Medication info
Genewon Ezetimibe Tablet 10 mg (Ezetimibe)

Genewon Ezetimibe Tablet 10 mg (Ezetimibe)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
White to almost white oblong tablets
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201701194 · Approved 2017.03.09 · Insurance code 671705220

Summary

Main use
Reduction of cholesterol and lipid levels in patients with hypercholesterolemia and sitosterolemia to mitigate the risk of vascular diseases.
Who uses it
Adults
Adult dosage
The recommended dosage for this medication is 10 mg once daily and may be taken regardless of meals. When administered in combination with HMG-CoA reductase inhibitors, start this medication at the recommended initial dosage for the HMG-CoA reductase inhibitor, and if the patient is already on a high dose of the HMG-CoA reductase inhibitor, continue the current dosage while adding this medication.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Reduction of cholesterol and lipid levels in patients with hypercholesterolemia and sitosterolemia to mitigate the risk of vascular diseases.

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

This medication helps lower elevated total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B levels in patients with primary hypercholesterolemia, and is used to reduce total cholesterol and non-high-density lipoprotein cholesterol in patients with mixed dyslipidemia. It can also be used as an adjunctive treatment in patients with homozygous familial hypercholesterolemia, in combination with statins. Additionally, it is effective in reducing sitosterol and campesterol levels as a dietary adjunct in patients with homozygous sitosterolemia. It is essential to monitor dietary management and evaluate risk factors during treatment and to identify and address secondary causes. This medication is used alongside dietary management in dyslipidemia treatment and effectively reduces cardiovascular disease risk by improving blood lipid levels.

Dosage and Administration

Adult dosage

The recommended dosage for this medication is 10 mg once daily and may be taken regardless of meals. When administered in combination with HMG-CoA reductase inhibitors, start this medication at the recommended initial dosage for the HMG-CoA reductase inhibitor, and if the patient is already on a high dose of the HMG-CoA reductase inhibitor, continue the current dosage while adding this medication.

Precautions

This medication should not be used in patients who are allergic to certain components. Patients with liver diseases or persistently elevated liver enzyme levels should not take this medication in combination with certain lipid-lowering agents. Pregnant or breastfeeding women should avoid concomitant use of this medication with specific lipid-lowering agents, hence caution is required. Patients with moderate to severe liver dysfunction may experience increased exposure to this medication, resulting in unexpected side effects; therefore, it is not recommended. This medication contains lactose and should not be administered to patients with lactose intolerance or related genetic conditions. Patients experiencing muscle pain, muscle weakness, or unexplained fatigue during treatment should immediately inform healthcare professionals, and in severe cases, discontinuation may be necessary. Periodic liver function tests may be required to monitor liver function. Caution is warranted when this medication is used in combination with other lipid-lowering agents due to the increased risk of liver enzyme elevation and muscle-related side effects. Patients with severe renal impairment should also be cautious during administration, and dosage adjustments may be necessary. In children, it is not recommended for those under six years old, and should only be used from six years of age if safety and efficacy have been confirmed. Elderly patients are generally safe but should be observed closely as some may be more sensitive to the medication. During treatment with this medication, there is potential for drug interactions; patients must inform their healthcare professional of any other medications currently in use. In the case of overdose, there is no specific antidote and symptomatic treatment will be provided. This medication should be stored out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), anaphylaxis, hypersensitivity reactions including rash and angioedema, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia with systemic symptoms drug reaction (DRESS), severe skin reactions including polymorphic erythema (SCARs), drug-induced liver injury, renal failure (kidney disease), liver dysfunction, rhabdomyolysis, myopathy, amino transferases elevation

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infections
  • pharyngitis
  • sinusitis
  • arthralgia
  • low back pain
  • cough
  • dizziness
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  • constipation
  • flatulence
  • nausea
  • AST elevation
  • ALT elevation
  • myalgia
  • headache
  • malaise
  • nausea
  • chest pain
  • discomfort in the chest
  • edema
  • weakness
  • generalized edema
  • diabetic neuropathy
  • tremor
  • epigastric pain
  • vomiting
  • gastritis
  • dry mouth
  • discomfort in the epigastric area
  • belching
  • gastrointestinal disorders
  • gastroesophageal reflux disease
  • tongue disorder
  • palpitations

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. The safest and most effective storage temperature is between 1°C and 30°C.

Appearance and packaging

Appearance

White to almost white oblong tablets

Package unit

30 tablets (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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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.