Medication info
Atorbanduo Tablet 10/40 mg

Atorbanduo Tablet 10/40 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Hydrate›43.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
동국제약(주)
Appearance
White oval film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202100225 · Approved 2021.01.08 · Insurance code 653404770

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed) and dyslipidemia
Who uses it
Adults
Adult dosage
This drug is taken once daily, regardless of meals. The dose range is between 10/10 mg to 10/40 mg per day. An initial dose of 10/10 mg or 10/20 mg per day is recommended. For patients requiring a greater reduction in LDL-cholesterol, the dose may be adjusted. After initiating treatment or adjusting the dose, lipid levels should be checked at intervals of at least 2 weeks, and dosing should be adjusted accordingly.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed) and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • increased LDL-cholesterol
  • increased Apo B protein
  • increased triglycerides
  • increased non-HDL-cholesterol
View approved original text

This drug is used to lower total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase the level of HDL-cholesterol, the good cholesterol. It is administered as an adjunct to dietary therapy to help manage dyslipidemia. It is particularly suitable for patients at risk of atherosclerotic vascular disease, and all other causes or risk factors must be checked before treatment. This drug is used to improve cardiovascular health through safe and effective lipid control.

Dosage and Administration

Adult dosage

This drug is taken once daily, regardless of meals. The dose range is between 10/10 mg to 10/40 mg per day. An initial dose of 10/10 mg or 10/20 mg per day is recommended. For patients requiring a greater reduction in LDL-cholesterol, the dose may be adjusted. After initiating treatment or adjusting the dose, lipid levels should be checked at intervals of at least 2 weeks, and dosing should be adjusted accordingly.

Precautions

This drug may cause a rare side effect known as rhabdomyolysis, which can lead to serious muscle problems. This poses a risk of acute kidney failure, so if severe muscle pain or muscle weakness occurs, it is important to consult a doctor immediately. This drug should not be used by individuals who are allergic to the active substance or other components, those with severely impaired liver function, patients with muscle diseases, pregnant or nursing women, individuals taking certain antiviral medications, or those with lactose intolerance. Particular caution should be taken when this drug is used by individuals with a history of alcoholism or liver disease, decreased kidney function, hypothyroidism, elderly patients, and those at high risk for myopathy, following their doctor's instructions carefully. Regular liver function tests are required during the use of this drug, and if symptoms of liver dysfunction (e.g. nausea, vomiting, fatigue) occur, medical advice should be sought immediately. This drug may interact with other medications, so dose adjustment or discontinuation may be necessary when taken with potent CYP3A4 inhibitors, cyclosporine, certain antibiotics, antiviral drugs, and fibrate class medications. Women of childbearing potential should practice adequate contraception while taking this drug, and should discontinue use immediately if pregnancy is confirmed. Symptoms such as dizziness or muscle pain may occur, and caution should be exercised when driving or operating machinery. In the case of overdose, there is no specific antidote, so appropriate treatment and supportive care should be provided according to the symptoms, and liver function and muscle-related tests should be conducted. The safety and efficacy of this drug have not been established in children, so its use is not recommended. Finally, this drug should be stored out of reach of children, and it is advisable not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme fatigue throughout the body, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues

Mild side effects

  • Dizziness
  • paresthesia
  • itching
  • urticaria
  • rash
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • nasopharyngitis
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  • cough
  • hypertension
  • diabetes
  • nausea
  • diarrhea
  • abdominal pain
  • headache
  • myalgia
  • arthralgia
  • muscle cramps
  • muscle fatigue
  • thrombocytopenia
  • hepatitis
  • cholestasis
  • blurred vision
  • tinnitus
  • hair loss
  • thrombocytopenia
  • anemia
  • erectile dysfunction
  • urinary tract infection
  • dysuria
  • hypoglycemia
  • weight gain
  • loss of appetite
  • malaise
  • edema
  • chest pain
  • angina

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

Storage

This drug should be stored in a tightly closed container to protect it from air and moisture, and it is recommended to be kept at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the drug's effectiveness and safety.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP x 3], 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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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.