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Brand Name
Pradax
Common Name
dabigatran
How does this medication work? What will it do for me?

Dabigatran belongs to the family of medications called anticoagulants. Anticoagulants prevent harmful blood clots from forming in the blood vessels by reducing the ability of the blood to clot. Dabigatran is used to prevent blood clots for people who have had total hip replacement or knee replacement surgery.

Dabigatran is also used to prevent stroke or blood clots in people with atrial fibrillation.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

For knee replacement surgery, the usual dose of dabigatran is 110 mg (one capsule) taken by mouth between 1 and 4 hours after the surgery, followed by 220 mg (2 capsules) once daily for a total of 10 days. If treatment is not started on the day of surgery, then treatment should be started with a dose of 220 mg once daily.

For hip replacement surgery, the usual dose of dabigatran is 110 mg (one capsule) taken by mouth between 1 and 4 hours after the surgery, then followed by 220 mg (2 capsules) once daily for a total of 28 to 35 days. If treatment is not started on the day of surgery, then treatment should be started with a dose of 220 mg once daily.

For stroke and clot prevention in people with atrial fibrillation, the usual dose is 300 mg taken as one 150 mg capsule twice daily. For people with a high risk of bleeding, the doctor may recommend a lower dose of 220 mg taken as one 110 mg capsule twice daily.

Dabigatran may be taken with food or on an empty stomach, with water. Swallow the capsules whole. Do not open, break, or chew the capsules.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from moisture, and keep it out of the reach of children.

What form(s) does this medication come in?

75 mg
Each light blue and cream-coloured capsule filled with yellowish pellets, imprinted with the Boehringer Ingelheim company symbol on one end and "R75" on the other end, contains 75 mg of dabigatran etexilate base. Nonmedicinal ingredients: tartaric acid, acacia, hypromellose, dimethicone, talc, and hydroxypropyl cellulose; capsule shell: carragenan, potassium chloride titanium dioxide, Sunset Yellow (E 110), Indigo Carmin (132), hypromellose, purified water, shellac, iron oxide black, and propylene glycol.

110 mg
Each light blue and cream-coloured capsule filled with yellowish pellets, imprinted with the Boehringer Ingelheim company symbol on one end and "R110" on the other end, contains 110 mg of dabigatran etexilate base. Nonmedicinal ingredients: tartaric acid, acacia, hypromellose, dimethicone, talc, and hydroxypropyl cellulose; capsule shell: carragenan, potassium chloride titanium dioxide, Sunset Yellow (E 110), Indigo Carmin (132), hypromellose, purified water, shellac, iron oxide black, and propylene glycol.

150 mg
Each light blue and cream-coloured capsule filled with yellowish pellets, imprinted with the Boehringer Ingelheim company symbol on one end and "R150" on the other end, contains 150 mg of dabigatrin etexilate base. Nonmedicinal ingredients: tartaric acid, acacia, hypromellose, dimethicone 350, talc, and hydroxypropyl cellulose; capsule shell: carragenan, potassium chloride titanium dioxide, Sunset Yellow (E 110), Indigo Carmin (132), hypromellose, purified water, shellac, iron oxide black, and propylene glycol.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to dabigatran or any ingredients of this medication
  • are taking certain other medications such as ketoconazole
  • are taking medications to reduce blood clotting (e.g., warfarin, heparin, enoxaparin)
  • have any condition that is associated with an increased risk of bleeding (e.g., bleeding problems)
  • have or have had a body lesion at risk of bleeding, such as a stroke within the past 6 months
  • have severely reduced kidney function
What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • bruising (mild)
  • diarrhea
  • nausea
  • stomach pain
  • upset stomach

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • bleeding or oozing from the surgical wound
  • joint pain or swelling
  • signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, cuts that don't stop bleeding, bleeding in the rectum or from hemorrhoids, bleeding from where a catheter enters a vein )
  • symptoms of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools, itching)
  • symptoms of unidentified bleeding (e.g., weakness, paleness, dizziness, headache, unexplained swelling)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (i.e., hives, difficulty breathing, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

December 21, 2012

Health Canada has issued new information concerning the use of Pradaxa® (dabigatran). To read the full Health Canada Advisories, visit Health Canada's web site at www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/pradaxa_hpc-cps-eng.php and www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/pradax_pc-cp-eng.php.

Increased bleeding risk: If you have an increased risk of bleeding (e.g., recent biopsy; major trauma; brain, spinal, or eye surgery; taking medications that increase the risk of bleeding; bleeding disorders; stomach or intestinal ulcers; stroke; inflammation of certain parts of the heart), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney or liver disease: If you have kidney or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. People with severely reduced kidney function should not take this medication.

Spinal or epidural catheters: This medication should not be taken by people who have spinal or epidural catheters in place (or for 2 hours after their removal) or by people receiving pain medications through an epidural catheter.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if dabigatran passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Women taking this medication should not breast-feed.

Children: The safety and effectiveness of using this medication have not been established for children under 18 years of age.

Seniors: Seniors are more likely to have age-related reductions in kidney function. Your doctor may adjust your dose based on your kidney function.

If you are over 75 years of age and taking dabigatran after knee or hip surgery, your doctor will likely prescribe a lower dose of 150 mg once daily. If you are 80 years of age or older and taking dabigatran to prevent a stroke or blood clots due to atrial fibrillation, your doctor will likely prescribe a lower dose of 110 mg twice daily.

What other drugs could interact with this medication?

There may be an interaction between dabigatran and any of the following:

  • acetylsalicylic acid
  • alteplase
  • amiodarone
  • antacids (e.g., aluminum hydroxide, sodium bicarbonate, calcium or magnesium compounds)
  • atorvastatin
  • carbamazepine
  • carvedilol
  • clarithromycin
  • clopidogrel
  • corticosteroids (e.g., hydrocortisone, methylprednisone, prednisone)
  • cyclosporine
  • dalteparin
  • dipyridamole
  • doxorubicin
  • enoxaparin
  • fondaparinux
  • grapefruit juice
  • heparin
  • itraconazole
  • ketoconazole
  • lopinavir
  • nelfinavir
  • nicardipine
  • nonsteroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
  • pantoprazole
  • prazosin
  • propranolol
  • quinidine
  • rifampin
  • ritonavir
  • saquinavir
  • St. John's wort
  • sulfinpyrazone
  • tacrolimus
  • tamoxifen
  • tenofovir
  • ticlopidine
  • tipranavir
  • trazodone
  • verapamil
  • vinblastine
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.





The contents of this site are for informational purposes only. Always seek the advice of your physician or other qualified healthcare provider regarding any questions you may have about a medical condition.
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