Clopidogrel Sandoz

Clopidogrel Sandoz

clopidogrel

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Clopidogrel bisulfate
Indications/Uses
Prevention of atherothrombotic events in patients suffering from MI (from a few days until <35 days), ischaemic stroke (from 7 days to <6 mth) or established peripheral arterial disease; acute coronary syndrome eg, non-ST segment elevation acute coronary syndrome (unstable angina or non-Q wave MI) including those w/ stent placement following percutaneous coronary intervention, in combination w/ acetylsalicylic acid (ASA) & ST segment elevation acute MI, in combination w/ ASA in patients eligible for thrombolytic therapy.
Dosage/Direction for Use
Adult & elderly 75 mg once daily. Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q wave MI) Initially 300 mg as single loading dose continued at 75 mg once daily (w/ ASA 75-325 mg daily). ST segment elevation acute MI 75 mg once daily. Initially 300 mg as loading dose in combination w/ ASA (w/ or w/o thrombolytics). Do not initiate w/ loading dose in patient >75 yr. Continue combination therapy for at least 4 wk.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Severe hepatic impairment, active pathological bleeding eg, peptic ulcer or intracranial hemorrhage.
Special Precautions
Patients at risk of increased bleeding from trauma, surgery or other pathological conditions. Discontinue 7 days prior to surgery. Patients who have lesions w/ a propensity to bleed (particularly GI & intraocular). Thrombotic thrombocytopenic purpura. Acute ischemic stroke (≤7 days). Concomitant use w/ CYP2C19 inhibitors. Renal impairment & moderate hepatic disease w/ bleeding diatheses. Pregnancy & lactation. Childn & adolescents <18 yr.
Adverse Reactions
Bleeding; hematoma; epistaxis; GI hemorrhage, diarrhea, abdominal pain, dyspepsia; bruising; bleeding at inj site.
Drug Interactions
Increased intensity of bleeding w/ oral anticoagulants, glycoprotein IIb/IIIa inhibitors, ASA, heparin, thrombolytics. May increase risk of GI bleeding w/ NSAIDs including COX-2 inhibitors. CYP2C19 inhibitors eg, omeprazole, esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine & chloramphenicol. Reduction of inhibition of platelet aggregation w/ proton-pump inhibitors.
ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Clopidogrel Sandoz FC tab 75 mg
Packing/Price
2 × 14's
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