適用於需要冠狀動脈介入性治療(PCI)的急性冠狀動脈症候群(ACS；不穩定型心絞痛[UA]、非ST段上升之心肌梗塞[NSTEMI]或ST段上升之心肌梗塞[STEMI])。
Indicated for patients with acute coronary syndrome (ACS; unstable angina [UA], non-ST elevation myocardial infarction [NSTEMI], or ST elevation myocardial infarction [STEMI]) who are to be managed with percutaneous coronary intervention (PCI).
Prasugrel 是一種前驅藥物，經代謝後形成活性代謝物，選擇性且不可逆地結合至血小板的P2Y12 ADP受體，抑制血小板凝集。
Prasugrel is a prodrug that is metabolized to an active metabolite, which selectively and irreversibly binds to the P2Y12 ADP receptor on platelets, inhibiting platelet aggregation.
Prasugrel在體內迅速吸收並代謝為活性代謝物R-138727，主要透過CYP3A和CYP2B6異構構代謝。活性代謝物的血漿濃度於用藥後1小時達到峰值。
Prasugrel is rapidly absorbed and metabolized in the body to its active metabolite R-138727, primarily via CYP3A and CYP2B6 isozymes. The plasma concentration of the active metabolite peaks approximately 1 hour after administration.
- 有活動性病理性出血的患者（例如消化道出血、顱內出血）。
- 有短暫性腦缺血發作（TIA）或中風病史的患者。
- 對 prasugrel 或其任何成分過敏的患者。
- Patients with active pathological bleeding (e.g., peptic ulcer, intracranial hemorrhage).
- Patients with a history of transient ischemic attack (TIA) or stroke.
- Patients with hypersensitivity to prasugrel or any component of the product.
只有在預期的治療效益高於可能的風險時，prasugrel 才可用於懷孕和可能懷孕的婦女。
Use of prasugrel during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.
哺乳母親在服用 prasugrel 時應避免授乳。
Breastfeeding mothers should avoid nursing while taking prasugrel.
- 出血 (發生率1.2%)：可能造成顱內出血、消化道出血、心包膜出血等。
- 血栓性血小板低下紫斑症(TTP)：早期症狀包括無力、厭食、出血、神經精神症狀等。
- 過敏反應：包括血管性水腫。
- Bleeding (incidence 1.2%): Can cause intracranial hemorrhage, gastrointestinal bleeding, pericardial bleeding, etc.
- Thrombotic thrombocytopenic purpura (TTP): Early signs include weakness, anorexia, bleeding, neuropsychiatric symptoms, etc.
- Allergic reactions: Including angioedema.
起始劑量為單次使用20 mg口服劑量，隨後的維持劑量為每日一次3.75 mg口服劑量。應合併aspirin使用 (81-100 mg/天，起始劑量最多為324 mg)。
The initial dose is a single oral dose of 20 mg, followed by a maintenance dose of 3.75 mg once daily. It should be used in combination with aspirin (81-100 mg/day, initial dose up to 324 mg).
尚未建立出生體重過低的嬰兒、新生兒、哺乳嬰兒、嬰兒或兒童的安全性。
Safety has not been established in low birth weight infants, neonates, breastfeeding infants, infants, or children.
中度腎功能不全患者（肌酸酐廓清率= 30 mL/min至50 mL/min）和健康成人其藥物動力學參數未有明顯不同。需透析治療的末期腎功能不全患者，活性代謝物的AUC和Cmax減少。
Pharmacokinetic parameters in patients with moderate renal impairment (creatinine clearance = 30 mL/min to 50 mL/min) are not significantly different from those in healthy adults. In end-stage renal disease patients requiring dialysis, the AUC and Cmax of the active metabolite are reduced.
中度肝功能不全患者（Child-Pugh分類B級）和健康成人其藥物動力學參數未有明顯不同。
Pharmacokinetic parameters in patients with moderate hepatic impairment (Child-Pugh Class B) are not significantly different from those in healthy adults.