What is the maximum recommended dose of pravastatin (a statin) for a patient with severe hypercholesterolemia?

Maximum Dose of Pravastatin

The maximum recommended dose of pravastatin is 80 mg once daily. 1

FDA-Approved Dosing

The FDA label establishes clear dosing parameters for pravastatin:

• Starting dose: 40-80 mg once daily in adults 1
• Maximum dose: 80 mg once daily 1
• Administration: Can be taken at any time of day, with or without food 1

Clinical Context: When 80 mg May Not Be Sufficient

For patients requiring high-intensity statin therapy (≥50% LDL-C reduction), pravastatin 80 mg should not be used—switch to atorvastatin 40-80 mg or rosuvastatin 20-40 mg instead. 2, 3

Expected LDL-C Reductions by Dose:

• Pravastatin 40 mg: 30-34% LDL-C reduction (moderate-intensity) 2, 4
• Pravastatin 80 mg: 37-38% LDL-C reduction (moderate-intensity) 2, 3

Since pravastatin 80 mg achieves only 37-38% LDL-C reduction, it falls short of the ≥50% reduction required for high-intensity therapy. 2

Dose Modifications for Special Populations

Renal Impairment:

• Severe renal impairment: Start at 10 mg once daily, maximum 40 mg once daily 1
• Mild-moderate renal impairment: No dose adjustment needed 1

Drug Interactions Requiring Dose Limitation:

• With cyclosporine: Start at 10 mg once daily, maximum 20 mg once daily 1
• With clarithromycin or erythromycin: Maximum 40 mg once daily 1

Pediatric Dosing (Ages 8+ with Heterozygous Familial Hypercholesterolemia):

• Ages 8-13 years: 20 mg once daily 1
• Ages 14-18 years: 40 mg once daily 1

Clinical Decision Algorithm

Step 1: Determine cardiovascular risk level and LDL-C goal 2

Step 2: If high-intensity statin needed (≥50% LDL-C reduction):

• Do NOT use pravastatin at any dose 2, 3
• Switch to atorvastatin 40-80 mg or rosuvastatin 20-40 mg 2

Step 3: If moderate-intensity statin appropriate (30-49% LDL-C reduction):

• Pravastatin 40-80 mg is acceptable 2
• Reassess LDL-C at 4 weeks 1

Step 4: Check for contraindications to maximum dosing:

• Severe renal impairment: Cap at 40 mg 1
• Cyclosporine use: Cap at 20 mg 1
• Clarithromycin/erythromycin use: Cap at 40 mg 1

Safety at Maximum Dose

Pravastatin 80 mg has been extensively studied and demonstrates favorable tolerability:

• Myopathy risk: <0.1% at recommended doses 1
• Liver enzyme elevations: Approximately 1.1% of patients 3, 5
• No cases of rhabdomyolysis observed with pravastatin 40 mg in major trials 2, 5

The 80 mg dose was well-tolerated in clinical trials, with adverse event rates similar to lower doses. 4, 6

Common Pitfall to Avoid

Do not escalate pravastatin to 80 mg in patients who need high-intensity statin therapy. This is a critical error—pravastatin 80 mg remains moderate-intensity and will not achieve the ≥50% LDL-C reduction required for high-risk patients with established ASCVD, diabetes with multiple risk factors, or severe hypercholesterolemia. 2, 3