Medication info
AtoEze 10/40 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

AtoEze 10/40 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
White to pale white, bi-convex, rectangular film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202101596 · Approved 2021.02.18 · Insurance code 646005240

Summary

Main use
Improvement of cholesterol levels by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia.
Who uses it
Adults
Adult dosage
This medication is administered once daily without regard to meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg once daily, with 10/10 mg or 10/20 mg as the recommended initial dose. For patients needing a greater reduction in LDL-cholesterol (55% or more), an initial dose of 10/40 mg once daily is recommended. After starting administration or adjusting the dose, the lipid levels should be checked every 2 weeks.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Improvement of cholesterol levels by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia.

  • Hypercholesterolemia
  • dyslipidemia
  • homozygous familial hypercholesterolemia
  • elevated total cholesterol
  • LDL-cholesterol
  • Apo B protein
  • triglycerides
  • increased non-HDL-cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia.
View approved original text

This medication is used to reduce total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase HDL-cholesterol, the good cholesterol. It is especially used for patients with homozygous familial hypercholesterolemia in combination with other therapies or alone to control cholesterol levels. This medication should be used in conjunction with an appropriate diet for lipid control, and is utilized as an adjunct therapy when dietary measures alone are insufficient. Additionally, it is important to identify and treat any secondary causes of illness such as diabetes and hypothyroidism before taking this medication. Blood lipid levels should be regularly monitored during treatment, and lipid testing is recommended upon admission for patients with acute coronary events. Overall, this medication is effectively used in the treatment of dyslipidemia to help reduce the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

This medication is administered once daily without regard to meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg once daily, with 10/10 mg or 10/20 mg as the recommended initial dose. For patients needing a greater reduction in LDL-cholesterol (55% or more), an initial dose of 10/40 mg once daily is recommended. After starting administration or adjusting the dose, the lipid levels should be checked every 2 weeks.

Precautions

This medication can cause severe adverse reactions to muscles, so it should be temporarily discontinued or discontinued in patients particularly at high risk for acute myopathy or rhabdomyolysis. Patients with an allergy to any of the components of this medication, severely impaired liver function, muscle disease, pregnant or breastfeeding women, patients taking certain antiviral drugs, and those with genetic lactose intolerance should not use this medication. Patients with a history of alcohol abuse or liver disease, severe liver dysfunction, kidney dysfunction or hypothyroidism, and elderly patients who are at higher risk for muscle damage should use this medication with caution. This medication may have side effects such as muscle pain, abdominal pain, elevated liver enzymes, dizziness, cough, nausea, diarrhea, joint pain, muscle weakness, musculoskeletal pain, hyperkalemia, bronchitis, sinusitis, flushing, headache, fatigue, constipation, hyperglycemia, hypoglycemia, indigestion, belching, pancreatitis, pharyngeal and laryngeal pain, nosebleed, insomnia, nightmares, sensory disturbances, sensory loss, taste disturbances, memory loss, peripheral neuropathy, muscle cramps, joint swelling, back pain, neck pain, muscle fatigue. Liver function tests should be conducted before and during treatment to check for liver damage, and treatment should be stopped if liver function worsens. This medication should not be used during pregnancy or breastfeeding, and women of childbearing age should use appropriate contraception during treatment. It may interact with other medications, so especially if taking medications that affect liver metabolism or may increase muscle toxicity, patients should inform their doctor, and dosage adjustments may be necessary when used together. Caution is required when administering to children and elderly patients, particularly seniors due to the higher risk of myopathy. In case of overdose, there is no specific antidote, so treatment should be symptomatic and liver and muscle enzyme tests should be conducted for management. This medication should be kept out of reach of children, and caution should be taken not to transfer it to other containers as quality may deteriorate.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • headache
  • fatigue
  • constipation
  • hyperglycemia
  • hypoglycemia
  • indigestion
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • sensory disturbances
  • sensory loss
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • muscle cramps
  • joint swelling
  • back pain
  • neck pain
  • muscle fatigue.

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White to pale white, bi-convex, 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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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.