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General: The patients should be placed on a standard cholesterol-lowering diet before receiving SANTORVASTIN 40 and continue on a standard cholesterol-lowering diet during treatment with SANTORVASTIN 40. The usual starting dose is 10 mg once a day. The dosage range is 10 mg to 80 mg once daily. Doses may be given any time of the day, with or without food.
Adults: Primary Hypercholesterolemia and Combined (Mixed) Hyperlipidemia: The majority of patients are controlled with 10 mg SANTORVASTIN 40 once daily. A therapeutic response is evident within 2 weeks, and the maximum response is usually achieved within 4 weeks. The response is maintained during chronic therapy.
Homozygous Familial Hypercholesterolemia: In patients with homozygous familial hypercholesterolemia, most patients responded to 80 mg SANTORVASTIN 40.
Children (10-17 years of age): Heterozygous Familial Hypercholesterolemia: The recommended starting dose of SANTORVASTIN 40 is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patients population). Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more.
Homozygous Familial Hypercholesterolemia: Treatment experience in a pediatric population with doses of SANTORVASTIN 40 up to 80 mg/day is limited.
Patient with Hepatic Insufficiency: In patient with moderate to severe hepatic insufficiency, the therapeutic response to SANTORVASTIN 40 in unaffected but plasma concentration of the drug is greatly increased. Therefore, caution should be exercised in patient who consume substantial quantities of alcohol and/or have a history of liver disease.
Patient with Renal Insufficiency: Renal disease has no influence on plasma concentrations or on the LDL-C reduction of SANTORVASTIN 40. Thus, no dose adjustment is required.
Elderly: Efficacy and safety in older patient (>70 years) using recommended dose is similar to that see in the general population.
