Medication info

Fenofibrate Tablets (Fenofibrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Fenofibrate›160mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
White oblong film-coated tablet
Packaging
100 tablets/box [10 tablets/PTP X 10]
Approval status
Expired

MFDS item code 202000077 · Approved 2020.01.06

This product's status changed to Expired on 2025.01.06. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of primary dyslipidemia (hypercholesterolemia, hypertriglyceridemia)
Who takes it
Adults · Children
Adult dose
As Fenofibrate, take 160 mg orally once daily immediately after a meal. Fenofibrate must be administered in conjunction with dietary therapy. This medication may be absorbed less effectively on an empty stomach, so it should be taken immediately after a meal.
Child dose
There is currently no clinical data regarding the use of this medication in pediatric patients.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Treatment of primary dyslipidemia (hypercholesterolemia, hypertriglyceridemia)

  • Primary dyslipidemia
  • hypercholesterolemia
  • hypertriglyceridemia
View approved original text

This medication is used to treat various types of dyslipidemia, including primary dyslipidemia, specifically hypercholesterolemia and hypertriglyceridemia. It is particularly effective for type IIa hypercholesterolemia and mixed dyslipidemia type IIb and type III, as well as type IV hypertriglyceridemia. By improving lipid levels in the blood, this medication promotes vascular health and reduces the risk of cardiovascular diseases. Patients are advised to consistently take this medication along with dietary control and lifestyle modifications. This drug helps to effectively manage lipid abnormalities in the blood.

How to take

Adult dose

As Fenofibrate, take 160 mg orally once daily immediately after a meal. Fenofibrate must be administered in conjunction with dietary therapy. This medication may be absorbed less effectively on an empty stomach, so it should be taken immediately after a meal.

Child dose

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

Precautions

This medication should not be used in patients with impaired liver function or severe kidney dysfunction. It is also advised to avoid this medication in pregnant women, women who are potentially pregnant, and nursing mothers. Additionally, patients who have had allergic reactions to this medication or its ingredients, those with gallbladder disease, children, patients with biliary cirrhosis, and those with pancreatitis should avoid its use. Caution is necessary when administering this drug to patients with mildly impaired kidney function, those with a history of liver issues, hypoalbuminemia, a history of gallstones, patients on anticoagulants, those taking specific dyslipidemia medications concurrently, and elderly patients. Adverse effects such as liver dysfunction, skin rash, myalgia, gastrointestinal issues, and, rarely, blood abnormalities or changes in kidney function may occur while taking this medication, so it is essential to consult a doctor immediately if these symptoms arise. Patients with reduced kidney function are at risk for muscle damage and worsening kidney function, thus requiring regular testing. Furthermore, this medication may interact with other drugs; care should be taken when used with anticoagulants or specific dyslipidemia agents, as well as hypoglycemics. It is safer not to use this medication during pregnancy or breastfeeding, and it should not be used in children. Elderly patients should be cautious due to potential declines in liver and kidney function, necessitating regular kidney function monitoring. No specific antidote is available in case of overdose, so strict adherence to dosage is crucial. This medication should be stored out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headaches, lightning headaches, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output, severe edema with elevated blood pressure

Mild side effects

Hepatomegaly, biliary duct cholestasis hepatitis, gallstones, rash, itching, hair loss, weakness, high fever, dizziness, headache, peripheral neuropathy, thromboembolism, elevated creatine kinase, myalgia, muscle cramps, arthralgia, gastrointestinal disturbances (abdominal pain, nausea, vomiting, diarrhea, bloating), seizures, hemoglobin decrease, leukopenia, eosinophilia, serum creatinine increase, elevated urea, eosinophilic pneumonia, ventricular arrhythmias, fatigue

Not everyone experiences these, and they can vary from person to person.

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture, and it should be kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

White oblong film-coated tablet

Package unit

100 tablets/box [10 tablets/PTP X 10]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.