Effient

Effient

prasugrel

Manufacturer:

Daiichi Sankyo

Distributor:

Zuellig Pharma

Marketer:

Daiichi Sankyo
Concise Prescribing Info
Contents
Prasugrel HCl
Indications/Uses
Prevention of atherothrombotic events in adults w/ acute coronary syndrome (ie, unstable angina, non-ST segment elevation MI [UA/NSTEMI] or ST segment elevation MI [STEMI] undergoing primary or delayed percutaneous coronary intervention [PCI]) in combination w/ acetylsalicylic acid.
Dosage/Direction for Use
Adult Initially single 60 mg loading dose, then continued at 10 mg once daily + acetylsalicylic acid 75 mg-325 mg. Patients <60 kg 60 mg as single loading dose, then continued at 5 mg once daily.
Administration
May be taken with or without food: Do not crush/break.
Contraindications
Hypersensitivity. Active pathological bleeding. History of stroke or transient ischemic attack. Severe hepatic impairment (Child-Pugh class C).
Special Precautions
Hypersensitivity including angioedema. Monitor patients w/ known allergy to thienopyridines. Increased risk of bleeding in patients ≥75 yr, w/ a propensity to bleed (eg, due to recent trauma, surgery or recurrent GI bleeding, or active PUD), w/ body wt <60 kg (10 mg maintenance dose is not recommended), concomitant use w/ medicines that may increase risk of bleeding including oral anticoagulants, clopidogrel, NSAIDs & fibrinolytics. Platelet transfusion for patients w/ active bleeding. Renal & moderate hepatic impairment (including end-stage renal disease). May prolong bleeding time. Discontinue treatment at least 7 days prior to surgery. Patients in whom the coronary anatomy has not been defined & urgent CABG is a possibility. Thrombotic thrombocytopenic purpura. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ morphine. Pregnancy & lactation. Childn <18 yr. Not recommended for patients ≥75 yr except in high-risk situations (patients w/ DM or history of MI).
Adverse Reactions
Anaemia; hematoma; epistaxis; GI hemorrhage; rash, ecchymosis; haematuria; vessel & hematoma puncture site hemorrhage; contusion.
Drug Interactions
Potential for increased risk of bleeding w/ warfarin, chronic NSAIDs including COX-2 inhibitors; acetylsalicylic acid; heparin. Decreased Cmax w/ drugs that elevate gastric pH. Reduced efficacy w/ morphine. Decreased exposure of hydroxypbupropion.
ATC Classification
B01AC22 - prasugrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Effient FC tab 5 mg
Packing/Price
2 × 14's
Form
Effient FC tab 10 mg
Packing/Price
2 × 14's
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