Dabigatran

If you have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) and are taking dabigatran to help prevent strokes or serious blood clots, you are at a higher risk of having a stroke after you stop taking this medication. Do not stop taking dabigatran without talking to your doctor. Continue to take dabigatran even if you feel well. Be sure to refill your prescription before you run out of medication so that you will not miss any doses of dabigatran. If you need to stop taking dabigatran, your doctor may prescribe another anticoagulant (‘blood thinner’) to help prevent a blood clot from forming and causing you to have a stroke.

If you have epidural or spinal anesthesia or a spinal puncture while taking a ‘blood thinner’ such as dabigatran, you are at risk of having a blood clot form in or around your spine that could cause you to become paralyzed. Tell your doctor if you have an epidural catheter that is left in your body or have or have ever had repeated epidural or spinal punctures, spinal deformity, or spinal surgery. Tell your doctor and pharmacist if you are taking any of the following: anagrelide (Agrylin), aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin), indomethacin (Indocin, Tivorbex), ketoprofen, and naproxen (Aleve, Anaprox, others), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine), eptifibatide (Integrilin), heparin, prasugrel (Effient), ticagrelor (Brilinta), ticlopidine, tirofiban (Aggrastat), and warfarin (Coumadin, Jantoven). If you experience any of the following symptoms, call your doctor immediately: back pain, muscle weakness (especially in your legs and feet), numbness or tingling (especially in your legs), or loss of control of your bowels or bladder.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body’s response to dabigatran.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with dabigatran and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

🔔 Why is this medication prescribed?

Dabigatran is used to treat deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE; a blood clot in the lung) in adults and children 3 months of age and older who have been treated with an injectable anticoagulant (‘blood thinner’). It is also used to reduce the risk of a DVT and PE from happening again after initial treatment is completed in adults and children 3 months of age and older. Dabigatran is used to help prevent DVT and PE in adults who have had hip replacement surgery. Dabigatran is also used to help prevent strokes or serious blood clots in adults who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) without heart valve disease. Dabigatran is in a class of anticoagulant medications called direct thrombin inhibitors. It works by preventing blood clots from forming in the body.

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🔔 How should this medicine be used?

Dabigatran comes as a capsule and pellets to take by mouth. When dabigatran is used to treat or prevent a DVT or PE or to prevent strokes or serious blood clots in people who have atrial fibrillation, it is usually taken twice a day. When dabigatran is used to prevent a DVT or PE after hip replacement surgery, it is usually taken 1 to 4 hours after surgery, and then once a day for another 28 to 35 days. Dabigatran capsules may be taken with or without food. Take dabigatran capsules with food if the medication upsets your stomach. Give dabigatran pellets before meals to make sure your child receives the full dose. Take dabigatran at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dabigatran exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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Swallow the capsules whole with a whole glass of water; do not split, chew, or crush them. Do not open the capsules and sprinkle the contents on food or into drinks.

Dabigatran pellets should be taken with soft foods or apple juice. Do not mix the pellets with milk or foods that contain milk products. To prepare a dose of dabigatran pellets with soft food, sprinkle the entire packet of pellets on soft food such as baby rice cereal (prepared with water), mashed carrots, mashed banana, or applesauce. Give the entire mixture within 30 minutes of sprinkling the pellets on the soft food. Alternatively you can give dabigatran pellets to your child along with apple juice. Spoon the pellets into your child’s mouth and offer them as much apple juice as necessary to swallow the pellets. Or you can mix the pellets in small amount of apple juice and have your child drink the entire mixture. If pellets stick to the cup, add a small amount of apple juice and give it to your child. Repeat as necessary until all of the pellets are gone. Do not store the mixture of dabigatran pellets and soft food or apple juice; use within 30 minutes after mixing.

If your child does not take the entire dose of dabigatran pellets, do not give another dose at this time. Continue with the next dose at the scheduled time.

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Dabigatran will help prevent strokes and blood clots only as long as you continue to take it. Continue to take dabigatran even if you feel well. Make sure to refill your prescription before you run out of medication so that you will not miss doses of dabigatran. Do not stop taking dabigatran without talking to your doctor. If you suddenly stop taking dabigatran, the risk that you will have clot or a stroke may increase.