Cholestor Dosage/Direction for Use

Dosage: Dosage of rosuvastatin calcium is expressed in terms of rosuvastatin. Before treatment initiation the patient should be placed on a standard choleterol-lowering diet that should continue during treatment. The dose should be individualised according to the goal of therapy and patient response, using current consensus guidelines.
Primary Hypercholesterolemia (Heterozygous Familial and Non-familial) and Mixed Dyslipidemia: The usual initial dosage of rosuvastatin in adults is 10 mg once daily given without regard to meals. Initiation of therapy with 5 mg once daily may be considered for patients requiring less aggressive LDL-cholesterol reductions or for those who have predisposing factors for myopathy. For patients with marked hypercholesterolemia (LDL-cholesterol exceeding 190 mg/dL) and aggressive lipid targets, an initial rosuvastatin dosage of 20 mg once daily may be considered. Dosage may be increased as necessary to a maximum recommended dosage of 40 mg daily. The 40-mg daily dosage of rosuvastatin should be reserved for those patients who have not achieved their LDL-cholesterol goal with the 20-mg daily dosage.
Homozygous Familial Hypercholesterolemia: The usual initial dosage of rosuvastatin in adults with homozygous familial hypercholesterolemia is 20 mg once daily; the maximum recommended dosage is 40 mg once daily. Rosuvastatin should be used in these patients as an adjunct to other lipid lowering treatments (e.g., LDL-cholesterol apheresis) or if such treatments are unavailable. Response to therapy in patients undergoing LDL-apheresis should be estimated based on per-apheresis LDL-cholesterol levels.
Hypertriglyceridemia: The usual initial dosage of rosuvastatin in adults with hypertriglyceridemia is 10 mg once daily; the usual dosage range is 5-40 mg daily. The recommended maximum dosage of rosuvastatin in patients with hypertriglyceridemia is 40 mg once daily and should be reserved for patients responding inadequately to the 20-mg daily dosage.
Prevention of Cardiovascular Events: The recommended start dose is 5 or 10 mg once daily in both statin naive patients or patients switched from another HMG-CoA reductase inhibitor. The choice of starting dose should take into account the individual patients cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions. A dose adjustment to 20 mg can be made after 2 to 4 weeks, if necessary.
Special Populations: Renal Impairment: No modification of dosage is necessary for patients with mild to moderate renal insufficiency. In patients with severe renal impairment (creatinine clearance less than 30 mL/minute per 1.73 m²) who are not undergoing hemodialysis, rosuvastatin should be initiated at a dose of 5 mg once daily and dosage should not exceed 10 mg once daily.
Pediatric Use: Safety and efficacy not established in prepubertal children or in children younger than 10 years of age; however, a few patients 8 years of age or older with homozygous familial hypercholesterolemia have been treated with the drug. Adolescent girls should be advised to use effective and appropriate contraceptive methods during therapy to reduce the likelihood of unintended pregnancy.
Geriatric Use: Mean reductions in LDL-cholesterol concentrations were slightly higher in geriatric patients (65 years of age and older) than in younger patients. However, no clinically relevant differences in laboratory abnormalities or rates of drug discontinuance were reported. Risk of myopathy is increased in patients (particularly women) of advanced age (65 years of age or older) and in those with small body frame and frailty; use with caution in such patients.
Mode of Administration: Administered orally at any time of day, with or without food.