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Clopidogrel

    Brands

    DEA Class; Rx

    Common Brand Names; Plavix

    • Antiplatelet Agents, Cardiovascular; 
    • Antiplatelet Agents, Hematologic

    Oral, P2Y12 platelet inhibitor
    Used for rate reduction of myocardial infarction (MI) and stroke in patients with non-ST-elevation acute coronary syndromes, STEMI, established peripheral arterial disease, or recent MI or stroke
    Associated with diminished antiplatelet effect in CYP2C19 poor metabolizers

    Indicated for arterial thromboembolism prophylaxis (i.e., myocardial infarction prophylaxis, stroke prophylaxis, thrombosis prophylaxis).

    For patients with unstable angina or acute myocardial infarction, NSTEMI (non-ST-elevation myocardial infarction).
    For patients with acute myocardial infarction, STEMI (ST-elevation myocardial infarction).
    For pediatric arterial thromboembolism prophylaxis (i.e., thrombosis prophylaxis or stroke prophylaxis, including in other cardiac conditions with a risk for arterial thrombosis (e.g., Kawasaki disease).

    Hypersensitivity

    Active pathologic bleeding (eg, peptic ulcer, intracranial hemorrhage)

    • Upper respiratory tract infection (8.7%)
    • Chest pain (8.3%)
    • Headache (7.6%)
    • Flulike syndrome (7.5%)
    • Arthralgia (6%)
    • Pain (6%)
    • Dizziness (6%)
    • Diarrhea (4.5%)
    • Rash (4.2%)
    • Rhinitis (4.2%)
    • Depression (3.6%)
    • Urinary tract infection (3.1%)
    • <1%
    • Severe neutropenia
    • Thrombotic thrombocytopenic purpura
    • Acute liver failure
    • Aplastic anemia
    • Hypotension
    • Hepatitis
    • Myalgia
    • Eczema
    • Erythema
    • Agranulocytosis

    Use with caution in patients with bleeding or platelet disorders

    Premature discontinuation increases risk of cardiovascular events; discontinue 5 days prior to elective surgery that has a major risk of bleeding

    Use caution in patients with atrial fibrillation; assess bleeding risk carefully; significant increase in major bleeding events reported in patients receiving clopidogrel plus aspirin instead of aspirin alone

    Patients allergic to aspirin who are undergoing PCI; see American Heart Association (AHA)/American College of Chest Physicians (ACCP)/American College of Cardiology (ACC) recommendations

    Rare but potentially fatal thrombotic thrombocytopenic purpura associated with use

    Risk of bleeding with potentially fatal outcome

    Hepatic or renal impairment

    Allergic cross-reactivity including rash, angioedema, or hematologic reaction among thienopyridines (eg, ticlopidine, prasugrel) reported; evaluate patient for history of hypersensitivity

    Use caution in patients with severe hepatic or renal impairment

    Use caution or avoid in patients with hypersensitivity or hematologic reactions to previous thienopyridine use, including ticlopidine and prasugrel

    Risk factors for bleeding include concomitant use of other drugs that increase the risk of bleeding (eg, anticoagulants, antiplatelet agents, and chronic use of NSAIDs)

    Premature interruption of therapy may result in stent thrombosis with subsequent fatal and nonfatal myocardial infarction; duration of therapy is determined by type of stent placed

    P2Y12 inhibitors (thienopyridines), including clopidogrel, inhibit platelet aggregation for lifetime of platelet (7-10 days); because half-life of clopidogrel’s active metabolite is short, it may be possible to restore hemostasis by administering exogenous platelets; however, platelet transfusions within 4 hours of loading dose or 2 hours of the maintenance dose may be less effective

    May increase risk of major hemorrhage in patients with recent lacunar stroke

    Available data from cases reported over two decades in published literature and postmarketing surveillance have not identified any drug-associated risks for major birth defects or miscarriage; there are risks to pregnant woman and fetus associated with myocardial infarction and stroke

    There are no data on presence of drug in human milk or effects on milk production; no adverse effects on breastfed infants observed during lactation in a small number of postmarketing cases; studies in rats have shown that clopidogrel and/or its metabolites are present in milk; when a drug is present in animal milk, it is likely that the drug will be present in human milk; consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or underlying maternal condition

    Adults

    75 mg/day PO chronic treatment (up to 600 mg PO for single loading dose).

    Geriatric

    75 mg/day PO chronic treatment (up to 600 mg PO for single loading dose).

    Adolescents

    Safety and efficacy have not been established; doses up to 6 mg/kg/day (Max: 75 mg/day) PO have been used off-label.

    Children

    3 to 12 years: Safety and efficacy have not been established; doses up to 6 mg/kg/day (Max: 75 mg/day) PO have been used off-label.
    1 to 2 years: Safety and efficacy have not been established; however, doses of 0.2 mg/kg/day PO have been used off-label.

    Infants

    Safety and efficacy have not been established; however, doses of 0.2 mg/kg/day PO have been used off-label.

    Neonates

    Safety and efficacy have not been established; however, doses of 0.2 mg/kg/day PO have been used off-label.

    Clopidogrel Bisulfate

    tablet

    • 75mg
    • 300mg