Medication info
Newstatin Duo Capsule

Newstatin Duo Capsule

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

MFDS item code 201902024 · Approved 2019.04.03 · Insurance code 647804860

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 immediately after a meal.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Regulation of LDL cholesterol and improvement of dyslipidemia

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

This drug helps to adequately control LDL cholesterol levels in adult patients at high risk of coronary artery disease. However, triglyceride levels may remain high, and it is effectively used for low HDL cholesterol types of mixed dyslipidemia. In other words, this drug assists in crucial lipid management for reducing cardiovascular disease risk and is used for the improvement of dyslipidemia.

How to take

Adult dose

As a recommended dosage, take 1 capsule once daily immediately after a meal.

Precautions

This drug lowers lipids, and there may be abnormalities in the muscles, so symptoms such as muscle pain, weakness, or cramps should be immediately reported to a doctor. Especially, individuals over 65, those with poor kidney function, those with hypothyroidism, and those who consume alcohol heavily should check their muscle condition before taking this drug. The risk of muscle damage may increase when taking this drug in combination with other lipid-lowering agents, so caution is needed when co-administering. Those allergic to this drug or with serious problems in the liver, gallbladder, or kidneys, women who are pregnant or may become pregnant, and children under 18 should not take this drug. Individuals with poor liver function, diabetes, the elderly, those with blood coagulation issues or hypothyroidism should use this drug cautiously and require regular testing. If symptoms of liver dysfunction or pancreatitis occur, the medication should be stopped immediately and the doctor consulted. This drug's liver and kidney functions should be checked regularly, especially during the first 3 months. It is advisable to take it with food, and it is safer to avoid alcohol. Caution is needed while driving or operating machinery as dizziness may occur. Pregnant or breastfeeding women should not take this drug, nor should it be given to children. There is no specific antidote for overdose, so appropriate treatment should be received based on symptoms. This drug should be stored out of reach of children, and it is safest to keep it in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, high fever with severe rash, blisters, peeling skin, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, breathing difficulties accompanied by cough+fever, respiratory issues, yellowing of skin or eyes (jaundice), severe generalized malaise, liver abnormalities (jaundice), sudden

Mild side effects

  • Nasopharyngitis
  • upper respiratory tract infection
  • gastroesophageal reflux disease
  • nausea
  • headache
  • dizziness
  • chronic gastritis
  • erosive gastritis
  • abdominal pain
  • dyspepsia
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  • thirst
  • constipation
  • vomiting
  • skin hypersensitivity
  • rash
  • itching
  • alopecia
  • weakness
  • palpitations
  • fatigue
  • skin pain
  • burning sensation
  • joint pain
  • swelling
  • blurred vision
  • photophobia
  • hearing loss
  • hematuria
  • elevated uric acid
  • elevated serum potassium and phosphorus
  • dysgeusia
  • discolored urine
  • malaise
  • positivity of antinuclear antibodies

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

Storage

This drug may be sensitive to air or moisture, so it must be stored in a tightly sealed container. The storage temperature should be kept at room temperature between 1 to 30 degrees. This helps to maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

A hard capsule with a green upper part and a white lower part containing white round film-coated tablets and white spherical microgranules.

Package unit

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

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.