Pronunciation: DA-bi-GAT-ran
Generic Name: Dabigatran
Brand Name: Pradaxa
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 severe kidney problems and you are also taking dronedarone or ketoconazole
- you are taking St. John's wort
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 blood or bleeding problems, kidney problems, or are on dialysis
- if you have had recent or repeated stomach or intestinal bleeding, or if you have a history of stomach ulcers
- 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 agents (eg, clopidogrel, prasugrel), aspirin, direct factor Xa inhibitors (eg, rivaroxaban), dronedarone, eptifibatide, heparin, ketoconazole, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), quinidine, sulfinpyrazone, thrombolytics (eg, alteplase), ticlopidine, or tirofiban because the risk of bleeding may be increased
- 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.
- 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.
- 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.
- 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 tests, 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.
- Pradaxa should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- 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:
Diarrhea; heartburn; indigestion; mild stomach pain or upset; nausea.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; 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 bruising or bleeding (eg, excessive bleeding from cuts, unusually heavy menstrual or vaginal bleeding, repeated nosebleeds, unusual bleeding from 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .
See also: Pradaxa side effects (in more detail)
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. Symptoms may include unusual or severe bruising or bleeding.
Proper storage of Pradaxa:
Store this 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.
General information:
- 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 you 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 is a summary only. It does not contain all information about Pradaxa. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
More Pradaxa resources
- Pradaxa Side Effects (in more detail)
- Pradaxa Use in Pregnancy & Breastfeeding
- Drug Images
- Pradaxa Drug Interactions
- Pradaxa Support Group
- 38 Reviews for Pradaxa - Add your own review/rating
- Pradaxa Prescribing Information (FDA)
- Pradaxa Advanced Consumer (Micromedex) - Includes Dosage Information
- Pradaxa Consumer Overview
Compare Pradaxa with other medications
- Prevention of Thromboembolism in Atrial Fibrillation
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