안국약품(주)

1) composition
(Each tablets)
Clopidogrel bisulfate(USP)------------------97.875mg
(the molar equivalent of 75mg of Clopidogrel)

2) Mechanism of Action
Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Biotransformation of clopidogrel is necessary to produce inhibition of platelet aggregation, but an active metabolite responsible for the activity of the drug has not been isolated. Clopidogrel also inhibits platelet aggregation induced by agonists other than ADP by blocking the amplification of platelet activation by released ADP. Clopidogrel does not inhibit phosphodiesterase activity.
Clopidogrel acts by irreversibly modifying the platelet ADP receptor. Consequently, platelets exposed to clopidogrel are affected for the remainder of their lifespan.

3) Indications
Cloffect (clopidogrel bisulfate) is indicated for the reduction of atherothrombotic events as follows:
- 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, Cloffect 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.
- Acute Coronary Syndrome
; For patients with non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI) including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or CABG, Cloffect 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-segment elevation acute myocardial infarction, Cloffect 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. This benefit is not known to pertain to patients who receive primary angioplasty

4) Dosage & Administration
- Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of Cloffect is 75 mg once daily.
- Acute Coronary Syndrome
For patients with non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI), Cloffect should be initiated with a single 300-mg loading dose and then continued at 75 mg once daily. Aspirin (75 mg-325 mg once daily) should be initiated and continued in combination with Cloffect. For patients with ST-segment elevation acute myocardial infarction, the recommended dose of Cloffect is 75 mg once daily, administered in combination with aspirin, with or without thrombolytics. Cloffect may be initiated with or without a loading dose. Cloffect can be administered with or without food. No dosage adjustment is necessary for elderly patients or patients with renal disease.

5) Storage
Store at 25° C ; excursions permitted to 15°–30° C

6) Package
100T