Fenostad 100

Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPAR alpha). Through activation of PPAR alpha, fenofibrate increases lipolysis and elimination of atherogenic triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of Apoprotein C-III. Activation of PPAR alpha also induces an increase in the synthesis of Apoproteins A-I and A-II.

Pack size Box of 30 capsules, 60 capsules
Shelf-life 24 months
Composition Fenofibrate
Dosage forms and strengths Hard gelatin capsule: Fenofibrate 100 mg
Product code :



Adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:

  • Severe hypertriglyceridaemia with or without low HDL cholesterol.
  • Mixed hyperlipidaemia when a statin is contraindicated or not tolerated or in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.


  • The recommended dose is 200 mg daily.
  • The dose can be titrated up to 267 mg daily. This maximum dose is not recommended in addition to a statin.

Special populations

  • Elderly patients (≥ 65 years old)
    No dose adjustment is necessary. The usual dose is recommended, except for decreased renal function with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2.
  • Renal impairment
    In patients with renal failure eGFR 30 – 59 mL/min/1.73 m2, the dose of fenofibrate should not exceed 100 mg standard or 67 mg micronized once daily.

Paediatric population

  • 1 capsule of Fenostad 67 (micronized)/day/20 kg body weight.


  • Fenostad 100 should be swallowed whole during a meal.
  • Hypersensitivity to any of the ingredients.
  • Hepatic insufficiency.
  • Known gallbladder disease.
  • Severe renal insufficiency.
  • Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia,
  • Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.


  • Abdominal pain, nausea, vomiting, diarrhoea, flatulence,
  • Transaminases increased,
  • Blood homocysteine level increased.
  • Identify a secondary cause of hyperlipidaemia (pathological or drug-induced) and correct before fenofibrate therapy is considered. Monitor transaminases every 3 months during the first 12 months of treatment and thereafter periodically; Continuous monitoring of creatinine during the first 3 months after initiation of treatment and periodically thereafter.
  • Risk of pancreatitis, muscle toxicity.
  • Consider benefit/risk in patients with predisposing factors for myopathy/rhabdomyolysis (above 70 years of age, personal or familial history of hereditary muscular disorders, renal impairment, hypothyroidism and high alcohol intake).
  • Discontinue if: AST/ALT > 3xULN or when symptoms of myalgia, myositis, muscle spasticity, weakness and/or CPK > 5xULN occur; creatinine > 50% ULN.
  • In children: Only hereditary disease (familial hyperlipidemia) justifies early treatment, it is recommended to begin treatment with controlled dietary restrictions for a period of at least 3 months, consider medication only when signs of severity and/or in cases where patients suffer from atherosclerotic cardiovascular disease before the age of 40.
  • Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Pregnancy, lactation: Use only after benefit/risk assessment.
  • Patients should be aware of how they react to drug before driving or operating machinery.