Pradaxa Dosage/Direction for Use

Adults: Primary Prevention of Venous Thromboembolism (VTE): Prevention of VTE Following Knee Replacement Surgery: Treatment with Pradaxa should be initiated orally within 1-4 hrs 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 VTE Following Hip Replacement Surgery: Treatment with Pradaxa should be initiated orally within 1-4 hrs of completed surgery with 1 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 capsule 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 DVT and/or 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.
Renal Impairment: Renal function should be assessed by calculating the CrCl prior to initiation of treatment with Pradaxa to exclude patients for treatment with severe renal impairment (ie, CrCl <30 mL/min). There are no data to support the use in patients with severe renal impairment (CrCl <30 mL/min); 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 (eg, hypovolemia, dehydration and with certain co-medications).
Dabigratan can be dialysed; there is limited clinical experience to demonstrate the utility of this approach in clinical studies.
Prevention of VTE 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 with moderate renal impairment (CrCl 30-50 mL/min).
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 is necessary. Patients should be treated with a daily dose of 300 mg taken orally as 150 mg hard capsule twice daily.
Treatment of Acute DVT and/or 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 DVT and/or 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 VTE in Patients Who Have Undergone Major Orthopaedic Surgery and Treatment of Acute DVT and/or 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 CrCl prior to initiation of treatment with Pradaxa to exclude patients for treatment with severe renal impairment (ie, 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 (eg, hypovolemia, dehydration and with certain co-medications).
No dose adjustment necessary. Patients should be treated with Pradaxa 220 mg taken once daily as 2 capsules of 110 mg or with a daily dose of 300 mg taken orally as 150 mg hard capsules twice daily.
Prevention of Stroke, Systemic Embolism and Reduction of Vascular Mortality in Patients with Atrial Fibrillation and Recurrent DVT and/or PE and Related Death: As renal impairment may be frequent in the elderly (>75 years), renal function should be assessed by calculating CrCl prior to initiation of treatment with Pradaxa to exclude patients for treatment with severe renal impairment (ie, 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 (eg, hypovolemia, dehydration and with certain co-medications). Patients aged ≥80 years should be treated with a daily dose of 220 mg taken orally as 110 mg hard capsules or 300 mg taken orally as 150 mg hard capsules twice daily. No dose adjustment is necessary. Pharmacokinetic studies in older subjects demonstrate an increase in drug exposure in those patients with age-related decline of renal function. (See Renal Impairment in previous text.)
Weight: No dose adjustment necessary.
Concomitant use of Pradaxa with Strong P-glycoprotein Inhibitors ie, 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 Stroke, Systemic Embolism and Reduction of Vascular Mortality in Patients with Atrial Fibrillation and Treatment of Acute DVT and/or 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 DVT and/or 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 [eg, patients ≥75 years, moderate renal impairment (CrCl 30-50 mL/min), concomitant treatment with strong P-gp inhibitors (see Special Populations under Pharmacokinetics under Actions), antiplatelets or previous gastrointestinal bleed (see Precautions).
For patients with ≥1 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 and Prevention of Acute or Recurrent DVT and/or PE and Prevention of Related Death: The presence of the following factors may increase the risk of bleeding: Eg, age ≥75 years, moderate renal impairment (CrCl 30-50 mL/min) or previous gastrointestinal 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 VTE Events in Patients Who Have Undergone Major Orthopaedic Surgery: Wait 24 hrs 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 hrs after the last dose before switching from Pradaxa to a parenteral anticoagulant.
Treatment and Prevention of Acute or Recurrent DVT and/or PE and Prevention of Related Death: Wait 12 hrs 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 hrs 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 [eg, IV unfractionated heparin (UFH)].
Switching from VKA to Pradaxa: Prevention of Stroke, Systemic Embolism and Reduction of Vascular Mortality in Patients with Atrial Fibrillation: The VKA should be stopped. Pradaxa can be given as soon as the international normalized ratio (INR) is <2.
Treatment and Prevention of Acute or Recurrent DVT and/or PE and Prevention of Related Death: The VKA should be stopped. Pradaxa can be given as soon as the international normalized ratio (INR) is <2.
Switching from Pradaxa to 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 to <50 mL/min, start VKA 2 days before discontinuing dabigatran etexilate.
Treatment and Prevention of Acute or Recurrent DVT and/or 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 to <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.
Missed Dose: Prevention of VTE 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 the 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 hrs prior to the next scheduled dose. From 6 hrs prior to the next scheduled dose, the missed dose should be omitted.
Do not take a double dose to make up for the missed individual doses.
Treatment and Prevention of Acute or Recurrent DVT and/or PE and Prevention of Related Death: A forgotten Pradaxa dose may still be taken up to 6 hrs prior to the next scheduled dose. From 6 hrs prior to the next scheduled dose, the missed dose should be omitted.
Do not take a double dose to make up for the missed individual doses.
Administration: 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. Do not open the capsule.