Thromboembolic disorders:

Indications for: PRADAXA

To reduce risk of stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults treated with parenteral anticoagulant for 5–10 days. To reduce risk of recurrent DVT/PE in adults who have been previously treated. Prophylaxis of DVT/PE after hip replacement surgery. Treatment of venous thromboembolic events (VTE) in patients aged 8–<18yrs who have been treated with a parenteral anticoagulant for at least 5 days. To reduce the risk of recurrent VTE in patients aged 8–<18yrs who have been previously treated.

Adult Dosage:

Swallow whole. Non-valvular AF: CrCl>30mL/min: 150mg twice daily. Severe renal impairment (CrCl 15–30mL/min): 75mg twice daily; CrCl<15mL/min or on dialysis: not recommended. Moderate renal impairment (CrCl 30–50mL/min) with concomitant dronedarone or systemic ketoconazole: 75mg twice daily. CrCl <30mL/min with concomitant P-gp inhibitors: avoid. DVT/PE treatment, recurrence: CrCl>30mL/min: 150mg twice daily (if treatment, give after 5–10 days of parenteral anticoagulation). CrCl ≤30mL/min or on dialysis: not recommended. CrCl <50mL/min with concomitant P-gp inhibitors: avoid. Prophylaxis after hip surgery: CrCl>30mL/min: 110mg for first day (given 1–4hrs post surgery and after hemostasis achieved), then 220mg daily for 28–35 days. CrCl ≤30mL/min or on dialysis: not recommended. CrCl <50mL/min with concomitant P-gp inhibitors: avoid. Converting from/to warfarin or parenteral anticoagulants, discontinuation for surgery and other interventions: see full labeling.

Children Dosage:

<8yrs: not established. Swallow whole. VTE treatment or reduction in risk of recurrent VTE: 8–<18yrs (11–<16kg): 75mg twice daily; (16–<26kg): 110mg twice daily; (26–<41kg): 150mg twice daily; (41–<61kg): 185mg twice daily; (61–<81kg): 220mg twice daily; (≥81kg): 260mg twice daily. Renal impairment (eGFR <50mL/min/1.73m2): avoid. Concomitant use with P-gp inhibitors: not studied. Converting from/to warfarin or parenteral anticoagulants, discontinuation for surgery and other interventions: see full labeling.

PRADAXA Contraindications:

Active pathological bleeding. Mechanical prosthetic heart valve.

Boxed Warning:

Premature discontinuation of Pradaxa increases the risk of thrombotic events. Spinal/epidural hematoma.

PRADAXA Warnings/Precautions:

Capsules and oral pellets are not substitutable on a mg-to-mg basis; do not combine dosage forms. Premature discontinuation increases risk of thrombotic events; if discontinued for reason other than bleeding or therapy completion, consider coverage with another anticoagulant and restart dabigatran as soon as appropriate. Increased risk of spinal/epidural hematoma in anticoagulated patients receiving neuraxial anesthesia or undergoing spinal puncture; monitor for signs/symptoms of neurological impairment. Increased risk of serious bleeding. Promptly evaluate signs/symptoms of blood loss (eg, a drop in hemoglobin and/or hematocrit or hypotension). Use specific reversal agent (idarucizumab) to reverse anticoagulant effect of dabigatran as needed (eg, emergency surgery/urgent procedures, life-threatening/uncontrolled bleeding); efficacy and safety of idarucizumab in pediatric patients have not been established. Suspend treatment before invasive therapy or surgery, including dental procedures (see full labeling); restart promptly. Bioprosthetic heart valve or triple-positive antiphospholipid syndrome: not recommended. Monitor renal function prior to initiation, then periodically as clinically indicated; discontinue if acute renal failure develops and consider alternate therapy. Avoid lapses in therapy. Renal impairment (see Adult dosage & Children dosage). Bleeding risk can be assessed by ecarin clotting time (ECT), or if not available, aPTT. Elderly (>75yrs). Labor & delivery. Neonates. Pregnancy. Females of reproductive potential. Abnormal uterine bleeding. Nursing mothers: not recommended.

PRADAXA Classification:

Direct thrombin inhibitor.

PRADAXA Interactions:

Antagonized by P-gp inducers (eg, rifampin); avoid. Increased dabigatran levels in renal impairment with concomitant P-gp inhibitors (eg, [dronedarone, systemic ketoconazole; reduce dabigatran dose], verapamil, amiodarone, quinidine, clarithromycin, ticagrelor). May be potentiated by P-gp inhibitors in pediatric patients: not studied. Concomitant NSAIDs, platelet inhibitors, heparin, fibrinolytic therapy: increased risk of bleeding. Switching to or from warfarin: monitor closely.

Adverse Reactions:

Gastritis-like symptoms (eg, GERD, esophagitis, erosive gastritis, gastric hemorrhage, ulcer), bleeding (may be fatal); also for oral pellets: dyspepsia, upper abdominal pain, vomiting, nausea, diarrhea.



Drug Elimination:

Renal. Half-life: 12–17 hours.

Generic Drug Availability:


How Supplied:

Caps, pellets (packets)—60