What is the maximum recommended dose of pravastatin?

Maximum Recommended Dose of Pravastatin

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

Pravastatin Dosing Information

Pravastatin is an HMG-CoA reductase inhibitor (statin) that is available in various dosage strengths. According to the FDA label, pravastatin is typically prescribed at doses ranging from 10 mg to 80 mg daily 1.

Dosage Classification and LDL-C Reduction

Pravastatin dosing can be categorized based on intensity and expected LDL-C reduction:

• Low-intensity: 10-20 mg daily (expected LDL-C reduction <30%) 2
• Moderate-intensity: 40-80 mg daily (expected LDL-C reduction 30-49%) 2, 3
• High-intensity: Not applicable - pravastatin cannot achieve ≥50% LDL-C reduction even at maximum dose 2, 3

Starting and Maximum Doses

• Standard starting dose: 40 mg once daily 1
• Maximum dose: 80 mg once daily 1
• Administration: Can be taken orally once daily at any time of the day, with or without food 1

Special Population Considerations

Renal Impairment

• For patients with severe renal impairment (CrCl <30 mL/min):
  • Starting dose: 10 mg once daily 3
  • Maximum dose: 40 mg once daily 3, 1

Pediatric Patients

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

Elderly Patients

• Standard dosing applies, but more cautious monitoring is recommended 3, 4
• Pravastatin has been shown to be well-tolerated in elderly patients 4

Clinical Efficacy and Considerations

• At the maximum dose of 80 mg daily, pravastatin typically achieves 30-49% reduction in LDL-C levels 2, 3
• For patients requiring high-intensity statin therapy (≥50% LDL-C reduction), an alternative statin such as atorvastatin 40-80 mg or rosuvastatin 20-40 mg should be considered 2, 3, 1

Drug Interactions

When prescribing pravastatin at maximum doses, be aware of these important drug interactions:

• Bile acid sequestrants: Administer pravastatin at least 1 hour before or 4 hours after bile acid sequestrants 1
• Amiodarone: No dose adjustment needed - combination therapy is reasonable 2
• Ranolazine: No dose adjustment needed - coadministration may be considered if clinically indicated 2
• Warfarin: Monitor INR more closely after initiation or dose changes 2

Monitoring Recommendations

• Assess LDL-C response 4-12 weeks after initiating therapy 3
• Monitor liver function tests initially, at 12 weeks after starting therapy, then annually 3
• Watch for muscle pain, tenderness, or weakness that could indicate myopathy or rhabdomyolysis 3, 1

Safety Profile

Pravastatin is generally well-tolerated with a favorable safety profile, even in elderly patients 4. The most common adverse reactions (≥2% and greater than placebo) include musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache 1.