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Guanidines / Anti-diabetic drugs / Organic chemistry / Diabetes / Thiazolidinediones / Metformin / Sitagliptin / Anti-diabetic medication / Sulfonylurea / Chemistry / Medicine / Biguanides


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. 
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Document Date: 2015-03-26 19:23:33


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Company

Merck Sharp & Dohme Corp. / Merck & Co. Inc. / /

Event

Product Issues / Product Recall / FDA Phase / /

Facility

Laboratory Tests *Sections / /

IndustryTerm

treatment for diabetes / healthcare / food / biguanide combination product / /

MedicalCondition

loss of consciousness / Metformin hydrochloride Hypoglycemia / headache / acidosis / Lactic Acidosis Metformin hydrochloride Lactic acidosis / tract infection / Nausea / anaphylaxis / Stevens-Johnson syndrome / Diabetes A / diabetic ketoacidosis / prerenal azotemia / obesity / symptomatic hypoglycemia / diarrhea / hypersensitivity / chronic metabolic acidosis / constipation / Renal dysfunction / hypoglycemia / pruritus / 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 / 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 / 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 / /

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Position

investigator / physician / /

Product

topiramate / JANUMET / XR Tablets / Glimepiride / zonisamide / acetazolamide / glyburide / metformin hydrochloride / Rosiglitazone / Metformin Disposition Concomitant medication / Hepatic Function Since / caloric intake / hepatic function / XR / /

Technology

tomography / Pharmacokinetics / Pharmacodynamics / dialysis / /

URL

www.fda.gov/medwatch / /

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