Fenofibrate
C10AB05INDICATIONS AND USAGE Treatment of Hypercholesterolemia Fenofibrate capsules, USP are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia.
Fenofibrate capsules are contraindicated in patients with: Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis [see Clinical Pharmacology ] . Active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warnings and Precautions ] . Pre-existing gallbladder disease [see Warnings and Precautions ] . .Hypersensitivity to fenofibrate, fenofibric acid, or any of the excipients of fenofibrate capsules. Serious hypersensitivity reactions including anaphylaxis and angioedema have.
The following serious adverse reactions are described below and elsewhere in the labeling: Mortality and coronary heart disease morbidity [see Warnings and Precautions ] Hepatoxicity [see Warnings and Precautions ] Pancreatitis [see Warnings and Precautions ] Hypersensitivity reactions [see Warnings and Precautions ] Venothromboembolic disease [see Warnings and Precautions ] Adverse reactions > 2% and at least 1% greater than placebo: Abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis . To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA.
Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of 160 mg once daily . Severe hypertriglyceridemia: Initial dose of 54 to 160 mg once daily. Maximum dose is 160 mg . Renally impaired patients: Initial dose of 54 mg once daily . Geriatric patients: Select the dose on the basis of renal function . Should be given with meals . neral Considerations Patients should be placed on an appropriate lipid-lowering diet before receiving Fenofibrate Tablets, USP, and should continue this diet during treatment with Fenofibrate Tablets, USP. Fenofibrate Tablets, USP should be given with.
12.1 Mechanism of Action The active moiety of fenofibrate tablets is fenofibric acid. 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 in vivo in transgenic mice and in vitro in human hepatocyte cultures by the activation of peroxisome proliferator activated receptor α (PPARα). Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by activating.
8.1 Pregnancy Risk Summary Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or comparable to the maximum recommended clinical dosage of 120 mg of fenofibrate tablets daily, based on body surface area (mg/m 2 ). Adverse reproductive outcomes occurred at higher doses in the.
Pharmacokinetics /Metabolism Clinical experience has been obtained with two different formulations of fenofibrate: a “micronized” and “non-micronized” formulation, which have been demonstrated to be bioequivalent. Comparisons of blood levels following oral administration of both formulations in healthy volunteers demonstrate that a single capsule containing 67 mg of the “micronized” formulation is bioequivalent to 100 mg of the “non-micronized” formulation. Three capsules containing 67 mg fenofibrate (micronized) are bioequivalent to a single 200 mg fenofibrate capsule (micronized).