Medication info

Ezevastatin Tablet 10/20 Milligrams

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)제뉴파마
Appearance
White to pale white, biconvex rectangular film-coated tablet
Packaging
30 tablets/box (10 tablets/PTP x 3)
Approval status
Approval withdrawn

MFDS item code 202101590 · Approved 2021.02.18 · Insurance code 698004410

This product's status changed to Approval withdrawn on 2025.08.25. 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 dyslipidemia, and prevention of cardiovascular disease risk by increasing HDL
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, a daily dose within the range of 10/10mg to 10/80mg is recommended, with an initial dose of either 10/10mg or 10/20mg. For patients requiring a significant reduction in LDL cholesterol, an initial dose of 10/40mg is recommended. After starting treatment or adjusting the dose, blood lipids should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)제뉴파마

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and prevention of cardiovascular disease risk by increasing HDL

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

This drug helps lower cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing the level of good cholesterol, HDL. It is particularly used for patients with familial and non-familial hypercholesterolemia and is administered as an adjunct to diet for managing blood lipid levels. It is also used as adjunctive therapy in patients with homozygous familial hypercholesterolemia when other treatments are ineffective. When treating dyslipidemia, it must be used alongside an appropriate diet, and it is important to check for and treat secondary causes. In addition, for patients with acute cardiovascular incidents, lipid levels should be checked upon admission and before discharge to inform treatment planning. This drug is used to improve hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, a daily dose within the range of 10/10mg to 10/80mg is recommended, with an initial dose of either 10/10mg or 10/20mg. For patients requiring a significant reduction in LDL cholesterol, an initial dose of 10/40mg is recommended. After starting treatment or adjusting the dose, blood lipids should be checked at intervals of more than 2 weeks.

Precautions

This drug can affect muscles, so if severe muscle pain or weakness occurs, consult a doctor immediately. Caution is especially needed in cases of severe infection, hypotension, major surgery or trauma, or metabolic disorders, as the risk of muscle damage is increased. Patients with allergies to any components of this drug or those with active liver disease should not use it. Women who are pregnant or nursing should not take this drug, nor should those with muscle disorders. Patients with alcohol addiction or liver dysfunction, as well as those with reduced kidney function or hypothyroidism, should use this drug cautiously. Elderly patients can also have a higher risk of muscle-related symptoms, so caution is advised. During treatment with this drug, liver function tests and muscle-related tests should be performed regularly, and any abnormal symptoms should be reported to healthcare personnel immediately. This drug has many interactions with other medications, so it is essential to inform your doctor or pharmacist about other medications being taken. Dose adjustments or monitoring may be necessary when used with drugs that interfere with liver metabolism or those that can cause muscle toxicity. Women of childbearing age should use appropriate contraception while taking this drug, and if pregnancy is confirmed, the drug should be stopped immediately. Nursing mothers should avoid this drug. It is not recommended for children or pediatric patients as its safety and efficacy have not been established. In case of overdose, there is no specific antidote, so treatment should be based on symptoms, with close monitoring of liver function and muscle status. This drug should be stored 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 oral or eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination difficulties.

Mild side effects

  • Muscle pain
  • abdominal pain
  • increased liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • increased ALT
  • increased AST
  • fatigue
  • nausea
  • diarrhea
  • pharyngitis
  • sinusitis
  • upper respiratory infection
  • back pain
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • throat and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • and others.

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

Storage

This drug should be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to maintain room temperature between 1°C and 30°C. This way, the drug's effectiveness and safety can be preserved.

Appearance and packaging

Appearance

White to pale white, biconvex rectangular film-coated tablet

Package unit

30 tablets/box (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.