CRESTOR

References

  1. Prescribing Information for CRESTOR. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
  2. National Heart, Lung, and Blood Institute. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III): Executive Summary. National Institutes of Health. Bethesda, MD; 2001. NIH Publication 01-3670.
  3. Grundy SM, Cleeman JI, Merz CNB, et al, for the Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004;110:227-239.
  4. Wolffenbuttel BHR, Franken AAM, Vincent HH, on behalf of the Dutch CORALL Study Group. Cholesterol-lowering effects of rosuvastatin compared with atorvastatin in patients with type 2 diabetes–CORALL Study. J Intern Med. 2005;257:531-539.
  5. Shepherd J, Vidt DG, Miller E, et al. Safety of rosuvastatin: update on 16,876 rosuvastatin-treated patients in a multinational clinical trial program. Cardiology. 2007;107:433-443.
  6. AstraZeneca Pharmaceuticals LP. Rosuvastatin Drug Safety—Postmarketing Experience: Spontaneous adverse event reporting information. Available at: http://www.rosuvastatininformation.com. Accessed March, 2008.
  7. Bays HE, Deedwania PC, Jones PH, Caplan RJ, Blasetto JW. Comparative effects of statins on low-density lipoprotein cholesterol and high-density lipoprotein cholesterol in patients ≥65 years of age. Poster presented at: Annual Scientific Meeting of the American Geriatrics Society; May 17-21, 2004; Las Vegas, NV.
  8. Jones PH, Davidson MH, Stein EA, et al, for the STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003;92:152-160.
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CRESTOR is indicated

1
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 patients with primary hyperlipidemia and mixed dyslipidemia.

As an adjunct to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.

The effect of CRESTOR on cardiovascular morbidity and mortality has not been determined; long-term outcomes studies are currently under way.

CRESTOR is contraindicated

1
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.

Important safety information about CRESTOR

1
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 ≥ 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.

CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg. Patients initiating CRESTOR therapy or switching from another statin should begin treatment with CRESTOR at the appropriate starting dose.

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 (eg, semiannually) thereafter. Should an increase in ALT or AST of >3 times ULN persist, reduction of dose or withdrawal of CRESTOR is recommended. CRESTOR should be used with caution in patients who consume substantial quantities of alcohol.

In the controlled clinical trials database, the most common adverse reactions were headache (3.7%), myalgia (3.1%), abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%).13



Please see full Prescribing Information for CRESTOR.

CRESTOR was licensed from SHIONOGI & CO. LTD, Osaka, Japan.

CRESTOR is a registered trademark of the AstraZeneca group of companies.
259343  3/08 ©2008 AstraZeneca Pharmaceuticals LP. All rights reserved.
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