Lexemin 100/Lexemin 300/Lexemin 160

Fenofibrate (tab: micronized).

Each capsule contains: Fenofibrate 100 mg.
Each capsule contains: Fenofibrate 300 mg.
Each film coated tablet contains: Fenofibrate micronized 160 mg.

Cap: Fenofibrate is a lipid regulating agent which reduces total cholesterol, LDL cholesterol, VLDL and triglycerides and increases HDL cholesterol.
Tab: 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 perioxisome 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 - 30 L.
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).

Cap: Treatment of hypercholesterolemia (Type IIa), and endogenous hypertriglyceridemia isolated (Type IV) or associated (Type IIb and III).
Tab: Indicated for hypercholesterolemia, primary hypercholesterolemia or mixed dyslipidemia (Frederickson Type 2a, 2b); hypertriglyceridemia, Frederickson types 4 and 5 hyperlipidemia, adjunct to diet.

Cap: Normal dose: 100 mg: 1 capsule three times daily with or after meal.
300 mg: 1 capsule daily during one of main meal.
Maintenance dose: 100 mg: 2 capsules daily during one of main meal OR AS PRESCRIBED BY THE PHYSICIAN.
Tab: 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 daily.
Pediatric dose: Safety and efficacy is not established in pediatric patients.

Cap: Patients with hepatic or severe renal dysfunction.
Tab: Gallbladder disease; history of hypersensitivity to fenofibrate, including severe skin rashes (e.g. 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.

Tab: Concomitant therapy with HMG-CoA reductase inhibitors (e.g. lovostatin, pravastatin, simvastatin), or fenofibric acid derivatives (e.g. gemfibrozil) should be avoided, if use is warranted administer cautiously.
Concomitant therapy with anticoagulants: exercise caution.
Cholelithiasis.
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.
Pancreatitis.
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.

Cap: Pregnancy: Have not shown any teratogenic effects when the studies carry out animals.

Cap: Not exceeding 2-4%: Digestive, gastric or intestinal troubles of dyspeptic type; cutaneous allergic reactions.
Tab: Common: Dermatologic: Rash.
Gastrointestinal: Diarrhea, flatulence, nausea, and vomiting.
Musculoskeletal: Myalgia.
Respiratory: Rhinitis.
Serious: Gastrointestinal: Pancreatitis (rare).
Hepatic: Hepatotoxicity (rare).
Musculoskeletal: Rhabdomyolysis (rare).

Cap: Fenofibrate potentiates anticoagulants and enhances the hemorrhagic risk through displacement of their binding with the plasma proteins.
Tab: Major: Acenocoumarol; anisindione; atorvastatin; cerivastatin; dicumarol; fluvastatin; lovastatin; phenindione; phenprocoumon; pravastatin; rosuvastatin; simvastatin; warfarin.
Moderate: Colestipol; ezetimibe; glimepiride.

Store at temperature not more than 30°C.

Dyslipidaemic Agents

C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.

P₁S₁S₃