Fenofibrate

Indications
 Oral
Hyperlipidaemias
Adult: Dose depends on the formulation used. For standard micronised formulations: Initially, 67 mg tid or 200 mg once daily, may reduce to 67 mg bid or increase to 67 mg 4 times daily. For non-micronised formulations: Initially, 200-300 mg daily in divided doses. Usual range: 200-400 mg daily. For formulations with improved bioavailability, doses between 40-160 mg daily may be used.
Child: 5 mg/kg daily.
Renal impairment: Dose reduction is necessary.

Special Populations: Reduce dose in patients with mild to moderate renal impairment: CrCl 20 mL/min: 100 mg daily; CrCl 60 mL/min: 200 mg daily.
Contraindications
 Hypersensitivity; severe hepatic and renal impairment. Unexplained persistent liver function abnormality and primary biliary cirrhosis; preexisting gall bladder disease. Pregnancy, lactation.
Warnings / Precautions
 Renal or hepatic impairment. Monitor LFTs and blood counts regularly. Increased risk of cholelithiasis, pancreatitis, skeletal muscle effects. Withdraw treatment if no adequate response after 2 mth of treatment at max recommended dose.
Adverse Reactions
 Headache, dizziness, asthaenia, fatigue, arrhythmia, photosensitivity, eczema, dizziness, vaginitis, paraesthesia, rhinitis, cough, sinusitis, allergic pulmonary alveolitis, polyuria, myopathy, myositis, arthralgia, myalgia, myasthenia.
Potentially Fatal: Hepatitis, cholecystitis.
Drug Interactions
 Resins impede the absorption of fenofibrate. May increase ciclosporin concentration and associated nephrotoxicity when used together.
Potentially Fatal: Statins increase the risk of rhabdomyolysis and myopathy with renal failure. May increase the effects of oral anticoagulants.
See Below for More fenofibrate Drug Interactions
Lab Interactions
 Increased creatinine and gamma glutamyl transpeptidase.
Food Interactions
 Food increases the bioavailability of fenofibrate.
Mechanism of Actions
 Fenofibrate lowers plasma TG by activating lipoprotein lipase thus increasing catabolism of very low-density lipoprotein with consequent increase in high-density lipoprotein levels.
Absorption: Readily absorbed from the GI tract (oral); reduced if taken after an overnight fast.
Distribution: >99% bound to plasma albumin.
Metabolism: Rapidly via hydrolysis; converted to fenofibric acid.
Excretion: Urine (60% metabolite, glucuronide conjugate); faeces (25%); 20 hr (elimination half-life).
Administration
 Should be taken with food.
Storage Conditions
 Oral: Store at 25°C.
ATC Classification
 C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.
Storage
 Oral: Store at 25°C.
Available As
  • Fenofibrate 145 mg
  • Micronised Fenofibrate 145 mg
  • Fenofibrate 160 mg
  • Micronised Fenofibrate 160 mg
  • Fenofibrate 20 mg
  • Fenofibrate 200 mg
  • Fenofibrate BP 200 mg
  • Fenofibrate 40 mg
  • Fenofibrate 60 mg
  • Fenofibrate 67 mg
  • Fenofibrate 80 mg

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