Zetia

[ezetimibe]

Indications & Dosage
INDICATIONS AND USAGE

Primary Hypercholesterolemia

Monotherapy

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ZETIA, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, and Apo B in patients with primary (heterozygous familial and non-familial) hypercholesterolemia. Combination therapy with HMG-CoA reductase inhibitors ZETIA, administered in combination with an HMG-CoA reductase inhibitor, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, and Apo B in patients with primary (heterozygous familial and non-familial) hypercholesterolemia.

Homozygous Familial Hypercholesterolemia (HoFH)

The combination of ZETIA and atorvastatin or simvastatin, is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e. g., LDL apheresis) or if such treatments are unavailable.

Homozygous Sitosterolemia

ZETIA is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.

Therapy with lipid-altering agents should be a component of multiple risk-factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid-altering agents should be used in addition to an appropriate diet (including restriction of saturated fat and cholesterol) and when the response to diet and other non-pharmacological measures has been inadequate. (See NCEP Adult Treatment Panel (ATP) III Guidelines, summarized in Table 7.)

Table 7
Summary of NCEP ATP III Guidelines

Risk Category LDL Goal (mg/ dL)
LDL Level at Which to Initiate

Therapeutic Lifestyle Changes a
(mg/ dL)

LDL level at Which to
Consider Drug Therapy
(mg/ dL)

CHD or CHD risk
equivalents b
(10-year risk >20%) c
<100 100 130 (100-129: drug optional) d

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