Medication info
Ezetimibe Tablets (Ezetimibe)

Ezetimibe Tablets (Ezetimibe)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tablet
Manufacturer / importer
(주)보령바이오파마
Appearance
White to off-white oblong tablet
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201903632 · Approved 2019.05.31 · Insurance code 670501680

Summary

Main use
Reduction of cholesterol and lipid levels in primary hypercholesterolemia (familial) and sitosterolemia to suppress cardiovascular disease risk
Who uses it
Adults
Adult dosage
The recommended dose of this medication is 10 mg once daily, administered regardless of meals. When used in combination with HMG-CoA reductase inhibitors, start at the recommended initial dose of the HMG-CoA reductase inhibitor and combine with this medication, maintaining the dose of the HMG-CoA reductase inhibitor if already taking a high dose.

Ingredients

Manufacturer
(주)보령바이오파마

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • homozygous sitosterolemia
  • plant sterolemia
  • dyslipidemia
View approved original text

This drug is used as an adjunct to diet for the reduction of elevated total cholesterol and low-density lipoprotein cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It may also be used in combination with other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia to enhance efficacy. In patients with homozygous sitosterolemia, it is used to reduce elevated sitosterol and campesterol levels. This medication should be administered in conjunction with an appropriate diet including restrictions on saturated fats and cholesterol, and it is useful when diet alone is insufficient. Prior to administration, the secondary causes of dyslipidemia must be identified and treated if necessary. Considering these aspects, this drug is used to improve hypercholesterolemia and related lipid abnormalities.

Dosage and Administration

Adult dosage

The recommended dose of this medication is 10 mg once daily, administered regardless of meals. When used in combination with HMG-CoA reductase inhibitors, start at the recommended initial dose of the HMG-CoA reductase inhibitor and combine with this medication, maintaining the dose of the HMG-CoA reductase inhibitor if already taking a high dose.

Precautions

This medication should not be used in patients allergic to any of its components. Patients with active liver disease or persistently elevated liver enzyme levels should not take this drug in combination with certain lipid-lowering agents. Pregnant or nursing women should be cautious as concurrent use with some lipid-lowering agents is contraindicated. It is not recommended for patients with moderate to severe liver dysfunction, and regular liver function tests should be performed. If symptoms such as myalgia or muscle weakness occur, contact a doctor immediately and discontinue use if necessary. Patients with impaired renal function can use this drug, but caution is advised in cases of severe kidney impairment. When taking this drug with other lipid-lowering agents or anticoagulants, follow a doctor's instructions due to potential drug interactions. In cases of pregnancy or breastfeeding, the potential risks and benefits of this drug should be carefully evaluated before use. This medication is not recommended for children under 6 years of age and should be used with caution in those over 6 years. It can be used safely in the elderly, but some older patients may react more sensitively, so caution is necessary. There is no specific treatment for overdose, and general treatment will be provided based on symptoms. This medication should be kept out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), anaphylaxis, hypersensitivity reactions including rash and angioedema, hepatitis, thrombocytopenia, pancreatitis, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome), drug reaction with eosinophilia and systemic symptoms (DRESS), severe skin reactions including erythema multiforme (SCARs), drug-induced liver damage, urticaria, thrombocytopenia, skin manifestations

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infections
  • pharyngitis
  • sinusitis
  • arthralgia
  • low back pain
  • cough
  • chest pain
Show 26 more
  • dizziness
  • constipation
  • bloating
  • nausea
  • elevated AST
  • elevated ALT
  • myalgia
  • vomiting
  • gastritis
  • dry mouth
  • epigastric discomfort
  • belching
  • gastrointestinal disturbances
  • gastroesophageal reflux disease
  • tongue disorders
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • phlegm
  • runny nose
  • limb pain
  • diabetes
  • hypoglycemia
  • anemia
  • urticaria

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 sealed container. It is best stored at room temperature between 1 to 30 degrees Celsius. This will safely maintain the efficacy of the drug.

Appearance and packaging

Appearance

White to off-white oblong tablet

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.