Medication info

Ezetimibe Tablet (Ezetimibe)

Prescription medicationTabletExpired
Ingredient · strength
Ezetimibe›10mg / 1 tablet
Manufacturer / importer
영풍제약(주)
Appearance
White to nearly white rectangular tablets
Packaging
30 tablets (10 tablets/PTP×3)
Approval status
Expired

MFDS item code 201902772 · Approved 2019.04.30

This product's status changed to Expired on 2024.04.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of cholesterol in hypercholesterolemia and sitosterolemia and inhibition of atherosclerosis risk
Who uses it
Adults
Adult dosage
The recommended dosage of this medication is 10 mg once daily, administered without regard to meals. When used in combination with HMG-CoA reductase inhibitors, treatment should begin at the recommended starting dose of HMG-CoA reductase inhibitors in conjunction with this medication, and if the patient is already receiving a high dose of HMG-CoA reductase inhibitors, this medication should be used concurrently while maintaining the dosage of HMG-CoA reductase inhibitors.

Ingredients

Manufacturer
영풍제약(주)

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia and sitosterolemia and inhibition of atherosclerosis risk

  • Primary hypercholesterolemia
  • hyperlipidemia
  • homozygous familial hypercholesterolemia
  • homozygous familial sitosterolemia
  • dyslipidemia
View approved original text

This medication is used for the treatment of primary hypercholesterolemia, mixed hyperlipidemia, homozygous familial hypercholesterolemia, and homozygous sitosterolemia. It is administered as an adjunct to dietary therapy aimed at lowering total cholesterol and low-density lipoprotein cholesterol levels, either alone or in combination with other lipid-lowering agents. It is particularly used in patients with an increased risk of atherosclerotic vascular disease due to hypercholesterolemia alongside appropriate dietary modifications, and it is important to identify and treat secondary causes. For patients with complex lipid abnormalities, regular testing of multiple lipid levels is conducted to monitor treatment effectiveness. This medication aids in effective cholesterol management and treatment of dyslipidemia.

Dosage and Administration

Adult dosage

The recommended dosage of this medication is 10 mg once daily, administered without regard to meals. When used in combination with HMG-CoA reductase inhibitors, treatment should begin at the recommended starting dose of HMG-CoA reductase inhibitors in conjunction with this medication, and if the patient is already receiving a high dose of HMG-CoA reductase inhibitors, this medication should be used concurrently while maintaining the dosage of HMG-CoA reductase inhibitors.

Precautions

This medication should not be used in patients with allergies to specific components. Patients with severely impaired liver function or persistently elevated liver enzyme levels without a known cause should not take this medication in conjunction with other drugs that may affect liver function. The use of this medication is prohibited in pregnant or breastfeeding women in conjunction with certain lipid-lowering agents, and women of childbearing age should consult a physician before use. Patients with lactose intolerance or specific genetic metabolic disorders should not take this medication. Patients with moderate to severe liver impairment should use caution as the effects of this medication may be exaggerated. Clinical trial results indicate that this medication can generally be used safely; however, side effects such as headache, abdominal pain, diarrhea, and fatigue may occur. When this medication is combined with other lipid-lowering agents, regular liver function testing is necessary due to the possibility of elevated liver enzyme levels. If symptoms such as myalgia or muscle weakness occur, patients should immediately inform their physician and discontinue medication if necessary. Patients with severely impaired kidney function can take this medication, but dosage adjustments or special care may be needed in some cases. This medication can interact with other drugs, so it is important to consult a physician when taking it with anticoagulants, immunosuppressants, or lipid-lowering agents. Use during pregnancy may pose a risk to the fetus, so pregnant women should use it cautiously under a doctor's guidance. Breastfeeding women should avoid this medication as it may be excreted in breast milk. It is not recommended for children under 6 years old, and children or adolescents over 6 years old should be administered under a doctor's guidance. It can also be safely used in elderly patients, although some elderly individuals may be more sensitive to the medication, thus caution is advised. In case of overdose, there is no specific antidote; treatment based on symptoms is important. This medication should be stored out of reach of children, and it is safer not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylaxis, angioedema, rash, erythema multiforme, hepatitis, thrombocytopenia, pancreatitis, cholelithiasis, cholecystitis, gallbladder-related adverse reactions, liver dysfunction, kidney failure (nephropathy), myopathy, rhabdomyolysis, persistent elevation of aminotransferase levels, increase in creatine phosphokinase levels, severe liver enzyme abnormalities, serious liver abnormalities, severe muscle abnormalities, severe edema or urinary abnormalities

Mild side effects

  • Headache
  • abdominal pain
  • diarrhea
  • fatigue
  • constipation
  • flatulence
  • nausea
  • myalgia
  • dizziness
  • sensory disturbance
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  • depression
  • vomiting
  • upper abdominal pain
  • gastroesophageal reflux disease
  • dry mouth
  • discomfort in the epigastric region
  • belching
  • gastrointestinal disturbances
  • tongue disorders
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • cough
  • sputum
  • runny nose
  • limb pain
  • arthralgia
  • diabetes mellitus
  • hypoglycemia
  • anemia
  • splenomegaly
  • sweating
  • rash
  • pruritus
  • upper respiratory tract infection
  • cold

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a sealed container. It is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius. This helps maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

White to nearly white rectangular tablets

Package unit

30 tablets (10 tablets/PTP×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.