Description

Pradaxa 110 mg hard capsules are indicated for:

1. Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
2. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension.
3. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
4. Treatment of VTE and prevention of recurrent VTE in paediatric patients from the time the child is able to swallow soft food to less than 18 years of age.

The recommended dose for primary prevention of VTE in orthopaedic surgery is 220 mg (2 capsules of 110 mg) taken as a single dose once daily, starting within 1-4 hours of completed surgery. Patients with moderately reduced kidney function (e.g. over 75 years) or patients taking certain medicines may have an increased risk of bleeding and may be prescribed a lower dose of 150 mg once daily, taken as 2 capsules of Pradaxa 75 mg.For stroke prevention in patients with atrial fibrillation, the recommended dose is 220 mg taken as 1 capsule of 110 mg in the morning and 1 capsule of 110 mg in the evening.Pradaxa 110 mg capsules are available in blister packs of 60 capsules. The capsules should be swallowed whole with a full glass of water and should not be crushed, chewed or broken open.                                                       

Unique Information

• Pradaxa 110 mg hard capsules are available in blister packs of 60 capsules.
• The capsules should be swallowed whole with a full glass of water and should not be crushed, chewed or broken open.

Indications

1. Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
2. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors.
3. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
4. Treatment of VTE and prevention of recurrent VTE in paediatric patients from the time the child is able to swallow soft food to less than 18 years of age.

Key Benefits of Pradaxa 110 mg Capsules

Based on the search results, the key benefits of Pradaxa 110 mg capsules include:

1. Reduced risk of debilitating or fatal strokes in patients with non-valvular atrial fibrillation (NVAF) and one or more risk factors .
2. Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or knee replacement surgery .
3. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults .
4. Treatment of VTE and prevention of recurrent VTE in pediatric patients from the time the child is able to swallow soft food to less than 18 years of age .

Key Ingredients

The key ingredient in Pradaxa 110 mg capsules is dabigatran etexilate, which is an anticoagulant or blood thinner that helps prevent and treat blood clots                                  

Pradaxa and Kidney Function

Based on the search results, the key points regarding how Pradaxa (dabigatran etexilate) affects kidney function are:Impaired Renal Function

• Impaired renal function is a major independent factor that can result in increased exposure to dabigatran, the active ingredient in Pradaxa .

Dosage Adjustments for Renal Impairment

• For patients with moderately reduced kidney function (e.g. over 75 years old), the recommended Pradaxa dose is lower at 150 mg once daily, taken as 2 capsules of 75 mg .
• For patients with atrial fibrillation and creatinine clearance (CrCl) between 30-50 mL/min, the use of certain P-gp inhibitors (e.g. dronedarone, ketoconazole) may require a dose reduction of Pradaxa .
• For treatment and prevention of DVT/PE, Pradaxa should be avoided if CrCl is less than 50 mL/min and P-gp inhibitors are being co-administered .
• For patients with severe renal impairment (CrCl <30 mL/min), the use of Pradaxa is not recommended, as it may lead to increased dabigatran exposure .

Dabigatran

Anticoagulant used to treat blood clots and prevent stroke

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Trade names

Pradaxa, Pradax, Prazaxa, others

Other names

BIBR-953, BIBR-1048

Drug class

Direct thrombin inhibitor

Dosage

• The recommended dose of Pradaxa 110 mg capsules is:
  • For stroke prevention in patients with atrial fibrillation: 220 mg taken as 1 capsule of 110 mg in the morning and 1 capsule of 110 mg in the evening.
  • For primary prevention of venous thromboembolism (VTE) after hip or knee replacement surgery: 220 mg (2 capsules of 110 mg) taken as a single dose once daily, starting within 1-4 hours of completed surgery.

Storage

• Pradaxa 110 mg capsules should be stored at room temperature between 20-25°C (68-77°F).
• The capsules should be kept in the original bottle or blister package to protect them from moisture.
• Once the bottle is opened, the capsules must be used within 4 months.
• The capsules should not be removed from the blister pack and repackaged into other containers like pill organizers.

Pradaxa 110 mg Capsule Reviews

Based on the available information, there are no specific reviews for the 110 mg strength of Pradaxa capsules. However, some general points about Pradaxa reviews include:

• Pradaxa is generally well-tolerated, with the most common side effects being indigestion, upset stomach, and minor bleeding.
• Some patients report good efficacy in preventing strokes and blood clots, especially compared to warfarin.
• A small percentage of patients experience more serious bleeding events, which is a known risk with all anticoagulant medications.
• Overall, Pradaxa appears to have a favorable benefit-risk profile when used as directed and with appropriate monitoring by healthcare providers.

The 110 mg strength is likely to have a similar safety and efficacy profile to the other Pradaxa dosage forms, but specific real-world data on the 110 mg capsules is limited in the available information.