Prevention of VTE in patients who have undergone orthopaedic surgery for knee or hip replacement; stroke, systemic embolism & reduction of vascular mortality in patients w/ atrial fibrillation. Treatment of acute DVT &/or pulmonary embolism (PE). Prevention of recurrent DVT &/or PE & related death.
AdultVTE prevention following knee replacement surgery Initially one 110-mg cap w/in 1-4 hr of completed surgery; continue w/ 2 cap once daily thereafter for 10 days. VTE prevention following hip replacement surgery Initially one 110-mg cap w/in 1-4 hr of completed surgery; continue w/ 2 cap once daily thereafter for 28-35 days. Prevention of stroke, systemic embolism & reduction of vascular mortality Recommended dose: 150 mg bid. Therapy should be continued life-long. Treatment of acute DVT &/or PE & related death Recommended dose: 150 mg bid following treatment w/ parenteral anticoagulant for at least 5 days. Therapy should be continued up to 6 mth. Prevention of recurrent DVT &/or PE & related death Recommended dose: 150 mg bid.Therapy should be continued life-long. Catheter ablation for atrial fibrillation 150-mg cap bid does not need to be interrupted.
View Pradaxa overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Known hypersensitivity. Severe renal impairment (CrCl <30 mL/min). Haemorrhagic manifestations, bleeding diathesis, spontaneous or pharmacological impairment of haemostasis; organ lesions at risk of clinically significant bleeding including haemorrhagic stroke w/in the last 6 mth. Concomitant use w/ systemic ketoconazole. Prosthetic heart valve replacement.
Hepatic impairment, renal insufficiency, increased hemorrhagic risk eg, recent biopsy or major trauma, bacterial endocarditis. Discontinue at least 24 hr before invasive or surgical procedure. Spinal/epidural anesth, lumbar puncture. Acute renal failure (discontinue). Patients w/ atrial fibrillation may stay on Pradaxa while being cardioverted. Pregnancy & lactation. Childn <18 yr.
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