Clopidogrel 75 mg Tablets — Generic For Plavix — Aurobindo

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 P2Y12 inhibitor in patients identified as CYP2C19 poor metabolizers. (5.1)

Indications And Usage

Clopidogrel tablets are a P2Y12 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 have been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1)

– For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.1)

Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.2)

Dosage And Administration

Acute coronary syndrome (2.1)

– Initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily.

– Initiating clopidogrel tablets 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

Film-coated tablets: 75 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)

• 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)

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

Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

CYP2C19 inducers: Increases levels of clopidogrel active metabolite and increases platelet inhibition. (7.1)

Opioids: Decreased exposure to clopidogrel. Consider use of parenteral antiplatelet agent. (7.3)

Nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs): Increases risk of bleeding. (7.4, 7.5, 7.6)

Other Antiplatelet Agents: Increases the risk of bleeding due to an additive effect. (7.7)

Repaglinide (CYP2C8 substrates): Increases substrate plasma concentrations. (7.8)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 9/2023