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Dabigatran

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

Medically reviewed by Drugs.com on Dec 27, 2018 – Written by Cerner Multum

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. dabigatran 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.

Important Information

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.

Before taking this medicine

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:

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 dabigatran 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.

Dabigatran side effects

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:

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.

Dabigatran dosing information

Usual Adult Dose for Deep Vein Thrombosis -- Prophylaxis:

Recommended doses: 150 mg orally twice a day

Comments: Generally, the extent of anticoagulation does not need to be assessed with this drug; however, when necessary, use aPTT or ECT, and not INR to assess anticoagulant activity.

Uses: Reduction of risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days; reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated.

Usual Adult Dose for Prevention of Thromboembolism in Atrial Fibrillation:

Recommended doses: 150 mg orally twice a day

Comments: Generally, the extent of anticoagulation does not need to be assessed with this drug; however, when necessary, use aPTT or ECT, and not INR to assess anticoagulant activity.

Uses: Reduction of risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days; reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated.

Usual Adult Dose for Deep Vein Thrombosis/Pulmonary Embolism Prophylaxis Following Hip Replacement Surgery:

110 mg orally 1 to 4 hours after surgery and after hemostasis has been achieved, then 220 mg orally once a day for 28 to 35 days

Comments: If this drug is not started on the day of surgery, initiate treatment with 220 mg orally once a day after hemostasis has been achieved.

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.

Further information

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.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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