Description:
DOSAGE FORMS AND STRENGTHS KOMBIGLYZE XR – saxagliptin hydrochloride and metformin hydrochloride tablet, film coated, extended release E.R. Squibb & Sons, L.L.C. ———- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KOMBIGLYZE XR safely and effectively. See full prescribing information for KOMBIGLYZE XR. KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets Initial U.S. Approval: 2010 WARNING: LACTIC ACIDOSIS Tablets: 5 mg saxagliptin/500 mg metformin HCl extended-release (3) 5 mg saxagliptin/1000 mg metformin HCl extended-release (3) 2.5 mg saxagliptin/1000 mg metformin HCl extended-release (3) CONTRAINDICATIONS Renal impairment. (4) Hypersensitivity to metformin hydrochloride. (4) Metabolic acidosis, including diabetic ketoacidosis. (4, 5.1) History of a serious hypersensitivity reaction, such as anaphylaxis or angioedema, to KOMBIGLYZE XR or saxagliptin (one of the components of KOMBIGLYZE XR) or any DPP4 inhibitor. (4) History of a serious hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to KOMBIGLYZE XR or saxagliptin. (4)
