Generic name: fenofibric acid
Dosage form: capsule, delayed release
This dosage information does not include all the information needed to use Trilipix safely and effectively. See full prescribing information for Trilipix.
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Patients should be placed on an appropriate lipid-lowering diet before receiving Trilipix as monotherapy or co-administered with a statin [see DOSAGE AND ADMINISTRATION (2.2, 2.3 and 2.4)], and should continue this diet during treatment. Trilipix delayed release capsules can be taken without regard to meals. Serum lipids should be monitored periodically. The maximum dose is 135 mg once daily.
Co-administration Therapy with Statins for the Treatment of Mixed Dyslipidemia
Trilipix 135 mg may be co-administered with an HMG-CoA reductase inhibitor (statin) in patients with mixed dyslipidemia. For convenience, the daily dose of Trilipix may be taken at the same time as a statin, according to the dosing recommendations for each medication. Co-administration with the maximum dose of a statin has not been evaluated in clinical studies and should be avoided unless the benefits are expected to outweigh the risks.
The initial dose of Trilipix is 45 to 135 mg once daily. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 135 mg once daily.
Impaired Renal Function
Treatment with Trilipix should be initiated at a dose of 45 mg once daily in patients with mild to moderate renal impairment and should only be increased after evaluation of the effects on renal function and lipid levels at this dose. The use of Trilipix should be avoided in patients with severely impaired renal function.
Dose selection for the elderly should be made on the basis of renal function [see USE IN SPECIFIC POPULATIONS (8.5)].