Apolets

Apolets

clopidogrel

Manufacturer:

Apotex

Distributor:

Berlin Pharm
Concise Prescribing Info
Contents
Clopidogrel
Indications/Uses
Reduction of atherothrombotic events in recent MI, stroke or established peripheral arterial disease; acute coronary syndrome & in patients w/ ST segment elevation acute MI in combination w/ aspirin. Prevention of atherothrombotic & thromboembolic events including stroke in atrial fibrillation in combination w/ aspirin.
Dosage/Direction for Use
Recent MI & stroke, established peripheral arterial disease 75 mg once daily. Acute coronary syndrome (unstable angina or non-Q-wave MI) Initially 300 mg single loading dose then 75 mg once daily in combination w/ aspirin 75-325 mg daily. ST segment elevation acute MI 75 mg once daily w/ or w/o loading dose in combination w/ aspirin & w/ or w/o thrombolytics. Prevention of atherothrombotic & thromboembolic events in atrial fibrillation 75 mg once daily in combination w/ aspirin 75-100 mg daily. CYP2C19 poor metabolizers 600 mg loading dose followed by 150 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active pathological bleeding eg, peptic ulcer or intracranial hemorrhage. Severe hepatic impairment.
Special Precautions
Discontinue treatment 5-10 days prior to elective surgery. Thrombotic thrombocytopenic purpura. Patients at risk of increased bleeding from trauma, surgery or other pathological conditions; w/ lesions w/ propensity to bleed eg, ulcers. Increased major bleeding in patients w/ recent transient ischaemic attacks or stroke who are at high risk for recurrent ischemic events in combination w/ aspirin. Consider blood cell count determination. Not recommended in concomitant use w/ oral anticoagulants (eg, warfarin). Concomitant use w/ drug-induced lesions. Moderate (CrCl 30-60 mL/min) & severe (CrCl 5-15 mL/min) renal impairment. Not to be used during pregnancy. Lactation.
Adverse Reactions
Haematoma; epistaxis; GI hemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; bleeding at puncture site. Bullous dermatitis (TEN, SJS, erythema multiforme).
Drug Interactions
Potentiated effect of aspirin on collagen-induced platelet. Increased bleeding risk w/ heparin. Increased occult GI blood loss w/ naproxen. Concomitant use w/ NSAIDs including COX-2 inhibitors; glycoprotein IIb/IIIa inhibitors; strong or moderate CYP2C19 inhibitors eg, omeprazole, esomeprazole. Increased bleeding intensity w/ warfarin. Decreased exposure w/ omeprazole; pantoprazole. Interfered metabolism w/ phenytoin, tamoxifen, tolbutamide, warfarin, torsemide, fluvastatin, NSAIDs.
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
Apolets FC tab 75 mg
Packing/Price
30's
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