dabigatran etexilate 75 mg
1 INDICATIONS AND USAGE Dabigatran etexilate capsules are 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 ) 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. 1.5 Treatment of Venous Thromboembolic Events in Pediatric Patients Dabigatran etexilate capsules are indicated 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 [see Dosage and Administration (2.3) ] . 1.6 Reduction in the Risk of Recurrence of Venous Thromboembolic Events in Pediatric Patients Dabigatran etexilate capsules are indicated to reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated [see Dosage and Administration (2.3) ] .
mylan pharmaceuticals inc.
CAPSULE WHITE MYLAN DE 75
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dabigatran etexilate 150 mg
mylan pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
DABIGATRAN ETEXILATE capsules are available containing 86.48 mg or 172.95 mg of
DABIGATRAN ETEXILATE mesylate equivalent to 75 mg or 150 mg of
DABIGATRAN ETEXILATE, respectively. The 75 mg capsules are hard-shell hypromellose capsules with a white opaque cap and a white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over DE 75 in black ink on both the cap and body. They are available as follows: NDC 0378-0265-93 bottles of 30 capsules NDC 0378-0265-91 bottles of 60 capsules The 150 mg capsules are hard-shell hypromellose capsules with a light purple opaque cap and a white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over DE 150 in black ink on both the cap and body. They are available as follows: NDC 0378-0266-93 bottles of 30 capsules NDC 0378-0266-91 bottles of 60 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Once opened, the product must be used within 4 months. Keep the bottle tightly closed. Store in the original package to protect from moisture. PHARMACIST: Dispense a Medication Guide with each prescription.
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