Medication info
Stafib Tablet 2/160 milligrams (Pitavastatin Calcium Hydrate, Fenofibrate)

Stafib Tablet 2/160 milligrams (Pitavastatin Calcium Hydrate, Fenofibrate)

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium Hydrate›2.205mg / 1 tabletFenofibrate›160mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
White oblong film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202502274 · Approved 2025.08.29 · Insurance code 694004560

Summary

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

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

LDL cholesterol control and improvement of dyslipidemia

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

Using Pitavastatin 2 mg monotherapy in adult patients at high risk for coronary artery disease can effectively control LDL cholesterol levels. However, this treatment may keep triglyceride levels elevated in patients with mixed dyslipidemia characterized by high triglycerides and may result in decreased HDL cholesterol levels. Therefore, Pitavastatin is primarily used to lower LDL cholesterol and reduce the risk of cardiovascular disease.

How to take

Adult dose

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

Precautions

This medication is used to lower blood lipid levels. Notify your doctor immediately if symptoms such as muscle pain, muscle weakness, or muscle cramps occur before taking. Patients aged 65 and older, those with impaired renal function, or those with hypothyroidism should exercise extra caution. The risk of muscle damage may increase when taken with other lipid-lowering agents, so discuss with your physician if you are combining medications. Patients with liver or kidney issues must consult with a doctor before using this medication. This medication should not be taken by pregnant or potentially pregnant women or nursing mothers. There is no established safety and efficacy of this medication in children, so it should not be used in pediatric patients. Regular blood tests should be conducted to monitor liver function and muscle condition during treatment. Patients undergoing surgery may need to temporarily discontinue this medication before the procedure. There is no specific antidote for overdose, and appropriate treatment should be administered according to symptoms. It is recommended to take this medication with food, and caution should be exercised as drowsiness may occur while driving or operating machinery. It is advisable to avoid alcohol while taking this medication. If hypersensitivity reactions such as skin rash, itching, or difficulty breathing occur, discontinue use immediately and seek medical attention.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, skin peeling, pain in mucous membranes of mouth/eyes (severe skin reactions: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), difficulty breathing (interstitial lung disease), jaundice of the skin or eyes, lethargy, sudden and severe headache, seizures, confusion, visual disturbances, paralysis, rhabdomyolysis with or without kidney failure, significantly reduced urine output

Mild side effects

Nasopharyngitis, upper respiratory tract infection, nausea, headache, dizziness, hypertension, chronic gastritis, erosive gastritis, gastrointestinal symptoms (abdominal pain, vomiting, diarrhea, bloating, etc.), thirst, indigestion, constipation, stomatitis, loss of appetite, glossitis, increased serum homocysteine levels, palpitations, fatigue, skin tenderness, flushing, arthralgia, edema, blurred vision, photophobia, hearing loss, hematuria, increased uric acid levels, elevated serum potassium and phosphorus levels, dysgeusia, discolored urine

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture ingress and should be kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy and safety.

Appearance and packaging

Appearance

White oblong film-coated tablet

Package unit

30 tablets/bottle, 300 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.