【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
Nonvalvular atrial fibrillation: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
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.
Venous thromboembolism prophylaxis in total hip arthroplasty: Prophylaxis of DVT and PE in adult patients who have undergone total hip arthroplasty.
#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; Bleeding diathesis; 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):
1.110 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)
2.Elderly
(1)Patients aged 80 and above:adjust their daily dosage to 220mg.
(2)For patients aged 75 to 80:the daily dosage may vary between 300mg and 220mg depending on the individual's risk of thrombosis or bleeding.
<20240308>
Deep vein thrombosis and/or pulmonary embolism:
1.150 mg twice daily after at least 5 days of initial therapy with a parenteral anticoagulant
2.Elderly
(1)Patients aged 80 and above:adjust their daily dosage to 220mg.
(2)For patients aged 75 to 80:the daily dosage may vary between 300mg and 220mg depending on the individual's risk of thrombosis or bleeding.
<20240308>
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

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.