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Capsule

Dabigatran Etexilate Mesylate

Strength: 150mg Count: 60

NDC

50268-200-16

Class

Rx

Brand Name

Pradaxa

Imprint Code

MD;75

Color(s)

White

Shape

Capsule

Score

No Score

Case Count

NA

Inactive Ingredients

croscarmellose sodium, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, magnesium stearate, talc, tartaric acid pellets. The capsule shell is composed of hypromellose, titanium dioxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac

Indications and Usage

1.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. 1.2 Treatment of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Dabigatran etexilate capsules are indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5-10 days. 1.3 Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated. 1.4 Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism in Adult Patients Following Hip Replacement Surgery Dabigatran etexilate capsules are indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients who have undergone hip replacement surgery.

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