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CRESTOR(R) Reduced CV Risk in Patients Achieving Low LDL and hsCRP Targets in New JUPITER Analysis
Date:3/29/2009

is in line with other marketed statins.

IMPORTANT SAFETY INFORMATION:

CRESTOR is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in adult patients with primary hyperlipidemia and mixed dyslipidemia. CRESTOR is also indicated as an adjunct to diet to slow the progression of atherosclerosis as part of a treatment strategy to lower Total-C and LDL-C to target levels. CRESTOR is not approved to prevent cardiovascular morbidity and mortality.

CRESTOR is contraindicated in patients with a known hypersensitivity to any component of this product, in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, in women who are pregnant or may become pregnant, and in nursing mothers.

Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including CRESTOR. These risks can occur at any dose level, but are increased at the highest dose (40 mg).

CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy (eg, age Greater Than or Equal to 65 years, inadequately treated hypothyroidism, renal impairment). 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.

Therapy with CRESTOR should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. All 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 perio
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SOURCE AstraZeneca
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