What is the maximum dose of Pravastatin (pravastatin sodium)?

From the Guidelines

The maximum dose of pravastatin is 80 mg once daily. Pravastatin is typically started at lower doses (10-40 mg daily) and can be titrated up to the maximum dose if needed to achieve desired cholesterol-lowering effects. The medication should be taken at the same time each day, preferably in the evening, as cholesterol synthesis is highest overnight. Pravastatin belongs to the statin class of medications that work by inhibiting HMG-CoA reductase, an enzyme crucial for cholesterol production in the liver. While 80 mg is the maximum approved dose, many patients achieve adequate lipid control with lower doses. Dose adjustments may be necessary for patients with kidney impairment, those taking certain interacting medications, or elderly patients who may be more sensitive to side effects. Regular monitoring of liver function and muscle symptoms is recommended while on pravastatin therapy, especially at higher doses.

Some key points to consider when prescribing pravastatin include:

• The PROVE-IT TIMI 22 study 1 compared 40 mg of pravastatin to 80 mg of atorvastatin daily and found a 16% reduction in the hazard ratio for the primary composite endpoint of all-cause death, MI, UA requiring rehospitalization, revascularization, and stroke in favor of the high-dose regimen.
• The NCEP Adult Treatment Panel III guidelines recommend a target LDL-C level of less than 100 mg per dL for patients with CHD or CHD equivalents, and consideration of drug therapy if LDL-C is above goal range 1.
• Pravastatin has been shown to be effective in reducing cardiovascular events and death in patients with CAD and hypercholesterolemia or with mild cholesterol elevation after MI and UA 1.
• The maximum dose of pravastatin is supported by the most recent study 1, which although does not directly address the max dose, implies the use of high intensity statins.

Overall, the use of pravastatin, particularly at higher doses, should be carefully considered and monitored to minimize potential side effects and maximize its cholesterol-lowering benefits.

From the FDA Drug Label

2.2 Recommended Dosage in Adult Patients The recommended starting dosage is pravastatin sodium tablets 40 mg to 80 mg once daily. 2. 4 Recommended Dosage in Patients with Renal Impairment ... The maximum recommended dosage of pravastatin sodium tablets in patients with severe renal impairment is 40 mg once daily In patients taking cyclosporine, the recommended starting dosage is pravastatin sodium 10 mg once daily. The maximum recommended dosage of pravastatin sodium tablets in patients taking cyclosporine is 20 mg once daily. Clarithromycin and Erythromycin The maximum recommended dosage is pravastatin sodium tablets 40 mg once daily

The maximum dose of pravastatin is 80 mg once daily in adult patients with normal renal function 2.

From the Research

Pravastatin Dosage

• The maximum dose of pravastatin is 80 mg per day, as shown in a study where high-dose pravastatin (80 mg/day) was administered to hypercholesterolemic subjects with chronic liver disease, significantly lowering LDL-C, TC, and TGs in comparison with the placebo and was safe and well tolerated 3.
• In another study, the efficacy of once-daily versus twice-daily dosing of pravastatin was determined, with doses of 20 mg and 40 mg once daily, and 10 mg and 20 mg twice daily 4.
• A comparison of low versus standard dose pravastatin therapy for the prevention of cardiovascular events in the elderly showed that standard-dose pravastatin (10-20 mg/day) is more effective in reducing the incidence of CVEs in the elderly than low dose pravastatin (5 mg/day) 5.
• The initial study on pravastatin showed that it reduces total and LDL-cholesterol levels in a dose-proportional manner, with reductions in LDL-cholesterol levels of 18% (10 mg/day), 23% (20 mg/day), and 31% (40 mg/day) after 12 weeks 6.

Dosage Comparison

• The studies suggest that higher doses of pravastatin (up to 80 mg/day) are safe and effective in reducing LDL-C, TC, and TGs in hypercholesterolemic patients, including those with chronic liver disease 3.
• Standard-dose pravastatin (10-20 mg/day) is more effective in reducing the incidence of CVEs in the elderly than low dose pravastatin (5 mg/day), especially in nondiabetic elderly patients with mild hypercholesterolemia or previous cardiovascular disease 5.
• Once-daily dosing of pravastatin is as effective as twice-daily dosing, with similar reductions in total cholesterol and LDL-cholesterol levels 4.