Tuesday, September 6, 2016

Pradaxa


Generic Name: dabigatran (da BIG a tran)

Brand Names: Pradaxa


What is dabigatran?

Dabigatran keeps the platelets in your blood from coagulating (clotting).


Dabigatran is used to prevent blood clots and to reduce the risk of stroke in people with a certain type of heart rhythm disorder.


Dabigatran may also be used for purposes not listed in this medication guide.


What is the most important information I should know about dabigatran?


Because dabigatran keeps your blood from coagulating (clotting) to prevent unwanted blood clots, this medicine can also make it easier for you to bleed, even from a minor injury. Avoid activities that may increase your risk of bleeding or injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.

Call your doctor at once if you have any signs of bleeding such as weakness, feeling like you might pass out, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin, pink or brown urine, bloody or tarry stools, coughing up blood, joint pain or swelling, or heavy menstrual bleeding.


If you need surgery, dental work, or any type of medical test or treatment, tell the doctor or dentist ahead of time if you have taken dabigatran within the past 12 hours. You may need to stop taking dabigatran for a short time before you have surgery or other medical procedures.


Do not stop taking the medicine without first talking to your doctor. You should not take dabigatran if you are allergic to it, or if you have any active bleeding from a surgery, injury, or other cause. Tell your doctor if you have recently used or received any other medications to treat or prevent blood clots.

Before taking dabigatran, tell your doctor if you have kidney disease, a history of stomach ulcer or bleeding, if you are older than 75, or if you are using a blood thinner such as heparin or warfarin (Coumadin, Jantoven).


Do not crush, chew, break, or open a dabigatran capsule. Swallow the pill whole.

What should I discuss with my healthcare provider before taking dabigatran?


You should not take dabigatran if you are allergic to it, or if you have any active bleeding from a surgery, injury, or other cause.

To make sure you can safely take dabigatran, tell your doctor if you have any of these other conditions:



  • kidney disease;




  • a history of stomach ulcer or bleeding; or




  • if you are older than 75.




FDA pregnancy category C. It is not known whether dabigatran will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether dabigatran passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take dabigatran?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Because dabigatran keeps your blood from coagulating (clotting) to prevent unwanted blood clots, this medicine can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have any bleeding that will not stop.

If you need surgery, dental work, or any type of medical test or treatment, tell the doctor or dentist ahead of time if you have taken dabigatran within the past 12 hours. You may need to stop taking dabigatran for a short time before you have surgery or other medical procedures.


Do not stop taking the medicine without first talking to your doctor. Do not crush, chew, break, or open a dabigatran capsule. Swallow the pill whole.

Your kidney function may need to be checked with blood tests before and during treatment with dabigatran. Visit your doctor regularly.


Keep the capsules in their original container or blister pack. Do not put dabigatran capsules into a daily pill box or pill organizer.


If you have received more than a 30-day supply of this medication, do not open more than one bottle at a time. Open a new bottle only after all the capsules in the old bottle are gone.


Store at room temperature, away from moisture and heat. Keep each capsule in the bottle or blister pack until you are ready to take the medicine. Keep the bottle tightly closed when not in use. Throw away any unused capsules if it has been longer than 4 months since you first opened the bottle. Capsules stored in a blister pack should be thrown away after the expiration date on the label has passed.

What happens if I miss a dose?


If you are less than 6 hours late in taking your medicine, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


Try not to miss any doses of dabigatran to best prevent a stroke.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include excessive bleeding or any bleeding that will not stop.


What should I avoid while taking dabigatran?


Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth. Avoid drinking alcohol. It may increase your risk of bleeding in your stomach or intestines.

Dabigatran side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • any bleeding that will not stop;




  • weakness, feeling like you might pass out;




  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;




  • blood in your urine or stools, black or tarry stools;




  • coughing up blood or vomit that looks like coffee grounds;




  • pink or brown urine;




  • joint pain or swelling; or




  • heavy menstrual bleeding.



Less serious side effects may include:



  • stomach pain or upset, indigestion, heartburn;




  • nausea, diarrhea; or




  • mild skin rash or itching.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect dabigatran?


Before you take dabigatran, tell your doctor if you have recently received any other medications to treat or prevent blood clots, such as:

  • abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), ticlopidine (Ticlid), tirofiban (Aggrastat);




  • heparin or warfarin (Coumadin, Jantoven);




  • argatroban (Acova), bivalirudin (Angiomax), lepirudin (Refludan);




  • dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra), tinzaparin (Innohep); or




  • alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase).



Tell your doctor about all other medications you use, especially:



  • rifampin (Rifater, Rifadin, Rifamate);




  • quinidine (Guin-G);




  • St. John's wort;




  • antifungal medicine such as itraconazole (Sporanox) or ketoconazole (Nizoral);




  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), ketoprofen (Actron, Orudis), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or




  • heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), dronedarone (Multaq), or verapamil (Calan, Covera, Isoptin, Verelan).



This list is not complete and other drugs may interact with dabigatran. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Pradaxa resources


  • Pradaxa Side Effects (in more detail)
  • Pradaxa Use in Pregnancy & Breastfeeding
  • Drug Images
  • Pradaxa Drug Interactions
  • Pradaxa Support Group
  • 38 Reviews for Pradaxa - Add your own review/rating


  • Pradaxa Prescribing Information (FDA)

  • Pradaxa Advanced Consumer (Micromedex) - Includes Dosage Information

  • Pradaxa MedFacts Consumer Leaflet (Wolters Kluwer)

  • Pradaxa Consumer Overview



Compare Pradaxa with other medications


  • Prevention of Thromboembolism in Atrial Fibrillation


Where can I get more information?


  • Your pharmacist can provide more information about dabigatran.

See also: Pradaxa side effects (in more detail)


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