CLOPIDOGREL BISULFATE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Clopidogrel bisulfate (UNII: 08I79HTP27) (Clopidogrel - UNII:A74586SNO7)

Saatavilla:

Preferred Pharmaceuticals, Inc.

INN (Kansainvälinen yleisnimi):

Clopidogrel bisulfate

Koostumus:

Clopidogrel 75 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

• 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 tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Clopidogrel tablets are contraindicated in patients with hypersens

Tuoteyhteenveto:

Clopidogrel Tablets USP, 75 mg are available as pink colored, circular, biconvex, film-coated tablets debossed with "L 11" on one side and plain on other side. Tablets are provided as follows: Bottle of 30 – 68788-9785-3 Bottle of 60 – 68788-9785-6 Bottle of 90 – 68788-9785-9 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].

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

Preferred Pharmaceuticals, Inc.
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Revised: 8/2019
Document Id: 07cde1a4-52d9-460e-b652-c6be210130b4
34391-3
Set id: 3e08ca1d-35ef-4b65-9799-5c62c6444d26
Version: 7
Effective Time: 20190812
Preferred Pharmaceuticals, Inc.

Valmisteyhteenveto

CLOPIDOGREL BISULFATE- CLOPIDOGREL BISULFATE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
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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)
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