To reduce risk of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI); patients with ST-elevation MI (STEMI)
Prasugrel is an thienopyridine and a prodrug which inhibits ADP receptors by irreversibly acting on the P2Y12 receptor on platelets. The active metabolite of prasugrel prevents binding of adenosine diphosphate (ADP) to its platelet receptor, impairing the ADP-mediated activation of the glycoprotein GPIIb/IIIa complex. Prasugrel is proposed to have a similar mechanism of action to clopidogrel.
In combination with aspirin for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing percutaneous coronary intervention BY MOUTH Adult 18-74 years (body-weight up to 60 kg): Initially 60 mg for 1 dose, then 5 mg once daily usually for up to 12 months Adult 18-74 years (body-weight 60 kg and above): Initially 60 mg for 1 dose, then 10 mg once daily usually for up to 12 months Adult 75 years and over: Initially 60 mg for 1 dose, then 5 mg once daily usually for up to 12 months Patients undergoing coronary angiography within 48 hours of admission for unstable angina or NSTEMI BY MOUTH Adult: Loading dose 60 mg, not to be administered until the time of percutaneous coronary intervention in order to minimise the risk of bleeding, maintenance dose of 10 mg or 5mg daily should then be selected as appropriate based on age and weight Alternative to clopidogrel in certain patients undergoing percutaneous coronary intervention BY MOUTH Adult: 60 mg, as a single dose.
Warfarin: Coadministration of Prasugrel and warfarin increases the risk of bleeding.
Non-Steroidal Anti-Inflammatory Drugs: Coadministration of Prasugrel and NSAIDs (used chronically) may increase the risk of bleeding.
Other Concomitant Medications: Prasugrel can be administered with drugs that are inducers or inhibitors of cytochrome P450 enzymes. Prasugrel can be administered with aspirin (75mg to 325mg per day), heparin, GPIIb/IIIa inhibitors, statins, digoxin, and drugs that elevate gastric pH, including proton pump inhibitors and H2.
Active bleeding . history of stroke or transient ischaemic attack. Body-weight less than 60 kg . discontinue at least 7 days before elective surgery if antiplatelet effect not desirable . elderly . patients at increased risk of bleeding (e.g. from recent trauma, surgery, gastro-intestinal bleeding, or active peptic ulcer disease).
Common or very common Anaemia . gastro-intestinal haemorrhage . haematoma . haematuria . haemorrhage . intracranial haemorrhage . rash Uncommon Angioedema . hypersensitivity reactions Rare Thrombocytopenia Frequency not known Thrombotic thrombocytopenic purpura
PREGNANCY Manufacturer advises use only if potential benefit outweighs risk. BREAST FEEDING Manufacturer advises avoid?no information available.
Overdose of Prasugrel may lead to prolonged bleeding time and subsequent bleeding complications. No data are available on the reversal of the pharmacological effect of prasugrel; however, if prompt correction of prolonged bleeding time is required, platelet transfusion and/or other blood products may be considered. Pharmaceutical precautions Store in a cool and dry place, protected from light.
Keep in dry place and away from light and heat. Keep out of the reach of children.
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