Odrel Plus

Odrel (clopidogrel bisulfate) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl ( )-(S)-α-(2-chlorophenyl)-6,7-dihydrolhieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16CINO2SH2SO4 and its molecular weight is 419.9.

Odrel for oral administration is provided as film coated tablets containing 97.875 mg clopidogrel bisulfate which is molar equivalent of 75 mg of clopidogrel base.

Indications

Acute Coronary Syndrome (ACS)

For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and these who are to be managed with coronary revascularization, Odrel has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (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 myocardial infarction (STEMI), Odrel 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 is unknown. The optimal duration of Odrel therapy in ACS is unknown.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease

For patients with a history of recent myocardial infarction (MI). recent stroke. or established peripheral arterial disease. Odrel 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 death.
Contra-indications

Active Bleeding

Odrel is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

Hypersensitivity

Odrel is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product.

Dosage & Administration

Acute Coronary Syndrome

Odrel can be administered with or without food.

For patients with non-ST-elevation ACS (UA/NSTEMI), initiate Odrel with a single 300 mg oral loading dose and then continue at 75 mg once daily.

Initiate aspirin (75-325mg once daily) and continue in combination with Odrel.

For patients with STEMI, the recommended dose of Odrel is 75 mg once daily orally. administered in combination with aspirin (75-325 mg once daily), with or without thrombolytics.

Odrel may be initiated with or without a loading dose.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of Odrel is 75 mg 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 (600 mg loading dose followed by 150 mg once daily) in poor metabolizers increases antiplatelet response. An appropriate dose regimen for this patient population has not been established in clinical outcome trials.