Indicated for:

Acute Coronary Syndrome (ACS)

• To reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. Plavix should be administered in conjunction with aspirin.

• Plavix is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Plavix should be administered in conjunction with aspirin.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease

• In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke Plavix is indicated to reduce the rate of MI and stroke.

The effectiveness of Plavix results from its antiplatelet activity, which is dependent on its conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19. Plavix 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. Consider use of another platelet P2Y12 inhibitor in patients identified as CYP2C19 poor metabolizers.

Plavix is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

P2Y12 inhibitors (Thienopyridines), including Plavix, increase the risk of bleeding.

P2Y12 inhibitors (Thienopyridines), inhibit platelet aggregation for the lifetime of the platelet (7-10 days). Because the 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 the loading dose or 2 hours of the maintenance dose may be less effective.

Discontinuation of Plavix increases the risk of cardiovascular events. If Plavix must be temporarily discontinued (e.g., to treat bleeding or for surgery with a major risk of bleeding), restart it as soon as possible. When possible, interrupt therapy with Plavix for five days prior to such surgery. Resume Plavix as soon as hemostasis is achieved.

TTP, sometimes fatal, has been reported following use of Plavix, sometimes after a short exposure (<2 weeks). TTP is a serious condition that requires urgent treatment including plasmapheresis (plasma exchange). 

Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving Plavix, including patients with a history of hypersensitivity or hematologic reaction to other thienopyridines.

Avoid using omeprazole or esomeprazole with Plavix.

Plavix increased repaglinide exposures by 3.9- to 5.1-fold. Avoid concomitant use of repaglinide with Plavix.

Use of drugs that induce the activity of CYP2C19 would be expected to result in increased drug levels of the active metabolite of clopidogrel and might potentiate the bleeding risk. As a precaution, avoid concomitant use of strong CYP2C19 inducers.

The acyl-β-glucuronide metabolite of clopidogrel is a strong inhibitor of CYP2C8. Plavix can increase the systemic exposure to drugs that are primarily cleared by CYP2C8, thereby needing dose adjustment and appropriate monitoring.

As with other oral P2Y₁₂ inhibitors, co-administration of opioid agonists delay and reduce the absorption of clopidogrel, presumably because of slowed gastric emptying, resulting in reduced exposure to its metabolites. Consider the use of a parenteral antiplatelet agent in acute coronary syndrome patients requiring co-administration of morphine or other opioid agonists.

Co-administration of Plavix and NSAIDs increases the risk of gastrointestinal bleeding.

In patients receiving long-term warfarin therapy, co-administration of Plavix with warfarin increases the risk of bleeding because of independent effects on hemostasis.

The concomitant administration of SSRIs and SNRIs with clopidogrel may increase the risk of bleeding.

Use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage.Clopidogrel use during labor or delivery will increase the risk of maternal bleeding and hemorrhage. Avoid neuraxial blockade during clopidogrel use because of the risk of spinal hematoma. When possible, discontinue clopidogrel 5 to 7 days prior to labor, delivery, or neuraxial blockade.

Animal studies show that clopidogrel and/or its metabolites are excreted in the milk. It is not known whether this drug is excreted in human milk.

GoToSource

• Use in patients under the age of 18. GoToSource

• Use in patients receiving coronary artery stent placement. GoToSource

• Use with aspirin after intracranial or craniocervical angioplasty. GoToSource

⚠️  Patients with CYP2C19 gene variation results in lower systemic active metabolite concentrations, lower antiplatelet response, and may result in higher cardiovascular risk.

Thrombotic thrombocytopenic purpura (blood-coagulation disorder). GoToSource

Upper gastrointestinal lesions and bleeding. GoToSource

Febrile illness, leukopenia (low white blood cell count) aplastic anemia (bone marrow doesn’t make enough new blood cells), angioedema (swelling in deep layers of the skin), serum sickness (allergic reaction), systemic inflammatory response syndrome (inflammatory reaction). GoToSource

Eosinophilic pneumonia (eosinophil, a type of white blood cell, accumulates in the lung). GoToSource

Spontaneous chest wall hematomas in patients using anticoagulant and antiplatelet agents. GoToSource

Myocardial infarction, stroke and unstable angina with the use of proton pump inhibitors (PPI) in patients treated with acetylsalicylic acid and Plavix. GoToSource

Significant risk of developing intracranial hemorrhage following minor head trauma. GoToSource

Liver damage and cholestatic jaundice. GoToSource

Lawsuits filed for heart attacks, strokes, internal bleeding, ulcers, thrombotic thrombocytopenic purpura and death.