CoPlavix Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing Local Product Insert

Concise Prescribing Info

Contents

Clopidogrel hydrogen sulphate 75 mg, ASA 75 mg

Indications/Uses

Prevention of atherothrombotic events. Continuation of therapy in non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI); ST-segment elevation acute MI in patients eligible for thrombolytic therapy; patients suffering from acute coronary syndrome & undergoing a stent placement following percutaneous coronary intervention; prevention of atherothrombotic & thromboembolic events in atrial fibrillation.

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Dosage/Direction for Use

Adult & elderly 1 tab as single daily dose used following an initial dose of clopidogrel 300 mg.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity to NSAIDs. Syndrome of asthma, rhinitis & nasal polyps; preexisting mastocytosis; severe hepatic & renal impairment; active pathological bleeding eg, peptic ulcer or intracranial haemorrhage. Pregnancy (3rd trimester).

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Special Precautions

Patients at risk of increased bleeding; lesions w/ propensity to bleed particularly GI & intraocular. Thrombotic thrombocytopenic purpura; acquired haemophilia, recent transient ischaemic attack or stroke; CYP2C19 poor metabolizers; cross-reactivity w/ thienopyridines; gout; history of asthma, allergic disorders, peptic ulcer, gastroduodenal haemorrhage or minor upper GI symptoms. Mild to moderate renal impairment; moderate hepatic impairment. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Discontinue 5-7 days prior to surgery. Childn & adolescents <18 yr. Pregnancy (1st & 2nd trimester). Lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Bleeding; severe neutropaenia; dyspepsia, abdominal pain, diarrhoea, GI haemorrhage; bruising.

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Drug Interactions

Increased intensity of bleeding w/ oral anticoagulants. Pharmacodynamic interaction w/ glycoprotein IIb/IIIa inhibitors & heparin. Thrombolytics. Increased occult GI blood loss w/ naproxen. Increased risk of bleeding w/ SSRIs. Reduced drug levels of active metabolite w/ CYP2C19 inhibitors. Inhibit effect of uricosurics (eg, benzbromarone, probenecid, sulfinpyrazone). Inhibit renal clearance of MTX. ACE inhibitors, acetazolamide, anticonvulsants (phenytoin & valproic acid), β-blockers, diuretics & oral hypoglycemic agents; Ca antagonists, cholesterol-lowering agents, coronary vasodilators, antidiabetic agents (insulin), antiepileptic agents & GPIIb/IIIa antagonist.

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Storage

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Description

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Action

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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.

Thai FDA Category

Presentation/Packing

Form

CoPlavix FC tab

Packing/Price

30's

CoPlavix

clopidogrel + aspirin

Manufacturer:

Sanofi-Aventis

Distributor:

DKSH