CLOPIDOGREL- 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:

Major Pharmaceuticals

INN (International Name):

CLOPIDOGREL BISULFATE

Composition:

CLOPIDOGREL 300 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)] . Risk Summary 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 correspondi

Product summary:

Clopidogrel tablets, USP 300 mg are pink, oblong, biconvex, film-coated tablets, engraved "APO" on one side and "CL 300" on the other side. They are supplied as follows: Carton of 20 tablets (10 tablets per blister pack x 2), NDC 0904-6467-10 Carton of 30 tablets (10 tablets per blister pack x 3), NDC 0904-6467-07 Store at 25°C(77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLOPIDOGREL- CLOPIDOGREL BISULFATE TABLET, FILM COATED
Major Pharmaceuticals
----------
MEDICATION GUIDE
Clopidogrel Tablets, USP 75 mg and 300 mg
(kloe pid’ oh grel)
Medication Guide available at www1.apotex.com/products/us
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

Summary of Product characteristics

CLOPIDOGREL- CLOPIDOGREL BISULFATE TABLET, FILM COATED
MAJOR PHARMACEUTICALS
----------
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:
2.
- For patients with non-ST-segment elevation ACS (unstable angina
[UA]/non-ST-elevation myocardial
infarction [NSTEMI]), clopidogrel tablets has been shown to reduce the
rate of myocardial infarction (MI)
and stroke. (1.1)
- For patients with ST-elevation myocardial infarction (STEMI),
clopidogrel tablets has been shown to
reduce the rate of MI and stroke. (1.1)
2.
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Film-coated 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 P2Y INHIBITOR IN PATIENTS IDENTIFIED AS CYP2C19
POOR METABOLIZERS. (5.1)
12
12
Acute coronary syndrome
Recent MI, recent stroke, or established peripheral arterial disease.
Clopidogrel tablets 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 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
loading dose.