What is the recommended dosing for Rosuvastatin (rosuvastatin) in patients with hyperlipidemia?

Rosuvastatin Dosing for Hyperlipidemia

Start with rosuvastatin 10 mg once daily for most patients with hyperlipidemia, titrating to 20-40 mg daily for high-risk patients requiring high-intensity therapy to achieve LDL-C reductions ≥50%. 1, 2

Standard Dosing Regimen

The FDA-approved dosage range is 5-40 mg orally once daily, taken at any time of day with or without food. 2 The specific dose depends on cardiovascular risk stratification and LDL-C goals:

Primary Prevention (No Established ASCVD)

• Moderate-intensity therapy: Rosuvastatin 5-10 mg daily for patients aged 40-75 years without ASCVD, targeting LDL-C reduction ≥30-49% and goal <70 mg/dL 1

• High-intensity therapy: Rosuvastatin 20-40 mg daily for patients with additional ASCVD risk factors (including elevated hsCRP ≥2 mg/L), targeting LDL-C reduction ≥50% and goal <70 mg/dL 3, 1

• Diabetes mellitus: Moderate-intensity statin (rosuvastatin 5-10 mg) is indicated for patients aged 40-75 years with diabetes for primary prevention 3

Secondary Prevention (Established ASCVD)

• High-intensity therapy is recommended: Rosuvastatin 20-40 mg daily to achieve LDL-C reduction ≥50% and goal <55 mg/dL 1

• If high-intensity therapy cannot be tolerated, use moderate-intensity therapy with ezetimibe added if LDL-C remains ≥70 mg/dL 3

Severe Hypercholesterolemia (LDL-C ≥190 mg/dL)

• Maximally tolerated statin therapy is recommended for patients aged 20-75 years, typically starting with rosuvastatin 20-40 mg daily 3

• Add ezetimibe if <50% LDL-C reduction achieved or LDL-C remains ≥100 mg/dL on maximally tolerated statin 3

Special Population Dosing Adjustments

Asian Patients

• Start at 5 mg once daily due to increased rosuvastatin plasma concentrations in this population 1, 2
• Consider risks and benefits when doses >20 mg daily are needed 2

Renal Impairment

• Mild to moderate impairment: No dosage adjustment needed 2
• Severe impairment (CrCl <30 mL/min/1.73 m²): Start at 5 mg daily and do not exceed 10 mg daily 1, 2

Pediatric Patients

• HeFH (ages 8-10 years): 5-10 mg once daily 2
• HeFH (ages ≥10 years): 5-20 mg once daily 2
• HoFH (ages ≥7 years): 20 mg once daily 2

Drug Interaction Dose Modifications

Critical dose limitations apply with specific concomitant medications: 2

• Do not exceed 5 mg daily: Cyclosporine, darolutamide 2
• Do not exceed 10 mg daily: Teriflunomide, enasidenib, capmatinib, regorafenib, gemfibrozil (if concomitant use unavoidable), atazanavir/ritonavir, lopinavir/ritonavir 2
• Do not exceed 20 mg daily: Fostamatinib, febuxostat, tafamidis (if concomitant use unavoidable) 2
• Avoid concomitant use: Gemfibrozil, tafamidis, multiple antiviral medications including sofosbuvir/velpatasvir/voxilaprevir 2

Monitoring and Titration

• Assess LDL-C as early as 4 weeks after initiation and adjust dosage accordingly 2
• The goal is to achieve target LDL-C levels based on risk category, with clinical trials demonstrating 52-63% LDL-C reduction at doses of 10-40 mg 4
• Rosuvastatin 10 mg achieves superior LDL-C reduction compared to atorvastatin 10 mg, simvastatin 10-40 mg, and pravastatin 10-40 mg 5, 6

Common Pitfalls to Avoid

• Inadequate dose titration: Many high-risk patients require 20-40 mg daily to achieve LDL-C goals; starting at 10 mg and failing to uptitrate is a common error 1, 7

• Ignoring drug interactions: Always review concomitant medications before prescribing, particularly cyclosporine, gemfibrozil, and antivirals which require significant dose restrictions 2

• Antacid timing: When using aluminum/magnesium hydroxide antacids, administer rosuvastatin at least 2 hours before the antacid 2

• Overlooking Asian ethnicity: Failure to start at 5 mg in Asian patients increases risk of adverse effects 2

• Renal dosing errors: Patients with severe renal impairment should never exceed 10 mg daily 2