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Plavix

Plavix

clopidogrel

Manufacturer:

Sanofi

Distributor:

DKSH
Concise Prescribing Info
Contents
Clopidogrel hydrogen sulfate
Indications/Uses
Secondary prevention of atherothrombotic events in MI (few days until <35 days), ischemic stroke (7 days until <6 mth) or established peripheral arterial disease. Acute coronary syndrome: In combination w/ ASA for non-ST segment elevation (unstable angina or non-Q-wave MI) including patients undergoing stent placement following percutaneous coronary intervention (PCI) & ST segment elevation acute MI in medically treated patients eligible for thrombo-/fibrinolytic therapy. Moderate to high-risk transient ischemic attack (TIA) or minor ischemic stroke (IS). 75 mg: In combination w/ ASA for prevention of atherothrombotic & thromboembolic events in atrial fibrillation including stroke.
Dosage/Direction for Use
Adult & elderly 75 mg single daily dose. Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) Initially 300 or 600 mg single loading dose then continued at 75 mg once daily w/ ASA 75-325 mg daily. ST segment elevation acute MI 75 mg single daily dose, initiated w/ 300 mg loading dose in combination w/ ASA & w/ or w/o thrombolytic. Patient undergoing primary PCI & receiving >24 hr fibrinolytic therapy Initially 600 mg loading dose then continued at 75 mg once daily w/ ASA 75-100 mg daily, w/in 24 hr of receiving fibrinolytic therapy 300 mg loading dose then continued at 75 mg once daily w/ ASA 75-100 mg daily. Adult Moderate to high-risk TIA or minor IS 300 mg loading dose followed by 75 mg once daily w/ ASA 75-100 mg once daily, initiate treatment w/in 24 hr & continue for 21 days followed by single antiplatelet therapy. Atrial fibrillation 75 mg single daily dose w/ ASA 75-100 mg daily. Elderly <75 yr Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) May consider 600 mg loading dose when PCI is intended, >75 yr ST segment elevation acute MI Initially w/o loading dose.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active pathological bleeding eg, peptic ulcer or intracranial hemorrhage. Severe hepatic impairment.
Special Precautions
History of hypersensitivity to thienopyridines eg, clopidogrel, ticlopidine or prasugrel. Discontinue use if acquired haemophilia is diagnosed. Increased risk of bleeding from trauma, surgery or other pathological conditions; GI & intraocular lesions w/ propensity to bleed; TTP. May cause stomach upset & diarrhoea due to hydrogenated castor oil. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Discontinue use 7 days prior to elective surgery. Not recommended in concomitant use w/ oral anticoagulants or dual antiplatelet therapy. Triple antiplatelet therapy (clopidogrel + ASA + dipyridamole) for stroke secondary prevention is not recommended in acute non-cardioembolic ischemic stroke or TIA. Concomitant use w/ ASA, heparin, glycoprotein IIb/IIIa inhibitors, NSAIDS eg, COX-2 inhibitors, SSRIs, strong CYP2C19 inducers or other medicinal products associated w/ bleeding risk eg, pentoxifylline; strong or moderate CYP2C19 inhibitors; CYP2C8 substrates. Moderate hepatic disease w/ bleeding diatheses. Renal impairment. Not to be used during pregnancy & lactation. Not to be used in childn. 600 mg loading dose: Not recommended in patients w/ non-ST segment elevation acute coronary syndrome. Elderly ≥75 yr w/ ST segment elevation MI PCI.
Adverse Reactions
Haematoma; epistaxis; GI hemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; bleeding at puncture site.
Drug Interactions
Increased risk of bleeding w/ medicinal products associated w/ bleeding risk, oral anticoagulants, ASA, heparin, SSRIs. Increased occult GI blood loss w/ naproxen. Increased drug levels by strong CYP2C19 inducers eg, rifampicin. Reduced drug levels by strong or moderate CYP2C19 inhibitors eg, omeprazole, esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, efavirenz. Reduced metabolite exposure w/ omeprazole, esomeprazole, pantoprazole or lansoprazole. Increased repaglinide, paclitaxel plasma conc. Increased rosuvastatin exposure. Concomitant use w/ glycoprotein IIb/IIIa inhibitors; thrombolytics; NSAIDs eg, COX-2 inhibitors; boosted anti-retroviral therapies.
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 300 mg
Packing/Price
10's
Form
Plavix FC tab 75 mg
Packing/Price
14's
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