Abbott and AstraZeneca Expand Relationship to Include Co-Promotion of ...(nsitivity toany component of this produc...)

Date:8/14/2008

nsitivity to any component of this product and in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, in women who are or may become pregnant, and in nursing mothers. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with drugs in this class, including CRESTOR. These risks can occur at any dose level but are increased at the highest dose (40 mg). The risk of myopathy during treatment with CRESTOR may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, or lopinavir/ritonavir. Combination therapy with rosuvastatin and gemfibrozil should be avoided. CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, advanced age, and inadequately treated hypothyroidism. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. It is recommended that liver enzyme tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. The most frequent adverse reactions thought to be related to CRESTOR were headache (3.7%), myalgia (3.1%), abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%).

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more
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