Prasugrel
Generic Name: prasugrel
Brand Names:
Prasugrel
11 DESCRIPTION Prasugrel tablet USP contains prasugrel, a thienopyridine class inhibitor of platelet activation and aggregation mediated by the P2Y 12 ADP receptor. Prasugrel tablet 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.
Overview
11 DESCRIPTION Prasugrel tablet USP contains prasugrel, a thienopyridine class inhibitor of platelet activation and aggregation mediated by the P2Y 12 ADP receptor. Prasugrel tablet 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.
Uses
1 INDICATIONS AND USAGE Prasugrel tablets is a P2Y 12 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 percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) ( 1.1 ). Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI ( 1.1 ).
Dosage
2 DOSAGE AND ADMINISTRATION Initiate prasugrel tablets treatment as a single 60 mg oral loading dose and then continue at 10 mg orally once daily. Patients taking prasugrel tablets should also take aspirin (75 mg to 325 mg) daily [see Drug Interactions ( 7.4 ) and Clinical Pharmacology ( 12.3 )] . Prasugrel tablets may be administered with or without food [see Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14 )] . Timing of Loading Dose In the clinical trial that established the efficacy and safety of prasugrel tablets, the loading dose of prasugrel tablets was not administered until coronary anatomy was established in UA/NSTEMI patients and in STEMI patients presenting more than 12 hours after symptom onset.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are also discussed elsewhere in the labeling: Bleeding [see Boxed Warning and Warnings and Precautions ( 5.1 , 5.2 )] Thrombotic thrombocytopenic purpura [see Warnings and Precautions ( 5.4 )] Hypersensitivity including Angioedema [see Warnings and Precautions ( 5.5 )] Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp.
Interactions
7 DRUG INTERACTIONS Opioids: Decreased exposure to prasugrel. Consider use of parenteral anti-platelet agent ( 7.3 ). 7.1 Warfarin Coadministration of prasugrel tablets and warfarin increases the risk of bleeding [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )]. 7.2 Nonsteroidal Anti-Inflammatory Drugs Coadministration of prasugrel tablets and NSAIDs (used chronically) may increase the risk of bleeding [see Warnings and Precautions ( 5.1 )]. 7.3 Opioids As with other oral P2Y 12 inhibitors, coadministration of opioid agonists delay and reduce the absorption of prasugrel's active metabolite presumably because of slowed gastric emptying [see Clinical Pharmacology ( 12.3 )] .
Warnings
WARNING: BLEEDING RISK Prasugrel tablets can cause significant, sometimes fatal, bleeding [see Warnings and Precautions ( 5.1 , 5.2 ) and Adverse Reactions ( 6.1 )]. Do not use prasugrel tablets in patients with active pathological bleeding or a history of transient ischemic attack or stroke [see Contraindications ( 4.1 , 4.2 )]. 5 WARNINGS AND PRECAUTIONS CABG-related bleeding: Risk increases in patients receiving prasugrel tablets who undergo CABG ( 5.2 ). CABG-related bleeding: Risk increases in patients receiving prasugrel tablets who undergo CABG ( 5.2 ). Discontinuation of prasugrel tablets: Premature discontinuation increases risk of stent thrombosis, MI, and death ( 5.3 ). Thrombotic thrombocytopenic purpura (TTP): TTP has been reported with prasugrel tablets ( 5.4 ). Hypersensitivity: Hypersensitivity including angioedema has been reported with prasugrel tablets including in patients with a history of hypersensitivity reaction to other thienopyridines ( 5.5 ). 5.1 General Risk of Bleeding Thienopyridines, including prasugrel tablets, increase the risk of bleeding. 4 CONTRAINDICATIONS Active pathological bleeding ( 4.1 ) Active pathological bleeding ( 4.1 ) Prior transient ischemic attack or stroke ( 4.2 ) Hypersensitivity to prasugrel or any component of the product ( 4.3 ) 4.1 Active Bleeding Prasugrel tablet is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions ( 5.1...
Pregnancy
8.1 Pregnancy Risk summary There are no data with prasugrel tablets use in pregnant women to inform a drug-associated risk. No structural malformations were observed in animal reproductive and developmental toxicology studies when rats and rabbits were administered prasugrel during organogenesis at doses of up to 30 times the recommended therapeutic exposures in humans [see Data ].
Storage
16.2 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Keep and dispense only in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet.
Frequently Asked Questions
What is Prasugrel used for?▼
1 INDICATIONS AND USAGE Prasugrel tablets is a P2Y 12 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 percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) ( 1.1 ). Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI ( 1.1 ).
What are the side effects of Prasugrel?▼
6 ADVERSE REACTIONS The following serious adverse reactions are also discussed elsewhere in the labeling: Bleeding [see Boxed Warning and Warnings and Precautions ( 5.1 , 5.2 )] Thrombotic thrombocytopenic purpura [see Warnings and Precautions ( 5.4 )] Hypersensitivity including Angioedema [see Warnings and Precautions ( 5.5 )] Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp.
Can I take Prasugrel during pregnancy?▼
8.1 Pregnancy Risk summary There are no data with prasugrel tablets use in pregnant women to inform a drug-associated risk. No structural malformations were observed in animal reproductive and developmental toxicology studies when rats and rabbits were administered prasugrel during organogenesis at doses of up to 30 times the recommended therapeutic exposures in humans [see Data ].
What are the important warnings for Prasugrel?▼
WARNING: BLEEDING RISK Prasugrel tablets can cause significant, sometimes fatal, bleeding [see Warnings and Precautions ( 5.1 , 5.2 ) and Adverse Reactions ( 6.1 )]. Do not use prasugrel tablets in patients with active pathological bleeding or a history of transient ischemic attack or stroke [see Contraindications ( 4.1 , 4.2 )]. 5 WARNINGS AND PRECAUTIONS CABG-related bleeding: Risk increases in patients receiving prasugrel tablets who undergo CABG ( 5.2 ). CABG-related bleeding: Risk increases in patients receiving prasugrel tablets who undergo CABG ( 5.2 ). Discontinuation of prasugrel tablets: Premature discontinuation increases risk of stent thrombosis, MI, and death ( 5.3 ). Thrombotic thrombocytopenic purpura (TTP): TTP has been reported with prasugrel tablets ( 5.4 ). Hypersensitivity: Hypersensitivity including angioedema has been reported with prasugrel tablets including in patients with a history of hypersensitivity reaction to other thienopyridines ( 5.5 ). 5.1 General Risk of Bleeding Thienopyridines, including prasugrel tablets, increase the risk of bleeding. 4 CONTRAINDICATIONS Active pathological bleeding ( 4.1 ) Active pathological bleeding ( 4.1 ) Prior transient ischemic attack or stroke ( 4.2 ) Hypersensitivity to prasugrel or any component of the product ( 4.3 ) 4.1 Active Bleeding Prasugrel tablet is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions ( 5.1...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.