Adjunct to diet for the reduction of elevated total-C, LDL-C, apo-B & triglycerides in patients w/ primary hypercholesterolemia, combined (mixed) hyperlipidemia, homozygous & heterozygous familial hypercholesterolemia when response to diet & other non-phamacological measures are inadequate. Adjunct to diet to reduce total-C, LDL-C & apo-B in post-puberty boys & girls, 10-17 yr w/ heterozygous familial hypercholesterolemia if after adequate trial of diet therapy the following findings are present: LDL-C remains ≥190 mg/dL or LDL-C remains ≥160 mg/dL & there is a positive family history of premature CV disease or ≥2 other CV disease risk factors are present in the ped patients.
Dosage/Direction for Use
Initially 10 mg once daily at a range of 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily for 2 wk & up to 4 wk for max response. Homozygous familial hypercholesterolemia 80 mg. Heterozygous familial hypercholesterolemiaChildn 10-17 yr Initially 10 mg/day. Max: 20 mg/day.
Contraindications
Hypersensitivity. Active liver disease or persistent elevations in serum transaminase exceed 3x ULN. Pregnancy & lactation or women of childbearing potential w/o using an adequate contraception.
Special Precautions
Liver function test should be performed prior to therapy & periodically thereafter. Discontinue if ALT or AST exceeds 3 times ULN & persist; if creatine phosphokinase elevation & diagnosed or suspected myopathy is founded.
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