Apo-Clopidogrel

Apo-Clopidogrel

clopidogrel

Manufacturer:

Apotex

Distributor:

Pharmaforte
Concise Prescribing Info
Contents
Clopidogrel
Indications/Uses
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.
Administration
May be taken with or without food.
Contraindications
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.
Presentation/Packing
Form
Apo-Clopidogrel film-coated tab 75 mg
Packing/Price
30's
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