Rosuvastatin Dosage

Usual Adult Dose for Hyperlipoproteinemia

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Hyperlipoproteinemia Type IIa (Elevated LDL)

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL)

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Hyperlipoproteinemia Type IV (Elevated VLDL)

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Atherosclerosis

Initial dose: 5 mg to 10 mg once a day with or without food
Maintenance dose: 5 mg to 40 mg once a day with or without food

Usual Adult Dose for Homozygous Familial Hypercholesterolemia

Initial dose: 20 mg once a day with or without food
Maintenance dose: 20 mg to 40 mg once a day with or without food

Usual Adult Dose for Prevention of Cardiovascular Disease

Initial dose: 5 mg to 10 mg once a day with or without food Maintenance dose: 5 mg to 40 mg once a day with or without food

Response to therapy should be estimated from preapheresis LDL-C levels.

Usual Geriatric Dose for Hyperlipidemia

Initial dose: 5 mg once a day with or without food
Maintenance dose: 5 mg to 20 mg once a day with or without food

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia

Pediatric patients 10 to 17 years of age:

Usual dose range: 5 to 20 mg orally once a day with or without food. Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more.

Maximum dose: 20 mg orally once a day

Renal Dose Adjustments

CrCl less than 30 mL/min (not on hemodialysis): Initial dose: 5 mg once a day
Maintenance dose: 5 mg to 10 mg once a day

Liver Dose Adjustments

Rosuvastatin is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases.

Dose Adjustments

Patients requiring less aggressive LDL-C reductions or those who have predisposing risk factors for myopathy should be initiated at a dose of 5 mg orally once a day. This includes patients taking cyclosporine, Asian patients, patients with severe renal insufficiency, those with inadequately treated hypothyroidism, and patients of advanced age.

The risk of skeletal muscle effects may be enhanced when rosuvastatin is used in combination with niacin or fenofibrate; a reduction in rosuvastatin dosage should be considered in this setting.

Combination therapy with gemfibrozil should be avoided because of an increase in rosuvastatin exposure with concomitant use; if rosuvastatin is used in combination with gemfibrozil, the dose of rosuvastatin should be limited to 10 mg once daily.

The 40 mg dose of rosuvastatin is reserved only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose of rosuvastatin once daily.

Precautions

Safety and effectiveness have not been established in pediatric patients less than 10 years of age.

Dialysis

Hemodialysis does not significantly enhance clearance of rosuvastatin. Steady-state plasma concentrations of rosuvastatin in patients on chronic hemodialysis were approximately 50% greater compared with healthy volunteer subjects with normal renal function.

Other Comments

Rosuvastatin may be taken with or without meals and at any time of day.

Liver enzymes should be checked before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter.

It has been suggested that prior to initiating statin therapy, all patients should have a baseline serum creatine kinase (CK) enzyme level measured and if at any time after initiating therapy a patient complains of muscle soreness, tenderness, or pain another CK level should be drawn for comparison. If elevated, the drug should be discontinued.

The results of one study indicate that withdrawal of HMG-CoA reductase inhibitors (statins; atorvastatin, fluvastatin, pravastatin, simvastatin) during the perioperative period in patients with acute coronary syndromes is associated with an increased risk for perioperative adverse cardiac events (i.e., increase postoperative troponin release and the combination of myocardial infarction and cardiovascular death). Patients receiving statins with extended-release formulations (i.e., fluvastatin) appeared to be associated with more favorable outcomes. Other studies appear to confirm these findings.

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