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).

Pradaxa - Bleeding Side Effects | Class Action Settlements

Pictures of Pradaxa (Dabigatran Etexilate Mesylate), drug imprint information, side effects for the patient.You may have a higher risk of bleeding if you take PRADAXA and.The safety and efficacy of PRADAXA in patients with bileaflet mechanical prosthetic heart valves was evaluated in the RE-ALIGN trial, in which patients with bileaflet mechanical prosthetic heart valves (recently implanted or implanted more than three months prior to enrollment) were randomized to dose adjusted warfarin or 150, 220, or 300 mg of PRADAXA twice a day.For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2).Instruct patient to remove only one capsule from the opened bottle at the time of use.

Common Side Effects of Pradaxa (Dabigatran Etexilate

Searcy Denney | Florida Pradaxa Drug Attorneys, Lawyers

You are now leaving a Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) site.The dose of PRADAXA should not be doubled to make up for a missed dose.The owners of these brands are not affiliated with and do not endorse Boehringer Ingelheim Pharmaceuticals, Inc., or its products.

Dabigatran 110 mg Similar in Benefit to 150 mg - Medscape

A summary of the effect of coadministered drugs on dabigatran exposure is shown in Figures 3.1 and 3.2.Safety and effectiveness of PRADAXA in pediatric patients have not been established.

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.

DailyMed - PRADAXA- dabigatran etexilate mesylate capsule

Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.Ask the doctor who prescribed PRADAXA for you when you should stop taking it.

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.