From the Guidelines
The maximum dose of rosuvastatin per day is 40 mg for patients with normal kidney function, but it should not exceed 10 mg daily for those with severe kidney disease (CCr < 30 mL/min/1.73 m²) who are not on hemodialysis. This recommendation is based on the dosing adjustments for medicines to treat lipid disorders in chronic kidney disease (CKD) as outlined in the KDOQI clinical practice guidelines 1. The dosing range for rosuvastatin is 5-40 mg daily, with no dose modification necessary for patients with mild to moderate kidney disease. However, for patients with severe kidney disease, the dose should be initiated at 5 mg daily and not exceeded 10 mg daily.
- Key considerations for rosuvastatin dosing include:
- Patient kidney function, with dose adjustments needed for those with severe renal impairment
- Starting dose, which is typically 5 mg daily for patients with severe kidney disease
- Maximum dose, which is 40 mg daily for patients with normal kidney function, but 10 mg daily for those with severe kidney disease
- Monitoring for side effects, such as muscle pain or damage (myopathy), especially at higher doses
- Individual patient factors, such as Asian descent, which may require lower doses due to higher blood levels achieved at equivalent doses.
From the FDA Drug Label
The dosage range for rosuvastatin tablets is 5 mg to 40 mg orally once daily. The recommended dose of rosuvastatin tablets depends on a patient’s indication for usage, LDL-C, and individual risk for CV events.
The maximum dose of rosuvastatin per day is 40 mg orally once daily 2.
From the Research
Rosuvastatin Maximum Dose Per Day
- The maximum dose of rosuvastatin per day is 40 mg, as indicated in several studies 3, 4, 5.
- This dose range is approved for use in patients with hypercholesterolemia and mixed dyslipidemia, and has been shown to be effective in reducing low-density lipoprotein cholesterol (LDL-C) levels 3, 4.
- The 40 mg dose is also well-tolerated, with a similar safety profile to other statins on the market 5.
- However, it's worth noting that higher doses of rosuvastatin (above 40 mg) may increase the risk of certain adverse events, such as mild tubular proteinuria 5.
- The American College of Cardiology/American Heart Association guidelines recommend that the dose of rosuvastatin be individualized based on the patient's response to treatment and their cardiovascular risk profile, but do not specify a maximum dose.
- Studies have shown that rosuvastatin 10-40 mg can be used in combination with ezetimibe 10 mg to achieve significant reductions in LDL-C levels, with a good safety profile 4.
Key Findings
- Rosuvastatin 5 mg is significantly more effective at reducing LDL-C and total cholesterol levels compared to atorvastatin 10 mg, simvastatin 20 mg, and pravastatin 20 mg 3.
- Rosuvastatin 10 mg is more effective than atorvastatin 10 mg in achieving an LDL-C goal of < 1.00 g/l in high cardiovascular risk patients 6.
- The combination of rosuvastatin and ezetimibe has been shown to be effective in reducing LDL-C levels in patients with hypercholesterolemia, including those at high risk and those with atherosclerotic cardiovascular disease 4.