Medication info

Dutor Tablet 10/40 mg

Prescription medicationTabletExpired
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
White, oval, film-coated tablets that are convex on both sides
Packaging
30 tablets/PTP [(10 tablets/PTP x 3)]
Approval status
Expired

MFDS item code 202101416 · Approved 2021.02.18

This product's status changed to Expired on 2026.02.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and improvement in lipids by increasing HDL.
Who uses it
Adults
Adult dosage
This medication is administered once daily without regard to meals. The dosage range is from 10/10 mg to 10/80 mg per day. An initial dose of 10/10 mg or 10/20 mg per day is recommended. For patients requiring greater reductions in LDL cholesterol, an initial dose of 10/40 mg per day is recommended. After starting treatment or adjusting the dose, check blood lipid levels at intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and improvement in lipids by increasing HDL.

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

This medication helps lower levels of total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol levels. It is also used as an adjunctive therapy when existing treatments are not effective for patients with homozygous familial hypercholesterolemia. This drug should be administered alongside an appropriate diet and should be used after treating other causes of dyslipidemia. It contributes to controlling blood lipid levels and reducing the risk of atherosclerotic vascular diseases. It should be used cautiously, considering individual risk factors. This medication is effective for treating hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily without regard to meals. The dosage range is from 10/10 mg to 10/80 mg per day. An initial dose of 10/10 mg or 10/20 mg per day is recommended. For patients requiring greater reductions in LDL cholesterol, an initial dose of 10/40 mg per day is recommended. After starting treatment or adjusting the dose, check blood lipid levels at intervals of more than 2 weeks.

Precautions

This medication can cause a rare side effect called rhabdomyolysis that may affect muscles, which increases the risk of kidney damage. Therefore, if severe muscle pain or weakness occurs, consult a doctor immediately. This drug should not be used in patients who are allergic to the active ingredient or excipients, or in those with liver disease or muscle disorders. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not take this medication. Patients taking medications such as glecaprevir or pibrentasvir should also avoid this drug. Caution is advised for those with alcohol dependence, impaired liver function, weak kidney function, or hypothyroidism. Additionally, special attention is needed for elderly patients over 70 years old or those with a family history of muscle disorders. Patients taking fibrate medications alongside this drug may have an increased risk of muscle adverse reactions, so care should be taken. This drug can affect liver function, so it is essential to have liver function tests before and during treatment. If liver function worsens or jaundice symptoms appear, treatment should be stopped immediately. Blood sugar levels may rise during treatment, so diabetic patients should carefully manage their blood sugar. Caution is also required when driving or operating machinery due to possible dizziness. This drug can interact with various medications, so inform your doctor or pharmacist if you are taking other drugs. Women of childbearing age should use appropriate contraception while taking this medication, and it should be avoided if planning for pregnancy or during pregnancy. Safety for use in children has not been established and is not recommended. In case of overdose, there is no specific antidote, so symptomatic treatment and supportive therapy are required, and liver function and muscle status should be monitored.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Muscle pain
  • abdominal pain
  • increased liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • arthralgia
  • muscle weakness
  • back pain
Show 26 more
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • malaise
  • headache
  • constipation
  • vomiting
  • pharyngitis
  • sinusitis
  • upper respiratory infection
  • urticaria
  • rash
  • itching
  • hair loss
  • thrombocytopenia
  • hepatitis
  • cholestasis
  • blurred vision
  • visual impairment
  • tinnitus
  • hearing loss
  • skin tumors
  • ingrown toenails
  • vitamin D deficiency.

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

Storage

This drug can be sensitive to air and moisture, so it should be stored in a tightly closed container. Avoid extremely hot or cold places, and it is best to keep it at room temperature between 1 degree to 30 degrees Celsius.

Appearance and packaging

Appearance

White, oval, film-coated tablets that are convex on both sides

Package unit

30 tablets/PTP [(10 tablets/PTP x 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.