What is Pradaxa (dabigatran)?

Pradaxa, also known as dabigatran, is an anticoagulant medication used to reduce the risk of stroke, systemic embolism, deep venous thromboembolism (DVT), and pulmonary embolism (PE) in at-risk patients.

Pradaxa (Dabigatran)

Prescription Required.

Product of Canada.

Express Ships from Canada.

Prescription Required.
Product of Canada.
Express Ships from Canada.

What is Pradaxa (dabigatran)?

Pradaxa, also known as dabigatran, is an anticoagulant medication used to reduce the risk of stroke, systemic embolism, deep venous thromboembolism (DVT), and pulmonary embolism (PE) in at-risk patients.

How does Pradaxa work?

Pradaxa (dabigatran) is a direct thrombin inhibitor. Thrombin converts fibrinogen to fibrin during the coagulation cascade leading to a thrombus (blood clot). Thrombin inhibition prevents the development of a thrombus.

Dosage and How to Use

Pradaxa is available in the following dosage forms and strengths:

  • 75 mg capsule
  • 110 mg capsule
  • 150 mg capsule

Pradaxa is dosed based on kidney function (creatinine clearance, CrCl), and the dosing is different for each indication. The typical dosing for most indications in patients with normal renal function (CrCl > 30 mL/min) is 150 mg twice daily, but make sure to take the medication exactly as directed by your doctor.

Pradaxa must be swallowed whole and cannot be chewed or crushed. Pradaxa should be taken with a full glass of water and can be taken with or without food.

If a dose of Pradaxa is not taken at the scheduled time, take the dose as soon as possible on the same day. The missed dose should be skipped if it cannot be taken at least 6 hours before the next scheduled dose. The Pradaxa dose should never be doubled up to make up for the missed dose.

Storage

Store at 25°C (77°F). Temperature excursions are permitted between 15° to 30°C (59° to 86°F). Once a bottle is opened, the product must be used within 4 months. Keep the bottle tightly closed. Store in the original bottle or blister pack to protect from moisture. Keep Pradaxa out of reach of children.

Overdosage

If there has been an overdose of Pradaxa, seek medical attention due to the risk of hemorrhagic complications. Praxbind (idarucizumab) is a reversal agent for Pradaxa that can be given under medical supervision.

Side Effects

The common side effects of Pradaxa may include the following:

  • Indigestion, upset stomach, or burning
  • Stomach pain

Serious side effects are possible with Pradaxa. Contact your doctor right away if you experience one of the following signs or symptoms of a serious side effect:

  • Unexpected bleeding
    • Unusual bleeding from the gums
    • Nose bleeds
    • Abnormal vaginal bleeding
  • Pink or brown urine
  • Red or black stool
  • Unusual bruising or bruises that get larger
  • Vomiting or coughing up blood
  • Headaches, feeling dizzy or weakness
  • Unexpected pain, swelling, or joint pain
  • Signs of an allergic reaction such as rash, hives, swollen skin, trouble breathing, or swelling of the lips and face

This is not a comprehensive list of all the possible side effects of Pradaxa. Please contact your doctor or pharmacist for more information.

Warnings & Precautions

Boxed Warnings

Premature discontinuation or Pradaxa Increases the Risk of Thrombotic Events

  • Premature discontinuation of any oral anticoagulant, including Pradaxa, increases the risk of thrombotic events. If anticoagulation with Pradaxa is discontinued for reasons other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.

Spinal/Epidural Hematoma

  • Epidural or spinal hematomas may occur in patients treated with Pradaxa who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis.

Other Warnings & Precautions

Risk of Bleeding

  • Pradaxa increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.

Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves

  • The safety and efficacy of Pradaxa in patients with bi-leaflet mechanical prosthetic heart valves was evaluated in the RE-ALIGN trial. Patients with bi-leaflet mechanical prosthetic heart valves were randomized to dose-adjusted warfarin or 150, 220, or 300 mg of Pradaxa twice daily. RE-ALIGN was terminated early due to significantly more thromboembolic events and an excess of major bleeding in the Pradaxa treatment arm compared to the warfarin treatment arm.

Effect of P-gp Inducers and Inhibitors on Dabigatran Exposure

  • The concomitant use of Pradaxa with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should be avoided if possible.

Drug Interactions and Other Interactions

Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation

  • The concomitant use of Pradaxa with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should be avoided if possible.

Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism

  • Avoid use of PRADAXA and P-gp inhibitors in patients with CrCl <50 mL/min

Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement Surgery

  • In patients with CrCl ?50 mL/min who have concomitant administration of P-gp inhibitors  (e.g., dronedarone or systemic ketoconazole), it is recommended to separate the timing of administration of Pradaxa and the P-gp inhibitor by several hours. The concomitant use of Pradaxa and P-gp inhibitors in patients with CrCl <50 mL/min should be avoided.

Contraindications

Pradaxa is contraindicated in patients with any of the following:

  • Active pathological bleeding
  • History of serious hypersensitivity reaction to Pradaxa
  • Mechanical prosthetic heart valve

Frequently Asked Questions

Pradaxa, also known as dabigatran, is a prescription medication used to prevent blood clots in certain patients at risk for stroke or blood clots in the legs or lungs.

Pradaxa (dabigatran) works by inhibiting an enzyme in your body called thrombin. Inhibiting thrombin prevents blood clots from forming.

You should not take Pradaxa if you have the following:

  • Active bleeding
  • History of serious allergic reaction to Pradaxa
  • Had a valve in your heart replaced

Take Pradaxa exactly as instructed by your doctor. Do not stop taking Pradaxa without speaking to your doctor. Abruptly stopping Pradaxa can increase your risk of stroke.

You must swallow Pradaxa whole, and it cannot be chewed or crushed. Pradaxa should be taken with a full glass of water every 12 hours and can be taken with or without food.

If a dose of Pradaxa is not taken at the scheduled time, take the dose as soon as possible on the same day. The missed dose should be skipped if it cannot be taken at least 6 hours before the next scheduled dose.

The Pradaxa dose should never be doubled up to make up for the missed dose.

The most common side effects of Pradaxa are stomach pain, indigestion, upset stomach, and heartburn. This is not a complete list of all possible side effects. Reach out to your pharmacist or doctor for more information.

Serious side effects are possible with Pradaxa. Contact your doctor immediately if you have any of the following signs of a serious side effect.

  • Unexpected bleeding
    • Unusual bleeding from your gums or nose
    • Abnormal vaginal bleeding
  • Pink or brown urine
  • Red or black stool
  • Unusual bruising or bruises that get larger
  • Vomiting or coughing up blood
  • Headaches, feeling dizzy, or weakness
  • Unexpected pain, swelling, or joint pain
  • Signs of an allergic reaction such as rash, hives, swollen skin, trouble breathing, or swelling of the lips and face

This is not a complete list of all the possible side effects of Pradaxa. Please contact your doctor or pharmacist for more information.

The active ingredient in Pradaxa is dabigatran etexilate mesylate. The inactive ingredients include acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid. The capsule shell is composed of carrageenan, hypromellose, potassium chloride, titanium dioxide, black edible ink, and FD&C Blue No. 2 (150 mg and 110 mg capsules only) or FD&C Yellow No. 6 (150 mg and 75 mg capsules only).

Store Pradaxa between 15° to 30°C (59° to 86°F). Once a bottle is opened, the medication must be used within 4 months. Keep the bottle tightly closed.

Always store in the original bottle or blister pack to protect from moisture. Keep Pradaxa out of reach of children.

If you miss a scheduled dose of Pradaxa, take the dose as soon as you remember on the same day. The missed dose should be skipped if it cannot be taken at least 6 hours before the next scheduled dose. You should not take 2 doses at once to make up for the missed dose.

Pradaxa does interact with medications that affect a specific transporter in your body called P-gp. Make sure your doctor knows about all the medications that you are taking, including prescription, over the counter, and natural supplements. Talk to your doctor or pharmacist before taking any new medications.

If you overdose on Pradaxa, seek medical attention due to the risk of bleeding complications. Praxbind (idarucizumab) is a reversal agent for Pradaxa that can be given under medical supervision.

Before taking Pradaxa, make sure to tell your doctor if you have any of the following:

  • have kidney problems
  • have ever had bleeding problems
  • have ever had stomach ulcers
  • have any other medical condition
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed
  • Tell your doctor about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements

If possible, avoid activities that have a high risk of bruising, bleeding, or serious injury. Be careful to prevent bleeding while shaving or brushing your teeth.

Pradaxa is not known to have interactions with any foods.

Always refill your Pradaxa prescription ahead of time, so you do not run out of medication. Abruptly stopping Pradaxa will increase your risk of forming a blood clot.