Medication info

Ezevi Tablet (Ezetimibe)

Prescription medicationTabletExpired
Ingredient · strength
Ezetimibe›10mg / 1 tablet
Manufacturer / importer
(유)한풍제약
Appearance
White to almost white rectangular tablets
Packaging
30 tablets/PTP [(10 tablets/PTPX3)]
Approval status
Expired

MFDS item code 201905472 · Approved 2019.08.01

This product's status changed to Expired on 2024.08.01. 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 primary hypercholesterolemia (familial) and sitosterolemia, thereby suppressing the risk of cardiovascular disease.
Who uses it
Adults
Adult dosage
The recommended dosage of this medication is 10 mg once daily and can be taken without regard to meals. When administered in combination with HMG-CoA reductase inhibitors, the combination should start at the recommended initial dose of the HMG-CoA reductase inhibitor, and if already receiving high doses of HMG-CoA reductase inhibitors, this medication should be added while maintaining the dose of the HMG-CoA reductase inhibitor. Phenofibrate.

Ingredients

Manufacturer
(유)한풍제약

Efficacy & effects

Reduction of cholesterol and lipid levels in primary hypercholesterolemia (familial) and sitosterolemia, thereby suppressing the risk of cardiovascular disease.

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

This medication is used for various dyslipidemias including primary hypercholesterolemia, homozygous familial hypercholesterolemia, and homozygous sitosterolemia. It helps lower high cholesterol, LDL cholesterol, and apolipoprotein B levels in patients and can be administered as a dietary adjunct alone or in combination with other lipid-lowering agents. Additionally, it plays an important role in improving lipid control and cholesterol levels in patients with an increased risk of atherosclerotic vascular disease. It is necessary to identify and treat other secondary causes prior to administration, and regular lipid tests should be conducted to monitor therapeutic effects. This medication is effectively used in comprehensive management of dyslipidemia, improving blood lipid levels.

Dosage and Administration

Adult dosage

The recommended dosage of this medication is 10 mg once daily and can be taken without regard to meals. When administered in combination with HMG-CoA reductase inhibitors, the combination should start at the recommended initial dose of the HMG-CoA reductase inhibitor, and if already receiving high doses of HMG-CoA reductase inhibitors, this medication should be added while maintaining the dose of the HMG-CoA reductase inhibitor. Phenofibrate.

Precautions

This medication should not be used in patients who are allergic to its components. Avoid combining this medication with certain cholesterol-lowering agents in patients with severely impaired liver function or unexplained elevations in liver enzyme levels. The use of this medication in pregnant or breastfeeding women is prohibited; therefore, women who may become pregnant need to exercise caution. Patients with severe liver dysfunction may experience increased exposure to this medication, leading to unexpected side effects; thus, its use is not recommended. While this medication is generally safe, side effects such as headache, abdominal pain, and diarrhea may occur, and rarely, muscle pain or elevated liver enzyme levels have been reported. When used in combination with other cholesterol-lowering agents, liver function and muscle status should be regularly monitored, and any symptoms of muscle pain or weakness should be reported to a physician immediately. Patients with severe kidney disease should also exercise caution when using this medication, particularly when combined with other drugs, following the physician's instructions. This medication is recommended for use in children aged 6 years and older, and it can also be safely used in the elderly, although individual sensitivity may vary. Women who are pregnant or breastfeeding should carefully consider the potential risks and benefits of using this medication, and it is advisable to avoid use during breastfeeding if possible. In case of overdose, as there are no specific antidotes, it is important to receive appropriate treatment based on symptoms. This medication should be kept out of reach of children, and transferring it to another container should be avoided.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • anaphylaxis
  • angioedema
  • erythema multiforme
  • rash
  • hepatitis
  • thrombocytopenia
  • pancreatitis
  • renal failure
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  • liver dysfunction
  • myopathy
  • rhabdomyolysis
  • hives
  • systemic edema.

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infection
  • pharyngitis
  • sinusitis
  • joint pain
  • low back pain
  • cough
  • chest pain
Show 21 more
  • dizziness
  • constipation
  • bloating
  • nausea
  • AST elevation
  • ALT elevation
  • myalgia
  • vomiting
  • gastritis
  • dry mouth
  • discomfort in the epigastrium
  • belching
  • gastrointestinal disorder
  • gastroesophageal reflux disease
  • tongue disease
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • sputum
  • runny nose.

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 tightly closed container. It is advisable to maintain the storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White to almost white rectangular tablets

Package unit

30 tablets/PTP [(10 tablets/PTPX3)]

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.