Medication info

Ezeta Tablet 10/20 mg

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Atorvastatin Calcium›21.7mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
한국유나이티드제약(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/box[(10 tablets/PTP*3)], 30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202100181 · Approved 2021.01.08 · Insurance code 644309600

This product's status changed to Approval withdrawn on 2025.08.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, mixed) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. The dosing range is from 10/10 mg to 10/40 mg once daily, with an initial recommended dose of either 10/10 mg or 10/20 mg. The dosage may be adjusted if more significant LDL cholesterol reduction is required. After starting treatment or adjusting the dose, blood lipid levels should be checked at intervals of more than 2 weeks to adjust the dosage accordingly.

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • dyslipidemia
  • elevated total cholesterol
  • LDL cholesterol
  • apolipoprotein B
  • triglycerides
  • non-HDL cholesterol
View approved original text

This medication is used to lower total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol levels, and to increase HDL cholesterol levels in patients with primary hypercholesterolemia, particularly heterozygous familial and non-familial, and mixed dyslipidemia. It should be taken in conjunction with a diet and is recommended as an adjunctive treatment when dietary management alone is insufficient. This medication may help reduce the risk of atherosclerotic vascular diseases caused by hypercholesterolemia, but there is no evidence that it is superior to atorvastatin. Secondary causes of dyslipidemia should be identified and treated if necessary before starting treatment. Additionally, total cholesterol, LDL, HDL, and triglyceride levels should be monitored regularly during treatment for appropriate management. This medication is safely and effectively used to improve cholesterol abnormalities.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. The dosing range is from 10/10 mg to 10/40 mg once daily, with an initial recommended dose of either 10/10 mg or 10/20 mg. The dosage may be adjusted if more significant LDL cholesterol reduction is required. After starting treatment or adjusting the dose, blood lipid levels should be checked at intervals of more than 2 weeks to adjust the dosage accordingly.

Precautions

This medication may cause serious muscle problems; therefore, if symptoms of muscle pain or weakness develop, the physician should be notified immediately. This medication should not be used in patients with certain liver diseases or poor liver function; liver function tests should be conducted before administration. Pregnant women, women who may become pregnant, and breastfeeding women should not take this medication. Patients who consume alcohol heavily or have a history of liver disease should exercise caution when taking this medication, and liver function should be checked regularly. This medication may interact with other drugs, so inform your doctor or pharmacist about any other medications you are currently taking. Caution is advised, particularly when taken in conjunction with certain antibiotics, antiviral drugs, or immunosuppressants due to an increased risk of muscle damage. During treatment with this medicine, if symptoms such as muscle pain, muscle cramps, fatigue, or fever occur, consult medical personnel immediately. Elderly patients or those with renal impairment also have a higher risk of muscle problems, requiring careful monitoring during treatment. Dizziness may occur while driving or operating machinery, so caution is recommended. The safety and efficacy of this medication have not been established in children, and it is not recommended for them. In cases of overdose, there is no specific antidote, so seek immediate medical attention for appropriate treatment, and liver function and muscle enzyme levels should be monitored regularly. Store this medication out of reach of children and do not transfer it 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, rash with high fever, blisters, skin sloughing, pain in mouth/eyes mucosa, breathlessness or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough + fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, lightning-like headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Fatigue
  • malaise
  • chest pain
  • peripheral edema
  • fever
  • nasopharyngitis
  • cough
  • pruritus
  • dizziness
  • headache
Show 28 more
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pharyngeal/laryngeal pain
  • epistaxis
  • insomnia
  • nightmares
  • paresthesia
  • sensory loss
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • muscle cramps
  • joint swelling
  • back pain
  • neck pain
  • muscle fatigue
  • thrombocytopenia
  • hepatitis
  • blurred vision

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius to safely preserve its efficacy.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/box[(10 tablets/PTP*3)], 30 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.