CLOPIDOGREL- clopidogrel bisulfate tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Westminster Pharmaceuticals, LLC

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

- Clopidogrel 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. Clopidogrel should be administered in conjunction with aspirin. - Clopidogrel 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. Clopidogrel 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 clopidogrel is indicated to reduce the rate of MI and stroke. Clopidogrel is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Clopidogrel is contraindicated in patients with hypersensitivity (e.g., anaph

Ապրանքի ամփոփագիր:

Clopidogrel tablets, USP 75 mg are available as pink colored, round shaped, biconvex, film coated tablets de-bossed on one side with SG and 124 on other side. Tablets are provided as follows: NDC 69367-200-90 Bottles of 90 NDC 69367-200-05 Bottles of 500 Clopidogrel tablets, USP 300 mg are available as pink colored, modified oval shaped, film coated tablets de-bossed on one side with SG and 121 on other side. Tablets are provided as follows: NDC 69367-194-30 Bottles of 30 NDC 69367-194-05 Bottles of 500 Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

Westminster Pharmaceuticals, LLC
----------
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 tablets may not work as well in people who:
•
have certain genetic factors that affect how the body breaks down
clopidogrel. Your doctor may
do genetic tests to make sure clopidogrel tablet 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 clopidogrel
tablets.
2. Clopidogrel tablets can cause bleeding which can be serious and can
sometimes lead to death.
Clopidogrel is 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 it 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 used to treat people
who have any of the following:

Ապրանքի հատկությունները

CLOPIDOGREL- CLOPIDOGREL BISULFATE TABLET, FILM COATED
WESTMINSTER PHARMACEUTICALS, LLC
----------
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, 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 CLOPIDOGREL 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
Clopidogrel is a P2Y
platelet inhibitor indicated for:
Acute coronary syndrome
–
–
Recent MI, recent stroke, or established peripheral arterial disease.
Clopidogrel has been shown to
reduce the rate of MI and stroke. (1.2)
DOSAGE AND ADMINISTRATION
Acute coronary syndrome (2.1)
–
–
Recent MI, recent stroke, or established peripheral arterial disease:
75 mg once daily orally without a
loading dose. (2.2)
DOSAGE FORMS AND STRENGTHS
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 AND PRECAUTIONS
CYP2C19 inhibitors: Avoid concomitant use of omeprazole or
esomeprazole. (5.1)
Bleeding: Clopidogrel increases risk of bleeding. (5.2)
Discontinuation: Premature discontinuation increases risk of
cardiovascular events. Discontinue 5 days
prior to elective surgery that has a major risk of bleeding. (5.3)
Thrombotic thrombocytopenic purpura (TTP) has been reported. (5.4)
Cross-reactivity among thienopyridines has been reported. (5.5)
ADVERSE REACTIONS
12
12
For patients with non–ST-se