Medication info
Ezetimibe Tablet (Ezetimibe)

Ezetimibe Tablet (Ezetimibe)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
White to almost white oblong tablets
Packaging
30 tablets/box [(10 tablets/PTP*3)]
Approval status
Active

MFDS item code 201902916 · Approved 2019.05.08 · Insurance code 694004000

Summary

Main use
Reduction of cholesterol and lipid levels in primary hypercholesterolemia (familial) and sitosterolemia to alleviate the risk of cardiovascular diseases
Who uses it
Adults
Adult dosage
The recommended dose of this drug is 10 mg once daily, administered without regard to meals. When taken in combination with HMG-CoA reductase inhibitors, start administration of this drug at the recommended initial dose of the HMG-CoA reductase inhibitor, and if already receiving a high dose of the HMG-CoA reductase inhibitor, continue maintaining the dose of the HMG-CoA reductase inhibitor while taking this drug. Fenofibrate should be considered as part of the management.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Reduction of cholesterol and lipid levels in primary hypercholesterolemia (familial) and sitosterolemia to alleviate the risk of cardiovascular diseases

  • Primary hypercholesterolemia
  • elevated total cholesterol
  • low-density lipoprotein cholesterol
  • apolipoprotein B
  • mixed hyperlipidemia
  • non-high-density lipoprotein cholesterol
  • homozygous familial hypercholesterolemia
  • homozygous familial sitosterolemia
  • elevated sitosterol
  • campesterol
View approved original text

This drug is primarily used as a dietary supplement to lower cholesterol levels in patients with primary hypercholesterolemia and mixed hyperlipidemia. It is particularly effective in reducing total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B). For patients with homozygous familial hypercholesterolemia, it may be used in conjunction with other lipid-lowering treatments or as an adjunct therapy, and it also helps reduce elevated sitosterol levels in patients with homozygous sitosterolemia. It should be used alongside an appropriate diet, and secondary causes of dyslipidemia should be ruled out and treated if necessary before administration. It is essential to monitor the patient's lipid levels regularly during treatment. Consequently, it is used to improve hypercholesterolemia and related lipid disorders.

Dosage and Administration

Adult dosage

The recommended dose of this drug is 10 mg once daily, administered without regard to meals. When taken in combination with HMG-CoA reductase inhibitors, start administration of this drug at the recommended initial dose of the HMG-CoA reductase inhibitor, and if already receiving a high dose of the HMG-CoA reductase inhibitor, continue maintaining the dose of the HMG-CoA reductase inhibitor while taking this drug. Fenofibrate should be considered as part of the management.

Precautions

This drug should not be used in patients who are allergic to specific components. Patients with active liver disease or persistently elevated liver enzyme levels should not take this drug along with specific lipid-lowering agents. Caution is required for pregnant or nursing women, as the use of this drug with certain lipid-lowering agents is prohibited. Patients with moderate to severe liver impairment should avoid using this drug and should undergo regular liver function tests. If symptoms such as myalgia or muscle weakness occur, the physician should be informed immediately, and care must be taken for muscle-related adverse reactions. Patients with impaired kidney function should also be cautious when taking this drug, and dosage adjustment or monitoring may be necessary. Drug interactions may occur when combined with other medications, especially anticoagulants, immunosuppressants, and lipid-lowering agents. The use of this drug in special populations such as children, the elderly, pregnant women, and nursing mothers should be restricted or carefully considered. In the case of overdose, there is no specific treatment, so immediate consultation with medical personnel is crucial, and general supportive therapy is essential. This drug should be stored out of reach of children, and changing containers should be avoided.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), mucous membrane syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), hypersensitivity reactions including rash and angioedema, severe allergic reactions, severe rash with high fever, blisters, exfoliative skin reactions, severe skin reactions including oral/ocular mucosal pain, drug reaction with eosinophilia and systemic symptoms (DRESS), severe skin abnormalities including erythema multiforme

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infection
  • pharyngitis
  • sinusitis
  • arthralgia
  • low back pain
  • cough
  • dizziness
Show 24 more
  • constipation
  • bloating
  • nausea
  • elevated AST
  • elevated ALT
  • myalgia
  • vomiting
  • gastritis
  • dry mouth
  • discomfort in the epigastrium
  • belching
  • gastrointestinal disorders
  • gastroesophageal reflux disease
  • tongue disorders
  • headache
  • chest pain
  • chest discomfort
  • edema
  • weakness
  • generalized edema
  • diabetic neuropathy
  • tremors
  • palpitations
  • congestive heart failure

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

Storage

Store this drug in a tightly closed container to protect it from exposure to air and moisture. Additionally, the medication should be kept at room temperature between 1°C and 30°C, avoiding very hot or very cold environments.

Appearance and packaging

Appearance

White to almost white oblong tablets

Package unit

30 tablets/box [(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

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.