Maximum Dose of Rosuvastatin

The maximum recommended dose of rosuvastatin is 40 mg once daily. 1

FDA-Approved Dosing Range

The FDA-approved dosage range for rosuvastatin is 5 mg to 40 mg orally once daily 1
Rosuvastatin can be administered at any time of day, with or without food 1

High-intensity rosuvastatin therapy is defined as 20-40 mg daily, which achieves ≥50% reduction in LDL cholesterol 2, 3
The American College of Cardiology guidelines specifically identify rosuvastatin 20 mg and 40 mg as high-intensity statin doses evaluated in randomized controlled trials that demonstrated reduction in major cardiovascular events 2

Rosuvastatin 40 mg is appropriate for:

Adults with severe hypercholesterolemia (LDL-C ≥190 mg/dL) requiring maximal LDL-C reduction 2
Patients with established ASCVD requiring aggressive secondary prevention 2
Pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia 1
Adults with heterozygous familial hypercholesterolemia who need intensive lipid lowering 2

Several clinical scenarios require dose limitations below the maximum:

Initiate at 5 mg daily due to increased rosuvastatin plasma concentrations 1
Consider risks and benefits when treating Asian patients not adequately controlled at doses up to 20 mg daily 1

In patients with severe renal impairment (CrCl <30 mL/min/1.73 m²) not on hemodialysis, start at 5 mg once daily and do not exceed 10 mg once daily 1

Cyclosporine: Do not exceed 5 mg once daily 1
Teriflunomide, enasidenib, capmatinib: Do not exceed 10 mg once daily 1
Gemfibrozil: Avoid concomitant use; if used, initiate at 5 mg and do not exceed 10 mg once daily 1
Multiple antivirals (atazanavir/ritonavir, lopinavir/ritonavir, glecaprevir/pibrentasvir): Do not exceed 10 mg once daily 1
Darolutamide: Do not exceed 5 mg once daily 1
Fostamatinib, febuxostat: Do not exceed 20 mg once daily 1

Rosuvastatin 40 mg produces approximately 60-66% reduction in LDL cholesterol from baseline 4, 5, 6
Long-term studies demonstrate that rosuvastatin 40 mg enables 83-84% of patients with severe hypercholesterolemia to achieve NCEP ATP III LDL cholesterol goals 6
At 96 weeks, rosuvastatin 40 mg reduced LDL cholesterol by 54% and increased HDL cholesterol by 13% in patients with severe hypercholesterolemia 6

Rosuvastatin 40 mg was well tolerated in long-term studies up to 96 weeks 6
The incidence of proteinuria or microscopic hematuria with rosuvastatin 40 mg is <1.5%, mostly transient and not associated with progressive renal deterioration 4
Myopathy incidence remains very low (≤0.1%) even at the 40 mg dose 4
Creatine phosphokinase elevations >10-fold the upper limit of normal occur in only 0.2-0.4% of patients at doses of 5-40 mg daily 4

Failing to check for drug interactions before prescribing maximum doses - many commonly used medications require dose caps well below 40 mg 1
Not adjusting for severe renal impairment - this population has a strict 10 mg maximum to avoid increased adverse events 1
Overlooking Asian ethnicity - these patients require lower starting doses and careful consideration before exceeding 20 mg daily 1
Not monitoring for dose-related adverse effects - while generally well tolerated, higher doses may show increased frequency of treatment-related adverse events 5