What is the highest dose of Rosuvastatin ( Crestor )?

Highest Dose of Rosuvastatin

The highest approved 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, with the specific dose depending on the patient's indication, baseline LDL-C levels, and cardiovascular risk profile. 1

High-Intensity Therapy Classification

Rosuvastatin 20-40 mg daily constitutes high-intensity statin therapy, achieving ≥50% reduction in LDL-C from baseline (approximately 50-63% reduction). 2 This classification places rosuvastatin 40 mg among the most potent lipid-lowering regimens available, comparable to atorvastatin 40-80 mg. 3

Clinical Efficacy at Maximum Dose

• Rosuvastatin 40 mg reduces LDL-C by approximately 63%, representing the upper end of achievable LDL-C reduction with statin monotherapy. 4, 5
• At 40 mg daily, rosuvastatin demonstrates superior LDL-C lowering compared to equivalent doses of other statins, with dose-to-dose potency exceeding atorvastatin (60% vs 50% reduction), simvastatin (60% vs 40%), and pravastatin (60% vs 30%). 5
• HDL-C increases by approximately 10-13% at the 40 mg dose. 4, 6

Critical Dosing Restrictions and Safety Considerations

Asian Patients

• Do not exceed 20 mg once daily in Asian patients due to increased rosuvastatin plasma concentrations. 1
• Initiate at 5 mg once daily and carefully consider risks versus benefits when escalating beyond 20 mg. 1

Severe Renal Impairment

• Maximum dose is 10 mg once daily in patients with CrCl <30 mL/min/1.73 m² not on hemodialysis. 1
• Start at 5 mg once daily in this population. 1

Drug Interactions Requiring Dose Limitation

• Cyclosporine/tacrolimus/everolimus/sirolimus: Do not exceed 5 mg daily due to 7-fold increase in rosuvastatin exposure and severe risk of muscle toxicity. 7, 1
• Teriflunomide, enasidenib, capmatinib: Do not exceed 10 mg daily. 1
• Fostamatinib, febuxostat: Do not exceed 20 mg daily. 1
• Gemfibrozil: Avoid concomitant use; if necessary, do not exceed 10 mg daily. 1
• Darolutamide: Do not exceed 5 mg daily. 1

Safety Profile at Maximum Dose

• Myopathy incidence remains <0.1% at the 40 mg dose, similar to other recommended doses. 2
• Proteinuria or microscopic hematuria occurs in <1.5% of patients on 40 mg (versus <1% at 10-20 mg), but these events are typically transient and not associated with progressive renal deterioration. 8
• Creatine phosphokinase elevations >10× ULN occur in 0.2-0.4% of patients across the 5-40 mg dose range. 8
• The 40 mg dose is generally well tolerated with adverse events (myalgia, constipation, asthenia, abdominal pain, nausea) being mostly transient and mild. 8

Clinical Indications for Maximum Dose

Consider rosuvastatin 40 mg in:

• Adults ≤75 years with established ASCVD requiring maximal LDL-C reduction. 2
• Patients with LDL-C ≥190 mg/dL who remain above goal on lower doses. 2
• Very high-risk patients with multiple major risk factors targeting LDL-C <70 mg/dL. 2
• Patients with homozygous familial hypercholesterolemia (though 20 mg is the recommended pediatric dose). 1

Common Pitfall

The most critical error is exceeding 5 mg daily in patients on immunosuppressants (cyclosporine, tacrolimus, everolimus, sirolimus), which dramatically increases the risk of severe rhabdomyolysis due to 7-fold elevation in drug exposure. 7 Always verify concomitant medications before prescribing doses above 20 mg.