| Document Date: 2012-10-22 15:48:00
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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 / renal tubular transport systems / food / biguanide combination product / thyroid products / / MedicalCondition loss of consciousness / Metformin hydrochloride Hypoglycemia / acidosis / headache / Lactic Acidosis Metformin hydrochloride Lactic acidosis / If acidosis / Nausea / anaphylaxis / Stevens-Johnson syndrome / Diabetes A / diabetic ketoacidosis / prerenal azotemia / obesity / symptomatic hypoglycemia / hypersensitivity / diarrhea / chronic metabolic acidosis / constipation / hypoglycemia / Renal dysfunction / back pain / resistant bradyarrhythmias / dose-dependent metabolic acidosis / hepatic disease / hepatic insufficiency / sepsis / upper respiratory tract infection / hypotension / acute myocardial infarction / acute congestive heart failure / Vitamin B12 deficiency / marked acidosis / arthralgia / metformin-induced lactic acidosis / Diarrhea Upper Respiratory Tract Infection Headache / nasopharyngitis / poorly defined illness / both intrinsic renal disease / shock / Carcinogenesis / Metabolic acidosis / hyperglycemia / 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 / Pain / 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 / Cause Hypoglycemia / rash / acute renal failure / anemia / respiratory distress / dehydration / pituitary insufficiency / not necessarily indicate impending lactic acidosis / / MedicalTreatment oral contraceptives / surgery / hemodialysis / dialysis / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position investigator / physician / / Product topiramate / JANUMET / XR Tablets / ranitidine / trimethoprim / Glimepiride / zonisamide / cimetidine / isoniazid / acetazolamide / phenytoin / digoxin / 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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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use JANUMET XR safely and effectively. See full prescribing information for JANUMET XR. •