What is the maximum recommended dose of atorvastatin (Lipitor)?

Maximum Dose of Atorvastatin

The maximum FDA-approved dose of atorvastatin is 80 mg once daily. 1

FDA-Approved Dosing Range

• Atorvastatin is available in doses of 10 mg, 20 mg, 40 mg, and 80 mg tablets, with a dosage range of 10-80 mg once daily. 1
• The FDA label specifies that patients requiring LDL-C reduction greater than 45% may be started at 40 mg once daily, with the option to titrate up to the maximum of 80 mg. 1

Guideline Recommendations on Maximum Dosing

• Multiple professional guidelines consistently identify 80 mg daily as the maximum dose of atorvastatin. 2
• The ACC/AHA/NHLBI 2002 clinical advisory explicitly lists atorvastatin's maximum FDA-approved dose as 80 mg in their summary table of HMG-CoA reductase inhibitors. 2
• The 2010 ACC/AHA peripheral artery disease performance measures document confirms 80 mg/day as the maximal dose for atorvastatin when treating patients with PAD. 2

Clinical Context for 80 mg Dosing

• The 80 mg dose should typically be used as a titration dose rather than a starting dose in most patients. 3
• High-intensity statin therapy (atorvastatin 40-80 mg) achieves ≥50% LDL-C reduction and is recommended for secondary prevention in patients with established cardiovascular disease. 3
• Starting at 80 mg is generally not recommended unless the patient is already on high-dose statin therapy and switching to atorvastatin. 3

Important Dose Modifications

Certain drug interactions require limiting atorvastatin to doses below the 80 mg maximum: 1

• Do not exceed 20 mg daily when taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir, letermovir, clarithromycin, or itraconazole. 1
• Do not exceed 40 mg daily when taking nelfinavir. 1
• Simvastatin should be limited to 20 mg daily when combined with amiodarone, but atorvastatin does not require dose adjustment with amiodarone according to FDA labeling. 2

Safety Considerations at Maximum Dose

• Myopathy and rhabdomyolysis risk increases at higher statin doses, particularly the 80 mg dose. 2
• Older patients, particularly thin or frail elderly women, and those with multisystem disease or chronic kidney disease with diabetes require more cautious dosing and monitoring. 2
• The ACC/AHA advisory emphasizes that doses should not exceed those required to attain treatment goals, as adverse events occur more frequently at higher doses. 2

Efficacy Data at Maximum Dose

• Clinical trials demonstrate that atorvastatin 80 mg produces approximately 52-61% reduction in LDL-C from baseline. 4, 5
• The NASDAC study showed dose-dependent LDL-C reductions across the 10-80 mg range (35.7%-52.2%), with each higher dose providing significantly greater decreases than lower doses. 4