what is the mechanism of fenofibrate endep

Data from observational studies indicate that the risk for rhabdomyolysis is increased when fibrates, in particular gemfibrozil, are co-administered with an HMG-CoA reductase inhibitor (statin). This decrease has been reported to occur within 2 weeks to years after initiation of fibrate therapy. Available in bottles of 90 (NDC 69367-254-09) and 500 (NDC 69367-254-05).Store at 20° to 25°C (68° to 77°F). Monitor renal function in patients with renal impairment taking fenofibrate tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: myalgia, rhabdomyolysis, pancreatitis, acute renal failure, muscle spasm, hepatitis, cirrhosis, anemia, arthralgia, decreases in hemoglobin, decreases in hematocrit, white blood cell decreases, asthenia, severely depressed HDL-cholesterol levels, and interstitial lung disease.

The pharmacological effects of fenofibric acid in both animals and humans have been extensively studied through oral administration of fenofibrate.The lipid-modifying effects of fenofibric acid seen in clinical practice have been explained  The resulting decrease in TG produces an alteration in the size and composition ofLDLfrom small, dense particles (which are thought to be atherogenic due to their susceptibility to oxidation), to large buoyant particles. ). The effect of fenofibrate therapy on reducing this risk has not been adequately studied.Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus

Induction of lipoprotein lipolysis. Similarly, decreased levels of HDL-C and its transport complex, apolipoprotein A (apo AI and apo AII) are associated with the development of atherosclerosis. Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.Urticaria was seen in 1.1% vs. 0%, and rash in 1.4% vs. 0.8% of fenofibrate and placebo patients respectively in controlled trials.The following adverse reactions have been identified during postapproval use of fenofibrate. Patients were treated for eight weeks under protocols that differed only in that one entered patients with baseline TG levels of 500 to 1500 mg/dL, and the other TG levels of 350 to 500 mg/dL. Adverse events reported by 2% or more of patients treated with fenofibrate (and greater than placebo) during the double-blind, placebo-controlled trials, regardless of causality, are listed in Table 1 below. Decreased pup survival was noted at 300 mg/kg/day (10 times the clinical exposure at the MRHD), which was associated with decreased maternal body weight gain/maternal After administration of radiolabelled fenofibrate, approximately 60% of the dose appeared in the urine and 25% was excreted in the feces.Fenofibric acid is eliminated with a half-life of 20 hours, allowing once daily dosing. Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Although cardiac deaths trended higher in the gemfibrozil group, this was not statistically significant (hazard ratio 2.2, 95% confidence interval: 0.94-5.05). See full prescribing information for FENOFIBRATE TABLETS. Post-implantation loss was observed at ≥ 75 mg/kg/day (≥ 2 times the clinical exposure at the MRHD) in the presence of maternal toxicity (decreased weight gain). Epidemiologic investigations have established that cardiovascular morbidity and mortality vary directly with the level of total-C,LDL-C, and TG, and inversely with the level ofHDL-C.

In the Coronary Drug Project, a large study of post myocardial infarction of patients treated for 5 years with clofibrate, there was no difference in mortality seen between the clofibrate group and the placebo group. Aborted litters were observed at maternally toxic doses ( Adverse reactions > 2% and at least 1% greater than placebo: Abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis ( In pregnant rats given oral dietary doses of 15, 75, and 300 mg/kg/day from gestation day 15 through lactation day 21 (weaning), no adverse developmental effects were observed at 15 mg/kg/day (less than the clinical exposure at the MRHD, based on body surface area comparisons), despite maternal toxicity (decreased weight gain). Updated

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