Plavix

Clopidogrel bisulfate

Secondary prevention of atherothrombotic events in adults suffering from MI (from a few days until <35 days), ischemic stroke (from 7 days until <6 mth) or established peripheral arterial disease. In combination w/ ASA for the secondary prevention of atherothrombotic events in adults suffering from non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI), including patients undergoing stent placement following percutaneous coronary intervention (PCI). In combination w/ ASA for the secondary prevention of atherothrombotic events in adults suffering from ST segment elevation acute MI, including patients undergoing PCI (including those undergoing stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. In combination w/ ASA for adults w/ moderate- to high-risk transient ischemic attack (TIA) or minor ischemic stroke (IS) w/in 24 hr of either TIA or IS event. In combination w/ ASA for the prevention of atherothrombotic & thromboembolic events (including stroke) in adults w/ atrial fibrillation who have at least 1 risk factor for vascular events, who are not suitable for treatment w/ vit K antagonists, & who have low bleeding risk.

Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) Initially 300 mg single loading dose, then continue at 75 mg once daily w/ ASA (75-325 mg daily). May consider 600 mg loading dose in patients <75 yr when PCI is intended. ST segment elevation acute MI Medically treated patient eligible for thrombolytic/fibrinolytic therapy 75 mg single daily dose, initiated w/ 300 mg loading dose in combination w/ ASA & w/ or w/o thrombolytics. Initiate w/o loading dose in medically treated patients >75 yr. Patient undergoing primary PCI & patient undergoing PCI >24 hr of receiving fibrinolytic therapy Initially 600 mg loading dose, then continue at 75 mg once daily w/ ASA (75-100 mg daily). Administer 600 mg loading dose w/ caution in patients ≥75 yr. Patient undergoing PCI w/in 24 hr of receiving fibrinolytic therapy Initially 300 mg loading dose, then continue at 75 mg once daily w/ ASA (75-100 mg daily). Moderate- to high-risk TIA (ABCD2 score ≥4) or minor IS (NIHSS ≤3) 300 mg loading dose, followed by 75 mg once daily w/ ASA (75-100 mg once daily). Start clopidogrel & ASA w/in 24 hr of the event & continue for 21 days followed by single antiplatelet therapy. Atrial fibrillation 75 mg single daily dose in combination w/ ASA (75-100 mg daily).

May be taken with or without food.

Hypersensitivity. Active pathological bleeding eg, peptic ulcer or intracranial hemorrhage. Severe hepatic impairment.

Cross-reactivity among thienopyridines (eg, ticlopidine, prasugrel). Risk of bleeding & haematological adverse reactions. Very rare reports of TTP. Reports of acquired haemophilia. Discontinue use 7 days prior to elective surgery. No data regarding the benefit-risk of short-term dual antiplatelet therapy in acute minor IS or moderate- to high-risk TIA patients w/ history of (non-traumatic) intracranial hemorrhage. Dual antiplatelet therapy is not recommended in recent minor IS or moderate- to high-risk TIA patients for whom treatment w/ carotid endarterectomy or intravascular thrombectomy is indicated, or in patients planned for thrombolysis or anticoagulant therapy. Clopidogrel monotherapy in non-minor IS patients should be started only after the 1st 7 days of the event. Dual antiplatelet therapy is not recommended in non-minor IS patients (NIHSS >4). Co-administration w/ oral anticoagulants is not recommended. Discourage concomitant use w/ strong or moderate CYP2C19 inhibitors, & strong CYP2C19 inducers. Caution w/ concomitant CYP2C8 substrates. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Contains hydrogenated castor oil, which may cause stomach upset & diarrhoea. Caution in patients w/ renal impairment, & in patients w/ moderate hepatic disease who may have bleeding diatheses. Do not use during pregnancy. Do not continue breast-feeding during treatment. Do not use in childn.

Haematoma; epistaxis; GI hemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; puncture site bleeding.

Increased risk of bleeding w/ medicinal products associated w/ bleeding risk (eg, oral anticoagulants, glycoprotein IIb/IIIa inhibitors, ASA, heparin, thrombolytics, NSAIDs, SSRIs). Increased levels of clopidogrel active metabolite w/ strong CYP2C19 inducers (eg, rifampicin). Reduced levels of clopidogrel active metabolite w/ strong or moderate CYP2C19 inhibitors (eg, omeprazole, esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine, chloramphenicol). High risk of vascular events w/ boosted anti-retroviral therapy in HIV patients. Increased plasma conc of CYP2C8 substrates (eg, repaglinide, paclitaxel). Potentially delayed & reduced absorption w/ opioid agonists. Increased exposure of rosuvastatin.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.

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