edoxaban 30 MG Oral Tablet Savaysa
1 INDICATIONS AND USAGE SAVAYSA is a factor Xa inhibitor indicated: To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) ( 1.1 ) Limitation of Use for NVAF SAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) ( 1.1 ) SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant ( 1.2 ) 1.1 Reduction in the Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation SAVAYSA is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). Limitation of Use for NVAF SAVAYSA should not be used in patients with CrCL > 95 mL/min because of an increased risk of ischemic stroke compared to warfarin [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) and Clinical Studies (14.1) ] . 1.2 Treatment of Deep Vein Thrombosis and Pulmonary Embolism SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.
daiichi sankyo inc.
ROUND PINK DSC L30
DSC L30 ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING SAVAYSA (edoxaban) is supplied as round shaped, film-coated, non-scored tablets containing
EDOXABAN TOSYLATE equivalent to 60, 30 or 15 mg of SAVAYSA, packaged in bottles and blisters. NDC 65597-xxx-yy Strength Color Deboss yy xxx Bottle of Blister of 30 90 500 10 × 10 10 blister cards of 10 counts 10 × 5 5 blister cards of 10 counts 15 mg orange DSC L15 201 30 - - - - 30 mg pink DSC L30 202 30 90 50 10 05 60 mg yellow DSC L60 203 30 90 50 10 05 Store at 20-25°C (68-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature] . Keep out of the reach of children.
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