The new class of drug promised safety and effectiveness without the monitoring and dose adjustment needed for warfarin. However, recent insights into the development and approval of dabigatran-the first new oral anticoagulant brought to market-have raised serious questions about its risks. New analysis...
DOACs generally should not be used in settings with increased risk of bleeding, morbid obesity (body weight >120 kg or BMI >40 mg/m2), drug-drug interactions, or GI complications affecting oral therapy (e.g., poor absorption, nausea and vomiting) because of lack of safety data....
Avoid use of concomitant P-gp inhibitors in patients with CrCl < 50 mL/min [see Warnings and Precautions ( 5.5), Drug Interactions ( 7.2) and Clinical Pharmacology ( 12.3)]. Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement Surgery Dosing recommendations for ...
Doing so can release all of the drug at once, increasing the risk of side effects. Do not put this medication in a pill box or medication reminder box. It must be kept tightly closed in the original bottle (or blister package) to protect it from moisture. See also Storage section for ...
For pediatric patients currently receiving a parenteral anticoagulant, start PRADAXA Oral Pellets 0 to 2 hours before the time that the next dose of the parenteral drug was to have been administered or at the time of discontinuation of a continuously administered parenteral drug (e.g., intravenous...
Dabigatran etexilate is an orally administered pro-drug of dabigatran, which is a direct inhibitor of thrombin and a potent anticoagulant. The serine protease thrombin is the final mediator in the coagulation cascade that leads to the production of fibrin, the main protein component of blood clots...
Meta-analysis demonstrated one third of all strokes or TIAs were associated with suspension of dabigatran for >24 h before pro- cedure, 50% of cases was related to a later tim- ing (>12 h) for restarting the drug post proce- dure [29, 30]. In our study the patient was not treated...
Dabigatran etexilate has been approved by the European Medicines Agency and the US Food and Drug Administration for prevention and treatment of venous thromboembolism after elective hip or knee replacement surgery and for the prevention of embolic stroke and non-systemic embolism in patient with non-...
Both doses of dabigatran etexilate showed significantly lower intracranial bleeding compared to well-controlled warfarin.2-4 Dabigatran etexilate does not require routine coagulation monitoring or dose adjustments, is not affected by food and has a low potential for drug-drug interactions. Up t...
Journal of the American College of CardiologyArtang R, Rome E, Vidaillet H (2012) Dabigatran and myocardial infarction, drug or class effect. Meta-analysis of randomized trials with oral direct thrombin inhibitors. J Am Coll Cardiol 59:E571...