| Document Date: 2014-02-13 12:49:50
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City Reference / / Company Merck Sharp & Dohme Corp. / Merck & Co. Inc. / / Event Product Issues / FDA Phase / Product Recall / / Facility Laboratory Tests FULL PRESCRIBING INFORMATION WARNING / / IndustryTerm treatment for diabetes / healthcare / food / biguanide combination product / / MedicalCondition loss of consciousness / Metformin hydrochloride Hypoglycemia / headache / acidosis / Lactic Acidosis Metformin hydrochloride Lactic acidosis / Nausea / anaphylaxis / Stevens-Johnson syndrome / Diabetes A / diabetic ketoacidosis / prerenal azotemia / obesity / Tract Infection Headache / symptomatic hypoglycemia / hypersensitivity / diarrhea / chronic metabolic acidosis / constipation / Renal dysfunction / hypoglycemia / back pain / resistant bradyarrhythmias / dose-dependent metabolic acidosis / hepatic disease / sepsis / hepatic insufficiency / upper respiratory tract infection / hypotension / acute myocardial infarction / acute congestive heart failure / Vitamin B12 deficiency / marked acidosis / arthralgia / metformin-induced lactic acidosis / nasopharyngitis / poorly defined illness / both intrinsic renal disease / shock / Carcinogenesis / Metabolic acidosis / serious disease / hypothermia / migraine / cutaneous vasculitis / congestive heart failure requiring pharmacologic management / diabetes / clinical illness / metabolic acidosis lacking evidence / fever / septicemia / serious hypersensitivity / seizure / poorly-controlled diabetes / Vomiting / Lactic acidosis / diabetes mellitus / urticaria / hyperchloremic metabolic acidosis / angioedema / fatal and non-fatal hemorrhagic and necrotizing pancreatitis / pancreatitis / LACTIC ACIDOSIS Lactic acidosis / epilepsy / infection / acute pancreatitis / rash / acute renal failure / anemia / respiratory distress / dehydration / pituitary insufficiency / not necessarily indicate impending lactic acidosis / / MedicalTreatment surgery / hemodialysis / dialysis / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position investigator / physician / Major / / Product topiramate / JANUMET / XR Tablets / Glimepiride / zonisamide / acetazolamide / glyburide / 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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Lactic acidosis: Warn against excessive alcohol intake. JANUMET XR is not recommended in hepatic impairment and is contraindicated in renal impairment. Ensure normal renal function before initiating and at least annu