What is the maximum recommended dose of Crestor (rosuvastatin)?

Maximum Dose of Crestor (Rosuvastatin)

The maximum recommended dose of rosuvastatin is 40 mg once daily for most patients, but this must be reduced to lower maximums (5-20 mg daily) depending on specific drug interactions and patient characteristics. 1

Standard Maximum Dosing

• The FDA-approved maximum dose is 40 mg orally once daily for the general adult population without contraindications or significant drug interactions 1
• The therapeutic dosage range spans 5 mg to 40 mg once daily, with high-intensity statin therapy defined as rosuvastatin 20-40 mg daily (achieving 50-63% LDL-C reduction) 2
• Rosuvastatin can be administered at any time of day, with or without food, as a single daily dose 1

Critical Dose Restrictions Based on Drug Interactions

Several commonly used medications require strict maximum dose limitations well below 40 mg:

Severe Restrictions (5 mg maximum daily):

• Cyclosporine, tacrolimus, everolimus, or sirolimus: Do not exceed 5 mg daily due to 7-fold increase in rosuvastatin exposure and severe rhabdomyolysis risk 2, 3, 1
• Darolutamide: Maximum 5 mg daily 1

Moderate Restrictions (10 mg maximum daily):

• Teriflunomide, enasidenib, capmatinib, regorafenib: Do not exceed 10 mg daily 1
• Gemfibrozil: Avoid concomitant use if possible; if used together, maximum 10 mg daily 1
• Antiviral medications (atazanavir/ritonavir, lopinavir/ritonavir, simeprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir): Maximum 10 mg daily 1
• Severe renal impairment (CrCl <30 mL/min/1.73 m² not on hemodialysis): Maximum 10 mg daily 1

Intermediate Restrictions (20 mg maximum daily):

• Fostamatinib, febuxostat: Do not exceed 20 mg daily 1
• Tafamidis: Avoid concomitant use if possible; if used together, maximum 20 mg daily 1
• Resmetirom (for MASH/NASH): Limit rosuvastatin to 20 mg daily 2

Contraindicated Combinations:

• Sofosbuvir/velpatasvir/voxilaprevir and ledipasvir/sofosbuvir: Concomitant use not recommended 1

Special Population Considerations

Asian Patients:

• Initiate at 5 mg once daily due to increased rosuvastatin plasma concentrations in this population 1
• Consider risks and benefits carefully when treating Asian patients requiring doses above 20 mg daily 1

Pediatric Patients:

• 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 20 mg daily 1

Elderly Patients (>75 years):

• While no specific dose restriction exists, moderate-intensity therapy (5-10 mg) may be more appropriate than high-intensity therapy, as there was no clear evidence of additional cardiovascular benefit from high-intensity therapy in this age group 2

Common Pitfalls to Avoid

• Never exceed 5 mg daily with immunosuppressants (cyclosporine, tacrolimus, everolimus, sirolimus) as this creates a severe drug-drug interaction through OATP1B1 and P-glycoprotein inhibition 2, 3
• Always check for drug interactions before prescribing or increasing doses, as multiple commonly used medications require dose restrictions 1
• Do not administer rosuvastatin simultaneously with aluminum and magnesium hydroxide antacids—separate by at least 2 hours 1
• Screen for renal impairment before prescribing higher doses, as severe renal impairment mandates a 10 mg maximum 1