CLOPIDOGREL tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (CLOPIDOGREL - UNII:A74586SNO7)

Dostupné z:

MedVantx, Inc.

INN (Medzinárodný Name):

CLOPIDOGREL BISULFATE

Zloženie:

CLOPIDOGREL 75 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

The optimal duration of clopidogrel tablet 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 USP have been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death. Clopidogrel is 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) ]. 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 ani

Prehľad produktov:

Clopidogrel tablets USP are available as follows: 75 mg – light-pink to pink, film-coated, capsule shaped tablets debossed with “TV” on one side and “7314” on the other side, in bottles of 30, 90, and 500. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

CLOPIDOGREL- CLOPIDOGREL TABLET, FILM COATED
MedVantx, Inc.
----------
MEDICATION GUIDE
Clopidogrel Tablets USP
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:
•
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 tablets can 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 are treated with a stent, and stop taking clopidogrel tablets too
soon, have a higher risk of getting a
blood clot on the stent, 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?
Clopid

Súhrn charakteristických

CLOPIDOGREL- CLOPIDOGREL TABLET, FILM COATED
MEDVANTX, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOPIDOGREL TABLETS USP 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._
•
•
•
•
RECENT MAJOR CHANGES
Dosage and Administration (2.4) 12/2011
Warnings and Precautions (5.1) 12/2011
INDICATIONS AND USAGE
Clopidogrel tablets USP are a P2Y platelet inhibitor indicated for:
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg (3)
CONTRAINDICATIONS
•
•
EFFECTIVENESS OF CLOPIDOGREL DEPENDS ON ACTIVATION TO AN ACTIVE
METABOLITE BY THE CYTOCHROME P450
(CYP) SYSTEM, PRINCIPALLY CYP2C19. (5.1)
POOR METABOLIZERS TREATED WITH CLOPIDOGREL 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)
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, 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 c