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Vytorin

[ezetimibe/simvastatin]

c Risk assessment for determining the 10-year risk for developing CHD is carried out using the Framingham risk scoring. Refer to JAMA,May 16, 2001; 285 (19): 2486-2497, or the NCEP website (http://www.nhlbi.nih.gov) for more details.

d Some authorities recommend use of LDL-lowering drugs in this category if an LDL cholesterol <100 mg/dL cannot be achieved bytherapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL, e.g., nicotinic acid or fibrate.Clinical judgment also may call for deferring drug therapy in this subcategory.

e Major risk factors (exclusive of LDL cholesterol) that modify LDL goals include cigarette smoking, hypertension (BP =140/90 mm Hg oron anti-hypertensive medication), low HDL cholesterol (<40 mg/dL), family history of premature CHD (CHD in male first-degree relative<55 years; CHD in female first-degree relative <65 years), age (men =45 years; women =55 years). HDL cholesterol =60 mg/dL countsas a "negative" risk factor; its presence removes one risk factor from the total count.

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f Almost all people with 0-1 risk factor have a 10-year risk <10%; thus, 10-year risk assessment in people with 0-1 risk factor is notnecessary.Prior to initiating therapy with VYTORIN, secondary causes for dyslipidemia (i.e., diabetes,hypothyroidism, obstructive liver disease, chronic renal failure, and drugs that increase LDL-C anddecrease HDL-C [progestins, anabolic steroids, and corticosteroids]), should be excluded or, ifappropriate, treated. A lipid profile should be performed to measure total-C, LDL-C, HDL-C and TG. ForTG levels >400 mg/dL (>4.5 mmol/L), LDL-C concentrations should be determined by ultracentrifugation.At the time of hospitalization for an acute coronary event, lipid measures should be taken on admissionor within 24 hours. These values can guide the physician on initiation of LDL-lowering therapy before or atdischarge.


DOSAGE AND ADMINISTRATION

The patient should be placed on a standard cholesterol-lowering diet before receiving VYTORIN and should continue on this diet during treatment with VYTORIN. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient's response.(See NCEP Adult Treatment Panel (ATP) III Guidelines, summarized in Table 4.) VYTORIN should betaken as a single daily dose in the evening, with or without food.The dosage range is 10/10 mg/day through 10/80 mg/day. The recommended usual starting dose is10/20 mg/day. Initiation of therapy with 10/10 mg/day may be considered for patients requiring lessaggressive LDL-C reductions.

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