Healthcare professionals should use sound clinical judgment and individualize patient care. Pradaxa dabigatran etexilate mesylate capsules for oral use warning. The anticoagulant effect of apixaban can be expected to persist for at least 24 hours after the last dose i. Dabigatran etexilate, a new oral direct thrombin inhibitor, for stroke prevention in patients with atrial fibrillation. Information for the patient pradaxa 150 mg hard capsules. Dabigatran pradaxa, rivaroxaban xarelto, apixaban eliquis the contents of this cpg are to be used as a guide. Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more of the following. Consult the full prescribing information prior to use for potential drug interactions. An agent to reverse the antifactor xa activity of rivaroxaban is available. The recommended dose of praxbind is 5 g, provided as 2 separate 50ml vials, each containing 2. Explore a range of informative materials designed to help you and your patients in using pradaxa. Please see important safety information and full prescribing information. Please see important safety information for pradaxa on. Please see accompanying full prescribing information for pradaxa, including boxed warning and medication guide, as well as full prescribing information for praxbind.
Product information on treatment with praxbind, the only fdaapproved specific reversal agent for a noac available in all 50 states. The recommended dose is 60 mg once daily in patients with. Pradaxa dabigatran etexilate mesylate capsules for oral use. Demonstrated to significantly reduce stroke compared to warfarin, pradaxa is first new oral anticoagulant approved by the fda in more than 50 years.
Explore resources just for you to help you on your treatment journey. Please see important safety information and full prescribing information, including boxed warning. Guideline for the prescribing of novel oral anticoagulants. Highlights of prescribing information these hig hlights do not include all the informatio n nee ded to use pradaxa safely and effectively. Medication guide pradaxa pra dax a dabigatran etexilate. For additional information, consult the prescribing information for protamine sulfate injection. Also learn about solutionsplus, and inside rx programs. Fdaapproved reversal treatment available in all 50 states. Praxbind is indicated in patients treated with pradaxa when reversal of the anticoagulant effects of dabigatran is needed.
Oct 04, 2019 use a specific reversal agent idarucizumab in case of emergency surgery or urgent procedures when reversal of the anticoagulant effect of dabigatran is needed. Pradaxa dabigatran etexilate mesylate capsules for oral use initial u. If you have to stop taking pradaxa, your doctor may prescribe another medicine to help prevent a blood clot from forming. Choose pradaxa dabigatran etexilate for afib, dvt or pe. Do not stop taking pradaxa without talking to the doctor who prescribes it for you. Xarelto rivaroxaban information for healthcare professionals. Highlights of prescribing information these highlights do not include all the information needed to use savaysa safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use pradaxa safely and effectively. Pradaxa dabigatran etexilate mesylate capsules prescribing information. Consider reducing the dose of pradaxa to 75 mg twice daily see drug. You can ask your pharmacist or doctor for information about pradaxa that is written for health professionals. Pradaxa dabigatran etexilate mesylate capsule boehringer ingelheim pharmaceuticals inc. Please see prescribing information for praxbind, and visit pradaxa.
Prophylaxis of dvt following hip or knee replacement surgery. Pradaxa 220 mg taken as one 110 mg capsule twice a day. See full prescribing information for other components of the formulation exelon. Fda approves pradaxa, marking a major milestone to reduce the risk of stroke in patients with nonvalvular atrial fibrillation. A specific reversal agent for pradaxa is available when reversal of the anticoagulant effect is needed, such as for emergency surgery and uncontrolled bleeding. Please see prescribing information for praxbind, and visit for more information. View important safety information and full prescribing information on website. Select safety information about pradaxa for people taking pradaxa for atrial fibrillation. Since certain patients who take pradaxa are at increased risk of bleeding, a number of precautions were included in the prescribing information. Use a specific reversal agent idarucizumab in case of emergency surgery or urgent procedures when reversal of the anticoagulant effect of dabigatran is needed. Highlights of prescribing information these highlights do not include all the information needed to use feiba safely and effectively. Us prescribing information for eliquis medication guide for eliquis dhcp letter for a period of 2 years the eliquis rems website is part of the rems and is appended. There are differences between pradaxa and warfarin. Praxbind idarucizumab is indicated in patients treated with pradaxa when reversal of the anticoagulant effects of dabigatran is needed.
The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Pradaxa ii31 revised product information european medicines. Refer to the idarucizumab prescribing information for additional information. For more information, contact your local sanofiaventis u. Most common adverse reactions with xarelto were bleeding complications. For emergency surgeryurgent procedures in lifethreatening or uncontrolled bleeding 2 dosage and administration 2. Highlights of prescribing information these highlights do not include all the information needed to use exelon safely and effectively. Instructions on starting patients on pradaxa, and dosing for multiple indications. Prescribing information spaf uk pradaxa dabigatran etexilate capsules containing 110 mg or 150 mg dabigatran etexilate as mesilate action. Please see additional important safety information on next page. Please see prescribing information and medication guide, and visit pradaxa. Xarelto rivaroxaban tablets, for oral use initial u.
Highlights of prescribing information these highlights do not. Exelon rivastigmine tartrate capsules, for oral use exelon rivastigmine tartrate oral solution initial u. Oral anticoagulant rx eliquis apixaban safety info. Your personalized doctor discussion guide fill out your guide and bring it with you to your next appointment. Pradaxa treatment can be initiated 24 hours after administration of praxbind. Heparin is a heterogenous group of straightchain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. Guideline for the prescribing of novel oral anticoagulants noacs. Patient brochure pradaxa dabigatran etexilate and its reversal. Boehringer ingelheim hopes that this link will be of interest and use to visitors, but it accepts no liability in relation to the website or its contents and gives no war. Because fatal reactions often resembling anaphylaxis have been reported with protamine, it should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available. Help your eligible patients start saving on pradaxa. Medication guide pradaxa pra dax a dabigatran etexilate mesylate capsules read this medication guide before you start taking pradaxa and each time you get a refill. Dec 18, 2017 recently, the american college of cardiology acc released the 2017 acc expert consensus decision pathway for periprocedural management of anticoagulation in patients with nonvalvular atrial fibrillation to provide guidance in this area. Pradaxa is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Click here for information on sharps medical waste disposal. These highlights do not include all the information needed to use. Please read full prescribing information, including boxed warnings for xarelto. Bring this doctor discussion guide with you if you are talking to your doctor about dvt or pe and pradaxa. Annexa4 interim data set, prior to day 30 from the prescribing information. For more information about pradaxa, including current prescribing information and medication guide, go to. Please see full prescribing information, including boxed warning. An agent to reverse the antifactor xa activity of apixaban is available. Highlights of prescribing information these highlights do not include all the information needed to use biktarvy safely and effectively. Dailymed pradaxa dabigatran etexilate mesylate capsule.
If youve been diagnosed with atrial fibrillation afib not caused by a heart valve problem, then its important to discuss. This product information was approved at the time this auspar was published. Stopping pradaxa increases your risk of hatving a stroke. Transition of anticoagulants 2019 van hellerslia, pharmd, bcps, cacp, clinical assistant professor of pharmacy practice, temple university school of pharmacy, philadelphia, pa. Review the comparison chart, then talk to your doctor about whether pradaxa is right for you. Highlights of prescribing information these highlights do. In patients with moderate renal impairment and concomitantly treated with dabigatran etexilate and verapamil, a dose reduction of pradaxa to 75. Pradaxa dabigatran etexilate mesylate capsules, for oral use. See full prescribing information for complete boxed. Learn more about pradaxa and its role in reducing risk of stroke in afib, and treating blood clots for dvt and pe. Pradaxa, inndabigatran etexilate european medicines agency.
Highlights of prescribing information these highlights do not include all the information needed to use coumadin safely and effectively. Jan 01, 2020 you can ask your pharmacist or doctor for information about pradaxa that is written for health professionals. If you have a potentially higher risk for bleeding, your doctor may decide to prescribe a dose of. Find easy to use information on the recommended dose and download preparation instructions for praxbind. Detailed information on this medicinal product is available on the website of the. Pradaxa fda prescribing information, side effects and uses. Refer to prescribing information for more complete information. Highlights of prescribing information vosevi is not. Pradaxa compared well with warfarin in reducing the risk of strokes in patients with atrial fibrillation without increasing the risk of major bleeding. Pradaxa dabigatran etexilate mesylate capsules for oral. Limited data shows that hemodialysis can remove 4957% of dabigatran over.
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