"Nov. 4, 2011 -- The FDA has approved Janssen's Xarelto to prevent stroke in patients with an abnormal heart rhythm called atrial fibrillation -- with a strong "black box" warning.
A black box warning is the FDA's strongest warning."...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
DABIGATRAN - ORAL
COMMON BRAND NAME(S): Pradaxa
USES: Dabigatran is used to prevent blood clots from forming because of a certain irregular heart rhythm (atrial fibrillation). Preventing these blood clots helps to reduce the risk of a stroke. Dabigatran is also approved in Canada to prevent blood clots from forming in your legs or lungs after hip or knee replacement surgery.
Dabigatran is an anticoagulant that works by blocking a certain substance (a type of clotting protein called thrombin) in your blood.
HOW TO USE: 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 this medication by mouth with or without food as directed by your doctor. Swallow the capsules whole. 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 transfer this medication to a pill box or medication reminder box. It must be kept tightly closed in the original bottle (or blister package) to protect it from moisture. See Storage section for additional important details.
Dabigatran is usually taken once a day to prevent clots after surgery or twice a day to prevent clots from atrial fibrillation. Avoid antacids within 24 hours after surgery, or dabigatran may not work as well. It is very important to take it exactly as directed. Do not increase the dose, take it more frequently, or stop using it unless directed by your doctor.
Dosage and treatment length are based on your medical condition, kidney function, and response to treatment. The dosage may also be based on 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 this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.
Additional Pradaxa Information
Pradaxa - User Reviews
Pradaxa User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
Find out what women really need.