Pradaxa (Dabigatran)

Pradaxa (dabigatran) is a direct thrombin inhibitor anticoagulant used to reduce the risk of stroke and blood clots in adults and children. Dabigatran works by blocking thrombin, an enzyme that plays a role in the formation of blood clots. The medication is prescribed to decrease the risk of stroke in patients with nonvalvular atrial fibrillation, treat deep vein thrombosis and pulmonary embolism, and prevent blood clots after hip replacement surgery.

Directions

Take Pradaxa by mouth with or without food, swallowing the capsules whole with water. Don't break, chew, or open the capsules.

The standard dosage for preventing stroke in adults with atrial fibrillation is 150 mg twice daily. For patients with reduced kidney function, the dosage may be changed to 75 mg twice daily. When treating blood clots like deep vein thrombosis or pulmonary embolism, patients typically receive another blood thinner for 5 to 10 days before starting Pradaxa at 150 mg twice daily.

If a dose is missed, take it as soon as possible on the same day, but skip it if there are fewer than 6 hours until the next scheduled dose. Never take two doses at once to make up for a missed one. Patients should store Pradaxa in its original bottle and keep it tightly closed to protect it from moisture.

Ingredients

The active ingredient in Pradaxa is dabigatran.

Cautions

• Before using this medication, you may want to consult a healthcare provider about the following:
  • Any existing health conditions
  • Any allergies
  • A list of all medications currently being taken
• Pradaxa helps prevent dangerous blood clots, but stopping it suddenly can increase the risk of stroke or other clots. Do not stop taking it unless your healthcare provider tells you to.
• This medicine increases the risk of bleeding, which can sometimes be serious or life-threatening. Consult your provider if you notice unusual bruising, bleeding, dizziness, weakness, or signs of blood loss.
• The risk of bleeding is higher if you take Pradaxa with other medicines that thin the blood, such as aspirin, NSAIDs, or certain injectable blood thinners. Kidney problems can also increase bleeding risks because the drug stays in the body longer.
• A specific reversal medicine is available for adults if Pradaxa needs to be quickly stopped due to emergency surgery or severe bleeding. This option is not approved for children, and dialysis may help remove the drug in some cases.
• If you receive spinal or epidural anesthesia or have a spinal tap while on Pradaxa, there is a rare risk of bleeding around the spine that can cause long-term nerve damage or paralysis. Tell your provider right away if you develop back pain, numbness, weakness, or bladder or bowel problems.
• Pradaxa should not be used in people with mechanical heart valves because it has been linked to higher rates of clots and serious bleeding in these patients. It is also not recommended for certain other valve conditions.
• Some medications can change how Pradaxa works in your body, especially drugs that affect how it is absorbed or cleared by the kidneys. Your dose may need adjustment, or some drug combinations may need to be avoided.
• Pradaxa is not recommended for people with a condition called triple-positive antiphospholipid syndrome because it may increase the risk of repeat blood clots in these patients.

Contraindications

Avoid taking or using this medication if any of the following apply:

• Active pathological bleeding, such as bleeding ulcers or bleeding in the brain
• Serious hypersensitivity reaction to dabigatran, including anaphylaxis or severe allergic reactions
• Mechanical prosthetic heart valve, as Pradaxa shouldn't be used in people who have artificial heart valves

Side Effects

Common side effects of Pradaxa include:

• Indigestion or upset stomach
• Stomach or abdominal pain or discomfort
• Nausea
• Vomiting
• Diarrhea

These side effects are usually related to irritation of the stomach and may improve over time. Taking Pradaxa exactly as prescribed can help reduce stomach discomfort. Let your healthcare provider know if digestive symptoms are persistent or bothersome.

More serious reactions can occur, including allergic reactions. Seek medical help right away if you develop chest tightness, trouble breathing or wheezing, swelling of the face or tongue, dizziness, or fainting. Contact your healthcare provider if you notice hives, rash, or itching, as these may be early signs of an allergic reaction.