saxagliptin 2.5 mg
1 INDICATIONS AND USAGE Saxagliptin tablets are a dipeptidyl peptidase-4 (DPP4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1.1 , 14 ) Limitation of use: • Not used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ( 1.2 ) 1.1 Monotherapy and Combination Therapy Saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [ see Clinical Studies (14) ]. 1.2 Limitation of Use Saxagliptin tablets are not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as they would not be effective in these settings.
mylan pharmaceuticals inc.
ROUND YELLOW SX1 M
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saxagliptin 5 mg
mylan pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied:
SAXAGLIPTIN Tablets are available containing 3.075 mg or 6.149 mg of
SAXAGLIPTIN hydrochloride dihydrate equivalent to 2.5 mg or 5 mg of
SAXAGLIPTIN. The 2.5 mg tablets are yellow, film-coated, round, unscored tablets imprinted with SX1 over M in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4705-93 bottles of 30 tablets NDC 0378-4705-77 bottles of 90 tablets The 5 mg tablets are white to off-white, film-coated, round, unscored tablets imprinted with SX2 over M in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4706-93 bottles of 30 tablets NDC 0378-4706-77 bottles of 90 tablets NDC 0378-4706-05 bottles of 500 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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