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CoPlavix

CoPlavix

clopidogrel + aspirin

Manufacturer:

sanofi-aventis

Distributor:

sanofi-aventis
Concise Prescribing Info
Contents
Clopidogrel bisulfate 75 mg, aspirin 100 mg
Indications/Uses
Prevention of atherothrombotic events in adult patients already taking both clopidogrel + aspirin. Fixed-dose combination for continuation of therapy in: Non-ST-segment elevation acute coronary syndrome (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. Prevention of atherothrombotic & thromboembolic events in patients w/ atrial fibrillation who cannot take vit K antagonist (VKA) therapy.
Dosage/Direction for Use
Adult & elderly Acute coronary syndrome & atrial fibrillation 1 tab as single daily dose. CoPlavix is used following initiation of therapy w/ clopidogrel & ASA given separately at the appropriate dose.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to clopidogrel, aspirin or NSAIDs. Patients w/ syndrome of asthma, rhinitis & nasal polyps. Severe hepatic & renal impairment. Active pathological bleeding eg, peptic ulcer or intracranial hemorrhage. Pregnancy (3rd trimester).
Special Precautions
Monitor blood cell count. Patients at risk of increased bleeding from trauma, surgery or other pathological conditions & those receiving other NSAIDs including COX-2 inhibitors, heparin, glycoprotein IIb/IIIa inhibitors, SSRIs or thrombolytics. Discontinue use 5-7 days prior to surgery. Concomitant use w/ oral anticoagulants & CYP2C19 inhibitors. Patients who have lesions w/ a propensity to bleed (ie, GI & intraocular); recent transient ischemic attack or stroke; TTP; acquired hemophilia; CYP2C19 poor metabolizers w/ ACS or undergoing percutaneous coronary intervention; cross-reactivity among thienopyridines; renal & hepatic impairment; history of asthma or allergic disorders; gout; chronic alcohol consumption; G6PD; history of peptic ulcer, gastroduodenal hemorrhage or minor upper GI symptoms; galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Pregnancy (1st & 2nd trimesters) & lactation. Childn & adolescents <18 yr.
Adverse Reactions
Dyspepsia, GI hemorrhage, abdominal pain, diarrhea; hematoma, epistaxis; bruising, bleeding at the puncture site.
Drug Interactions
Oral & injectable anticoagulants, glycoprotein IIb/IIIa inhibitors, heparin, thrombolytics, NSAIDs including COX-2 inhibitors; SSRIs; ibuprofen. CYP2C19 inhibitors eg, omeprazole. PPIs. Uricosurics, MTX, metamizole, ACE inhibitors, acetazolamide, anticonvulsants eg, phenytoin & valproic acid, β-blockers, diuretics & oral hypoglycemic agents. Thienopyridines eg, ticlopidine & prasugrel.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AC30 - combinations ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
CoPlavix FC tab
Packing/Price
30's (P1,772/box)
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