| Document Date: 2009-03-31 14:51:13
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City Ducrocq / / Company Simvastatin Group / Pooled Simvastatin Monotherapy Group / Merck/Schering-Plough Pharmaceuticals / / Currency pence / / Event Product Recall / Product Issues / / Facility Laboratory Tests Marked / Achieve stable INR / / IndustryTerm medicinal products / food / treatment groups / treatment for a lipid disorder / / MedicalCondition Tablets 9619511XX hypercholesterolemia / atherosclerotic vascular disease / primary hypercholesterolemia therapy / cholecystitis / HIV / headache / cholelithiasis / polymyalgia rheumatica / myopathy / Skin disorders / mixed hyperlipidemia / arthritis / erythematous-like syndrome / bronchitis / subcutaneous tissue disorders / primary hypercholesterolemia / nausea / Ear disorders / thrombocytopenia / anaphylaxis / alopecia / peripheral neuropathy / Homozygous Familial Hypercholesterolemia / dyspnea / toxic epidermal necrolysis / spontaneous abortions / StevensJohnson syndrome / fatigue / gastritis / erythema multiforme / Cardiac disorders / Myopathy/Rhabdomyolysis / lipid disorder / myoglobinuria / diarrhea / Hypersensitivity / urinary tract infections / sinusitis / hepatitis / muscle cramps / familial hypercholesterolemia / constipation / lupus / liver disease / pruritus / Infections / Back pain / Heterozygous Familial Hypercholesterolemia / upper respiratory tract infection / purpura / Musculoskeletal system disorders / abdominal pain / insomnia / fetal deaths / long-standing diabetes mellitus / chronic process / vasculitis / flushing / arthralgia / Atherosclerosis / Primary Hyperlipidemia / myalgia / upper respiratory tract infection / chills / Carcinogenesis / eczema / Diarrhea Infections / Active liver disease / vertigo / leukopenia / hemolytic anemia / muscle pain / hyperlipidemia / labyrinth disorders / severe renal insufficiency / fever / rhabdomyolysis / uncontrolled hypothyroidism / Pain / CONTRAINDICATIONS Hypersensitivity / vomiting / renal insufficiency / diabetes mellitus / hepatic failure / urticaria / angioedema / pancreatitis / Active liver diseases / atrial fibrillation / increased ALT / V dyslipidemias / dizziness / depression / rash / paresthesia / apparent hypersensitivity syndrome / cholestasis / acute renal failure / anemia / dermatomyositis / hypercholesterolemia / eosinophilia / Primary Hyperlipidemia VYTORIN / disorders / / MedicalTreatment antibiotics / contraception / adjunctive therapy / apheresis / major surgery / Drug therapy / / Organization Concomitant administration / DOSAGE AND ADMINISTRATION / FDA / / / Position Major / / Product Itraconazole / simvastatin / Cyclosporine / niacin / danazol / gemfibrozil / clarithromycin / erythromycin / capsule40 mg / capsule80 mg / VYTORIN / Digoxin / capsule20 mg / ketoconazole / Coumarin / Lovastatin / Cholestyramine / therapy with VYTORIN / / ProvinceOrState M.B. / / Technology Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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9619511XX 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.