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:

ReadyMeds

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, clopidogrel tablets, USP have 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), clopidogrel tablets, USP have 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 clopidogrel tablets, USP therapy in ACS is unknown. For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel tablets, U

Product summary:

Clopidogrel Tablets USP, 75 mg are pink colored, round, biconvex, beveled edge, film-coated tablets debossed with ‘E’ on one side and ‘34’ on the other side.          Bottles of 30                                        NDC 65862-357-30          Bottles of 90                                        NDC 65862-357-90          Bottles of 100                                      NDC 65862-357-01          Bottles of 500                                      NDC 65862-357-05          Bottles of 1000                                    NDC 65862-357-99          10 x 10 Unit-dose Tablets                    NDC 65862-357-10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.  Preserve in well-closed containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLOPIDOGREL- CLOPIDOGREL BISULFATE TABLET, FILM COATED
ReadyMeds
----------
MEDICATION GUIDE
Clopidogrel Tablets, USP
(Kloe pid’ oh grel)
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 tabletsmay not work as well in people who:
•
have certain genetic factors that affect how the body breaks down
clopidogrel tablets. Your doctor
may do genetic tests to make sure clopidogrel tablets are 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 clopidogrel
tablets.
2. Clopidogrel tabletscan cause bleeding which can be serious and can
sometimes lead to death.
Clopidogrel tablets are a blood thinner medicine that lowers the
chance of blood clots forming in your
body. While you take clopidogrel tablets:
•
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 tablets without talking to the doctor
who prescribes them 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 tablets?
Clopidogrel tablets are a prescription medicine

Summary of Product characteristics

CLOPIDOGREL- CLOPIDOGREL BISULFATE TABLET, FILM COATED
READYMEDS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOPIDOGREL BISULFATE SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR CLOPIDOGREL TABLETS, USP.
CLOPIDOGREL TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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)
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 12/2013
INDICATIONS AND USAGE
Clopidogrel tablets, USP are 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)], clopidogrel tablets, USP have 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 tablets, USP have 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 PCI is unknown. (1.1)
Recent MI, recent stroke, or established peripheral arterial disease.
Clopidogrel ta