PRADAXA

Generic Name/API: dabigatran etexilate

Manufacturer: Boehringer Ingelheim

Dosage Forms & Strength & Pack Size:
Capsules: 75 mg, 110 mg and 150 mg

Storage:
Store PRADAXA Capsules at room temperature 68°F to 77°F (20°C to 25°C).
After opening the bottle, use PRADAXA Capsules within 4 months. Safely throw away any unused PRADAXA Capsules after 4 months.
Keep PRADAXA Capsules in the original bottle or blister package to keep them dry (protect the capsules from moisture). Do not put PRADAXA
Capsules in pill boxes or pill organizers.
Tightly close your bottle of PRADAXA Capsules right away after you take your dose.
Keep PRADAXA Capsules and all medicines out of the reach of children.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

PRADAXA Capsules is a direct thrombin inhibitor indicated:
To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation
(1.1)
For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2)
To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4)
For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5)
To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6)

WARNINGS AND PRECAUTIONS
Bleeding: PRADAXA can cause serious and fatal bleeding (5.2)
Bioprosthetic heart valves: PRADAXA use not recommended (5.4)
Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome: PRADAXA use not recommended (5.6)

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