Label: CLOPIDOGREL BISULFATE tablet, film coated
- NDC Code(s): 43598-121-05, 43598-121-10, 43598-121-30, 43598-121-90, view more
- Packager: Dr.Reddy's Laboratories Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 7, 2025
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 ...
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Table of ContentsTable of Contents
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BOXED WARNING
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WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE
The effectiveness of clopidogrel results from its antiplatelet activity, which is dependent on its conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19 [see Warnings and Precautions (5.1), Clinical Pharmacology (12.3)]. Clopidogrel at recommended doses forms less of the active metabolite and so has a reduced effect on platelet activity in patients who are homozygous for nonfunctional alleles of the CYP2C19 gene, (termed “CYP2C19 poor metabolizers”). Tests are available to identify patients who are CYP2C19 poor metabolizers [see Clinical Pharmacology (12.5)]. Consider use of another platelet P2Y12 inhibitor in patients identified as CYP2C19 poor metabolizers.
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1 INDICATIONS AND USAGE1.1 Acute Coronary Syndrome (ACS) Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable ...
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2 DOSAGE AND ADMINISTRATION2.1 Acute Coronary Syndrome In patients who need an antiplatelet effect within hours, initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once ...
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3 DOSAGE FORMS AND STRENGTHSClopidogrel tablets USP, 75 mg are pink, round, coated tablets, 7 debossed on one side, plain on the other side and free from physical defects. Clopidogrel tablets USP, 300 mg are pink ...
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4 CONTRAINDICATIONS4.1 Active Bleeding - Clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. 4.2 ...
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5 WARNINGS AND PRECAUTIONS5.1 Diminished Antiplatelet Activity in Patients with Impaired CYP2C19 Function - Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is achieved through an active ...
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6 ADVERSE REACTIONSThe following serious adverse reactions are discussed below and elsewhere in the labeling: Bleeding [see Warnings and Precautions (5.2)] ] Thrombotic thrombocytopenic purpura [see Warnings and ...
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7 DRUG INTERACTIONS7.1 CYP2C19 Inducers - Since clopidogrel is metabolized to its active metabolite partly by CYP2C19, use of drugs that induce the activity of this enzyme would be expected to result in increased ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - Available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any ...
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10 OVERDOSAGEPlatelet inhibition by clopidogrel is irreversible and will last for the life of the platelet. Overdose following clopidogrel administration may result in bleeding complications. A single oral ...
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11 DESCRIPTIONClopidogrel tablets USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Clopidogrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - There was no evidence of tumorigenicity when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats at dosages up to ...
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14 CLINICAL STUDIES14.1 Acute Coronary Syndrome - CURE - The CURE study included 12,562 patients with ACS without ST-elevation (UA or NSTEMI) and presenting within 24 hours of onset of the most recent episode ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGClopidogrel tablets USP, 75 mg are pink, round, coated tablets, 7 debossed on one side, plain on the other side and free from physical defects. Tablets are provided as follows: Bottles of 30 NDC ...
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17 PATIENT COUNSELING INFORMATIONAdvise patients to read FDA approved patient labeling (Medication Guide). Discontinuation - Advise patients not to discontinue clopidogrel tablets without first discussing it with the healthcare ...
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MEDICATION GUIDEMedication 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 ...
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTIONContainer Label
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PRINCIPAL DISPLAY PANEL
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PRINCIPAL DISPLAY PANELCarton Label - Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.
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INGREDIENTS AND APPEARANCEProduct Information