Reduce risk of total mortality by reducing CHD deaths; major vascular & coronary events; stroke; angina pectoris. Reduce need for coronary revascularization procedures, peripheral & other non-coronary revascularization procedures. Adjunct to diet to reduce elevated total-C, LDL-C, TG & Apo B, & increase HDL-C in patients w/ primary hypercholesterolemia including heterozygous familial hypercholesterolemia (Fredrickson type IIA), or combined (mixed) hyperlipidaemia (Fredrickson type IIb) when response to diet & other non-pharmacological measures is inadequate. Hypertriglyceridaemia (Fredrickson type IV hyperlipidaemia) w/ baseline LDL-C <3.37 mmol/L & >2.26 mmol/L TG despite adequate dietary intervention. Primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia) not responding to diet alone w/ VLDL/TG ratios >0.25 & raised total-C, TG & apolipoprotein E levels. Adjunct to diet & other non-dietary measures for the treatment of homozygous familial hypercholesterolemia. Ped heterozygous familial hypercholesterolemia. Adjunct to diet to reduce total-C, LDL-C, TG & Apo B levels in adolescent boys & girls (at least 1 yr post-menarch), 10-17 yr heterozygous familial hypercholesterolemia.
20-mg tab Starting dose: 5-10 mg once in the evening. Dosage range: 5-40 mg/day as a single dose in the evening. Max: 40 mg/day. Patient requiring reduction in LDL-C of ≥20% 10 mg/day. Elderly & patient requiring smaller LDL-C reductions 5 mg/day. Max reduction: ≤20 mg/day. Severe renal insufficiency Start at 5 mg/day. 40-mg tab 10-80 mg/day as single dose in the evening. May adjust dose intervals not <4 wk to max of 80 mg/day as single dose in the evening.
Elevated creatinine phosphokinase & transaminase levels. Unexplained muscle pain, tenderness or weakness; malaise or fever. Perform liver function tests prior to therapy at 6 or 12 wk, after therapy or elevation in dose & periodically thereafter. Temporarily w/hold or discontinue therapy in any patient w/ acute, serious condition suggestive of myopathy or risk factor predisposing to development of renal failure secondary to rhabdomyolysis (eg, severe infection, hypotension, major surgery, trauma, severe metabolic disorders, endocrine & electrolyte disorders & uncontrolled seizures). Concomitant use w/ HMG-CoA reductase inhibitors or other agents used to lower cholesterol levels eg, ketoconazole, spironolactone & cimetidine. Pregnancy & lactation. Childn <10 yr & premenarchal girls.
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