Plavix (clopidogrel)
PLAVIX (clopidogrel) – a platelet inhibitor drug commonly used to prevent stroke and other circulatory complications of atrial fibrillation, and other cardiovascular conditions. Clopidogrel exerts its clinical effects by inhibiting platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets.
FDA approved uses:
Acute coronary syndrome
– For 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 has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
– For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary PCI is unknown.
Recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease – Plavix has been shown to reduce the combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
Available dosage forms: Tablet – 75, 300 mg.
Usual dosage: Acute coronary syndrome – Non-ST-segment elevation ACS (UA/NSTEMI): 300 mg loading dose followed by 75 mg once daily, in combination with aspirin (75-325 mg once daily). STEMI: 75 mg once daily, in combination with aspirin (75-325 mg once daily), with or without a loading dose and with or without thrombolytics. Recent MI, recent stroke, or established peripheral arterial disease – 75 mg once daily.
Contraindications: Active pathological bleeding, such as peptic ulcer or intracranial hemorrhage; Hypersensitivity to clopidogrel or any component of the product..
Special warnings: Effectiveness of Plavix depends on activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19. Poor metabolizers treated with Plavix at recommended doses exhibit higher cardiovascular event rates following acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) than patients with normal CYP2C19 function. Tests are available to identify a patient’s CYP2C19 genotype and can be used as an aid in determining therapeutic strategy. Consider alternative treatment or treatment strategies in patients identified as CYP2C19 poor metabolizers.
Adverse reactions (side effects) of Plavix: The most common side effects of Plavix include Bleeding, including life-threatening and fatal bleeding. Other adverse events reported include pruritis, gastrointestinal disorders, fever, hemorrhage, hypersensitivity reactions, anaphylactoid reactions, serum sickness, arthralgia, arthritis, taste disorders, bronchospasm, interstitial pneumonitis, and Stevens-Johnson syndrome.
Common drug interactions: Documented or potential drug interactions with Plavix includes CYP2C19 inhibitors, proton pump inhibitors (especially omeprazole and esomeprazole), nonsteroidal anti-inflammatory drugs (NSAIDs), and warfarin.
Special instructions for patients: Take this medication exactly as directed by physician. Read the official Medication Guide before starting Plavix and when you receive new refills. Call your doctor right away if you experience any of the following:
Full prescribing information may be found at the manufacturer‘s official website BMS.com or at the U.S. Food and Drug Administration’s website at Plavix Info at Drugs@FDA
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