empagliflozin and linagliptin 25 mg
1 INDICATIONS AND USAGE GLYXAMBI is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see Clinical Studies (14.2) ] . However, the effectiveness of GLYXAMBI on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established. GLYXAMBI is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. However, the effectiveness of GLYXAMBI on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established ( 1 ) Limitations of Use Not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis ( 1 ) Has not been studied in patients with a history of pancreatitis ( 1 ) Limitations of Use GLYXAMBI is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis [see Warnings and Precautions (5.4) ] . GLYXAMBI has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using GLYXAMBI [see Warnings and Precautions (5.1) ].
REMEDYREPACK INC.
TRIANGLE PINK logo 25 5
logo 25 5 TRIANGLE PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING GLYXAMBI (empagliflozin and linagliptin) tablets are available in 10 mg/5 mg and 25 mg/5 mg strengths as follows: 10 mg/5 mg tablets: pale yellow, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol; the other side is debossed with "10/5". Bottles of 30 (NDC 0597-0182-30) Bottles of 90 (NDC 0597-0182-90) Cartons containing 3 blister cards of 10 tablets each (3 × 10) (NDC 0597-0182-39), institutional pack. 25 mg/5 mg tablets: pale pink, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol; the other side is debossed with "25/5". Bottles of 30 (NDC 0597-0164-30) Bottles of 90 (NDC 0597-0164-90) Cartons containing 3 blister cards of 10 tablets each (3 × 10) (NDC 0597-0164-39), institutional pack. If repackaging is required, dispense in a tight container as defined in USP. Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
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