CLOPIVAS Film-coated tablet Ref.[50463] Active ingredients: Clopidogrel

Source: Web Search Revision Year: 2016

1. Indications and Usage

Acute Coronary Syndrome

For patients with non-ST-segment elevation acute coronary syndrome (ACS) [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization, clopidogrel has been shown to decrease the rate of a combined endpoint of cardiovascular death, MI, or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
For patients with ST-elevation MI (STEMI), clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention (PCI) is unknown.

The optimal duration of clopidogrel therapy in ACS is unknown.

Recent MI, Recent Stroke or Established Peripheral Arterial Disease

For patients with a history of recent MI, recent stroke, or established peripheral arterial disease (PAD), clopidogrel has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular deaths.

2. Dosage and Administration

Acute Coronary Syndrome

CLOPIVAS can be administered with or without food.

For patients with non-ST-elevation ACS (UA/NSTEMI), initiate with a single oral loading dose of CLOPIVAS 300 and then continue at CLOPIVAS 75 once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with CLOPIVAS.
For patients with STEMI, the recommended dose is CLOPIVAS 75 once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. CLOPIVAS may be initiated with or without a loading dose.

Recent MI, Recent Stroke or Established PAD

The recommended dose is CLOPIVAS 75 once daily orally, with or without food.

CYP2C19 Poor Metabolizers

CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response, an appropriate dose regimen for this patient population has not been established.

Use with Proton-Pump Inhibitors

Avoid using omeprazole or esomeprazole with CLOPIVAS. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel. When concomitant administration of a proton-pump inhibitor (PPI) is required, consider using another acid-reducing agent with minimal or no CYP2C19 inhibitory effect on the formation of clopidogrel active metabolite.

10. Overdosage

Platelet inhibition by clopidogrel is irreversible and will last for the life of the platelet. Overdose following clopidogrel administration may result in bleeding complications. A single oral dose of clopidogrel at 1,500 or 2,000 mg/kg was lethal to mice and to rats and at 3,000 mg/kg to baboons. Symptoms of acute toxicity were vomiting, prostration, difficult breathing, and gastrointestinal hemorrhage in animals.

Based on biological plausibility, platelet transfusion may restore clotting ability.

16.2. Storage and Handling

Store in a cool, dry place. Protect from moisture.

Shelf-Life

CLOPIVAS 75: 1 year.

CLOPIVAS 300: 2 years.

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