Medication info
Ezetimibe/Atorvastatin 10/10 mg

Ezetimibe/Atorvastatin 10/10 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
명문제약(주)
Appearance
White or off-white oval film-coated tablet
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 202101560 · Approved 2021.02.18 · Insurance code 649807810

Summary

Main use
Reduction of cholesterol in primary hypercholesterolemia (homozygous familial) and dyslipidemia, suppression of cardiovascular disease risk through cholesterol reduction and HDL increase
Who uses it
Adults
Adult dosage
This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/80mg daily, with an initial recommended dose of 10/10mg or 10/20mg daily. For patients requiring significant LDL-cholesterol reduction, an initial dose of 10/40mg daily is recommended. After starting treatment or adjusting the dosage, lipid levels in the blood should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

Reduction of cholesterol in primary hypercholesterolemia (homozygous familial) and dyslipidemia, suppression of cardiovascular disease risk through cholesterol reduction and HDL increase

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medication is used as an adjunct to dietary therapy to lower total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels and to increase HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It may also be administered as an adjunct or alternative treatment for patients with homozygous familial hypercholesterolemia. It should be used alongside an appropriate diet, and other causes of dyslipidemia should be identified and treated if necessary. This medication aids in reducing cardiovascular disease risk and is used to improve health through overall lipid management.

Dosage and Administration

Adult dosage

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

Precautions

This medication can cause rare side effects that may harm muscles, so if severe muscle pain or weakness occurs, you should inform your doctor immediately. Special caution is needed before use in patients with severe infections, low blood pressure, recent major surgery or trauma, hypothyroidism, and kidney dysfunction. Patients who are allergic to the ingredients of this medication or have liver disease should not use it. Women who are pregnant or may become pregnant, and those who are breastfeeding should also avoid this medication. Patients with alcoholism, poor liver function, or the elderly should use this medication with great caution. Additionally, when taken with certain other medications, the risk of muscle damage may increase, so a doctor should be consulted. If any liver dysfunction is found, this medication should be discontinued or the dosage adjusted, and if symptoms of hepatitis (nausea, vomiting, fatigue, etc.) occur, medical attention should be sought immediately. It is advisable to undergo regular liver function tests and muscle-related tests while taking this medication. This medication has not been shown to be safe or effective in children and is not recommended for use in this population. Caution is advised while driving or operating machinery, as dizziness may occur. In case of overdose, there is no specific antidote, so treatment should be based on symptoms while monitoring liver function and muscle condition.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), severe systemic fatigue, sudden severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues

Mild side effects

  • Muscle pain
  • abdominal pain
  • headache
  • dizziness
  • nausea
  • diarrhea
  • joint pain
  • bronchitis
  • sinusitis
  • flushing
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  • fatigue
  • lethargy
  • chest pain
  • chest discomfort
  • asthenia
  • fever
  • hyperkalemia
  • vomiting
  • dyspepsia
  • belching
  • pancreatitis
  • pharyngitis/laryngitis
  • nosebleed
  • insomnia
  • nightmares
  • sensory loss
  • taste abnormalities
  • memory loss
  • urticaria
  • skin rash
  • itching
  • hair loss
  • thrombocytopenia
  • hepatitis
  • blurry vision
  • tinnitus
  • erectile dysfunction
  • urinary tract infection

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture and should be kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

White or off-white oval film-coated tablet

Package unit

30 tablets/box [10 tablets/Alu-Alu 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.