| Document Date: 2012-04-26 16:06:05
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City Metformin HCl / Reference / / Company Novo Nordisk / / Event FDA Phase / Product Issues / Product Recall / / Facility Laboratory Tests *Sections / / IndustryTerm renal tubular transport systems / food / biguanide combination product / / MedicalCondition deformities / loss of consciousness / chest pain / headache / acidosis / severe hepatic dysfunction / Lactic Acidosis Metformin hydrochloride Lactic acidosis / Exposed Gastrointestinal System Disorder / Tract Infection / If acidosis / coma / nausea / alopecia / Stevens-Johnson Syndrome / Diabetes A / prerenal azotemia / diabetic ketoacidosis / obesity / diarrhea / hypersensitivity / angina / hepatitis / chronic metabolic acidosis / hypoglycemia / resistant bradyarrhythmias / hepatic disease / sepsis / hypotension / acute myocardial infarction / acute congestive heart failure / hemolytic anemia / vitamin B12 deficiency / hypertension / marked acidosis / poorly defined illness / both intrinsic renal disease / shock / metabolic acidosis / Carcinogenesis / serious disease / hypothermia / congestive heart failure requiring pharmacologic management / diabetes / clinical illness / fever / metabolic acidosis lacking evidence / seizure / vomiting / myocardial infarction / lactic acidosis / diabetes mellitus / pancreatitis / severe hypoglycemia / infection / dizziness / neurologic findings / anemia / myocardial ischemia / respiratory distress / poorly controlled diabetes / pituitary insufficiency / dehydration / not necessarily indicate impending lactic acidosis / / MedicalTreatment surgery / hemodialysis / / Organization Administration of PrandiMet / ··································DOSAGE AND ADMINISTRATION / FDA / / Person Repaglinide Repaglinide / / / Position Investigator / Physician / / Product itraconazole / ranitidine / trimethoprim / cyclosporine / polyethylene glycol / Gemfibrozil / repaglinide / rifampin / PrandiMet / talc / glipizide / patients / digoxin / sorbitol / glyburide / NPH insulin / Metformin hydrochloride / DOSAGE FORMS AND STRENGTHS································· Tablets / Metformin Disposition Concomitant medication / Renal Function Patients / HCl / glycemic control / hepatic function / / 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 PrandiMet safely and effectively. See full prescribing information for PrandiMet. ·················