Dabigatran (Pradaxa®) Considerations for Use*
US/FDA Approved Indications: Stroke Prevention in Non-valvular Atrial Fibrillation
Mechanism of Action
Direct thrombin inhibitor
Adult: 150 mg PO twice daily
Elderly: No dosage adjustment necessary
Hepatic Impairment: No dosage adjustment necessary
Active pathological bleeding, mechanical prosthetic heart valve
|Major Side Effects||
|Dosage forms and Strengths||
PO: 75, 150mg capsules
There is no rapid reversal agent for dabigatran.
Surgery and interventions:
|Conversion to/from other drugs||
From dabigatran to warfarin:
From dabigatran to parenteral anticoagulant:
From warfarin to dabigatran:
From parenteral anticoagulant to dabigatran:
Has many potential drug interactions.
Can increase INR. INR will better reflect only warfarin’s effect when the patient has been off the dabigatran for at least 2 days.
DO NOT break, chew or open the capsules.
Keep this medication in its original bottle or blister package to protect it from moisture. Do not put this medication into a pillbox or pill organizer.
Tightly close the bottle right away after you take the dose.
Only remove the medication from the blister package when it is time to take the dose.
When you open a new bottle, write down the date that you opened the bottle. Discard the bottle 4 months after it was first opened, even if you have not taken all the medication in the bottle.
Do not discontinue this medication without talking to the healthcare provider who prescribed it. Consult healthcare professional prior to using new drug (prescription, OTC, herbal).
Report signs and symptoms of bleeding (e.g., unexpected bleeding or bleeding that lasts a long time; red or black, tarry stool; pink or brown urine; unusual bruising; coughing up blood; vomiting blood or vomit that looks like coffee grounds; unexplained pain, swelling, or joint pain; unusual headaches, dizziness, or weakness; recurring nose bleeds).
Tell your healthcare professional if you have had or will have surgery to place a prosthetic heart valve.
Tell your healthcare professional if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed during treatment.
*Refer to prescribing information for more complete information.
†Dosages given in the table may differ from those recommended by the manufacturers.
- American College of Cardiology (ACC), American Heart Association (AHA), and Heart Rhythm Society (HRS). 2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Update on Dabigatran). Washington, DC: American College of Cardiology Foundation. 2011.
- Pradaxa® Prescribing information, 12/19/12.
- Chest Supplement, Antithrombotic Therapy and Prevention of Thrombosis, 9th edition, American College of Chest Physicians.