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:

Blenheim Pharmacal, Inc.

INN (International Name):

CLOPIDOGREL BISULFATE

Composition:

CLOPIDOGREL 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

The optimal duration of clopidogrel bisulfate therapy in ACS is unknown. For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel bisulfate has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death. Clopidogrel bisulfate is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Clopidogrel bisulfate is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see Adverse Reactions (6.2)] . Reproduction studies performed in rats and rabbits at doses up to 500 and 300 mg/kg/day, respectively (65 and 78 times the recommended daily human dose, respectively, on a mg/m2 basis), revealed no evidence of impaired fertility or fetotoxicity due to clopidogrel. There are, however, no adequate and well-controlled studies in pregnant women. Beca

Product summary:

Clopidogrel Tablets, USP 75 mg tablets are available as pink, round, biconvex, film-coated tablets engraved "APO' on one side and "CL" over "75" on the other side. They are supplied as follows: Bottles of 30, NDC 62034-015-30 Bottles of 90, NDC 62034-015-90 Bottles of 100, NDC 62034-015-01 Carton of 100 (10 x 10 Blister Pack) NDC 62034-015-77 Store at 25° C (77° F); excursions permitted to 15°–30° C (59°–86° F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLOPIDOGREL BISULFATE- CLOPIDOGREL BISULFATE TABLET, FILM COATED
Blenheim Pharmacal, Inc.
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17.6 MEDICATION GUIDE
Clopidogrel Bisulfate Tablets, USP 75 mg
(kloe pid’ oh grel bye sul’ fate)
Read this Medication Guide before you start taking clopidogrel
bisulfate 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
Bisulfate Tablets?
1.
Clopidogrel bisulfate 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 clopidogdrel 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
clopiodgrel.
2.
Clopiodgrel bisulfate 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 clopiodgrel:
•
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 bisulfate tablets without talking to
the doctor who prescribes it for you.
People who are treated with a stent, and stop taking clopidogrel 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 bisulfate tablets
b

Summary of Product characteristics

CLOPIDOGREL BISULFATE- CLOPIDOGREL BISULFATE TABLET, FILM COATED
BLENHEIM PHARMACAL, INC.
----------
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
INITIAL U.S. APPROVAL: 1997
WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
RECENT MAJOR CHANGES
Dosage and Administration (2.4) 12/2011
Warnings and Precautions (5.1) 12/2011
INDICATIONS AND USAGE
Clopidogrel bisulfate is a P2Y platelet inhibitor indicated for:
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
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)
12
Acute coronary syndrome
1.
2.
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 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 has been shown to reduce the ra