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Concise Prescribing Info
Clopidogrel bisulfate
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/ acetylsalicylic 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 adults w/ atrial fibrillation who have at least 1 risk factor for vascular events, not suitable for treatment w/ vit K antagonists (VKA) & have a low bleeding risk, in combination w/ ASA.
Dosage/Direction for Use
Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) Initial loading dose: 300 mg. Followed by 75 mg once daily (w/ ASA 75-325 mg daily). ST segment elevation acute MI 75 mg once daily, initiated w/ 300-mg loading dose in combination w/ ASA & w/ or w/o thrombolytics. Elderly >75 yr Initiate w/o loading dose. Atrial fibrillation 75 mg once daily (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.
Special Precautions
Reports of cross-reactivity among thienopyridines (eg, clopidogrel, ticlopidine, prasugrel). Reduced effectiveness in poor clopidogrel metabolizers. Risk of bleeding & haematological disorders; thrombotic thrombocytopenic purpura; acquired haemophilia. Not recommended during the 1st 7 days after acute ischaemic stroke. Avoid use w/ strong or moderate CYP2C19 inhibitors. Caution when co-administered w/ CYP2C8 substrate medicinal products. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Stomach upset & diarrhoea due to hydrogenated castor oil. Patients w/ renal impairment & moderate hepatic disease. Pregnancy & lactation. Should not be used in childn.
Adverse Reactions
Haematoma; epistaxis; GI haemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; bleeding at puncture site.
Drug Interactions
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 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).
ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Clopistad FC tab 75 mg
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