Clopistad

Secondary prevention of atherothrombotic events in adults suffering from MI (from a few days to <35 days), ischaemic stroke (from 7 days to <6 mth) or established peripheral arterial disease; non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI), including patients undergoing stent placement following percutaneous coronary intervention, in combination w/ ASA; ST segment elevation acute MI, in combination w/ ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic & thromboembolic events, including stroke, in adults w/ atrial fibrillation who have at least 1 risk factor for vascular events, are not suitable for treatment w/ vit K antagonists & have low bleeding risk, in combination w/ ASA.

Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) Initiate w/ single loading dose of 300 mg, then continue at 75 mg once daily (w/ ASA 75-325 mg daily). ST segment elevation acute MI Single daily dose of 75 mg initiated w/ loading dose of 300 mg in combination w/ ASA & w/ or w/o thrombolytics. Elderly >75 yr Initiate w/o loading dose. Atrial fibrillation Single daily dose of 75 mg (w/ ASA 75-100 mg daily).

May be taken with or without food.

Hypersensitivity. Active pathological bleeding eg, peptic ulcer, intracranial hemorrhage. Concomitant use w/ repaglinide. Severe hepatic impairment.

Reports of cross-reactivity among thienopyridines (eg, clopidogrel, ticlopidine, prasugrel). Reduced effectiveness in poor clopidogrel metabolizers. Risk of bleeding & haematological disorders; TTP; acquired haemophilia. Discontinue 7 days prior to surgery if patient is to undergo elective surgery & antiplatelet effect is temporarily not desirable. Not recommended during the 1st 7 days after acute ischaemic stroke. Concomitant administration w/ oral anticoagulants is not recommended. Concomitant use w/ strong or moderate CYP2C19 inhibitors should be discouraged. Caution when co-administered w/ CYP2C8 substrates. Contains lactose; should not be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Contains hydrogenated castor oil, which may cause stomach upset & diarrhoea. Limited therapeutic experience in patients w/ renal impairment; patients w/ moderate hepatic disease who may have bleeding diatheses. Preferable not to be used during pregnancy. Breast-feeding should not be continued during treatment. Should not be used in childn.

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

Increased risk of bleeding w/ oral anticoagulants, glycoprotein IIb/IIIa inhibitors, ASA, heparin, thrombolytics, NSAIDs including COX-2 inhibitors, SSRIs, & other medicinal products associated w/ bleeding risk. Reduced drug levels of clopidogrel's active metabolite w/ strong or moderate CYP2C19 inhibitors eg, omeprazole, esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, efavirenz. Reduced inhibition of platelet aggregation w/ omeprazole or esomeprazole. Increased exposure of repaglinide (CYP2C8 substrate).

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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