Platel

Clopidogrel

MI, ischaemic stroke or established peripheral arterial disease. Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI), including patients undergoing a stent placement following percutaneous coronary intervention, in combination w/ acetylsalicyclic acid (ASA); ST segment elevation acute MI, in combination w/ ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic & thromboembolic events in atrial fibrillation in patients who have at least 1 risk factor for vascular events, are not suitable for vit K antagonist treatment & who have low bleeding risk.

Adult & elderly 75 mg as a single dose. Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) Initiate 300-mg loading dose, continue at 75 mg once daily [w/ ASA 75-325 mg daily (recommended max dose: 100 mg)]. ST segment elevation acute MI Initiate 75-mg single daily dose w/ a 300-mg loading dose in combination w/ ASA & w/ or w/o thrombolytics. Initiate w/o loading dose for patient >75 yr. Initiate combined therapy as early as possible after symptoms start & continued for at least 4 wk. Atrial fibrillation 75-mg single daily dose. Initiate ASA 75-100 mg daily & continue in combination w/ clopidogrel.

May be taken with or without food.

Hypersensitivity to clopidogrel, soya or peanut oil or any of the excipients. Severe hepatic impairment. Active pathological bleeding eg, peptic ulcer or intracranial haemorrhage.

Hypersensitivity to thienopyridines. Promptly consider blood cell count determination &/or other appropriate testing whenever clinical symptoms suggestive of bleeding arise during treatment. Patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions & in patients receiving treatment w/ ASA, heparin, glycoprotein IIb/IIIa inhibitors or NSAIDs including Cox-2 inhibitors or SSRIs. Follow for any signs of bleeding including occult bleeding, especially during the 1st wk of treatment &/or after invasive cardiac procedures or surgery. Not recommended to be used concomitantly w/ oral anticoagulants. Discontinue treatment, 7 days prior elective surgery if antiplatelet effect is temporarily not desirable. Patients who have lesions w/ a propensity to bleed (particularly GI & intraocular). Potentially fatal, thrombotic thrombocytopenic purpura). Discontinue in patients w/ confirmed diagnosis of acquired haemophilia. Recent transient ischaemic attack or stroke or who are at high risk of recurrent ischaemic events. Patients who are poor CYP2C19 metabolisers. Avoid use or carefully monitor blood glucose in concomitant use w/ repaglinide. Renal impairment. Patients w/ moderate hepatic disease who may have bleeding diatheses. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Preferably not to be used during pregnancy. Not to continue breast-feeding during treatment.

Haemotoma; epitaxis; GI haemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; bleeding at puncture site.

Potential additive effect w/ drug associated w/ bleeding risk. Concomitant administration w/ oral anticoagulants may increase intensity of bleedings. Caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors. Possible increased risk of bleeding w/ heparin. Increased occult GI blood loss w/ naproxen; caution when co-administered w/ NSAIDs including Cox-2 inhibitors. Platelet activation may be affected & risk of bleeding is increased by w/ SSRIs. Reduced drug levels of clopidogrel's active metabolite w/ strong or moderate CYP2C19 inhibitors eg, omeprazole & esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine & chloramphenicol. Increased repaglinide exposure.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

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

POM