75-mg & 110-mg cap: Primary prevention of venous thromboembolic (pVTEp) events in adult patients who have undergone elective total hip or knee replacement surgery. 110-mg & 150-mg cap: Reduce risk of stroke & systemic embolism in patients w/ non-valvular atrial fibrillation (SPAF). Treatment & prevention of recurrent DVT & pulmonary embolism (PE) in adults.
Adult pVTEp events Initially two 110-mg cap w/in 1-4 hr of completed surgery w/ single cap & continue w/ 2 cap once daily thereafter for 10 days after knee replacement surgery & 28-35 days after hip replacement surgery. Delay initiation of treatment for both surgeries if haemostatis is not secured. Initiate treatment w/ 2 cap once daily if treatment is not started on surgery day. Reduce risk of stroke & SPAF 150 mg bd. Patient ≥80 yr, patient receiving concomitant verapamil 110 mg bd. DVT & PE 150 mg bd followed by parenteral anticoagulant for at least 5 days. Patient 75-80 yr, moderate renal impairment, w/ gastritis, esophagitis or gastroesophageal reflux, patient at increased risk of bleeding 300 mg or 220 mg daily based on individual assessment. pVTEp events Moderate renal impairment (CrCl 30-50 mL/min) Initially two 75-mg cap once daily w/in 1-4 hr of completed surgery w/ single cap & continue w/ two 75-mg cap once daily thereafter for 10 days after knee replacement surgery & 28-35 days after hip replacement surgery. Delay initiation of treatment for both surgeries if haemostatis is not secured. Initiate treatment w/ 2 cap once daily if treatment is not started on surgery day.
View Pradaxa overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Swallow whole w/ water, do not open cap.
Contraindications
Hypersensitivity. Clinically significant active bleeding; lesion or condition at significant risk of major bleeding; prosthetic heart valves requiring anticoagulant treatment. Concomitant use w/ other anticoagulants; strong P-gp inhibitors eg, systemic ketoconazole, cyclosporine, itraconazole, dronedarone. Severe renal impairment (CrCl <30 mL/min). Hepatic impairment or disease.
Discontinue use in patients who develop acute renal failure. Not recommended in patients w/ elevated liver enzymes >2 times ULN. Increased haemorrhagic risk. Spinal & epidural anaesth; lumbar puncture; post-procedural period. Temporarily discontinue use at least 24 hr prior to surgery or invasive procedures. Patients w/ antiphospholipid syndrome. Assess renal function prior to initiation of treatment. Closely monitor patients w/ body wt <50 kg. Not recommended w/ concomitant use of dronedarone. Concomitant use of strong P-gp inducers & drugs increasing risk of bleeding. Moderate renal impairment. Not to be used in severe renal impairment. Women of childbearing potential. Not to be used during pregnancy & lactation. Not recommended in childn <18 yr. Elderly >75 yr.
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