Medication info
Ilsung Ezetimibe Atorvastatin Calcium 10/20mg Tablet

Ilsung Ezetimibe Atorvastatin Calcium 10/20mg Tablet

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
일성아이에스(주)
Appearance
White or off-white oblong film-coated tablet
Packaging
Alu-Alu - 30 tablets/box [(10 tablets/Alu-Alu*3)]
Approval status
Active

MFDS item code 202101656 · Approved 2021.02.18 · Insurance code 655404180

Summary

Main use
Improvement of lipids through the reduction of cholesterol in cases of hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and increase in HDL.
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/10mg or 10/20mg once daily is recommended. Patients requiring a larger reduction in LDL cholesterol (more than 55%) may be initiated on 10/40mg once daily. Blood lipid levels should be monitored for adjustment of dosage after a minimum interval of 2 weeks from the initiation of therapy or dose adjustment.

Ingredients

Manufacturer
일성아이에스(주)

Efficacy & effects

Improvement of lipids through the reduction of cholesterol in cases of hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and increase in HDL.

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

This medication helps lower blood cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and increases levels of HDL cholesterol, often referred to as 'good' cholesterol. It may also be used alongside or as an alternative to other treatments in patients with homozygous familial hypercholesterolemia. This medication is used in conjunction with dietary therapy, and lifestyle changes such as limiting saturated fat and cholesterol intake are essential. It is important to identify and treat any secondary causes such as diabetes or hypothyroidism before use. This medication is utilized to reduce the risk of atherosclerotic vascular disease by controlling blood lipid levels.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/10mg or 10/20mg once daily is recommended. Patients requiring a larger reduction in LDL cholesterol (more than 55%) may be initiated on 10/40mg once daily. Blood lipid levels should be monitored for adjustment of dosage after a minimum interval of 2 weeks from the initiation of therapy or dose adjustment.

Precautions

This medication may cause serious muscle problems, so any symptoms such as muscle pain or weakness should be reported to a doctor immediately. Especially in cases of severe muscle pain, there is a risk of kidney function issues, and treatment should be stopped and a doctor consulted in such cases. Individuals with allergies to any ingredients in this medication, severely impaired liver function, muscle diseases, pregnant or potentially pregnant women, and nursing mothers should not use this medication. Additionally, special caution is required for patients with certain liver diseases or alcohol dependence, the elderly, and those with impaired kidney function when taking this medication. It can affect liver function, so regular liver function tests should be conducted before and during use, and any symptoms indicating liver dysfunction must be reported to a doctor immediately. This medication may increase blood sugar levels, so patients at risk for diabetes should manage their blood sugar closely. The risk of side effects may increase due to drug interactions when taken with other medications, so current medications should be disclosed to a doctor or pharmacist. Women of childbearing potential should use appropriate contraception to avoid pregnancy while taking this medication and should discontinue use immediately if pregnancy is confirmed. Dizziness or fatigue may occur, so caution is advised during driving or operating machinery. In the case of overdose, there is no specific antidote, and treatment should be symptomatic while monitoring liver function and muscle status. This medication is not recommended for children as its safety and efficacy have not been established in this population. Medications should be stored out of reach of children and preferably in their original containers.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • dizziness
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
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  • headache
  • constipation
  • indigestion
  • vomiting
  • belching
  • pancreatitis
  • oropharyngeal discomfort
  • nosebleed
  • insomnia
  • nightmares
  • paresthesia
  • sensory loss
  • taste disturbance
  • memory loss
  • arthralgia
  • muscle weakness
  • musculoskeletal pain
  • muscle cramps
  • joint swelling
  • back pain
  • neck pain
  • muscle fatigue
  • thrombocytopenia
  • allergic reactions
  • hepatitis
  • blurred vision

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White or off-white oblong film-coated tablet

Package unit

Alu-Alu - 30 tablets/box [(10 tablets/Alu-Alu*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.