Alert

dabigatran

Pronunciation: da BIG a tran

Brand: Pradaxa

Pradaxa

slide 1 of 2, Pradaxa,

150 mg, capsule, blue/white, imprinted with LOGO, R150

Image of Pradaxa
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Pradaxa

slide 2 of 2, Pradaxa,

75 mg, capsule, white, imprinted with LOGO, R75

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

Dabigatran can cause you to bleed more easily. Call your doctor at once if you have: bleeding gums, nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Many other drugs can increase your risk of bleeding when used with dabigatran. Tell your doctor about all medicines you have recently used.

Dabigatran can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). Tell any doctor who treats you that you are taking dabigatran.

Do not stop taking dabigatran without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.

What is dabigatran?

Dabigatran is used to lower the risk of stroke caused by a blood clot in people with a heart rhythm disorder called atrial fibrillation. This medicine is used when the atrial fibrillation is not caused by a heart valve problem.

Dabigatran is also used after hip replacement surgery to prevent a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism).

Dabigatran is also used to treat DVT or pulmonary embolism (PE), and to lower your risk of having a repeat DVT or PE.

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

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:

  • an artificial heart valve; or
  • active bleeding from a surgery, injury, or other cause.

Dabigatran can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if:

  • you have a genetic spinal defect;
  • you have a spinal catheter in place;
  • you have a history of spinal surgery or repeated spinal taps;
  • you have recently had a spinal tap or epidural anesthesia;
  • you are taking an NSAID--Advil, Aleve, Motrin, and others; or
  • you are using other medicines to treat or prevent blood clots.

Dabigatran may cause you to bleed more easily, especially if:

  • you have a stomach ulcer or bleeding in your stomach or intestines;
  • you have kidney disease (especially if you also take dronedarone or ketoconazole);
  • you take certain other medicines that can increase bleeding risk, such as aspirin, clopidogrel (Plavix), heparin, prasugrel, warfarin (Coumadin, Jantoven);
  • you take an NSAID (nonsteroidal anti-inflammatory drug) on a regular basis, such as ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, indomethacin, meloxicam, and others; or
  • you are older than 75.

Tell your doctor if you have ever had:

  • kidney disease;
  • a bleeding disorder that is inherited or caused by disease;
  • a stomach ulcer; or
  • if you have been taking rifampin.

Tell your doctor if you are pregnant or if you become pregnant. Taking dabigatran during pregnancy may cause bleeding in the mother or the newborn baby. However, the risk of blood clots is higher during pregnancy. The benefit of preventing a blood clot may outweigh any risks to the baby.

You should not breast-feed while using dabigatran.

How should I take dabigatran?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take this medicine with a full glass of water. You may take dabigatran with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it.

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 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 dabigatran within the past 12 hours.

Your kidney function may need to be checked before and during treatment with dabigatran.

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

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

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?

Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not take two doses at one time.

To best prevent a stroke, try not to miss any doses.

What happens if I overdose?

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

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 alcohol. Heavy drinking can increase your risk of stomach bleeding.

What are the possible side effects of dabigatran?

Get emergency medical help if you have signs of an allergic reaction: hives; pain or tight feeling in your chest, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Call your doctor at once if you have:

  • any bleeding that will not stop;
  • headache, weakness, dizziness, or feeling like you might pass out;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • blood in your urine or stools, black or tarry stools;
  • cough with bloody mucus or vomit that looks like coffee grounds;
  • pink or brown urine;
  • joint pain or swelling; or
  • heavy menstrual bleeding.

Common side effects may include:

  • stomach pain or discomfort;
  • indigestion; or
  • nausea, diarrhea.

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?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

When you start or stop taking dabigatran, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs can affect dabigatran. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about dabigatran.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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 1996-2019 Cerner Multum, Inc. Version: 14.01. Revision date: 12/27/2018.

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