Posology : מינונים

4.2   Posology and method of administration
Posology


Primary prevention of Venous Thromboembolism in Orthopaedic Surgery ( VTE) 
The recommended doses of dabigatran etexilate and the duration of therapy for primary prevention of venous thromboembolism(VTE) in orthopaedic surgery are shown in table 1.


Pradaxa 75                                                                             Prescribing Information Boehringer Ingelheim                                                                               January 2022 Table 1: Dose recommendations and duration of therapy for primary prevention of venous thromboembolism (VTE) in orthopaedic surgery

Treatment initiation       Maintenance          Duration of on the day of surgery      dose starting        maintenance dose
1-4 hours after            on the first day completed surgery          after surgery
Patients following elective knee                                    220 mg replacement surgery                                                 dabigatran           10 days single capsule of etexilate once
Patients following elective hip          110 mg dabigatran daily taken as replacement surgery                      etexilate                                       28-35 days 2 capsules of
110 mg
Dose reduction recommended
Patients with moderate renal impairment (creatinine clearance                                    150 mg               10 days (knee (CrCL 30-50 mL/min)                                                 dabigatran           replacement single capsule of etexilate once       surgery) or 28-
Patients who receive concomitant         75 mg dabigatran daily taken as       35 days (hip verapamil*, amiodarone, quinidine        etexilate
2 capsules of        replacement
Patients aged 75 or above                                           75 mg                surgery) 
*For patients with moderate renal impairment concomitantly treated with verapamil see Special populations 
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.

Assessment of renal function prior to and during dabigatran etexilate treatment 
In all patients and especially in the elderly (>75 years), as renal impairment may be frequent in this age group:
•      Renal function should be assessed by calculating the creatinine clearance (CrCL) prior to initiation of treatment with dabigatran etexilate to exclude patients with severe renal impairment (i.e.
CrCL <30 mL/min) (see sections 4.3, 4.4 and 5.2).
•      Renal function should also be assessed when a decline in renal function is suspected during treatment (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products ).

The method to be used to estimate renal function (CrCL in mL/min) is the Cockcroft-Gault method.

Missed dose
It is recommended to continue with the remaining daily doses of dabigatran etexilate at the same time of the next day.

No double dose should be taken to make up for missed individual doses.

Discontinuation of dabigatran etexilate
Dabigatran etexilate treatment should not be discontinued without medical advice. Patients should be instructed to contact the treating physician if they develop gastrointestinal symptoms such as dyspepsia (see section 4.8).
Pradaxa 75                                                                           Prescribing Information Boehringer Ingelheim                                                                            January 2022 
Switching
Dabigatran etexilate treatment to parenteral anticoagulant:It is recommended to wait 24 hours after the last dose before switching from dabigatran etexilate to a parenteral anticoagulant (see section 4.5).

Parenteral anticoagulants to dabigatran etexilate:
The parenteral anticoagulant should be discontinued and dabigatran etexilate should be started 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 Unfractionated Heparin (UFH)) (see section 4.5).

Special populations

Renal impairment
Treatment with dabigatran etexilate in patients with severe renal impairment (CrCL <30 mL/min) is contraindicated (see section 4.3).

In patients with moderate renal impairment (CrCL 30-50 mL/min), a dose reduction is recommended (see table 1 above and sections 4.4 and 5.1).

Concomitant use of dabigatran etexilate with mild to moderate P-glycoprotein (P-gp) inhibitors, i.e.
amiodarone, quinidine or verapamil

Dosing should be reduced as indicated in table 1 (see also sections 4.4 and 4.5). In this situation dabigatran etexilate and these medicinal products should be taken at the same time.

In patients with moderate renal impairment and concomitantly treated with verapamil, a dose reduction of dabigatran etexilate to 75 mg daily should be considered (see sections 4.4 and 4.5).

Elderly

For elderly patients >75 years, a dose reduction is recommended. In elderly patients (> 75 years) there is limited clinical experience. These patients should be treated with caution. The recommended dose is 150 mg taken once daily as 2 capsules of 75 mg (see table 1 above and sections 4.4 and 5.1).

Weight

There is very limited clinical experience in patients with a body weight <50 kg or >110 kg at the recommended posology. Given the available clinical and kinetic data no adjustment is necessary (see section 5.2), but close clinical surveillance is recommended (see section 4.4).

Gender

No dose adjustment is necessary (see section 5.2).
Paediatric population

There is no relevant use of dabigatran etexilate in the paediatric population for the indication of primary prevention of venous thromboembolic events(VTE) in patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Pradaxa 75                                                                          Prescribing Information Boehringer Ingelheim                                                                           January 2022 

Method of administration

This medicinal product is for oral use.
The capsules can be taken with or without food. The capsules should be swallowed as a whole with a glass of water, to facilitate delivery to the stomach.
Patients should be instructed not to open the capsule as this may increase the risk of bleeding (see sections 5.2 and 6.6).