In controlled long-term (48 week) extensions, which included both newly-treated and previously-treated patients, the incidence of consecutive elevations (=3 X ULN) in serum transaminases was 1.8 percent overall and 3.6 percent for patients treated with VYTORIN 10/80 mg. These elevations in transaminases were generally asymptomatic, not associated with cholestasis and returned to baseline after discontinuation of therapy or with continued treatment. Doctors should perform blood tests before, and periodically during treatment with VYTORIN when clinically indicated to check for liver problems. People taking VYTORIN 10/80 mg should receive an additional liver function test prior to and three months after titration and periodically during the first year.

Due to the unknown effects of increased exposure to ezetimibe (an ingredient in VYTORIN) in patients with moderate or severe hepatic insufficiency, VYTORIN is not recommended in these patients. The safety and effectiveness of VYTORIN with fibrates have not been established; therefore, co-administration with fibrates is not recommended. Caution should be exercised when initiating VYTORIN in patients treated with cyclosporine and in patients with severe renal insufficiency.

VYTORIN to be available in various doses

VYTORIN has been approved for use in patients at the following doses: 10/10 mg, 10/20 mg, 10/40 mg and 10/80 mg. Across the dosing range, the ezetimibe component of VYTORIN is held constant at 10 mg, while the simvastatin component ranges from 10 mg to 80 mg. The recommended starting dose for VYTORIN is 10/20 mg. Patients requiring LDL cholesterol reductions greater than 55 percent can be started on 10/40 mg. Patients requiring less aggressive LDL cholesterol reductions may be started at 10/10 mg. The dose of VYTORIN should be limited to 10/10 mg daily in patients on cyclosporine and 10/20 mg daily in patients on amiodarone or verapamil.

VYTORIN was well tolerate
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23-Jul-2004

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