| Document Date: 2009-03-31 14:09:46
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Company ACE / Pfizer Inc / GGT / Ames / / Country United States / / Currency pence / / Event Product Issues / FDA Phase / Product Recall / Reorganization / / Facility Hospital Unit Dose INSPRA Tablets / / IndustryTerm food / treatment of hypertension / / MedicalCondition persistent hyperkalemia / both diabetes / clinical hypertension / Metabolic Hypercholesterolemia / tremors / increased rabbit fetal resorptions / headache / Central/Peripheral Nervous System Dizziness / left ventricular dysfunction / angina pectoris/myocardial infarction / Congestive Heart Failure Post-Myocardial Infarction INSPRA / stable heart failure / Respiratory Coughing / dysfunction / hyperkalemia and increased creatinine / hyperkalemia increase / systolic dysfunction / Hypertension INSPRA / Congestive Heart Failure Post-MI Serum Potassium / fatigue / Congestive Heart Failure Post-Myocardial Infarction / diarrhea / angina / pulmonary congestion / drug-related tumor / Gynecomastia / ventricular arrhythmia / hypotension / acute myocardial infarction / Urinary Albuminuria / MI included hypertension / proteinuria / Abdominal pain / Hyperkalemia / congestive heart failure / atrial arrhythmia / hypertension / severe hyperkalemia / post-acute myocardial infarction / sudden cardiac death / either diabetes / unstable post-infarct angina / Hypertriglyceridemia / benign thyroid tumors / Geriatric Use Congestive Heart Failure Post-Myocardial Infarction / Carcinogenesis / symptomatic hypotension / dyslipidemia / stroke / thyroid tumors / diabetes / coughing / lymphoma cells / vomiting / myocardial infarction / heart failure / Hepatic failure / coronary artery disease / Digestive Diarrhea / laboratory-documented hyperkalemia / dizziness / Whole Fatigue / low renin hypertension / Hypokalemia / hyperkalemia / myocardial infarction / rash / angioneurotic edema / / MedicalTreatment oral contraceptives / angioplasty / surgery / bypass / hemodialysis / drug therapy / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position physician / prescribing physician / / Product methylprednisolone / itraconazole / dexamethasone / simvastatin / cyclosporine / polyethylene glycol / ACTH / triazolam / clarithromycin / erythromycin / nifedipine / fluconazole / losartan / fluoxetine / phenytoin / talc / estradiol / tolbutamide / digoxin / chlorzoxazone / INSPRA / ketoconazole / glyburide / spironolactone / lovastatin / hydrochlorothiazide / CYP3A4 / Hepatic Function / INSPRA Daily Dosage / Renal Function / / ProvinceOrState Michigan / / Technology alpha / x-ray / Pharmacokinetics / DNA synthesis / / URL www.fda.gov/medwatch / /
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INSPRA (eplerenone) tablets Initial U.S. Approval: 2002 • Concomitant use with strong CYP3A4 inhibitors (4, 7.1) For the treatment of hypertension: • Type 2 diabetes with microalbuminuria (4)