Phenofibrate Tablets (Fenofibrate)

Adult dose

Fenofibrate should be taken orally once daily at 160 mg immediately after meals. Fenofibrate must be administered in conjunction with dietary therapy. Administration on an empty stomach may result in less absorption, so it should be taken immediately after meals.

Child dose

There is currently no clinical data regarding the use of this drug in pediatric patients.

This drug should not be administered to patients with poor liver function. It should also be avoided in patients with moderate to severe kidney function impairment due to the risk of serious muscle damage known as rhabdomyolysis. Pregnant women and those who may become pregnant, as well as nursing mothers, should not use this medication. Patients with a history of allergic reactions to this drug should avoid taking it. Patients with gallbladder disease or gallstones are also advised to avoid this medication. Careful attention is needed for patients who previously exhibited photosensitivity reactions while taking fibrate class drugs or ketoprofen. This drug is not to be administered to children. Patients with biliary cirrhosis or pancreatitis should avoid its use. Patients with genetic metabolic disorders such as lactose intolerance should not receive this medication. In patients with mild renal impairment, dosage should be reduced or intervals between doses increased for careful use. Patients with liver function abnormalities or past histories of liver disease also require caution. Patients with hypoalbuminemia, a history of gallstones, those taking anticoagulants, and the elderly should be carefully administered this drug. This medication may affect the liver and biliary system, leading to elevated liver enzyme levels or the development of gallstones and hepatitis. Skin rash or itching, photosensitivity reactions may occur, and rare cases of hair loss have been reported. Neurological symptoms such as dizziness, headache, and weakness may occur. There is also a risk of thromboembolism, so caution is advised. Myalgia or muscle cramps, and elevated creatine kinase levels may appear, and in severe cases, muscle damage can occur. Allergic reactions such as hives or photodermatitis may occur, so any unusual symptoms should be discussed with a healthcare professional immediately. Gastrointestinal symptoms such as abdominal pain, nausea, vomiting, and diarrhea are common, and pancreatitis may seldom occur. Very rare occurrences of interstitial pulmonary disease, blood cell reductions, and renal function impairment have been reported. Regular liver function tests and blood lipid assessments should be performed before and after administration, and if liver function abnormalities are found, dosage adjustment or discontinuation may be necessary. If cholelithiasis is suspected, gallbladder examinations should be conducted, and treatment should be stopped if gallstones are detected. This drug has many interactions with other medications, especially with statin class drugs that increase the risk of muscle damage, so caution is necessary. Co-administration with anticoagulants increases the risk of bleeding, requiring dosage adjustment and monitoring. When used with antidiabetic drugs, hypoglycemic symptoms may occur, so patient condition should be closely observed. This medication should be avoided during pregnancy as it may harm the fetus, and it is also advisable not to administer while breastfeeding. Elderly individuals have a higher risk of adverse effects due to decreased liver and kidney function, so extra caution is necessary when administering. There are no specific antidotes for overdose, so the prescribed dosage must be followed, and it should be stored out of reach of children.

Serious side effects

Hives, severe swelling (edema), liver dysfunction (including jaundice), severe allergic reactions (anaphylaxis, angioedema), severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), respiratory problems (difficulty breathing, asthma attacks), severe neurological symptoms (seizures, confusion), rhabdomyolysis, acute pancreatitis, thromboembolism (pulmonary embolism, deep vein thrombosis), acute hypersensitivity, DRESS syndrome, SCA

Mild side effects

Elevated serum aminotransferase levels, liver enlargement, cholestatic hepatitis, rash, itching, photosensitivity reactions, hair loss, weakness, fever, dizziness, headache, peripheral neuropathy, thromboembolism, elevated creatine kinase (CK) levels, myalgia, muscle cramps, arthralgia, gastrointestinal disturbances (abdominal pain, nausea, vomiting, diarrhea, abdominal bloating), interstitial pulmonary disease, decreased hemoglobin, leukopenia, eosinophilia, elevated serum creatinine and urea levels,

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to ensure the drug's effectiveness and safety over time.

Appearance

White oval film-coated tablet

Package unit

100 tablets/box [(10 tablets/PTP*10)]