| Document Date: 2013-12-23 15:37:49
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City Reference / / Company Gilead Sciences Inc. / QT / / Event FDA Phase / / Facility Laboratory Abnormalities RANEXA / / IndustryTerm rate-pressure product / treatment for diabetes / food / ranolazine solution / / MedicalCondition paresthesia / abnormal coordination / ventricular tachycardia / hyperhidrosis Vascular Disorders / headache / ear and labyrinth disorders / leukopenia / hallucinations / dysphasia / anorexia Nervous System Disorders / nausea / thrombocytopenia / vision Gastrointestinal Disorders / pulmonary fibrosis / tremor / syncope / dyspepsia General Disorders / renal failure independent / unsteady gait/incoordination / hypoesthesia / Severe tremor / Cardiac Disorders / bradycardia / Nervous System Disorders Tremor / Liver cirrhosis / angina / constipation / Diabetes Mellitus A / pruritus / Heart Failure Heart failure / skin and subcutaneous tissue disorders / With liver cirrhosis / hypotension / Nutrition Disorders / long QT syndrome / arrhythmia / Mediastinal Disorders / abdominal pain / congestive heart failure / Urinary Disorders / Chronic Stable Angina / Carcinogenesis / bradycardia / supraventricular tachycardia / angioedema / renal failure / diabetes / acute coronary syndrome / chronic angina / vomiting / Psychiatric Disorders / concomitant disease / reactive airway disease / diabetes mellitus / Heart Failure / angioedema / Precautions Renal Failure / atrial fibrillation / vertigo Eye Disorders / dizziness / Renal failure / diplopia / paresthesia / acute renal failure / tinnitus / eosinophilia / pancytopenia / / MedicalTreatment hemodialysis / drug therapy / dialysis / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position General / / Product itraconazole / simvastatin / cyclosporine / carbamazepine / polyethylene glycol / clarithromycin / erythromycin / rifampin / fluconazole / phenytoin / talc / digoxin / ketoconazole / RANEXA / lovastatin / / Technology Pharmacokinetics / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / /
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• Renal failure: Monitor renal function after initiation and HIGHLIGHTS OF PRESCRIBING INFORMATION periodically in patients with moderate to severe renal impairment (CrCL < 60 mL/min). If acute renal failure develops,