PLAVIX- 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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

CLOPIDOGREL BISULFATE

Composition:

CLOPIDOGREL 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- Plavix is indicated to reduce the rate of myocardial infarction (MI) and stroke in 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. Plavix should be administered in conjunction with aspirin. - Plavix is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Plavix should be administered in conjunction with aspirin. In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke Plavix is indicated to reduce the rate of MI and stroke. Plavix is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Plavix is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any comp

Product summary:

Plavix (clopidogrel tablets) 75 mg are available as pink, round, biconvex, film-coated tablets debossed with "75" on one side and "1171" on the other. Tablets are provided as follows: Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

PD-Rx Pharmaceuticals, Inc.
----------
Medication Guide
Plavix ® (PLAV-iks)
(clopidogrel
tablets)
Read this Medication Guide before you start taking Plavix 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 Plavix?
1.
Plavix may not work as well in people who:
•
have certain genetic factors that affect how the body breaks down
Plavix. Your doctor may do
genetic tests to make sure Plavix 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
Plavix.
2.
Plavix can cause bleeding which can be serious and can sometimes lead
to death. Plavix is a blood
thinner medicine that lowers the chance of blood clots forming in your
body. While you take Plavix:
•
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 Plavix without talking to the doctor who prescribes
it for you. People who stop taking
Plavix too soon have a higher risk of having a heart attack or dying.
If you must stop Plavix because of
bleeding, your risk of a heart attack may be higher.
What is Plavix?
Plavix 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
Plavix is used alone or with aspirin t

Summary of Product characteristics

PLAVIX- CLOPIDOGREL BISULFATE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PLAVIX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PLAVIX.
PLAVIX (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._
EFFECTIVENESS OF PLAVIX 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)
INDICATIONS AND USAGE
Plavix 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]), Plavix has been shown to reduce the rate of
myocardial infarction (MI) and
stroke. ( 1.1)
For patients with ST-elevation myocardial infarction (STEMI), Plavix
has been shown to reduce the
rate of MI and stroke. ( 1.1)
Recent MI, recent stroke, or established peripheral arterial disease.
Plavix has been shown to reduce
the rate of MI and stroke. ( 1.2)
DOSAGE AND ADMINISTRATION
Acute coronary syndrome ( 2.1)
Initiate Plavix with a single 300 mg oral loading dose and then
continue at 75 mg once daily.
Initiating Plavix 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. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Film-coated tablets: 75 mg, 300 mg ( 3)
CONTRAINDICATIONS
Active pathological bleeding, such as peptic ulcer or intracranial
hemorrhage ( 4.1)
Hypersensitivity to clopidogrel or any component of the product ( 4.2)
WARNINGS