Clopidogrel

Class
Antiplatelets
Subclass
P2Y12 inhibitors
Substance name
Clopidogrel bisulfate
Brand names
Plavix®
Common formulations
Film-coated tablet
Dosage and administration
Adults patients
Prevention
Atherothrombotic events in patients with NSTEMI • Receiving medical treatment
•
Loading: 300 mg PO once
•
Maintenance: 75 mg PO daily
Administered in combination with aspirin.
Atherothrombotic events in patients with NSTEMI, during coronary revascularization
•
Loading: 300 mg PO once
•
Maintenance: 75 mg PO daily
Administered in combination with aspirin.
Alternative
•
Loading: 300-600 mg PO once
•
Maintenance: 75 mg PO daily
Administered in combination with aspirin.
Atherothrombotic events in patients with PAD
•
75 mg PO daily
Atherothrombotic events in patients with STEMI • Receiving medical treatment
•
Loading: 300 mg PO once
•
Maintenance: 75 mg PO daily
Administered in combination with aspirin.
Alternative
•
Loading: 300 mg PO once
•
Maintenance: 75 mg PO daily for at least 14 days and up to 1 year
Administered in combination with aspirin. Administer a 75 mg loading dose in patients aged > 75 years.
Atherothrombotic events in patients with unstable angina • Receiving medical treatment
•
Loading: 300 mg PO once
•
Maintenance: 75 mg PO daily
Administered in combination with aspirin.
Atherothrombotic events in patients with unstable angina, during coronary revascularization
•
Loading: 300 mg PO once
•
Maintenance: 75 mg PO daily
Administered in combination with aspirin.
Alternative
•
Loading: 300-600 mg PO once
•
Maintenance: 75 mg PO daily for up to 1 year
Administered in combination with aspirin.
Arterial thromboembolism in patients with aortic valve disease, after bioprosthetic aortic valve replacement • Off-label
•
75 mg PO daily for 3-6 months
Administered in combination with aspirin.
Atherothrombotic events in patients with STEMI, during coronary revascularization • Off-label
•
Loading: 600 mg PO once
•
Maintenance: 75 mg PO daily for 1 year
Administered in combination with aspirin. Consider administering a 300 mg loading dose in patients undergoing PCI after fibrinolytic therapy.
Stent thrombosis in patients with coronary artery disease, after PCI • Off-label
•
Loading: 600 mg PO once
•
Maintenance: 75 mg PO daily for at least 1 month after bare metal stent implantation and for at least 6 months after drug-eluting stent implantation
Administered in combination with aspirin.
Secondary prevention
AIS
•
75 mg PO daily
Myocardial infarction
•
75 mg PO daily
Indications for use
Labeled indications
Adults
•
Prevention of atherothrombotic events in patients with STEMI (receiving medical treatment)
•
Prevention of atherothrombotic events in patients with NSTEMI (receiving medical treatment)
•
Prevention of atherothrombotic events in patients with NSTEMI, in patients undergoing coronary revascularization
•
Prevention of atherothrombotic events in patients with PAD
•
Prevention of atherothrombotic events in patients with unstable angina (receiving medical treatment)
•
Prevention of atherothrombotic events in patients with unstable angina, in patients undergoing coronary revascularization
•
Secondary prevention of AIS
•
Secondary prevention of myocardial infarction
Off-label indications
Adults
•
Prevention of arterial thromboembolism in patients with aortic valve disease, after bioprosthetic aortic valve replacement
•
Prevention of atherothrombotic events in patients with STEMI, in patients undergoing coronary revascularization
•
Prevention of stent thrombosis in patients with coronary artery disease, after PCI
Safety risks
Boxed warnings
Decreased antiplatelet effect
•
Do not use clopidogrel in patients with two loss-of-function alleles of the CYP2C19 gene.
Contraindications
Hypersensitivity to clopidogrel or its components
Active bleeding
•
Do not use clopidogrel in patients with active bleeding, such as peptic ulcer bleeding or intracranial bleeding.
CABG
•
Discontinue clopidogrel 24 hours before urgent CABG and 5 days before elective CABG.
Concomitant use of CYP2C19 inhibitors
•
Do not use clopidogrel with CYP2C19 inhibitors, such as omeprazole or esomeprazole.
Warnings and precautions
Bleeding
•
Use caution in patients taking other drugs increasing the risk of bleeding, including anticoagulants, antiplatelets, and long-term NSAIDs. Discontinue clopidogrel 5 days before elective surgeries with a major risk of bleeding.
Cardiovascular events
•
Use caution when discontinuing clopidogrel. Restart clopidogrel as soon as possible if temporarily discontinued.
Drug hypersensitivity reaction
•
Use caution Hypersensitivity to other thienopyridines.
TTP
•
Maintain a high level of suspicion, as an increased incidence has been reported in patients receiving clopidogrel.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Limited experience in patients with moderate and severe renal impairment.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
•
Use acceptable. No dose adjustment required.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B1
•
Use only if benefits outweigh potential risks. Monitor for postpartum hemorrhage. There are risks to the pregnant woman and fetus associated with myocardial infarction and stroke. Do not withhold treatment from pregnant women because of potential concerns about the effects of clopidogrel on the fetus.
•
Clopidogrel use during labor or obstetric delivery will increase the risk of maternal bleeding and hemorrhage. Avoid neuraxial blockade in patients receiving clopidogrel because of the risk of spinal hematoma. Discontinue clopidogrel 5-7 days before labor, delivery, or neuraxial blockade if possible.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
•
Bleeding, gastrointestinal bleeding
Uncommon < 1%
•
Agranulocytosis, aplastic anemia, ↓ WBC count, ↓ blood neutrophil count, ↓ platelet count, intracranial hemorrhage, hemorrhagic stroke, ocular hemorrhage, thrombotic thrombocytopenic purpura
Unknown frequency
•
Acute liver failure, hepatitis, acute generalized exanthematous pustulosis, acute pancreatitis, angioedema, bronchospasm, colitis, subdural hematoma, peptic ulcer disease, DRESS syndrome, ↓ blood glucose, eosinophilic pneumonia, erythema multiforme, postoperative bleeding, fixed drug eruption, hemolytic uremic syndrome, hypotension, interstitial lung disease, ↑ liver enzymes, ↑ serum creatinine, insulin autoimmune syndrome, lichen planus, pancytopenia, platelet dysfunction, ↑QT interval, pulmonary edema, arthralgia, change in taste, confusion, diarrhea, hallucinations, headache, hematuria, hematospermia, myalgia, pruritus, skin rash, serum sickness, Stevens-Johnson syndrome, stomatitis, toxic epidermal necrolysis, urticaria, fever, vasculitis, bullous pemphigoid
Interactions
Drug(s)
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