CLOPIDOGREL BISULFATE tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

State of Florida DOH Central Pharmacy

INN (Tên quốc tế):

CLOPIDOGREL BISULFATE

Thành phần:

CLOPIDOGREL 75 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

- 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 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 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 tablet therapy in ACS is unknown. For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel tablets has been shown to

Tóm tắt sản phẩm:

Clopidogrel tablets USP, 75 mg are white, film coated, round, biconvex tablets debossed with “R” on one side and “196” on other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

State of Florida DOH Central Pharmacy
----------
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 ctan cause bleeding which can be serious and
can sometimes lead to death.
Clopidogrel tablets are 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 it 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?
Clopidogrel tablets are prescri

Đặc tính sản phẩm

CLOPIDOGREL BISULFATE - CLOPIDOGREL BISULFATE TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
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 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 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)
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 09/2013
INDICATIONS AND USAGE
Clopidogrel tablets 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 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. (1.1)
- For patients with ST-elevation myocardial infarction (STEMI),
clopidogrel tablets 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 PCI is unknown. (1.1)
Recent MI, recent stroke, or established peripheral arterial disease.
clopidogrel tablets