Dabigatran

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

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

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Pradaxa^®

Dabigatran is part of the drug class:

• Direct thrombin inhibitors

• Store dabigatran at room temperature between 59°F to 86°F (15°C to 30°C). After opening the bottle, use dabigatran within 4 months. Safely throw away any unused dabigatran after 4 months.
• Keep dabigatran in the original bottle or blister package to keep it dry (protect the capsules from moisture). Do not put dabigatran in pill boxes or pill organizers.
• Tightly close your bottle of dabigatran right away after you take your dose.
• Keep dabigatran and all medicines out of the reach of children.

You should not take dabigatran if you are allergic to it, or if you have:

• an artificial heart valve; or

• any active bleeding from a surgery, injury, or other cause.

Dabigatran may cause you to bleed more easily, especially if:

• you have a stomach ulcer;

• you have recent or recurring bleeding in your stomach or intestines;

• you have kidney disease (especially if you also take dronedarone or ketoconazole);

• you take certain other medicines that can increase bleeding risk, such as aspirin, clopidogrel (Plavix), heparin, prasugrel, warfarin (Coumadin, Jantoven);

• you take an NSAID (nonsteroidal anti-inflammatory drug) on a regular basis, such as ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, indomethacin, meloxicam, and others; or

• you are older than 75.

Dabigatran can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if:

• you have a genetic spinal defect;

• you have a spinal catheter in place;

• you have a history of spinal surgery or repeated spinal taps;

• you have recently had a spinal tap or epidural anesthesia;

• you are taking an NSAID--Advil, Aleve, Motrin, and others; or

• you are using other medicines to treat or prevent blood clots.

To make sure dabigatran is safe for you, tell your doctor if you have:

• kidney disease;

• a history of stomach ulcer or bleeding; or

• if you are older than 75.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether dabigatran passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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.

Usual Adult Dose for Deep Vein Thrombosis/Pulmonary Embolism Prophylaxis Following Hip Replacement Surgery:

110 mg orally 1 to 4 hours after surgery and after hemostasis has been achieved, then 220 mg orally once a day for 28 to 35 days

Comments: If this drug is not started on the day of surgery, initiate treatment with 220 mg orally once a day after hemostasis has been achieved.

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 dabigatran, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to dabigatran 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.

Pediatric

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.

Geriatric

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

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.

Interactions with 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 dabigatran, 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 dabigatran 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.

• Defibrotide
• Itraconazole

Using dabigatran 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
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amiodarone
• Amtolmetin Guacil
• Anagrelide
• Anistreplase
• Apixaban
• Argatroban
• Aspirin
• Bemiparin
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Cangrelor
• Carbamazepine
• Celecoxib
• Choline Salicylate
• Cilostazol
• Clarithromycin
• Clonixin
• Clopidogrel
• Collagenase, Clostridium histolyticum
• Cyclosporine
• Dalteparin
• Danaparoid
• Darunavir
• Desirudin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Dronedarone
• Drotrecogin Alfa
• Droxicam
• Edoxaban
• Eliglustat
• Enoxaparin
• Epoprostenol
• Eptifibatide
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenofibrate
• Fenofibric Acid
• Fenoprofen
• Fepradinol
• Feprazone
• Flibanserin
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fondaparinux
• Fosphenytoin
• Heparin
• Ibuprofen
• Iloprost
• Indomethacin
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lepirudin
• Levomilnacipran
• Lornoxicam
• Lovastatin
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nintedanib
• Orlistat
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piracetam
• Piroxicam
• Pranoprofen
• Prasugrel
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Quinidine
• Ranolazine
• Reteplase, Recombinant
• Rifampin
• Ritonavir
• Rivaroxaban
• Rofecoxib
• Selexipag
• Simvastatin
• St John's Wort
• Streptokinase
• Sulfinpyrazone
• Sulindac
• Telaprevir
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tipranavir
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Treprostinil
• Urokinase
• Valdecoxib
• Venlafaxine
• Verapamil
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin

Interactions with Food/Tobacco/Alcohol

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 dabigatran. 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.

It is very important that your doctor check your progress at regular visits to make sure that dabigatran 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 dabigatran. You may need to stop using dabigatran for several days before having surgery, including dental procedures.

You may bleed and bruise more easily while you are using dabigatran. 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 dabigatran without asking first your doctor. Doing so may increase risk of blood clots and stroke.

dabigatran 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 dabigatran.

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

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.

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:

• 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

• 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

• 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.

Applies to dabigatran: oral capsule

Along with its needed effects, dabigatran 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 while taking dabigatran:

• 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

• 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

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

110 mg orally 1 to 4 hours after surgery and after hemostasis has been achieved, then 220 mg orally once a day for 28 to 35 days

Comments: If this drug is not started on the day of surgery, initiate treatment with 220 mg orally once a day after hemostasis has been achieved.

Data not available

When converting patients from warfarin therapy to dabigatran, discontinue warfarin and start dabigatran when the international normalized ratio (INR) is below 2.0.

When converting from dabigatran to warfarin, adjust the starting time of warfarin based on creatinine clearance as follows:
-CrCl greater than 50 mL/min, start warfarin 3 days before discontinuing dabigatran
-CrCl 30 to 50 mL/min, start warfarin 2 days before discontinuing dabigatran
-CrCl 15 to 30 mL/min, start warfarin 1 day before discontinuing dabigatran
-CrCl less than 15 mL/min, no recommendations can be made

When converting from a parenteral anticoagulant, start dabigatran 0 to 2 hours before the scheduled administration of the parenteral anticoagulant or at the time of discontinuation of a continuously administered parenteral anticoagulant.

When converting to a parenteral anticoagulant, start the parenteral anticoagulant 12 hours (CrCl 30 mL/min or greater) or 24 hours (CrCl less than 30 mL/min) after the last dose of dabigatran.