Medication info
Pitastin Duo Tablets (Pitavastatin Calcium, Fenofibrate)

Pitastin Duo Tablets (Pitavastatin Calcium, Fenofibrate)

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

MFDS item code 202502269 · Approved 2025.08.29 · Insurance code 656005880

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
알리코제약(주)

Efficacy & effects

LDL cholesterol control and improvement of dyslipidemia

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

Pitavastatin 2 mg monotherapy can effectively control LDL cholesterol levels in high-risk adult patients with coronary heart disease. However, this treatment has limitations in lowering triglyceride levels and has a limited effect on increasing HDL cholesterol levels. Therefore, this medication is suitable for therapy focusing particularly on LDL cholesterol control in mixed dyslipidemia. It helps improve overall lipid levels, thereby reducing cardiovascular risk. Additional treatments may be necessary depending on the patient's condition, so regular check-ups and consultations are recommended. This medication is used in the treatment of mixed dyslipidemia.

How to take

Adult dose

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

Precautions

This medication carries a risk of muscle problems, so if symptoms such as muscle pain or weakness occur before taking it, you must inform your healthcare provider. Special caution is necessary for the elderly over 65 years, women, individuals with poor kidney function, those with uncontrolled hypothyroidism, and those with a history of muscle disorders or alcoholism. The risk of muscle toxicity may increase when taking this medication with other lipid-lowering agents or certain medications, so consult with your healthcare provider before combination therapy. Individuals with impaired liver function or liver disease should undergo liver function tests prior to taking this medication and continue to have regular liver function tests during use. If severe liver impairments or hepatitis symptoms occur, discontinue use immediately. Patients with moderate to severe kidney impairment should not take this medication, and those with mild kidney impairment should carefully monitor kidney function during use. This medication should not be administered to individuals with pancreatitis or gallbladder disease, and in cases where gallstones are suspected, confirmation through testing should be performed before deciding to take it. Pregnant or potentially pregnant women and breastfeeding women should not use this medication. It has not been confirmed safe or effective for use in children. During treatment with this medication, blood lipid levels should be monitored regularly, and if no effect is observed within 3 months, discontinuation should be considered. If surgery is planned or significant clinical events occur, consider temporary discontinuation. Symptoms such as fatigue, dizziness, headache, dyspepsia, and muscle pain may occur, and if these symptoms are severe or persist, consult with your healthcare provider. It is recommended to take this medication with food, as particularly fenofibrate is better absorbed when taken with food. Caution is needed as dizziness can occur while driving or operating machinery. Inform your healthcare provider if you are taking other medications during treatment, as there may be potential interactions. There are no specific antidotes for overdose, so appropriate treatment should be received according to symptoms, and keep out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe allergic reactions, severe skin adverse reactions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), thrombosis (pulmonary embolism, deep vein thrombosis), pancreatitis, jaundice, liver abnormalities, rhabdomyolysis, myopathy, muscle cramps, proximal muscle weakness, immune-mediated necrotizing myopathy, acute renal failure, worsening renal function, interstitial lung disease, sudden and severe headache, paralysis, altered consciousness

Mild side effects

  • Nasopharyngitis
  • upper respiratory tract infections
  • dizziness
  • hypertension
  • chronic gastritis
  • erosive gastritis
  • headache
  • fatigue
  • stiffness
  • drowsiness
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  • insomnia
  • heaviness in the head
  • numbness
  • thrombocytopenia
  • anemia
  • thirst
  • dyspepsia
  • abdominal pain
  • abdominal bloating
  • constipation
  • stomatitis
  • vomiting
  • loss of appetite
  • glossitis
  • nausea
  • gastric discomfort
  • diarrhea
  • decreased aldosterone
  • increased aldosterone
  • increased adrenocorticotropic hormone
  • increased cortisol
  • decreased testosterone
  • alopecia
  • photosensitivity

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature. Proper storage will help safely maintain the medication's effectiveness.

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

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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.