saxagliptin 5 mg metformin 500 mg
1 INDICATIONS AND USAGE Saxagliptin and metformin hydrochloride extended-release tablets are 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) ]. Saxagliptin and metformin hydrochloride extended-release tablets are 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 used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ( 1.1 ) 1.1 Limitation of Use Saxagliptin and metformin hydrochloride extended-release tablets are not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
mylan pharmaceuticals inc.
ROUND PINK SM3 M
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16 HOW SUPPLIED/STORAGE AND HANDLING
SAXAGLIPTIN AND METFORMIN Hydrochloride Extended-Release Tablets, 5 mg/500 mg, are pink, film-coated, round, unscored tablets imprinted with SM3 over M in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-8175-93 bottles of 30 tablets NDC 0378-8175-77 bottles of 90 tablets
SAXAGLIPTIN AND METFORMIN Hydrochloride Extended-Release Tablets, 5 mg/1000 mg, are pink, film-coated, capsule shaped, unscored tablets imprinted with SM6 over M in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-8177-93 bottles of 30 tablets NDC 0378-8177-77 bottles of 90 tablets
SAXAGLIPTIN AND METFORMIN Hydrochloride Extended-Release Tablets, 2.5 mg/1000 mg, are light peach, film-coated, capsule shaped, unscored tablets imprinted with SM4 over M in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-8176-93 bottles of 30 tablets NDC 0378-8176-91 bottles of 60 tablets Storage and Handling: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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