| Document Date: 2011-04-18 16:26:28
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City Reference / / Company Merck Sharp & Dohme Corp. / Merck & Co. Inc. / / Event Product Issues / FDA Phase / Product Recall / / Facility Laboratory Tests JANUMET / / IndustryTerm treatment for diabetes / renal tubular transport systems / food / biguanide combination product / / MedicalCondition loss of consciousness / Metformin hydrochloride Hypoglycemia / Tablets 9984502XXXXXXX disease / acidosis / headache / Lactic Acidosis Metformin hydrochloride Lactic acidosis / tract infection / If acidosis / coma / nausea/vomiting / Nausea / anaphylaxis / Stevens-Johnson syndrome / Diabetes A / diabetic ketoacidosis / prerenal azotemia / obesity / symptomatic hypoglycemia / Renal disease / diarrhea / hypersensitivity / chronic metabolic acidosis / constipation / hypoglycemia / Renal dysfunction / hepatic disease / resistant bradyarrhythmias / hepatic insufficiency / sepsis / upper respiratory tract infection / hypotension / acute myocardial infarction / acute congestive heart failure / marked acidosis / indigestion / Diarrhea Upper Respiratory Tract Infection Headache / Nasopharyngitis / poorly defined illness / both intrinsic renal disease / shock / Carcinogenesis / serious disease / hypothermia / cutaneous vasculitis / congestive heart failure requiring pharmacologic management / diabetes / significant renal insufficiency / clinical illness / fever / metabolic acidosis lacking evidence / septicemia / serious hypersensitivity / seizure / Vomiting / Lactic acidosis / diabetes mellitus / urticaria / angioedema / fatal and non-fatal hemorrhagic and necrotizing pancreatitis / pancreatitis / LACTIC ACIDOSIS Lactic acidosis / infection / acute pancreatitis / Cause Hypoglycemia / rash / acute renal failure / anemia / respiratory distress / poorly controlled diabetes / dehydration / pituitary insufficiency / / MedicalTreatment surgery / hemodialysis / dialysis / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position investigator / physician / / Product JANUMET / ranitidine / trimethoprim / Glimepiride / cimetidine / Nifedipine / digoxin / Glyburide / Furosemide / Metformin / metformin hydrochloride / Rosiglitazone / Metformin Disposition Concomitant medication / Hepatic Function Since / caloric intake / Hepatic Function / / Technology tomography / Pharmacokinetics / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / /
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9984502XXXXXXX HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use JANUMET safely and effectively. See full prescribing information for JANUMET.