What is the maximum approved dose of rosuvastatin in adults?

Maximum Approved Dose of Rosuvastatin

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

FDA-Approved Dosing Range

• The FDA-approved dosage range for rosuvastatin in adults is 5 mg to 40 mg once daily, taken orally with or without food at any time of day. 1

• Rosuvastatin is administered as a single daily dose across its entire therapeutic range, from the lowest 5 mg dose through the maximum 40 mg dose. 1

Clinical Context and Dose-Response

• Rosuvastatin 40 mg produces approximately 55–63% LDL-C reduction, representing the highest intensity achievable with this agent. 2, 3

• The dose-response relationship shows that rosuvastatin 10 mg reduces LDL-C by approximately 52%, 20 mg by 52–55%, and 40 mg by 55–63%, demonstrating incremental but diminishing returns at higher doses. 2, 3, 4

• High-intensity statin therapy is defined as ≥50% LDL-C reduction, which rosuvastatin achieves at doses of 20–40 mg daily according to ACC/AHA guidelines. 2, 5

Special Population Dose Restrictions

Asian Patients

• Asian patients should be initiated at 5 mg once daily due to significantly higher rosuvastatin plasma concentrations compared to Caucasian patients. 5, 1
• Clinicians should carefully consider risks and benefits if doses above 20 mg daily are contemplated in Asian patients. 5, 1

Severe Renal Impairment

• Patients with severe renal impairment (CrCl <30 mL/min) not on hemodialysis should be initiated at 5 mg once daily and must not exceed 10 mg once daily. 2, 5, 1
• This represents a critical safety restriction, as rosuvastatin exposure increases substantially in severe renal dysfunction. 2

Drug Interaction Restrictions

• When co-administered with cyclosporine, tacrolimus, everolimus, or sirolimus, rosuvastatin must not exceed 5 mg daily due to a 7-fold increase in drug exposure and severe risk of muscle toxicity. 5
• When used with resmetirom for MASH/NASH, rosuvastatin should be limited to 20 mg daily. 5

Pediatric Dosing Limits

• For pediatric patients aged 8 to <10 years with heterozygous familial hypercholesterolemia (HeFH), the maximum dose is 10 mg once daily. 1
• For pediatric patients ≥10 years with HeFH, the maximum dose is 20 mg once daily. 1
• For pediatric patients ≥7 years with homozygous familial hypercholesterolemia (HoFH), the recommended dose is 20 mg once daily. 1

Safety Profile at Maximum Dose

• At the 40 mg dose, rosuvastatin maintains an acceptable safety profile with myopathy incidence <0.1% at recommended doses of 5–40 mg daily. 5
• The incidence of proteinuria or microscopic hematuria with rosuvastatin 40 mg/day is <1.5%, and these events are mostly transient and not associated with progressive renal deterioration. 6
• Very few patients (0.2–0.4%) experience creatine phosphokinase elevations >10× upper limit of normal at doses of 5–40 mg/day. 6

Clinical Application

• For secondary prevention in adults ≤75 years with established ASCVD, initiate rosuvastatin 20–40 mg daily to achieve ≥50% LDL-C reduction and target LDL-C <70 mg/dL. 5
• For very high-risk patients (recent ACS, multivessel disease, or LDL-C ≥190 mg/dL), rosuvastatin 40 mg may be required to achieve LDL-C <55 mg/dL with ≥50% reduction from baseline. 5
• LDL-C should be reassessed as early as 4 weeks after initiating or adjusting rosuvastatin, with dose adjustment as necessary. 1

Important Caveat

• The 40 mg dose should not be used as a starting dose in most patients; initiation typically begins at 5–20 mg depending on cardiovascular risk, with uptitration to 40 mg reserved for patients who fail to achieve LDL-C goals on lower doses or who have very high baseline LDL-C (≥190 mg/dL). 5, 1