Rhea Clopidogrel Bisulfate Dosage & Drug Information

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

Concise Prescribing Info

Contents

Clopidogrel bisulfate

Indications/Uses

Prevention of atherothrombotic events in patients w/ recent MI, stroke or established peripheral arterial disease; non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI) or ST-segment elevation acute MI; atrial fibrillation at increased risk of vascular events who can take vit K antagonist therapy.

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Dosage/Direction for Use

Recent MI/stroke or established peripheral arterial disease 75 mg as a single daily dose. Non-ST-segment acute coronary syndrome (unstable angina/non-Q-wave MI) Initiate a single 300-mg loading dose & then continue at 75 mg once daily. Initiate acetylsalicylic acid (ASA) (75-235 mg once daily) & continue in combination. ST-segment elevation acute MI 75 mg once daily in combination w/ ASA, w/ or w/o thrombolytics. May be initiated w/ or w/o loading dose. Atrial fibrillation 75 mg as a single daily dose. Initiate ASA (75-100 mg/day) & continue in combination. Patient who are poor CYP2C19 metabolisers Consider higher dose regimen (600-mg loading dose followed by 150 mg once daily).

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Active pathological bleeding eg, peptic ulcer or intracranial haemorrhage.

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Special Precautions

Bleeding & haemotological disorders. Patients w/ lesions w/ a propensity to bleed (particularly GI & intraocular); recent transient ischemic attack/stroke; thrombotic thrombocytopenic purpura; acquired haemophilia; history of hypersensitivity to another thienopyridine (eg, ticlopidine, prasugrel); recent ischemic stroke; galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Discontinue use 5-7 days prior to patients undergoing elective surgery. Concomitant use w/ warfarin & other anti-platelet agents, ASA, heparin, glycoprotein IIb/IIIa inhibitors, NSAIDs or SSRIs. Renal & hepatic impairment; thrombotic thrombocytopenic purpura. Pregnancy & lactation. Childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

Major bleeding. Dyspepsia, abdominal pain, diarrhoea.

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Drug Interactions

Glycoprotein IIb/IIIa inhibitors; heparin. Increased risk of bleeding w/ warfarin, SSRIs & NSAIDs. Increased occult GI blood loss w/ naproxen.

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Storage

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Description