Transcription of Reference ID: 4233773 - accessdata.fda.gov
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Reference ID: 4233773 - accessdata.fda.gov
_____ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PRADAXA safely and effectively. See full prescribing information for PRADAXA. PRADAXA (dabigatran etexilate mesylate) capsules, for oral use Initial Approval: 2010 WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events.
after the last dose of PRADAXA before initiating . Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation . For patients with creatinine clearance (CrCl) >30 mL/min, the recommended dose of PRADAXA is 150 mg taken orally, twice daily.
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