Adult Dosing
Prophylaxis of thromboembolism in nonvalvular atrial fibrillation
Converting from or to warfarin
- When converting patients from warfarin to dabigatran: Discontinue warfarin and start therapy with this drug when the international normalized ratio (INR) is less than 2.0
- When converting from dabigatran to warfarin: Adjust the starting time of warfarin based on CrCl
- >50 mL/min: Start warfarin 3 days before discontinuing dabigatran
- 31-50 mL/min: Start warfarin 2 days before discontinuing dabigatran
- 15-30 mL/min: Start warfarin 1 day before discontinuing dabigatran
- <15 mL/min: Dose adjustments not defined
Converting from or to parenteral anticoagulants
- Conversion from a parenteral anticoagulant: Start dabigatran 0-2 hrs before administration of the next dose of the parenteral drug or at the time of discontinuation of a continuously administered parenteral drug
- Conversion to a parenteral anticoagulant: Wait 12 hrs (CrCl 30 mL/min) or 24 hrs (CrCl <30 mL/min) after the last dose of dabigatran before initiating treatment with a parenteral anticoagulant
Note:
- Advise patients to swallow the capsules whole. 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 therapy 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
Pediatric Dosing
- Safety and effectiveness in pediatric patients has not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- <15 mL/min: Dose adjustments not defined
- 15-30 mL/min: 75 mg PO bid (Caution: FDA approved but not studied in humans; based on PK)
- >30 mL/min: 150 mg PO bid
- Hemodialysis: Dose adjustments not defined
Hepatic Dose Adjustment
- Hepatic impairment: Dose adjustments not defined
- Increased risk of thrombotic events have been reported after discontinuing dabigatran. If anticoagulation with dabigatran must be discontinued for a reason other than pathological bleeding, consider administering another anticoagulant [FDA Black Box Warning]
- Increased risk of significant and fatal bleeding is associated with use of dabigatran. Labor and delivery and use of anti-platelet agents, heparin, fibrinolytic therapy, chronic use of NSAIDs are the risk factors associated with increased risk of bleeding. Discontinue therapy in patients with active bleed
- Avoid concomitant use of this drug with P-gp inducers (rifampin) as it reduces dabigatran bioavailability
- Use for the prophylaxis of thromboembolic events in patients with atrial fibrillation in the setting of other forms of valvular heart disease (including the presence of a bioprosthetic heart valve) is not recommended
Cautions: Use cautiously in
- Risk of bleeding
- Elective surgery
- Invasive procedure
Pregnancy Category:C
Breastfeeding: Unknown whether this drug is excreted in human milk. Manufacturer recommends caution.
Pricing data from www.DrugStore.com in U.S.A.
- Pradaxa 75 MG CAPS [Bottle] (BOEHRINGER INGELHEIM)
30 mg = $123.99
90 mg = $353.98 - Pradaxa 150 MG CAPS [Bottle] (BOEHRINGER INGELHEIM)
60 mg = $245.99
180 mg = $706.93
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.