CRESTOR

Dosing


Start with the single-agent solution

  • CRESTOR is priced the same at every dose (AWP)16
  • No restrictions on time of day of administration — can be taken with or without food1
Dosing chart

* Therapy should be individualized according to goal of therapy and response. After initiation and/or upon titration of CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

Patients taking cyclosporine, Asian patients, and patients with severe renal insufficiency.

Significant LDL-C reductions at each dose

1,15

LDL-C reduction by dose

P<.001 vs 7% placebo.

  • As with other HMG-CoA reductase inhibitors, reports of rhabdomyolysis with rosuvastatin have been reported, but higher at the highest marketed dose (40 mg)
  • If CRESTOR is used in combination with gemfibrozil, the dose of CRESTOR should be limited to 10 mg once daily; in patients taking cyclosporine, therapy should be limited to CRESTOR 5 mg once daily
  • In patients with HIV taking a combination of lopinavir and ritonavir, the dose of CRESTOR should be limited to 10 mg once daily

CRESTOR is indicated

1
As an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, non–HDL-C, and triglyceride levels and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.

CRESTOR is indicated 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.

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 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 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 function 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 40 mg should only be used 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.

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%).1,13

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



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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