Concise Prescribing Info
Clopidogrel hydrogen sulfate
Secondary prevention of atherothrombotic events in MI (few days until <35 days), ischaemic 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 & ST segment elevation acute MI in medically treated patients eligible for thrombolytic 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 mg single loading dose & continue 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 thrombolytics. Atrial fibrillation 75 mg single daily dose 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.
May be taken with or without food.
Hypersensitivity. Active pathological bleeding eg, peptic ulcer & intracranial haemorrhage. 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 in patients w/ galactose intolerance, Lapp 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. Concomitant use w/ ASA, heparin, glycoprotein IIb/IIIa inhibitors, NSAIDS eg, COX-2 inhibitors, SSRIs or other medicinal products associated w/ bleeding risk eg, pentoxifylline; strong or moderate CYP2C19 inhibitors; strong CYP2C19 inducers; 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.
Adverse Reactions
Haematoma; epistaxis; GI haemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; bleeding at puncture site.
Drug Interactions
Increased risk of bleeding w/ medicinal products associated w/ bleeding risk, oral anticoagulant, ASA, heparin, SSRIs. Increased occult GI blood loss w/ NSAIDs eg, naproxen, COX-2 inhibitors. 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 metabolic exposure w/ pantoprazole or lansoprazole. Increased repaglinide, paclitaxel plasma conc. Glycoprotein IIb/IIIa inhibitors & thrombolytics.
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.
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