Hypercholesterolemia type IIa & pure endogenous hypertriglyceridemia type IV or combined hyperlipidemia type IIb & III if correct diet is inadequate, elevated blood cholesterol level following correct diet &/or correlated w/ risk factors.
Dosage/Direction for Use
Adult Initially 100 mg 3 times daily or 300 mg daily as a single dose. Micronized FC caplet 1 FC caplet once daily.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to fenofibrate, nuts, peanut oil, soy lecithin or other associated products. Liver & kidney disorders. Pregnancy & lactation. Childn. Cap: Primary biliary cirrhosis. Micronized FC caplet: Phototoxicity during therapy w/ fibrates or ketoprofen may occur. Gallbladder disease; chronic or acute pancreatitis w/ exception of acute pancreatitis due to severe hypertriglyceridemia.
Special Precautions
Monitor transaminase level every 3 mth for the 1st 12-mth therapy. Discontinue use if increased SGOT & SGPT >100 IU occurs. Micronized FC caplet: Pancreatitis. Increased risk of rhabdomyolysis in patients w/ pre-existing hypoalbuminemia & renal impairment; who have history of congenital or genetic muscle disorders, hypothyroidism or high alcohol consumption. Discontinue use if muscle toxicity is suspected. Closely monitor patients w/ signs of muscle toxicity if given concomitantly w/ another fibrate or HMG-CoA reductase inhibitors, especially in pre-existing muscular disorders. Possible lipid values elevation w/ concomitant estrogens or OCs. Contains lactose. Should not be used in patients w/ hereditary galactosemia, glucose-galactose malabsorption disorder or lactase deficiency. Discontinue treatment if increased creatinine >50% normal limit occurs. Monitor creatinine level during 1st 3 mth of treatment. Elderly >70 yr.
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