which can be serious and
can sometimes lead to
death. Clopidogrel tablets USP is a blood thinner medicine that lowers
the chance of blood clots
forming in your body. While you take clopidogrel tablets USP:
•
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 stop taking clopidogrel tablets USP too soon have a higher risk of
having a heart attack or dying. If
you must stop clopidogrel tablets USP because of bleeding, your risk
of a heart attack may be higher.
What are clopidogrel tablets USP?
Clopidogrel tablets USP are a prescription medi

Summary of Product characteristics

CLOPIDOGREL - CLOPIDOGREL BISULPHATE TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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 EFFECTIVENESS IN POOR METABOLIZERS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
EFFECTIVENESS OF CLOPIDOGREL BISULFATE DEPENDS ON ACTIVATION TO AN
ACTIVE METABOLITE BY THE
CYTOCHROME P450 (CYP) SYSTEM, PRINCIPALLY CYP2C19. (5.1)
POOR METABOLIZERS TREATED WITH CLOPIDOGREL BISULFATE 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
Warnings and Precautions (5.6) 12/2013
INDICATIONS AND USAGE
Clopidogrel tablets USP are a P2Y platelet inhibitor indicated for:
Acute coronary syndrome
-
-
Recent (MI), recent stroke, or established peripheral arterial
disease. Clopidogrel tablets USP have been shown to
reduce the combined endpoint of new ischemic stroke, new MI, and other
vascular death. (1.2)
DOSAGE AND ADMINISTRATION
Acute coronary syndrome (2.1)
- UA/NSTEMI: 300 mg loading dose followed by 75 mg once daily, in
combination with aspirin (75 to 325 mg once daily)
- STEMI: 75 mg once daily, in combination with aspirin (75 to 325 mg
once daily), with or without a loading dose.
Recent MI, recent stroke, or established peripheral arterial disease:
75 mg once daily (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg, 300 mg (3)
CONTRAINDICATIONS
Active pathological bleeding, such as peptic ulcer or int