Plavix

Secondary prevention of atherothrombotic events in adult patients suffering from MI (from a few days until <35 days), ischemic stroke (from 7 days until <6 mth) or established peripheral arterial disease; 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; ST segment elevation acute MI in combination w/ ASA in patients undergoing PCI (including those undergoing stent placement) or medically-treated patients eligible for thrombolytic/fibrinolytic therapy. In combination w/ ASA for adult patients w/ moderate to high-risk transient ischemic attack (TIA) (ABCD2 score ≥4) or minor ischemic stroke (IS) (NIHSS ≤3) w/in 24 hr of either TIA or IS event. In combination w/ ASA for prevention of atherothrombotic & thromboembolic events including stroke in adult patients w/ atrial fibrillation (AF) who have at least 1 factor for vascular events, unsuitable for treatment w/ vit K antagonists (VKA) & who have low bleeding risk.

Adult & elderly 75 mg as a single daily dose. Non-ST segment elevation acute coronary syndrome Initiate w/ a single 300 or 600 mg loading dose & then continue at 75 mg once daily (w/ ASA 75-325 mg daily). Elderly <75 yr Consider 600 mg loading dose when PCI is intended. ST segment elevation acute MI Medically treated patient eligible for thrombolytic/fibrinolytic therapy Initiate w/ 300 mg loading dose w/ ASA & w/ or w/o thrombolytics then give as 75 mg as a single daily dose. Medically treated patient >75 yr eligible for thrombolytic/fibrinolytic therapy Initiate w/o loading dose. Adult <75 yr undergoing primary PCI or those undergoing PCI >24 hr of receiving fibrinolytic therapy Initiate w/ 600 mg loading dose then continue at 75 mg once daily w/ ASA 75-100 mg daily. Adult <75 yr undergoing PCI w/in 24 hr of receiving fibrinolytic therapy Initiate w/ 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 & 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. Patient w/ AF 75 mg as a single daily dose. Initiate ASA 75-100 mg daily & continue in combination w/ clopidogrel.

May be taken with or without food.

Hypersensitivity. Active pathological bleeding (eg, peptic ulcer & intracranial hemorrhage). Severe liver impairment.

History of hypersensitivity to another thienopyridine (eg, ticlopidine, prasugrel). Promptly consider blood cell count determination &/or other appropriate testing whenever clinical symptoms suggestive of bleeding arise. Patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions & those receiving treatment w/ ASA, heparin, glycoprotein IIb/IIIa inhibitors or NSAIDs including COX-2 inhibitors, SSRIs or CYP2C19 strong inducers. Triple antiplatelet therapy (clopidogrel + ASA + dipyridamole) for stroke secondary prevention is not recommended in patients w/ acute non-cardioembolic ischemic stroke or TIA. Carefully follow patients for any bleeding signs including occult bleeding especially during 1st wk of treatment &/or after invasive cardiac procedures or surgery. Concomitant administration w/ oral anticoagulants is not recommended. Discontinue use 7 days prior to surgery. Patients who have lesions w/ a propensity to bleed particularly GI & intraocular. Advise to report any unusual bleeding (site or duration) to physician. Not recommended to use 600 mg loading dose in patients w/ non-ST segment elevation acute coronary syndrome & ≥75 yr. Possible TTP. Discontinue use in patients w/ confirmed diagnosis of acquired haemophilia. Recent ischemic stroke. Not recommended to use dual antiplatelet therapy in non-minor IS patients (NIHSS >4); patients for whom treatment w/ carotid endarterectomy or intravascular thrombectomy is indicated or in those who planned for thrombolysis or anticoagulant therapy. Patients who are poor CYP2C19 metabolisers. Not to 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. Moderate hepatic disease who may have bleeding diatheses. Renal impairment. Pregnancy & lactation. Not to be used in childn. Elderly ≥75 yr undergoing primary PCI.

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

Increased risk of bleeding w/ oral anticoagulants, glycoprotein IIb/IIIa inhibitors, heparin, thrombolytics, SSRIs. Potentiated effects of ASA on collagen-induced platelet aggregation. May increase occult GI blood loss w/ NSAIDs including COX-2 inhibitors. Increased drug levels of clopidogrel active metabolite w/ CYP2C19 inducers (eg, rifampicin). Reduced drug levels of clopidogrel active metabolite w/ CYP2C19 inhibitors (eg, omeprazole & esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine & chloramphenicol). Decreased exposure of clopidogrel active metabolite w/ PPIs (eg, omeprazole or esomeprazole). Increased exposure of CYP2C8 substrate drugs (eg, repaglinide, paclitaxel). Potential delayed & reduced absorption when co-administered w/ opioid agonists; consider using parenteral antiplatelet agent in acute coronary syndrome patients requiring co-administration of morphine or other 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.

POM