"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."...
Pradaxa Consumer (continued)
Some products that may interact with this drug include: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin, enoxaparin).
Other medications can affect the removal of dabigatran from your body, which may affect how dabigatran works. Examples include amiodarone, dronedarone, ketoconazole, quinidine, rifampin, St. John's wort, and verapamil, among others.
Aspirin, aspirin-like drugs (salicylates), and nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, naproxen, celecoxib) may have effects similar to dabigatran. These drugs may increase the risk of bleeding problems if taken during treatment with dabigatran. Carefully check all prescription/nonprescription product labels (including drugs applied to the skin such as pain-relieving creams) since the products may contain NSAIDs or salicylates. Talk to your doctor about using a different medication (such as acetaminophen) to treat pain/fever. Ask your doctor if low-dose aspirin and related drugs (such as clopidogrel, ticlopidine) should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention. Consult your doctor or pharmacist for more details.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: bloody/black/tarry stools, pink/dark urine, unusual/prolonged bleeding.
NOTES: Do not share this medication with others.
Laboratory and/or medical tests (such as kidney/liver function, clotting times) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is less than 6 hours until the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Open only one bottle at a time, and once the bottle is opened, the medication must be discarded after 4 months. If your capsules are in a blister package, then keep the capsules in the blister package until you are ready to take the medication. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
MEDICAL ALERT: Your condition and medication can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (US) or 1-800-668-1507 (Canada).
Information last revised November 2011. Copyright(c) 2011 First Databank, Inc.
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