Hematological Agents : Anticoagulants
OPRAD1 “Pradaxa capsule” 110 mg/cap
OPRAD2 “Pradaxa capsule” 150 mg/cap
適應症：預防非瓣膜性心房纖維顫動病患發生中風與全身性栓塞。
Usual dose:
Adult (CrCl > 30 mL/min): 150 mg PO bid, with or without food.
Dosage in Renal Failure:
CrCl 30-50 mL/min or who receive concomitant P-glycoprotein inhibitors dronedarone or systemic ketoconazole ): 75 mg PO bid.
CrCl of 15-30 mL/min: 75 mg PO bid. And concomitant use of P-glycoprotein inhibitors should be avoided.
End-stage Renal Disease or Dialysis (CrCl < 15 mL/min or who are on dialysis): no recommendations.
Adverse effect:
Common: Esophagitis, Gastritis, Gastroesophageal reflux disease, Gastrointestinal hemorrhage, Gastrointestinal ulcer, Indigestion, Bleeding.
Serious: Myocardial infarction, Gastrointestinal hemorrhage, Major, Bleeding, Major or Life Threatening, Anaphylaxis, Intracranial hemorrhage.
健保使用規範：Dabigatran（如Pradaxa）
1.限用於非瓣膜性心房纖維顫動病患，且須符合下列條件之一：(1)曾發生中風或全身性栓塞。(2)左心室射出分率小於40%。(3)有症狀之心臟衰竭：收案前依紐約心臟協會衰竭功能分級為第二級或以上。(4)年齡75歲(含)以上。(5)年齡介於65歲至74歲且合併有糖尿病、高血壓或冠狀動脈疾病。
2.排除標準：(1)病人曾有嚴重心臟瓣膜疾病。(2)14 天內發生中風。(3)收案前的6個月內發生嚴重中風。(4)有增加出血風險的情況。(5)肌酸酐清除率小於 30 mL/min。(6)活動性肝病和懷孕。（104/12/1）