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Dabigatran (Oral route)

Pronunciation:

da-bi-GAT-ran e-TEX-i-late MES-i-late

Brand Names:

  • Pradaxa

Dosage Forms:

  • Capsule

Warnings:

Oral route(Capsule)

Premature discontinuation of dabigatran etexilate mesylate increases the risk of thrombotic events. If anticoagulation with dabigatran etexilate mesylate must be discontinued for other than pathological bleeding, consider another anticoagulant. Epidural or spinal hematomas may occur with dabigatran etexilate mesylate therapy in patients undergoing neuraxial anesthesia or spinal puncture. Monitor patients for neurological impairment and treat urgently .

Classifications:

Therapeutic—

Anticoagulant

Pharmacologic—

Dabigatran Etexilate

Uses of This Medicine:

Dabigatran is used to decrease the risk of stroke and blood clots in patients with a serious heart rhythm problem called nonvalvular atrial fibrillation. Dabigatran is also used to treat and prevent blood clots (eg, deep vein thrombosis, pulmonary embolism) from occurring again in patients who already have received other medicines. It works by preventing harmful clots from forming in the blood vessels.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of dabigatran in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dabigatran in the elderly. However, elderly patients are more likely to have age-related stroke, bleeding, or kidney problems, which may require caution and an adjustment in the dose for patients receiving dabigatran.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Itraconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abciximab
  • Abiraterone Acetate
  • Aceclofenac
  • Acemetacin
  • Acenocoumarol
  • Alipogene Tiparvovec
  • Alteplase, Recombinant
  • Amiodarone
  • Amtolmetin Guacil
  • Anistreplase
  • Apixaban
  • Argatroban
  • Aspirin
  • Azithromycin
  • Bivalirudin
  • Bosutinib
  • Bromfenac
  • Bufexamac
  • Captopril
  • Carbamazepine
  • Carvedilol
  • Celecoxib
  • Choline Salicylate
  • Cilostazol
  • Clarithromycin
  • Clonixin
  • Clopidogrel
  • Cobicistat
  • Collagenase, Clostridium histolyticum
  • Conivaptan
  • Cyclosporine
  • Daclatasvir
  • Dalteparin
  • Danaparoid
  • Desirudin
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Diltiazem
  • Dipyridamole
  • Dipyrone
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Dronedarone
  • Drotrecogin Alfa
  • Eliglustat
  • Enoxaparin
  • Eptifibatide
  • Erythromycin
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Felodipine
  • Fenofibrate
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Fluoxetine
  • Flurbiprofen
  • Fondaparinux
  • Fosphenytoin
  • Heparin
  • Ibuprofen
  • Ibuprofen Lysine
  • Indomethacin
  • Ivacaftor
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Lepirudin
  • Levomilnacipran
  • Lomitapide
  • Lopinavir
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nilotinib
  • Nimesulide
  • Nintedanib
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Pentosan Polysulfate Sodium
  • Phenindione
  • Phenprocoumon
  • Phenylbutazone
  • Phenytoin
  • Piketoprofen
  • Piroxicam
  • Pranoprofen
  • Prasugrel
  • Primidone
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Protein C, Human
  • Quercetin
  • Quinidine
  • Ranolazine
  • Reteplase, Recombinant
  • Rifampin
  • Ritonavir
  • Rivaroxaban
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Simeprevir
  • Sodium Salicylate
  • St John's Wort
  • Streptokinase
  • Sulfinpyrazone
  • Sulindac
  • Sunitinib
  • Telaprevir
  • Tenecteplase
  • Tenoxicam
  • Tiaprofenic Acid
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tipranavir
  • Tirofiban
  • Tocophersolan
  • Tolfenamic Acid
  • Tolmetin
  • Ulipristal
  • Urokinase
  • Valdecoxib
  • Verapamil
  • Vorapaxar
  • Vortioxetine
  • Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding, active or
  • Prosthetic (artificial) mechanical heart valve—Should not be used in patients with these conditions.
  • Bleeding problems, history of or
  • Kidney problems or
  • Stomach bleeding or ulcers, recent—May have an increase risk of bleeding.
  • Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Also, do not stop using this medicine without checking first with your doctor.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the capsule whole with a full glass of water. Do not crush, break, chew, or open it.

If you are taking another medicine to thin the blood, (eg, heparin, warfarin, 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.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For prevention of stroke and blood clots in patients with nonvalvular atrial fibrillation:
      • Adults—75 to 150 milligrams (mg) two times a day.
      • Children—Use and dose must be determined by your doctor.
    • For treatment and prevention of blood clots from occurring again:
      • Adults—150 milligrams (mg) two times a day.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you have less than 6 hours before your next scheduled dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep your medicine in the original package (blister package or bottle) until you are ready to use it. Do not store the capsules in any other container (eg, pill boxes or pill organizers). After you open a bottle for the first time, you must take all of the capsules within 4 months. If you have not used the capsules within 4 months, you must dispose of the remaining capsules and start a new bottle.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine for several days before having surgery, including dental procedures.

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.

Do not suddenly stop using this medicine without asking first your doctor. Doing so may increase risk of stroke.

This medicine may increase your risk of developing spinal or epidural blood clot. This usually occurs if you have an epidural catheter placed in your back to give you certain medicine, are taking NSAIDs or medicine to prevent blood clotting, or have a history of spinal problems or have had surgery on your spine. Check with your doctor if you have midline back pain, loss of bladder or bowel control, or numbness, tingling, or weakness of your legs or feet while you are using this medicine.

Check with your doctor right away if you have stomach pain or upset, nausea, heartburn, or indigestion while you are taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Acid or sour stomach
belching
black, tarry stools
bloody stools
constipation
diarrhea
heartburn
indigestion
nausea
pain or burning in the throat
stomach discomfort, upset, burning, or pain
vomiting
vomiting of blood or material that looks like coffee grounds
Rare
Cough
difficulty with swallowing
dizziness
fainting or loss of consciousness
fast heartbeat
fast or irregular breathing
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
redness of the skin
skin rash, hives, welts, or itching skin
tightness in the chest
trouble breathing
unusual tiredness or weakness
Incidence not known
Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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


Last Updated: 11/4/2014

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