Concise Prescribing Info
Prevention of atherothrombotic events in patients w/ MI (from a few days until <35 days), ischaemic stroke (from 7 days until <6 mth) or established peripheral arterial disease; non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI); 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.
Dosage/Direction for Use
Adult & elderly 75 mg as single daily dose. Non-ST segment elevation acute coronary syndrome Initiate w/ a single 300-mg loading dose followed by 75 mg once daily (w/ ASA 75-325 mg daily). ST segment elevation acute MI 75 mg as single daily dose, initiated w/ a loading dose w/ ASA & w/ or w/o thrombolytics. >75 yr Initiate therapy w/o loading dose.
May be taken with or without food.
Hypersensitivity. Severe liver impairment. Active pathological bleeding eg, peptic ulcer or intracranial haemorrhage. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Lactation.
Special Precautions
Perform blood cell count determination. Patients at risk of increased bleeding from trauma, surgery or other pathological conditions. Discontinue use 7 days prior to elective surgery. Lesions w/ a propensity to bleed especially GI & intraocular; acute MI w/ ST segment elevation (do not initiate clopidogrel therapy w/in the 1st few days following MI); acute ischaemic stroke (<7 days); renal impairment; moderate hepatic disease. Thrombotic thrombocytopaenic purpura may occur. Concomitant therapy w/ drugs inhibiting CYP2C19. Pregnancy. Childn <18 yr.
Adverse Reactions
Diarrhoea, abdominal pain, dyspepsia; GI bleeding; purpura/bruising/haematoma & epistaxis; severe neutropenia.
Drug Interactions
Concomitant use of omeprazole & esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine & chloramphenicol would reduce drug levels of active metabolite of clopidogrel & a reduction in clinical efficacy. Concomitant use of proton pump inhibitors should be avoided unless absolutely necessary. Concomitant administration of ASA co-administered w/ thrombolytic agents & heparin may lead to increased risk of bleeding. Concomitant administration of naproxen may increase occult GI blood loss.
ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Apo-Clopidogrel film-coated tab 75 mg
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