Pradaxa (dabigatran etexilate 75mg) 60 Capsules/Pack

General Information

What is Pradaxa used for?

Pradaxa is used for several conditions involving clot prevention or management-

How does Pradaxa work?

Pradaxa is an anticoagulant (blood thinner) in the class of direct thrombin inhibitors. It works by inhibiting thrombin (factor IIa), which prevents clot formation and extension of existing clots. It is a prodrug (dabigatran etexilate) that is converted in the body to the active dabigatran.

What does Pradaxa contain?

The active ingredient is 75 mg dabigatran etexilate given as 86.48 mg dabigatran etexilate mesilate per capsule .

The inactive ingredients: Capsule fill is acacia, dimeticone , hyprolose , hypromellose , purified talc , tartaric acid. The Capsule shell is carrageenan, potassium chloride, titanium dioxide , Hypromellose, purified water.

What are the side effects of Pradaxa?

The common side effects are

• Dyspepsia (indigestion), upset stomach
• Stomach pain or GI discomfort

• Bleeding, including gastrointestinal bleeding, minor bleeding

When should Pradaxa not be used ?

• Bleeding: As with all anticoagulants, the biggest risk is bleeding (e.g. gastrointestinal, intracranial).
• Epidural hematoma: Especially in those receiving neuraxial anesthesia or spinal puncture.
• Premature discontinuation: Stopping the drug abruptly may increase risk of thrombotic events (clots).
• Severe renal impairment: In patients with CrCl ≤ 30 mL/min (or less), dosing recommendations may not be provided, or use may be contraindicated.
• Mechanical prosthetic heart valves: Use of dabigatran is contraindicated in patients with mechanical heart valves; higher risk of clot formation and bleeding in those cases.
• Pregnancy / lactation: Use in pregnancy or breastfeeding requires caution; data is limited.Patients should be monitored for signs of bleeding, changes in kidney function, and drug interactions.

What medications interact with Pradaxa?

1.       Other blood thinners (anticoagulants)

        These can greatly increase bleeding risk:

• Warfarin (Coumadin)
• Heparin
• Enoxaparin (Lovenox)
• Apixaban (Eliquis)
• Rivaroxaban (Xarelto)
• Edoxaban (Savaysa)

You should not take more than one anticoagulant unless your doctor specifically instructs you to.

2. Antiplatelet medications

Also increase bleeding risk when combined:

• Aspirin
• Clopidogrel (Plavix)
• Ticagrelor (Brilinta)
• Prasugrel (Effient)
• Dipyridamole (Persantin, Aggrenox)

3. Nonsteroidal anti-inflammatory drugs (NSAIDs)

Used for pain or inflammation — these can irritate your stomach and raise bleeding risk:

• Ibuprofen (Nurofen, Advil)
• Naproxen (Naprogesic)
• Diclofenac (Voltaren)
• Celecoxib (Celebrex)

4. Certain heart rhythm or blood pressure medications

These can increase Pradaxa levels in your body:

• Amiodarone
• Dronedarone
• Verapamil
• Quinidine

5. Some antibiotics and antifungal drugs

These affect how Pradaxa is cleared:

• Ketoconazole (oral)
• Itraconazole
• Clarithromycin
• Erythromycin

6. Certain antivirals (HIV or Hepatitis C medications)

These may raise Pradaxa levels:

• Ritonavir
• Cobicistat
• Boceprevir

7. Seizure medications that reduce Pradaxa effectiveness

• Carbamazepine
• Phenytoin
• Rifampin (an antibiotic often used for TB)

   Always tell your doctor or pharmacist if you start or stop any prescription medicine or Over-the-counter pain relievers or Herbal supplements (especially St. John’s Wort or ginkgo biloba)

How should Pradaxa be taken and for how long?

Pradaxa should be taken exactly as prescribed by your doctor, as the correct dose and duration depend on the reason you’re taking it, and your individual health situation. As a general overview:

• Take by mouth, usually twice a day (every 12 hours).
• Swallow the capsules whole with a full glass of water.
• Do not open, crush, or chew the capsules — doing so can increase the risk of side effects like bleeding.
• You can take Pradaxa with or without food.

Missed dose of Pradaxa

If your next dose is more than 6 hours away:
then take the missed dose as soon as you remember.

 If your next dose is less than 6 hours away:
then skip the missed dose. Just take your next dose at the regular time.

 Do NOT take a double dose to make up for a missed one.

If you miss multiple doses or aren’t sure what to do, contact your doctor, pharmacist, or anticoagulation clinic for advice.

How should Pradaxa be stored?

You should store your Pradaxa in a cool dry place below 30°C