Each film coated tablet contains: Fenofibrate, USP 160 mg.
Pharmacology: Mechanism of Actions: Systemic: Fenofibrate is a lipid-regulating agent that has chemical, pharmacologic, and clinical similarities to the other fibrate drugs, Clofibrate and Gemfibrozil. Although the exact mechanism of action of Fenofibrate is not completely understood, Fenofibric acid, the active metabolite of Fenofibrate, produces reduction in total cholesterol. LDL cholesterol, apolipoprotein B, total triglycerides and triglyceride rich lipoprotein (VLDL) in treated patients. Treatment with Fenofibrate also results in increase in high density lipoprotein (HDL) and apoproteins apoAI and apoAII.
Fenofibric acid effects have been explained by the activation of peroxisome proliferator activated receptor alpha (PPARalpha). Through this mechanism, Fenofibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of an inhibitor of lipoprotein lipase activity, apoprotein C-III. The fall in triglycerides produces an alteration in the composition and size of LDL from dense, small particles (possibly atherogenic), to buoyant, large particles. These larger particles are catabolized rapidly due to a greater affinity for cholesterol receptors. An increase in the synthesis of apoproteins A-I, A-II, and HDL-cholesterol also results by activation of PPARalpha.
Fenofibrate reduces serum uric acid concentrations in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid.
Pharmacokinetics: Absorption: Effect on food, micronized Fenofibrate: no effect.
Distribution: Vd: 30L.
Metabolism: Systemic: active metabolite: Fenofibric acid.
Excretion: Systemic: Fecal: 25%; Renal: 60% metabolites.
Elimination: Half-life: Fenofibric acid, mean 20 hours (range 10-35 hours).
It is used to reduce low density lipoprotein (LDL) cholesterol, total cholesterol, triglycerides and apolipoprotein B and to increase high density lipoprotein (HDL) cholesterol, in the management of hyperlipidemias, including type IIa, type IIb, type III, type IV and type V hyperlipoproteinemias.
Oral: Usual adult dose: Hypercholesterolemia, primary hypercholesterolemia or mixed dyslipidemia (Frederickson Type 2a, 2b): 160 mg daily with or without food; Max 160 mg per day.
Hypertriglyceridemia, Frederickson types 4 and 5 hyperlipidemia, adjunct to diet: Initial, 50 to 160 mg once daily with or without food, adjust dose after repeated lipid tests at 4 to 8 week intervals; Max 160 mg orally daily.
Usual pediatric dose: Safety and efficacy is not established in pediatric patients for tablets.
Treatment should be symptomatic and supportive.
Specific treatment: Hemodialysis should not be considered in the treatment of Fenofibrate overdosage because Fenofibrate is extensively bound to plasma proteins.
Supportive care: Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.
Gallbladder disease; History of hypersensitivity to Fenofibrate, including severe skin rashes (eg. Stevens-Johnson syndrome, toxic epidermal necrolysis); Liver disease, active, including primary biliary cirrhosis and unexplained persistent liver function abnormality; Nursing mothers; Severe renal dysfunction, including patients receiving dialysis.
Concomitant therapy with HMG-CoA reductase inhibitors (eg. Lovastatin, Pravastatin, Simvastatin), or Fenofibric acid derivatives (eg. Gemfibrozil) should be avoided, if use is warranted administer cautiously.
Concomitant therapy with anticoagulants; exercise caution.
Diabetic patients; increased risk of myopathies including rhabdomyolysis.
Elderly patients; increased risk of myopathies including rhabdomyolysis.
Hypothyroidism; increased risk of myopathies including rhabdomyolysis.
Hypersensitivity reactions have occurred including skin rashes requiring hospitalization and Stevens-Johnson syndrome.
Myopathies may occur; discontinuation of therapy may be warranted.
Renal dysfunction; increased risk of myopathies including rhabdomyolysis.
Serum transaminases (AST and ALT) increases of more than 3 times the upper limit of normal have been reported: monitoring is recommended, discontinuation of therapy may be warranted.
Diarrhea, flatulence, nausea, and vomiting.
Store at temperatures not exceeding 30°C.
C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.
FC tab 160 mg x 10 x 10's.