Pradaxa Capsules are NOT substitutable on a milligram-to-milligram basis with other dabigatran etexilate dosage forms.For pediatric patients: weight-based dosage, twice daily after previous treatment ( 2.3).
Reduction in the Risk of Recurrence of Pediatric VTE:.For pediatric patients: weight-based dosage, twice daily after at least 5 days of parenteral anticoagulant ( 2.3).For patients with CrCl >30 mL/min: 110 mg orally first day, then 220 mg once daily ( 2.2).Prophylaxis of DVT and PE Following Hip Replacement Surgery in Adult Patients:.For patients with CrCl >30 mL/min: 150 mg orally, twice daily after previous treatment ( 2.2).Reduction in the Risk of Recurrence of DVT and PE in Adult Patients:.For patients with CrCl >30 mL/min: 150 mg orally, twice daily after 5-10 days of parenteral anticoagulation ( 2.2).Treatment of DVT and PE in Adult Patients:.For patients with CrCl 15-30 mL/min: 75 mg orally, twice daily ( 2.2).For patients with CrCl >30 mL/min: 150 mg orally, twice daily ( 2.2).Non-valvular Atrial Fibrillation in Adult Patients:.
Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated ( 5.3). Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently. These hematomas may result in long-term or permanent paralysis ( 5.3). (B) SPINAL/EPIDURAL HEMATOMA: Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. To reduce this risk, consider coverage with another anticoagulant if PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy ( 2.6, 2.7, 2.8, 5.1). (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.
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
0 kommentar(er)
