Vytorin Indications & Dosage

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Vytorin - Indications & Dosage [ezetimibe/simvastatin]

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Vytorin - Indications & Dosage

INDICATIONS AND USAGE

Primary Hypercholesterolemia

VYTORIN is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B,TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and nonfamilial) hypercholesterolemia or mixed hyperlipidemia. Homozygous Familial Hypercholesterolemia (HoFH)VYTORIN is indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Therapy with lipid-altering agents should be a component of multiple risk-factor intervention inindividuals 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 VYTORIN 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 4.)

Table 4

Summary of NCEP ATP III Guidelines
Risk Category
LDL Goal
(mg/dL)
LDL Level at Which to Initiate
Therapeutic Lifestyle Changesa
(mg/dL)
LDL level at Which to
Consider Drug Therapy
(mg/dL)
CHD or CHD risk equivalentsb
(10-year risk >20%)c
<100 =100 =130
(100-129: drug optional)d
2+ Risk factorse
(10-year risk =20%)c
<130 =130
10-year risk 10-20%: =130c
10-year risk <10%: =160c
0-1 Risk factorf <160 =160
=190
(160-189: LDL-lowering drug
optional)

a Therapeutic lifestyle changes include:

1) dietary changes: reduced intake of saturated fats (<7% of total calories) and cholesterol(<200 mg per day), and enhancing LDL lowering with plant stanols/sterols (2 g/d) and increased viscous (soluble) fiber (10-25 g/d),
2) weight reduction, and
3) increased physical activity.