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:

Aphena Pharma Solutions - Tennessee, LLC

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 bisulfate is indicated to reduce the rate of MI and stroke. 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)] . Pregnancy Category B 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. Because animal reproduction studies are not always predictive of a human response, clopidogrel bisulfate should be used during pregnancy only if cl

Product summary:

Clopidogrel tablets, USP 75 mg are 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 60429-301-30 Bottles of 90 NDC 60429-301-90 Bottles of 1,000 NDC 60429-301-01 Bottles of 1,000 NDC 60429-301-10 Blisters of 100 tablets (10 x 10 Unit Dose) NDC 60429-301-77 Store at 25°C(77°F); excursions permitted from 15° to 30°C (59° to 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
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
Clopidogrel Bisulfate Tablets, USP 75 mg and 300 mg
(kloe pid’ oh grel bye sul’ fate)
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:
1.
have certain genetic factors that affect how the body breaks down
clopidogrel.
Your doctor may do genetic tests to make sure clopidogrel is right for
you.
2.
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:
1.
you may bruise and bleed more easily
2.
you are more likely to have nose bleeds
3.
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 tab

Summary of Product characteristics

CLOPIDOGREL BISULFATE- CLOPIDOGREL BISULFATE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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._
•
•
•
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 bisulfate is a P2Y12 platelet inhibitor indicated for:
2.
- For patients with non-ST-segment elevation ACS [unstable angina
(UA)/non-ST-elevation myocardial infarction
(NSTEMI)], clopidogrel bisulfate has been shown to reduce the rate of
myocardial infarction (MI) and stroke. (1.1)
- For patients with ST-elevation myocardial infarction (STEMI),
clopidogrel bisulfate has been shown to reduce the rate of
MI and stroke. (1.1)
2.
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
EFFECTIVENESS OF CLOPIDOGREL BISULFATE 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)
Acute coronary syndrome
Recent MI, recent stroke, or established peripheral arterial disease.
Clopidogrel bisulfate has been shown to reduce
the rate of MI and stroke. (1.2)
Acute coronary syndrome (2.1)
3.
4.
Initiate clopidogrel with a single 300-mg oral loading dose and then
continue at 75 mg once daily
Initiating clopidogrel without a loading dose will dela