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Prasugrel Hcl

Prasugrel Hcl

What is Prasugrel?

Effient contains prasugrel, a thienopyridine class inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP receptor. Effient is formulated as the hydrochloride salt, a racemate, which is chemically designated as 5-[(1RS)-2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride. Prasugrel HCl has the empirical formula C20H20FNO3S•HCl representing a molecular weight of 409.90.

Prasugrel hydrochloride is a white to practically white solid. It is soluble at pH 2, slightly soluble at pH 3 to 4, and practically insoluble at pH 6 to 7.5. It also dissolves freely in methanol and is slightly soluble in 1- and 2-propanol and acetone. It is practically insoluble in diethyl ether and ethyl acetate.

Effient is a P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with PCI as follows:

Patients with unstable angina or, non-ST-elevation myocardial infarction (NSTEMI).

Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI.

Prasugrel Drug Interactions

Coadministration of Effient and warfarin increases the risk of bleeding.

Non-Steroidal Anti-Inflammatory Drugs

Coadministration of Effient and NSAIDs (used chronically) may increase the risk of bleeding.

Other Concomitant Medications

Effient can be administered with drugs that are inducers or inhibitors of cytochrome P450 enzymes.

Effient can be administered with aspirin (75 mg to 325 mg per day), heparin, GPIIb/IIIa inhibitors, statins, digoxin, and drugs that elevate gastric pH, including proton pump inhibitors and H2 blockers.

Precautions before using Prasugrel

  • CABG-related bleeding: Risk increases in patients receiving Effient who undergo CABG.
  • Discontinuation of Effient: Premature discontinuation increases risk of stent thrombosis, MI, and death.
  • Thrombotic thrombocytopenic purpura (TTP): TTP has been reported with Effient.
  • Hypersensitivity: Hypersensitivity including angioedema has been reported with Effient including in patients with a history of hypersensitivity reaction to other thienopyridines.

Dosage Forms and Strengths

Prasugrel Tablets, 5 mg, are available as tan colored, oval shaped, film-coated, non-scored tablets, debossed with “AN001” on one side and plain on the other side.

Prasugrel Tablets, 10 mg, are available as tan colored, oval shaped, film-coated, non-scored tablets, debossed with “AN002” on one side and plain on the other side.