Fenofibrate: Uses, Dosage, Side Effects

Generic Name
Therapeutic Class: Cardiovascular / Fibrates

Fenofibrate is indicated for hyperlipidemias of type lla, llb, III, IV & V in patients who have not responded adequately to diet & other appropriate measures.

Fenofibrate: Each capsule contains Fenofibrate BP (micronised) 200 mg.

Fenofibrate is a fibric acid derivative. Fenofibrate is rapidly hydrolyzed after oral ingestion to its pharmacologically active form, fenofibric acid. Fenofibric acid produces reductions in total cholesterol, LDL cholesterol, Apo-lipoprotein B, Total triglycerides and VLDL. In addition, treatment with Fenofibrate results in increases in HDL and apo-proteins apoAI apoAII. Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid. The micronised form of Nofiate (Fenofibrate) has enhanced absorption over the non-micronized formulation.

Dosage & Administration:
For the treatment of adult patients with hypercholesterolemia or mixed hyperlipidemia, the initial dose of Fenofibrate is 200 mg per day.
For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day.
The dose should be individualized according to patient response. Fenofibrate should be given with meal thereby, optimizing the bioavailability of the medication. Or, as directed by the registered physician.

Fenofibrate has been reported to potentiate the anticoagulant effects of warfarin. When administered with the antidiabetic drug it may improve glucose tolerance and have an additive effect. Fenofibrate may also increase the nephrotoxicity of cyclosporine. Due to a potential increase in the risk of rhabdomyolysis, caution should be taken against the use of Fenofibrate with HMG-CoA reductase inhibitors. However, the use of low-dose statins with Fenofibrate appears to be well tolerated.

Fenofibrate is contraindicated in patients with hypersensitivity to Fenofibrate, severe renal or hepatic impairment, existing gall bladder disease, breastfeeding mothers, photosensitivity to ketoprofen.

Side Effects:
Gastrointestinal (e.g. nausea, anorexia, gastric pain), pruritus, urticaria, impotence, also headache, dizziness, vertigo, fatigue, hair loss; myotoxicity.

Pregnancy & Lactation:
Fenofibrate is not recommended for pregnant women.

Precautions & Warnings:
Special care is needed in patients with renal disease, as progressive increases in serum creatinine concentration or failure to follow dosage guidelines may result in myotoxicity; discontinue if myotoxicity is suspected or creatinine kinase concentration increases significantly. Liver function tests are recommended every 3 months for the first year.

There is no specific treatment for overdose with Fenofibrate. General supportive care of the patients is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. Because Fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.

Do not store above 30°C. Keep away from light and out of the reach of children.

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