What is the maximum dose of Lipitor (atorvastatin)?

Maximum Dose of Lipitor (Atorvastatin)

The maximum FDA-approved dose of Lipitor (atorvastatin) is 80 mg per day. 1, 2

Dosing Information

Atorvastatin is available in the following strengths:

• 10 mg tablets
• 20 mg tablets
• 40 mg tablets
• 80 mg tablets 1

The dosage range for atorvastatin is 10 mg to 80 mg once daily, with the following recommendations:

• Starting dose: 10-20 mg once daily for most patients 1
• Patients requiring >45% LDL-C reduction: May start at 40 mg once daily 1
• Maximum dose: 80 mg once daily 2

Dose Titration

Dose titration should be based on:

• Patient's cardiovascular risk
• LDL-C reduction needed
• Response to initial therapy
• Tolerability

The LDL-C response should be assessed 4-12 weeks after initiating therapy or changing doses 3.

Special Dosing Considerations

Drug Interactions

Certain medications require dose limitations of atorvastatin:

• With protease inhibitors (saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir): Do not exceed 20 mg daily 1
• With nelfinavir: Do not exceed 40 mg daily 1
• With clarithromycin or itraconazole: Do not exceed 20 mg daily 1

Special Populations

• Elderly patients: High-dose atorvastatin (up to 80 mg) is generally well tolerated in patients aged ≥65 years, with no dose-dependent increase in adverse events 4, 5
• Renal dysfunction: No dosage adjustment required 4

Safety Considerations at Maximum Dose

While 80 mg is the maximum approved dose, it's important to note:

• Higher doses (80 mg) are associated with slightly higher rates of liver enzyme elevations compared to lower doses 4
• The risk of myopathy increases with higher doses, though atorvastatin has a lower incidence of muscular toxicity compared to some other statins 4
• No cases of rhabdomyolysis were observed in clinical trials comparing atorvastatin 80 mg with pravastatin 40 mg 2

Clinical Applications of Maximum Dose

The 80 mg dose is particularly useful in:

1. Very high-risk patients: For those requiring ≥50% LDL-C reduction or to achieve LDL-C <70 mg/dL 3
2. Post-acute coronary syndrome: High-intensity statin therapy (atorvastatin 80 mg) reduced major cardiovascular events compared to standard therapy 2
3. Stroke prevention: Atorvastatin 80 mg daily is indicated for patients with ischemic stroke with LDL-C >100 mg/dL to reduce stroke recurrence 2

Monitoring at Maximum Dose

When using the maximum dose of 80 mg:

• Monitor liver function tests initially, approximately 12 weeks after starting therapy, then annually or more frequently if indicated 2
• Evaluate muscle symptoms and CK before starting therapy, 6-12 weeks after initiation, and at each follow-up visit 2
• Obtain CK measurement when patients report muscle soreness, tenderness, or pain 2

In conclusion, while 80 mg is the maximum approved dose of atorvastatin, the appropriate dose should be determined based on the required LDL-C reduction, cardiovascular risk, and potential for drug interactions.