Generic Name: dabigatran (da BIG a tran)
Brand Names: Pradaxa

What is Pradaxa?

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

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

It is also used for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE).

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

Important information

You should not take Pradaxa if you have an artificial heart valve, or if you have any active bleeding from a surgery, injury, or other cause.

Because Pradaxa 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 such as a fall or a bump on the head. 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.

Slideshow: Atrial Fibrillation - Stroke Prevention Guidelines & Treatment Options

Do not stop taking Pradaxa without your doctor's advice. Stopping the medication can increase your risk of stroke.

Before taking this medicine

You should not take Pradaxa if you are allergic to dabigatran, if you have an artificial heart valve, or if you have any active bleeding from a surgery, injury, or other cause.

To make sure Pradaxa is safe for you, tell your doctor if you have:

  • 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 Pradaxa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether dabigatran passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take Pradaxa?

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

Because Pradaxa 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 such as a fall or a bump on the head. Contact your doctor or seek emergency medical attention if you fall or hit your head, or 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 Pradaxa within the past 12 hours. You may need to stop taking this medicine for a short time before you have surgery or other medical procedures.

Do not stop taking Pradaxa without your doctor's advice. Stopping the medication can increase your risk of stroke. Your doctor may recommend another medication to prevent blood clots if you need to stop taking this medicine.

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

Your kidney function may need to be checked with blood tests before and during treatment with Pradaxa.

Keep the capsules in their original container or blister pack. Do not put Pradaxa 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 Pradaxa 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.

What should I avoid?

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.

Pradaxa side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Pradaxa: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • 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.

Common Pradaxa 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.

See also: Side effects (in more detail)

What other drugs will affect Pradaxa?

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

  • heparin or warfarin (Coumadin);

  • argatroban, bivalirudin, fondaparinux, lepirudin, rivaroxaban;

  • abciximab, eptifibatide, tirofiban;

  • dalteparin, enoxaparin, tinzaparin;

  • anagrelide, cilostazol, clopidogrel, dipyridamole, eltrombopag, oprelvekin, prasugrel, romiplostim, ticagrelor, ticlopidine; or

  • alteplase, reteplase, tenecteplase, urokinase.

Tell your doctor about all other medicines you use, and those you start or stop using during your treatment with Pradaxa, especially:

  • rifampin;

  • St. John's wort;

  • tipranavir when given with ritonavir; or

  • seizure medication - carbamazepine, phenytoin.

This list is not complete. Other drugs may interact with Pradaxa, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Pradaxa.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Pradaxa only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 11.01. Revision Date: 2013-06-16, 11:39:11 PM.

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