PRADAXA safely and effectively. See full prescribing information for. PRADAXA. PRADAXA® (dabigatran etexilate mesylate) capsules, for oral use. Initial U.S. produce dabigatran exposure similar to that observed in severe renal impairment . Consider reducing the dose of PRADAXA to 75 mg twice daily [see Drug. This is a summary of the European public assessment report (EPAR) for Pradaxa. It explains how the Committee for Medicinal Products for Human Use (CHMP).

Author: Nisida Kagazilkree
Country: Thailand
Language: English (Spanish)
Genre: Health and Food
Published (Last): 19 August 2009
Pages: 117
PDF File Size: 10.54 Mb
ePub File Size: 6.84 Mb
ISBN: 287-9-55705-672-6
Downloads: 25738
Price: Free* [*Free Regsitration Required]
Uploader: Nikazahn

After removal of a catheter, an interval of at least 2 hours should elapse before the administration of the first dose of Pradaxa. People who take PRADAXA and have medicine injected into their spinal and epidural dabigarran, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move paralysis.

Pradaxa | European Medicines Agency

It is recommended to continue with the remaining daily doses of Pradaxa at the same time of the next day. Myocardial infarction rates were slightly increased with dabigatran etexilate mg twice daily and dabigartan twice daily compared to warfarin hazard ratio 1. Caution should be exercised when interpreting these tests. Pharmacodynamic effects In vivo and ex vivo animal studies have demonstrated antithrombotic efficacy and anticoagulant activity of dabigatran after intravenous administration and of dabigatran etexilate after oral administration in various animal models of thrombosis.

The study in patients with non-valvular atrial fibrillation showed that the proportion of patients who had a stroke or other problems caused by blood clots each year was around 1. Pradaxa treatment does not need to be interrupted see section 5.

Pradaxa was as effective as enoxaparin in preventing the formation of blood clots or death. Concomitant use not recommended Tacrolimus Tacrolimus has been found in vitro to have a similar level of inhibitory effect on P-gp as that seen with itraconazole and cyclosporine. The health information contained in this Website is provided for educational purposes only and is not intended to replace discussions with a healthcare professional.


Elimination Plasma concentrations of dabigatran showed a biexponential decline with a mean terminal half-life of 11 hours in healthy elderly subjects. Ticagrelor When a single dose of 75 mg dabigatran etexilate was coadministered simultaneously with a loading dose of mg ticagrelor, the dabigatran AUC and C max were increased by 1.

Patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events. A study evaluating post-operative absorption of dabigatran etexilate, hours following surgery, demonstrated relatively slow absorption compared with that in healthy volunteers, showing a smooth plasma concentration-time profile without high peak plasma concentrations.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. Multipack containing 2 packs of 50 x 1 hard capsules hard capsules in perforated aluminium unit dose blisters. Cartons containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in perforated aluminium unit dose blisters. These observations in real-world settings are consistent with the established safety and efficacy profile for dabigatran etexilate in the RE-LY study in this indication.

In addition, dabigatran AUC ,ss and C max,ss and the coagulation measures for dabigatran effect or the inhibition of platelet aggregation as measure of clopidogrel effect remained essentially unchanged comparing combined treatment and the respective mono-treatments.

Pradaxa 75 mg hard capsules

In case of an overdose suspicion, coagulation tests can help to determine a bleeding risk see sections 4. There is a clear correlation between plasma dabigatran concentration and degree of anticoagulant effect based on phase II studies. Women of childbearing potential Women of childbearing potential should avoid pregnancy during treatment with Pradaxa. Risk factors which may increase the haemorrhagic risk.

Concomitant administration of a loading dose of mg ticagrelor and mg dabigatran etexilate in steady state increased the dabigatran AUC ,ss and C max,ss by 1.

For patients randomized to warfarin, the median time in therapeutic range INR 2. Due to the pharmacological mode of action, the use of Pradaxa may be associated with an increased risk of occult or overt bleeding from any tissue or organ.


Pradaxa 150 mg hard capsules

Diluted thrombin time dTTecarin clotting time ECT and activated partial thromboplastin time aPTT may provide useful information, but results should be interpreted with caution due to inter-test variability see section 5. Concomitant administration is expected to result in decreased dabigatran concentrations. Company dabigtran details Boehringer Ingelheim Limited. The most common side effect with Pradaxa seen in more than one patient in 10 is bleeding.

Product details Name Pradaxa. Dabigatran inhibits free thrombin, fibrin-bound thrombin and thrombin-induced platelet aggregation. Last updated on eMC: Concomitant administration of P-gp inhibitors see table 5 is expected to result in increased dabigatran plasma concentrations.

Haemorrhagic complications adbigatran present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea, and unexplained shock. The CHMP considered that the benefits of the medicine outweigh its risk and recommended that it be given marketing authorisation. More detail is available in the summary of product characteristics. The potential risk for humans is unknown. Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

Pantoprazole and other proton-pump inhibitors PPI were co-administered with Pradaxa in clinical trials, and concomitant PPI treatment did not appear to reduce the efficacy of Pradaxa.

The half-life was independent of dose. After oral administration, dabigatran etexilate is rapidly and completely converted to dabigatran, which dabigatdan the active form in plasma.

Pregnancy There is limited amount of data from the use of Pradaxa in pregnant women. Until then, INR values should be interpreted with caution. Dabigatran is subject to conjugation forming pharmacologically active acylglucuronides.