Medication info
Pitanuphen Capsule (Pitavastatin Calcium, Fenofibrate Granule)

Pitanuphen Capsule (Pitavastatin Calcium, Fenofibrate Granule)

Prescription medicationHard capsule경구
Ingredient · strength
Pitavastatin Calcium›2mg / 1 capsuleFenofibrate Granules›241.51mg
Manufacturer / importer
(주)바이넥스
Appearance
A hard capsule with an upper dark green and lower white color containing white round film-coated tablets and white spherical fine granules.
Packaging
30 capsules/box [10 capsules/PTP*3], 300 capsules/bottle
Approval status
Active

MFDS item code 202501756 · Approved 2025.07.11 · Insurance code 643105890

Summary

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

Ingredients

Manufacturer
(주)바이넥스

Efficacy & effects

Regulation of LDL cholesterol and improvement of dyslipidemia

  • Increased LDL cholesterol levels
  • increased triglyceride levels
  • decreased HDL cholesterol levels
  • mixed dyslipidemia
View approved original text

In adult patients at high risk for coronary heart disease (CHD), pitavastatin 2mg monotherapy effectively controls LDL cholesterol levels. However, this treatment may elevate triglyceride levels and is applicable to low HDL cholesterol levels in mixed dyslipidemia. In such cases, appropriate lipid management is critical, and pitavastatin helps reduce the risk of cardiovascular disease by lowering LDL cholesterol. Variations in triglyceride and HDL cholesterol levels may require additional management. Therefore, pitavastatin is used for the treatment of dyslipidemia.

How to take

Adult dose

As a recommended dosage, take 1 capsule once daily right after meals.

Precautions

This medication, as a lipid-lowering agent, may cause serious muscle issues when taken together with fibrate and statin medications, so caution is necessary. Symptoms such as muscle pain, weakness, muscle cramps should be reported to a doctor immediately, and tests should be conducted to check for muscle damage. Patients over 65 years old, women, those with poor kidney function, uncontrolled hypothyroidism, and those with a history of genetic muscle disorders should be particularly careful. This medication should not be used in individuals allergic to certain ingredients or those with liver disease, biliary disease, severe kidney impairment, pregnant women, or children under 18. Patients with compromised liver function or heavy alcohol consumption may have an increased risk of liver function deterioration and need regular liver function tests. If liver enzyme levels rise significantly in blood tests, discontinuation of this medication is necessary, and immediate treatment should be sought if symptoms of hepatitis appear. This medication can cause pancreatitis or gallstones, so if abdominal pain or dyspeptic symptoms persist, consult a doctor. Patients with poor kidney function may have an increased risk of kidney function deterioration and require regular kidney assessments and symptom monitoring. While taking this medication, regular testing of blood lipid levels should be performed to verify treatment efficacy, and if ineffective, discontinuation should be considered. If surgery is planned, this medication should be temporarily discontinued several days beforehand, and discontinuation may also be necessary in the case of major disease occurrence. The risk of muscle damage may increase if this medication is taken with other lipid-lowering agents, niacin, cyclosporine, so patients should consult their physician before combination therapy. It is best taken with food, especially right after meals. Pregnant women or those who may become pregnant and nursing mothers should not take this medication. Elderly patients do not require dosage adjustment; however, it should not be used in patients with severely impaired kidney function. In case of overdose, there is no specific antidote; symptomatic treatment and supportive care are necessary. This medication has not been proven safe and effective for children and should not be used by them. When storing, keep in a place out of reach of children and keep it in its original container to prevent misuse or quality degradation.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, severe allergic reactions, high fever with severe rash, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe skin adverse reactions, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, serious neurological symptoms, significantly reduced urine output, severe systemic edema along with elevated blood pressure, severe edema or urinary issues

Mild side effects

  • Nasopharyngitis
  • upper respiratory infection
  • abnormal liver function tests
  • gastroesophageal reflux disease
  • nausea
  • headache
  • dizziness
  • chronic gastritis
  • erosive gastritis
  • myalgia
Show 25 more
  • myositis
  • muscle cramps
  • weakness
  • elevated blood pressure
  • thirst
  • dyspepsia
  • abdominal pain
  • constipation
  • nausea
  • pruritus
  • urticaria
  • hair loss
  • thrombocytopenia
  • hematuria
  • palpitations
  • fatigue
  • skin pain
  • flushing
  • arthralgia
  • edema
  • blurred vision
  • photophobia
  • hearing loss
  • taste disturbances
  • colored urine

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve its efficacy.

Appearance and packaging

Appearance

A hard capsule with an upper dark green and lower white color containing white round film-coated tablets and white spherical fine granules.

Package unit

30 capsules/box [10 capsules/PTP*3], 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.