Comment
Author: Admin | 2025-04-28
Impairment. Reduce the dosage of PRADAXA Capsules to 75 mg twice daily.Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary EmbolismDosing recommendations for patients with CrCl ≤ 30 mL/min cannot be provided. Avoid use of concomitant P-gp inhibitors in patients with CrCl Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement SurgeryDosing recommendations for patients with CrCl ≤ 30 mL/min or on dialysis cannot be provided. Avoid use of concomitant P-gp inhibitors in patients with CrCl Pediatric patients with renal impairmentTreatment and reduction in risk of recurrence of VTE in pediatric patientsDue to lack of data in pediatric patients with eGFR 2 and the risk of increased exposure, avoid use of PRADAXA Capsules in these patients. Prior to the initiation of treatment with PRADAXA Capsules, estimate the glomerular filtration rate (eGFR) using the Schwartz formula: eGFR (Schwartz) = (0.413 × height in cm) / serum creatinine in mg/dL.Treat patients with an eGFR > 50 mL/min/1.73 m2 with the dosage according to Table 1. AdministrationPRADAXA Capsules should be swallowed whole. PRADAXA Capsules should be taken with a full glass of water. Breaking, chewing, or emptying the contents of the capsule can result in increased exposure.If a dose of PRADAXA Capsules is not taken at the scheduled time, the dose should be taken as soon as possible on the same day; the missed dose should be skipped if it cannot be taken at least 6 hours before the next scheduled dose. The dose of PRADAXA Capsules should not be doubled to make up for a missed dose.Consider administration with food if gastrointestinal distress occurs with PRADAXA Capsules. Converting from or to WarfarinWhen converting patients from warfarin therapy to PRADAXA Capsules, discontinue warfarin and start PRADAXA Capsules when the INR is below 2.0.When converting from PRADAXA Capsules to warfarin, adjust the starting time of warfarin as follows:AdultsFor CrCl ≥ 50 mL/min, start warfarin 3 days before discontinuing PRADAXA Capsules.For CrCl 30-50 mL/min, start warfarin 2 days before discontinuing PRADAXA Capsules.For CrCl 15-30 mL/min, start warfarin 1 day before discontinuing PRADAXA Capsules.For CrCl PediatricsFor eGFR ≥ 50 mL/min/1.73 m2, start warfarin 3 days before discontinuing PRADAXA Capsules.Pediatric patients with an eGFR 2 have not been studied. Avoid use of PRADAXA Capsules in these patients.Because PRADAXA Capsules can increase INR, the INR will better reflect warfarin's effect only after PRADAXA Capsules has been stopped for at least 2 days. Converting from or to Parenteral AnticoagulantsFor adult and pediatric patients currently receiving a parenteral anticoagulant, start PRADAXA Capsules 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
Add Comment