【藥品性質提示】 ★不建議NG管灌：打開膠囊直接服用顆粒可能大幅增加生體可用率，導致病人出血風險提高。 根據 2019 AGS Beers Criteria，本藥品為【潛在不適當用藥 (PIM)】，75歲以上患者用於治療VTE或Af時須謹慎使用；腎功能不佳之老年人 (CrCl<30mL/min) 須避免使用。 #高警訊藥品

抗凝血口服
1. Nonvalvular atrial fibrillation: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
2. Deep venous thrombosis and pulmonary embolism treatment and prevention: Treatment and prevention of DVT and PE in pediatric patients ≥3 months to <12 years of age.
3. Venous thromboembolism prophylaxis in total hip arthroplasty: Prophylaxis of DVT and PE in adult patients who have undergone total hip arthroplasty.
4. Prevention of recurrent Deep Vein Embolism and/or Pulmonary Embolism in adults <20220921>
#仿單變更2021

Direct Oral Anticoagulant (DOAC)
Inhibits coagulation by preventing thrombin-mediated effects, including cleavage of fibrinogen to fibrin monomers, activation of factors V, VIII, XI, and XIII, and inhibition of thrombin-induced platelet aggregation.

1. Bioavailability: 3-7%; Plasma protein binding: 35%
2. Metabolism: Hepatic
3. Renal clearance: 80%
4. Elimination half-life: 12 to 17 hrs, prolonged in severe renal impairment
5. Dabigatran is dialyzable (~60% removed over 2-3 hrs)

1. Active pathological bleeding; Haemorrhagic manifestations; Patients with spontaneous or pharmacological impairment of haemostasis; Organic lesion at risk of bleeding
2. History of a serious hypersensitivity reaction to PRADAXA
3. Severe renal impairment (CrCl<30 mL/min)

C

Excretion in breast milk unknown/use caution

Common: gastritis-like symptoms, bleeding
Postmarketing: Agranulocytosis, neutropenia <20210205>

Nonvalvular atrial fibrillation (to prevent stroke and systemic embolism):
110 mg or 150 mg twice daily; administer with an appropriate antithrombotic regimen including clopidogrel with or without aspirin (depending on the risks for thrombosis and bleeding, and time since PCI)
Deep vein thrombosis and/or pulmonary embolism:
150 mg twice daily after at least 5 days of initial therapy with a parenteral anticoagulant
Venous thromboembolism prophylaxis in total hip arthroplasty:
1. Initial dose: Initial 110 mg given 1 to 4 hours after completion of surgery or when dabigatran is not initiated on day of surgery, give an initial dose of 220 mg after hemostasis has been achieved
2. Maintenance dose: Continue maintenance 220 mg once daily for a minimum of 10 to 14 days
Older Adult
Nonvalvular atrial fibrillation (to prevent stroke and systemic embolism)
1.For patients aged 80 and over, it is recommended that the daily dose be adjusted to 220 mg (one 110 mg capsule orally twice a day).
2.For patients aged 75 to 80, the daily dose of 300 mg or 220 mg can be selected according to the patient's risk of thromboembolism or bleeding.
Deep vein thrombosis and/or pulmonary embolism
1.For patients aged 80 and over, it is recommended that the daily dose be adjusted to 220 mg (one 110 mg capsule orally twice a day).
2.For patients aged 75 to 80, the daily dose of 300 mg or 220 mg can be selected according to the patient's risk of thromboembolism or bleeding.
<20240514>

Nonvalvular atrial fibrillation (to prevent stroke and systemic embolism):
1. CrCl >30 mL/minute: No dosage adjustment necessary.
2. CrCl 15 to ≤30 mL/minute: 75 mg twice daily
3. CrCl <15 mL/minute, Hemodialysis: Avoid use
Deep vein thrombosis and/or pulmonary embolism:
1. CrCl >30 mL/minute: No dosage adjustment necessary.
2. CrCl ≤30 mL/minute, Hemodialysis: Avoid use
Venous thromboembolism prophylaxis:
1. CrCl >30 mL/minute: No dosage adjustment necessary.
2. CrCl ≤30 mL/minute, Hemodialysis: Avoid use

There are no dosage adjustments provided in the manufacturer's labeling; consistent changes in exposure or pharmacodynamics were not observed in a study of patients with moderate impairment.