Medication info
DuoPito Tablets 10/40 mg

DuoPito Tablets 10/40 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›43.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
건일제약(주)
Appearance
White to off-white, bilaterally convex oval film-coated tablet
Packaging
30 tablets/PTP [10 tablets/PTP × 3]
Approval status
Active

MFDS item code 202101418 · Approved 2021.02.18

Summary

Main use
Reduction of cholesterol in primary hypercholesterolemia (homozygous familial) and dyslipidemia, and reduction of cardiovascular disease risk through increased HDL.
Who uses it
Adults
Adult dosage
This medication is administered once daily, irrespective of meals. For primary hypercholesterolemia, dose range is 10/10 mg to 10/80 mg per day, and the recommended starting doses are 10/10 mg or 10/20 mg per day. For patients requiring a greater reduction in LDL cholesterol (above 55%), the recommended starting dose is 10/40 mg per day. After starting the treatment or adjusting the dose, check blood lipid levels after an interval of more than two weeks.

Ingredients

Manufacturer
건일제약(주)

Efficacy & effects

Reduction of cholesterol in primary hypercholesterolemia (homozygous familial) and dyslipidemia, and reduction of cardiovascular disease risk through increased HDL.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • atherosclerotic vascular diseases due to hypercholesterolemia.
View approved original text

This medication is used as an adjunct to diet for patients with primary hypercholesterolemia and mixed dyslipidemia, effectively lowering elevated levels of total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol, while increasing levels of HDL cholesterol (good cholesterol). Additionally, it is administered as an adjunct treatment for patients with homozygous familial hypercholesterolemia when other treatments are not effective, and it is used in combination to reduce cardiovascular disease risk. This medication is to be used alongside appropriate dietary measures, and it is crucial to confirm and treat other dyslipidemias or secondary causes. This helps regulate blood lipid levels and reduce the risk of atherosclerotic vascular diseases. Therefore, this medication may be used for the treatment of dyslipidemia and the prevention of complications.

Dosage and Administration

Adult dosage

This medication is administered once daily, irrespective of meals. For primary hypercholesterolemia, dose range is 10/10 mg to 10/80 mg per day, and the recommended starting doses are 10/10 mg or 10/20 mg per day. For patients requiring a greater reduction in LDL cholesterol (above 55%), the recommended starting dose is 10/40 mg per day. After starting the treatment or adjusting the dose, check blood lipid levels after an interval of more than two weeks.

Precautions

This medication may cause a rare side effect, rhabdomyolysis, which can affect the muscles; therefore, if symptoms like muscle pain or weakness occur, you must consult a doctor immediately. In particular, if there are risk factors such as acute infections, hypotension, major surgery or trauma, severe metabolic abnormalities, or seizures, it may be necessary to temporarily stop or discontinue the use of this medication. Patients allergic to any components of this medication or those with active liver disease, unexplained elevation of liver enzymes, muscle disorders, pregnant or breastfeeding women, and patients taking certain antiviral agents should not take this medication. Caution is also required for those with a history of alcohol abuse or liver disease or severe liver dysfunction, those with poor kidney function, hypothyroidism, or a history of genetic muscle diseases. Additionally, elderly patients aged 70 and older or those who are using it in combination with certain medications should exercise caution. This medication may affect liver function, so liver function tests should be performed prior to treatment initiation, and if there are signs of liver damage during treatment, tests should be repeated. Women who are pregnant or may become pregnant should not take this medication, and women of childbearing age should use appropriate contraception while taking it. Breastfeeding women are also advised to avoid taking this medication. Symptoms such as dizziness or muscle pain may occur, so caution should be exercised when driving or operating machinery. While taking this medication, there is a possibility of drug interactions, so if you are taking other medications, you must inform your doctor or pharmacist. In case of overdose, specific antidotes are not available; thus, treatment should be symptomatic, including appropriate supportive care, and liver function and muscle-related tests should be monitored continuously.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • hyperkalemia
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  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • headache
  • diarrhea
  • constipation
  • indigestion
  • vomiting
  • belching
  • throat/laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • sensory disturbances
  • numbness
  • taste disturbances
  • amnesia
  • peripheral neuropathy
  • muscle cramps
  • muscle fatigue
  • myositis
  • tendon disorders
  • thrombocytopenia
  • allergic reactions

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is recommended to keep it in a cool place below 30 degrees Celsius. This helps maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

White to off-white, bilaterally convex oval film-coated tablet

Package unit

30 tablets/PTP [10 tablets/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.