Fenofibrate

Indication

It is used as adjunctive therapy to diet in primary hyper­cholesterolemia or mixed dyslipidemia and hypertrigly­ceridemia. But it is not indicated for patients with type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low-densi...read more

Dosage and Administration

Usual dose: 160 mg once daily with meal. In elderly or patients with impaired renal function, it should be initiated at low dose. Lipid levels should be monitored periodically, and consideration should be given to reducing the dosage of fenofibrate if lipid levels fall significantly below the target...read more

Composition

Each film-coated tablet contains:

Fenofibrate USP ... 160 mg.

Description

Fenofibrate is a lipid regulating agent. Chemically, it is isopropyl 2-[p-(p-chlorobenzoyl)phenoxy]-2-methylpr­opanoate. Its molecular formula is C20H21ClO4 and molecular weight is 360.83.

Clinical Pharmacology

Fenofibrate is a pro-drug of active moiety, fenofibric acid that increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-lll (an inhibitor of lipoprotein lipase activity). The resulting decrease in TG pro...read more

Pharmacokinetics

Fenofibrate is well absorbed from gastrointestinal tract and increased absorption with food. It is widely distributed to most tissues. Serum protein binding was approximately 99% in normal and hyperlipidemic subjects. Fenofibrate is rapidly hydrolyzed by esterases to the active metabolite, fenofibri...read more

Contraindication

It is contraindicated in patient with hypersensitivity to Fenofibrate; active liver disease including primary biliary cirrhosis and persistent unexplained liver function abnormalities; severe renal impairment (GFR <30 mL/ min/I.73 m2) including those with end-stage renal disease and those receiving ...read more

Precaution

Use with caution in patients with pre-disposing factors for myopathy and/or rhabdomyolysis (diabetes mellitus, personal or familial history of hereditary muscular dis­ orders, hypoalbuminaemia, hypothyroidism, high alcohol intake), risk factors for venous thromboembolism, elderly and pregnancy. Labo...read more

Adverse Effects

Adverse effects may include nausea, constipation, abdominal pain, diarrhea, hepatitis, hepatomegaly, liver function test abnormal, cholelithasis, cholecystitis, tenosynovitis, joint disorder, arthrosis, rhabdomyolysis, myopathy, myalgia, myasthenia, arthralgia, arthritis, myositis, leg cramps, bursi...read more

Drug Interaction

Coumarin Anticoagulants: Potentiation of anticoagulants in prolonging the prothrombin time. Dosage of antico­ agulants should be reduced to maintain the prothrombin time/fNR at the desired level.

HMG-CoA reductase inhibitors: Combination will mar­ kedly increase levels of creatinine kinase (CK) levels and myoglobinuria leading in high proportion of cases of renal failure.

lmmunosuppressants: lmmunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatine and because renal excretion is the primary elimination route of fibrate drug, there is a risk that an interaction will lead to dete...read more

Bile Acid Binding Resin: Since bile acid binding resins may bind other drugs given concurrently, fenofibrate should be taken at least I hour before or 4 to 6 hours after a bile acid binding resin to avoid impeding its absorption.

Colchicine: Cases ofmyopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine and caution should be exercised when pres­ cribing fenofibrate with colchicine.

Contraceptives: Oestrogen-containing contraceptives may interfere with the effects of fenofibrate.

Storage

Store below 30°C in cool, dry place. Protect from light and moisture. Keep out of reach and sight of children.

Presentation

10 x 10's Blisters.