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4. The dose of VYTORIN should not exceed 10/10 mg daily in patients receiving concomitantmedication with cyclosporine. The benefits of the use of VYTORIN in patients receiving cyclosporineshould be carefully weighed against the risks of this combination. (See PRECAUTIONS, Drug Interactions, Other Drug Interactions, Cyclosporine.) 5. The dose of VYTORIN should not exceed 10/20 mg daily in patients receiving concomitant medication with amiodarone or verapamil. The combined use of VYTORIN at doses higher than10/20 mg daily with amiodarone or verapamil should be avoided unless the clinical benefit is likelyto outweigh the increased risk of myopathy. 6. All patients starting therapy with VYTORIN, or whose dose of VYTORIN is being increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness. VYTORIN therapy should be discontinued immediately if myopathyis diagnosed or suspected. The presence of these symptoms, and/or a CK level >10 times the ULN indicates myopathy. In most cases, when patients were promptly discontinued from simvastatin treatment, muscle symptoms and CK increases resolved. Periodic CK determinations may be considered in patients starting therapy with VYTORIN or whose dose is being increased, but there is no assurance that such monitoring will prevent myopathy. Text Continues Below
7. Many of the patients who have developed rhabdomyolysis on therapy with simvastatin have had complicated medical histories, including renal insufficiency usually as a consequence of long-standing diabetes mellitus. Such patients taking VYTORIN merit closer monitoring. Therapy with VYTORIN should be temporarily stopped a few days prior to elective major surgery and when any major medical or surgical condition supervenes. Liver Enzymes In three placebo-controlled, 12-week trials, the incidence of consecutive elevations (=3 X ULN) in serum transaminases was 1.7% overall for patients treated with VYTORIN and appeared to be doserelatedwith an incidence of 2.6% for patients treated with VYTORIN 10/80. 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% overall and 3.6% for patients treated with VYTORIN 10/80. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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