Medication info

Mega Ezetimibe Tablet 10 mg (Ezetimibe)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Ezetimibe›10mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
White to off-white oblong tablet
Packaging
10 tablets/box [10 tablets/PTP X 1], 30 tablets/box [10 tablets/PTP X 3], 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202000591 · Approved 2020.02.04

This product's status changed to Approval withdrawn on 2024.07.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of cholesterol and lipid levels in hypercholesterolemia (primary, familial) and sitosterolemia to suppress the risk of cardiovascular disease
Who uses it
Adults
Adult dosage
The recommended dose of this drug is 10 mg once a day, administered regardless of meals. When used in combination with HMG-CoA reductase inhibitors, administration should begin at the recommended starting dose of the HMG-CoA reductase inhibitor along with this drug; when already receiving a high dose of HMG-CoA reductase inhibitors, it should be used in conjunction with maintenance of the HMG-CoA reductase inhibitor dose.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Reduction of cholesterol and lipid levels in hypercholesterolemia (primary, familial) and sitosterolemia to suppress the risk of cardiovascular disease

  • Primary hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • homozygous familial sitosterolemia
  • dyslipidemia
  • hypercholesterolemia
  • increased risk of atherosclerotic vascular disease
View approved original text

This drug is used to reduce elevated total cholesterol and LDL cholesterol in patients with primary hypercholesterolemia and mixed hyperlipidemia. Particularly, it is administered alone or in conjunction with other lipid-lowering agents to enhance effect alongside diet. In patients with homozygous familial hypercholesterolemia, it is used as an adjunct to other therapies, sometimes alone or in combination with statins. It is also utilized to lower plant sterols (sitosterol, campesterol) in patients with homozygous sitosterolemia. Before administering this medication, it is important to assess and treat other underlying conditions and evaluate treatment effectiveness through lipid tests. This drug management helps in reducing the risk of cardiovascular disease and improving lipid status.

Dosage and Administration

Adult dosage

The recommended dose of this drug is 10 mg once a day, administered regardless of meals. When used in combination with HMG-CoA reductase inhibitors, administration should begin at the recommended starting dose of the HMG-CoA reductase inhibitor along with this drug; when already receiving a high dose of HMG-CoA reductase inhibitors, it should be used in conjunction with maintenance of the HMG-CoA reductase inhibitor dose.

Precautions

This drug should not be used in patients with hypersensitivity to specific components. Patients with active liver disease or persistently elevated liver enzymes in blood tests should avoid combination therapy with this drug and other specific lipid-lowering agents. The use of this drug and specific lipid-lowering agents is prohibited in pregnant or nursing women, so women of childbearing potential should take caution. The use of this drug is not recommended in patients with moderate to severe liver dysfunction. Although this drug is generally safe, side effects such as headache, abdominal pain, diarrhea, fatigue, and muscle pain may occur; therefore, medical consultation should be sought in case of abnormal symptoms. If symptoms such as muscle pain or weakness occur, medical personnel should be informed immediately, and discontinuation of therapy may be necessary. Patients with severe kidney impairment should also take caution, and renal function should be regularly monitored during administration. This drug may interact with other medications, so it is essential to inform the doctor or pharmacist of any ongoing medications. Pregnant or nursing mothers should carefully consider the potential risks and benefits of using this drug. It is recommended for use in children aged 6 years and older, and it is best not to use it in children under 6 years. Elderly patients can use it safely, but some elderly individuals may be more sensitive to the drug, requiring caution. No specific treatment is available for overdose, but appropriate treatment should be provided based on symptoms. This drug should be kept out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, rash, hepatitis, pancreatitis, thrombocytopenia, cholelithiasis, cholecystitis, renal failure, liver dysfunction, persistent elevation of liver enzymes (more than three times the normal upper limit), myopathy, rhabdomyolysis, severe allergic reactions, severe skin adverse reactions, respiratory problems, liver abnormalities (jaundice), severe neurological symptoms, severe edema or urination abnormalities

Mild side effects

  • Headache
  • abdominal pain
  • diarrhea
  • fatigue
  • constipation
  • nausea
  • muscle pain
  • joint pain
  • back pain
  • dizziness
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  • sensory disturbances
  • vomiting
  • gastritis
  • discomfort in the epigastric region
  • belching
  • gastrointestinal disturbances
  • gastroesophageal reflux disease
  • tongue disease
  • chest discomfort
  • weakness
  • generalized edema
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • sputum
  • runny nose
  • limb pain
  • diabetes
  • hypoglycemia
  • anemia
  • splenomegaly
  • sweating
  • pruritus
  • upper respiratory tract infection
  • conjunctival congestion
  • blood

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

Storage

This drug is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, to maintain the drug's effectiveness, it is best to store it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White to off-white oblong tablet

Package unit

10 tablets/box [10 tablets/PTP X 1], 30 tablets/box [10 tablets/PTP X 3], 100 tablets/bottle

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.