| Document Date: 2011-03-04 07:44:55
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City Reference / / Company Abbott Laboratories / / Currency pence / / Event Product Recall / Delayed Filing / Product Issues / / Facility Laboratory Abnormalities Increase / Laboratory Abnormalities / Achieve stable INR / / IndustryTerm medicinal products / monitor for any signs and symptoms / / MedicalCondition atherosclerotic vascular disease / primary hypercholesterolemia therapy / HIV / headache / myopathy / Liver Dysfunction / primary hypercholesterolemia / nausea / pruritis / anaphylaxis / Known hypersensitivity / laryngismus / Myopathy/Rhabdomyolysis / myoglobinuria / hypersensitivity / diarrhea / peptic ulcer disease / pruritus / liver disease / fulminant hepatic necrosis / back pain / sepsis / hypotension / active peptic ulcer disease / mixed dyslipidemia / chronic process / Flushing / Atherosclerosis / dyspnea / hypothyroidism / hypertriglyceridemia / Carcinogenesis / uncontrolled seizures / electrolyte disorders / Active liver disease / Muscle Pain / fever / rhabdomyolysis / renal insufficiency / urticaria / angioedema / Dizziness / acute renal failure / hypercholesterolemia / SIMCOR Myopathy / dehydration / / MedicalTreatment antibiotics / major surgery / Drug therapy / dialysis / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position Major / / Product itraconazole / simvastatin / cyclosporine / niacin / danazol / simcor / gemfibrozil / clarithromycin / erythromycin / Digoxin / ketoconazole / Coumarin / Fenofibrate / NIASPAN / / Technology Pharmacokinetics / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / /
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Dn2189v1-proposed-simcor-2010-oct-20 SIMCOR - simvastatin and niacin tablet, film coated, extended release Abbott Laboratories[removed]HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the infor