Dosing and Administration

CRESTOR® (rosuvastatin calcium) is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and triglycerides, and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia, and 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.1

CRESTOR is indicated to reduce the risk of myocardial infarction, stroke, and arterial revascularization procedures in patients without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD) based on age (men ≥50 and women ≥60), high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease.1

Start Dose Information CRESTOR® (rosuvastatin calcium) 5 mg5 mg Once daily Consider for patients taking cyclosporine, gemfibrozil, lopinavir and ritonavir, atazanavir and ritonavir or simeprevir, Asian patients, and patients with severe renal impairment not on hemodialysis
Start Dose Information CRESTOR® (rosuvastatin calcium) 10 mg10 mg Once daily Usual recommended start dose
Start Dose Information CRESTOR® (rosuvastatin calcium) 20 mg20 mg Once daily Usual recommended start dose
Titration Dose CRESTOR® (rosuvastatin calcium) 40 mg40 mg Once daily Reserve only for patients not achieving LDL-C goal with 20 mg

(Tablets shown not actual size)

  • In patients taking cyclosporine, the dose of CRESTOR should not exceed 5 mg once daily1
  • In patients taking a combination of lopinavir and ritonavir, atazanavir and ritonavir or simeprevir, the dose of CRESTOR should not exceed 10 mg once daily1
  • Combination therapy with CRESTOR and gemfibrozil should be avoided. If used together, do not exceed CRESTOR 10 mg once daily1
  • 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 exceed 10 mg once daily1
  • When initiating CRESTOR therapy or switching from another statin, the appropriate CRESTOR starting dose should first be used and only then titrated according to the patient's response and individualized goal of therapy1
  • After initiation or upon titration of CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly1

In patients with hyperlipidemia,

Significant LDL-C reductions at each dose*1,2

Chart of LDL-C Reductions by Dose

*A multicenter, double-blind, placebo-controlled, dose-ranging study in patients with hyperlipidemia given CRESTOR as a single daily dose for 6 weeks.

P<.001 vs -7% with placebo (n=13).

CRESTOR 40 mg should only be used for those patients not achieving their LDL-C goal with 20 mg.

  • Eligible patients can pay as low as $3 for each prescription of CRESTOR

    Subject to eligibility. Restrictions apply. Click here for eligibility information.

    Learn more

  • Help your patients reach LDL-C goal with CRESTOR

    In the STELLAR trial, in patients with hyperlipidemia or mixed dyslipidemia

    Nearly 9 out of 10

    met their LDL-C goal with CRESTOR 20 mg.3

    View the data

1976103-3214100 Last Updated 2/16

Important Safety Information for CRESTOR Tablets

  • 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 statins, 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, lopinavir/ritonavir, atazanavir/ritonavir, or simeprevir
  • Therapy with CRESTOR should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. There have been rare reports of immune-mediated necrotizing myopathy associated with statin use. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, and if muscle signs and symptoms persist after discontinuing CRESTOR
  • It is recommended that liver enzyme tests be performed before the initiation of CRESTOR and if signs or symptoms of liver injury occur. All patients treated with CRESTOR should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including CRESTOR. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with CRESTOR, promptly interrupt therapy. If an alternate etiology is not found, do not restart CRESTOR
  • CRESTOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease
  • CRESTOR significantly increased INR in patients receiving coumarin anticoagulants. In patients taking coumarin anticoagulants and CRESTOR concomitantly, INR should be determined before starting CRESTOR and frequently enough during early therapy to ensure that no significant alteration of INR occurs
  • Dipstick-positive proteinuria and microscopic hematuria were observed among patients treated with CRESTOR. These findings were more frequent in patients taking CRESTOR 40 mg, though it was generally transient and was not associated with worsening renal function. Although the clinical significance of this finding is unknown, dose reduction should be considered for patients on CRESTOR therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing
  • Increases in HbA1c and fasting serum glucose levels have been reported with statins, including CRESTOR. Based on clinical trial data with CRESTOR, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus
  • 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%)#,‡‡
  • Rare postmarketing reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) have been associated with statin use, including CRESTOR. These reports are generally nonserious and reversible upon statin discontinuation
  • CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg

Important Safety Information from the JUPITER Study

  • A higher percentage of rosuvastatin-treated patients vs placebo-treated patients (6.6% and 6.2%, respectively) discontinued study medication due to an adverse event, irrespective of treatment causality. Myalgia was the most common adverse reaction that led to treatment discontinuation
  • In JUPITER, there was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) vs patients taking placebo (2.3%). Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients. The number of patients with HbA1c >6.5% at the end of the trial was significantly higher in rosuvastatin-treated patients vs placebo-treated patients
  • The most common adverse reactions reported were myalgia (7.6% vs 6.6%), arthralgia (3.8% vs 3.2%), constipation (3.3% vs 3.0%), and nausea (2.4% vs 2.3%) for CRESTOR vs placebo, respectively

Indications

  • CRESTOR is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and triglycerides, and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia, and 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 indicated to reduce the risk of myocardial infarction, stroke, and arterial revascularization procedures in patients without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD) based on age (men ≥50 and women ≥60), high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease

Read full Prescribing Information (PDF - 152k) 

#Prescribing Information for CRESTOR. AstraZeneca Pharmaceuticals LP, Wilmington, DE.

‡‡Data on File, 268255, AstraZeneca Pharmaceuticals LP.

References:

  1. Prescribing Information for CRESTOR. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
  2. Data on File, 266992, AstraZeneca Pharmaceuticals LP.
  3. Jones PH, Davidson MH, Stein EA, et al; STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003;93(2):152-160.

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