Medication info
Stafenocapsule (Pitavastatin Calcium, Fenofibrate)

Stafenocapsule (Pitavastatin Calcium, Fenofibrate)

Prescription medicationHard capsule경구
Ingredient · strength
Pitavastatin Calcium›2mg / 1 capsuleFenofibrate Granules›241.51mg / 1 capsule
Manufacturer / importer
신풍제약(주)
Appearance
A hard capsule with an upper light green part and a white lower part, containing round white film-coated tablets and white spherical fine granules.
Packaging
Bottle - 30 capsules/bottle, Bottle - 300 capsules/bottle
Approval status
Active

MFDS item code 202501046 · Approved 2025.04.30 · Insurance code 648508420

Summary

Main use
Control of LDL cholesterol and improvement of dyslipidemia
Who takes it
Adults
Adult dose
The recommended dosage is 1 capsule once daily, taken immediately after a meal.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Control of LDL cholesterol and improvement of dyslipidemia

  • Coronary heart disease
  • abnormal LDL cholesterol levels
  • elevated triglyceride levels
  • reduced HDL cholesterol levels
  • mixed dyslipidemia.
View approved original text

This medication is used in adult patients at high risk of coronary heart disease, helping to effectively lower LDL cholesterol levels and reduce the risk of cardiovascular disease. It also applies to mixed dyslipidemia characterized by elevated triglycerides and low HDL cholesterol, thereby improving serum lipid balance. This enhances vascular health and contributes to a decreased likelihood of cardiovascular disease. Overall, this medication plays an important role in controlling dyslipidemia and improving patients' health.

How to take

Adult dose

The recommended dosage is 1 capsule once daily, taken immediately after a meal.

Precautions

This medication is used to lower serum lipid levels. Caution is advised as unusual symptoms may occur in muscles while taking this medication. Patients should notify their physician immediately if symptoms such as muscle pain, muscle weakness, or muscle cramps appear. Extra caution is warranted for those aged 65 and older, women, patients with renal impairment, hypothyroidism, or a history of muscle disease. Coadministration with other lipid-lowering agents or specific medications may increase the risk of muscle damage, so consult a physician. Patients with liver or kidney issues, gallbladder disease, or pancreatitis should not use this medication. It should also be avoided by pregnant or nursing women and children under 18. Regular liver function tests are required as this medication may affect liver function, and it should be discontinued immediately if symptoms of hepatitis appear. Blood tests may show increased levels indicating muscle damage, thus requiring periodic checks. This medication should be used with caution in patients with excessive alcohol consumption. Additionally, this drug may increase the risk of thrombosis; hence, caution is advised for those with a history of thromboembolism. It is advisable to take this medication with food and to use caution while driving or operating machinery, as dizziness may occur. There are no specific antidotes for overdose, and appropriate treatment should be provided based on symptoms. This medication has not been confirmed for safety in children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), severe allergic reactions, hepatic abnormalities (jaundice), pancreatitis, thromboembolism (pulmonary embolism, deep vein thrombosis), severe edema, rhabdomyolysis with or without renal failure, rhabdomyolysis, myopathy, interstitial lung disease, severe neurological symptoms (headaches, paralysis, etc., although severe symptoms have not been clearly reported).

Mild side effects

  • Nasopharyngitis
  • upper respiratory infection
  • dizziness
  • chronic gastritis
  • erosive gastritis
  • headache
  • fatigue
  • drowsiness
  • insomnia
  • muscle pain
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  • muscle cramps
  • weakness
  • abdominal pain
  • dyspepsia
  • thirst
  • constipation
  • nausea
  • itching
  • hair loss
  • increased blood pressure
  • palpitations
  • skin pain
  • burning sensation
  • joint pain
  • blurred vision
  • photophobia
  • hearing loss
  • malaise
  • loss of appetite
  • increased serum creatinine
  • increased BUN
  • increased hematuria
  • thrombocytopenia
  • increased plasma homocysteine levels.

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

Storage

Store this medication in a tightly sealed container to avoid exposure to air or moisture, and keep it at room temperature between 1 and 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

A hard capsule with an upper light green part and a white lower part, containing round white film-coated tablets and white spherical fine granules.

Package unit

Bottle - 30 capsules/bottle, Bottle - 300 capsules/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.