Dabigatran (By mouth)

Introduction

Dabigatran Etexilate Mesylate (da-bye-GAT-ran e-TEX-i-late MES-i-late)

Prevents stroke and blood clots in patients with a heart rhythm problem called nonvalvular atrial fibrillation.

Brand Name(s)

There may be other brand names for this medicine.

Pradaxa

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to dabigatran, or if you are actively bleeding for any reason.

How to Use This Medicine

Capsule

  • Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
  • You may take this medicine with or without food.
  • Swallow the capsules whole. Do not break, crush, or chew them. Do not open the capsules and sprinkle the pellets over food or into liquids.
  • This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.
  • If you are taking another medicine to thin the blood, (e.g., heparin, warfarin, or Coumadin®), your doctor will give you very specific instructions about how to switch to dabigatran. Carefully follow the instructions and ask your doctor if you have any questions.

If a dose is missed:

  • If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose. If you have less than 6 hours before your next scheduled dose, skip the missed dose and go back to your regular dosing schedule.

How to Store and Dispose of This Medicine

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep your medicine in the original package (blister package or bottle) until you are ready to use it. After you open a bottle for the first time, you must take all of the capsules within 30 days. If you have not used the capsules within 30 days, you must dispose of the remaining capsules and start a new bottle.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
  • Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are also using rifampin (Rifadin®, Rimactane®), a blood thinner (such as heparin, warfarin, or Coumadin®), or pain or arthritis medicines that are also called NSAIDs (such as aspirin, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Motrin®, Relafen®, or Voltaren®).

Warnings While Using This Medicine

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease.
  • You may bleed and bruise more easily while you are using this medicine. Be extra careful to avoid injuries. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Gently brush and floss your teeth. Be careful when using sharp objects, including razors and fingernail clippers. Avoid picking your nose. If you need to blow your nose, blow it gently.
  • Check with your doctor right away if you have any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; headache, dizziness, or weakness; pain, swelling, or discomfort in a joint; pinpoint red spots on your skin; unusual nosebleeds; or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.
  • Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
  • Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
  • Black, tarry stools.
  • Red or dark brown urine or stools.
  • Stomach upset or pain, heartburn, or indigestion.
  • Unusual bleeding, bruising, or weakness.
  • Unusual nosebleeds or vaginal bleeding.
  • Vomiting of blood or material that looks like coffee grounds.

If you notice these less serious side effects, talk with your doctor:

  • Nausea or vomiting.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Review Date: 2011-02-04 Reviewed By: Keywords: ,
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