Medication info

Ezevastatin Tablets 10/10 Milligrams

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)제뉴파마
Appearance
A white to light white, double convex film-coated tablet in rectangular shape
Packaging
30 tablets/Blister pack (10 tablets/PTP x 3)
Approval status
Approval withdrawn

MFDS item code 202101591 · Approved 2021.02.18 · Insurance code 698004420

This product's status changed to Approval withdrawn on 2025.08.25.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
Lipid improvement through cholesterol reduction and HDL increase in hypercholesterolemia (primary, homozygous familial) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg once daily. An initial dose of 10/10 mg or 10/20 mg once daily is recommended. For patients requiring a significant reduction in LDL cholesterol (greater than 55%), an initial dose of 10/40 mg once daily is recommended. After initiation of therapy or adjustment of the dose, lipid levels should be checked at intervals of at least 2 weeks, and dosage should be adjusted accordingly.

Ingredients

Manufacturer
(주)제뉴파마

Efficacy & effects

Lipid improvement through cholesterol reduction and HDL increase in hypercholesterolemia (primary, homozygous familial) and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
View approved original text

This medication is used as an adjunct to diet to lower total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels, and to raise HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. In particular, it can be used alone or in conjunction with other lipid-lowering therapies to manage cholesterol levels in homozygous familial hypercholesterolemia patients. This medication should be administered when dietary and non-drug therapies are insufficient, and it is essential to identify and treat secondary causes such as diabetes and hypothyroidism before starting therapy. Additionally, for patients with acute coronary event, lipid tests should be performed at the time of hospitalization to inform treatment planning. This medication helps to reduce the risk of atherosclerotic vascular diseases associated with dyslipidemia and effectively manages cholesterol levels.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg once daily. An initial dose of 10/10 mg or 10/20 mg once daily is recommended. For patients requiring a significant reduction in LDL cholesterol (greater than 55%), an initial dose of 10/40 mg once daily is recommended. After initiation of therapy or adjustment of the dose, lipid levels should be checked at intervals of at least 2 weeks, and dosage should be adjusted accordingly.

Precautions

This medication is primarily used to lower cholesterol, and muscle-related side effects may occur, so if severe muscle pain or weakness arises, it should be reported to a doctor immediately. Rhabdomyolysis, a serious muscle damage condition, has rarely been reported, and it may lead to renal function issues, so caution is required for patients with risk factors. Patients allergic to this medication or with severe liver dysfunction, those with muscle diseases, pregnant or breastfeeding women, and those on certain antiviral medications should not use it. Patients with liver dysfunction or heavy alcohol consumption, elderly patients, and those with compromised renal function should use this medication cautiously and require regular monitoring. Additionally, when taken with other medications, the risk of side effects due to interactions may increase, so any current medications should be discussed with healthcare providers. Women who are pregnant or may become pregnant should avoid using this medication and ensure proper contraception during treatment. Symptoms such as dizziness or muscle pain may occur, so caution is advised when driving or operating machinery. There is no specific antidote for overdose, so treatment should be symptomatic, monitoring liver function and muscle status. Safety in children has not been established and is therefore not recommended. Store the 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, paleness, severe allergic reactions, high fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, respiratory problems, yellowing of skin or eyes (jaundice), severe lethargy, liver abnormalities (jaundice), sudden

Mild side effects

  • Dizziness
  • cough
  • abdominal pain
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • hyperkalemia
  • bronchitis
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  • sinusitis
  • flushing
  • increased ALT
  • increased AST
  • fatigue
  • malaise
  • fever
  • weakness
  • chest pain
  • peripheral edema
  • constipation
  • abdominal distension
  • dyspepsia
  • belching
  • pancreatitis
  • throat and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • paresthesia
  • sensory loss
  • dysgeusia
  • amnesia
  • peripheral neuropathy
  • thrombocytopenia

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly closed container. It is advisable to maintain storage temperatures between 1 and 30 degrees Celsius to preserve the medication's effectiveness for a longer time.

Appearance and packaging

Appearance

A white to light white, double convex film-coated tablet in rectangular shape

Package unit

30 tablets/Blister pack (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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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.