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:

Physicians Total Care, Inc.

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, Plavix 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. - For patients with ST-elevation myocardial infarction (STEMI), Plavix has 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 Plavix therapy in ACS is unknown. For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, Plavix has been shown to reduce the rate of a combined endpoint of new ischemi

Product summary:

Plavix (clopidogrel bisulfate) 75 mg tablets 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°–30° C (59°–86° F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

Physicians Total Care, Inc.
----------
Medication Guide
Plavix® (PLAV-iks)
(clopidogrel bisulfate)
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 are treated
with a stent, and stop taking Plavix too soon, have a higher risk of
getting a blood clot on the stent, 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 disea

Summary of Product characteristics

PLAVIX - CLOPIDOGREL BISULFATE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
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 BISULFATE) TABLETS
INITIAL U.S. APPROVAL: 1997
WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
EFFECTIVENESS OF PLAVIX DEPENDS ON ACTIVATION TO AN ACTIVE METABOLITE
BY THE CYTOCHROME P450 (CYP)
SYSTEM, PRINCIPALLY CYP2C19. (5.1)
POOR METABOLIZERS TREATED WITH PLAVIX 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
Dosage and Administration (2.4)
12/2011
Warnings and Precautions (5.1)
12/2011
INDICATIONS AND USAGE
Plavix is a P2Y platelet inhibitor indicated for:
Acute coronary syndrome
-
-
Recent myocardial infarction (MI), recent stroke, or established
peripheral arterial disease. Plavix has been shown to
reduce the combined endpoint of new ischemic stroke (fatal or not),
new MI (fatal or not), and other vascular death.
(1.2)
DOSAGE AND ADMINISTRATION
Acute coronary syndrome (2.1)
-
-
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
12
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, Plavix has been shown to decrease the rate of a
combined endpoint of