Medication info
Ezetimibe/Atorvastatin 10/40 Milligrams

Ezetimibe/Atorvastatin 10/40 Milligrams

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
명문제약(주)
Appearance
White or whitish oval film-coated tablets
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 202101558 · Approved 2021.02.18 · Insurance code 649807790

Summary

Main use
Improvement of lipids by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This drug is taken once daily without regard to meals. For primary hypercholesterolemia, it is administered in a dosage range of 10/10mg to 10/80mg per day; the initial recommended dose is 10/10mg or 10/20mg per day. For patients requiring a significant reduction in LDL cholesterol, the initial dose of 10/40mg per day is recommended. After starting treatment or adjusting dosage, lipid levels should be checked more than 2 weeks apart.

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

Improvement of lipids by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia

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

This drug is used as an adjunct to diet to lower high total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase levels of HDL cholesterol. It may also be administered to patients with homozygous familial hypercholesterolemia (HoFH) in combination with or as an alternative to other lipid-lowering therapies. This drug is used to manage the risk of atherosclerotic vascular disease due to hypercholesterolemia, and it is important to take it along with an appropriate diet. Before administration, it is essential to check the patient's other diseases or medication use, and if necessary, to conduct secondary cause treatments. This drug plays a crucial role in the treatment of dyslipidemia, helping to regulate blood lipid levels and maintain healthy vascular conditions.

Dosage and Administration

Adult dosage

This drug is taken once daily without regard to meals. For primary hypercholesterolemia, it is administered in a dosage range of 10/10mg to 10/80mg per day; the initial recommended dose is 10/10mg or 10/20mg per day. For patients requiring a significant reduction in LDL cholesterol, the initial dose of 10/40mg per day is recommended. After starting treatment or adjusting dosage, lipid levels should be checked more than 2 weeks apart.

Precautions

This drug is helpful in lowering blood cholesterol levels to reduce the risk of cardiovascular diseases. When taking this drug, serious muscle abnormalities may occur; thus, patients should inform their doctor immediately if they experience symptoms such as muscle pain, cramps, or weakness. In particular, if severe muscle pain is accompanied by fever, immediate medical attention is needed, and blood tests can be conducted to check for muscle damage. Since it may affect liver function, liver function tests should be conducted before starting this drug, and if any abnormal liver function symptoms occur during treatment, patients should consult healthcare professionals. Patients with severe liver disease or persistent unexplained elevations in liver enzyme levels should not take this drug. This drug should not be administered to patients with certain liver diseases, muscle diseases, pregnant women or women who may become pregnant, lactating women, and patients taking certain other medications. Patients who consume excessive alcohol or have a history of liver disease, patients with reduced kidney function, patients with hypothyroidism, elderly patients, etc., require caution when taking this drug. This drug may interact with various other medications, so if a patient is taking other medications, they must inform their healthcare providers, especially when combined with certain antibiotics, antiviral agents, antifungal agents, immunosuppressants, antihypertensives, hypoglycemic agents, or fibrate medications. Women of childbearing age should use appropriate contraceptive methods to avoid pregnancy during the use of this drug and should stop taking it immediately if pregnancy is confirmed. Symptoms like dizziness or headache may occur, so caution is needed when driving or operating machinery. In case of overdose, there is no specific antidote; therefore, appropriate treatment should be provided based on symptoms, and liver function and muscle damage should be monitored. The safety and efficacy of this drug in children have not been established, so it is not recommended for pediatric use. It is important to regularly check liver function and muscle status through doctor's appointments and blood tests during the course of this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in the oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue throughout the body, sudden and severe headache, lightning-like headache, seizures, confusion, visual disturbances, paralysis, urination difficulty

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • constipation
  • diarrhea
  • headache
  • fatigue
Show 28 more
  • joint pain
  • muscle weakness
  • bronchitis
  • sinusitis
  • flushing
  • hyperkalemia
  • pharyngitis
  • upper respiratory infection
  • limb pain
  • low back pain
  • weakness
  • malaise
  • chest pain
  • discomfort in the chest
  • swelling
  • generalized edema
  • tremor
  • depression
  • hives
  • rash
  • itching
  • hair loss
  • thrombocytopenia
  • hepatitis
  • cholestasis
  • blurred vision
  • tinnitus
  • hearing loss

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

Storage

This drug should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White or whitish oval film-coated tablets

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.