Maximum Dose of Crestor (Rosuvastatin)
The maximum recommended dose of rosuvastatin is 40 mg once daily for most adult patients. 1
Standard Dosing Range
- The FDA-approved dosage range for rosuvastatin is 5 mg to 40 mg orally once daily 1
- Rosuvastatin 20-40 mg daily is classified as high-intensity statin therapy, achieving approximately 50-63% LDL-C reduction from baseline 2
Critical Dose Restrictions Based on Drug Interactions
Several medications require strict maximum dose limitations to prevent severe muscle toxicity:
- Cyclosporine, tacrolimus, everolimus, or sirolimus: Do not exceed 5 mg daily due to 7-fold increase in rosuvastatin exposure and severe risk of rhabdomyolysis 2, 1
- Teriflunomide, enasidenib, capmatinib, darolutamide, or regorafenib: Do not exceed 10 mg daily 1
- Fostamatinib or febuxostat: Do not exceed 20 mg daily 1
- Gemfibrozil: Avoid concomitant use; if necessary, do not exceed 10 mg daily 1
- Multiple antiviral medications (including ledipasvir/sofosbuvir, atazanavir/ritonavir, lopinavir/ritonavir): Do not exceed 10 mg daily 1
Special Population Restrictions
Severe Renal Impairment
- Patients with CrCl <30 mL/min/1.73 m² not on hemodialysis: Start at 5 mg daily and do not exceed 10 mg daily 3, 1
- No dose adjustment needed for mild to moderate renal impairment 1
Asian Patients
- Initiate at 5 mg once daily due to increased plasma concentrations 1
- Consider risks and benefits when treating Asian patients not adequately controlled at doses up to 20 mg daily 1
Disease-Specific Restrictions
- When used with resmetirom for MASH/NASH: Limit to 20 mg daily 2
Pediatric Maximum Doses
- Ages 8 to <10 years with HeFH: Maximum 10 mg daily 1
- Ages ≥10 years with HeFH: Maximum 20 mg daily 1
- Ages ≥7 years with HoFH: Recommended dose is 20 mg daily 1
Safety Profile at Maximum Dose
- Myopathy incidence is <0.1% at recommended doses of 5-40 mg daily 2
- Elevations in serum CPK >10-fold the upper limit of normal occur in only 0.2-0.4% of patients at 40 mg daily 4
- Proteinuria or microscopic hematuria incidence is <1.5% with rosuvastatin 40 mg daily, mostly transient and not associated with progressive renal deterioration 4
Common Pitfall to Avoid
The most critical error is failing to reduce the maximum dose when patients are on interacting medications, particularly immunosuppressants like cyclosporine, which can increase rosuvastatin exposure 7-fold and lead to severe rhabdomyolysis. 2, 1 Always review the patient's medication list before prescribing or increasing rosuvastatin doses.