"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
WARNING: Do not stop taking dabigatran unless directed by your doctor. If you have to stop taking it, you may have a higher risk of forming a blood clot, which may increase your risk of having a stroke. Your doctor may direct you to take a different "blood thinning" or anti-platelet medication to reduce your risk. Get medical help right away if you have any of the following symptoms: weakness on one side of the body, slurred speech, sudden vision changes, or confusion.
USES: Dabigatran is used to prevent blood clots from forming because of a certain type of irregular heartbeat (atrial fibrillation). Preventing these blood clots helps to reduce the risk of a stroke. Dabigatran is an anticoagulant that works by blocking a certain substance (a type of clotting protein called thrombin) in your blood.
Dabigatran should not be used to prevent blood clots from forming after mechanical heart valve replacements. If you 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 your health 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.
This medication may also be used to prevent blood clots from forming in your legs or lungs after hip or knee replacement surgery.
HOW TO USE: See also Warning section.
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 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 this medication in 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 also Storage section for more important details.
Dabigatran is usually taken once a day to prevent clots after surgery or twice a day to prevent clots from irregular heartbeat (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 taking it unless directed by your doctor.
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 this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.
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