Composition

Each film-coated tablet of Agrepres 5 mg contains :

• Prasugrel HCl: 5 mg.
• Excipients: S.Q. for one film-coated tablet.

Indications

Acute Coronary Syndrome:

Agrepres is indicated to reduce the rate of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with Percutaneous Coronary Intervention (PCI) as follows:

• Patients with unstable angina or Non-ST-Elevation Myocardial Infarction (NSTEMI).
• Patients with ST-Elevation Myocardial Infarction (STEMI) when managed with primary or delayed Percutaneous Coronary Intervention (PCI).

Prasugrel has been shown to reduce the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke compared to clopidogrel.

It is generally recommended that antiplatelet therapy be administered promptly in the management of Acute Coronary Syndrome (ACS) because many cardiovascular events occur within hours of initial presentation.

Dosage and Administration

Initiate Agrepres treatment as a single 60 mg oral loading dose and then continue at 10 mg orally once daily. Patients taking Agrepres should also take aspirin (75 mg to 325 mg) daily. Agrepres may be administered with or without food.

Dosing in low weight patients:

Patients weighing < 60 kg have an increased exposure to the active metabolite of prasugrel and an increased risk of bleeding on a 10 mg once daily maintenance dose. Consider lowering the maintenance dose to 5 mg in patients < 60 kg