The effect of short-term fenofibrate treatment on kidney function was investigated in subjects with normal kidney function. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from fenofibrate, a decision should be made whether to discontinue nursing or administration of fenofibrate taking into account the importance of the drug to the lactating woman.Safety and efficacy in pediatric patients have not been established.Fenofibric acid is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. This medicine is only for patients whose blood fats are not controlled by diet.

Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. TRICOR therapy lowered LDL-C, Total-C, and the LDL-C/HDL-C ratio. Fenofibrate belongs to a group of drugs known as "fibrates." Fenofibric acid exposure is not influenced by age. The benefits and risks of using TRICOR (fenofibrate tablets) with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed and renal function monitored. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, and magnesium stearate.polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum, D&C Yellow #10 aluminum lake, FD&C Yellow #6 /sunset yellow FCF aluminum lake, FD&C Blue #2 /indigo carmine aluminum lake.polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum.A variety of clinical studies have demonstrated that elevated levels of total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apo B), an LDL membrane complex, are associated with human atherosclerosis. Therefore, fenofibrate should be taken at least 1 hour before or 4-6 hours after a bile acid binding resin to avoid impeding its absorption. Similarly, decreased levels of high density lipoprotein cholesterol (HDL-C) and its transport complex, apolipoprotein A (apo AI and apo AII) are associated with the development of atherosclerosis. These elevations tend to return to baseline following discontinuation of fenofibrate. Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. In a pooled analysis of 10 placebo-controlled trials, increases to > 3 times the upper limit of normal occurred in 5.3% of patients taking fenofibrate versus 1.1% of patients treated with placebo.When transaminase determinations were followed either after discontinuation of treatment or during continued treatment, a return to normal limits was usually observed. Total mortality was numerically higher in the gemfibrozil randomization group but did not achieve statistical significance (p = 0.19, 95% confidence interval for relative risk G:P = .91-1.64). (See Concomitant administration of fenofibrate (equivalent to TRICOR 145 mg) with pravastatin (40 mg) once daily for 10 days has been shown to increase the mean CConcomitant administration of a single dose of fenofibrate (equivalent to 145 mg TRICOR) and a single dose of fluvastatin (40 mg) resulted in a small increase (approximately 15-16%) in exposure to (+)3R,5S-fluvastatin, the active enantiomer of fluvastatin. However, these levels stabilize during long-term administration. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries).. TriCor is used along with a proper diet to help to treat high cholesterol and high triglyceride levels..

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