| Document Date: 2013-06-04 11:53:49
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City Reference / / Company Bristol-Myers Squibb / / Currency pence / / Event Product Issues / / IndustryTerm treatment for diabetes / food / / MedicalCondition congestive heart failure / acute congestive heart failure / Metformin hydrochloride Hypoglycemia / Vitamin B12 Deficiency / marked acidosis / headache / acidosis / nasopharyngitis / poorly defined illness / both intrinsic renal disease / shock / Metabolic acidosis / Carcinogenesis / urinary tract infection / serious disease / If acidosis / hypothermia / nausea/vomiting / anaphylaxis / angioedema / exfoliative skin conditions / diabetes / significant renal insufficiency / clinical illness / metabolic acidosis lacking evidence / serious hypersensitivity / septicemia / Diabetes A / Lactic acidosis / diabetes mellitus / diabetic ketoacidosis / obesity / urticaria / angioedema / pancreatitis / LACTIC ACIDOSIS Lactic acidosis / diarrhea / Hypersensitivity / chronic metabolic acidosis / Diabetes Hypoglycemia / Acute Pancreatitis / Hypoglycemia / renal dysfunction / anemia / hepatic disease / resistant bradyarrhythmias / sepsis / upper respiratory tract infection / respiratory distress / hypotension / poorly controlled diabetes / pituitary insufficiency / dehydration / acute myocardial infarction / / MedicalTreatment hemodialysis / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position physician / / Product Glipizide / itraconazole / ketoconazole / clarithromycin / metformin hydrochloride / KOMBIGLYZE XR tablets / Metformin Disposition Concomitant medication / Hepatic Function Vitamin B12 Concentrations Alcohol Intake Surgical Procedures Change / caloric intake / / Technology Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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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. •