What is the maximum recommended daily dose of rosuvastatin for a patient with chronic kidney disease stage 3b (estimated glomerular filtration rate 30–44 mL/min/1.73 m²)?

Maximum Rosuvastatin Dose in CKD Stage 3b

For patients with CKD stage 3b (eGFR 30–44 mL/min/1.73 m²), the maximum recommended dose of rosuvastatin is 10 mg once daily, with a starting dose of 5 mg once daily. 1, 2, 3

Dosing Framework by Renal Function

The FDA-approved prescribing information establishes clear dose restrictions based on creatinine clearance 3:

• For severe renal impairment (CrCl <30 mL/min/1.73 m²): Start at 5 mg once daily and do not exceed 10 mg once daily 3
• For mild to moderate renal impairment (CrCl ≥30 mL/min/1.73 m²): No dose adjustment required; standard dosing applies 1, 4

CKD stage 3b (eGFR 30–44 mL/min/1.73 m²) falls into the mild-to-moderate category, meaning standard dosing is appropriate without mandatory restriction. 1 However, the KDIGO guidelines recommend cautious dose selection in advanced CKD due to increased myopathy risk and reduced renal excretion 2, 4.

Practical Dosing Algorithm for CKD Stage 3b

Step 1: Determine cardiovascular risk category

• High-intensity therapy indicated (established coronary disease, diabetes with CKD): Target rosuvastatin 20–40 mg daily in patients with eGFR ≥30 mL/min/1.73 m² 1
• Moderate-intensity therapy indicated (primary prevention, age ≥50 years): Target rosuvastatin 5–10 mg daily 1

Step 2: Initiate at appropriate dose

• Start at 5 mg daily if age ≥65 years, Asian ethnicity, or concern for drug interactions 1, 3
• Start at 10 mg daily for most other patients requiring moderate-intensity therapy 1
• Start at 20 mg daily if high-intensity therapy is indicated and eGFR is stable at 30–44 mL/min/1.73 m² 1

Step 3: Monitor and adjust

• Assess LDL-C at 4 weeks after initiation 3
• Monitor for myopathy symptoms, especially in patients >65 years or with hypothyroidism 1, 3
• If eGFR declines to <30 mL/min/1.73 m², reduce dose to maximum 10 mg daily 3

Critical Distinction: Stage 3b vs. Severe Renal Impairment

The 10 mg maximum dose restriction applies only when CrCl drops below 30 mL/min/1.73 m² (CKD stage 4 or worse). 3 CKD stage 3b patients with eGFR 30–44 mL/min/1.73 m² can receive higher doses (20–40 mg) if clinically indicated for high-intensity therapy, though this should be done cautiously 1, 4.

The KDIGO guidelines note that rosuvastatin has reduced renal excretion in patients with eGFR <60 mL/min/1.73 m², supporting careful dose selection but not mandating restriction in stage 3b 2.

Special Considerations

Asian patients: Start at 5 mg daily regardless of renal function due to 2-fold higher plasma concentrations 1, 3

Drug interactions requiring dose restriction: 3

• Cyclosporine: Do not exceed 5 mg daily
• Teriflunomide, enasidenib, capmatinib: Do not exceed 10 mg daily
• Gemfibrozil: Avoid concomitant use; if necessary, do not exceed 10 mg daily

Dialysis patients: If the patient progresses to dialysis, continue rosuvastatin if already established, but do not initiate new therapy 1, 2

Common Pitfalls to Avoid

• Do not automatically restrict to 10 mg in stage 3b patients—this restriction applies only to CrCl <30 mL/min/1.73 m² 3
• Do not use high-intensity doses (20–40 mg) in patients with rapidly declining eGFR or multiple myopathy risk factors 1, 4
• Do not combine rosuvastatin with gemfibrozil—this significantly increases myopathy risk 3
• Do not ignore age ≥65 years as a myopathy risk factor—consider starting at 5 mg in elderly patients even with preserved eGFR 1, 3