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Fenofibrate has been demonstrated to be devoid of mutagenic potential in the following testsAmesmouse lymphomachromosomal aberration and unscheduled DNA synthesis in primary rat hepatocytes.
Caution should be exercised when coumarin anticoagulants are given in conjunction with TRICOR because of the potentiation of coumarin-type anticoagulant effects in prolonging the Prothrombin Time/International Normalized RatioPT/INRTo prevent bleeding complicationsfrequent monitoring of PT/INR and dose adjustment of the anticoagulant are recommended until PT/INR has stabilizedsee DRUG INTERACTIONS
Patients should be placed on an appropriate lipid-lowering diet before receiving TRICORand should continue this diet during treatment with TRICORTRICOR tablets should be given with mealsthereby optimizing the bioavailability of the medication.
Safety in pregnant women has not been establishedThere are no adequate and well controlled studies of fenofibrate in pregnant womenFenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Fenofibric acidthe active metabolite of fenofibrateproduces reductions in total cholesterolLDL cholesterolapolipoprotein Btotal triglycerides and triglyceride rich lipoproteinVLDLin treated patientsIn additiontreatment with fenofibrate results in increases in high density lipoproteinHDLand apolipoproteins apoAI and apoAII.
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