Generic name: dabigatran [da-BIG-a-tran]
Brand name: Pradaxa
Dosage forms: oral pill (110 mg; 150 mg; 75 mg), oral granule (110 mg; 150 mg; 20 mg; 30 mg; 40 mg; 50 mg)
Type of drug: Thrombin Inhibitors
What is dabigatran?
Dabigatran is used to treat blood clots deep in the body (deep vein thrombosis, or DVT) and in the lungs (pulmonary embolism, or PE) in adult people who have been given injections of blood thinners for 5 to 10 days.
Dabigatran is used to treat blood clots in kids between 3 months and 18 years old who have been taking an injectable blood thinner for at least 5 days.
Dabigatran is used to lower the chance of a blood clot coming back after treatment for blood clots in people and children ages 3 months to less than 18 years old.
Dabigatran is also used to keep blood from clotting deep in the body (deep vein thrombosis, DVT) or in the lungs (pulmonary embolism, PE) after surgery to replace a hip.
Dabigatran is also used to lower the chance of stroke and blood clots in adults with a heart rhythm disorder called atrial fibrillation. Atrial fibrillation is treated with dabigatran when it is not caused by a problem with a heart valve.
Dabigatran can also be used for other things that aren’t in this book.
Warnings
Stop taking dabigatran only if your doctor tells you to. Stopping it all of a sudden can make you more likely to have a blood clot or a stroke.
When taken with dabigatran, some drugs can make you more likely to bleed. Tell your doctor about any other medicines you take.
Call your doctor right away if you have headaches, joint pain or swelling, feeling very weak or dizzy, bleeding gums, nosebleeds, heavy menstrual periods or unusual vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood, vomiting what looks like coffee grounds, or any bleeding that won’t stop.
If you get an epidural or a spinal tap while taking dabigatran, it can cause a very dangerous blood clot around your spinal cord. Tell any doctor who cares for you that you are taking dabigatran.
Before you take this drug
If you are allergic to dabigatran or if you are bleeding because of a surgery, an accident, or something else, you shouldn’t take it.
If you get a spinal tap or spinal anesthesia (epidural) while taking dabigatran, it can cause a dangerous blood clot. This kind of blood clot could leave a person paralyzed for life or for a long time.
Even a small cut can cause you to bleed more easily if you are taking dabigatran. If you can’t stop bleeding, you should call your doctor.
Tell your doctor if you have or ever had any of the following:
- A genetic spinal defect;
- A thin tube (catheter) placed in your back to give you medicine;
- A history of problems with your spine or a spinal surgery;
- A history of difficult or repeated spinal taps;
- Bleeding problems;
- A stomach ulcer or bleeding in your stomach or intestines;
- Taking certain other medicines that can make you more likely to bleed;
- Antiphospholipid syndrome, an immune system disorder that makes you more likely to get blood clots;
- Planning for surgery.
- Kidney Disease
It is not known if dabigatran will hurt a baby that is still in the womb. Taking dabigatran while pregnant could cause the mother or the developing child to bleed. If you are pregnant or want to get pregnant, you should tell your doctor.
While taking dabigatran, you shouldn’t breastfeed.
How do I take the dabigatran?
Follow all of the rules on the label of your prescription, and read any guides or instruction sheets that come with it. Your doctor may change your dose from time to time. Follow the directions to the letter.
For children and teens, dosages are based on their weight. If your child gets or loses weight, the dose may change.
Take one pill of dabigatran with a full glass of water. This pill can be taken with or without food.
If dabigatran pills make you feel sick, take them with food.
Do not crush, chew, break, or open the dabigatran tablet. Instead, swallow it whole.
Give your child dabigatran pellets by mouth before a meal to make sure they get the full dose.
You can also mix the pellets with apple juice or soft food at room temperature, such as apple sauce, apple juice, mashed carrots, or mashed bananas. Oral pellets should not be mixed with any other food, milk, milk products, or drink.
Medicine that has been mixed should be used right away or within 30 minutes. You shouldn’t give dabigatran with a syringe or a feeding tube.
This medicine can also make it easier for you to bleed, even if you just fell or hit your head. If you fall, hit your head, or are bleeding and can’t stop, call your doctor or go to the emergency room.
You may need to have your kidney health checked often.
How long you should take dabigatran will be up to your doctor. Do not change the amount you take or stop taking this medicine without first talking to your doctor. Stopping all of a sudden can make you more likely to have a blood clot or a stroke.
Tell any doctor who cares for you that you are taking dabigatran. If you need surgery or oral work while taking this medicine, tell the doctor or dentist ahead of time. You may need to stop taking dabigatran for a short time if you need anesthesia for a medical treatment or surgery.
If your child does not take all of the dabigatran oral pellets, do not give another dose at that time. Instead, go back to the standard schedule.
Do not open more than one bottle of capsules containing dabigatran at a time. Only open a new bottle once all of the capsules in the old bottle have been used up.
Keep the dabigatran pill tightly closed at room temperature, away from moisture and heat. Keep the pills in the original container or blister pack until it’s time to take the medicine. Don’t put dabigatran capsules in a pill holder or pill box.
If it’s been more than 4 months since you first opened the bottle of dabigatran, you should throw away any pills that haven’t been used.
Oral dabigatran oral pellets should be kept at room temperature, away from heat and wetness. Keep the medicine in the silver metal bag it came in and don’t open it until you’re ready to take it. After opening the metal bag, you have 6 months to use the oral pellets.
What will happen if I don’t take a dose?
Take the medicine as soon as you can, but skip the missed dose if your next dose is coming up in less than 6 hours. Don’t take both doses at the same time.
Get a refill on your medication before you run out of all of your medicine.
What happens if I overdose?
Get help from a doctor right away or call 1-800-222-1222 to reach the Poison Help line.
If you take too much, you might bleed a lot.
What should I stay away from while I’m on dabigatran?
Don’t do things that could make you bleed or hurt yourself. When you shave or brush your teeth, be extra careful.
Dabigatran side effects
If you have hives, trouble breathing, or swelling in your face, lips, tongue, or throat, you may be having an allergic response.
If you have back pain, numbness, tingling, muscle weakness in your lower body, or you can’t control your bladder or bowels, these could all be signs of a spine blood clot.
Side effects from dabigatran could be very bad. Call your doctor right away if you have:
- bruising or bleeding that won’t stop (nosebleeds, bleeding gums, heavy menstrual or vaginal bleeding);
- headache, weakness, dizziness, or a feeling like you might pass out;
- bloody or tarry stools, coughing up blood, or vomit that looks like coffee grounds;
- urine that looks red, pink, or brown; or
- sudden pain, joint pain, or swelling.
Some common side effects of dabigatran include
- pain or soreness in the stomach,
- an upset or burning stomach,
- bleeding,
- heavy menstrual bleeding, or
- nausea, vomiting, diarrhea.
This isn’t a full list of all possible side effects, and there may be others. You should talk to your doctor about any side effects. You can call 1-800-FDA-1088 to tell the FDA about side affects.
How does dabigatran interact with other drugs?
Tell your doctor what drugs you’re taking. There are many drugs that can affect dabigatran, including:
- dronedarone;
- rifampin;
- ketoconazole;
- medicine used to prevent blood clots–enoxaparin, warfarin, heparin, clopidogrel, dipyridamole, prasugrel, and others; or
- NSAIDs (nonsteroidal anti-inflammatory drugs)–aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
This list is not full, and dabigatran may also interact with many other drugs. This includes medicines you get from a doctor or buy over the counter, vitamins, and herbal goods. Not every drug combination that could happen is on this list.
For more details,
Remember to keep this and all other medicines out of the reach of children, to never give your medicines to other people, and to only use Xadago for the reason your doctor told you to.
Talk to your doctor or other healthcare source to make sure that the information on this page applies to your situation.
Copyright 1996–2023 Cerner Multum, Inc. Version: 16.01.
