Medication info

Ezetimibe and Atorvastatin Tablets 10/40 Milligrams

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Atorvastatin Calcium Trihydrate›43.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)제뉴파마
Appearance
White to light white, biconvex film-coated rectangular tablets
Packaging
30 tablets/PTP (10 tablets/PTP x 3)
Approval status
Approval withdrawn

MFDS item code 202101589 · Approved 2021.02.18

This product's status changed to Approval withdrawn on 2025.08.25.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
Improvement of lipids by reduction of cholesterol and increase of HDL 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 10/10mg to 10/80mg daily. A starting dose of 10/10mg or 10/20mg daily is recommended. For patients requiring more significant reduction in LDL cholesterol (55% or more), a starting dose of 10/40mg daily is recommended. After starting treatment or adjusting the dosage, measurements of blood lipid levels should be taken at intervals of two weeks or more.

Ingredients

Manufacturer
(주)제뉴파마

Efficacy & effects

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

  • Primary hypercholesterolemia
  • elevated total cholesterol
  • LDL cholesterol
  • apo B protein
  • triglycerides
  • non-HDL cholesterol
  • homozygous familial hypercholesterolemia
View approved original text

This medication is used to reduce elevated total cholesterol, LDL cholesterol, apo B protein, triglycerides, and non-HDL cholesterol levels, and to increase HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It may be administered as an adjunct to other lipid-lowering therapies or when other treatments are ineffective in patients with homozygous familial hypercholesterolemia. This medication should be used in conjunction with an appropriate diet, and it is important to treat any secondary causes, such as diabetes and hypothyroidism, before administering this medication. Additionally, in the case of patients with acute coronary events, measurements of blood lipid levels may provide useful information when starting treatment. This medication is very helpful in treating hypercholesterolemia and dyslipidemia, improving vascular health.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/80mg daily. A starting dose of 10/10mg or 10/20mg daily is recommended. For patients requiring more significant reduction in LDL cholesterol (55% or more), a starting dose of 10/40mg daily is recommended. After starting treatment or adjusting the dosage, measurements of blood lipid levels should be taken at intervals of two weeks or more.

Precautions

This medication is used to lower blood cholesterol levels and carries a risk of muscle abnormalities. If severe muscle pain or muscle weakness occurs, a physician should be consulted immediately. There is a risk of kidney impairment due to muscle damage, so caution is needed in patients with kidney disease or risk factors. Those allergic to ingredients in this medication, individuals with severe liver dysfunction, or those with muscle diseases should not take this medication. Women who are pregnant, may become pregnant, or are breastfeeding should also not use it. Since liver function abnormalities may occur, regular liver function tests should be conducted before and during treatment. There may be interactions with other medications, especially those that affect liver metabolism, so caution is needed when used together. Individuals who consume excessive alcohol or have a history of liver disease should use this medication with care. Elderly patients also have a higher risk of muscle abnormalities and should be cautious when taking it. Dizziness may occur when driving or operating machinery, so caution is advised. In case of overdose, there is no specific antidote, thus treatment according to symptoms and testing for liver function and muscle enzymes are necessary. This medication is not recommended for children as its safety and efficacy have not been established. Any unusual symptoms or discomfort during usage should be reported immediately to healthcare professionals for consultation.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination changes

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
  • chest pain
  • lethargy
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • belching
  • pancreatitis
  • throat/laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • paresthesia
  • decreased sensation
  • dysgeusia
  • memory loss

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air and moisture. It is advisable to keep the storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White to light white, biconvex film-coated rectangular tablets

Package unit

30 tablets/PTP (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.