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The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature CVD is summarized below.

two or more other cardiovascular disease risk factors are present.

there is a positive family history of premature cardiovascular disease or.

as an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10-16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present:.

as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG) and apolipoprotein B (Apo B) levels, and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb).

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Check liver enzyme tests before initiating therapy and as clinically indicated thereafter ( 5.3)ДЇULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 1.1 Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia 1.2 Secondary Prevention of Cardiovascular Disease 1.3 Limitations of Use 2 DOSAGE AND ADMINISTRATION 2.1 General Dosing Information 2.2 Adult Patients With Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia 2.3 Pediatric Patients (10 to 16 years of age) With Heterozygous Familial Hypercholesterolemia 2.4 Use With Cyclosporine 2.5 Use With Fluconazole 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 4.1 Hypersensitivity to Any Component of This Medication 4.2 Active Liver Disease 4.3 Pregnancy 4.4 Nursing Mothers 5 WARNINGS AND PRECAUTIONS 5.1 Skeletal Muscle 5.2 Immune-Mediated Necrotizing Myopathy 5.3 Liver Enzymes 5.4 Endocrine Effects 5.5 Central Nervous System Toxicity 6 ADVERSE REACTIONS 6.1 Clinical Studies Experience in Adult Patients 6.2 Clinical Studies Experience in Pediatric Patients 6.3 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Cyclosporine 7.2 Fluconazole 7.3 Gemfibrozil 7.4 Other Fibrates 7.5 Niacin 7.6 Glyburide 7.7 Phenytoin 7.8 Warfarin 7.9 Colchicine 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 8.7 Renal Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia 14.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients 14.3 Secondary Prevention of Cardiovascular Disease 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.ДЎ.1 Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia

Liver enzyme abnormalities:В Persistent elevations in hepatic transaminases can occur.

IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment positive anti-HMG CoA reductase antibody muscle biopsy showing necrotizing myopathy and improvement with imunosuppressive agents ( 5.2)

Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use.

LESCOL XL therapy should be discontinued if myopathy is diagnosed or suspected ( 5.1) Patients should be advised to report promptly any symptoms of myopathy.Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue LESCOL XL if myopathy is diagnosed or suspected ( 5.1, 8.5, 8.7) Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with advanced age (в‰Ґ 65), uncontrolled hypothyroidism, renal impairment, and combination use with cyclosporine, or gemfibrozil.