Pradaxa 75 Mg Capsule (10 Cap)

PRADAXA 75 MG CAPSULE is an anticoagulant medication used to prevent and treat various blood clot-related conditions.

Name

• Brand Name: PRADAXA
• Common Name: Dabigatran Etexilate

Composition

Each PRADAXA 75 MG CAPSULE contains 75 mg of dabigatran etexilate (as 86.48 mg dabigatran etexilate mesylate), which is the active ingredient.

Uses

PRADAXA is prescribed for:

• Reducing the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AFib).
• Treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adults who have already received parenteral anticoagulant treatment for 5-10 days.
• Reducing the risk of recurrent DVT and PE in adult patients.
• Prophylaxis of DVT and PE in adult patients following hip replacement surgery.
• Treatment of venous thromboembolic events (VTE) in pediatric patients aged 8 to less than 18 years, following at least 5 days of parenteral anticoagulation.

Dosage and Administration

PRADAXA capsules are typically taken orally twice daily, approximately every 12 hours. The 75 mg dose is recommended for specific patient populations, such as those with severe renal impairment (creatinine clearance 15-30 mL/min) for stroke risk reduction in NVAF, or when co-administered with certain P-gp inhibitors like dronedarone or systemic ketoconazole in patients with moderate renal impairment (CrCl 30-50 mL/min).

Capsules must be swallowed whole with a full glass of water. They should not be opened, broken, chewed, or the pellets emptied, as this can lead to mouth or throat ulcers and affect drug absorption. It can be taken with or without food; however, if stomach upset occurs, taking it with food may help. Do not discontinue PRADAXA without consulting a doctor, as premature cessation increases the risk of thrombotic events.

Side Effects

Common Side Effects:

• Gastrointestinal issues such as stomach pain, heartburn, indigestion, nausea, vomiting, and diarrhea.
• Minor bleeding, including nosebleeds, bleeding gums, easy bruising, or heavier menstrual bleeding.

Serious Side Effects:

• Severe or uncontrolled bleeding (e.g., bloody or tarry stools, red or dark brown urine, coughing or vomiting blood, severe headache, dizziness, unusual weakness).
• Increased risk of blood clots if the medicine is stopped prematurely.
• Spinal or epidural hematoma (blood clot around the spine) after spinal procedures, which can potentially lead to paralysis.
• Severe allergic reactions (e.g., skin rash, hives, swelling of the face, lips, tongue, or throat, trouble breathing).

Precautions

• Patients with an increased risk of bleeding (e.g., those over 75 years old, with kidney problems, recent bleeding, stomach ulcers, or taking other medications that affect clotting like NSAIDs or aspirin) should exercise caution.
• Concomitant use of PRADAXA with certain P-gp inhibitors (e.g., dronedarone, systemic ketoconazole, cyclosporine, itraconazole) should be avoided in patients with severe renal impairment (CrCl 15-30 mL/min).
• Inform healthcare providers about all medical conditions, especially kidney problems, bleeding issues, stomach ulcers, or antiphospholipid syndrome.
• Not recommended for patients with severely reduced liver function or those with prosthetic heart valves.
• Discuss pregnancy and breastfeeding with your doctor, as PRADAXA is generally not recommended unless the benefits outweigh the risks.
• Always inform healthcare professionals about PRADAXA before any surgery, dental work, or medical procedure due to the increased bleeding risk.

Storage

• Store PRADAXA capsules in their original bottle or blister package to protect them from moisture.
• Do not transfer capsules to pill boxes or other organizers.
• Keep in a cool, dry place, typically below 30°C (68-77°F).
• The bottle cap should be tightly closed immediately after removing a capsule.
• Dispose of any unused medication four months (or 60 days) after opening the bottle.

PRADAXA 75 MG CAPSULE: Frequently Asked Questions

What is Pradaxa used for?

Pradaxa (dabigatran etexilate) is an anticoagulant, also known as a blood thinner, used to prevent and treat blood clots. It is primarily prescribed to reduce the risk of stroke and systemic embolism in adults with non-valvular atrial fibrillation (an irregular heartbeat not caused by a heart valve problem). It is also used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) after initial treatment with an injectable anticoagulant, and to reduce the risk of their recurrence. Additionally, Pradaxa is used to prevent DVT and PE in adults following hip replacement surgery.

How does Pradaxa work?

Pradaxa works by directly inhibiting thrombin, a key protein (serine protease) in the blood clotting cascade. By blocking thrombin, Pradaxa prevents the conversion of fibrinogen to fibrin, which is essential for clot formation. This action helps to prevent the development of a thrombus (blood clot). Pradaxa inhibits both free and clot-bound thrombin and also affects thrombin-induced platelet aggregation. Pradaxa is a prodrug that is converted to its active form, dabigatran, after oral administration.

What is the usual dosage of Pradaxa 75 mg?

The dosage of Pradaxa 75 mg capsules depends on the patient's condition and kidney function. For adult patients with severe renal impairment (creatinine clearance (CrCl) 15-30 mL/min), the recommended dose for reducing the risk of stroke and systemic embolism in non-valvular atrial fibrillation is 75 mg taken orally twice daily. This dosage may also be considered for patients with moderate renal impairment (CrCl 30-50 mL/min) when co-administered with certain P-gp inhibitors like dronedarone or systemic ketoconazole. For some specific post-surgical preventions, like after knee replacement surgery, a daily dose of 150 mg (two 75 mg capsules) might be used for patients with moderately reduced kidney function or those over 75 years, initiated with a single 75 mg capsule within 1-4 hours post-surgery. It is crucial to follow your doctor's exact prescription.

What are the possible side effects of Pradaxa?

The most common side effects of Pradaxa include indigestion, upset stomach, heartburn, and bleeding or bruising more easily than usual (e.g., nosebleeds, bleeding gums). More serious side effects, though less common, can include severe bleeding, which can sometimes be fatal. Other potential serious side effects include an increased risk of blood clots if the medication is stopped prematurely, and spinal or epidural blood clots if spinal procedures are performed. Allergic reactions are also possible.

Is Pradaxa safe during pregnancy or breastfeeding?

Pradaxa is generally not recommended during pregnancy unless your doctor advises it is safe. It is not known if Pradaxa will harm an unborn baby, and pregnant rats treated with dabigatran showed increased risk of bleeding-related offspring and maternal death during labor. Females of child-bearing age should avoid becoming pregnant while taking Pradaxa. It is not known if dabigatran passes into human breast milk. Therefore, breastfeeding is generally not recommended while taking Pradaxa. Discuss pregnancy planning and feeding your baby with your healthcare provider.

Can Pradaxa be taken with other medications?

Pradaxa can interact with various medications, increasing the risk of bleeding. It is important to inform your doctor about all medicines, vitamins, and herbal supplements you are taking. Medications that increase the risk of bleeding, such as anti-platelet agents (e.g., aspirin, clopidogrel), other anticoagulants (e.g., warfarin, heparin, rivaroxaban, apixaban), fibrinolytic therapy, and chronic use of NSAIDs (e.g., ibuprofen, naproxen) should generally be avoided or used with caution. Concomitant use of P-gp inhibitors (e.g., dronedarone, systemic ketoconazole, amiodarone, quinidine, clarithromycin) can increase dabigatran levels, especially in patients with renal impairment, and may require a dose adjustment to 75 mg twice daily. P-gp inducers (e.g., rifampin) can reduce dabigatran exposure and should generally be avoided.

What precautions should be taken?

Patients taking Pradaxa should be aware of an increased risk of bleeding. Be cautious with activities that may cause injury and report any signs of unusual bleeding or bruising to your doctor immediately. Do not stop taking Pradaxa without consulting your healthcare provider, as premature discontinuation can increase the risk of blood clots and stroke. Inform your care team about all medical conditions, especially kidney or liver problems, bleeding disorders, recent surgery or trauma, stomach ulcers, or if you have an artificial heart valve. Before any surgery, dental work, or medical procedure, tell your healthcare provider that you are taking Pradaxa. They may advise you to temporarily stop the medication.

What happens if a dose is missed?

If you miss a dose of Pradaxa, take it as soon as you remember. However, if your next dose is less than 6 hours away, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

How should Pradaxa capsules be stored?

Pradaxa capsules should be stored at room temperature, typically between 68°F to 77°F (20°C to 25°C). It is crucial to keep Pradaxa capsules in their original bottle or blister package to protect them from moisture. Do not put them into pill boxes or other pill organizers. After opening the bottle, use the capsules within 4 months (some sources say 60 days for bottles, refer to specific product label). Always close the bottle tightly immediately after taking a dose. Safely discard any unused capsules after the specified period.