Clopidogrel

Plavix is a P2Y 12 platelet inhibitor indicated for: Acute coronary syndrome – For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. – For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. Recent MI, recent stroke, or established peripheral arterial disease. Plavix has been shown to reduce the rate of MI and stroke.

Clopidogrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y 12 class of ADP receptors on platelets.

Acute coronary syndrome – Initiate Plavix with a single 300 mg oral loading dose and then continue at 75 mg once daily. – Initiating Plavix 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.

Active pathological bleeding, such as peptic ulcer or intracranial hemorrhage. Hypersensitivity to clopidogrel or any component of the product

Boxed warning: Effectiveness of Plavix depends on conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19. Tests are available to identify patients who are CYP2C19 poor metabolizers. Consider use of another platelet P2Y 12 inhibitor in patients identified as CYP2C19 poor metabolizers. CYP2C19 inhibitors: Avoid concomitant use of omeprazole or esomeprazole. Bleeding: Plavix increases risk of bleeding. Discontinuation: Premature discontinuation increases risk of cardiovascular events. Discontinue 5 days prior to elective surgery that has a major risk of bleeding. Thrombotic thrombocytopenic purpura (TTP) has been reported. Cross-reactivity among thienopyridines has been reported.

The following serious adverse reactions are discussed below and elsewhere in the labeling: Bleeding Thrombotic thrombocytopenic purpura Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction.

CYP2C19 inducers: Increases levels of clopidogrel active metabolite and increases platelet inhibition. Opioids: Decreased exposure to clopidogrel. Consider use of parenteral antiplatelet agent. Nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs): Increases risk of bleeding. Other Antiplatelet Agents: Increases the risk of bleeding due to an additive effect. Repaglinide (CYP2C8 substrates): Increases substrate plasma concentrations.

Store at 25°C (77°F), excursions permitted to 15°C–30°C (59°F–86°F).