| Document Date: 2014-03-04 13:22:49
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City Reference / / Company Merck Sharp & Dohme Corp. / Merck & Co. Inc. / / Currency pence / / Facility Laboratory Tests Marked / Achieve stable INR / / IndustryTerm medicinal products / food / cobicistat containing products / / MedicalCondition atherosclerotic vascular disease / cholecystitis / HIV / polymyalgia rheumatica / cholelithiasis / headache / myopathy / Skin disorders / mixed hyperlipidemia / arthritis / erythematous-like syndrome / bronchitis / subcutaneous tissue disorders / nausea / Ear disorders / anaphylaxis / thrombocytopenia / muscle weakness / alopecia / peripheral neuropathy / Homozygous Familial Hypercholesterolemia / dyspnea / toxic epidermal necrolysis / StevensJohnson syndrome / significant inflammation / fatigue / Chronic Kidney Disease / gastritis / erythema multiforme / Cardiac disorders / Myopathy/Rhabdomyolysis / Hypersensitivity / myoglobinuria / diarrhea / urinary tract infections / hepatitis / sinusitis / muscle cramps / memory loss / familial hypercholesterolemia / constipation / lupus / serious liver injury / liver disease / pruritus / Infections / Back pain / proximal muscle weakness / sepsis / upper respiratory tract infection / hypotension / purpura / Musculoskeletal system disorders / Renal Impairment/Chronic Kidney Disease / abdominal pain / insomnia / long-standing diabetes mellitus / Cancer / vasculitis / flushing / disease / Atherosclerosis / arthralgia / hypothyroidism / Primary Hyperlipidemia / amnesia / unexplained muscle weakness / myalgia / upper respiratory tract infection / chills / Carcinogenesis / erectile dysfunction / electrolyte disorders / chronic / fatal and non-fatal hepatic failure / eczema / cognitive impairment / Precautions Myopathy/Rhabdomyolysis / Active liver disease / Diarrhea Infections / vertigo / leukopenia / hemolytic anemia / muscle pain / hyperlipidemia / labyrinth disorders / fever / rhabdomyolysis / uncontrolled hypothyroidism / vomiting / renal insufficiency / myocardial infarction / diabetes mellitus / urticaria / angioedema / pancreatitis / Active liver diseases / autoimmune myopathy / atrial fibrillation / increased ALT / V dyslipidemias / uncontrolled epilepsy / dizziness / renal failure / depression / rash / immune-mediated necrotizing myopathy / apparent hypersensitivity syndrome / paresthesia / cholestasis / dermatomyositis / acute renal failure / anemia / hypercholesterolemia / eosinophilia / interstitial lung disease / disorders / / MedicalTreatment antibiotics / statin therapies / adjunctive therapy / apheresis / major surgery / Drug therapy / / Organization Concomitant administration / DOSAGE AND ADMINISTRATION / FDA / / / Product itraconazole / simvastatin / cyclosporine / niacin / danazol / gemfibrozil / clarithromycin / erythromycin / VYTORIN / Digoxin / ketoconazole / Coumarin / fenofibrate / Cholestyramine / / 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 VYTORIN safely and effectively. See full prescribing information for VYTORIN. VYTORIN® (ezetimibe/simvastatin) Tabl