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Dabigatran Etexilate

Pronunciation

Generic Name: Dabigatran Etexilate (da BIG a tran ett EX ill ate)
Brand Name: Pradaxa

  • Do not stop taking dabigatran etexilate without talking to your doctor. Stopping this medicine when you are not supposed to may raise the chance of blood clots. This includes stroke in certain people. You may need to stop dabigatran etexilate before certain types of dental or health care. Your doctor will tell you when to start taking it again. Follow what your doctor tells you closely.
  • People who have any type of spinal or epidural procedure are more likely to have bleeding problems around the spine when already on this drug. This bleeding rarely happens, but can lead to not being able to move body (paralysis) long-term or paralysis that will not go away. The risk is raised in people who have problems with their spine, a certain type of epidural catheter, or have had spinal surgery. The risk is also raised in people who take any other drugs that may affect how the blood clots like blood-thinner drugs (like warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs). Talk with the doctor.
  • Tell your doctor you use this medicine before you have a spinal or epidural procedure. Call your doctor right away if you have any signs of nerve problems like back pain, numbness or tingling, muscle weakness, paralysis, or loss of bladder or bowel control.
  • Talk with your doctor if you have recently had or will be having a spinal or epidural procedure. Some time may need to pass between the use of dabigatran etexilate and your procedure. Talk with your doctor.

Uses of Dabigatran Etexilate:

  • It is used to thin the blood so that clots will not form.
  • It is used to treat blood clots.

What do I need to tell my doctor BEFORE I take Dabigatran Etexilate?

  • If you have an allergy to dabigatran etexilate or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have bleeding problems.
  • If you have had a heart valve replaced.
  • If you have kidney problems.
  • If you are taking any of these drugs: Dronedarone or ketoconazole.
  • If you are taking rifampin.
  • If you are taking or will be taking another drug like this one.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with dabigatran etexilate.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Dabigatran Etexilate?

  • Tell all of your health care providers that you take dabigatran etexilate. This includes your doctors, nurses, pharmacists, and dentists. This medicine may need to be stopped before certain types of surgery as your doctor has told you. If this medicine is stopped, your doctor will tell you when to start taking dabigatran etexilate again after your surgery or procedure.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor. Rarely, some bleeding problems have been deadly.
  • If you fall or hurt yourself, or if you hit your head, call your doctor right away. Talk with your doctor even if you feel fine.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using dabigatran etexilate while you are pregnant.

How is this medicine (Dabigatran Etexilate) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • To gain the most benefit, do not miss doses.
  • Keep taking dabigatran etexilate as you have been told by your doctor or other health care provider, even if you feel well.
  • Take with or without food.
  • Swallow whole. Do not chew, open, or crush.
  • Take with a full glass of water.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is less than 6 hours until the next dose, skip the missed dose and go back to the normal time.
  • Do not take 2 doses at the same time or extra doses.

See also: Dosage Information (in more detail)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Very bad dizziness or passing out.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Feeling confused.
  • Feeling very tired or weak.
  • Very bad headache.
  • Very bad swelling.
  • Very bad belly pain.
  • Joint pain or swelling.

What are some other side effects of Dabigatran Etexilate?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach.
  • Belly pain or heartburn.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Dabigatran Etexilate?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep capsules in the bottle they come in and do not move to a pill holder.
  • Keep lid tightly closed.
  • Throw away any unused capsules left in bottle after 4 months.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about dabigatran etexilate, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about dabigatran etexilate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using dabigatran etexilate.

Review Date: October 4, 2017

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