CLOPIDOGREL BISULFATE- clopidogrel bisulfate tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Graviti Pharmaceuticals Private Limited

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

- 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

Περίληψη προϊόντος:

Clopidogrel Tablets USP, 75 mg are available as pink, round, film-coated tablets debossed with "111" on one side and plain on the other. Tablets are provided as follows: NDC 69844-036-01      Bottles of 30 with child-resistant closure NDC 69844-036-02      Bottles of 90 with child-resistant closure NDC 69844-036-03      Bottles of 500 NDC 69844-036-04      Bottles of 1,000 Store at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

Graviti Pharmaceuticals Private Limited
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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 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 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 a

Αρχείο Π.Χ.Π.

CLOPIDOGREL BISULFATE - CLOPIDOGREL BISULFATE TABLET
GRAVITI PHARMACEUTICALS PRIVATE LIMITED
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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
- For patients with non-ST-segment elevation ACS (unstable angina
[UA]/non-ST-elevation
myocardial infarction [NSTEMI]), clopidogrel has been shown to reduce
the rate of myocardial infarction
(MI) and stroke. ( 1.1)
- For patients with ST-elevation myocardial infarction (STEMI),
clopidogrel has been shown to reduce
the rate of MI and stroke. ( 1.1)
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)
- Initiate clopidogrel with a single 300 mg oral loading dose and then
continue at 75 mg once daily
- Initiating clopidogrel without a loading dose will delay
establishment of an antiplatelet effect by several
days
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 ( 3)
CONTRAINDICATIONS
Active pathological bleeding, such as peptic ulcer or intracranial
hemorrhage ( 4.1)
Hypersensitivity to clopidogr