Medication info
Ilseong Ezetimibe Tablets 10/40 mg

Ilseong Ezetimibe Tablets 10/40 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
일성아이에스(주)
Appearance
White, biconvex, rectangular film-coated tablet
Packaging
30 tablets (10 tablets/PTP × 3)
Approval status
Active

MFDS item code 202101657 · Approved 2021.02.18

Summary

Main use
Improvement of lipids through cholesterol reduction and HDL increase in hypercholesterolemia (primary, homozygous familial) and dyslipidemia.
Who uses it
Adults
Adult dosage
This medication is to be administered once daily, regardless of meals. For primary hypercholesterolemia, dosages range from 10/10 mg to 10/80 mg per day. The recommended initial dose is 10/10 mg or 10/20 mg once daily. For patients requiring significant LDL cholesterol reduction, the initial dose of 10/40 mg once daily is recommended. After administration, lipid levels should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
일성아이에스(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • dyslipidemia
  • homozygous familial hypercholesterolemia
  • increased risk of atherosclerotic vascular disease caused by hypercholesterolemia.
View approved original text

This medication helps lower elevated total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia, and increases good cholesterol, HDL cholesterol. Furthermore, it is used as an adjunctive treatment for homozygous familial hypercholesterolemia patients in combination with other lipid-lowering therapies or when other treatments are ineffective. This medication is used alongside appropriate dietary management in patients at high risk for cardiovascular disease and is recommended when dietary adjustments alone are insufficient. Before treatment, screen for secondary causes such as diabetes and hypothyroidism, and regularly monitor the patient's lipid levels. In cases of acute coronary events, lipid tests should be quickly performed upon admission, and the results should inform the treatment plan. This medication effectively regulates cholesterol and lipid levels, contributing to improved cardiovascular health.

Dosage and Administration

Adult dosage

This medication is to be administered once daily, regardless of meals. For primary hypercholesterolemia, dosages range from 10/10 mg to 10/80 mg per day. The recommended initial dose is 10/10 mg or 10/20 mg once daily. For patients requiring significant LDL cholesterol reduction, the initial dose of 10/40 mg once daily is recommended. After administration, lipid levels should be checked at intervals of more than 2 weeks.

Precautions

This medication is used to lower blood cholesterol levels. Before taking it, be aware of the risk of serious muscle-related side effects, such as myopathy and rhabdomyolysis, and report any symptoms of muscle pain or weakness to your doctor immediately. Additionally, this medication is contraindicated in patients with liver dysfunction, and liver enzyme levels must be regularly checked to monitor liver health. Patients with a history of alcohol addiction or liver disease should exercise particular caution. This medication can increase blood concentration when taken with certain drugs, raising the risk of side effects; therefore, consult with healthcare professionals if you are taking other medications. Pregnant women, women who may become pregnant, and breastfeeding women should not take this medication, and women of childbearing age should use appropriate contraception while on this medication. Caution is also necessary when prescribing this medication to elderly patients or those with impaired kidney function, while safety and effectiveness in pediatric patients have not been established, and it is therefore not recommended. In the case of overdose, there is no specific antidote, and appropriate treatment and supportive care are required based on symptoms; monitoring of liver function and muscle enzyme levels is necessary. During treatment with this medication, symptoms such as dizziness, muscle pain, or abdominal pain may occur, so caution is necessary when driving or operating machinery. Finally, this medication should be kept out of reach of children and should not be transferred to other 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 with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory difficulties accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urine.

Mild side effects

  • Muscle pain
  • abdominal pain
  • dizziness
  • headache
  • nausea
  • diarrhea
  • malaise
  • fatigue
  • cough
  • joint pain
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  • muscle weakness
  • musculoskeletal pain
  • muscle cramps
  • throat pain
  • vomiting
  • dyspepsia
  • constipation
  • pharyngitis
  • sinusitis
  • upper respiratory tract infection
  • itching
  • rash
  • hair loss
  • sweating
  • thrombocytopenia
  • anemia
  • tinnitus
  • blurred vision
  • tinnitus
  • dry mouth
  • abnormal liver function tests
  • increased blood pressure
  • elevated creatine kinase levels
  • increased blood urea.

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 and moisture, ideally at a temperature between 1°C and 30°C. Proper storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

White, biconvex, rectangular film-coated tablet

Package unit

30 tablets (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.