Asurel

Prasugrel

Prasugrel

Presentation:

Asurel-5: Each tablet contains Prasugrel INN 5 mg

Asurel-10: Each tablet contains Prasugrel INN 10 mg

Indications & Usages:

Prasugrel is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:

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

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

Doses and Administration:

Prasugrel should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day. Patients taking Prasugrel should also take aspirin (75 mg to 325 mg) daily. Prasugrel may be administered with or without food.

In patients with acute coronary syndrome (ACS) who are managed with PCI, premature discontinuation of any antiplatelet agent, including Prasugrel, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient's underlying disease. A treatment of up to 12 months is recommended, unless the discontinuation of Prasugrel is clinically indicated.

In case of patients weighing <_ 60 kg or patient's >_ 75 years old, Prasugrel should be given as a single 60 mg loading dose and then continued at a 5 mg once-daily dose. 

Contraindication: 

Prasugrel should be avoided in case of hypersensitivity to the active substance or to any of the excipients, active pathological bleeding, and history of stroke or transient ischaemic attack (TIA), severe hepatic impairment.

Use in pregnancy and lactation:

Pregnancy Category B. There are no adequate and well-controlled studies of Prasugrel use in pregnant women. Prasugrel should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. It is not known whether Prasugrel is excreted in human milk. Because many drugs are excreted in human milk, prasugrel should be used during nursing only if the potential benefit to the mother justifies the potential risk to the nursing infant.

Side Effect:

Bleeding, anemia, hematoma, epistaxis, GI hemorrhage, rash ecchymosis, hematuria, vessel puncture site hematoma, puncture site hemorrhage, contusion.

Precaution & Warning:

General Risk of Bleeding: Thienopyridines, including Prasugrel, increase the risk of bleeding. Prasugrel should not be used in patients with active bleeding, prior TIA or stroke.

Age >_ 75 years: Because of the risk of bleeding (including fatal bleeding) and uncertain effectiveness in patients >_ 75 years of age, use of Prasugrel is generally not recommended in these patients, except in high-risk situations (patients with diabetes or history of myocardial infarction) where its effect appears to be greater and its use may be considered.

Propensity to bleed (e.g., recent trauma, recent surgery, recent or recurrent gastrointestinal (GI) bleeding, active peptic ulcer disease, or severe hepatic impairment): Prasugrel should be used with caution. Coronary Artery Bypass Graft surgery related bleeding: The risk of bleeding is increased in patients receiving Prasugrel who undergo CABG. If possible, Prasugrel should be discontinued at least 7 days prior to CABG. Do not start Prasugrel in patients likely to undergo urgent CABG. Discontinuation of Prasugrel: Discontinue thienopyridines, including Prasugrel, for active bleeding, elective surgery, stroke, or TIA.

Drug Interactions:

Oral anticoagulants eg warfarin & other coumarin derivatives, clopidogrel, NSAIDs & fibrinolytics.

Commercial supply:

Asurel-5: Each box contains 3x10 tablets in Alu Alu blister pack.

Asurel-10: Each box contains 2x10 tablets in Alu Alu blister pack