Medication info
Zefino Tablet 2/160 mg (Pitavastatin Calcium, Fenofibrate)

Zefino Tablet 2/160 mg (Pitavastatin Calcium, Fenofibrate)

Prescription medicationTablet경구
Ingredient · strength
Fenofibrate Micronized›160mg / 1 tabletPitavastatin Calcium›2mg / 1 tablet
Manufacturer / importer
(주)제뉴파마
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202501045 · Approved 2025.04.30 · Insurance code 698004790

Summary

Main use
Regulation of LDL cholesterol and improvement of dyslipidemia
Who takes it
Adults
Adult dose
As a recommended dose, take 1 tablet once daily immediately after meals.

Ingredients

Manufacturer
(주)제뉴파마

Efficacy & effects

Regulation of LDL cholesterol and improvement of dyslipidemia

  • Coronary artery disease
  • LDL cholesterol levels
  • triglyceride levels
  • HDL cholesterol levels
  • mixed dyslipidemia
View approved original text

In adult patients at high risk for coronary artery disease, single therapy with 2 mg of Pitavastatin is effective for adequately controlling LDL cholesterol levels. However, it is used for patients with mixed dyslipidemia where triglyceride levels remain high and HDL cholesterol levels are low. This medication primarily focuses on reducing LDL cholesterol to help reduce the risk of cardiovascular disease. Additional treatment may be necessary for comprehensive improvement of mixed dyslipidemia. Pitavastatin contributes to cardiovascular health through hyperlipidemia management.

How to take

Adult dose

As a recommended dose, take 1 tablet once daily immediately after meals.

Precautions

This drug is used to regulate blood lipid levels and may cause muscle-related side effects, requiring caution. If symptoms such as muscle pain, weakness, or cramps occur, inform healthcare personnel immediately. In patients over 65 years old, women, patients with poor kidney function, those uncontrolled hypothyroidism, those with low albumin levels, or those with a history or family history of muscle diseases should be checked for muscle damage prior to starting this medication. This drug may increase the risk of muscle toxicity when taken with other lipid-lowering agents or certain medications, thus caution is needed in combination. Patients with liver or pancreatic issues, those with moderate or severe kidney impairment, pregnant women or those who may become pregnant, and children under 18 should not use this drug. Regular monitoring of liver function tests during treatment is required, and if liver enzymes rise significantly, the medication should be discontinued. Additionally, this drug may cause gallstones, so patients with a history of gallstones should be cautious. Patients with blood coagulation disorders or those taking anticoagulants should consult healthcare personnel to reduce bleeding risk. This drug does not affect the ability to drive or operate machinery, but caution should be exercised as dizziness may occur. Patients who consume excessive alcohol or have a history of liver disease should be especially careful when using this medication. If any abnormal symptoms or allergic reactions occur, medical consultation should be sought immediately. This drug must be taken with food, and regular checks of blood lipid levels and kidney function should be performed to ensure there are no abnormalities. Pregnant or nursing women should not take this drug, and women planning to become pregnant must consult healthcare personnel before taking it. Safety and effectiveness have not been established for use in children. In case of overdose, there is no specific antidote, so treatment should be based on symptoms. This medication should be stored out of reach of children and kept in its original container to prevent misuse or degradation in quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, acute hypersensitivity, anaphylaxis, systemic skin adverse reactions (severe skin reactions, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), severe rash with high fever, blisters, skin peeling, oral/eye mucosal pain, interstitial lung disease, jaundice (yellowing of skin or eyes), systemic fatigue, pancreatitis, sudden and very severe

Mild side effects

  • Pharyngitis
  • upper respiratory infections
  • dizziness
  • chronic gastritis
  • erosive gastritis
  • nausea
  • headache
  • fatigue
  • stiffness
  • drowsiness
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  • insomnia
  • heaviness in the head
  • numbness
  • dizziness
  • itching
  • hair loss
  • increased serum creatinine
  • increased BUN
  • elevated blood pressure
  • dry mouth
  • dyspepsia
  • abdominal pain
  • constipation
  • nausea
  • thrombocytopenia
  • increased hematuria
  • palpitations
  • skin pain
  • burning sensation
  • joint pain
  • edema
  • blurred vision
  • photophobia
  • hearing loss
  • and urinary hematuria.

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This way, the efficacy of the medication can be preserved for a longer time.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

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

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

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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.