Fenofibrate (Nanocrystallized)
Tablets (nanocrystallized): 48 mg, 145 mg
*Fenofibrate is also available in non-AB rated 54 mg and 160 mg tablets and 67 mg, 134 mg, and 200 mg capsules.
As adjunctive therapy to diet to reduce elevated LDL-C, total-C, triglycerides and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Type IIa and IIb): The recommended dose is 145 mg daily with meals.
As an adjunctive therapy to diet for treatment of adults with hypertriglyceridemia (Fredrickson Types IV and V): The recommended dose is 48-145 mg with meals.
Treatment of patients with renal impairment: Initial dose should be 48 mg daily with meals.
Monitor: LFT, RFT, Lipid panel
Pharmacology/Pharmacokinetics:
Fenofibrate lowers total-C, LDL-C, and triglycerides by activation of peroxisome proliferator activated receptor-a (PPARa). Through this mechanism, fenofibrate increases lipolysis and elimination of triglycerides-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III. A decrease in triglycerides results in a change in the composition of LDL to larger particles which are catabolized rapidly. Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing urinary excretion of uric acid. Peak plasma levels are reached in 6-8 hours with steady state levels reached within 5 days. Esterases metabolize fenofibrate to its active metabolite fenofibric acid and excretion occurs in the urine.
Drug Interactions:
Fenofibrate may increase the actions of WARFARIN. Use with HMG-CoA reductase inhibitors should be avoided due to an increase in serious adverse effects (rhabdomyolysis). Cholestyramine may decrease the absorption of fenofibrate.
Contraindications/Precaution:
Contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, in patients with unexplained persistent liver function abnormality, and in patients with preexisting gallbladder disease. Serious liver toxicity is a potential adverse effect of fenofibrate therapy. Initial and periodic liver function tests should be performed and treatment discontinued if enzyme levels persist above three times the normal limit. Increased cholesterol excretion into bile may precipitate gallstones. Do not use during pregnancy and in nursing mothers. Pregnancy Category C.
Adverse Effects:
Adverse effects occur at a similar rate as placebo except for a higher risk of abnormal liver function tests. Promptly report RASH, MUSCLE PAIN, TENDERNESS, or WEAKNESS. May frequently cause respiratory disorders, abdominal pain, back pain, and headache.
Closely follow prescribed diet.
Contact a physician if the above side effects are severe or persistent.
Call a physician if signs of myositis show. This includes muscle pain, tenderness, or weakness.
Store in a cool, dry place away from sunlight and children.
If a dose is missed take it as soon as possible. If it is closer to the time of your next dose than the dose you missed, skip the missed dose and return to your dosing schedule. Do not double doses.
