24 HR Metformin hydrochloride 1000 MG saxagliptin 2.5 MG Extended Release Oral Tablet Kombiglyze
1 INDICATIONS AND USAGE KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. [See Clinical Studies (14) .] KOMBIGLYZE XR is a combination of saxagliptin, a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. (1 , 14) Limitations of Use: • Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.1) • Has not been studied in patients with a history of pancreatitis. (1.1 , 5.2) 1.1 Limitations of Use KOMBIGLYZE XR should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. KOMBIGLYZE XR 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 KOMBIGLYZE XR. [See Warnings and Precautions (5.2) .]
E.R. Squibb & Sons, L.L.C.
OVAL YELLOW 2 5 1000 4222
2 5 1000 4222 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied KOMBIGLYZE™ XR (saxagliptin and metformin HCl extended-release) tablets have markings on both sides and are available in the strengths and packages listed in Table 12. Table 12: KOMBIGLYZE XR Tablet Presentations Tablet Strength (saxagliptin and metformin HCl extended-release) film-coated Tablet Color/Shape Tablet Markings Package Size NDC Code 5 mg/500 mg light brown to brown, biconvex, capsule-shaped “5/500” on one side and “4221” on the reverse, in blue ink Bottles of 30 0003-4221-11 5 mg/1000 mg pink, biconvex, capsule-shaped “5/1000” on one side and “4223” on the reverse, in blue ink Bottles of 30 Bottles of 90 Bottles of 500 0003-4223-11 0003-4223-21 0003-4223-31 2.5 mg/1000 mg pale yellow to light yellow, biconvex, capsule-shaped “2.5/1000” on one side and “4222” on the reverse, in blue ink Bottles of 60 Bottles of 500 0003-4222-16 0003-4222-31 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
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