Pradaxa Dosage/Direction for Use

PRADAXA hard capsules can be taken with or without food. PRADAXA should be taken with a glass of water, to facilitate delivery to the stomach. If gastrointestinal symptoms develop it is recommended to take Pradaxa with a meal and/or a proton pump inhibitor such as pantoprazole.
Do not open the capsule.
Adults: Primary Prevention of Venous Thromboembolism (VTE): Prevention of Venous Thromboembolism (VTE) following knee replacement surgery: Treatment with PRADAXA should be initiated orally within 1-4 hours of completed surgery with a single capsule (110 mg) and continuing with 2 capsules once daily thereafter for a total of 10 days. If haemostasis is not secured, initiation of treatment should be delayed. If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.
Prevention of Venous Thromboembolism (VTE) following hip replacement surgery: Treatment with PRADAXA should be initiated orally within 1-4 hours of completed surgery with a single capsule (110 mg) and continuing with 2 capsules once daily thereafter for a total of 28-35 days. If haemostasis is not secured, initiation of treatment should be delayed. If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.
Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation: The recommended daily dose of PRADAXA is 300 mg taken orally as 150 mg hard capsules twice daily. Therapy should be continued life-long.
Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death: The recommended daily dose of PRADAXA is 300 mg taken orally as 150 mg hard capsules twice daily following treatment with a parenteral anticoagulant for at least 5 days. Therapy should be continued for up to 6 months.
Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and related death: The recommended daily dose of PRADAXA is 300 mg taken orally as 150 mg hard capsules twice daily. Therapy could be continued life-long depending on the individual patient risk.
Paediatric population: Prevention of venous thromboembolic events in patients who have undergone major orthopaedic surgery: PRADAXA has not been investigated in patients <18 years of age. Treatment of children with PRADAXA is not recommended.
Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation: PRADAXA has not been investigated in patients <18 years of age. Treatment of children with PRADAXA is not recommended.
Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death: Treatment of paediatric patients with PRADAXA in the indication of treatment of acute DVT and/or PE and prevention of related death is not registered.
Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and related death: Treatment of paediatric patients with PRADAXA in the indication of prevention of recurrent DVT and/or PE and prevention of related death is not registered.
Renal impairment: Renal function should be assessed by calculating the creatinine clearance (CrCl) prior to initiation of treatment with PRADAXA to exclude patients for treatment with severe renal impairment (i.e. CrCl <30 ml/min). There are no data to support use in patients with severe renal impairment (<30 mL/min creatinine clearance); treatment in this population with PRADAXA is not recommended (see Contraindications).
While on treatment renal function should be assessed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (such as hypovolemia, dehydration, and with certain comedications, etc).
Dabigatran can be dialysed; there is limited clinical experience to demonstrate the utility of this approach in clinical studies.
Prevention of Venous Thromboembolic Events in patients who have undergone major orthopaedic surgery: Dosing should be reduced to 150 mg PRADAXA taken once daily as 2 capsules of 75 mg in patients with moderate renal impairment (30-50 mL/min creatinine clearance).
Prevention of Venous Thromboembolic events following knee or hip replacement surgery: Treatment with PRADAXA should be initiated orally within 1-4 hours of completed surgery with a single capsule of 75 mg and continuing with 2 capsules of 75 mg once daily thereafter for a total of 10 days (following knee replacement surgery) or 28-35 days (following hip replacement surgery).
For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed. If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.
Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation: In patients with moderate renal impairment (CrCl 30-50 ml/min) the renal function should be assessed at least once a year.
No dose adjustment necessary, patients should be treated with a daily dose of 300 mg taken orally as 150 mg hard capsules twice daily.
Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death: No dose adjustment necessary in patients with renal function over CrCl 30 mL/min. Patients should be treated with a daily dose of 300 mg taken orally as 150 mg hard capsules twice daily.
Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and related death: In patients with moderate renal impairment (CrCl 30-50 ml/min) the renal function should be assessed at least once a year.
No dose adjustment necessary in patients with renal function over CrCl 30 mL/min. Patients should be treated with a daily dose of 300 mg taken orally as 150 mg hard capsules twice daily.
Elderly: Prevention of Venous Thromboembolic Events in patients who have undergone major orthopaedic surgery: As renal impairment may be frequent in the elderly (>75 years), renal function should be assessed by calculating the creatinine clearance (CrCl) prior to initiation of treatment with PRADAXA to exclude patients for treatment with severe renal impairment (i.e. CrCl <30 ml/min). The renal function should also be assessed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (such as hypovolemia, dehydration, and with certain comedications, etc).
No dose adjustment necessary, patients should be treated with 220 mg PRADAXA taken once daily as 2 capsules of 110 mg.
Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation: As renal impairment may be frequent in the elderly (>75 years), renal function should be assessed by calculating the creatinine clearance (CrCl) prior to initiation of treatment with PRADAXA to exclude patients for treatment with severe renal impairment (i.e. CrCl <30 ml/min). The renal function should also be assessed at least once a year in patients treated with PRADAXA or more frequently as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (such as hypovolemia, dehydration, and with certain comedications, etc).
Patients aged 80 years or above should be treated with a daily dose of 220 mg taken orally as 110 mg hard capsules twice daily.
Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death: As renal impairment may be frequent in the elderly (>75 years), renal function should be assessed by calculating the creatinine clearance (CrCl) prior to initiation of treatment with PRADAXA to exclude patients for treatment with severe renal impairment (i.e. CrCl <30 mL/min). The renal function should also be assessed in patients treated with PRADAXA as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (such as hypovolemia, dehydration, and with certain comedications, etc).
No dose adjustment necessary, patients should be treated with a daily dose of 300 mg taken orally as 150 mg hard capsules twice daily.
Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and related death: As renal impairment may be frequent in the elderly (>75 years), renal function should be assessed by calculating the creatinine clearance (CrCl) prior to initiation of treatment with PRADAXA to exclude patients for treatment with severe renal impairment (i.e. CrCl <30 mL/min). The renal function should also be assessed at least once a year in patients treated with PRADAXA or more frequently as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (such as hypovolemia, dehydration, and with certain comedications, etc).
No dose adjustment necessary, patients should be treated with a daily dose of 300 mg taken orally as 150 mg hard capsules twice daily.
Pharmacokinetic studies in older subjects demonstrate an increase in drug exposure in those patients with age-related decline of renal function.
See also Renal impairment as previously mentioned.
Weight: No dose adjustment necessary.
Concomitant use of PRADAXA with strong P-glycoprotein inhibitors, i.e. amiodarone, quinidine or verapamil: Prevention of Venous Thromboembolic Events in patients who have undergone major orthopaedic surgery: Dosing should be reduced to PRADAXA 150 mg taken once daily as 2 capsules of 75 mg in patients who concomitantly receive PRADAXA and amiodarone, quinidine or verapamil (see Interactions).
Treatment initiation with verapamil should be avoided in patients who have undergone major orthopaedic surgery who are already treated with PRADAXA. Simultaneous initiation of treatment with PRADAXA and verapamil should also be avoided.
Prevention of Venous Thromboembolic events following knee or hip replacement surgery: Treatment with PRADAXA should be initiated orally within 1-4 hours of completed surgery with a single capsule of 75 mg and continuing with 2 capsules of 75 mg once daily thereafter for a total of 10 days (following knee replacement surgery) or 28-35 days (following hip replacement surgery).
For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed. If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.
Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation: No dose adjustment necessary, patients should be treated with a daily dose of 300 mg taken orally as 150 mg hard capsules twice daily.
Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death: No dose adjustment necessary, patients should be treated with a daily dose of 300 mg taken orally as 150 mg hard capsules twice daily.
Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and related death: No dose adjustment necessary, patients should be treated with a daily dose of 300 mg taken orally as 150 mg hard capsules twice daily.
Patients at risk of bleeding: Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation: The presence of the following factors may increase the risk of bleeding: e.g. age ≥75 years, moderate renal impairment 30-50 mL CrCL/min), concomitant treatment with strong P-gp inhibitors (see Pharmacology: Pharmacokinetics: PK in specific populations under Actions), antiplatelets or previous gastro-intestinal bleed (see Precautions). For patients with one or more than one of these risk factors, a reduced daily dose of 220 mg given as 110 mg twice daily may be considered at the discretion of the physician
Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death: The presence of the following factors may increase the risk of bleeding: e.g. age ≥75 years, moderate renal impairment (30-50 mL/min CrCl) or previous gastro-intestinal bleed (see Precautions).
No dose adjustment is necessary for patients with single risk factors.
Limited clinical data are available for patients with multiple risk factors.
In these patients, PRADAXA should only be given if the expected benefit outweighs bleeding risks.
Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and related death: The presence of the following factors may increase the risk of bleeding: e.g. age ≥75 years, moderate renal impairment (30-50 mL/min CrCl) or previous gastro-intestinal bleed (see Precautions).
No dose adjustment is necessary for patients with single risk factors.
Limited clinical data are available for patients with multiple risk factors.
In these patients, PRADAXA should only be given if the expected benefit outweighs bleeding risks.
Switching from PRADAXA treatment to parenteral anticoagulant: Prevention of Venous Thromboembolic Events in patients who have undergone major orthopaedic surgery: Wait 24 hours after the last dose before switching from PRADAXA to a parenteral anticoagulant.
Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation: Wait 12 hours after the last dose before switching from PRADAXA to a parenteral anticoagulant.
Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) prevention of related death: Wait 12 hours after the last dose before switching from PRADAXA to a parenteral anticoagulant.
Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and related death: Wait 12 hours after the last dose before switching from PRADAXA to a parenteral anticoagulant.
Switching from parenteral anticoagulants treatment to PRADAXA: PRADAXA should be given 0-2 hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment (e.g. intravenous UFH).
Switching from Vit. K antagonists (VKA) to PRADAXA: Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation: The Vit. K antagonist should be stopped. PRADAXA can be given as soon as the INR is <2.0.
Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death: The Vit. K antagonist should be stopped. PRADAXA can be given as soon as the INR is <2.0.
Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and related death: The Vit. K antagonist should be stopped. PRADAXA can be given as soon as the INR is <2.0.
Switching from PRADAXA to Vit. K antagonists (VKA): Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation: The starting time of the VKA should be adjusted according to the patient's CrCL as follows: CrCL ≥50 ml/min, start VKA 3 days before discontinuing dabigatran etexilate; CrCL ≥30-<50 ml/min, start VKA 2 days before discontinuing dabigatran etexilate.
Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death: The starting time of the VKA should be adjusted according to the patient's CrCl as follows: CrCl ≥50 mL/min, start VKA 3 days before discontinuing dabigatran etexilate; CrCl ≥30-<50 mL/min, start VKA 2 days before discontinuing dabigatran etexilate.
Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and related death: The starting time of the VKA should be adjusted according to the patient's CrCl as follows: CrCl ≥50 mL/min, start VKA 3 days before discontinuing dabigatran etexilate; CrCl ≥30-<50 mL/min, start VKA 2 days before discontinuing dabigatran etexilate.
Cardioversion: Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation: Patients can stay on PRADAXA while being cardioverted.
Catheter ablation for atrial fibrillation: Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation: Catheter ablation can be conducted in patients on 150 mg twice daily PRADAXA treatment.
PRADAXA treatment does not need to be interrupted (see Pharmacology under Actions).
Percutaneous coronary intervention (PCI) with stenting: Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation: Patients with non valvular atrial fibrillation who undergo a PCI with stenting can be treated with PRADAXA in combination with antiplatelets after haemostasis is achieved (see Pharmacology under Actions)
Missed dose: Prevention of Venous Thromboembolic Events in patients who have undergone major orthopaedic surgery: Continue with the remaining daily doses of PRADAXA at the same time of the next day.
Do not take a double dose to make up for missed individual doses.
Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation: A forgotten PRADAXA dose may still be taken up to 6 hours prior to the next scheduled dose. From 6 hours prior to the next scheduled dose on, the missed dose should be omitted.
Do not take a double dose to make up for missed individual doses.
Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death: A forgotten PRADAXA dose may still be taken up to 6 hours prior to the next scheduled dose. From 6 hours prior to the next scheduled dose on, the missed dose should be omitted.
Do not take a double dose to make up for missed individual doses.
Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and related death: A forgotten PRADAXA dose may still be taken up to 6 hours prior to the next scheduled dose. From 6 hours prior to the next scheduled dose on, the missed dose should be omitted.
Do not take a double dose to make up for missed individual doses.