What is dabigatran?

By

Generic Name: Dabigatran Brand Name(s): Generics only. No brands available.

Know the basics

What is dabigatran used for?

Dabigatran is used to prevent stroke and harmful blood clots (such as in your legs or lungs) if you have a certain type of irregular heartbeat (atrial fibrillation). With atrial fibrillation, part of the heart does not beat the way it should. This can lead to blood clots forming and increase your risk of a stroke or heart attack. Dabigatran is also used to treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and to reduce the risk of them occurring again. Dabigatran is an anticoagulant that works by blocking a certain substance (a clotting protein called thrombin) in your blood. This helps to keep blood flowing smoothly in your body.

Dabigatran should not be used to prevent blood clots from forming after artificial heart valve replacement. If you have had heart valve surgery, talk to your doctor about the best medication for you. Do not stop taking any medication, including dabigatran, without talking to your doctor first.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by yourhealth care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Dabigatran may also be used to prevent blood clots from forming in your legs or lungs after hip or knee replacement surgery.

How should I take dabigatran?

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking dabigatran and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take dabigatran by mouth with or without food as directed by your doctor, usually twice a day. To prevent clots after hip or knee replacement surgery, take it as directed by your doctor usually once a day. Avoid antacids within 24 hours after surgery, or dabigatran may not work as well.

Swallow the capsules whole with a full glass of water (8 ounces/240 milliliters). Do not crush, chew, or break open the capsules. Doing so can release all of the drug at once, increasing the risk of side effects. Do not put dabigatran in a pill box or medication reminder box. It must be kept tightly closed in the original bottle (orblister package) to protect it from moisture. See also Storage section for more important details.

The dosage is based on your medical condition, kidney function, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Use dabigatran regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

It is very important to take it exactly as directed. Do not increase your dose or take this drug more often than directed. Do not stop taking dabigatran without consulting your doctor.

How do I store dabigatran?

Dabigatran is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store dabigatran in the bathroom or the freezer. There may be different brands of dabigatran that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush dabigatran down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Know the precautions & warnings

What should I know before using dabigatran?

Before taking dabigatran,

  • Tell your doctor and pharmacist if you are allergic to dabigatran, any other medications, or any of the ingredients in dabigatran capsules. Ask your pharmacist or check the medication guide for a list of the ingredients.
  • Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: dronedarone (multaq), ketoconazole (nizoral), and rifampin (rifadin, rimactane, in rifamate, in rifater). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • Tell your doctor if you have had a valve in your heart replaced or if you have recently noticed any unusual bruising or bleeding. Your doctor probably will tell you not to take dabigatran.
  • Tell your doctor if you are 75 years of age or older; if you have or have ever had a bleeding problem, bleeding or an ulcer in your stomach or intestine; or kidney disease.
  • Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking dabigatran, call your doctor. Taking dabigatran may increase the risk that you will experience severe bleeding during labor and delivery.
  • If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking dabigatran.

Is it safe to take dabigatran during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this medication during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this medication. This medication is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Know the side effects

What are the side effects of dabigatran?

Side effects can include bruising and minor bleeding, nausea, and abdominal or stomach pain.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dabigatran and call your doctor at once if you have a serious side effect such as:

  • Any bleeding that will not stop;
  • Weakness, feeling like you might pass out;
  • Easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • Blood in your urine or stools, black or tarry stools;
  • Coughing up blood or vomit that looks like coffee grounds;
  • Pink or brown urine;
  • Joint pain or swelling;
  • Heavy menstrual bleeding.

Less serious side effects may include:

  • Stomach pain or upset, indigestion, heartburn;
  • Nausea, diarrhea; or
  • Mild skin rash or itching.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Know the interactions

What drugs may interact with dabigatran?

Dabigatran may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

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.

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, Anagrelide, 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, Phenobarbital, 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.

Does food or alcohol interact with dabigatran?

Dabigatran may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with dabigatran?

Dabigatran may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have, especially:

  • Bleeding, active;
  • Prosthetic (artificial) mechanical heart valve—Should not be used in patients with these conditions.
  • Bleeding problems, history of;
  • Kidney problems;
  • 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.

Understand the Dosage

The information provided is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist before using this medication.

What is the dose of Dabigatran for an adult?

Usual Adult Dose for Deep Vein Thrombosis – Prophylaxis

Recommended doses: 150 mg orally twice a day

Comments: Generally, the extent of anticoagulation does not need to be assessed with this drug; however, when necessary, use aPTT or ECT, and not INR to assess anticoagulant activity.

Uses: Reduction of risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days; reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated.

Usual Adult Dose for Prevention of Thromboembolism in Atrial Fibrillation

Recommended doses: 150 mg orally twice a day

Comments: Generally, the extent of anticoagulation does not need to be assessed with this drug; however, when necessary, use aPTT or ECT, and not INR to assess anticoagulant activity.

Uses: Reduction of risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days; reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated.

Renal Dose Adjustments

To Reduce Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation:
-CrCl greater than 30 mL/min: 150 mg orally twice a day
-CrCl 15 to 30 mL/min: 75 mg orally twice a day
-CrCl less than 15 mL/min: Dosing recommendation cannot be provided

When coadministered with dronedarone or systemic ketoconazole:
-CrCl 30 to 50 mL/min: Dose may be reduced to 75 mg twice a day

Concomitant use with P-gp inhibitors:
-CrCl 30 to 50 mL/min: No adjustment recommended
-CrCl less than 30 mL/min: Avoid coadministration

For Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism:
-CrCl greater than 30 mL/min: 150 mg orally twice a day
-CrCl less than 30 mL/min: Dosing recommendation cannot be provided

Concomitant use with P-gp inhibitors:
-CrCl less than 50 mL/min: Avoid coadministration

What is the dose of Dabigatran for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is dabigatran available?

Dabigatran is available in the following dosage forms and strengths:

  • Capsules, oral 75 mg
  • Capsules, oral 150 mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

Symptoms of overdose may include the following:

  • Unusual bruising or bleeding;
  • Pink or brown urine;
  • Red or black, tarry stools;
  • Vomiting material that is bloody or looks like coffee grounds;
  • Coughing up blood.

What should I do if I miss a dose?

If you miss a dose of dabigatran, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: May 30, 2016 | Last Modified: January 4, 2017

Want to live your best life?
Get the Hello Doktor Daily newsletter for health tips, wellness updates and more.
You might also like