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Plavix

Plavix

clopidogrel

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Concise Prescribing Info
Contents
Clopidogrel hydrogen sulphate
Indications/Uses
Secondary prevention of atherothrombotic events in adult patients suffering from MI (from a few days until <35 days), ischemic stroke (from 7 days until <6 mth) or established peripheral arterial disease; suffering from non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) including patients undergoing stent placement following percutaneous coronary intervention (PCI) in combination w/ ASA; ST segment elevation acute MI in combination w/ ASA in patients undergoing PCI (including those undergoing stent placement) or medically-treated patients eligible for thrombolytic/fibrinolytic therapy. In combination w/ ASA for adult patients w/ moderate to high-risk transient ischemic attack (TIA) (ABCD2 score ≥4) or minor ischemic stroke (IS) (NIHSS ≤3) w/in 24 hr of either TIA or IS event. In combination w/ ASA for prevention of atherothrombotic & thromboembolic events in atrial fibrillation (AF) in adult patients w/ at least 1 factor for vascular events, are unsuitable for treatment w/ vit K antagonists (VKA) & who have low bleeding risk.
Dosage/Direction for Use
Adult & elderly 75 mg as a single daily dose. Non-ST segment elevation acute coronary syndrome Initiate w/ a single 300 or 600 mg loading dose & then continue at 75 mg once daily (w/ ASA 75-325 mg daily). ST segment elevation acute MI Medically treated patient eligible for thrombolytic/fibrinolytic therapy Initiate w/ 300 mg loading dose w/ ASA & w/ or w/o thrombolytics then give as 75 mg as a single daily dose. Adult <75 yr undergoing primary PCI or those undergoing PCI >24 hr of receiving fibrinolytic therapy Initiate w/ 600 mg loading dose then continue at 75 mg once daily w/ ASA 75-100 mg daily. Adult <75 yr undergoing PCI w/in 24 hr of receiving fibrinolytic therapy Initiate w/ 300 mg loading dose then continue at 75 mg once daily w/ ASA 75-100 mg daily. Patient w/ atrial fibrillation 75 mg as a single daily dose (ASA 75-100 mg daily should be initiated & continued in combination w/ clopidogrel). Elderly >75 yr Initiate w/o loading dose. Combined therapy should be started after symptoms start & continued for at least 4 wk.
Administration

Contraindications
Hypersensitivity. Active pathological bleeding (eg, peptic ulcer & intracranial hemorrhage). Severe liver impairment.
Special Precautions
Monitor blood cell count. Patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions & patients receiving treatment w/ ASA, heparin, glycoprotein IIb/IIIa inhibitors or NSAIDs including COX-2 inhibitors & SSRIs. Concomitant administration w/ oral anticoagulants is not recommended. Discontinue 7 days prior to surgery. Patient who have lesions w/ a propensity to bleed. Thrombotic thrombocytopenic purpura; acquired haemophilia; recent transient ischaemic attack or stroke. Patients who are poor CYP2C19 metabolisers. History of hypersensitivity to another thienopyridine (eg, ticlopidine, prasurgel). Moderate hepatic disease who may have bleeding diatheses. Renal impairment. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Contains hydrogenated castor oil. Pregnancy & lactation. Do not use in childn.
Adverse Reactions
Haematoma; epistaxis; GI haemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; bleeding at punctured site.
Drug Interactions
Increased risk of bleeding w/ oral anticoagulants, glycoprotein IIb/IIIa inhibitors, heparin, thrombolytics, SSRIs. Potentiated effects of ASA on collagen-induced platelet aggregation. Increased occult GI blood loss w/ NSAIDs including COX-2 inhibitors. Reduced drug levels of the active metabolite of clopidogrel w/ CYP2C19 inhibitors (eg, omeprazole & esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine & chloramphenicol. Increased CYP2C8 substrate drug exposure (eg, repaglinide & paclitaxel).
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Plavix FC tab 75 mg
Packing/Price
14's;84's
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