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STORAGE NAME: h0069z.hr.doc DATE: December 10, 2001 PAGE: 3 name drug is when the drug is listed on the negative drug formulary. When a doctor writes an outpatient prescription for a brand name version of a drug listed on the negative drug formulary, substitution of the generic drug by the pharmacist is precluded. The pharmacist may only dispense the brand name drug as written by the doctor. The Orange Book states that drug products are classified by the FDA as therapeutically equivalent when they meet five criteria: 1 ; 2 ; 3 ; Are approved as safe and effective; Are pharmaceutical equivalents in that the drug products contain identical amounts of the same active ingredient in the same dosage form and route of administration; Are bioequivalent in that the drug products do not present a known or potential problem, and they meet an acceptable in vitro standard, or, if the drug products do present such a known or potential problem, the drug products are shown to meet an appropriate bioequivalence standard; Are adequately labeled; and Are manufactured in compliance with Current Good Manufacturing Practice regulations. Breakdown of the global antithrombotics market by drug class, 200102 95 Breakdown of the global antithrombotics market by leading brands, 200102 97 Summary of key recent events in the antithrombotics market 99 Global sales forecasts for drug classes within the anti- antithrombotics market, 2003 08 114 Breakdown of the global cardiac therapies market by drug class, 200102 115 Breakdown of the global cardiac therapies market by leading brands, 200102 117 Summary of key recent events in the cardiac therapies market 118 Summary of AMIOVIRT trial results 122 Key players in the global cardiovascular market, 20002002 130 Pfizer's marketed cardiovascular portfolio, 2003 132 Pfizer's cardiovascular R&D pipeline, 2003 133 Forecast sales for Pfizer's cardiovascular portfolio, 200208 135 Merck & Co.'s marketed cardiovascular portfolio, 2003 136 Merck's cardiovascular R&D pipeline, 2003 137 Forecast sales for Merck's cardiovascular portfolio, 200208 138 Bristol-Myers Squibb's marketed cardiovascular portfolio, 2003 139 Bristol-Myers Squibb's cardiovascular R&D pipeline, 2003 140 Forecast sales for Bristol-Myers Squibb's cardiovascular portfolio, 200208 141 Novartis' marketed cardiovascular portfolio, 2003 142 Novartis' cardiovascular R&D pipeline, 2003 143 Forecast sales for Novartis' cardiovascular portfolio, 200308 144 AstraZeneca's marketed cardiovascular portfolio, 2003 145 AstraZeneca's cardiovascular R&D pipeline, 2003 146 Forecast sales for AstraZeneca's cardiovascular portfolio, 200308 147 Aventis' marketed cardiovascular portfolio, 2003 148 Aventis' cardiovascular R&D pipeline, 2003 149 Forecast sales for Aventis' cardiovascular portfolio, 200308 150 Summary of profiled future cardiovascular blockbusters 155 New indications under development for melagatran ximelagatran 159 Comparative table of future indications and corresponding patient potential in the US for melagatran and ximelagatran 160 Forecast global sales of Exanta 200208 163 Forecast global sales of Cres5or 200208 167 Forecast global sales of pitavastatin 200208 172 Forecast global sales of Benicar 200208 177 Forecast global sales of Norvasc Lipitor 200208 182 Forecast global sales of Inspra 200208 187. The drug may even unmask dementia that had not been previously noticed. Since its arrival in the market, the fda's records indicate at least 25 patients already have been diagnosed with rhabdomyolysis following use of crestor, with 11 of those patients reporting the condition in a relatively short period between late february 2004 and early may 200 public citizen petitions the fda pressure group urges rosuvastatin recall fda public health advisory for crestor rosuvastatin ; : june 9, 2004 contact our experienced pharmaceutical drug attorneys if you or a family member has experienced serious side effects or personal injury after taking crestor or zocor, you may be eligible to file a claim against the manufacturer. Of course crestor is known as the superstatin.
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Table 1. Influence of 10% human serum 5.1 mM cholesterol ; on cholesterol and lathosterol synthesis and on the ratio of lathosterol to cholesterol L C Ratio ; compared to cholesterol free media in HepG2 cells.

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The U.S. Food and Drug Administration FDA ; is advising consumers not to purchase prescription drugs from websites that have orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health in Manitoba, Canada following reports of counterfeit versions of prescription drug products being sold by these companies to U.S. consumers. FDA is investigating these reports and is coordinating with international law enforcement authorities on this matter. FDA recommends that consumers who have purchased drugs from these websites not use the products because they may be unsafe. Laboratory analyses are underway for intercepted product that was destined for the U.S. market. Preliminary laboratory results to date have found counterfeits of the following drug products from these websites: Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol known as Zetia in the United States ; , Crestor, Celebrex, Arimidex, and Propecia. All of these medications require a prescription from a licensed health care provider to be legally dispensed. DRUG NAME USE S ; LIPITOR Cholesterol disorders CRESTOR Cholesterol disorders ZETIA US name ; EZETROL Canadian name ; Cholesterol disorders DIOVAN High blood pressure HYZAAR High blood pressure ACTONEL Osteoporosis in postmenopausal women NEXIUM Gastroesophageal reflux disease GERD ; CELEBREX Arthritis-related pain ARIMIDEX Breast cancer PROPECIA Male-pattern baldness Some of the websites that are operated by Mediplan or that have order fulfillment through Mediplan are.

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The study was one of a series of randomized clinical trials performed and coordinated at the University Hospital Vinohrady Prague ; . From this series is derived the acronym PRAGUE-4. The study protocol was approved by the local ethics committee and by the Ministry of Health of the Czech Republic. It is fully described in the original article, which analyzed early surgical outcomes.9 In brief, patients were randomized to either on-pump or off-pump surgical technique by a cardiologist after indication for bypass surgery. The surgeons could not influence the randomization; ie, they were not allowed to influence the selection of patients specifically, surgeons were not allowed to exclude from randomization patients with anatomy unsuitable for off-pump surgery ; . All consecutive patients with chronic coronary artery disease or unstable postinfarction angina pectoris who signed written informed consent were randomized. Thus, the study population represents all nonselected ; real-life patients scheduled for coronary bypass surgery. The exclusion criteria were emergency surgery for ongoing myocardial ischemia, significant valvular disease, or significant aortic aneurysm requiring surgery ; . One-year follow-up coronary angiography was part of the protocol and misoprostol. CRESTOR should be individualized according to goal of therapy and response. The usual recommended starting dose of CRESTOR is 10 mg once daily. Initiation of therapy with 5 mg once daily may be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy see WARNINGS, Myopathy Rhabdomyolysis ; . For patients with marked hypercholesterolemia LDL-C 190 mg dL ; and aggressive lipid targets, a 20-mg starting dose may be considered. The 40-mg dose of CRESTOR should be reserved for those patients who have not achieved goal LDL-C at 20 mg see WARNINGS, Myopathy Rhabdomyolysis ; . After initiation and or upon titration of CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly. Homozygous Familial Hypercholesterolemia The recommended starting dose of CRESTOR is 20 mg once daily in patients with homozygous FH. The maximum recommended daily dose is 40 mg. CRESTOR should be used in these patients as an adjunct to other lipid-lowering treatments e.g., LDL apheresis ; or if such treatments are unavailable. Response to therapy should be estimated from pre-apheresis LDL-C levels. Dosage in Patients Taking Cyclosporine In patients taking cyclosporine, therapy should be limited to CRESTOR 5 mg once daily see WARNINGS, Myopathy Rhabdomyolysis, and PRECAUTIONS, Drug Interactions ; . Concomitant Lipid-Lowering Therapy The effect of CRESTOR on LDL-C and total-C may be enhanced when used in combination with a bile acid binding resin. If CRESTOR is used in combination with gemfibrozil, the dose of CRESTOR should be limited to 10 mg once daily see WARNINGS, Myopathy Rhabdomyolysis, and PRECAUTIONS, Drug Interactions ; . Dosage in Patients With Renal Insufficiency No modification of dosage is necessary for patients with mild to moderate renal insufficiency. For patients with severe renal impairment CLcr 30 mL min 1.73 m2 ; not on hemodialysis, dosing of CRESTOR should be started at 5 mg once daily and not to exceed 10 mg once daily see PRECAUTIONS, General, and CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency ; . Rx only References: 1. Data on file, DA-CRS-02. 2. Shepherd J, Hunninghake DB, Stein EA, et al. The safety of rosuvastatin. J Cardiol. 2004; 94: 882-888. Prescribing Information for CRESTOR. AstraZeneca, Wilmington, DE. 4. Data on file, DA-CRS-01. CRESTOR is a registered trademark of the AstraZeneca group of companies. "Ride the CREST" and "Ride the CREST with CRESTOR" are trademarks of the AstraZeneca group of companies. AstraZeneca 2004 Licensed from SHIONOGI & CO., LTD., Osaka, Japan Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 By: IPR Pharmaceuticals, Inc. Carolina, PR 00984 PCC 630100 10 04 t critically important for people with type 2 diabetes to understand the important link between diabetes, insulin resistance and cardiovascular disease. That is why the American Heart Association developed the Heart Of Diabetes: Understanding Insulin Resistance, which helps people learn this linkage and reduce their risk for heart disease and stroke. Since the program began in 2001, more than 30, 000 people have enrolled. Program participants receive the "Getting to the Heart of Diabetes" booklet and information on the Heart Of Diabetes Thriver's Program in which participants receive a journal to track their progress in managing their diabetes and reducing risk. They also receive free monthly newsletters and incentives throughout the year to keep them focused and motivated. The Heart Of Diabetes program offers a Heart Healthy Tracker, an online blood glucose, blood pressure and cholesterol tracking tool and a family history tree, which is an interactive way to map family links to diabetes and cardiovascular disease. People who enroll in the program can also draw inspiration from online testimonials by successful program members. The Heart Of Diabetes: Understanding Insulin Resistrance is supported by an educational grant from Takeda Pharmaceuticals North America, Inc. and Eli Lilly and Company. 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DETERMINING DOSAGE: Healthy person: 2 4 - 36 day; Type I D M: 0.5 - 1 u kg Total daily dose: Lean: 0.3 - 0.5 u kg day Obese: 0.5 - 1.0 Stress: 1 + GLUCOSE MONITORING: OB TA IN INIT IALLY TH EN Q MO'S Diet: periodically. Oral agents: 1-2x d. Insulin QD: 1-2x d. BID insulin: 2-4 x day TID insulin: 3- 6x day Criteria Fasting 2 hours po st prandially HS Hgb A1 C Hgb A1 C varies Hgb A1 C 5 Goal 90- 130 180 with every 35 mg dL of glucose. For example, Gluco se 100 135 170.
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