Classes
DEA Class; Rx
Common Brand Names; Plavix
- Antiplatelet Agents, Cardiovascular;
- Antiplatelet Agents, Hematologic
Description
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
Indications
Indicated for arterial thromboembolism prophylaxis (i.e., myocardial infarction prophylaxis, stroke prophylaxis, thrombosis prophylaxis).
Contraindications
Hypersensitivity
Active pathologic bleeding (eg, peptic ulcer, intracranial hemorrhage)
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
75 mg/day PO chronic treatment (up to 600 mg PO for single loading dose).
75 mg/day PO chronic treatment (up to 600 mg PO for single loading dose).
Safety and efficacy have not been established; doses up to 6 mg/kg/day (Max: 75 mg/day) PO have been used off-label.
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.
Safety and efficacy have not been established; however, doses of 0.2 mg/kg/day PO have been used off-label.
Safety and efficacy have not been established; however, doses of 0.2 mg/kg/day PO have been used off-label.
How supplied
Clopidogrel Bisulfate
tablet
- 75mg
- 300mg
