Medication info
Pitaef Tablets (Pitavastatin Calcium, Fenofibrate)

Pitaef Tablets (Pitavastatin Calcium, Fenofibrate)

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

MFDS item code 202502270 · Approved 2025.08.29 · Insurance code 647304750

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 a meal.

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Regulation of LDL cholesterol and improvement of dyslipidemia

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

Pitavastatin 2mg monotherapy effectively regulates LDL cholesterol levels in adults at high risk of coronary heart disease. However, this treatment alone may not completely improve combined dyslipidemia characterized by high triglyceride levels and low HDL cholesterol levels. Additional therapies may be required to improve triglycerides and HDL cholesterol along with the regulation of LDL cholesterol in these patients. Pitavastatin helps reduce LDL cholesterol levels and thereby lowers the risk of cardiovascular diseases. This medication is primarily used for the treatment of dyslipidemia and contributes to improving cardiovascular health.

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. When taking this medication, caution is needed as muscle-related symptoms such as muscle pain, muscle weakness, and cramping may occur. Particularly, elderly individuals, women, those with poor renal function, individuals with uncontrolled hypothyroidism, and those with a history of muscle disorders should be more cautious. If any abnormal muscle symptoms develop, immediately consult a doctor and perform blood tests to check for muscle damage. This medication may affect liver function, so individuals with liver diseases or elevated liver enzyme levels should have regular liver function tests, and if symptoms of hepatitis appear, the medication should be discontinued immediately. This medication should not be used in patients with moderate to severe renal impairment, and caution is required in mild renal impairment patients. Regular monitoring of serum creatinine levels should be conducted to monitor changes in kidney function. This medication should not be administered to patients with pancreatitis or gallbladder diseases, and if gallstones are suspected, tests should be performed to confirm before considering use. Additionally, this medication may increase the risk of muscle toxicity when taken with other lipid-lowering agents, especially fibrates, statins, and niacin, therefore it should be used with extreme caution when combined. Pregnant women or those who may become pregnant, as well as nursing mothers, should not take this medication, and it is not to be administered to children or adolescents under 18 years of age. Symptoms such as dizziness or headache may occur during treatment, so care should be taken when driving or operating machinery. Prior to taking this medication, a sufficient diet and exercise regimen should be practiced, and if the treatment is ineffective, the medication should be discontinued. In case of overdose, there is no specific antidote available, so symptomatic treatment should be provided, and it should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, angioedema, pancreatitis, jaundice, liver abnormalities (jaundice), sudden and very severe headache, paralysis, rhabdomyolysis, pulmonary embolism, deep vein thrombosis, thromboembolism, interstitial lung disease, DRESS syndrome, severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), rhabdomyolysis with or without acute renal failure, severe cases

Mild side effects

  • Pharyngitis
  • upper respiratory infection
  • increased ALT
  • increased AST
  • increased GGT
  • abnormal liver function tests
  • gastroesophageal reflux disease
  • nausea
  • headache
  • dizziness
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  • increased CPK
  • hypertension
  • chronic gastritis
  • erosive gastritis
  • dry mouth
  • dyspepsia
  • abdominal pain
  • diarrhea
  • constipation
  • stomatitis
  • loss of appetite
  • glossitis
  • nausea
  • gastric discomfort
  • alopecia
  • headache
  • fatigue
  • dizziness
  • stiffness
  • drowsiness
  • insomnia
  • heaviness
  • paralysis
  • increased blood pressure
  • chest discomfort
  • weakness

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

White, oblong, 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

No questions yet.

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.