Generic Name: dabigatran (DA-bi-GAT-ran)
Brand Name: Pradaxa
Do not stop taking Pradaxa without checking with your doctor. This may increase the risk of developing a blood clot, including stroke in certain patients. If you need to stop taking Pradaxa, follow your doctor's directions carefully.
Tell your doctor you use Pradaxa before you have any type of spinal or epidural procedure. Patients who have these procedures while they use Pradaxa are at risk of serious bleeding problems on or near the spine. This could result in long-term or permanent paralysis.
The risk is increased in patients who have a certain type of epidural catheter. It is also increased in patients with a history of traumatic or repeated epidural or spinal puncture, a deformed spine, or spinal surgery. It is also increased in patients who use medicines that may affect blood clotting, such as other anticoagulants (eg, warfarin), aspirin, platelet inhibitors (eg, clopidogrel), and nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen).
If you have a spinal or epidural procedure while you use Pradaxa, tell your doctor at once if you notice any symptoms of nerve problems (eg, back pain, numbness [especially in the legs and feet], tingling, muscle weakness, paralysis, loss of bowel or bladder control).
Talk with your doctor if you have recently had or will be having a spinal or epidural procedure. Some time may need to pass between the use of Pradaxa and your procedure. Discuss any questions or concerns with your doctor.
Pradaxa is used for:
Reducing the risk of stroke and serious blood clots in certain patients with atrial fibrillation.
Pradaxa is a direct thrombin inhibitor. It works by preventing the formation of a blood clot.
Do NOT use Pradaxa if:
- you are allergic to any ingredient in Pradaxa
- you have certain types of active bleeding
- you have an artificial (prosthetic) heart valve
- you have severe kidney problems and you are also taking dronedarone or ketoconazole
Contact your doctor or health care provider right away if any of these apply to you.
Before using Pradaxa:
Some medical conditions may interact with Pradaxa. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have kidney problems or if you are on dialysis
- if you have had recent or repeated stomach or intestinal bleeding
- if you have a history of stomach ulcers, or blood or bleeding problems
- if you plan to have a valve in your heart replaced
- if you will be having surgery or other medical procedures (including dental procedures)
Some MEDICINES MAY INTERACT with Pradaxa. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Abciximab, anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel, prasugrel, ticagrelor, ticlopidine), apixaban, aspirin, eptifibatide, heparin, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), rivaroxaban, sulfinpyrazone, thrombolytics (eg, alteplase), or tirofiban because the risk of bleeding may be increased
- Dronedarone , ketoconazole, or quinidine because they may increase the risk of Pradaxa's side effects
- Enzalutamide, rifampin, or St. John's wort because they may decrease Pradaxa's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Pradaxa may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Pradaxa:
Use Pradaxa as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Pradaxa comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Pradaxa refilled.
- Take Pradaxa by mouth with or without food.
- Swallow Pradaxa whole. Do not break, crush, chew, or open before swallowing.
- Take Pradaxa with a full glass of water (8 oz/240 mL).
- Keep Pradaxa in the original bottle or blister package. Do not store it in any other bottle or container, such as pill boxes or pill organizers.
- When it is time to take your dose of Pradaxa, only remove 1 dose of medicine from the bottle. Close the bottle tightly right away after you remove your dose.
- Open only 1 bottle of Pradaxa at a time. Finish your opened bottle before you open a new bottle.
- If you miss a dose of Pradaxa, take it as soon as possible. If it is less than 6 hours until your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Pradaxa.
Important safety information:
- Do not suddenly stop taking Pradaxa without checking with your doctor. Doing so may increase the risk of stroke. If you need to stop taking Pradaxa for any reason, talk to the doctor who prescribed Pradaxa. You will need to find out when you should stop taking it. Your doctor will also tell you when to start taking Pradaxa again. Be sure to follow your doctor's directions carefully.
- Do not take Pradaxa more often than prescribed without checking with your doctor.
- When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not run out of Pradaxa.
- Pradaxa decreases blood clotting. It may make you bleed more easily or bleed longer. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding; pink or brown urine; dark, tarry, or bloody stools; if you cough up blood; or have vomit that looks like blood or coffee grounds.
- Call your doctor right away if you fall or injure yourself, especially if you hit your head. You may need to get checked out by your doctor.
- Tell your doctor or dentist that you take Pradaxa before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including kidney function, may be performed while you take Pradaxa. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Pradaxa with caution in the ELDERLY; they may be more sensitive to its effects, especially unusual or severe bleeding.
- PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Pradaxa while you are pregnant. It is not known if Pradaxa is found in breast milk. If you are or will be breast-feeding while you take Pradaxa, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Pradaxa:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; heartburn; indigestion; mild stomach pain or upset; nausea.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); black, tarry, or bloody stools; chest pain; confusion; coughing up blood; dizziness, weakness, or unusual headaches; fainting; joint pain, swelling, or discomfort; one-sided weakness; pink, brown, or dark urine; severe or persistent sore throat or stomach pain; slurred speech; unusual or persistent bruising or bleeding (eg, excessive bleeding from cuts, unusually heavy menstrual or vaginal bleeding, repeated nosebleeds, unusual bleeding from the gums); vision problems; vomit that looks like blood or coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Pradaxa:
Store Pradaxa between 59 and 86 degrees F (15 and 30 degrees C) in its original package. Store away from heat, moisture, and light. Do not store in the bathroom. Pradaxa may be packaged in a blister pack or a bottle. If your medicine comes in a bottle, it must be used within 4 months after opening the bottle. Throw away any unused medicine 4 months after opening the bottle. Keep Pradaxa out of the reach of children and away from pets.
- If you have any questions about Pradaxa, please talk with your doctor, pharmacist, or other health care provider.
- Pradaxa is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Pradaxa or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Pradaxa. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Pradaxa. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Pradaxa.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.