apixaban 5 mg Eliquis
1 INDICATIONS AND USAGE ELIQUIS is a factor Xa inhibitor indicated: • to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. (1.1) • for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. (1.2) • for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE in adult patients following initial therapy. (1.3 , 1.4 , 1.5) • Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment. (1.6) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. 1.2 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. 1.3 Treatment of Deep Vein Thrombosis ELIQUIS is indicated for the treatment of adults with deep vein thrombosis (DVT). 1.4 Treatment of Pulmonary Embolism ELIQUIS is indicated for the treatment of adults with pulmonary embolism (PE). 1.5 Reduction in the Risk of Recurrence of Deep Vein Thrombosis and Pulmonary Embolism ELIQUIS is indicated to reduce the risk of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) in adult patients following initial therapy. 1.6 Treatment of Venous Thromboembolism and Reduction in the Risk of Recurrent Venous Thromboembolism in Pediatric Patients ELIQUIS is indicated for the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment.
E.R. Squibb & Sons, L.L.C.
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ELIQUIS (apixaban) tablets for oral use, ELIQUIS (apixaban) tablets for oral suspension, and ELIQUIS SPRINKLE (apixaban) for oral suspension are available as listed in the table below. Strength Dosage form/Description Markings Package Size NDC Code 0.15 mg Powder In a yellow, opaque capsule Printed with “898” Bottles of 28 0003-0898-28 0.5 mg film-coated Tablet for oral suspension, pink, round N/A Carton of 28 packets 28 count tablet carton (1 tablet per packet) 84 count tablet carton (3 tablets per packet) 112 count tablet carton (4 tablets per packet) 0003-1028-28 0003-3084-28 0003-4112-28 2.5 mg film-coated Tablet yellow, round, biconvex debossed with “893” on one side and “2½” on the other side Bottles of 60 Hospital Unit-Dose Blister Package of 100 0003-0893-21 0003-0893-31 5 mg film-coated Tablet pink, oval, biconvex debossed with “894” on one side and “5” on the other side Bottles of 60 Bottles of 74 Hospital Unit-Dose Blister Package of 100 30-Day Starter Pack for Treatment of DVT and PE Containing 74 Tablets (1 blister pack of 42 tablets and 1 blister pack of 32 tablets) 0003-0894-21 0003-0894-70 0003-0894-31 0003-3764-74 Storage and Handling Store ELIQUIS and ELIQUIS SPRINKLE at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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