Bleeding Events-Full Treatment Period Including Parenteral Treatment.Blister package containing 60 capsules (10 x 6 capsule blister cards).In the RE-LY trial, the median (10 th to 90 th percentile) trough ECT in patients receiving the 150 mg dose was 63 (44 to 103) seconds.Sections or subsections omitted from the full prescribing information are not listed.In the RE-SONATE study, the rate of any gastrointestinal bleeds in patients receiving PRADAXA 150 mg was 0.7% (0.3% on placebo).
To reduce the risk of recurrence of DVT and PE in patients who have been previously treated (1.3).Instruct patients to seek emergency care right away if they have any of the following, which may be a sign or symptom of serious bleeding.Dabigatran etexilate is an oral prodrug that is metabolized by a serum esterase to dabigatran.Gastrointestinal Adverse Reactions In the four pivotal studies, patients on PRADAXA 150 mg had a similar incidence of gastrointestinal adverse reactions (24.7% vs. 22.7% on warfarin).
BIPI is not responsible for the way information is processed by sites linked to this one.Safety and effectiveness of PRADAXA during labor and delivery have not been studied in clinical trials.This Medication Guide summarizes the most important information about PRADAXA.There may be quantitative differences between various established methods for aPTT assessment.Pradaxa official prescribing information for healthcare professionals.
Your doctor will tell you when you may start taking PRADAXA again after your surgery or procedure.
For patients randomized to warfarin, the mean percentage of time in therapeutic range (INR 2 to 3) was 64%.
A total of 18,113 patients were randomized and followed for a median of 2 years.To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (1.1).RE-SONATE was a placebo-controlled study in which 684 patients received PRADAXA 150 mg twice daily following 6 to 18 months of oral anticoagulant regimen.Tell your doctor if you have any side effect that bothers you or that does not go away.After oral administration of dabigatran etexilate in healthy volunteers, C max occurs at 1 hour post-administration in the fasted state.
The prescription blood-thinner Pradaxa was considered an upgrade from warfarin because it limited strokes.The red blood cell to plasma partitioning of dabigatran measured as total radioactivity is less than 0.3. The volume of distribution of dabigatran is 50 to 70 L.Pradaxa 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral Capsule.